Practice Economics

Chemotherapy has fallen out of favor for treating cancer toward the end of life. The toxicity is too high, and the benefit, if any, is often too low.

Immunotherapy, however, has been taking its place. Checkpoint inhibitors are increasingly being initiated to treat metastatic cancer in patients approaching the end of life and have become the leading driver of end-of-life cancer spending.

This means “there are patients who are getting immunotherapy who shouldn’t,” said Yale University, New Haven, Connecticut, surgical oncologist Sajid Khan, MD, senior investigator on a recent study that highlighted the growing use of these agents in patients’ last month of life.

What’s driving this trend, and how can oncologists avoid overtreatment with immunotherapy at the end of life?
 

The N-of-1 Patient

With immunotherapy at the end of life, “each of us has had our N-of-1” where a patient bounces back with a remarkable and durable response, said Don Dizon, MD, a gynecologic oncologist at Brown University, Providence, Rhode Island.

He recalled a patient with sarcoma who did not respond to chemotherapy. But after Dr. Dizon started her on immunotherapy, everything turned around. She has now been in remission for 8 years and counting.

The possibility of an unexpected or remarkable responder is seductive. And the improved safety of immunotherapy over chemotherapy adds to the allure.

Meanwhile, patients are often desperate. It’s rare for someone to be ready to stop treatment, Dr. Dizon said. Everybody “hopes that they’re going to be the exceptional responder.”

At the end of the day, the question often becomes: “Why not try immunotherapy? What’s there to lose?”

This thinking may be prompting broader use of immunotherapy in late-stage disease, even in instances with no Food and Drug Administration indication and virtually no supportive data, such as for metastatic ovarian cancer, Dr. Dizon said.
 

Back to Earth

The problem with the hopeful approach is that end-of-life turnarounds with immunotherapy are rare, and there’s no way at the moment to predict who will have one, said Laura Petrillo, MD, a palliative care physician at Massachusetts General Hospital, Boston.

Even though immunotherapy generally comes with fewer adverse events than chemotherapy, catastrophic side effects are still possible.

Dr. Petrillo recalled a 95-year-old woman with metastatic cancer who was largely asymptomatic.

She had a qualifying mutation for a checkpoint inhibitor, so her oncologist started her on one. The patient never bounced back from the severe colitis the agent caused, and she died of complications in the hospital.

Although such reactions with immunotherapy are uncommon, less serious problems caused by the agents can still have a major impact on a person’s quality of life. Low-grade diarrhea, for instance, may not sound too bad, but in a patient’s daily life, it can translate to six or more episodes a day.

Even with no side effects, prescribing immunotherapy can mean that patients with limited time left spend a good portion of it at an infusion clinic instead of at home. These patients are also less likely to be referred to hospice and more likely to be admitted to and die in the hospital.

And with treatments that can cost $20,000 per dose, financial toxicity becomes a big concern.

In short, some of the reasons why chemotherapy is not recommended at the end of life also apply to immunotherapy, Dr. Petrillo said.
 

Prescribing Decisions

Recent research highlights the growing use of immunotherapy at the end of life.

Dr. Khan’s retrospective study found, for instance, that the percentage of patients starting immunotherapy in the last 30 days of life increased by about fourfold to fivefold over the study period for the three cancers analyzed — stage IV melanoma, lung, and kidney cancers.

Among the population that died within 30 days, the percentage receiving immunotherapy increased over the study periods — 0.8%-4.3% for melanoma, 0.9%-3.2% for NSCLC, and 0.5%-2.6% for kidney cell carcinoma — prompting the conclusion that immunotherapy prescriptions in the last month of life are on the rise.

Prescribing immunotherapy in patients who ultimately died within 1 month occurred more frequently at low-volume, nonacademic centers than at academic or high-volume centers, and outcomes varied by practice setting.

Patients had better survival outcomes overall when receiving immunotherapy at academic or high-volume centers — a finding Dr. Khan said is worth investigating further. Possible explanations include better management of severe immune-related side effects at larger centers and more caution when prescribing immunotherapy to “borderline” candidates, such as those with several comorbidities.

Importantly, given the retrospective design, Dr. Khan and colleagues already knew which patients prescribed immunotherapy died within 30 days of initiating treatment.

More specifically, 5192 of 71,204 patients who received immunotherapy (7.3%) died within a month of initiating therapy, while 66,012 (92.7%) lived beyond that point.

The study, however, did not assess how the remaining 92.7% who lived beyond 30 days fared on immunotherapy and the differences between those who lived less than 30 days and those who survived longer.

Knowing the outcome of patients at the outset of the analysis still leaves open the question of when immunotherapy can extend life and when it can’t for the patient in front of you.

To avoid overtreating at the end of life, it’s important to have “the same standard that you have for giving chemotherapy. You have to treat it with the same respect,” said Moshe Chasky, MD, a community medical oncologist with Alliance Cancer Specialists in Philadelphia, Pennsylvania. “You can’t just be throwing” immunotherapy around “at the end of life.”

While there are no clear predictors of risk and benefit, there are some factors to help guide decisions.

As with chemotherapy, Dr. Petrillo said performance status is key. Dr. Petrillo and colleagues found that median overall survival with immune checkpoint inhibitors for advanced non–small cell lung cancer was 14.3 months in patients with an Eastern Cooperative Oncology Group performance score of 0-1 but only 4.5 months with scores of ≥ 2.

Dr. Khan also found that immunotherapy survival is, unsurprisingly, worse in patients with high metastatic burdens and more comorbidities.

“You should still consider immunotherapy for metastatic melanoma, non–small cell lung cancer, and renal cell carcinoma,” Dr. Khan said. The message here is to “think twice before using” it, especially in comorbid patients with widespread metastases.

“Just because something can be done doesn’t always mean it should be done,” he said.

At Yale, when Dr. Khan works, immunotherapy decisions are considered by a multidisciplinary tumor board. At Mass General, immunotherapy has generally moved to the frontline setting, and the hospital no longer prescribes checkpoint inhibitors to hospitalized patients because the cost is too high relative to the potential benefit, Dr. Petrillo explained.

Still, with all the uncertainties about risk and benefit, counseling patients is a challenge. Dr. Dizon called it “the epitome of shared decision-making.”

Dr. Petrillo noted that it’s critical not to counsel patients based solely on the anecdotal patients who do surprisingly well.

“It’s hard to mention that and not have that be what somebody anchors on,” she said. But that speaks to “how desperate people can feel, how hopeful they can be.”

Dr. Khan, Dr. Petrillo, and Dr. Chasky all reported no relevant conflicts of interest.

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

Chemotherapy has fallen out of favor for treating cancer toward the end of life. The toxicity is too high, and the benefit, if any, is often too low.

Immunotherapy, however, has been taking its place. Checkpoint inhibitors are increasingly being initiated to treat metastatic cancer in patients approaching the end of life and have become the leading driver of end-of-life cancer spending.

This means “there are patients who are getting immunotherapy who shouldn’t,” said Yale University, New Haven, Connecticut, surgical oncologist Sajid Khan, MD, senior investigator on a recent study that highlighted the growing use of these agents in patients’ last month of life.

What’s driving this trend, and how can oncologists avoid overtreatment with immunotherapy at the end of life?
 

The N-of-1 Patient

With immunotherapy at the end of life, “each of us has had our N-of-1” where a patient bounces back with a remarkable and durable response, said Don Dizon, MD, a gynecologic oncologist at Brown University, Providence, Rhode Island.

He recalled a patient with sarcoma who did not respond to chemotherapy. But after Dr. Dizon started her on immunotherapy, everything turned around. She has now been in remission for 8 years and counting.

The possibility of an unexpected or remarkable responder is seductive. And the improved safety of immunotherapy over chemotherapy adds to the allure.

Meanwhile, patients are often desperate. It’s rare for someone to be ready to stop treatment, Dr. Dizon said. Everybody “hopes that they’re going to be the exceptional responder.”

At the end of the day, the question often becomes: “Why not try immunotherapy? What’s there to lose?”

This thinking may be prompting broader use of immunotherapy in late-stage disease, even in instances with no Food and Drug Administration indication and virtually no supportive data, such as for metastatic ovarian cancer, Dr. Dizon said.
 

Back to Earth

The problem with the hopeful approach is that end-of-life turnarounds with immunotherapy are rare, and there’s no way at the moment to predict who will have one, said Laura Petrillo, MD, a palliative care physician at Massachusetts General Hospital, Boston.

Even though immunotherapy generally comes with fewer adverse events than chemotherapy, catastrophic side effects are still possible.

Dr. Petrillo recalled a 95-year-old woman with metastatic cancer who was largely asymptomatic.

She had a qualifying mutation for a checkpoint inhibitor, so her oncologist started her on one. The patient never bounced back from the severe colitis the agent caused, and she died of complications in the hospital.

Although such reactions with immunotherapy are uncommon, less serious problems caused by the agents can still have a major impact on a person’s quality of life. Low-grade diarrhea, for instance, may not sound too bad, but in a patient’s daily life, it can translate to six or more episodes a day.

Even with no side effects, prescribing immunotherapy can mean that patients with limited time left spend a good portion of it at an infusion clinic instead of at home. These patients are also less likely to be referred to hospice and more likely to be admitted to and die in the hospital.

And with treatments that can cost $20,000 per dose, financial toxicity becomes a big concern.

In short, some of the reasons why chemotherapy is not recommended at the end of life also apply to immunotherapy, Dr. Petrillo said.
 

Prescribing Decisions

Recent research highlights the growing use of immunotherapy at the end of life.

Dr. Khan’s retrospective study found, for instance, that the percentage of patients starting immunotherapy in the last 30 days of life increased by about fourfold to fivefold over the study period for the three cancers analyzed — stage IV melanoma, lung, and kidney cancers.

Among the population that died within 30 days, the percentage receiving immunotherapy increased over the study periods — 0.8%-4.3% for melanoma, 0.9%-3.2% for NSCLC, and 0.5%-2.6% for kidney cell carcinoma — prompting the conclusion that immunotherapy prescriptions in the last month of life are on the rise.

Prescribing immunotherapy in patients who ultimately died within 1 month occurred more frequently at low-volume, nonacademic centers than at academic or high-volume centers, and outcomes varied by practice setting.

Patients had better survival outcomes overall when receiving immunotherapy at academic or high-volume centers — a finding Dr. Khan said is worth investigating further. Possible explanations include better management of severe immune-related side effects at larger centers and more caution when prescribing immunotherapy to “borderline” candidates, such as those with several comorbidities.

Importantly, given the retrospective design, Dr. Khan and colleagues already knew which patients prescribed immunotherapy died within 30 days of initiating treatment.

More specifically, 5192 of 71,204 patients who received immunotherapy (7.3%) died within a month of initiating therapy, while 66,012 (92.7%) lived beyond that point.

The study, however, did not assess how the remaining 92.7% who lived beyond 30 days fared on immunotherapy and the differences between those who lived less than 30 days and those who survived longer.

Knowing the outcome of patients at the outset of the analysis still leaves open the question of when immunotherapy can extend life and when it can’t for the patient in front of you.

To avoid overtreating at the end of life, it’s important to have “the same standard that you have for giving chemotherapy. You have to treat it with the same respect,” said Moshe Chasky, MD, a community medical oncologist with Alliance Cancer Specialists in Philadelphia, Pennsylvania. “You can’t just be throwing” immunotherapy around “at the end of life.”

While there are no clear predictors of risk and benefit, there are some factors to help guide decisions.

As with chemotherapy, Dr. Petrillo said performance status is key. Dr. Petrillo and colleagues found that median overall survival with immune checkpoint inhibitors for advanced non–small cell lung cancer was 14.3 months in patients with an Eastern Cooperative Oncology Group performance score of 0-1 but only 4.5 months with scores of ≥ 2.

Dr. Khan also found that immunotherapy survival is, unsurprisingly, worse in patients with high metastatic burdens and more comorbidities.

“You should still consider immunotherapy for metastatic melanoma, non–small cell lung cancer, and renal cell carcinoma,” Dr. Khan said. The message here is to “think twice before using” it, especially in comorbid patients with widespread metastases.

“Just because something can be done doesn’t always mean it should be done,” he said.

At Yale, when Dr. Khan works, immunotherapy decisions are considered by a multidisciplinary tumor board. At Mass General, immunotherapy has generally moved to the frontline setting, and the hospital no longer prescribes checkpoint inhibitors to hospitalized patients because the cost is too high relative to the potential benefit, Dr. Petrillo explained.

Still, with all the uncertainties about risk and benefit, counseling patients is a challenge. Dr. Dizon called it “the epitome of shared decision-making.”

Dr. Petrillo noted that it’s critical not to counsel patients based solely on the anecdotal patients who do surprisingly well.

“It’s hard to mention that and not have that be what somebody anchors on,” she said. But that speaks to “how desperate people can feel, how hopeful they can be.”

Dr. Khan, Dr. Petrillo, and Dr. Chasky all reported no relevant conflicts of interest.

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

Chemotherapy has fallen out of favor for treating cancer toward the end of life. The toxicity is too high, and the benefit, if any, is often too low.

Immunotherapy, however, has been taking its place. Checkpoint inhibitors are increasingly being initiated to treat metastatic cancer in patients approaching the end of life and have become the leading driver of end-of-life cancer spending.

This means “there are patients who are getting immunotherapy who shouldn’t,” said Yale University, New Haven, Connecticut, surgical oncologist Sajid Khan, MD, senior investigator on a recent study that highlighted the growing use of these agents in patients’ last month of life.

What’s driving this trend, and how can oncologists avoid overtreatment with immunotherapy at the end of life?
 

The N-of-1 Patient

With immunotherapy at the end of life, “each of us has had our N-of-1” where a patient bounces back with a remarkable and durable response, said Don Dizon, MD, a gynecologic oncologist at Brown University, Providence, Rhode Island.

He recalled a patient with sarcoma who did not respond to chemotherapy. But after Dr. Dizon started her on immunotherapy, everything turned around. She has now been in remission for 8 years and counting.

The possibility of an unexpected or remarkable responder is seductive. And the improved safety of immunotherapy over chemotherapy adds to the allure.

Meanwhile, patients are often desperate. It’s rare for someone to be ready to stop treatment, Dr. Dizon said. Everybody “hopes that they’re going to be the exceptional responder.”

At the end of the day, the question often becomes: “Why not try immunotherapy? What’s there to lose?”

This thinking may be prompting broader use of immunotherapy in late-stage disease, even in instances with no Food and Drug Administration indication and virtually no supportive data, such as for metastatic ovarian cancer, Dr. Dizon said.
 

Back to Earth

The problem with the hopeful approach is that end-of-life turnarounds with immunotherapy are rare, and there’s no way at the moment to predict who will have one, said Laura Petrillo, MD, a palliative care physician at Massachusetts General Hospital, Boston.

Even though immunotherapy generally comes with fewer adverse events than chemotherapy, catastrophic side effects are still possible.

Dr. Petrillo recalled a 95-year-old woman with metastatic cancer who was largely asymptomatic.

She had a qualifying mutation for a checkpoint inhibitor, so her oncologist started her on one. The patient never bounced back from the severe colitis the agent caused, and she died of complications in the hospital.

Although such reactions with immunotherapy are uncommon, less serious problems caused by the agents can still have a major impact on a person’s quality of life. Low-grade diarrhea, for instance, may not sound too bad, but in a patient’s daily life, it can translate to six or more episodes a day.

Even with no side effects, prescribing immunotherapy can mean that patients with limited time left spend a good portion of it at an infusion clinic instead of at home. These patients are also less likely to be referred to hospice and more likely to be admitted to and die in the hospital.

And with treatments that can cost $20,000 per dose, financial toxicity becomes a big concern.

In short, some of the reasons why chemotherapy is not recommended at the end of life also apply to immunotherapy, Dr. Petrillo said.
 

Prescribing Decisions

Recent research highlights the growing use of immunotherapy at the end of life.

Dr. Khan’s retrospective study found, for instance, that the percentage of patients starting immunotherapy in the last 30 days of life increased by about fourfold to fivefold over the study period for the three cancers analyzed — stage IV melanoma, lung, and kidney cancers.

Among the population that died within 30 days, the percentage receiving immunotherapy increased over the study periods — 0.8%-4.3% for melanoma, 0.9%-3.2% for NSCLC, and 0.5%-2.6% for kidney cell carcinoma — prompting the conclusion that immunotherapy prescriptions in the last month of life are on the rise.

Prescribing immunotherapy in patients who ultimately died within 1 month occurred more frequently at low-volume, nonacademic centers than at academic or high-volume centers, and outcomes varied by practice setting.

Patients had better survival outcomes overall when receiving immunotherapy at academic or high-volume centers — a finding Dr. Khan said is worth investigating further. Possible explanations include better management of severe immune-related side effects at larger centers and more caution when prescribing immunotherapy to “borderline” candidates, such as those with several comorbidities.

Importantly, given the retrospective design, Dr. Khan and colleagues already knew which patients prescribed immunotherapy died within 30 days of initiating treatment.

More specifically, 5192 of 71,204 patients who received immunotherapy (7.3%) died within a month of initiating therapy, while 66,012 (92.7%) lived beyond that point.

The study, however, did not assess how the remaining 92.7% who lived beyond 30 days fared on immunotherapy and the differences between those who lived less than 30 days and those who survived longer.

Knowing the outcome of patients at the outset of the analysis still leaves open the question of when immunotherapy can extend life and when it can’t for the patient in front of you.

To avoid overtreating at the end of life, it’s important to have “the same standard that you have for giving chemotherapy. You have to treat it with the same respect,” said Moshe Chasky, MD, a community medical oncologist with Alliance Cancer Specialists in Philadelphia, Pennsylvania. “You can’t just be throwing” immunotherapy around “at the end of life.”

While there are no clear predictors of risk and benefit, there are some factors to help guide decisions.

As with chemotherapy, Dr. Petrillo said performance status is key. Dr. Petrillo and colleagues found that median overall survival with immune checkpoint inhibitors for advanced non–small cell lung cancer was 14.3 months in patients with an Eastern Cooperative Oncology Group performance score of 0-1 but only 4.5 months with scores of ≥ 2.

Dr. Khan also found that immunotherapy survival is, unsurprisingly, worse in patients with high metastatic burdens and more comorbidities.

“You should still consider immunotherapy for metastatic melanoma, non–small cell lung cancer, and renal cell carcinoma,” Dr. Khan said. The message here is to “think twice before using” it, especially in comorbid patients with widespread metastases.

“Just because something can be done doesn’t always mean it should be done,” he said.

At Yale, when Dr. Khan works, immunotherapy decisions are considered by a multidisciplinary tumor board. At Mass General, immunotherapy has generally moved to the frontline setting, and the hospital no longer prescribes checkpoint inhibitors to hospitalized patients because the cost is too high relative to the potential benefit, Dr. Petrillo explained.

Still, with all the uncertainties about risk and benefit, counseling patients is a challenge. Dr. Dizon called it “the epitome of shared decision-making.”

Dr. Petrillo noted that it’s critical not to counsel patients based solely on the anecdotal patients who do surprisingly well.

“It’s hard to mention that and not have that be what somebody anchors on,” she said. But that speaks to “how desperate people can feel, how hopeful they can be.”

Dr. Khan, Dr. Petrillo, and Dr. Chasky all reported no relevant conflicts of interest.

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

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.

This fall, the Supreme Court of the United States (SCOTUS) will announce when they will hear oral arguments for Dobbs v Jackson Women’s Health Organization. The court will examine a Mississippi law, known as the “Gestational Age Act,” originally passed in 2018, that sought to “limit abortions to fifteen weeks’ gestation except in a medical emergency or in cases of severe fetal abnormality.”¹ This sets the stage for SCOTUS to make a major ruling on abortion, one which could affirm or upend landmark decisions and nearly 50 years of abortion legislative precedent. Additionally, SCOTUS’ recent decision to not intervene on Texas’ Senate Bill 8 (SB8), which essentially bans all abortions after 6 weeks’ gestational age, may foreshadow how this case will be decided. The current abortion restrictions in Texas and the implications of SB8 will be discussed in a forthcoming column.

SCOTUS and abortion rights

The decision to hear this case comes on the heels of another recent decision regarding a Louisiana law in June Medical Services v Russo. This case examined Louisiana Act 620, which would have required physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.² The law was deemed constitutionally invalid, with the majority noting the law would have drastically burdened a woman’s right to access abortion services. The Court ruled similarly in 2016 in Whole Women’s Health (WWH) v Hellerstedt, in which WWH challenged Texas House Bill 2, a nearly identical law requiring admitting privileges for abortion care providers. In both of these cases, SCOTUS pointed to precedent set by Southeastern Pennsylvania v Casey, which established that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ The precedent to this, Roe v Wade, and 5 decades of abortion legislation set may be upended by a SCOTUS decision this next term.

Dobbs v Jackson

On March 19, 2018, Mississippi enacted the “Gestational Age Act” into law. The newly enacted law would limit abortions to 15 weeks’ gestation except in a medical emergency or in cases of severe fetal anomalies. Jackson Women’s Health Organization, the only licensed abortion provider in the state, challenged the constitutionality of the law with legal support from Center for Reproductive Rights (CRR). The US District Court for the Southern District of Mississippi granted summary judgement in favor of the clinic and placed an injunction on the law’s enforcement. The state appealed to the Fifth Circuit Court of Appeals, which upheld the district court decision in a 3-0 decision in November 2019. Mississippi appealed to the Supreme Court, with their petition focusing on multiple questions from the appeals process. After repeatedly rescheduling the case, and multiple reviews in conference, SCOTUS agreed to hear the case. Most recently, the state has narrowed its argument, changing course, and attacking Roe v Wade directly. In a brief submitted in July 2021, the state argues the court should hold that all pre-viability prohibitions on elective abortions are constitutional.

Interestingly, during this time the Mississippi legislature also passed a law, House Bill 2116, also known as the “fetal heartbeat bill,” banning abortion with gestational ages after detection of a fetal heartbeat. This was also challenged, deemed unconstitutional, and affirmed on appeal by the Fifth US Circuit Court.

While recent challenges have focused on the “undue burden” state laws placed on those trying to access abortion care, this case will bring the issue of “viability” and gestational age limits to the forefront.^4,5 In addition to Roe v Wade, the Court will have the opportunity to reexamine other relevant precedent, such as Southeastern Pennsylvania v Casey, in considering the most recent arguments of the state. In this most recent brief, the state argues that the Court should, “reject viability as a barrier to prohibiting elective abortions” and that a “viability rule has no constitutional basis.” The state goes on to argue the “Constitution does not protect a right to abortion or limit States’ authority to restrict it.”⁶ The language and tone in this brief are more direct and aggressive than the states’ petition submitted last June.

However, the composition of the Court is different than in the past. This case will be argued with Justice Amy Coney Barrett seated in place of Justice Ruth Bader Ginsburg, who was a strong advocate for women’s rights.⁷ She joins Justices Neil Gorsuch and Brett Kavanaugh, also appointed by President Donald Trump and widely viewed as conservative judges, tipping the scales to a more conservative Supreme Court. This case will also be argued in a polarized political environment.^8,9 Given the conservative Supreme Court in the setting of an increasingly politically charged environment, reproductive right advocates are understandably worried that members of the anti-abortion movement view this as an opportunity to weaken or remove federal constitutional protections for abortion.

Continue to: Potential outcome of Dobbs v Jackson...

Should SCOTUS choose to rule in favor of Mississippi, it could severely weaken, or even overturn Roe v Wade. This would leave a legal path for states with pre-Roe abortion bans and currently unenforced post-Roe bans to take effect. These “trigger” laws are bans or severe restrictions on abortion providers and patients intended to take effect if Roe were to be overturned. Alternatively, the Court may overturn Southeastern Pennsylvania v Casey, but maintain Roe v Wade, essentially leaving the regulation of pre-viability abortion care to individual states. Currently 21 states have laws that would restrict the legal status of abortion.¹⁰ In addition, state legislatures are aggressively introducing abortion restrictions. As of June 2021, there have been 561 abortion restrictions, including 165 abortion bans, introduced across 47 states, putting 2021 on course to be the most devastating anti-abortion state legislative session in decades.¹¹

The damage caused by such restriction on abortion care would be significant. It would block or push access out of reach for many. The negative effects of such legislative action would most heavily burden those already marginalized by systemic, structural inequalities including those of low socioeconomic status, people of color, young people, those in rural communities, and members of the LGBTQ community. The medical community has long recognized the harm caused by restricting access to abortion care. Restriction of access to safe abortion care paradoxically has been shown not to decrease the incidence of abortion, but rather increases the number of unsafe abortions.¹² The American College of Obstetricians and Gynecologists (ACOG) acknowledge “individuals require access to safe, legal abortion” and that this represents “a necessary component for comprehensive health care.”^13,14 They joined the American Medical Association and other professional groups in a 2019 amicus brief to SCOTUS opposing restrictions on abortion access.¹⁵ In addition, government laws restricting access to abortion care undermine the fundamental relationship between a person and their physician, limiting a physician’s obligation to honor patient autonomy and provide appropriate medical care.

By taking up the question whether all pre-viability bans on elective abortions violate the Constitution, SCOTUS is indicating a possible willingness to revisit the central holding of abortion jurisprudence. Their decision regarding this case will likely be the most significant ruling regarding the legal status of abortion care in decades, and will significantly affect the delivery of abortion care in the future.

Action items

• Reach out to your representatives to support the Women’s Health Protection Act, an initiative introduced to Congress to protect access to abortion care. If you reside in a state where your federal representatives support the Women’s Health Protection Act, reach out to friends and colleagues in states without supportive elected officials and ask them to call their representatives and ask them to support the bill.
• Get involved with local grassroots groups fighting to protect abortion access.
• Continue to speak out against laws and policies designed to limit access to safe abortion care.
• Connect with your local ACOG chapter for more ways to become involved.
• As always, make sure you are registered to vote, and exercise your right whenever you can.

This fall, the Supreme Court of the United States (SCOTUS) will announce when they will hear oral arguments for Dobbs v Jackson Women’s Health Organization. The court will examine a Mississippi law, known as the “Gestational Age Act,” originally passed in 2018, that sought to “limit abortions to fifteen weeks’ gestation except in a medical emergency or in cases of severe fetal abnormality.”¹ This sets the stage for SCOTUS to make a major ruling on abortion, one which could affirm or upend landmark decisions and nearly 50 years of abortion legislative precedent. Additionally, SCOTUS’ recent decision to not intervene on Texas’ Senate Bill 8 (SB8), which essentially bans all abortions after 6 weeks’ gestational age, may foreshadow how this case will be decided. The current abortion restrictions in Texas and the implications of SB8 will be discussed in a forthcoming column.

SCOTUS and abortion rights

The decision to hear this case comes on the heels of another recent decision regarding a Louisiana law in June Medical Services v Russo. This case examined Louisiana Act 620, which would have required physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.² The law was deemed constitutionally invalid, with the majority noting the law would have drastically burdened a woman’s right to access abortion services. The Court ruled similarly in 2016 in Whole Women’s Health (WWH) v Hellerstedt, in which WWH challenged Texas House Bill 2, a nearly identical law requiring admitting privileges for abortion care providers. In both of these cases, SCOTUS pointed to precedent set by Southeastern Pennsylvania v Casey, which established that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ The precedent to this, Roe v Wade, and 5 decades of abortion legislation set may be upended by a SCOTUS decision this next term.

Dobbs v Jackson

On March 19, 2018, Mississippi enacted the “Gestational Age Act” into law. The newly enacted law would limit abortions to 15 weeks’ gestation except in a medical emergency or in cases of severe fetal anomalies. Jackson Women’s Health Organization, the only licensed abortion provider in the state, challenged the constitutionality of the law with legal support from Center for Reproductive Rights (CRR). The US District Court for the Southern District of Mississippi granted summary judgement in favor of the clinic and placed an injunction on the law’s enforcement. The state appealed to the Fifth Circuit Court of Appeals, which upheld the district court decision in a 3-0 decision in November 2019. Mississippi appealed to the Supreme Court, with their petition focusing on multiple questions from the appeals process. After repeatedly rescheduling the case, and multiple reviews in conference, SCOTUS agreed to hear the case. Most recently, the state has narrowed its argument, changing course, and attacking Roe v Wade directly. In a brief submitted in July 2021, the state argues the court should hold that all pre-viability prohibitions on elective abortions are constitutional.

Interestingly, during this time the Mississippi legislature also passed a law, House Bill 2116, also known as the “fetal heartbeat bill,” banning abortion with gestational ages after detection of a fetal heartbeat. This was also challenged, deemed unconstitutional, and affirmed on appeal by the Fifth US Circuit Court.

While recent challenges have focused on the “undue burden” state laws placed on those trying to access abortion care, this case will bring the issue of “viability” and gestational age limits to the forefront.^4,5 In addition to Roe v Wade, the Court will have the opportunity to reexamine other relevant precedent, such as Southeastern Pennsylvania v Casey, in considering the most recent arguments of the state. In this most recent brief, the state argues that the Court should, “reject viability as a barrier to prohibiting elective abortions” and that a “viability rule has no constitutional basis.” The state goes on to argue the “Constitution does not protect a right to abortion or limit States’ authority to restrict it.”⁶ The language and tone in this brief are more direct and aggressive than the states’ petition submitted last June.

However, the composition of the Court is different than in the past. This case will be argued with Justice Amy Coney Barrett seated in place of Justice Ruth Bader Ginsburg, who was a strong advocate for women’s rights.⁷ She joins Justices Neil Gorsuch and Brett Kavanaugh, also appointed by President Donald Trump and widely viewed as conservative judges, tipping the scales to a more conservative Supreme Court. This case will also be argued in a polarized political environment.^8,9 Given the conservative Supreme Court in the setting of an increasingly politically charged environment, reproductive right advocates are understandably worried that members of the anti-abortion movement view this as an opportunity to weaken or remove federal constitutional protections for abortion.

Continue to: Potential outcome of Dobbs v Jackson...

Should SCOTUS choose to rule in favor of Mississippi, it could severely weaken, or even overturn Roe v Wade. This would leave a legal path for states with pre-Roe abortion bans and currently unenforced post-Roe bans to take effect. These “trigger” laws are bans or severe restrictions on abortion providers and patients intended to take effect if Roe were to be overturned. Alternatively, the Court may overturn Southeastern Pennsylvania v Casey, but maintain Roe v Wade, essentially leaving the regulation of pre-viability abortion care to individual states. Currently 21 states have laws that would restrict the legal status of abortion.¹⁰ In addition, state legislatures are aggressively introducing abortion restrictions. As of June 2021, there have been 561 abortion restrictions, including 165 abortion bans, introduced across 47 states, putting 2021 on course to be the most devastating anti-abortion state legislative session in decades.¹¹

The damage caused by such restriction on abortion care would be significant. It would block or push access out of reach for many. The negative effects of such legislative action would most heavily burden those already marginalized by systemic, structural inequalities including those of low socioeconomic status, people of color, young people, those in rural communities, and members of the LGBTQ community. The medical community has long recognized the harm caused by restricting access to abortion care. Restriction of access to safe abortion care paradoxically has been shown not to decrease the incidence of abortion, but rather increases the number of unsafe abortions.¹² The American College of Obstetricians and Gynecologists (ACOG) acknowledge “individuals require access to safe, legal abortion” and that this represents “a necessary component for comprehensive health care.”^13,14 They joined the American Medical Association and other professional groups in a 2019 amicus brief to SCOTUS opposing restrictions on abortion access.¹⁵ In addition, government laws restricting access to abortion care undermine the fundamental relationship between a person and their physician, limiting a physician’s obligation to honor patient autonomy and provide appropriate medical care.

By taking up the question whether all pre-viability bans on elective abortions violate the Constitution, SCOTUS is indicating a possible willingness to revisit the central holding of abortion jurisprudence. Their decision regarding this case will likely be the most significant ruling regarding the legal status of abortion care in decades, and will significantly affect the delivery of abortion care in the future.

Action items

• Reach out to your representatives to support the Women’s Health Protection Act, an initiative introduced to Congress to protect access to abortion care. If you reside in a state where your federal representatives support the Women’s Health Protection Act, reach out to friends and colleagues in states without supportive elected officials and ask them to call their representatives and ask them to support the bill.
• Get involved with local grassroots groups fighting to protect abortion access.
• Continue to speak out against laws and policies designed to limit access to safe abortion care.
• Connect with your local ACOG chapter for more ways to become involved.
• As always, make sure you are registered to vote, and exercise your right whenever you can.

This fall, the Supreme Court of the United States (SCOTUS) will announce when they will hear oral arguments for Dobbs v Jackson Women’s Health Organization. The court will examine a Mississippi law, known as the “Gestational Age Act,” originally passed in 2018, that sought to “limit abortions to fifteen weeks’ gestation except in a medical emergency or in cases of severe fetal abnormality.”¹ This sets the stage for SCOTUS to make a major ruling on abortion, one which could affirm or upend landmark decisions and nearly 50 years of abortion legislative precedent. Additionally, SCOTUS’ recent decision to not intervene on Texas’ Senate Bill 8 (SB8), which essentially bans all abortions after 6 weeks’ gestational age, may foreshadow how this case will be decided. The current abortion restrictions in Texas and the implications of SB8 will be discussed in a forthcoming column.

SCOTUS and abortion rights

The decision to hear this case comes on the heels of another recent decision regarding a Louisiana law in June Medical Services v Russo. This case examined Louisiana Act 620, which would have required physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.² The law was deemed constitutionally invalid, with the majority noting the law would have drastically burdened a woman’s right to access abortion services. The Court ruled similarly in 2016 in Whole Women’s Health (WWH) v Hellerstedt, in which WWH challenged Texas House Bill 2, a nearly identical law requiring admitting privileges for abortion care providers. In both of these cases, SCOTUS pointed to precedent set by Southeastern Pennsylvania v Casey, which established that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ The precedent to this, Roe v Wade, and 5 decades of abortion legislation set may be upended by a SCOTUS decision this next term.

Dobbs v Jackson

On March 19, 2018, Mississippi enacted the “Gestational Age Act” into law. The newly enacted law would limit abortions to 15 weeks’ gestation except in a medical emergency or in cases of severe fetal anomalies. Jackson Women’s Health Organization, the only licensed abortion provider in the state, challenged the constitutionality of the law with legal support from Center for Reproductive Rights (CRR). The US District Court for the Southern District of Mississippi granted summary judgement in favor of the clinic and placed an injunction on the law’s enforcement. The state appealed to the Fifth Circuit Court of Appeals, which upheld the district court decision in a 3-0 decision in November 2019. Mississippi appealed to the Supreme Court, with their petition focusing on multiple questions from the appeals process. After repeatedly rescheduling the case, and multiple reviews in conference, SCOTUS agreed to hear the case. Most recently, the state has narrowed its argument, changing course, and attacking Roe v Wade directly. In a brief submitted in July 2021, the state argues the court should hold that all pre-viability prohibitions on elective abortions are constitutional.

Interestingly, during this time the Mississippi legislature also passed a law, House Bill 2116, also known as the “fetal heartbeat bill,” banning abortion with gestational ages after detection of a fetal heartbeat. This was also challenged, deemed unconstitutional, and affirmed on appeal by the Fifth US Circuit Court.

While recent challenges have focused on the “undue burden” state laws placed on those trying to access abortion care, this case will bring the issue of “viability” and gestational age limits to the forefront.^4,5 In addition to Roe v Wade, the Court will have the opportunity to reexamine other relevant precedent, such as Southeastern Pennsylvania v Casey, in considering the most recent arguments of the state. In this most recent brief, the state argues that the Court should, “reject viability as a barrier to prohibiting elective abortions” and that a “viability rule has no constitutional basis.” The state goes on to argue the “Constitution does not protect a right to abortion or limit States’ authority to restrict it.”⁶ The language and tone in this brief are more direct and aggressive than the states’ petition submitted last June.

However, the composition of the Court is different than in the past. This case will be argued with Justice Amy Coney Barrett seated in place of Justice Ruth Bader Ginsburg, who was a strong advocate for women’s rights.⁷ She joins Justices Neil Gorsuch and Brett Kavanaugh, also appointed by President Donald Trump and widely viewed as conservative judges, tipping the scales to a more conservative Supreme Court. This case will also be argued in a polarized political environment.^8,9 Given the conservative Supreme Court in the setting of an increasingly politically charged environment, reproductive right advocates are understandably worried that members of the anti-abortion movement view this as an opportunity to weaken or remove federal constitutional protections for abortion.

Continue to: Potential outcome of Dobbs v Jackson...

Should SCOTUS choose to rule in favor of Mississippi, it could severely weaken, or even overturn Roe v Wade. This would leave a legal path for states with pre-Roe abortion bans and currently unenforced post-Roe bans to take effect. These “trigger” laws are bans or severe restrictions on abortion providers and patients intended to take effect if Roe were to be overturned. Alternatively, the Court may overturn Southeastern Pennsylvania v Casey, but maintain Roe v Wade, essentially leaving the regulation of pre-viability abortion care to individual states. Currently 21 states have laws that would restrict the legal status of abortion.¹⁰ In addition, state legislatures are aggressively introducing abortion restrictions. As of June 2021, there have been 561 abortion restrictions, including 165 abortion bans, introduced across 47 states, putting 2021 on course to be the most devastating anti-abortion state legislative session in decades.¹¹

The damage caused by such restriction on abortion care would be significant. It would block or push access out of reach for many. The negative effects of such legislative action would most heavily burden those already marginalized by systemic, structural inequalities including those of low socioeconomic status, people of color, young people, those in rural communities, and members of the LGBTQ community. The medical community has long recognized the harm caused by restricting access to abortion care. Restriction of access to safe abortion care paradoxically has been shown not to decrease the incidence of abortion, but rather increases the number of unsafe abortions.¹² The American College of Obstetricians and Gynecologists (ACOG) acknowledge “individuals require access to safe, legal abortion” and that this represents “a necessary component for comprehensive health care.”^13,14 They joined the American Medical Association and other professional groups in a 2019 amicus brief to SCOTUS opposing restrictions on abortion access.¹⁵ In addition, government laws restricting access to abortion care undermine the fundamental relationship between a person and their physician, limiting a physician’s obligation to honor patient autonomy and provide appropriate medical care.

By taking up the question whether all pre-viability bans on elective abortions violate the Constitution, SCOTUS is indicating a possible willingness to revisit the central holding of abortion jurisprudence. Their decision regarding this case will likely be the most significant ruling regarding the legal status of abortion care in decades, and will significantly affect the delivery of abortion care in the future.

Action items

• Reach out to your representatives to support the Women’s Health Protection Act, an initiative introduced to Congress to protect access to abortion care. If you reside in a state where your federal representatives support the Women’s Health Protection Act, reach out to friends and colleagues in states without supportive elected officials and ask them to call their representatives and ask them to support the bill.
• Get involved with local grassroots groups fighting to protect abortion access.
• Continue to speak out against laws and policies designed to limit access to safe abortion care.
• Connect with your local ACOG chapter for more ways to become involved.
• As always, make sure you are registered to vote, and exercise your right whenever you can.

The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

The decline in the number of cosmetic procedures performed in 2020, compared with 2019, very closely matched the amount of the time lost to physicians because of the COVID-19 pandemic, according to the American Society of Plastic Surgeons.

There were an estimated 15.6 million cosmetic procedures performed in 2020, compared with 18.4 million in 2019, a drop of 15.2%. Meanwhile, society members reported that they stopped performing elective surgery for an average of 8.1 weeks, which works out to 15.6% of a 52-week year, the ASPS said in its annual statistics report.

“The pandemic isn’t over, but thanks to vaccines, a new normal is starting to define itself – and some surgeons’ offices that were closed or offered only limited services within the last year are seeing higher demand,” Lynn Jeffers, MD, MBA, immediate past president of the ASPS, said in a written statement.

Minimally invasive procedures, which made up the majority of cosmetic procedures in 2020, dropped by a slightly higher 16%, compared with 14% on the surgical side. “Injectables continued to be the most sought-after treatments in 2020,” the ASPS said, with survey respondents citing “a significant uptick in demand during the coronavirus pandemic.”

OnabotuliumtoxinA injection, the most popular form of minimally invasive procedure, was down by 13% from 2019, while use of soft-tissue fillers fell by 11%. Laser skin resurfacing was third in popularity and had the smallest drop, just 8%, among the top five from 2019 to 2020, the ASPS data show.

The drop in volume for chemical peels was large enough (33%), to move it from third place in 2019 to fourth in 2020, and a slightly less than average drop of 12% moved intense pulsed-light treatments from sixth place in 2019 to fifth in 2020, switching places with laser hair removal (down 28%), the ASPS reported.

Among the surgical procedures, rhinoplasty was the most popular in 2020, as it was in 2019, after dropping by just 3%. Blepharoplasty was down by 8% from 2019, but two other common procedures, liposuction and breast augmentation, fell by 20% and 33%, respectively, the ASPS said.

rfranki@mdedge.com

The decline in the number of cosmetic procedures performed in 2020, compared with 2019, very closely matched the amount of the time lost to physicians because of the COVID-19 pandemic, according to the American Society of Plastic Surgeons.

There were an estimated 15.6 million cosmetic procedures performed in 2020, compared with 18.4 million in 2019, a drop of 15.2%. Meanwhile, society members reported that they stopped performing elective surgery for an average of 8.1 weeks, which works out to 15.6% of a 52-week year, the ASPS said in its annual statistics report.

“The pandemic isn’t over, but thanks to vaccines, a new normal is starting to define itself – and some surgeons’ offices that were closed or offered only limited services within the last year are seeing higher demand,” Lynn Jeffers, MD, MBA, immediate past president of the ASPS, said in a written statement.

Minimally invasive procedures, which made up the majority of cosmetic procedures in 2020, dropped by a slightly higher 16%, compared with 14% on the surgical side. “Injectables continued to be the most sought-after treatments in 2020,” the ASPS said, with survey respondents citing “a significant uptick in demand during the coronavirus pandemic.”

OnabotuliumtoxinA injection, the most popular form of minimally invasive procedure, was down by 13% from 2019, while use of soft-tissue fillers fell by 11%. Laser skin resurfacing was third in popularity and had the smallest drop, just 8%, among the top five from 2019 to 2020, the ASPS data show.

The drop in volume for chemical peels was large enough (33%), to move it from third place in 2019 to fourth in 2020, and a slightly less than average drop of 12% moved intense pulsed-light treatments from sixth place in 2019 to fifth in 2020, switching places with laser hair removal (down 28%), the ASPS reported.

Among the surgical procedures, rhinoplasty was the most popular in 2020, as it was in 2019, after dropping by just 3%. Blepharoplasty was down by 8% from 2019, but two other common procedures, liposuction and breast augmentation, fell by 20% and 33%, respectively, the ASPS said.

rfranki@mdedge.com

The decline in the number of cosmetic procedures performed in 2020, compared with 2019, very closely matched the amount of the time lost to physicians because of the COVID-19 pandemic, according to the American Society of Plastic Surgeons.

There were an estimated 15.6 million cosmetic procedures performed in 2020, compared with 18.4 million in 2019, a drop of 15.2%. Meanwhile, society members reported that they stopped performing elective surgery for an average of 8.1 weeks, which works out to 15.6% of a 52-week year, the ASPS said in its annual statistics report.

“The pandemic isn’t over, but thanks to vaccines, a new normal is starting to define itself – and some surgeons’ offices that were closed or offered only limited services within the last year are seeing higher demand,” Lynn Jeffers, MD, MBA, immediate past president of the ASPS, said in a written statement.

Minimally invasive procedures, which made up the majority of cosmetic procedures in 2020, dropped by a slightly higher 16%, compared with 14% on the surgical side. “Injectables continued to be the most sought-after treatments in 2020,” the ASPS said, with survey respondents citing “a significant uptick in demand during the coronavirus pandemic.”

OnabotuliumtoxinA injection, the most popular form of minimally invasive procedure, was down by 13% from 2019, while use of soft-tissue fillers fell by 11%. Laser skin resurfacing was third in popularity and had the smallest drop, just 8%, among the top five from 2019 to 2020, the ASPS data show.

The drop in volume for chemical peels was large enough (33%), to move it from third place in 2019 to fourth in 2020, and a slightly less than average drop of 12% moved intense pulsed-light treatments from sixth place in 2019 to fifth in 2020, switching places with laser hair removal (down 28%), the ASPS reported.

Among the surgical procedures, rhinoplasty was the most popular in 2020, as it was in 2019, after dropping by just 3%. Blepharoplasty was down by 8% from 2019, but two other common procedures, liposuction and breast augmentation, fell by 20% and 33%, respectively, the ASPS said.

rfranki@mdedge.com

Retail Health Clinics (RHCs) are health care facilities located in high-traffic retail outlets with adjacent pharmacies that are intended to provide convenient and affordable care without sacrificing quality. The clinics add an option that complements services to individuals and families who otherwise would need to wait for an appointment with a traditional primary care physician or provider.¹ Appointments are not necessary for episodic health needs. Usually open 7 days a week, RHCs offer extended hours on weekdays.²

The clinics are staffed by licensed, qualified advance practice providers, such as nurse practitioners and physician assistants, who are supervised by family physicians where required by state law. These clinicians have advanced education to diagnose, treat, and prescribe for nonemergent ailments such as colds and flu, rashes and skin irritation, and muscle strains or sprains.³ They are supported by an electronic health record that contains established evidence-based protocols.^2,4

Evolution of retail health clinics

The first RHC, operated by QuickMedx, opened its doors in 2000 in Minneapolis– St. Paul.^1,5 Only patients with a very limited number of illnesses were seen, and payment was cash. In 2005, this clinic was acquired by a major pharmacy retailer, which led to several acquisitions by other retailers and health care systems. In addition to accepting cash for a visit, the clinics formed contracts with health insurance companies. The average cost of a visit to an RHC in 2016 was estimated to be $70, considerably less than the cost at urgent care clinics ($124) and emergency rooms ($356).⁶

Today, more than 20 companies provide health care services at RHCs (TABLE 1). CVS (MinuteClinic) has the most retail clinics, followed by Walgreens, Kroger, Rite Aid, and Zoom+Care.^1,2 There are now about 3,300 clinics in the United States, Canada, and Mexico (nearly all are located in the United States).² Currently, RHCs are present in 44 states and the District of Columbia. Alabama, Alaska, Idaho, North Dakota, Vermont, and Wyoming are the only states without an RHC, while large-population states (California, Florida, Ohio, Pennsylvania, and Texas) have experienced an explosion in clinic openings.²

RHCs are found in high foot traffic locations, such as large retailers and grocery stores, and in prioritizing services such as drug stores. By analyzing 2019 clinic openings and population centers, the Convenient Care Association determined that more than half of the US population now lives within a 10-minute drive of an RHC.² New locations are established on a regular basis, resulting in some flux in the total number of clinics.

Continue to: Services that RHCs provide...

As RHC locations expand, so do their services. Most RHCs pursue 1 of 2 models: health hubs or virtual care. Health hubs offer an expansion of services, which has resulted in retail health looking and operating more like the primary care providers in their communities.^1,2 While most chains intend for patient visits to be brief, the growing health hub model intends to expand the period for patient visits. The major companies, CVS, Kroger, and Walmart, are offering an increase in their services and granting their providers a greater capacity to screen and treat patients for a wider range of conditions. By contrast, other clinic operators, such as Rite Aid RediClinics, are pursuing a more episodic and convenient care model with a greater adoption and expansion of telehealth and telemedicine.

Services at RHCs involve primarily acute care as well as some basic chronic disease management. About 90% of visits are for the following conditions: influenza, immunizations, upper respiratory infections, sinusitis, bronchitis, sore throat, inner ear infection, conjunctivitis, urinary tract infections, and blood tests.^1-3 Other services available at most RHC locations involve screening and monitoring, wellness and physicals, travel health, treatment of minor injuries, and vaccinations and injections.

Women constitute half of all customers, and all RHCs offer women’s health services.⁷ Along with addressing acute care needs, women’s health services include contraception care and options, human papillomavirus (HPV) screening, pregnancy testing and initial prenatal evaluation, and evaluation for and treatment of urinary tract, bladder, and yeast infections.^2,6

All RHCs provide counseling on sexual health concerns. Nearly all retail clinics in the United States provide screening and treatment for patients and their partners with sexually transmitted infections. RHC providers are required to follow up with patients regarding any blood work or culture results. When positive test results are confirmed for serious infections, such as hepatitis B and C, syphilis, and HIV, patients customarily are referred for treatment.²

The RHC patient base

RHCs serve an expanding base of patients who cite convenience as their primary motivation for utilizing these clinics. This consumer-driven market now encompasses, by some measures, nearly 50 million visits annually.² These numbers have risen every year alongside a consistent increase in the number and spread of clinics across the country. During the COVID-19 pandemic, visits declined, consistent with other health care touchpoints, due to concerns about spreading the coronavirus.

The RHC industry has continued to adapt to a changing health care climate by embracing new telehealth solutions, enabling remote care, and expanding services by consumer demand.^1,7 While convenience is a primary motivation for visiting an RHC, about two-thirds of RHC patients do not have a primary care provider.¹ To support a broader continuum of care, RHCs regularly refer patients who do not have a primary care provider to other health care touchpoints when necessary.

Young and middle-aged adults (18–44 years) comprise the largest group of RHC patients. When patients were asked why they chose an RHC over “traditional doctors’ clinics,” many cited difficulties in accessing care, the appeal of lower costs, and proximity. The proportion of female RHC users was 50.9% and 56.8% for RHC nonusers.^1-3

How RHCs compare with other episodic care clinics

The consumer has more choices to seek episodic care other than at physicians’ clinics or emergency rooms. An RHC, urgent care clinic, or freestanding emergency clinic increase access points for consumers. Along with the expanding number of RHCs, there are nearly 9,000 US urgent care centers, according to the Urgent Care Association, and more than 550 freestanding emergency rooms.⁸

The main differences between these episodic care clinics are shown in TABLE 2. Hours of operation, types of conditions, available providers, location of the facility, and estimated costs are compared. All provide expanded business hours. Retail clinics address some chronic disease management along with acute care, engage only advanced practitioners, use retail stores, and are less costly to consumers.^3,4,9

An RHC, urgent care clinic, or emergency department increases access points for consumers. Many emergency department visits can be handled in ambulatory settings such as RHCs and urgent care clinics.^9,10 This can be helpful, especially in rural areas with a shortage of physicians. Most people want a relationship with a physician who will manage their care rather than seeing a different provider at every visit. While ObGyns deliver comprehensive care to women, however, in some underserved areas non-ObGyn clinics can fill the void. For example, RHCs can sometimes provide needed immunizations and health care information required in underserved areas.¹¹

Many physicians are frustrated when they see patients who do not have a complete copy of their medical record and must piecemeal how to treat a patient. RHCs have adopted electronic medical records, and they regularly encourage patients to contact their physician (or find one, which can be difficult). Another limitation can be a referral from an RHC to a subspecialist rather than a primary care physician who could equally handle the condition.

Continue to: What ObGyns can do...

What ObGyns can do

Consumers have become accustomed to obtaining services where and when they want them, and they expect the same from their health care providers. While ObGyn practices are less affected by RHCs than family physicians or general internists, health care delivery in traditional clinics must be user friendly—that is, better, cheaper, and faster—for the patient-consumer to be more satisfied. Looking ahead, a nearby women’s health care group needs to have someone on call 24 hours a day, 7 days a week. That way, you can tell your patients that they can call you first if they need help. In the case of an ObGyn recommending that a patient go to an RHC or urgent care center, you will be aware of the visit and can follow up with your patient afterward.

Traditional clinics need to create ways for patients with acute illnesses to be seen that same day. Offering extended hours or technology options, such as online support, can help. Text message reminders, same-day access for appointments, and price transparency are necessary. It is important to encourage your women’s health patients to become more responsible for their own health and care, while taking into consideration their social determinants of health. While ObGyns should discuss with their patients when to visit an RHC (especially when their clinic is closed), emphasize that your own clinic is the patient’s medical home and encourage the importance of communicating what occurred during the RHC visit.

Working as a team by communicating well can create a community of health. It would be appropriate for you to represent your group by meeting practitioners at the nearby RHC. Being accessible and helpful would create a friendly and open professional relationship. Conversely, providers at retail clinics need to continually appreciate that women’s health clinics offer more comprehensive care. Select referrals from RHCs would help the most important person, the patient herself. ●

Retail Health Clinics (RHCs) are health care facilities located in high-traffic retail outlets with adjacent pharmacies that are intended to provide convenient and affordable care without sacrificing quality. The clinics add an option that complements services to individuals and families who otherwise would need to wait for an appointment with a traditional primary care physician or provider.¹ Appointments are not necessary for episodic health needs. Usually open 7 days a week, RHCs offer extended hours on weekdays.²

The clinics are staffed by licensed, qualified advance practice providers, such as nurse practitioners and physician assistants, who are supervised by family physicians where required by state law. These clinicians have advanced education to diagnose, treat, and prescribe for nonemergent ailments such as colds and flu, rashes and skin irritation, and muscle strains or sprains.³ They are supported by an electronic health record that contains established evidence-based protocols.^2,4

Evolution of retail health clinics

The first RHC, operated by QuickMedx, opened its doors in 2000 in Minneapolis– St. Paul.^1,5 Only patients with a very limited number of illnesses were seen, and payment was cash. In 2005, this clinic was acquired by a major pharmacy retailer, which led to several acquisitions by other retailers and health care systems. In addition to accepting cash for a visit, the clinics formed contracts with health insurance companies. The average cost of a visit to an RHC in 2016 was estimated to be $70, considerably less than the cost at urgent care clinics ($124) and emergency rooms ($356).⁶

Today, more than 20 companies provide health care services at RHCs (TABLE 1). CVS (MinuteClinic) has the most retail clinics, followed by Walgreens, Kroger, Rite Aid, and Zoom+Care.^1,2 There are now about 3,300 clinics in the United States, Canada, and Mexico (nearly all are located in the United States).² Currently, RHCs are present in 44 states and the District of Columbia. Alabama, Alaska, Idaho, North Dakota, Vermont, and Wyoming are the only states without an RHC, while large-population states (California, Florida, Ohio, Pennsylvania, and Texas) have experienced an explosion in clinic openings.²

RHCs are found in high foot traffic locations, such as large retailers and grocery stores, and in prioritizing services such as drug stores. By analyzing 2019 clinic openings and population centers, the Convenient Care Association determined that more than half of the US population now lives within a 10-minute drive of an RHC.² New locations are established on a regular basis, resulting in some flux in the total number of clinics.

Continue to: Services that RHCs provide...

As RHC locations expand, so do their services. Most RHCs pursue 1 of 2 models: health hubs or virtual care. Health hubs offer an expansion of services, which has resulted in retail health looking and operating more like the primary care providers in their communities.^1,2 While most chains intend for patient visits to be brief, the growing health hub model intends to expand the period for patient visits. The major companies, CVS, Kroger, and Walmart, are offering an increase in their services and granting their providers a greater capacity to screen and treat patients for a wider range of conditions. By contrast, other clinic operators, such as Rite Aid RediClinics, are pursuing a more episodic and convenient care model with a greater adoption and expansion of telehealth and telemedicine.

Services at RHCs involve primarily acute care as well as some basic chronic disease management. About 90% of visits are for the following conditions: influenza, immunizations, upper respiratory infections, sinusitis, bronchitis, sore throat, inner ear infection, conjunctivitis, urinary tract infections, and blood tests.^1-3 Other services available at most RHC locations involve screening and monitoring, wellness and physicals, travel health, treatment of minor injuries, and vaccinations and injections.

Women constitute half of all customers, and all RHCs offer women’s health services.⁷ Along with addressing acute care needs, women’s health services include contraception care and options, human papillomavirus (HPV) screening, pregnancy testing and initial prenatal evaluation, and evaluation for and treatment of urinary tract, bladder, and yeast infections.^2,6

All RHCs provide counseling on sexual health concerns. Nearly all retail clinics in the United States provide screening and treatment for patients and their partners with sexually transmitted infections. RHC providers are required to follow up with patients regarding any blood work or culture results. When positive test results are confirmed for serious infections, such as hepatitis B and C, syphilis, and HIV, patients customarily are referred for treatment.²

The RHC patient base

RHCs serve an expanding base of patients who cite convenience as their primary motivation for utilizing these clinics. This consumer-driven market now encompasses, by some measures, nearly 50 million visits annually.² These numbers have risen every year alongside a consistent increase in the number and spread of clinics across the country. During the COVID-19 pandemic, visits declined, consistent with other health care touchpoints, due to concerns about spreading the coronavirus.

The RHC industry has continued to adapt to a changing health care climate by embracing new telehealth solutions, enabling remote care, and expanding services by consumer demand.^1,7 While convenience is a primary motivation for visiting an RHC, about two-thirds of RHC patients do not have a primary care provider.¹ To support a broader continuum of care, RHCs regularly refer patients who do not have a primary care provider to other health care touchpoints when necessary.

Young and middle-aged adults (18–44 years) comprise the largest group of RHC patients. When patients were asked why they chose an RHC over “traditional doctors’ clinics,” many cited difficulties in accessing care, the appeal of lower costs, and proximity. The proportion of female RHC users was 50.9% and 56.8% for RHC nonusers.^1-3

How RHCs compare with other episodic care clinics

The consumer has more choices to seek episodic care other than at physicians’ clinics or emergency rooms. An RHC, urgent care clinic, or freestanding emergency clinic increase access points for consumers. Along with the expanding number of RHCs, there are nearly 9,000 US urgent care centers, according to the Urgent Care Association, and more than 550 freestanding emergency rooms.⁸

The main differences between these episodic care clinics are shown in TABLE 2. Hours of operation, types of conditions, available providers, location of the facility, and estimated costs are compared. All provide expanded business hours. Retail clinics address some chronic disease management along with acute care, engage only advanced practitioners, use retail stores, and are less costly to consumers.^3,4,9

An RHC, urgent care clinic, or emergency department increases access points for consumers. Many emergency department visits can be handled in ambulatory settings such as RHCs and urgent care clinics.^9,10 This can be helpful, especially in rural areas with a shortage of physicians. Most people want a relationship with a physician who will manage their care rather than seeing a different provider at every visit. While ObGyns deliver comprehensive care to women, however, in some underserved areas non-ObGyn clinics can fill the void. For example, RHCs can sometimes provide needed immunizations and health care information required in underserved areas.¹¹

Many physicians are frustrated when they see patients who do not have a complete copy of their medical record and must piecemeal how to treat a patient. RHCs have adopted electronic medical records, and they regularly encourage patients to contact their physician (or find one, which can be difficult). Another limitation can be a referral from an RHC to a subspecialist rather than a primary care physician who could equally handle the condition.

Continue to: What ObGyns can do...

What ObGyns can do

Consumers have become accustomed to obtaining services where and when they want them, and they expect the same from their health care providers. While ObGyn practices are less affected by RHCs than family physicians or general internists, health care delivery in traditional clinics must be user friendly—that is, better, cheaper, and faster—for the patient-consumer to be more satisfied. Looking ahead, a nearby women’s health care group needs to have someone on call 24 hours a day, 7 days a week. That way, you can tell your patients that they can call you first if they need help. In the case of an ObGyn recommending that a patient go to an RHC or urgent care center, you will be aware of the visit and can follow up with your patient afterward.

Traditional clinics need to create ways for patients with acute illnesses to be seen that same day. Offering extended hours or technology options, such as online support, can help. Text message reminders, same-day access for appointments, and price transparency are necessary. It is important to encourage your women’s health patients to become more responsible for their own health and care, while taking into consideration their social determinants of health. While ObGyns should discuss with their patients when to visit an RHC (especially when their clinic is closed), emphasize that your own clinic is the patient’s medical home and encourage the importance of communicating what occurred during the RHC visit.

Working as a team by communicating well can create a community of health. It would be appropriate for you to represent your group by meeting practitioners at the nearby RHC. Being accessible and helpful would create a friendly and open professional relationship. Conversely, providers at retail clinics need to continually appreciate that women’s health clinics offer more comprehensive care. Select referrals from RHCs would help the most important person, the patient herself. ●

Retail Health Clinics (RHCs) are health care facilities located in high-traffic retail outlets with adjacent pharmacies that are intended to provide convenient and affordable care without sacrificing quality. The clinics add an option that complements services to individuals and families who otherwise would need to wait for an appointment with a traditional primary care physician or provider.¹ Appointments are not necessary for episodic health needs. Usually open 7 days a week, RHCs offer extended hours on weekdays.²

The clinics are staffed by licensed, qualified advance practice providers, such as nurse practitioners and physician assistants, who are supervised by family physicians where required by state law. These clinicians have advanced education to diagnose, treat, and prescribe for nonemergent ailments such as colds and flu, rashes and skin irritation, and muscle strains or sprains.³ They are supported by an electronic health record that contains established evidence-based protocols.^2,4

Evolution of retail health clinics

The first RHC, operated by QuickMedx, opened its doors in 2000 in Minneapolis– St. Paul.^1,5 Only patients with a very limited number of illnesses were seen, and payment was cash. In 2005, this clinic was acquired by a major pharmacy retailer, which led to several acquisitions by other retailers and health care systems. In addition to accepting cash for a visit, the clinics formed contracts with health insurance companies. The average cost of a visit to an RHC in 2016 was estimated to be $70, considerably less than the cost at urgent care clinics ($124) and emergency rooms ($356).⁶

Today, more than 20 companies provide health care services at RHCs (TABLE 1). CVS (MinuteClinic) has the most retail clinics, followed by Walgreens, Kroger, Rite Aid, and Zoom+Care.^1,2 There are now about 3,300 clinics in the United States, Canada, and Mexico (nearly all are located in the United States).² Currently, RHCs are present in 44 states and the District of Columbia. Alabama, Alaska, Idaho, North Dakota, Vermont, and Wyoming are the only states without an RHC, while large-population states (California, Florida, Ohio, Pennsylvania, and Texas) have experienced an explosion in clinic openings.²

RHCs are found in high foot traffic locations, such as large retailers and grocery stores, and in prioritizing services such as drug stores. By analyzing 2019 clinic openings and population centers, the Convenient Care Association determined that more than half of the US population now lives within a 10-minute drive of an RHC.² New locations are established on a regular basis, resulting in some flux in the total number of clinics.

Continue to: Services that RHCs provide...

As RHC locations expand, so do their services. Most RHCs pursue 1 of 2 models: health hubs or virtual care. Health hubs offer an expansion of services, which has resulted in retail health looking and operating more like the primary care providers in their communities.^1,2 While most chains intend for patient visits to be brief, the growing health hub model intends to expand the period for patient visits. The major companies, CVS, Kroger, and Walmart, are offering an increase in their services and granting their providers a greater capacity to screen and treat patients for a wider range of conditions. By contrast, other clinic operators, such as Rite Aid RediClinics, are pursuing a more episodic and convenient care model with a greater adoption and expansion of telehealth and telemedicine.

Services at RHCs involve primarily acute care as well as some basic chronic disease management. About 90% of visits are for the following conditions: influenza, immunizations, upper respiratory infections, sinusitis, bronchitis, sore throat, inner ear infection, conjunctivitis, urinary tract infections, and blood tests.^1-3 Other services available at most RHC locations involve screening and monitoring, wellness and physicals, travel health, treatment of minor injuries, and vaccinations and injections.

Women constitute half of all customers, and all RHCs offer women’s health services.⁷ Along with addressing acute care needs, women’s health services include contraception care and options, human papillomavirus (HPV) screening, pregnancy testing and initial prenatal evaluation, and evaluation for and treatment of urinary tract, bladder, and yeast infections.^2,6

All RHCs provide counseling on sexual health concerns. Nearly all retail clinics in the United States provide screening and treatment for patients and their partners with sexually transmitted infections. RHC providers are required to follow up with patients regarding any blood work or culture results. When positive test results are confirmed for serious infections, such as hepatitis B and C, syphilis, and HIV, patients customarily are referred for treatment.²

The RHC patient base

RHCs serve an expanding base of patients who cite convenience as their primary motivation for utilizing these clinics. This consumer-driven market now encompasses, by some measures, nearly 50 million visits annually.² These numbers have risen every year alongside a consistent increase in the number and spread of clinics across the country. During the COVID-19 pandemic, visits declined, consistent with other health care touchpoints, due to concerns about spreading the coronavirus.

The RHC industry has continued to adapt to a changing health care climate by embracing new telehealth solutions, enabling remote care, and expanding services by consumer demand.^1,7 While convenience is a primary motivation for visiting an RHC, about two-thirds of RHC patients do not have a primary care provider.¹ To support a broader continuum of care, RHCs regularly refer patients who do not have a primary care provider to other health care touchpoints when necessary.

Young and middle-aged adults (18–44 years) comprise the largest group of RHC patients. When patients were asked why they chose an RHC over “traditional doctors’ clinics,” many cited difficulties in accessing care, the appeal of lower costs, and proximity. The proportion of female RHC users was 50.9% and 56.8% for RHC nonusers.^1-3

How RHCs compare with other episodic care clinics

The consumer has more choices to seek episodic care other than at physicians’ clinics or emergency rooms. An RHC, urgent care clinic, or freestanding emergency clinic increase access points for consumers. Along with the expanding number of RHCs, there are nearly 9,000 US urgent care centers, according to the Urgent Care Association, and more than 550 freestanding emergency rooms.⁸

The main differences between these episodic care clinics are shown in TABLE 2. Hours of operation, types of conditions, available providers, location of the facility, and estimated costs are compared. All provide expanded business hours. Retail clinics address some chronic disease management along with acute care, engage only advanced practitioners, use retail stores, and are less costly to consumers.^3,4,9

An RHC, urgent care clinic, or emergency department increases access points for consumers. Many emergency department visits can be handled in ambulatory settings such as RHCs and urgent care clinics.^9,10 This can be helpful, especially in rural areas with a shortage of physicians. Most people want a relationship with a physician who will manage their care rather than seeing a different provider at every visit. While ObGyns deliver comprehensive care to women, however, in some underserved areas non-ObGyn clinics can fill the void. For example, RHCs can sometimes provide needed immunizations and health care information required in underserved areas.¹¹

Many physicians are frustrated when they see patients who do not have a complete copy of their medical record and must piecemeal how to treat a patient. RHCs have adopted electronic medical records, and they regularly encourage patients to contact their physician (or find one, which can be difficult). Another limitation can be a referral from an RHC to a subspecialist rather than a primary care physician who could equally handle the condition.

Continue to: What ObGyns can do...

What ObGyns can do

Consumers have become accustomed to obtaining services where and when they want them, and they expect the same from their health care providers. While ObGyn practices are less affected by RHCs than family physicians or general internists, health care delivery in traditional clinics must be user friendly—that is, better, cheaper, and faster—for the patient-consumer to be more satisfied. Looking ahead, a nearby women’s health care group needs to have someone on call 24 hours a day, 7 days a week. That way, you can tell your patients that they can call you first if they need help. In the case of an ObGyn recommending that a patient go to an RHC or urgent care center, you will be aware of the visit and can follow up with your patient afterward.

Traditional clinics need to create ways for patients with acute illnesses to be seen that same day. Offering extended hours or technology options, such as online support, can help. Text message reminders, same-day access for appointments, and price transparency are necessary. It is important to encourage your women’s health patients to become more responsible for their own health and care, while taking into consideration their social determinants of health. While ObGyns should discuss with their patients when to visit an RHC (especially when their clinic is closed), emphasize that your own clinic is the patient’s medical home and encourage the importance of communicating what occurred during the RHC visit.

Working as a team by communicating well can create a community of health. It would be appropriate for you to represent your group by meeting practitioners at the nearby RHC. Being accessible and helpful would create a friendly and open professional relationship. Conversely, providers at retail clinics need to continually appreciate that women’s health clinics offer more comprehensive care. Select referrals from RHCs would help the most important person, the patient herself. ●

The coronavirus disease 2019 (COVID-19) pandemic has upended the traditional 2020–2021 application season for ObGyn residency programs. In May 2020, the 2 national ObGyn education organizations, the Association of Professors of Gynecology and Obstetrics (APGO) and Council on Resident Education in ObGyn (CREOG), issued guidelines to ensure a fair and equitable application process.¹ These guidelines are consistent with recommendations from the Association of American Medical Colleges (AAMC) and the Coalition for Physician Accountability. Important recommendations include:

• limiting away rotations
• being flexible in the number of specialty-specific letters of recommendation required
• encouraging residency programs to develop alternate means of conveying information about their curriculum.

In addition, these statements provide timing on when programs should release interview offers and when to begin interviews. Finally, programs are required to commit to online interviews and virtual visits for all applicants, including local students, rather than in-person interviews.

Here, we focus on identifying apps that students can use to help them with the application process—apps for the nuts and bolts of applying and interviewing and apps to learn more about individual programs.

Students must use the Electronic Residency Application Service (ERAS) platform from AAMC to enter their information and register with the National Resident Matching Program (NRMP). Students also must use the ERAS to submit their applications to their selected residency programs. The ERAS platform does not include an app to aid in the completion or submission of an application. The NRMP has developed the MATCH PRISM app, but this does not allow students to register for the match or submit their rank list. To learn about how to schedule interviews, residency programs may use one of the following sources: ERAS, Interview Broker, or Thalamus. Moreover, APGO/CREOG has partnered with Thalamus for the upcoming application cycle, which provides residency programs and applicants tools for application management, interview scheduling, and itinerary building. Thalamus offers a free app.

This year offers some unique challenges. The application process for ObGyn residencies is likely to be more competitive, and students face the added stress of having to navigate the interview season:

• without away rotations (audition interviews)
• without in-person visits of the city/hospital/program or social events before or after interview day
• with an all-virtual interview day.

Continue to: To find information on individual residency programs...

To find information on individual residency programs, the APGO website lists the FREIDA and APGO Residency Directories, which are not apps. Students are also aware of the Doximity Residency Navigator, which does include an app. The NRMP MATCH PRISM app is another resource, as it provides students with a directory of residency programs and information about each program.

The American College of Obstetricians and Gynecologists (ACOG) recognizes that residency program websites and social media will be crucial in helping applicants learn about individual programs, faculty, and residents. As such, ACOG hosted a Virtual Residency Showcase in September 2020 in which programs posted content on Instagram and Twitter using the hashtag #ACOG-ResWeek20.² Similarly, APGO and CREOG produced a report containing a social media directory, which lists individual residency programs and whether or not they have a social media handle/account.³ In a recent webinar,⁴ Drs. Sarah Santiago and Elizabeth Southworth noted that the number of residency programs that have an Instagram account more than doubled (from 60 to 128) between May and September 2020.

The coronavirus disease 2019 (COVID-19) pandemic has upended the traditional 2020–2021 application season for ObGyn residency programs. In May 2020, the 2 national ObGyn education organizations, the Association of Professors of Gynecology and Obstetrics (APGO) and Council on Resident Education in ObGyn (CREOG), issued guidelines to ensure a fair and equitable application process.¹ These guidelines are consistent with recommendations from the Association of American Medical Colleges (AAMC) and the Coalition for Physician Accountability. Important recommendations include:

• limiting away rotations
• being flexible in the number of specialty-specific letters of recommendation required
• encouraging residency programs to develop alternate means of conveying information about their curriculum.

In addition, these statements provide timing on when programs should release interview offers and when to begin interviews. Finally, programs are required to commit to online interviews and virtual visits for all applicants, including local students, rather than in-person interviews.

Here, we focus on identifying apps that students can use to help them with the application process—apps for the nuts and bolts of applying and interviewing and apps to learn more about individual programs.

Students must use the Electronic Residency Application Service (ERAS) platform from AAMC to enter their information and register with the National Resident Matching Program (NRMP). Students also must use the ERAS to submit their applications to their selected residency programs. The ERAS platform does not include an app to aid in the completion or submission of an application. The NRMP has developed the MATCH PRISM app, but this does not allow students to register for the match or submit their rank list. To learn about how to schedule interviews, residency programs may use one of the following sources: ERAS, Interview Broker, or Thalamus. Moreover, APGO/CREOG has partnered with Thalamus for the upcoming application cycle, which provides residency programs and applicants tools for application management, interview scheduling, and itinerary building. Thalamus offers a free app.

This year offers some unique challenges. The application process for ObGyn residencies is likely to be more competitive, and students face the added stress of having to navigate the interview season:

• without away rotations (audition interviews)
• without in-person visits of the city/hospital/program or social events before or after interview day
• with an all-virtual interview day.

Continue to: To find information on individual residency programs...

To find information on individual residency programs, the APGO website lists the FREIDA and APGO Residency Directories, which are not apps. Students are also aware of the Doximity Residency Navigator, which does include an app. The NRMP MATCH PRISM app is another resource, as it provides students with a directory of residency programs and information about each program.

The American College of Obstetricians and Gynecologists (ACOG) recognizes that residency program websites and social media will be crucial in helping applicants learn about individual programs, faculty, and residents. As such, ACOG hosted a Virtual Residency Showcase in September 2020 in which programs posted content on Instagram and Twitter using the hashtag #ACOG-ResWeek20.² Similarly, APGO and CREOG produced a report containing a social media directory, which lists individual residency programs and whether or not they have a social media handle/account.³ In a recent webinar,⁴ Drs. Sarah Santiago and Elizabeth Southworth noted that the number of residency programs that have an Instagram account more than doubled (from 60 to 128) between May and September 2020.

The coronavirus disease 2019 (COVID-19) pandemic has upended the traditional 2020–2021 application season for ObGyn residency programs. In May 2020, the 2 national ObGyn education organizations, the Association of Professors of Gynecology and Obstetrics (APGO) and Council on Resident Education in ObGyn (CREOG), issued guidelines to ensure a fair and equitable application process.¹ These guidelines are consistent with recommendations from the Association of American Medical Colleges (AAMC) and the Coalition for Physician Accountability. Important recommendations include:

• limiting away rotations
• being flexible in the number of specialty-specific letters of recommendation required
• encouraging residency programs to develop alternate means of conveying information about their curriculum.

In addition, these statements provide timing on when programs should release interview offers and when to begin interviews. Finally, programs are required to commit to online interviews and virtual visits for all applicants, including local students, rather than in-person interviews.

Here, we focus on identifying apps that students can use to help them with the application process—apps for the nuts and bolts of applying and interviewing and apps to learn more about individual programs.

Students must use the Electronic Residency Application Service (ERAS) platform from AAMC to enter their information and register with the National Resident Matching Program (NRMP). Students also must use the ERAS to submit their applications to their selected residency programs. The ERAS platform does not include an app to aid in the completion or submission of an application. The NRMP has developed the MATCH PRISM app, but this does not allow students to register for the match or submit their rank list. To learn about how to schedule interviews, residency programs may use one of the following sources: ERAS, Interview Broker, or Thalamus. Moreover, APGO/CREOG has partnered with Thalamus for the upcoming application cycle, which provides residency programs and applicants tools for application management, interview scheduling, and itinerary building. Thalamus offers a free app.

This year offers some unique challenges. The application process for ObGyn residencies is likely to be more competitive, and students face the added stress of having to navigate the interview season:

• without away rotations (audition interviews)
• without in-person visits of the city/hospital/program or social events before or after interview day
• with an all-virtual interview day.

Continue to: To find information on individual residency programs...

To find information on individual residency programs, the APGO website lists the FREIDA and APGO Residency Directories, which are not apps. Students are also aware of the Doximity Residency Navigator, which does include an app. The NRMP MATCH PRISM app is another resource, as it provides students with a directory of residency programs and information about each program.

The American College of Obstetricians and Gynecologists (ACOG) recognizes that residency program websites and social media will be crucial in helping applicants learn about individual programs, faculty, and residents. As such, ACOG hosted a Virtual Residency Showcase in September 2020 in which programs posted content on Instagram and Twitter using the hashtag #ACOG-ResWeek20.² Similarly, APGO and CREOG produced a report containing a social media directory, which lists individual residency programs and whether or not they have a social media handle/account.³ In a recent webinar,⁴ Drs. Sarah Santiago and Elizabeth Southworth noted that the number of residency programs that have an Instagram account more than doubled (from 60 to 128) between May and September 2020.

Patrick J. Culligan, MD: We all know that burnout is an important problem among surgeons. In fact, it seems that, in the United States, we are working longer hours than ever before, and that higher education correlates with less balance in life. This dysfunction seems to start in school, when we are encouraged to be competitive, and overwork just becomes another way to compete. It’s very easy to get swept up in the traditional model of academic medicine, the engine of which is competition and overwork.

My impression of our younger colleagues, however, is that many of them are not attracted to the traditional ivory tower research model of academic advancement to which many in previous generations aspired. They seem more concerned with work-life balance as their measure of success rather than the classic metrics of money and prestige. Everyone still needs role models and mentors, though, and that’s where all of you come in. I asked each of you to be on this panel because I admire you for your varying approaches to work-life balance while achieving success as gynecologic surgeons. I thought others in the field might be inspired by hearing your stories.

Cultivating your passions

Kristie Greene, MD: What I have come to learn and appreciate is a really simple point: you do not have to do everything. Determining who you want to be both personally and professionally is step 1.

Granted, answering the question, “Who do I want to be?” is not as simple as it sounds. Many factors figure into the decisions we make in our personal and professional lives. Also, it is not a question we often stop and ask ourselves. From early on, we are placed on an escalator moving up through medical school, residency, fellowship, good job, better job, etc. We are so accustomed to being competitive, to winning, and to wanting to be the best that we sometimes forget to ask ourselves, “What is it exactly that I want, and why? What is my endpoint? And does it make me happy?”

Multitasking is regarded as a talent. As much as we would like to believe that we can do everything at the same time and do it all well, we actually can’t. A friend of mine made me read a book a couple of years ago, called Feeling Good, by David Burns. The book encourages you to consider the different tasks you do in a day and rate how good you are at each of them on a scale of 1 to 10. It then asks you to think about how much enjoyment you derive from each of the tasks and about why you are doing the ones that bring you little to no enjoyment.

I ultimately decided that, for me professionally, the most important thing was my interest in global health. So I decided to do whatever it took to make this happen. But you don’t get something for nothing, and everything comes with sacrifices.

Continue to: Charles Rardin, MD...

Charles Rardin, MD: How exactly did you decide that you were going to focus your career toward pursuing international health? How did you know it was more important? And how did you overcome some of those obstacles?

Dr. Greene: You have to ask the hard question again about what brings you the most joy professionally and personally. That was the easy part of it for me because global health has always been that source of happiness and fulfillment for me. The more challenging parts are the sacrifices and hard choices that come with it. With global health, it can be difficult to balance the demands of a clinical practice.

All of our jobs are a business. I am still struggling with the money part of it. For my husband and I, that meant we had to start small—do what we could afford. But then it blossomed into something that was involving residents, fellows, and med students, which requires far more funding than we had. So I reached out to family. Most of our families donate to different organizations or charities every year, so why not donate to a loved one for something they are passionate about?

At the University of South Florida (USF), we set up a fund, a foundation for global health, which helps support our work abroad as well as the costs associated with involvement of our trainees. Right now, what we have is still small potatoes to a country, but we are making it happen by starting at a small level and growing it.

Beyond the money aspect, traveling abroad means less involvement in meetings, missed opportunities to teach courses that might interest me, and time away from my family. I guess my advice on this whole thing is that you can make things happen if they are important enough to you, and if you are willing to make sacrifices in other areas because you can’t have it all.

Making time for you

Dr. Culligan: So you have found what is important to you, and you have found a way to make it happen. But you are faced with more work; you have given yourself additional work on top of your regular work. How do you make time for a personal life?

Catherine Matthews, MD: In preparing for this discussion, I decided to break down my advice into 3 buckets: The first bucket is discovering and knowing your authentic self. The second is building a community, which I’ll elaborate on. And the third, which we have discussed, is to let go of the money.

Dr. Culligan: I love the concept of the authentic self, but how does that jive with a tendency to strive for perfection? We all think we can do it all. How do we narrow down to what really matters?

Dr. Matthews: We often focus on the things that bring us happiness and what we are good at, but it’s the things that make us unhappy that tend to bring us down. It’s the presence of unhappiness, not the absence of happiness, that seems to be the undoing of many, including myself.

None of us are born with dramatic insight. It is experience that leads to insight. People who are actually present are able to gain insight through observation. A person becomes a better surgeon by observing the outcome of doing a stitch this way versus that; you learn how to do it by seeing what it looks like afterward.

Finding our authentic selves happens in much the same way. Having the presence of mind to ask the right questions, such as, “How am I feeling while I’m doing this?” leads to insights into the true self.

Continue to: It takes a village...

Dr. Greene: Catherine mentioned community earlier, and that is extremely important. The people who surround us can have a huge impact on the way we perceive things, including ourselves. Having a mix of people in our lives—some who practice medicine and others who don’t—helps us stay balanced and answer some of the tough questions. Catherine, for example, has helped me in various stages of my career to ask myself meaningful questions and get real answers.

Dr. Rardin: Part of finding balance is luck, and part of it is making a choice between money and everything else. In considering my first job out of training, I knew that money had the potential to distract me from what was important to me. So I chose a position that was almost entirely salaried so that the decisions I made clinically, surgically, and regarding work-life balance would be less likely to directly impact what was important to me.

Sally Huber, MD: I am still in the “getting there” phase of my life, but one thing I have found is that getting my family involved and excited about what I do has made them much more accepting of when I have longer work days or work to do on the weekend. My spouse has become quite involved with what I have been doing with transgender health in Atlanta. It has been a great bonding experience; she shares my passions, and together we are creating something about which we both can be proud.

When work invades home life

Dr. Culligan: That is great. Sally, I think when we talked, you were just learning about the necessity of mental separation and of not taking your work home with you, which is so hard for all of us with all of our devices.

Dr. Huber: Yes, this year has been about seeing what works best as far as being efficient at work and having quality time at home. At the end of every day I ask myself, “What worked well today? What didn’t work well? What else can I do to maximize time with my family?” I am slowly becoming more efficient, but it has been a challenge. During fellowship, your day is pretty set, but once you are practicing on your own, your hours and responsibilities are completely different, and you have to figure out what works best for you, your values, and your expectations of private life. It takes some time, and I am still figuring it out.

Dr. Culligan: How often would you say that you bring work home? I try hard once I am home to quit working, but sometimes on the weekends I break that rule.

Dr. Matthews: I must say that I do feel like there are certain times when I am better at that than others. Work comes in waves with pressing deadlines. If I averaged it out, probably a third of the time I have some email or some conference call or something that I have got to do at home. I do really try to limit the obligations that I have after 5:30 or 6:00 pm. I resent intrusions after that time. As far as weekends, I delegate about one weekend every 2 months to work, instead of doing a little bit every weekend.

Dr. Greene: I agree. I try hard to make 5:30 to 7:30 pm unequivocal time for a family dinner and time for my kids. During that time, I do not have my phone near me so I can’t look at email or texts. I try not to schedule conference calls. I try to be there to read books to my kids at night. Then if I need to do work, I do it later at night, which interferes with time with my spouse, and is not ideal, but that’s what happens.

Dr. Matthews: One of the things that I think is a huge part of work-life balance is work-related travel. When you are present at work on a consistent basis, the work does not pile up to the extent that it does when you are absent on a trip. When you come back, you invariably pay the price by seeing more patients and doing more surgery. Then it becomes a stressful event.

My advice to young people is to be very thoughtful about planning trips, especially distant ones. You do not want to sit on a plane all day when you could be doing something more productive. If I could have done something differently in my mid-career, I would have traveled less.

Continue to: Prioritizing “out of office” time...

Dr. Greene: How do you all mentally separate yourself from work, so that when you are on vacation with your family you are not thinking about the office, the patients, and all of the things on your to-do list?

Dr. Rardin: I don’t have a great answer for that except that it is about being present. You have to decide that now is the time when I am home, now is the time when I am a parent, now is the time when I am a boy scout leader, etc. I guess maybe it’s a skill, or maybe it’s about making something a priority. Work will always be waiting for you when you turn your attention back to it.

Dr. Matthews: Kristie, the answer to your question goes back to community. Partners in a practice cover for each other. You have to trust them to take care of things so that you can relax during your time away.

Some people recommend not scheduling challenging cases right before going away because invariably something goes wrong, and then you are asking, “Why did I schedule 3 colpopexies before getting on a plane?”

Dr. Rardin: Yes, I completely agree with all of that. Personally, I feel fortunate that I can compartmentalize pretty well. When I am home with my kids, I allow myself to shed some of the doctor/surgeon/leadership persona; I am able to be goofy and completely non–doctor-like. It works to help me leave work behind.

Dr. Matthews: Other things you can do include setting up an out-of-office notice on your email that says when you will be back and what to do in case of urgent matters. This basically says to the world, “Don’t expect to hear from me until X date.” It removes the expectation that you will respond sooner. Otherwise, we would all be on our smartphones all the time and not enjoying our time away.

What I wish I knew then

Dr. Culligan: How would you complete the sentence, “I wish they had told me X when I was embarking on my career?”

Dr. Rardin: I keep coming back to the phrase, “Don’t do anything that you can reasonably pay someone else to do.” By that I mean, if you don’t get energy from housework, consider spending some of your money to get help with the housework. Resolve to make a relatively small expenditure to maximize the quality of the time that you give to yourself and your family. Those are the sorts of things that I think can go a long way.

Dr. Culligan: Charley, your wife is an ObGyn. How do you navigate a dual medical career household? What advice do you have for others?

Dr. Rardin: When I was going into fellowship, we had a conversation about how hard it is for both people in a relationship to have an academic fire in the belly and to be truly engaged in climbing the academic ladder. We made a decision that Jane would go into private practice. There has got to be some give and take in a dual medical relationship; a lot of sacrifices and compromises need to happen. We are fortunate in that there are complementary aspects to our jobs. We both spend about the same number of nights away from the house, but my travel is more in chunks and hers is overnight calls for labor and delivery. We have different ways of (briefly) single-parenting, and you have to come up with ways to handle the domestic chores.

Dr. Matthews: I wish someone had explained to me that the people you work with are much more important than the place. The human connection is what defines your experience, much more than any ego-driven outcome.

Dr. Greene: I wish someone had explained to me the competing aspects of academic medicine. The cards are stacked in a way that make it difficult for you to win. For example, you may love to teach and may be really good at it, but if you let your students handle too many cases, your relative value units plummet and then the hospital is on your back. There are the interests of people, and there are the interests of the business. Everything is a balance, and it’s really tricky.

Dr. Huber: Luckily, Pat counselled me as I was finishing my fellowship about the importance of negotiating a good contract, of being pushy and knowing what you want out of it and knowing what your limitations are. I joined a private practice that had 3 different physical locations. If I had to drive to all of them, as they wanted, it would have meant up to a one-and-a-half-hour commute. But I pushed to stay in one location and to put that extra hour to better use. I am glad I did, but it was terrifying at the time because I didn’t want to lose the offer. I know people that did not do that and took the first thing they got. Now, they are driving all over the place or they have these crazy hours or terrible call responsibilities that if they had just been a little firmer, they probably could have gotten out of. As they start trying to find work-life balance, they are already handicapped.

Continue to: Passions outside the office...

Passions outside the office

Dr. Culligan: One thing I would like to touch on is what is going on in each of your personal lives because all of you have interesting stories to tell outside of what you do professionally. What drives you other than medicine?

Dr. Rardin: I am the father of 3 boys. The oldest one just got his Eagle Scout rank yesterday in Boy Scouts. I would be a woodworker if I wasn’t in medicine. I am a Deacon at church. And I love to spend my downtime reading with my family in front of the fireplace.

Dr. Matthews: For me, it’s music. When my husband and I first met, he asked me if I played a musical instrument. I said I played the cello in primary school. He said, “Great, go rent a cello.” I was never at all interested in playing the cello by myself, but because he plays guitar and piano we became able to play a lot of music together. Our son, Alexander, plays drums. We now have a family band.

In addition, I do yoga. I would never have labeled myself an anxious person, but I learned through this process that I am and need to manage it. It took a lot of years to figure that out. If I don’t leave myself an hour each day to go to a yoga class, I am not a happy person and neither is anyone around me. Also, I get tremendous pleasure from reading books and magazines as opposed to watching a screen.

Dr. Greene: I have found that my passions outside of work often change depending on my stage of life. Right now, I have two young babies and so my life outside of work revolves around them. Before the babies, my dad, who lives in Buffalo, was ill. So for awhile, we were flying to Buffalo almost every weekend that I was not on call. I would say, in general what fuels me is connecting with the people I love as often as I can. A typical night involves me and my husband going for a walk with our kids and dog after dinner and talking to each other. We connect with neighbors and chat on the front porch. It doesn’t really matter what we are doing; it is about being surrounded by people who matter.

Dr. Huber: It’s similar for me. Having a child completely shifts your world view. My goal every day is to give my daughter her first feeding in the morning and to get home as soon as possible at the end of the day to do her last feeding and put her to sleep. She crawled for the first time yesterday, and I was so excited that I could be there for that.

Also, I love being outdoors. I love hiking and camping. Going on a hike and being outside with nature is my way of decompressing.

Continue to: Thinking about upcoming generations...

Dr. Matthews: One other thing I would like to propose is looking at what can we do to make the profession better for the next generation. As a group, our profession is somewhat inflexible. We tend to fall into the trap of, “since this is the way we have always done it this is how we should continue doing it.” The OR still starts at 7:00 or 7:30 am, ignoring the need for school drop-offs, etc. We are not innovative about flexibility in the work week. Honestly, it does not work well for many people, patients and physicians alike. Flexible scheduling should be something that is on the table for both men and women who are trying to balance being full-time parents and full-time surgeons. We need to create an environment in which it is okay for you to spend 10 years instead of 6 as an assistant professor because you are also a young parent, and it will not count against you when you come up for promotion.

Dr. Culligan: I agree with you, Catherine. Full “Professor” is a nice title, but it means time away from family and a lot of other things. Each of us has to decide whether it is worth it, especially since it often does not come with any extra money.

Dr. Huber: A question on a recent survey of residents asked, “Do you see yourself going into private practice or academic medicine when you’ve completed your residency?” When I was a resident, everyone wanted to go into academic medicine, but now it seems like more and more residents have their sights set on private practice because that is where they see the opportunities to create work-life balance.

In the academic world, you have to try to get a promotion in X number of years, and get X number of publications, and be a great teacher, doctor, and administrator all at the same time. I am wondering if we are going to start seeing more and more residents and fellows going into private or hospital-owned practice where there aren’t those added expectations.

Dr. Rardin: I agree, and we are back to what we said in the beginning about doing an honest assessment of what is meaningful and important. We are all trained to try to reach for that shiny brass ring, but do we really want that brass ring? Will it be an asset or a hindrance once we get it? It is okay to be honest and say, “I really don’t want that promotion. I would rather spend more time with my family.” ●

Patrick J. Culligan, MD: We all know that burnout is an important problem among surgeons. In fact, it seems that, in the United States, we are working longer hours than ever before, and that higher education correlates with less balance in life. This dysfunction seems to start in school, when we are encouraged to be competitive, and overwork just becomes another way to compete. It’s very easy to get swept up in the traditional model of academic medicine, the engine of which is competition and overwork.

My impression of our younger colleagues, however, is that many of them are not attracted to the traditional ivory tower research model of academic advancement to which many in previous generations aspired. They seem more concerned with work-life balance as their measure of success rather than the classic metrics of money and prestige. Everyone still needs role models and mentors, though, and that’s where all of you come in. I asked each of you to be on this panel because I admire you for your varying approaches to work-life balance while achieving success as gynecologic surgeons. I thought others in the field might be inspired by hearing your stories.

Cultivating your passions

Kristie Greene, MD: What I have come to learn and appreciate is a really simple point: you do not have to do everything. Determining who you want to be both personally and professionally is step 1.

Granted, answering the question, “Who do I want to be?” is not as simple as it sounds. Many factors figure into the decisions we make in our personal and professional lives. Also, it is not a question we often stop and ask ourselves. From early on, we are placed on an escalator moving up through medical school, residency, fellowship, good job, better job, etc. We are so accustomed to being competitive, to winning, and to wanting to be the best that we sometimes forget to ask ourselves, “What is it exactly that I want, and why? What is my endpoint? And does it make me happy?”

Multitasking is regarded as a talent. As much as we would like to believe that we can do everything at the same time and do it all well, we actually can’t. A friend of mine made me read a book a couple of years ago, called Feeling Good, by David Burns. The book encourages you to consider the different tasks you do in a day and rate how good you are at each of them on a scale of 1 to 10. It then asks you to think about how much enjoyment you derive from each of the tasks and about why you are doing the ones that bring you little to no enjoyment.

I ultimately decided that, for me professionally, the most important thing was my interest in global health. So I decided to do whatever it took to make this happen. But you don’t get something for nothing, and everything comes with sacrifices.

Continue to: Charles Rardin, MD...

Charles Rardin, MD: How exactly did you decide that you were going to focus your career toward pursuing international health? How did you know it was more important? And how did you overcome some of those obstacles?

Dr. Greene: You have to ask the hard question again about what brings you the most joy professionally and personally. That was the easy part of it for me because global health has always been that source of happiness and fulfillment for me. The more challenging parts are the sacrifices and hard choices that come with it. With global health, it can be difficult to balance the demands of a clinical practice.

All of our jobs are a business. I am still struggling with the money part of it. For my husband and I, that meant we had to start small—do what we could afford. But then it blossomed into something that was involving residents, fellows, and med students, which requires far more funding than we had. So I reached out to family. Most of our families donate to different organizations or charities every year, so why not donate to a loved one for something they are passionate about?

At the University of South Florida (USF), we set up a fund, a foundation for global health, which helps support our work abroad as well as the costs associated with involvement of our trainees. Right now, what we have is still small potatoes to a country, but we are making it happen by starting at a small level and growing it.

Beyond the money aspect, traveling abroad means less involvement in meetings, missed opportunities to teach courses that might interest me, and time away from my family. I guess my advice on this whole thing is that you can make things happen if they are important enough to you, and if you are willing to make sacrifices in other areas because you can’t have it all.

Making time for you

Dr. Culligan: So you have found what is important to you, and you have found a way to make it happen. But you are faced with more work; you have given yourself additional work on top of your regular work. How do you make time for a personal life?

Catherine Matthews, MD: In preparing for this discussion, I decided to break down my advice into 3 buckets: The first bucket is discovering and knowing your authentic self. The second is building a community, which I’ll elaborate on. And the third, which we have discussed, is to let go of the money.

Dr. Culligan: I love the concept of the authentic self, but how does that jive with a tendency to strive for perfection? We all think we can do it all. How do we narrow down to what really matters?

Dr. Matthews: We often focus on the things that bring us happiness and what we are good at, but it’s the things that make us unhappy that tend to bring us down. It’s the presence of unhappiness, not the absence of happiness, that seems to be the undoing of many, including myself.

None of us are born with dramatic insight. It is experience that leads to insight. People who are actually present are able to gain insight through observation. A person becomes a better surgeon by observing the outcome of doing a stitch this way versus that; you learn how to do it by seeing what it looks like afterward.

Finding our authentic selves happens in much the same way. Having the presence of mind to ask the right questions, such as, “How am I feeling while I’m doing this?” leads to insights into the true self.

Continue to: It takes a village...

Dr. Greene: Catherine mentioned community earlier, and that is extremely important. The people who surround us can have a huge impact on the way we perceive things, including ourselves. Having a mix of people in our lives—some who practice medicine and others who don’t—helps us stay balanced and answer some of the tough questions. Catherine, for example, has helped me in various stages of my career to ask myself meaningful questions and get real answers.

Dr. Rardin: Part of finding balance is luck, and part of it is making a choice between money and everything else. In considering my first job out of training, I knew that money had the potential to distract me from what was important to me. So I chose a position that was almost entirely salaried so that the decisions I made clinically, surgically, and regarding work-life balance would be less likely to directly impact what was important to me.

Sally Huber, MD: I am still in the “getting there” phase of my life, but one thing I have found is that getting my family involved and excited about what I do has made them much more accepting of when I have longer work days or work to do on the weekend. My spouse has become quite involved with what I have been doing with transgender health in Atlanta. It has been a great bonding experience; she shares my passions, and together we are creating something about which we both can be proud.

When work invades home life

Dr. Culligan: That is great. Sally, I think when we talked, you were just learning about the necessity of mental separation and of not taking your work home with you, which is so hard for all of us with all of our devices.

Dr. Huber: Yes, this year has been about seeing what works best as far as being efficient at work and having quality time at home. At the end of every day I ask myself, “What worked well today? What didn’t work well? What else can I do to maximize time with my family?” I am slowly becoming more efficient, but it has been a challenge. During fellowship, your day is pretty set, but once you are practicing on your own, your hours and responsibilities are completely different, and you have to figure out what works best for you, your values, and your expectations of private life. It takes some time, and I am still figuring it out.

Dr. Culligan: How often would you say that you bring work home? I try hard once I am home to quit working, but sometimes on the weekends I break that rule.

Dr. Matthews: I must say that I do feel like there are certain times when I am better at that than others. Work comes in waves with pressing deadlines. If I averaged it out, probably a third of the time I have some email or some conference call or something that I have got to do at home. I do really try to limit the obligations that I have after 5:30 or 6:00 pm. I resent intrusions after that time. As far as weekends, I delegate about one weekend every 2 months to work, instead of doing a little bit every weekend.

Dr. Greene: I agree. I try hard to make 5:30 to 7:30 pm unequivocal time for a family dinner and time for my kids. During that time, I do not have my phone near me so I can’t look at email or texts. I try not to schedule conference calls. I try to be there to read books to my kids at night. Then if I need to do work, I do it later at night, which interferes with time with my spouse, and is not ideal, but that’s what happens.

Dr. Matthews: One of the things that I think is a huge part of work-life balance is work-related travel. When you are present at work on a consistent basis, the work does not pile up to the extent that it does when you are absent on a trip. When you come back, you invariably pay the price by seeing more patients and doing more surgery. Then it becomes a stressful event.

My advice to young people is to be very thoughtful about planning trips, especially distant ones. You do not want to sit on a plane all day when you could be doing something more productive. If I could have done something differently in my mid-career, I would have traveled less.

Continue to: Prioritizing “out of office” time...

Dr. Greene: How do you all mentally separate yourself from work, so that when you are on vacation with your family you are not thinking about the office, the patients, and all of the things on your to-do list?

Dr. Rardin: I don’t have a great answer for that except that it is about being present. You have to decide that now is the time when I am home, now is the time when I am a parent, now is the time when I am a boy scout leader, etc. I guess maybe it’s a skill, or maybe it’s about making something a priority. Work will always be waiting for you when you turn your attention back to it.

Dr. Matthews: Kristie, the answer to your question goes back to community. Partners in a practice cover for each other. You have to trust them to take care of things so that you can relax during your time away.

Some people recommend not scheduling challenging cases right before going away because invariably something goes wrong, and then you are asking, “Why did I schedule 3 colpopexies before getting on a plane?”

Dr. Rardin: Yes, I completely agree with all of that. Personally, I feel fortunate that I can compartmentalize pretty well. When I am home with my kids, I allow myself to shed some of the doctor/surgeon/leadership persona; I am able to be goofy and completely non–doctor-like. It works to help me leave work behind.

Dr. Matthews: Other things you can do include setting up an out-of-office notice on your email that says when you will be back and what to do in case of urgent matters. This basically says to the world, “Don’t expect to hear from me until X date.” It removes the expectation that you will respond sooner. Otherwise, we would all be on our smartphones all the time and not enjoying our time away.

What I wish I knew then

Dr. Culligan: How would you complete the sentence, “I wish they had told me X when I was embarking on my career?”

Dr. Rardin: I keep coming back to the phrase, “Don’t do anything that you can reasonably pay someone else to do.” By that I mean, if you don’t get energy from housework, consider spending some of your money to get help with the housework. Resolve to make a relatively small expenditure to maximize the quality of the time that you give to yourself and your family. Those are the sorts of things that I think can go a long way.

Dr. Culligan: Charley, your wife is an ObGyn. How do you navigate a dual medical career household? What advice do you have for others?

Dr. Rardin: When I was going into fellowship, we had a conversation about how hard it is for both people in a relationship to have an academic fire in the belly and to be truly engaged in climbing the academic ladder. We made a decision that Jane would go into private practice. There has got to be some give and take in a dual medical relationship; a lot of sacrifices and compromises need to happen. We are fortunate in that there are complementary aspects to our jobs. We both spend about the same number of nights away from the house, but my travel is more in chunks and hers is overnight calls for labor and delivery. We have different ways of (briefly) single-parenting, and you have to come up with ways to handle the domestic chores.

Dr. Matthews: I wish someone had explained to me that the people you work with are much more important than the place. The human connection is what defines your experience, much more than any ego-driven outcome.

Dr. Greene: I wish someone had explained to me the competing aspects of academic medicine. The cards are stacked in a way that make it difficult for you to win. For example, you may love to teach and may be really good at it, but if you let your students handle too many cases, your relative value units plummet and then the hospital is on your back. There are the interests of people, and there are the interests of the business. Everything is a balance, and it’s really tricky.

Dr. Huber: Luckily, Pat counselled me as I was finishing my fellowship about the importance of negotiating a good contract, of being pushy and knowing what you want out of it and knowing what your limitations are. I joined a private practice that had 3 different physical locations. If I had to drive to all of them, as they wanted, it would have meant up to a one-and-a-half-hour commute. But I pushed to stay in one location and to put that extra hour to better use. I am glad I did, but it was terrifying at the time because I didn’t want to lose the offer. I know people that did not do that and took the first thing they got. Now, they are driving all over the place or they have these crazy hours or terrible call responsibilities that if they had just been a little firmer, they probably could have gotten out of. As they start trying to find work-life balance, they are already handicapped.

Continue to: Passions outside the office...

Passions outside the office

Dr. Culligan: One thing I would like to touch on is what is going on in each of your personal lives because all of you have interesting stories to tell outside of what you do professionally. What drives you other than medicine?

Dr. Rardin: I am the father of 3 boys. The oldest one just got his Eagle Scout rank yesterday in Boy Scouts. I would be a woodworker if I wasn’t in medicine. I am a Deacon at church. And I love to spend my downtime reading with my family in front of the fireplace.

Dr. Matthews: For me, it’s music. When my husband and I first met, he asked me if I played a musical instrument. I said I played the cello in primary school. He said, “Great, go rent a cello.” I was never at all interested in playing the cello by myself, but because he plays guitar and piano we became able to play a lot of music together. Our son, Alexander, plays drums. We now have a family band.

In addition, I do yoga. I would never have labeled myself an anxious person, but I learned through this process that I am and need to manage it. It took a lot of years to figure that out. If I don’t leave myself an hour each day to go to a yoga class, I am not a happy person and neither is anyone around me. Also, I get tremendous pleasure from reading books and magazines as opposed to watching a screen.

Dr. Greene: I have found that my passions outside of work often change depending on my stage of life. Right now, I have two young babies and so my life outside of work revolves around them. Before the babies, my dad, who lives in Buffalo, was ill. So for awhile, we were flying to Buffalo almost every weekend that I was not on call. I would say, in general what fuels me is connecting with the people I love as often as I can. A typical night involves me and my husband going for a walk with our kids and dog after dinner and talking to each other. We connect with neighbors and chat on the front porch. It doesn’t really matter what we are doing; it is about being surrounded by people who matter.

Dr. Huber: It’s similar for me. Having a child completely shifts your world view. My goal every day is to give my daughter her first feeding in the morning and to get home as soon as possible at the end of the day to do her last feeding and put her to sleep. She crawled for the first time yesterday, and I was so excited that I could be there for that.

Also, I love being outdoors. I love hiking and camping. Going on a hike and being outside with nature is my way of decompressing.

Continue to: Thinking about upcoming generations...

Dr. Matthews: One other thing I would like to propose is looking at what can we do to make the profession better for the next generation. As a group, our profession is somewhat inflexible. We tend to fall into the trap of, “since this is the way we have always done it this is how we should continue doing it.” The OR still starts at 7:00 or 7:30 am, ignoring the need for school drop-offs, etc. We are not innovative about flexibility in the work week. Honestly, it does not work well for many people, patients and physicians alike. Flexible scheduling should be something that is on the table for both men and women who are trying to balance being full-time parents and full-time surgeons. We need to create an environment in which it is okay for you to spend 10 years instead of 6 as an assistant professor because you are also a young parent, and it will not count against you when you come up for promotion.

Dr. Culligan: I agree with you, Catherine. Full “Professor” is a nice title, but it means time away from family and a lot of other things. Each of us has to decide whether it is worth it, especially since it often does not come with any extra money.

Dr. Huber: A question on a recent survey of residents asked, “Do you see yourself going into private practice or academic medicine when you’ve completed your residency?” When I was a resident, everyone wanted to go into academic medicine, but now it seems like more and more residents have their sights set on private practice because that is where they see the opportunities to create work-life balance.

In the academic world, you have to try to get a promotion in X number of years, and get X number of publications, and be a great teacher, doctor, and administrator all at the same time. I am wondering if we are going to start seeing more and more residents and fellows going into private or hospital-owned practice where there aren’t those added expectations.

Dr. Rardin: I agree, and we are back to what we said in the beginning about doing an honest assessment of what is meaningful and important. We are all trained to try to reach for that shiny brass ring, but do we really want that brass ring? Will it be an asset or a hindrance once we get it? It is okay to be honest and say, “I really don’t want that promotion. I would rather spend more time with my family.” ●

Patrick J. Culligan, MD: We all know that burnout is an important problem among surgeons. In fact, it seems that, in the United States, we are working longer hours than ever before, and that higher education correlates with less balance in life. This dysfunction seems to start in school, when we are encouraged to be competitive, and overwork just becomes another way to compete. It’s very easy to get swept up in the traditional model of academic medicine, the engine of which is competition and overwork.

My impression of our younger colleagues, however, is that many of them are not attracted to the traditional ivory tower research model of academic advancement to which many in previous generations aspired. They seem more concerned with work-life balance as their measure of success rather than the classic metrics of money and prestige. Everyone still needs role models and mentors, though, and that’s where all of you come in. I asked each of you to be on this panel because I admire you for your varying approaches to work-life balance while achieving success as gynecologic surgeons. I thought others in the field might be inspired by hearing your stories.

Cultivating your passions

Kristie Greene, MD: What I have come to learn and appreciate is a really simple point: you do not have to do everything. Determining who you want to be both personally and professionally is step 1.

Granted, answering the question, “Who do I want to be?” is not as simple as it sounds. Many factors figure into the decisions we make in our personal and professional lives. Also, it is not a question we often stop and ask ourselves. From early on, we are placed on an escalator moving up through medical school, residency, fellowship, good job, better job, etc. We are so accustomed to being competitive, to winning, and to wanting to be the best that we sometimes forget to ask ourselves, “What is it exactly that I want, and why? What is my endpoint? And does it make me happy?”

Multitasking is regarded as a talent. As much as we would like to believe that we can do everything at the same time and do it all well, we actually can’t. A friend of mine made me read a book a couple of years ago, called Feeling Good, by David Burns. The book encourages you to consider the different tasks you do in a day and rate how good you are at each of them on a scale of 1 to 10. It then asks you to think about how much enjoyment you derive from each of the tasks and about why you are doing the ones that bring you little to no enjoyment.

I ultimately decided that, for me professionally, the most important thing was my interest in global health. So I decided to do whatever it took to make this happen. But you don’t get something for nothing, and everything comes with sacrifices.

Continue to: Charles Rardin, MD...

Charles Rardin, MD: How exactly did you decide that you were going to focus your career toward pursuing international health? How did you know it was more important? And how did you overcome some of those obstacles?

Dr. Greene: You have to ask the hard question again about what brings you the most joy professionally and personally. That was the easy part of it for me because global health has always been that source of happiness and fulfillment for me. The more challenging parts are the sacrifices and hard choices that come with it. With global health, it can be difficult to balance the demands of a clinical practice.

All of our jobs are a business. I am still struggling with the money part of it. For my husband and I, that meant we had to start small—do what we could afford. But then it blossomed into something that was involving residents, fellows, and med students, which requires far more funding than we had. So I reached out to family. Most of our families donate to different organizations or charities every year, so why not donate to a loved one for something they are passionate about?

At the University of South Florida (USF), we set up a fund, a foundation for global health, which helps support our work abroad as well as the costs associated with involvement of our trainees. Right now, what we have is still small potatoes to a country, but we are making it happen by starting at a small level and growing it.

Beyond the money aspect, traveling abroad means less involvement in meetings, missed opportunities to teach courses that might interest me, and time away from my family. I guess my advice on this whole thing is that you can make things happen if they are important enough to you, and if you are willing to make sacrifices in other areas because you can’t have it all.

Making time for you

Dr. Culligan: So you have found what is important to you, and you have found a way to make it happen. But you are faced with more work; you have given yourself additional work on top of your regular work. How do you make time for a personal life?

Catherine Matthews, MD: In preparing for this discussion, I decided to break down my advice into 3 buckets: The first bucket is discovering and knowing your authentic self. The second is building a community, which I’ll elaborate on. And the third, which we have discussed, is to let go of the money.

Dr. Culligan: I love the concept of the authentic self, but how does that jive with a tendency to strive for perfection? We all think we can do it all. How do we narrow down to what really matters?

Dr. Matthews: We often focus on the things that bring us happiness and what we are good at, but it’s the things that make us unhappy that tend to bring us down. It’s the presence of unhappiness, not the absence of happiness, that seems to be the undoing of many, including myself.

None of us are born with dramatic insight. It is experience that leads to insight. People who are actually present are able to gain insight through observation. A person becomes a better surgeon by observing the outcome of doing a stitch this way versus that; you learn how to do it by seeing what it looks like afterward.

Finding our authentic selves happens in much the same way. Having the presence of mind to ask the right questions, such as, “How am I feeling while I’m doing this?” leads to insights into the true self.

Continue to: It takes a village...

Dr. Greene: Catherine mentioned community earlier, and that is extremely important. The people who surround us can have a huge impact on the way we perceive things, including ourselves. Having a mix of people in our lives—some who practice medicine and others who don’t—helps us stay balanced and answer some of the tough questions. Catherine, for example, has helped me in various stages of my career to ask myself meaningful questions and get real answers.

Dr. Rardin: Part of finding balance is luck, and part of it is making a choice between money and everything else. In considering my first job out of training, I knew that money had the potential to distract me from what was important to me. So I chose a position that was almost entirely salaried so that the decisions I made clinically, surgically, and regarding work-life balance would be less likely to directly impact what was important to me.

Sally Huber, MD: I am still in the “getting there” phase of my life, but one thing I have found is that getting my family involved and excited about what I do has made them much more accepting of when I have longer work days or work to do on the weekend. My spouse has become quite involved with what I have been doing with transgender health in Atlanta. It has been a great bonding experience; she shares my passions, and together we are creating something about which we both can be proud.

When work invades home life

Dr. Culligan: That is great. Sally, I think when we talked, you were just learning about the necessity of mental separation and of not taking your work home with you, which is so hard for all of us with all of our devices.

Dr. Huber: Yes, this year has been about seeing what works best as far as being efficient at work and having quality time at home. At the end of every day I ask myself, “What worked well today? What didn’t work well? What else can I do to maximize time with my family?” I am slowly becoming more efficient, but it has been a challenge. During fellowship, your day is pretty set, but once you are practicing on your own, your hours and responsibilities are completely different, and you have to figure out what works best for you, your values, and your expectations of private life. It takes some time, and I am still figuring it out.

Dr. Culligan: How often would you say that you bring work home? I try hard once I am home to quit working, but sometimes on the weekends I break that rule.

Dr. Matthews: I must say that I do feel like there are certain times when I am better at that than others. Work comes in waves with pressing deadlines. If I averaged it out, probably a third of the time I have some email or some conference call or something that I have got to do at home. I do really try to limit the obligations that I have after 5:30 or 6:00 pm. I resent intrusions after that time. As far as weekends, I delegate about one weekend every 2 months to work, instead of doing a little bit every weekend.

Dr. Greene: I agree. I try hard to make 5:30 to 7:30 pm unequivocal time for a family dinner and time for my kids. During that time, I do not have my phone near me so I can’t look at email or texts. I try not to schedule conference calls. I try to be there to read books to my kids at night. Then if I need to do work, I do it later at night, which interferes with time with my spouse, and is not ideal, but that’s what happens.

Dr. Matthews: One of the things that I think is a huge part of work-life balance is work-related travel. When you are present at work on a consistent basis, the work does not pile up to the extent that it does when you are absent on a trip. When you come back, you invariably pay the price by seeing more patients and doing more surgery. Then it becomes a stressful event.

My advice to young people is to be very thoughtful about planning trips, especially distant ones. You do not want to sit on a plane all day when you could be doing something more productive. If I could have done something differently in my mid-career, I would have traveled less.

Continue to: Prioritizing “out of office” time...

Dr. Greene: How do you all mentally separate yourself from work, so that when you are on vacation with your family you are not thinking about the office, the patients, and all of the things on your to-do list?

Dr. Rardin: I don’t have a great answer for that except that it is about being present. You have to decide that now is the time when I am home, now is the time when I am a parent, now is the time when I am a boy scout leader, etc. I guess maybe it’s a skill, or maybe it’s about making something a priority. Work will always be waiting for you when you turn your attention back to it.

Dr. Matthews: Kristie, the answer to your question goes back to community. Partners in a practice cover for each other. You have to trust them to take care of things so that you can relax during your time away.

Some people recommend not scheduling challenging cases right before going away because invariably something goes wrong, and then you are asking, “Why did I schedule 3 colpopexies before getting on a plane?”

Dr. Rardin: Yes, I completely agree with all of that. Personally, I feel fortunate that I can compartmentalize pretty well. When I am home with my kids, I allow myself to shed some of the doctor/surgeon/leadership persona; I am able to be goofy and completely non–doctor-like. It works to help me leave work behind.

Dr. Matthews: Other things you can do include setting up an out-of-office notice on your email that says when you will be back and what to do in case of urgent matters. This basically says to the world, “Don’t expect to hear from me until X date.” It removes the expectation that you will respond sooner. Otherwise, we would all be on our smartphones all the time and not enjoying our time away.

What I wish I knew then

Dr. Culligan: How would you complete the sentence, “I wish they had told me X when I was embarking on my career?”

Dr. Rardin: I keep coming back to the phrase, “Don’t do anything that you can reasonably pay someone else to do.” By that I mean, if you don’t get energy from housework, consider spending some of your money to get help with the housework. Resolve to make a relatively small expenditure to maximize the quality of the time that you give to yourself and your family. Those are the sorts of things that I think can go a long way.

Dr. Culligan: Charley, your wife is an ObGyn. How do you navigate a dual medical career household? What advice do you have for others?

Dr. Rardin: When I was going into fellowship, we had a conversation about how hard it is for both people in a relationship to have an academic fire in the belly and to be truly engaged in climbing the academic ladder. We made a decision that Jane would go into private practice. There has got to be some give and take in a dual medical relationship; a lot of sacrifices and compromises need to happen. We are fortunate in that there are complementary aspects to our jobs. We both spend about the same number of nights away from the house, but my travel is more in chunks and hers is overnight calls for labor and delivery. We have different ways of (briefly) single-parenting, and you have to come up with ways to handle the domestic chores.

Dr. Matthews: I wish someone had explained to me that the people you work with are much more important than the place. The human connection is what defines your experience, much more than any ego-driven outcome.

Dr. Greene: I wish someone had explained to me the competing aspects of academic medicine. The cards are stacked in a way that make it difficult for you to win. For example, you may love to teach and may be really good at it, but if you let your students handle too many cases, your relative value units plummet and then the hospital is on your back. There are the interests of people, and there are the interests of the business. Everything is a balance, and it’s really tricky.

Dr. Huber: Luckily, Pat counselled me as I was finishing my fellowship about the importance of negotiating a good contract, of being pushy and knowing what you want out of it and knowing what your limitations are. I joined a private practice that had 3 different physical locations. If I had to drive to all of them, as they wanted, it would have meant up to a one-and-a-half-hour commute. But I pushed to stay in one location and to put that extra hour to better use. I am glad I did, but it was terrifying at the time because I didn’t want to lose the offer. I know people that did not do that and took the first thing they got. Now, they are driving all over the place or they have these crazy hours or terrible call responsibilities that if they had just been a little firmer, they probably could have gotten out of. As they start trying to find work-life balance, they are already handicapped.

Continue to: Passions outside the office...

Passions outside the office

Dr. Culligan: One thing I would like to touch on is what is going on in each of your personal lives because all of you have interesting stories to tell outside of what you do professionally. What drives you other than medicine?

Dr. Rardin: I am the father of 3 boys. The oldest one just got his Eagle Scout rank yesterday in Boy Scouts. I would be a woodworker if I wasn’t in medicine. I am a Deacon at church. And I love to spend my downtime reading with my family in front of the fireplace.

Dr. Matthews: For me, it’s music. When my husband and I first met, he asked me if I played a musical instrument. I said I played the cello in primary school. He said, “Great, go rent a cello.” I was never at all interested in playing the cello by myself, but because he plays guitar and piano we became able to play a lot of music together. Our son, Alexander, plays drums. We now have a family band.

In addition, I do yoga. I would never have labeled myself an anxious person, but I learned through this process that I am and need to manage it. It took a lot of years to figure that out. If I don’t leave myself an hour each day to go to a yoga class, I am not a happy person and neither is anyone around me. Also, I get tremendous pleasure from reading books and magazines as opposed to watching a screen.

Dr. Greene: I have found that my passions outside of work often change depending on my stage of life. Right now, I have two young babies and so my life outside of work revolves around them. Before the babies, my dad, who lives in Buffalo, was ill. So for awhile, we were flying to Buffalo almost every weekend that I was not on call. I would say, in general what fuels me is connecting with the people I love as often as I can. A typical night involves me and my husband going for a walk with our kids and dog after dinner and talking to each other. We connect with neighbors and chat on the front porch. It doesn’t really matter what we are doing; it is about being surrounded by people who matter.

Dr. Huber: It’s similar for me. Having a child completely shifts your world view. My goal every day is to give my daughter her first feeding in the morning and to get home as soon as possible at the end of the day to do her last feeding and put her to sleep. She crawled for the first time yesterday, and I was so excited that I could be there for that.

Also, I love being outdoors. I love hiking and camping. Going on a hike and being outside with nature is my way of decompressing.

Continue to: Thinking about upcoming generations...

Dr. Matthews: One other thing I would like to propose is looking at what can we do to make the profession better for the next generation. As a group, our profession is somewhat inflexible. We tend to fall into the trap of, “since this is the way we have always done it this is how we should continue doing it.” The OR still starts at 7:00 or 7:30 am, ignoring the need for school drop-offs, etc. We are not innovative about flexibility in the work week. Honestly, it does not work well for many people, patients and physicians alike. Flexible scheduling should be something that is on the table for both men and women who are trying to balance being full-time parents and full-time surgeons. We need to create an environment in which it is okay for you to spend 10 years instead of 6 as an assistant professor because you are also a young parent, and it will not count against you when you come up for promotion.

Dr. Culligan: I agree with you, Catherine. Full “Professor” is a nice title, but it means time away from family and a lot of other things. Each of us has to decide whether it is worth it, especially since it often does not come with any extra money.

Dr. Huber: A question on a recent survey of residents asked, “Do you see yourself going into private practice or academic medicine when you’ve completed your residency?” When I was a resident, everyone wanted to go into academic medicine, but now it seems like more and more residents have their sights set on private practice because that is where they see the opportunities to create work-life balance.

In the academic world, you have to try to get a promotion in X number of years, and get X number of publications, and be a great teacher, doctor, and administrator all at the same time. I am wondering if we are going to start seeing more and more residents and fellows going into private or hospital-owned practice where there aren’t those added expectations.

Dr. Rardin: I agree, and we are back to what we said in the beginning about doing an honest assessment of what is meaningful and important. We are all trained to try to reach for that shiny brass ring, but do we really want that brass ring? Will it be an asset or a hindrance once we get it? It is okay to be honest and say, “I really don’t want that promotion. I would rather spend more time with my family.” ●

© TRENDOBJECTS/SHUTTERSTOCK

I often say that there are both “guardrail” days and very good days when it comes to the ins and outs of health care builds and product launches. The process is much like starting down the path of a country road in the middle of a blizzard—unless you have dependable wipers and a good defrost system, that path can get murky very quickly. With this article I hope to offer my counsel to inventors, featuring a few of my prior launches as well as case studies of health care launches I was not involved with, and sharing the lessons learned and hurdles that were overcome. I encourage all entrepreneurs to act on their ideas because, in the world of health care startups, the only failure is not acting on an invention.

Case study 1: Cerezyme

Today, Cerezyme is indicated for patients with Gaucher, which is a lysosomal storage disorder. Cerezyme’s first-generation product, called Ceredase, was a human tissue-derived protein that we extracted from human placentas. At the time, the concept of moving this program forward was denied by the Board of Directors because they said that even if you could collect enough placentas to make the enzyme, it would be too expensive to manufacture. In fact, early scale-up modeling for manufacturing the protein demonstrated that Genzyme would need 4 tons of placentas per Gaucher patient per year.

Gaucher is a severe, early-onset disease that has a significant negative outcome for patients. Patients with Gaucher are in dire need of treatment. Genzyme went forward with the Ceredase program by financing it through the families of patients with the disease, by starting an LLC separate from the business and funding the initial clinical trial and the development of the protein through the families of Gaucher patients. That approach was a successful endeavor. A great example of a creative capital structure to advance a program.

This was in the late 1980s/early 1990s, and at the height of the AIDS challenge. Genzyme based the manufacturing in Lille, France, and we cryopreserved placentas in the United States and Europe and shipped them to Lille to be processed into therapy. Genzyme eventually received approval for Ceredase from the US Food and Drug Administration (FDA) and the European Medicines Agency. At the height of the placenta collection, we were gathering about 10% to 15% of the placentas in the United States and 30% to 40% of the placentas in Europe. Resources supply became an issue until we developed a recombinant form of the protein, accomplished by using a manufacturing system called a CHO cell line.

This is a very good success story: If this invention was not pursued, Gaucher patients would not benefit from the treatment today. In addition, there are a plethora of patients with different lysosomal storage disorders treated with additional proteins that have been aided by us going through the entire development, manufacturing, and global commercialization process. We figured out how to manufacture and deliver the treatment, working through multiple countries’ political systems, and today the therapy is paid for by insurance and government systems on a worldwide basis.

Continue to: Case study 2...

Case study 2: ThinPrep

I like to use the approval of ThinPrep as an example of avoiding a false negative—a stoppage in the development of the product or drug for the wrong reasons. False negatives, in my mind, occur when you are developing a technology and you run into issues during the clinical phase and/or with FDA approval, or with a technical failure or you run out of capital prior to knowing whether or not the innovation actually works. In the case of ThinPrep, a poorly run clinical trial almost resulted in a false negative.

The company at the time was Cytyc, and an initial clinical study presented to the FDA yielded a neutral-negative outcome. The FDA said that there were not enough data to show the differentiation from the current Pap smear standard of care.

The founders of the company at that time had inherited the study protocol from a prior leadership team, so they had to finish the trial with the initial protocol. Given the FDA’s advisement, they developed a new trial. It took the persistence of these two founders, who mortgaged their homes and spent their personal dollars to take this through the next wave of clinical development. In the end it was successful. The revised clinical trial yielded an approval for ThinPrep, which is now considered a standard of care.

The use of ThinPrep reduced cervical cancer deaths by 40% from preapproval. The challenging path from clinical development to eventual commercial launch and physician leadership in advancing patient care makes the story of ThinPrep a great example of not allowing an early false negative of a poorly designed and run clinical trial stop important innovation.

Case study 3: Cologuard

The development of Cologuard is a case study demonstrating that, sometimes, when your first attempt does not work, you need to have the persistence to raise additional capital and/or use a slightly different technical approach. The approval story of Cologuard is important to share because it is an important cancer screening diagnostic, using DNA from stool samples to test for colon cancer, giving access to important colon cancer screening to many patients. Currently, caregivers are only scraping the surface with Cologuard’s ability to screen the population. There are many more patients that need access to the test, and I believe they will get it in the years ahead.

Cologuard went through a first- and second-generational technical failure. They could not get the test’s specificity and sensitivity to be at the level of a screening tool; there were too many false-positive results. With the third iteration came the technical breakthrough, and a very large, expensive study was conducted—one the leadership team was criticized for. However, that study yielded the data that achieved a New England Journal of Medicine article, and reimbursement support across the country. The combination of the right technical team and the right leadership team, who planned a proper commercial launch, with a CEO that supported the extensive clinical study, has resulted in the fourth generation of Cologuard—an important breakthrough offering a very useful new standard of care in colon cancer detection and screening.

Continue to: Pearls for moving your innovations forward...

Pearls for moving your innovations forward

Because of my experience in undergoing health care start-ups, and contributing to several of those advancements of innovation, many inventors approach me for advice on their paths from idea to full-concept company. Here are a few of my lessons learned.

Consider purpose, not financial gain, first and foremost. Financial gain is typically the by-product or outcome of a standard-of-care breakthrough for inventors, but it’s a very hard road. Pursue your invention for advancing patient care and moving a new standard of care forward in health care versus financial gain at the end.

Determine whether your invention is a product or a company, or potentially, not capitalizable at all. Figure this out early. Analyze your idea to make sure it is sound and truly novel. Analyze the competition and to make sure it is sound and truly novel. Analyze the competition and the market dynamics to support a new product. Can the development path be defined very clearly to raise capital? Is your innovation a big enough breakthrough in the market with several current products to actually make a difference in patient outcomes (and eventually achieve product reimbursement)? The creation of a company may be the right strategy if the innovation can support a differentiated enough breakthrough where you can actually support all the infrastructure to build the business. If you find that the market is not there to support and develop your idea to eventual success, backing off early is important to preserve invested capital.

Protect early. Is your invention patentable, or has someone else already thought of the idea? What kind of patent(s) are appropriate? Where, geographically, do you want to protect your invention? Find a good patent attorney in your local area, early in the process, to help you answer all of these critical questions. Patents are expensive to file and maintain, but it is not expensive to do a literature search to find out if your idea is novel. A provisional patent, which would be your first step, is an important cost-effective step.

Capital is out there. If your invention or idea deserves capital, it is available. I will address raising capital in more detail in the next section.

Consider regulatory and manufacturing as achievable hurdles. Inventors often get tripped up here, considering the regulatory hurdles and manufacturing too challenging and abandoning their ideas because the risk is too great. Regulatory and manufacturing are very important aspects of health care standard-of-care builds. Cutting corners is not an option. That said, regulatory and manufacturing should not stop you. Challenges often can be worked through as long as the clinical need is there, and the clinical data support bringing that technology forward.

Consider corporate partnerships. I am a fan of corporate partners. But which ones should you target, and when and why? Corporate partnerships can bring significant capital, which is great, but there is enough investor capital out there that you should not pursue a corporate partner just for capital. The main benefit of a corporate partner is enterprise intellect. They typically know more about the field that you are entering than the investors or a small company leadership team.

Establish and listen to advisors. When thinking about who to trust, research their track record. Advisors who have gone through this process before, and specifically in your product area, are important to have access to.

Persistence is key. I have observed a tremendous “compression of innovation” in the health care areas that I have been involved with—human tissue-derived proteins, robotic surgery, stem cell therapy, and digital health (which is still in its infancy). For each of these breakthrough categories, early on, it appeared that it couldn’t be done. However, after the first 2 or 3 major breakthroughs in each one of these areas, a compression of innovation occurred. For instance, after approximately 15 years of protein development, we came out with the recombinant manufacturing systems for proteins. Very quickly, within 10 years, there were more than 70 proteins on the market. The persistence of the inventors to overcome early obstacles in each of these health care areas was critical to future success in each area.

Continue to: Raising capital...

Raising capital

There are different investors who specialize in different types of investment opportunities. The first phase of raising capital is the seed round—where there is typically early data, or even no data and just a concept. From this seed round forward, there is less risk as you develop your technology; thus, there are different investors that support different stages of development and that specialize in different types of investing. It is important to target the right investors and raise enough capital to be able to go achieve multiple operational milestones. Otherwise, when you go through your first round of capital, or the Series A or B financing rounds, there may not be a set of investors out there to fund the company moving forward. Health care investors will make it known that they invest in certain rounds of capital. You can determine who those investors are by doing a search online.

A mistake health care inventors can make is not taking enough capital from investors, because they are concerned about dilution. I advise investors not to focus on dilution but rather on, how big can you make “the pie” (value of the company) worth? The entire process is about bringing a true product through to a new standard-of-care curve.

Trust is the most important thing to earn with investors, and there is zero tolerance for a lack of trust. Share your vision as the inventor with investors, who want to know where this category could be in the next 5 or 10 years. Clinical data will always win, and health care investors and industry leaders should be focused on executing the most robust clinical data to demonstrate the clearest potential clinical outcome. Investors will follow a good plan that has been developed to achieve FDA approval, successful commercialization or “go to market” launch, and eventual reimbursement to support a true standard-of-care change.

Failure is defined by inaction

The 3 case studies that I have shared were success stories because the ideas and inventions were acted upon. When I was at Genzyme, we built the company up to more than $1 billion in revenue. We commercialized proteins in over 50 countries. Most importantly, many patients benefited from the innovation. If you have an invention and an idea, act on it—and surround yourself with great people in every discipline. Having the right people and team is extremely important. ●

© TRENDOBJECTS/SHUTTERSTOCK

I often say that there are both “guardrail” days and very good days when it comes to the ins and outs of health care builds and product launches. The process is much like starting down the path of a country road in the middle of a blizzard—unless you have dependable wipers and a good defrost system, that path can get murky very quickly. With this article I hope to offer my counsel to inventors, featuring a few of my prior launches as well as case studies of health care launches I was not involved with, and sharing the lessons learned and hurdles that were overcome. I encourage all entrepreneurs to act on their ideas because, in the world of health care startups, the only failure is not acting on an invention.

Case study 1: Cerezyme

Today, Cerezyme is indicated for patients with Gaucher, which is a lysosomal storage disorder. Cerezyme’s first-generation product, called Ceredase, was a human tissue-derived protein that we extracted from human placentas. At the time, the concept of moving this program forward was denied by the Board of Directors because they said that even if you could collect enough placentas to make the enzyme, it would be too expensive to manufacture. In fact, early scale-up modeling for manufacturing the protein demonstrated that Genzyme would need 4 tons of placentas per Gaucher patient per year.

Gaucher is a severe, early-onset disease that has a significant negative outcome for patients. Patients with Gaucher are in dire need of treatment. Genzyme went forward with the Ceredase program by financing it through the families of patients with the disease, by starting an LLC separate from the business and funding the initial clinical trial and the development of the protein through the families of Gaucher patients. That approach was a successful endeavor. A great example of a creative capital structure to advance a program.

This was in the late 1980s/early 1990s, and at the height of the AIDS challenge. Genzyme based the manufacturing in Lille, France, and we cryopreserved placentas in the United States and Europe and shipped them to Lille to be processed into therapy. Genzyme eventually received approval for Ceredase from the US Food and Drug Administration (FDA) and the European Medicines Agency. At the height of the placenta collection, we were gathering about 10% to 15% of the placentas in the United States and 30% to 40% of the placentas in Europe. Resources supply became an issue until we developed a recombinant form of the protein, accomplished by using a manufacturing system called a CHO cell line.

This is a very good success story: If this invention was not pursued, Gaucher patients would not benefit from the treatment today. In addition, there are a plethora of patients with different lysosomal storage disorders treated with additional proteins that have been aided by us going through the entire development, manufacturing, and global commercialization process. We figured out how to manufacture and deliver the treatment, working through multiple countries’ political systems, and today the therapy is paid for by insurance and government systems on a worldwide basis.

Continue to: Case study 2...

Case study 2: ThinPrep

I like to use the approval of ThinPrep as an example of avoiding a false negative—a stoppage in the development of the product or drug for the wrong reasons. False negatives, in my mind, occur when you are developing a technology and you run into issues during the clinical phase and/or with FDA approval, or with a technical failure or you run out of capital prior to knowing whether or not the innovation actually works. In the case of ThinPrep, a poorly run clinical trial almost resulted in a false negative.

The company at the time was Cytyc, and an initial clinical study presented to the FDA yielded a neutral-negative outcome. The FDA said that there were not enough data to show the differentiation from the current Pap smear standard of care.

The founders of the company at that time had inherited the study protocol from a prior leadership team, so they had to finish the trial with the initial protocol. Given the FDA’s advisement, they developed a new trial. It took the persistence of these two founders, who mortgaged their homes and spent their personal dollars to take this through the next wave of clinical development. In the end it was successful. The revised clinical trial yielded an approval for ThinPrep, which is now considered a standard of care.

The use of ThinPrep reduced cervical cancer deaths by 40% from preapproval. The challenging path from clinical development to eventual commercial launch and physician leadership in advancing patient care makes the story of ThinPrep a great example of not allowing an early false negative of a poorly designed and run clinical trial stop important innovation.

Case study 3: Cologuard

The development of Cologuard is a case study demonstrating that, sometimes, when your first attempt does not work, you need to have the persistence to raise additional capital and/or use a slightly different technical approach. The approval story of Cologuard is important to share because it is an important cancer screening diagnostic, using DNA from stool samples to test for colon cancer, giving access to important colon cancer screening to many patients. Currently, caregivers are only scraping the surface with Cologuard’s ability to screen the population. There are many more patients that need access to the test, and I believe they will get it in the years ahead.

Cologuard went through a first- and second-generational technical failure. They could not get the test’s specificity and sensitivity to be at the level of a screening tool; there were too many false-positive results. With the third iteration came the technical breakthrough, and a very large, expensive study was conducted—one the leadership team was criticized for. However, that study yielded the data that achieved a New England Journal of Medicine article, and reimbursement support across the country. The combination of the right technical team and the right leadership team, who planned a proper commercial launch, with a CEO that supported the extensive clinical study, has resulted in the fourth generation of Cologuard—an important breakthrough offering a very useful new standard of care in colon cancer detection and screening.

Continue to: Pearls for moving your innovations forward...

Pearls for moving your innovations forward

Because of my experience in undergoing health care start-ups, and contributing to several of those advancements of innovation, many inventors approach me for advice on their paths from idea to full-concept company. Here are a few of my lessons learned.

Consider purpose, not financial gain, first and foremost. Financial gain is typically the by-product or outcome of a standard-of-care breakthrough for inventors, but it’s a very hard road. Pursue your invention for advancing patient care and moving a new standard of care forward in health care versus financial gain at the end.

Determine whether your invention is a product or a company, or potentially, not capitalizable at all. Figure this out early. Analyze your idea to make sure it is sound and truly novel. Analyze the competition and to make sure it is sound and truly novel. Analyze the competition and the market dynamics to support a new product. Can the development path be defined very clearly to raise capital? Is your innovation a big enough breakthrough in the market with several current products to actually make a difference in patient outcomes (and eventually achieve product reimbursement)? The creation of a company may be the right strategy if the innovation can support a differentiated enough breakthrough where you can actually support all the infrastructure to build the business. If you find that the market is not there to support and develop your idea to eventual success, backing off early is important to preserve invested capital.

Protect early. Is your invention patentable, or has someone else already thought of the idea? What kind of patent(s) are appropriate? Where, geographically, do you want to protect your invention? Find a good patent attorney in your local area, early in the process, to help you answer all of these critical questions. Patents are expensive to file and maintain, but it is not expensive to do a literature search to find out if your idea is novel. A provisional patent, which would be your first step, is an important cost-effective step.

Capital is out there. If your invention or idea deserves capital, it is available. I will address raising capital in more detail in the next section.

Consider regulatory and manufacturing as achievable hurdles. Inventors often get tripped up here, considering the regulatory hurdles and manufacturing too challenging and abandoning their ideas because the risk is too great. Regulatory and manufacturing are very important aspects of health care standard-of-care builds. Cutting corners is not an option. That said, regulatory and manufacturing should not stop you. Challenges often can be worked through as long as the clinical need is there, and the clinical data support bringing that technology forward.

Consider corporate partnerships. I am a fan of corporate partners. But which ones should you target, and when and why? Corporate partnerships can bring significant capital, which is great, but there is enough investor capital out there that you should not pursue a corporate partner just for capital. The main benefit of a corporate partner is enterprise intellect. They typically know more about the field that you are entering than the investors or a small company leadership team.

Establish and listen to advisors. When thinking about who to trust, research their track record. Advisors who have gone through this process before, and specifically in your product area, are important to have access to.

Persistence is key. I have observed a tremendous “compression of innovation” in the health care areas that I have been involved with—human tissue-derived proteins, robotic surgery, stem cell therapy, and digital health (which is still in its infancy). For each of these breakthrough categories, early on, it appeared that it couldn’t be done. However, after the first 2 or 3 major breakthroughs in each one of these areas, a compression of innovation occurred. For instance, after approximately 15 years of protein development, we came out with the recombinant manufacturing systems for proteins. Very quickly, within 10 years, there were more than 70 proteins on the market. The persistence of the inventors to overcome early obstacles in each of these health care areas was critical to future success in each area.

Continue to: Raising capital...

Raising capital

There are different investors who specialize in different types of investment opportunities. The first phase of raising capital is the seed round—where there is typically early data, or even no data and just a concept. From this seed round forward, there is less risk as you develop your technology; thus, there are different investors that support different stages of development and that specialize in different types of investing. It is important to target the right investors and raise enough capital to be able to go achieve multiple operational milestones. Otherwise, when you go through your first round of capital, or the Series A or B financing rounds, there may not be a set of investors out there to fund the company moving forward. Health care investors will make it known that they invest in certain rounds of capital. You can determine who those investors are by doing a search online.

A mistake health care inventors can make is not taking enough capital from investors, because they are concerned about dilution. I advise investors not to focus on dilution but rather on, how big can you make “the pie” (value of the company) worth? The entire process is about bringing a true product through to a new standard-of-care curve.

Trust is the most important thing to earn with investors, and there is zero tolerance for a lack of trust. Share your vision as the inventor with investors, who want to know where this category could be in the next 5 or 10 years. Clinical data will always win, and health care investors and industry leaders should be focused on executing the most robust clinical data to demonstrate the clearest potential clinical outcome. Investors will follow a good plan that has been developed to achieve FDA approval, successful commercialization or “go to market” launch, and eventual reimbursement to support a true standard-of-care change.

Failure is defined by inaction

The 3 case studies that I have shared were success stories because the ideas and inventions were acted upon. When I was at Genzyme, we built the company up to more than $1 billion in revenue. We commercialized proteins in over 50 countries. Most importantly, many patients benefited from the innovation. If you have an invention and an idea, act on it—and surround yourself with great people in every discipline. Having the right people and team is extremely important. ●

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I often say that there are both “guardrail” days and very good days when it comes to the ins and outs of health care builds and product launches. The process is much like starting down the path of a country road in the middle of a blizzard—unless you have dependable wipers and a good defrost system, that path can get murky very quickly. With this article I hope to offer my counsel to inventors, featuring a few of my prior launches as well as case studies of health care launches I was not involved with, and sharing the lessons learned and hurdles that were overcome. I encourage all entrepreneurs to act on their ideas because, in the world of health care startups, the only failure is not acting on an invention.

Case study 1: Cerezyme

Today, Cerezyme is indicated for patients with Gaucher, which is a lysosomal storage disorder. Cerezyme’s first-generation product, called Ceredase, was a human tissue-derived protein that we extracted from human placentas. At the time, the concept of moving this program forward was denied by the Board of Directors because they said that even if you could collect enough placentas to make the enzyme, it would be too expensive to manufacture. In fact, early scale-up modeling for manufacturing the protein demonstrated that Genzyme would need 4 tons of placentas per Gaucher patient per year.

Gaucher is a severe, early-onset disease that has a significant negative outcome for patients. Patients with Gaucher are in dire need of treatment. Genzyme went forward with the Ceredase program by financing it through the families of patients with the disease, by starting an LLC separate from the business and funding the initial clinical trial and the development of the protein through the families of Gaucher patients. That approach was a successful endeavor. A great example of a creative capital structure to advance a program.

This was in the late 1980s/early 1990s, and at the height of the AIDS challenge. Genzyme based the manufacturing in Lille, France, and we cryopreserved placentas in the United States and Europe and shipped them to Lille to be processed into therapy. Genzyme eventually received approval for Ceredase from the US Food and Drug Administration (FDA) and the European Medicines Agency. At the height of the placenta collection, we were gathering about 10% to 15% of the placentas in the United States and 30% to 40% of the placentas in Europe. Resources supply became an issue until we developed a recombinant form of the protein, accomplished by using a manufacturing system called a CHO cell line.

This is a very good success story: If this invention was not pursued, Gaucher patients would not benefit from the treatment today. In addition, there are a plethora of patients with different lysosomal storage disorders treated with additional proteins that have been aided by us going through the entire development, manufacturing, and global commercialization process. We figured out how to manufacture and deliver the treatment, working through multiple countries’ political systems, and today the therapy is paid for by insurance and government systems on a worldwide basis.

Continue to: Case study 2...

Case study 2: ThinPrep

I like to use the approval of ThinPrep as an example of avoiding a false negative—a stoppage in the development of the product or drug for the wrong reasons. False negatives, in my mind, occur when you are developing a technology and you run into issues during the clinical phase and/or with FDA approval, or with a technical failure or you run out of capital prior to knowing whether or not the innovation actually works. In the case of ThinPrep, a poorly run clinical trial almost resulted in a false negative.

The company at the time was Cytyc, and an initial clinical study presented to the FDA yielded a neutral-negative outcome. The FDA said that there were not enough data to show the differentiation from the current Pap smear standard of care.

The founders of the company at that time had inherited the study protocol from a prior leadership team, so they had to finish the trial with the initial protocol. Given the FDA’s advisement, they developed a new trial. It took the persistence of these two founders, who mortgaged their homes and spent their personal dollars to take this through the next wave of clinical development. In the end it was successful. The revised clinical trial yielded an approval for ThinPrep, which is now considered a standard of care.

The use of ThinPrep reduced cervical cancer deaths by 40% from preapproval. The challenging path from clinical development to eventual commercial launch and physician leadership in advancing patient care makes the story of ThinPrep a great example of not allowing an early false negative of a poorly designed and run clinical trial stop important innovation.

Case study 3: Cologuard

The development of Cologuard is a case study demonstrating that, sometimes, when your first attempt does not work, you need to have the persistence to raise additional capital and/or use a slightly different technical approach. The approval story of Cologuard is important to share because it is an important cancer screening diagnostic, using DNA from stool samples to test for colon cancer, giving access to important colon cancer screening to many patients. Currently, caregivers are only scraping the surface with Cologuard’s ability to screen the population. There are many more patients that need access to the test, and I believe they will get it in the years ahead.

Cologuard went through a first- and second-generational technical failure. They could not get the test’s specificity and sensitivity to be at the level of a screening tool; there were too many false-positive results. With the third iteration came the technical breakthrough, and a very large, expensive study was conducted—one the leadership team was criticized for. However, that study yielded the data that achieved a New England Journal of Medicine article, and reimbursement support across the country. The combination of the right technical team and the right leadership team, who planned a proper commercial launch, with a CEO that supported the extensive clinical study, has resulted in the fourth generation of Cologuard—an important breakthrough offering a very useful new standard of care in colon cancer detection and screening.

Continue to: Pearls for moving your innovations forward...

Pearls for moving your innovations forward

Because of my experience in undergoing health care start-ups, and contributing to several of those advancements of innovation, many inventors approach me for advice on their paths from idea to full-concept company. Here are a few of my lessons learned.

Consider purpose, not financial gain, first and foremost. Financial gain is typically the by-product or outcome of a standard-of-care breakthrough for inventors, but it’s a very hard road. Pursue your invention for advancing patient care and moving a new standard of care forward in health care versus financial gain at the end.

Determine whether your invention is a product or a company, or potentially, not capitalizable at all. Figure this out early. Analyze your idea to make sure it is sound and truly novel. Analyze the competition and to make sure it is sound and truly novel. Analyze the competition and the market dynamics to support a new product. Can the development path be defined very clearly to raise capital? Is your innovation a big enough breakthrough in the market with several current products to actually make a difference in patient outcomes (and eventually achieve product reimbursement)? The creation of a company may be the right strategy if the innovation can support a differentiated enough breakthrough where you can actually support all the infrastructure to build the business. If you find that the market is not there to support and develop your idea to eventual success, backing off early is important to preserve invested capital.

Protect early. Is your invention patentable, or has someone else already thought of the idea? What kind of patent(s) are appropriate? Where, geographically, do you want to protect your invention? Find a good patent attorney in your local area, early in the process, to help you answer all of these critical questions. Patents are expensive to file and maintain, but it is not expensive to do a literature search to find out if your idea is novel. A provisional patent, which would be your first step, is an important cost-effective step.

Capital is out there. If your invention or idea deserves capital, it is available. I will address raising capital in more detail in the next section.

Consider regulatory and manufacturing as achievable hurdles. Inventors often get tripped up here, considering the regulatory hurdles and manufacturing too challenging and abandoning their ideas because the risk is too great. Regulatory and manufacturing are very important aspects of health care standard-of-care builds. Cutting corners is not an option. That said, regulatory and manufacturing should not stop you. Challenges often can be worked through as long as the clinical need is there, and the clinical data support bringing that technology forward.

Consider corporate partnerships. I am a fan of corporate partners. But which ones should you target, and when and why? Corporate partnerships can bring significant capital, which is great, but there is enough investor capital out there that you should not pursue a corporate partner just for capital. The main benefit of a corporate partner is enterprise intellect. They typically know more about the field that you are entering than the investors or a small company leadership team.

Establish and listen to advisors. When thinking about who to trust, research their track record. Advisors who have gone through this process before, and specifically in your product area, are important to have access to.

Persistence is key. I have observed a tremendous “compression of innovation” in the health care areas that I have been involved with—human tissue-derived proteins, robotic surgery, stem cell therapy, and digital health (which is still in its infancy). For each of these breakthrough categories, early on, it appeared that it couldn’t be done. However, after the first 2 or 3 major breakthroughs in each one of these areas, a compression of innovation occurred. For instance, after approximately 15 years of protein development, we came out with the recombinant manufacturing systems for proteins. Very quickly, within 10 years, there were more than 70 proteins on the market. The persistence of the inventors to overcome early obstacles in each of these health care areas was critical to future success in each area.

Continue to: Raising capital...

Raising capital

There are different investors who specialize in different types of investment opportunities. The first phase of raising capital is the seed round—where there is typically early data, or even no data and just a concept. From this seed round forward, there is less risk as you develop your technology; thus, there are different investors that support different stages of development and that specialize in different types of investing. It is important to target the right investors and raise enough capital to be able to go achieve multiple operational milestones. Otherwise, when you go through your first round of capital, or the Series A or B financing rounds, there may not be a set of investors out there to fund the company moving forward. Health care investors will make it known that they invest in certain rounds of capital. You can determine who those investors are by doing a search online.

A mistake health care inventors can make is not taking enough capital from investors, because they are concerned about dilution. I advise investors not to focus on dilution but rather on, how big can you make “the pie” (value of the company) worth? The entire process is about bringing a true product through to a new standard-of-care curve.

Trust is the most important thing to earn with investors, and there is zero tolerance for a lack of trust. Share your vision as the inventor with investors, who want to know where this category could be in the next 5 or 10 years. Clinical data will always win, and health care investors and industry leaders should be focused on executing the most robust clinical data to demonstrate the clearest potential clinical outcome. Investors will follow a good plan that has been developed to achieve FDA approval, successful commercialization or “go to market” launch, and eventual reimbursement to support a true standard-of-care change.

Failure is defined by inaction

The 3 case studies that I have shared were success stories because the ideas and inventions were acted upon. When I was at Genzyme, we built the company up to more than $1 billion in revenue. We commercialized proteins in over 50 countries. Most importantly, many patients benefited from the innovation. If you have an invention and an idea, act on it—and surround yourself with great people in every discipline. Having the right people and team is extremely important. ●