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Beware of private equity–owned nursing homes: study
When you have to help a parent choose a nursing home or you need nursing home care yourself, you can consult a health care professional, talk to friends, or look at the Nursing Home Compare website of the Centers for Medicare and Medicaid Services (CMS). The CMS website includes star ratings for each nursing home, both overall and on health inspections, staffing and certain quality measures.
But what you might not know is what financial incentives a particular nursing home might have to provide high-quality care, depending on what kind of entity owns the facility.
According to the study, you can expect a somewhat lower level of quality in a PE-owned nursing home than in other for-profit facilities.
The researchers compared CMS data on 302 nursing homes owned by 79 PE firms to data on 9,562 for-profit facilities not owned by such companies from 2013 to 2017. Among fee-for-service Medicare patients in long-term care, private equity acquisitions of nursing homes were associated with an 11.1% increase in ambulatory-care-sensitive (ACS) visits to the emergency department (ED) and an 8.7% increase in ACS hospitalizations per quarter, compared to the changes that occurred in the non-PE-owned facilities, they found.
What’s more, Medicare costs per beneficiary increased 3.9% more – or about $1,000 a year – in the PE-owned nursing homes than they did in the other cohort during the study period.
And when the acquired nursing homes were compared to the nursing homes prior to their acquisition by PE firms, there were no statistically significant differences in unadjusted outcomes, the researchers found. That means the two cohorts were broadly comparable.
The researchers adjusted the numbers in their study for various characteristics of the facilities and their residents. For example, the PE-acquired nursing homes were likely to have a higher percentage of patients covered by Medicare and a lower percentage covered by Medicaid than their non-PE counterparts.
The mean percentages of Black residents, female residents, and residents aged 85 or older were 12.4%, 65.4%, and 36.2%, respectively, for the PE-owned nursing homes and 15.7%, 67.8%, and 39%, respectively, for the non–PE-owned facilities.
Less than optimal outcomes
On average, the residents of non–PE-owned nursing homes had better outcomes than did the patients in the PE-owned facilities. But that doesn’t mean that the average for-profit nursing home had terrific outcomes.
For all the nursing homes in the study, the mean quarterly rate of ACS emergency department visits was 14.1%, and the mean quarterly rate of ACS hospitalizations was 17.3%.
“These events should be largely, although not completely, preventable with appropriate care,” the researchers pointed out.
To date, PE firms have invested about $750 billion in U.S. health care, with nursing homes being a major target of these companies, which currently own 5% of skilled nursing facilities, per the study. PE companies seek annual returns of 20% or more, the paper says, and thus feel pressure to generate high short-term profits. That could lead to reduced staffing, services, supplies, or equipment in their facilities.
Some nursing homes purchased by PE firms may be responsible for the debt incurred in their own leveraged buyouts, the researchers noted. There is also concern that PE firms may focus their properties disproportionately on short-term post-acute care, which is reimbursed at a higher rate than long-term care, the study says.
For all these reasons, some health policy makers are concerned about the long-term impact of private-equity nursing home acquisitions, according to the study.
A version of this article first appeared on WebMD.com.
When you have to help a parent choose a nursing home or you need nursing home care yourself, you can consult a health care professional, talk to friends, or look at the Nursing Home Compare website of the Centers for Medicare and Medicaid Services (CMS). The CMS website includes star ratings for each nursing home, both overall and on health inspections, staffing and certain quality measures.
But what you might not know is what financial incentives a particular nursing home might have to provide high-quality care, depending on what kind of entity owns the facility.
According to the study, you can expect a somewhat lower level of quality in a PE-owned nursing home than in other for-profit facilities.
The researchers compared CMS data on 302 nursing homes owned by 79 PE firms to data on 9,562 for-profit facilities not owned by such companies from 2013 to 2017. Among fee-for-service Medicare patients in long-term care, private equity acquisitions of nursing homes were associated with an 11.1% increase in ambulatory-care-sensitive (ACS) visits to the emergency department (ED) and an 8.7% increase in ACS hospitalizations per quarter, compared to the changes that occurred in the non-PE-owned facilities, they found.
What’s more, Medicare costs per beneficiary increased 3.9% more – or about $1,000 a year – in the PE-owned nursing homes than they did in the other cohort during the study period.
And when the acquired nursing homes were compared to the nursing homes prior to their acquisition by PE firms, there were no statistically significant differences in unadjusted outcomes, the researchers found. That means the two cohorts were broadly comparable.
The researchers adjusted the numbers in their study for various characteristics of the facilities and their residents. For example, the PE-acquired nursing homes were likely to have a higher percentage of patients covered by Medicare and a lower percentage covered by Medicaid than their non-PE counterparts.
The mean percentages of Black residents, female residents, and residents aged 85 or older were 12.4%, 65.4%, and 36.2%, respectively, for the PE-owned nursing homes and 15.7%, 67.8%, and 39%, respectively, for the non–PE-owned facilities.
Less than optimal outcomes
On average, the residents of non–PE-owned nursing homes had better outcomes than did the patients in the PE-owned facilities. But that doesn’t mean that the average for-profit nursing home had terrific outcomes.
For all the nursing homes in the study, the mean quarterly rate of ACS emergency department visits was 14.1%, and the mean quarterly rate of ACS hospitalizations was 17.3%.
“These events should be largely, although not completely, preventable with appropriate care,” the researchers pointed out.
To date, PE firms have invested about $750 billion in U.S. health care, with nursing homes being a major target of these companies, which currently own 5% of skilled nursing facilities, per the study. PE companies seek annual returns of 20% or more, the paper says, and thus feel pressure to generate high short-term profits. That could lead to reduced staffing, services, supplies, or equipment in their facilities.
Some nursing homes purchased by PE firms may be responsible for the debt incurred in their own leveraged buyouts, the researchers noted. There is also concern that PE firms may focus their properties disproportionately on short-term post-acute care, which is reimbursed at a higher rate than long-term care, the study says.
For all these reasons, some health policy makers are concerned about the long-term impact of private-equity nursing home acquisitions, according to the study.
A version of this article first appeared on WebMD.com.
When you have to help a parent choose a nursing home or you need nursing home care yourself, you can consult a health care professional, talk to friends, or look at the Nursing Home Compare website of the Centers for Medicare and Medicaid Services (CMS). The CMS website includes star ratings for each nursing home, both overall and on health inspections, staffing and certain quality measures.
But what you might not know is what financial incentives a particular nursing home might have to provide high-quality care, depending on what kind of entity owns the facility.
According to the study, you can expect a somewhat lower level of quality in a PE-owned nursing home than in other for-profit facilities.
The researchers compared CMS data on 302 nursing homes owned by 79 PE firms to data on 9,562 for-profit facilities not owned by such companies from 2013 to 2017. Among fee-for-service Medicare patients in long-term care, private equity acquisitions of nursing homes were associated with an 11.1% increase in ambulatory-care-sensitive (ACS) visits to the emergency department (ED) and an 8.7% increase in ACS hospitalizations per quarter, compared to the changes that occurred in the non-PE-owned facilities, they found.
What’s more, Medicare costs per beneficiary increased 3.9% more – or about $1,000 a year – in the PE-owned nursing homes than they did in the other cohort during the study period.
And when the acquired nursing homes were compared to the nursing homes prior to their acquisition by PE firms, there were no statistically significant differences in unadjusted outcomes, the researchers found. That means the two cohorts were broadly comparable.
The researchers adjusted the numbers in their study for various characteristics of the facilities and their residents. For example, the PE-acquired nursing homes were likely to have a higher percentage of patients covered by Medicare and a lower percentage covered by Medicaid than their non-PE counterparts.
The mean percentages of Black residents, female residents, and residents aged 85 or older were 12.4%, 65.4%, and 36.2%, respectively, for the PE-owned nursing homes and 15.7%, 67.8%, and 39%, respectively, for the non–PE-owned facilities.
Less than optimal outcomes
On average, the residents of non–PE-owned nursing homes had better outcomes than did the patients in the PE-owned facilities. But that doesn’t mean that the average for-profit nursing home had terrific outcomes.
For all the nursing homes in the study, the mean quarterly rate of ACS emergency department visits was 14.1%, and the mean quarterly rate of ACS hospitalizations was 17.3%.
“These events should be largely, although not completely, preventable with appropriate care,” the researchers pointed out.
To date, PE firms have invested about $750 billion in U.S. health care, with nursing homes being a major target of these companies, which currently own 5% of skilled nursing facilities, per the study. PE companies seek annual returns of 20% or more, the paper says, and thus feel pressure to generate high short-term profits. That could lead to reduced staffing, services, supplies, or equipment in their facilities.
Some nursing homes purchased by PE firms may be responsible for the debt incurred in their own leveraged buyouts, the researchers noted. There is also concern that PE firms may focus their properties disproportionately on short-term post-acute care, which is reimbursed at a higher rate than long-term care, the study says.
For all these reasons, some health policy makers are concerned about the long-term impact of private-equity nursing home acquisitions, according to the study.
A version of this article first appeared on WebMD.com.
How to deal with offensive or impaired doctors
Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.
Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .
“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.
She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.
After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
Confront, correct, and/or counsel
The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.
Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.
She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.
She also recommends implementing these strategies to prevent and deal with disruptive physicians:
- Implement a code of conduct and share it during interviews;
- Have zero tolerance policies and procedures for documenting behavior;
- Get advice from a good employment attorney;
- Implement written performance improvement plans;
- Provide resources to change the behavior;
- Follow through with suspension and termination; and
- Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.
Getting impaired doctors help
Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.
Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.
She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”
Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.
Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:
- Include “fit for duty” examinations, especially after age 65.
- Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
- Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
- Establish a voting mechanism for terminating a physician.
Aging doctors who won’t retire
Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.
She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.
Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.
She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”
Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.
“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.
A version of this article first appeared on Medscape.com.
Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.
Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .
“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.
She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.
After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
Confront, correct, and/or counsel
The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.
Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.
She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.
She also recommends implementing these strategies to prevent and deal with disruptive physicians:
- Implement a code of conduct and share it during interviews;
- Have zero tolerance policies and procedures for documenting behavior;
- Get advice from a good employment attorney;
- Implement written performance improvement plans;
- Provide resources to change the behavior;
- Follow through with suspension and termination; and
- Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.
Getting impaired doctors help
Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.
Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.
She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”
Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.
Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:
- Include “fit for duty” examinations, especially after age 65.
- Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
- Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
- Establish a voting mechanism for terminating a physician.
Aging doctors who won’t retire
Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.
She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.
Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.
She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”
Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.
“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.
A version of this article first appeared on Medscape.com.
Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.
Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .
“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.
She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.
After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
Confront, correct, and/or counsel
The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.
Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.
She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.
She also recommends implementing these strategies to prevent and deal with disruptive physicians:
- Implement a code of conduct and share it during interviews;
- Have zero tolerance policies and procedures for documenting behavior;
- Get advice from a good employment attorney;
- Implement written performance improvement plans;
- Provide resources to change the behavior;
- Follow through with suspension and termination; and
- Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.
Getting impaired doctors help
Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.
Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.
She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”
Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.
Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:
- Include “fit for duty” examinations, especially after age 65.
- Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
- Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
- Establish a voting mechanism for terminating a physician.
Aging doctors who won’t retire
Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.
She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.
Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.
She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”
Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.
“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.
A version of this article first appeared on Medscape.com.
Medical technology should keep patient in mind
Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.
Threats to the physician-patient relationship
Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.
In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.1
Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.
After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.
Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”2
We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.
Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.
In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.
‘From the Beating End of the Stethoscope’
John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:
I speak, as I say, the patient’s point of view.
But, given time, doctors are patients, too.
And there’s our bond: beyond anatomy,
Or in it, through it, to the mystery
Medicine takes the pulse of and lets go
Forever unexplained. It’s art, we know,
Not science at the heart. Doctor be whole,
I won’t insist the patient is a soul,
But he’s a something, possibly laughable,
Or possibly sublime, but not quite graphable.
Not quite containable on a bed chart.
Where science touches man it turns to art.3
This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.
Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.4 As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.
References
1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1
2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.
3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.
4. Albert Einstein, Out of My Later Years, 1950.
Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.
Threats to the physician-patient relationship
Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.
In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.1
Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.
After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.
Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”2
We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.
Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.
In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.
‘From the Beating End of the Stethoscope’
John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:
I speak, as I say, the patient’s point of view.
But, given time, doctors are patients, too.
And there’s our bond: beyond anatomy,
Or in it, through it, to the mystery
Medicine takes the pulse of and lets go
Forever unexplained. It’s art, we know,
Not science at the heart. Doctor be whole,
I won’t insist the patient is a soul,
But he’s a something, possibly laughable,
Or possibly sublime, but not quite graphable.
Not quite containable on a bed chart.
Where science touches man it turns to art.3
This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.
Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.4 As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.
References
1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1
2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.
3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.
4. Albert Einstein, Out of My Later Years, 1950.
Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.
Threats to the physician-patient relationship
Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.
In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.1
Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.
After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.
Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”2
We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.
Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.
In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.
‘From the Beating End of the Stethoscope’
John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:
I speak, as I say, the patient’s point of view.
But, given time, doctors are patients, too.
And there’s our bond: beyond anatomy,
Or in it, through it, to the mystery
Medicine takes the pulse of and lets go
Forever unexplained. It’s art, we know,
Not science at the heart. Doctor be whole,
I won’t insist the patient is a soul,
But he’s a something, possibly laughable,
Or possibly sublime, but not quite graphable.
Not quite containable on a bed chart.
Where science touches man it turns to art.3
This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.
Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.4 As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.
References
1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1
2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.
3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.
4. Albert Einstein, Out of My Later Years, 1950.
Words from the wise
“When 900-years-old you reach, look as good you will not.” –Yoda
I’ve been on a roll lately: 100, 94, 90, 97, 94. These aren’t grades or even what I scratched on my scorecard for 18 holes (that’s more like 112), but rather patients I’ve seen.
Our oldest-old have been in COVID-19 protection for the last couple of years and only now feel safe to come out again. Many have skin cancers. Some of them have many. I’m grateful that for all their health problems, basal cell carcinomas at least I can cure. And
From a 94-year-old woman who was just discharged from the hospital for sepsis: First, sepsis can sneak up from behind and jump you when you’re 94. She was sitting in a waiting room for a routine exam when she passed out and woke up in the ICU. She made it home and is back on her feet, literally. When I asked her how she made it though, she was very matter of fact. Trust that the doctors know what’s right. Trust that someone will tell you what to do next. Trust that you know your own body and what you can and cannot do. Ask for help, then simply trust it will all work out. It usually does.
From a 97-year-old fighter pilot who fought in the Korean War: Let regrets drop away and live to fight another day. He’s had multiple marriages, built and lost companies, been fired and fired at, and made some doozy mistakes, some that caused considerable pain and collateral damage. But each day is new and requires your best. He has lived long enough to love dozens of grandkids and give away more than what most people ever make. His bottom line, if you worry and fret and regret, you’ll make even more mistakes ahead. Look ahead, the ground never comes up from behind you.
From a 94-year-old whose son was killed in a car accident nearly 60 years ago: You can be both happy and sad. When she retold the story of how the police knocked on her door with the news that her son was dead, she started to cry. Even 60 years isn’t long enough to blunt such pain. She still thinks of him often and to this day sometimes finds it difficult to believe he’s gone. Such pain never leaves you. But she is still a happy person with countless joys and is still having such fun. If you live long enough, both will likely be true.
From a 90-year old who still played tennis: “Just one and one.” That is, one beer and one shot, every day. No more. No less. I daren’t say I recommend this one; however, it might also be the social aspect of drinking that matters. He also advised to be free with friendships. You’ll have many people come in and out of your life; be open to new ones all the time. Also sometimes let your friends win.
From a 100-year-old, I asked how he managed to get through the Great Depression, WWII, civil unrest of the 1950s, and the Vietnam War. His reply? “To be honest, I’ve never seen anything quite like this before.”
When there’s time, consider asking for advice from those elders who happen to have an appointment with you. Bring you wisdom, they will.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
“When 900-years-old you reach, look as good you will not.” –Yoda
I’ve been on a roll lately: 100, 94, 90, 97, 94. These aren’t grades or even what I scratched on my scorecard for 18 holes (that’s more like 112), but rather patients I’ve seen.
Our oldest-old have been in COVID-19 protection for the last couple of years and only now feel safe to come out again. Many have skin cancers. Some of them have many. I’m grateful that for all their health problems, basal cell carcinomas at least I can cure. And
From a 94-year-old woman who was just discharged from the hospital for sepsis: First, sepsis can sneak up from behind and jump you when you’re 94. She was sitting in a waiting room for a routine exam when she passed out and woke up in the ICU. She made it home and is back on her feet, literally. When I asked her how she made it though, she was very matter of fact. Trust that the doctors know what’s right. Trust that someone will tell you what to do next. Trust that you know your own body and what you can and cannot do. Ask for help, then simply trust it will all work out. It usually does.
From a 97-year-old fighter pilot who fought in the Korean War: Let regrets drop away and live to fight another day. He’s had multiple marriages, built and lost companies, been fired and fired at, and made some doozy mistakes, some that caused considerable pain and collateral damage. But each day is new and requires your best. He has lived long enough to love dozens of grandkids and give away more than what most people ever make. His bottom line, if you worry and fret and regret, you’ll make even more mistakes ahead. Look ahead, the ground never comes up from behind you.
From a 94-year-old whose son was killed in a car accident nearly 60 years ago: You can be both happy and sad. When she retold the story of how the police knocked on her door with the news that her son was dead, she started to cry. Even 60 years isn’t long enough to blunt such pain. She still thinks of him often and to this day sometimes finds it difficult to believe he’s gone. Such pain never leaves you. But she is still a happy person with countless joys and is still having such fun. If you live long enough, both will likely be true.
From a 90-year old who still played tennis: “Just one and one.” That is, one beer and one shot, every day. No more. No less. I daren’t say I recommend this one; however, it might also be the social aspect of drinking that matters. He also advised to be free with friendships. You’ll have many people come in and out of your life; be open to new ones all the time. Also sometimes let your friends win.
From a 100-year-old, I asked how he managed to get through the Great Depression, WWII, civil unrest of the 1950s, and the Vietnam War. His reply? “To be honest, I’ve never seen anything quite like this before.”
When there’s time, consider asking for advice from those elders who happen to have an appointment with you. Bring you wisdom, they will.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
“When 900-years-old you reach, look as good you will not.” –Yoda
I’ve been on a roll lately: 100, 94, 90, 97, 94. These aren’t grades or even what I scratched on my scorecard for 18 holes (that’s more like 112), but rather patients I’ve seen.
Our oldest-old have been in COVID-19 protection for the last couple of years and only now feel safe to come out again. Many have skin cancers. Some of them have many. I’m grateful that for all their health problems, basal cell carcinomas at least I can cure. And
From a 94-year-old woman who was just discharged from the hospital for sepsis: First, sepsis can sneak up from behind and jump you when you’re 94. She was sitting in a waiting room for a routine exam when she passed out and woke up in the ICU. She made it home and is back on her feet, literally. When I asked her how she made it though, she was very matter of fact. Trust that the doctors know what’s right. Trust that someone will tell you what to do next. Trust that you know your own body and what you can and cannot do. Ask for help, then simply trust it will all work out. It usually does.
From a 97-year-old fighter pilot who fought in the Korean War: Let regrets drop away and live to fight another day. He’s had multiple marriages, built and lost companies, been fired and fired at, and made some doozy mistakes, some that caused considerable pain and collateral damage. But each day is new and requires your best. He has lived long enough to love dozens of grandkids and give away more than what most people ever make. His bottom line, if you worry and fret and regret, you’ll make even more mistakes ahead. Look ahead, the ground never comes up from behind you.
From a 94-year-old whose son was killed in a car accident nearly 60 years ago: You can be both happy and sad. When she retold the story of how the police knocked on her door with the news that her son was dead, she started to cry. Even 60 years isn’t long enough to blunt such pain. She still thinks of him often and to this day sometimes finds it difficult to believe he’s gone. Such pain never leaves you. But she is still a happy person with countless joys and is still having such fun. If you live long enough, both will likely be true.
From a 90-year old who still played tennis: “Just one and one.” That is, one beer and one shot, every day. No more. No less. I daren’t say I recommend this one; however, it might also be the social aspect of drinking that matters. He also advised to be free with friendships. You’ll have many people come in and out of your life; be open to new ones all the time. Also sometimes let your friends win.
From a 100-year-old, I asked how he managed to get through the Great Depression, WWII, civil unrest of the 1950s, and the Vietnam War. His reply? “To be honest, I’ve never seen anything quite like this before.”
When there’s time, consider asking for advice from those elders who happen to have an appointment with you. Bring you wisdom, they will.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
Surgery offers best chance in cancer but needs more ‘support’
warns a European expert.
In addition, there are many obstacles to the delivery of optimal cancer surgery, says Domenico M. D’Ugo, MD, professor of surgery at the Catholic University of Rome – A. Gemelli Medical School, Rome, Italy.
Dr. D’Ugo, who is president of the European Society of Surgical Oncology (ESSO), calls for a range of measures to improve the quality of cancer surgery and patient access in Europe.
These measures include recognition of surgical oncology as a specialist discipline, greater support for surgical research and innovation, and a greater role for surgery in multidisciplinary care.
The demands were made in open letter that was published by ESSO on Nov. 9 to coincide with the society’s annual meeting, held in Lisbon, Portugal.
The theme of this year’s meeting was the future of cancer surgery in Europe – a future that “holds many promises to make surgical oncology safer, more efficient and minimally invasive,” writes Dr. D’Ugo.
However, ESSO needs the support of European leaders to bring the recommendations to life and, ultimately, to help provide high-quality cancer treatment, he adds. This is particularly important given the upcoming implementation of Europe’s Beating Cancer Plan.
The open letter is addressed to Stella Kyriakides, European commissioner for health and food safety, and Bartosz Arłukowicz, chair of the European Parliament Special Committee on Beating Cancer, among others.
Best chance of cure
“High-quality surgery remains the best chance to cure solid cancer when diagnosed early,” Dr. D’Ugo notes in his letter. It is also the most cost-effective treatment for the majority of nonmetastasized tumors, he writes.
In addition, surgery is “fundamental” to the prevention of cancer in patients with inherited susceptibility and to the diagnosis and staging of cancer, as well as to the treatment of metastatic disease, the preservation of quality of life, and the alleviation of cancer symptoms, he writes.
There is thus a substantial and steadily growing demand for surgical oncology.
It is estimated that approximately 80% of cancer patients will require surgical intervention at some point during the course of their disease, and 45 million surgical procedures will be needed worldwide by 2030.
Dr. D’Ugo says that at present, fewer than a quarter of cancer patients receive safe, affordable, or timely surgery.
It is time to give surgical oncology the political and financial attention it deserves, he argues. He outlines a four-point plan to achieve this.
The first point is to enhance recognition of surgical oncology as a specialist discipline through, for example, the global curriculum proposed by ESSO and the Society of Surgical Oncology in 2016.
At present, only eight countries in Europe recognize surgical oncology as a specialty, and the lack of harmonization is “causing disparities in training, qualifications and practices,” as well as in patient access, Dr. D’Ugo says.
Next is a call to support research and innovation. Despite recent advances, research in cancer surgery “remains highly underfunded in Europe when compared with pharmaceutical research,” he says.
Improved screening and early detection of cancer are the next key area, because when the disease is diagnosed at an early stage, curative surgery has “a greater chance to be successful.”
At present, screening programs in Europe address only colorectal, breast, and cervical cancers, and the uptake remains “low,” he writes.
Lastly, he emphasizes that surgery is “integral” to multidisciplinary care and that outcomes for patients are better in comprehensive cancer centers that support patients throughout the disease pathway.
Dr. D’Ugo suggests that surgical oncologists take on a “bigger role” in multidisciplinary care, and he calls for the certification and accreditation of cancer units to increase and unify standards of care across the region.
D’Ugo has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
warns a European expert.
In addition, there are many obstacles to the delivery of optimal cancer surgery, says Domenico M. D’Ugo, MD, professor of surgery at the Catholic University of Rome – A. Gemelli Medical School, Rome, Italy.
Dr. D’Ugo, who is president of the European Society of Surgical Oncology (ESSO), calls for a range of measures to improve the quality of cancer surgery and patient access in Europe.
These measures include recognition of surgical oncology as a specialist discipline, greater support for surgical research and innovation, and a greater role for surgery in multidisciplinary care.
The demands were made in open letter that was published by ESSO on Nov. 9 to coincide with the society’s annual meeting, held in Lisbon, Portugal.
The theme of this year’s meeting was the future of cancer surgery in Europe – a future that “holds many promises to make surgical oncology safer, more efficient and minimally invasive,” writes Dr. D’Ugo.
However, ESSO needs the support of European leaders to bring the recommendations to life and, ultimately, to help provide high-quality cancer treatment, he adds. This is particularly important given the upcoming implementation of Europe’s Beating Cancer Plan.
The open letter is addressed to Stella Kyriakides, European commissioner for health and food safety, and Bartosz Arłukowicz, chair of the European Parliament Special Committee on Beating Cancer, among others.
Best chance of cure
“High-quality surgery remains the best chance to cure solid cancer when diagnosed early,” Dr. D’Ugo notes in his letter. It is also the most cost-effective treatment for the majority of nonmetastasized tumors, he writes.
In addition, surgery is “fundamental” to the prevention of cancer in patients with inherited susceptibility and to the diagnosis and staging of cancer, as well as to the treatment of metastatic disease, the preservation of quality of life, and the alleviation of cancer symptoms, he writes.
There is thus a substantial and steadily growing demand for surgical oncology.
It is estimated that approximately 80% of cancer patients will require surgical intervention at some point during the course of their disease, and 45 million surgical procedures will be needed worldwide by 2030.
Dr. D’Ugo says that at present, fewer than a quarter of cancer patients receive safe, affordable, or timely surgery.
It is time to give surgical oncology the political and financial attention it deserves, he argues. He outlines a four-point plan to achieve this.
The first point is to enhance recognition of surgical oncology as a specialist discipline through, for example, the global curriculum proposed by ESSO and the Society of Surgical Oncology in 2016.
At present, only eight countries in Europe recognize surgical oncology as a specialty, and the lack of harmonization is “causing disparities in training, qualifications and practices,” as well as in patient access, Dr. D’Ugo says.
Next is a call to support research and innovation. Despite recent advances, research in cancer surgery “remains highly underfunded in Europe when compared with pharmaceutical research,” he says.
Improved screening and early detection of cancer are the next key area, because when the disease is diagnosed at an early stage, curative surgery has “a greater chance to be successful.”
At present, screening programs in Europe address only colorectal, breast, and cervical cancers, and the uptake remains “low,” he writes.
Lastly, he emphasizes that surgery is “integral” to multidisciplinary care and that outcomes for patients are better in comprehensive cancer centers that support patients throughout the disease pathway.
Dr. D’Ugo suggests that surgical oncologists take on a “bigger role” in multidisciplinary care, and he calls for the certification and accreditation of cancer units to increase and unify standards of care across the region.
D’Ugo has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
warns a European expert.
In addition, there are many obstacles to the delivery of optimal cancer surgery, says Domenico M. D’Ugo, MD, professor of surgery at the Catholic University of Rome – A. Gemelli Medical School, Rome, Italy.
Dr. D’Ugo, who is president of the European Society of Surgical Oncology (ESSO), calls for a range of measures to improve the quality of cancer surgery and patient access in Europe.
These measures include recognition of surgical oncology as a specialist discipline, greater support for surgical research and innovation, and a greater role for surgery in multidisciplinary care.
The demands were made in open letter that was published by ESSO on Nov. 9 to coincide with the society’s annual meeting, held in Lisbon, Portugal.
The theme of this year’s meeting was the future of cancer surgery in Europe – a future that “holds many promises to make surgical oncology safer, more efficient and minimally invasive,” writes Dr. D’Ugo.
However, ESSO needs the support of European leaders to bring the recommendations to life and, ultimately, to help provide high-quality cancer treatment, he adds. This is particularly important given the upcoming implementation of Europe’s Beating Cancer Plan.
The open letter is addressed to Stella Kyriakides, European commissioner for health and food safety, and Bartosz Arłukowicz, chair of the European Parliament Special Committee on Beating Cancer, among others.
Best chance of cure
“High-quality surgery remains the best chance to cure solid cancer when diagnosed early,” Dr. D’Ugo notes in his letter. It is also the most cost-effective treatment for the majority of nonmetastasized tumors, he writes.
In addition, surgery is “fundamental” to the prevention of cancer in patients with inherited susceptibility and to the diagnosis and staging of cancer, as well as to the treatment of metastatic disease, the preservation of quality of life, and the alleviation of cancer symptoms, he writes.
There is thus a substantial and steadily growing demand for surgical oncology.
It is estimated that approximately 80% of cancer patients will require surgical intervention at some point during the course of their disease, and 45 million surgical procedures will be needed worldwide by 2030.
Dr. D’Ugo says that at present, fewer than a quarter of cancer patients receive safe, affordable, or timely surgery.
It is time to give surgical oncology the political and financial attention it deserves, he argues. He outlines a four-point plan to achieve this.
The first point is to enhance recognition of surgical oncology as a specialist discipline through, for example, the global curriculum proposed by ESSO and the Society of Surgical Oncology in 2016.
At present, only eight countries in Europe recognize surgical oncology as a specialty, and the lack of harmonization is “causing disparities in training, qualifications and practices,” as well as in patient access, Dr. D’Ugo says.
Next is a call to support research and innovation. Despite recent advances, research in cancer surgery “remains highly underfunded in Europe when compared with pharmaceutical research,” he says.
Improved screening and early detection of cancer are the next key area, because when the disease is diagnosed at an early stage, curative surgery has “a greater chance to be successful.”
At present, screening programs in Europe address only colorectal, breast, and cervical cancers, and the uptake remains “low,” he writes.
Lastly, he emphasizes that surgery is “integral” to multidisciplinary care and that outcomes for patients are better in comprehensive cancer centers that support patients throughout the disease pathway.
Dr. D’Ugo suggests that surgical oncologists take on a “bigger role” in multidisciplinary care, and he calls for the certification and accreditation of cancer units to increase and unify standards of care across the region.
D’Ugo has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pandemic stresses harder on physician moms than physician dads: Study
COVID-19 has been difficult for parents trying to balance careers, home life, and keeping their loved ones safe. A new study indicates that, not only are physicians not immune to these stressors, but the long-term effects could be devastating for health care overall.
In a study published Nov. 11, 2021, in JAMA Network Open , researchers found that stresses to work/life balance and family life caused by the pandemic have differed among men and women physicians.
Physicians and other health care workers have been at the front lines of the COVID-19 pandemic, and their work lives have been the focus of a lot of attention in the media and by researchers. Their family lives, not so much. But physicians have families, and the pandemic has upended almost everything about their lives, particularly where work life and home life intersect. School and day care closures, working from home, working extra hours, or working less – all of these changes have consequences on family life and the mental health of parents who are also physicians.
Findings from a Medscape survey published in early 2021 indicate that more female physicians than male physicians were either “conflicted” or “very conflicted” as parents because of work demands (42% vs. 23%) nearly 6 months into the pandemic.
In the current study, researchers from the University of Michigan, Harvard University, and the Medical University of South Carolina teamed up to investigate gender differences in how work/family factors affected the mental health of early-career physician parents in the United States during the first year of the COVID-19 pandemic. The results suggest that the pandemic has increased gender disparity and added disproportionately to the burden of female physicians.
Managing the household falls mostly on moms
Participants were physicians enrolled in the Intern Health Study, a longitudinal study that regularly surveys medical interns in the United States to assess stress and mood. When researchers compared survey results from before the onset of the pandemic (2018) with later results (2020), they found a striking gender difference in how the pandemic has changed family and work duties for physicians.
The authors of the study pointed out that previous research had found that female physicians take on a greater share of household and childcare duties than male physicians. The current study found that their share had increased with the pandemic. Physician moms are now 30 times more likely to be in charge of these tasks than physician dads.
In families in which both parents were physicians, none of the men said they took the primary role in managing the extra demands caused by the pandemic. In addition, women were twice as likely as men to work primarily from home and to work reduced hours.
The extra stress seems to be taking a toll on women physicians. In the 2020 survey, physician mothers had higher scores for anxiety and depression symptoms, compared with men. Notably, the 2018 survey did not show a significant difference in depression scores between men and women. Nor were there significant differences in depression and anxiety scores between women and men who were not parents or in reports of work/family conflict before and after the pandemic.
In general, the results indicate that the pandemic has only widened the gender gap between women and men physicians when it comes to managing family life and dealing with the stresses of maintaining a suitable work-life balance.
‘Long-term repercussions’ for gender equity in medicine
Although these are serious problems for women physicians and their families, the effects go beyond the home and beyond individuals. Even before the pandemic, women in medicine struggled for parity in career advancement and opportunities as well as in pay, and this new setback could make those challenges even greater.
“Even short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact opportunities for promotion, further exacerbating gender inequalities in compensation and advancement,” the study’s authors wrote.
The potential damage extends to the entire profession and the health care system itself. The profession is already struggling to retain young female physicians, and this situation is likely to make that problem worse and have long-term consequences. Citing data showing that female physicians spend more time with patients and that their patients may have better outcomes, the authors wrote that the consequences of losing more early-career female physicians “could be devastating to the U.S. health care system, particularly in the context of a global pandemic and an impending physician shortage.”
The sample size was small (276 U.S. physicians), and the study relied on self-reported data. The findings suggest that more research on this topic is needed, especially research that includes other demographic factors, such as sexual orientation and ethnicity. The authors recommend that institutional and public policymakers take into account the effects of the pandemic on physician mothers to ensure that recent gains in gender equity for women physicians do not fall victim to COVID-19.
A version of this article first appeared on Medscape.com.
COVID-19 has been difficult for parents trying to balance careers, home life, and keeping their loved ones safe. A new study indicates that, not only are physicians not immune to these stressors, but the long-term effects could be devastating for health care overall.
In a study published Nov. 11, 2021, in JAMA Network Open , researchers found that stresses to work/life balance and family life caused by the pandemic have differed among men and women physicians.
Physicians and other health care workers have been at the front lines of the COVID-19 pandemic, and their work lives have been the focus of a lot of attention in the media and by researchers. Their family lives, not so much. But physicians have families, and the pandemic has upended almost everything about their lives, particularly where work life and home life intersect. School and day care closures, working from home, working extra hours, or working less – all of these changes have consequences on family life and the mental health of parents who are also physicians.
Findings from a Medscape survey published in early 2021 indicate that more female physicians than male physicians were either “conflicted” or “very conflicted” as parents because of work demands (42% vs. 23%) nearly 6 months into the pandemic.
In the current study, researchers from the University of Michigan, Harvard University, and the Medical University of South Carolina teamed up to investigate gender differences in how work/family factors affected the mental health of early-career physician parents in the United States during the first year of the COVID-19 pandemic. The results suggest that the pandemic has increased gender disparity and added disproportionately to the burden of female physicians.
Managing the household falls mostly on moms
Participants were physicians enrolled in the Intern Health Study, a longitudinal study that regularly surveys medical interns in the United States to assess stress and mood. When researchers compared survey results from before the onset of the pandemic (2018) with later results (2020), they found a striking gender difference in how the pandemic has changed family and work duties for physicians.
The authors of the study pointed out that previous research had found that female physicians take on a greater share of household and childcare duties than male physicians. The current study found that their share had increased with the pandemic. Physician moms are now 30 times more likely to be in charge of these tasks than physician dads.
In families in which both parents were physicians, none of the men said they took the primary role in managing the extra demands caused by the pandemic. In addition, women were twice as likely as men to work primarily from home and to work reduced hours.
The extra stress seems to be taking a toll on women physicians. In the 2020 survey, physician mothers had higher scores for anxiety and depression symptoms, compared with men. Notably, the 2018 survey did not show a significant difference in depression scores between men and women. Nor were there significant differences in depression and anxiety scores between women and men who were not parents or in reports of work/family conflict before and after the pandemic.
In general, the results indicate that the pandemic has only widened the gender gap between women and men physicians when it comes to managing family life and dealing with the stresses of maintaining a suitable work-life balance.
‘Long-term repercussions’ for gender equity in medicine
Although these are serious problems for women physicians and their families, the effects go beyond the home and beyond individuals. Even before the pandemic, women in medicine struggled for parity in career advancement and opportunities as well as in pay, and this new setback could make those challenges even greater.
“Even short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact opportunities for promotion, further exacerbating gender inequalities in compensation and advancement,” the study’s authors wrote.
The potential damage extends to the entire profession and the health care system itself. The profession is already struggling to retain young female physicians, and this situation is likely to make that problem worse and have long-term consequences. Citing data showing that female physicians spend more time with patients and that their patients may have better outcomes, the authors wrote that the consequences of losing more early-career female physicians “could be devastating to the U.S. health care system, particularly in the context of a global pandemic and an impending physician shortage.”
The sample size was small (276 U.S. physicians), and the study relied on self-reported data. The findings suggest that more research on this topic is needed, especially research that includes other demographic factors, such as sexual orientation and ethnicity. The authors recommend that institutional and public policymakers take into account the effects of the pandemic on physician mothers to ensure that recent gains in gender equity for women physicians do not fall victim to COVID-19.
A version of this article first appeared on Medscape.com.
COVID-19 has been difficult for parents trying to balance careers, home life, and keeping their loved ones safe. A new study indicates that, not only are physicians not immune to these stressors, but the long-term effects could be devastating for health care overall.
In a study published Nov. 11, 2021, in JAMA Network Open , researchers found that stresses to work/life balance and family life caused by the pandemic have differed among men and women physicians.
Physicians and other health care workers have been at the front lines of the COVID-19 pandemic, and their work lives have been the focus of a lot of attention in the media and by researchers. Their family lives, not so much. But physicians have families, and the pandemic has upended almost everything about their lives, particularly where work life and home life intersect. School and day care closures, working from home, working extra hours, or working less – all of these changes have consequences on family life and the mental health of parents who are also physicians.
Findings from a Medscape survey published in early 2021 indicate that more female physicians than male physicians were either “conflicted” or “very conflicted” as parents because of work demands (42% vs. 23%) nearly 6 months into the pandemic.
In the current study, researchers from the University of Michigan, Harvard University, and the Medical University of South Carolina teamed up to investigate gender differences in how work/family factors affected the mental health of early-career physician parents in the United States during the first year of the COVID-19 pandemic. The results suggest that the pandemic has increased gender disparity and added disproportionately to the burden of female physicians.
Managing the household falls mostly on moms
Participants were physicians enrolled in the Intern Health Study, a longitudinal study that regularly surveys medical interns in the United States to assess stress and mood. When researchers compared survey results from before the onset of the pandemic (2018) with later results (2020), they found a striking gender difference in how the pandemic has changed family and work duties for physicians.
The authors of the study pointed out that previous research had found that female physicians take on a greater share of household and childcare duties than male physicians. The current study found that their share had increased with the pandemic. Physician moms are now 30 times more likely to be in charge of these tasks than physician dads.
In families in which both parents were physicians, none of the men said they took the primary role in managing the extra demands caused by the pandemic. In addition, women were twice as likely as men to work primarily from home and to work reduced hours.
The extra stress seems to be taking a toll on women physicians. In the 2020 survey, physician mothers had higher scores for anxiety and depression symptoms, compared with men. Notably, the 2018 survey did not show a significant difference in depression scores between men and women. Nor were there significant differences in depression and anxiety scores between women and men who were not parents or in reports of work/family conflict before and after the pandemic.
In general, the results indicate that the pandemic has only widened the gender gap between women and men physicians when it comes to managing family life and dealing with the stresses of maintaining a suitable work-life balance.
‘Long-term repercussions’ for gender equity in medicine
Although these are serious problems for women physicians and their families, the effects go beyond the home and beyond individuals. Even before the pandemic, women in medicine struggled for parity in career advancement and opportunities as well as in pay, and this new setback could make those challenges even greater.
“Even short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact opportunities for promotion, further exacerbating gender inequalities in compensation and advancement,” the study’s authors wrote.
The potential damage extends to the entire profession and the health care system itself. The profession is already struggling to retain young female physicians, and this situation is likely to make that problem worse and have long-term consequences. Citing data showing that female physicians spend more time with patients and that their patients may have better outcomes, the authors wrote that the consequences of losing more early-career female physicians “could be devastating to the U.S. health care system, particularly in the context of a global pandemic and an impending physician shortage.”
The sample size was small (276 U.S. physicians), and the study relied on self-reported data. The findings suggest that more research on this topic is needed, especially research that includes other demographic factors, such as sexual orientation and ethnicity. The authors recommend that institutional and public policymakers take into account the effects of the pandemic on physician mothers to ensure that recent gains in gender equity for women physicians do not fall victim to COVID-19.
A version of this article first appeared on Medscape.com.
New Mexico oncologist faces legal woes once again
A New Mexico oncologist has once again found himself at odds with the law.
Mohamed Aswad, MD, was still under probation for a past misdemeanor involving misbranded cancer drugs when he allegedly underdosed chemotherapy in a patient with colon cancer. The patient later died.
In a wrongful death case, a jury has awarded $2.3 million in damages to the patient’s wife. The patient, James Hoag, was diagnosed with stage IIIB colon cancer in 2015. He underwent surgery and then went for chemotherapy to Dr. Aswad, who was the only oncologist in the area.
Mr. Hoag’s attorneys alleged that
“It was statistically likely that James would beat his cancer with proper treatment,” said his lawyers during the trial, according to a report in the Albuquerque Journal.
The jury deliberated for only 4 hours, and found that negligence by Dr. Aswad was a proximate cause of the patient’s “lost chance to avoid the loss of his life and resulting damages,” and the jury further described Dr. Aswad’s actions as “wanton,” according to a verdict form filed in the case.
The form also shows that the jury decided Dr. Aswad had obtained Mr. Hoag’s informed consent as to the treatment, but still felt that negligence was a cause of Mr. Hoag’s injury and damages. The original judgment of $2.9 million in damages was subsequently reduced to $2.3 million as the jury found Mr. Hoag was 30% responsible for his injuries.
Dr. Aswad could not be reached for comment. The Albuquerque Journal reports that he plans to appeal the verdict.
Only oncologist in the county
The patient had lived in the rural community of Deming, N.M. following his retirement from a career in law enforcement in Michigan. He was diagnosed with colon cancer in 2015, underwent surgical resection, and then went to Dr. Aswad for follow-up chemotherapy.
Dr. Aswad was the only oncologist in the area. Like many other rural communities throughout the United States, this region has a severe shortage of medical specialists.
Sheila Hoag, the patient’s widow, testified during the trial that following her husband’s surgery in August 2015, which removed the tumor, his “prognosis was very good because they had caught it before it spread.” He had an estimated 5-year survival of about 69%.
However, even though Dr. Aswad followed the National Comprehensive Cancer Network (NCCN) guidelines for adjuvant chemotherapy, he did not use the proper dosing. According to trial testimony, he administered “woefully lower doses” than are recommended, and also exceeded the recommended 6-month duration of chemotherapy by more than double. In addition, Dr. Aswad also failed to adequately monitor the disease during treatment, said Hoag’s lawyers.
Aswad has denied the charges and says that he prescribed a modified regimen spread out over a longer period of time because his patient had requested it. He said that Mr. Hoag did not want to undergo chemotherapy that could cause significant side effects, and this was the reason for the altered treatment plan.
However, the chemotherapy failed to slow the cancer’s progression, and Mr. Hoag never returned to see him after November 2016.
By December 2017, Mr. Hoag had been hospitalized and was being treated by another oncologist, located in Las Cruces, 62 miles away from his home. The new oncologist administered the standard treatment, but by then his cancer had metastasized. Mr. Hoag died in 2020 at age 59.
Previous misdemeanor with misbranded drugs
At the time he was treating Mr. Hoag, Dr. Aswad was on federal probation after pleading guilty in 2014 to one misdemeanor count of the unlawful introduction of misbranded drugs into interstate commerce.
Dr. Aswad had treated cancer patients with a “misbranded” drug imported from abroad and not approved by the U.S. Food and Drug Administration (FDA). Altuzan is a form of bevacizumab that is approved for use in Turkey but not the United States. Between July 2010 and April 2012, Dr. Aswad ordered prescription cancer drugs, including Altuzan, from a Canadian company and then administered the “misbranded” drugs to his patients.
A prescription drug is considered to be “misbranded” if it is manufactured in a facility that has not been registered with the FDA for commercial distribution within the United States.
According to various media reports, Dr. Aswad paid significantly less for these drugs than he would have if had he purchased the U.S.-approved product bearing the same brand or generic name, and then billed federal programs such as Medicare for the full price. He has admitted to making just under $1.3 million in profits.
Under the terms of the plea agreement, he was sentenced to three years of probation, required to pay just under $1.3 million in restitution to Medicare and Tricare, the victims of his criminal conduct, and also to forfeit $750,000, which represented part of his net criminal proceeds, to the United States.
At the trial, Dr. Aswad denied that there was any profit motive in extending Mr. Hoag’s treatment, and in a 2019 deposition, he also denied he was under financial pressure to increase his billings because of the $2 million debt that he owed because of the misbranded drugs fine.
Allowed to resume practice
In late 2015, Dr. Aswad was essentially barred by the federal government from accepting any reimbursement from Medicaid or Medicare for a minimum of 13 years. But because of the urgent need for medical specialists, the New Mexico Human Services Department requested a waiver that would permit him to continuing treating cancer patients since he is the only oncologist in Luna County.
He is currently allowed to treat Medicaid and Medicare patients in four other medically underserved New Mexico counties.
Dr. Aswad, a graduate of the University of Aleppo, in Syria, had an internal medicine residency at Our Lady of Mercy Hospital in New York City, where he also had a fellowship in oncology and hematology. He then settled in Deming and has been licensed in New Mexico since 2003.
With the onset of the COVID-19 pandemic, which caused major disruption to healthcare services, Medicare & Medicaid Services officials requested that Dr. Aswad also be allowed to provide internal medicine services for Medicare patients in Catron and Hildalgo counties for the “duration of the Coronavirus Disease 2019 public health emergency declared by the federal government in January 2020.”
A version of this article first appeared on Medscape.com.
A New Mexico oncologist has once again found himself at odds with the law.
Mohamed Aswad, MD, was still under probation for a past misdemeanor involving misbranded cancer drugs when he allegedly underdosed chemotherapy in a patient with colon cancer. The patient later died.
In a wrongful death case, a jury has awarded $2.3 million in damages to the patient’s wife. The patient, James Hoag, was diagnosed with stage IIIB colon cancer in 2015. He underwent surgery and then went for chemotherapy to Dr. Aswad, who was the only oncologist in the area.
Mr. Hoag’s attorneys alleged that
“It was statistically likely that James would beat his cancer with proper treatment,” said his lawyers during the trial, according to a report in the Albuquerque Journal.
The jury deliberated for only 4 hours, and found that negligence by Dr. Aswad was a proximate cause of the patient’s “lost chance to avoid the loss of his life and resulting damages,” and the jury further described Dr. Aswad’s actions as “wanton,” according to a verdict form filed in the case.
The form also shows that the jury decided Dr. Aswad had obtained Mr. Hoag’s informed consent as to the treatment, but still felt that negligence was a cause of Mr. Hoag’s injury and damages. The original judgment of $2.9 million in damages was subsequently reduced to $2.3 million as the jury found Mr. Hoag was 30% responsible for his injuries.
Dr. Aswad could not be reached for comment. The Albuquerque Journal reports that he plans to appeal the verdict.
Only oncologist in the county
The patient had lived in the rural community of Deming, N.M. following his retirement from a career in law enforcement in Michigan. He was diagnosed with colon cancer in 2015, underwent surgical resection, and then went to Dr. Aswad for follow-up chemotherapy.
Dr. Aswad was the only oncologist in the area. Like many other rural communities throughout the United States, this region has a severe shortage of medical specialists.
Sheila Hoag, the patient’s widow, testified during the trial that following her husband’s surgery in August 2015, which removed the tumor, his “prognosis was very good because they had caught it before it spread.” He had an estimated 5-year survival of about 69%.
However, even though Dr. Aswad followed the National Comprehensive Cancer Network (NCCN) guidelines for adjuvant chemotherapy, he did not use the proper dosing. According to trial testimony, he administered “woefully lower doses” than are recommended, and also exceeded the recommended 6-month duration of chemotherapy by more than double. In addition, Dr. Aswad also failed to adequately monitor the disease during treatment, said Hoag’s lawyers.
Aswad has denied the charges and says that he prescribed a modified regimen spread out over a longer period of time because his patient had requested it. He said that Mr. Hoag did not want to undergo chemotherapy that could cause significant side effects, and this was the reason for the altered treatment plan.
However, the chemotherapy failed to slow the cancer’s progression, and Mr. Hoag never returned to see him after November 2016.
By December 2017, Mr. Hoag had been hospitalized and was being treated by another oncologist, located in Las Cruces, 62 miles away from his home. The new oncologist administered the standard treatment, but by then his cancer had metastasized. Mr. Hoag died in 2020 at age 59.
Previous misdemeanor with misbranded drugs
At the time he was treating Mr. Hoag, Dr. Aswad was on federal probation after pleading guilty in 2014 to one misdemeanor count of the unlawful introduction of misbranded drugs into interstate commerce.
Dr. Aswad had treated cancer patients with a “misbranded” drug imported from abroad and not approved by the U.S. Food and Drug Administration (FDA). Altuzan is a form of bevacizumab that is approved for use in Turkey but not the United States. Between July 2010 and April 2012, Dr. Aswad ordered prescription cancer drugs, including Altuzan, from a Canadian company and then administered the “misbranded” drugs to his patients.
A prescription drug is considered to be “misbranded” if it is manufactured in a facility that has not been registered with the FDA for commercial distribution within the United States.
According to various media reports, Dr. Aswad paid significantly less for these drugs than he would have if had he purchased the U.S.-approved product bearing the same brand or generic name, and then billed federal programs such as Medicare for the full price. He has admitted to making just under $1.3 million in profits.
Under the terms of the plea agreement, he was sentenced to three years of probation, required to pay just under $1.3 million in restitution to Medicare and Tricare, the victims of his criminal conduct, and also to forfeit $750,000, which represented part of his net criminal proceeds, to the United States.
At the trial, Dr. Aswad denied that there was any profit motive in extending Mr. Hoag’s treatment, and in a 2019 deposition, he also denied he was under financial pressure to increase his billings because of the $2 million debt that he owed because of the misbranded drugs fine.
Allowed to resume practice
In late 2015, Dr. Aswad was essentially barred by the federal government from accepting any reimbursement from Medicaid or Medicare for a minimum of 13 years. But because of the urgent need for medical specialists, the New Mexico Human Services Department requested a waiver that would permit him to continuing treating cancer patients since he is the only oncologist in Luna County.
He is currently allowed to treat Medicaid and Medicare patients in four other medically underserved New Mexico counties.
Dr. Aswad, a graduate of the University of Aleppo, in Syria, had an internal medicine residency at Our Lady of Mercy Hospital in New York City, where he also had a fellowship in oncology and hematology. He then settled in Deming and has been licensed in New Mexico since 2003.
With the onset of the COVID-19 pandemic, which caused major disruption to healthcare services, Medicare & Medicaid Services officials requested that Dr. Aswad also be allowed to provide internal medicine services for Medicare patients in Catron and Hildalgo counties for the “duration of the Coronavirus Disease 2019 public health emergency declared by the federal government in January 2020.”
A version of this article first appeared on Medscape.com.
A New Mexico oncologist has once again found himself at odds with the law.
Mohamed Aswad, MD, was still under probation for a past misdemeanor involving misbranded cancer drugs when he allegedly underdosed chemotherapy in a patient with colon cancer. The patient later died.
In a wrongful death case, a jury has awarded $2.3 million in damages to the patient’s wife. The patient, James Hoag, was diagnosed with stage IIIB colon cancer in 2015. He underwent surgery and then went for chemotherapy to Dr. Aswad, who was the only oncologist in the area.
Mr. Hoag’s attorneys alleged that
“It was statistically likely that James would beat his cancer with proper treatment,” said his lawyers during the trial, according to a report in the Albuquerque Journal.
The jury deliberated for only 4 hours, and found that negligence by Dr. Aswad was a proximate cause of the patient’s “lost chance to avoid the loss of his life and resulting damages,” and the jury further described Dr. Aswad’s actions as “wanton,” according to a verdict form filed in the case.
The form also shows that the jury decided Dr. Aswad had obtained Mr. Hoag’s informed consent as to the treatment, but still felt that negligence was a cause of Mr. Hoag’s injury and damages. The original judgment of $2.9 million in damages was subsequently reduced to $2.3 million as the jury found Mr. Hoag was 30% responsible for his injuries.
Dr. Aswad could not be reached for comment. The Albuquerque Journal reports that he plans to appeal the verdict.
Only oncologist in the county
The patient had lived in the rural community of Deming, N.M. following his retirement from a career in law enforcement in Michigan. He was diagnosed with colon cancer in 2015, underwent surgical resection, and then went to Dr. Aswad for follow-up chemotherapy.
Dr. Aswad was the only oncologist in the area. Like many other rural communities throughout the United States, this region has a severe shortage of medical specialists.
Sheila Hoag, the patient’s widow, testified during the trial that following her husband’s surgery in August 2015, which removed the tumor, his “prognosis was very good because they had caught it before it spread.” He had an estimated 5-year survival of about 69%.
However, even though Dr. Aswad followed the National Comprehensive Cancer Network (NCCN) guidelines for adjuvant chemotherapy, he did not use the proper dosing. According to trial testimony, he administered “woefully lower doses” than are recommended, and also exceeded the recommended 6-month duration of chemotherapy by more than double. In addition, Dr. Aswad also failed to adequately monitor the disease during treatment, said Hoag’s lawyers.
Aswad has denied the charges and says that he prescribed a modified regimen spread out over a longer period of time because his patient had requested it. He said that Mr. Hoag did not want to undergo chemotherapy that could cause significant side effects, and this was the reason for the altered treatment plan.
However, the chemotherapy failed to slow the cancer’s progression, and Mr. Hoag never returned to see him after November 2016.
By December 2017, Mr. Hoag had been hospitalized and was being treated by another oncologist, located in Las Cruces, 62 miles away from his home. The new oncologist administered the standard treatment, but by then his cancer had metastasized. Mr. Hoag died in 2020 at age 59.
Previous misdemeanor with misbranded drugs
At the time he was treating Mr. Hoag, Dr. Aswad was on federal probation after pleading guilty in 2014 to one misdemeanor count of the unlawful introduction of misbranded drugs into interstate commerce.
Dr. Aswad had treated cancer patients with a “misbranded” drug imported from abroad and not approved by the U.S. Food and Drug Administration (FDA). Altuzan is a form of bevacizumab that is approved for use in Turkey but not the United States. Between July 2010 and April 2012, Dr. Aswad ordered prescription cancer drugs, including Altuzan, from a Canadian company and then administered the “misbranded” drugs to his patients.
A prescription drug is considered to be “misbranded” if it is manufactured in a facility that has not been registered with the FDA for commercial distribution within the United States.
According to various media reports, Dr. Aswad paid significantly less for these drugs than he would have if had he purchased the U.S.-approved product bearing the same brand or generic name, and then billed federal programs such as Medicare for the full price. He has admitted to making just under $1.3 million in profits.
Under the terms of the plea agreement, he was sentenced to three years of probation, required to pay just under $1.3 million in restitution to Medicare and Tricare, the victims of his criminal conduct, and also to forfeit $750,000, which represented part of his net criminal proceeds, to the United States.
At the trial, Dr. Aswad denied that there was any profit motive in extending Mr. Hoag’s treatment, and in a 2019 deposition, he also denied he was under financial pressure to increase his billings because of the $2 million debt that he owed because of the misbranded drugs fine.
Allowed to resume practice
In late 2015, Dr. Aswad was essentially barred by the federal government from accepting any reimbursement from Medicaid or Medicare for a minimum of 13 years. But because of the urgent need for medical specialists, the New Mexico Human Services Department requested a waiver that would permit him to continuing treating cancer patients since he is the only oncologist in Luna County.
He is currently allowed to treat Medicaid and Medicare patients in four other medically underserved New Mexico counties.
Dr. Aswad, a graduate of the University of Aleppo, in Syria, had an internal medicine residency at Our Lady of Mercy Hospital in New York City, where he also had a fellowship in oncology and hematology. He then settled in Deming and has been licensed in New Mexico since 2003.
With the onset of the COVID-19 pandemic, which caused major disruption to healthcare services, Medicare & Medicaid Services officials requested that Dr. Aswad also be allowed to provide internal medicine services for Medicare patients in Catron and Hildalgo counties for the “duration of the Coronavirus Disease 2019 public health emergency declared by the federal government in January 2020.”
A version of this article first appeared on Medscape.com.
Cancer drug revenue increased 70% over a decade
Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.
By comparison, revenues from other types of medications decreased by 18% during the same period.
“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.
To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.
The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.
Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.
Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.
Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.
“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”
No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.
By comparison, revenues from other types of medications decreased by 18% during the same period.
“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.
To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.
The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.
Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.
Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.
Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.
“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”
No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.
By comparison, revenues from other types of medications decreased by 18% during the same period.
“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.
To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.
The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.
Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.
Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.
Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.
“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”
No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The Supreme Court 2020‒2021: What will affect ObGyns?
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 others2,3 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 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. Reference Am. Coll. of Obstetricians & Gynecologists v. United States FDA, 467 F. Supp. 3d 282, 284 (D. Md. 2020).
Reference
1. Am. Coll. of Obstetricians & Gynecologists v. United States FDA, 467 F. Supp. 3d 282, 284 (D. Md. 2020).
The “Shadow Docket”
The ACOG mifepristone decisions do not appear on the Supreme Court’s “Court Opinions” website.1 They appear in what has become known in recent years as “The Shadow Docket,” an informal term that includes many orders of the Court and statements of individual justices regarding some cases.2 There are hundreds of orders by the Court each Term, there is nothing particularly shadowy about any of these items—they are all publicly available on the Court’s website and later in paper format. It is, however, a little harder to find and much harder to sort through than the major opinions. In some cases, it is not possible to tell what the vote was, how each justice voted, and what the reasoning of the Court was. In a few cases it is difficult to know exactly what the Court was holding or otherwise leaves some confusion about what the law actually is.3
The part of the Shadow Docket that is most intriguing for commentators, and where the ACOG cases appear, is the “Opinions Relating to Orders.”4 These are a variety of opinions, some written by the Court and many by individual justices. It also includes the action of the Court in some cases in which there was not full briefing or oral argument. The statements by justices often are to dissent from the denial of cert of decisions of the Court. These opinions have become much more common over the years. In this past term, there were approximately 60 such opinions related to about 50 cases. In part, this relates to the number of pandemic cases that could not wait for a Court decision going through the extended ordinary process. Although the Shadow Docket has been of interest to academic observers and Court watchers for years, this year it has attracted the attention of Congress.5
References
1. Opinions of the Court. Supreme Court website. https://www.supremecourt.gov/opinions/slipopinion/20#list. Accessed October 10, 2021.
2. Baude W. Foreword: the Supreme Court’s Shadow Docket, 9 N.Y.U. J.L. & Liberty 1 (2015).
3. Vladeck SI. The Solicitor General and the Shadow Docket, 133 Harvard Law Review. 123 (2019).
4. Opinions relating to orders. Supreme Court website. https://www.supremecourt.gov/opinions/relatingtoorders/20#list. Accessed October 10, 2021.
5. The Supreme Court’s Shadow Docket: Hearing Before the Subcommittee on Courts, Intellectual Property and the Internet of the H. Committee on the Judiciary, 117th Congress (2021).
- American College of Obstetricians & Gynecologists v. United States FDA, 472 F. Supp. 3d 183 (D. Md. 2020).
- Michael Kunzelman, Doctors Sue to Block FDA Abortion Pill Rule During Pandemic, (May 29, 2020).
- ACLU, American College Of Obstetricians And Gynecologists V. U.S. Food And Drug Administration, https://www.aclu.org/cases/american-college-obstetricians-and-gynecologists-v-us-food-and-drug-administration. Updated February 12, 2021. Accessed August 27, 2021.
- Whole Woman’s Health v Hellerstedt, 579 US ___ (2016), 136 S Ct 2292.
- 2016 Clinical Review at 39, 47, 49, Opp’n Mot. PI Ex. 19, ECF No. 62-11.
- American College of Obstetricians and Gynecologists v FDA (I), decided October 8, 2020.
- October 8, 2020, dissenting opinion by Justice Alito.
- January 12, 2021, dissenting opinion by Justice Sotomayor.
- Questions and answers on Mifeprex. U.S. Food and Drug Administration website. Published April 13, 2021. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex. Accessed October 9, 2021.
- Whole Woman’s Health v Jackson, decided September 1, 2021.
- Texas Senate Bill 8, relating to abortion, including abortions after detection of unborn child’s heartbeat; authorizing a private civil right of action. LegiScan website. https://legiscan.com/TX/text/SB8/id/2395961. Accessed October 9, 2021.
- Planned Parenthood of Southeastern Pennsylvania v Casey, 505 U. S. 833 (1992); Roe v Wade, 410 U. S. 113 (1973).
- Dobbs v Jackson Women’s Health Organization, No. 19-1392.
- Roman Catholic Diocese of Brooklyn v Cuomo, decided November 25, 2020.
- Alabama Association of Realtors v Department of Health and Human Services, decided June 29, 2021.
- Temporary halt in residential evictions in communities with substantial or high levels of community transmission of COVID-19 to prevent the further spread of COVID-19. August 6, 2021. https://www.federalregister.gov/documents/2021/08/06/2021-16945/temporary-halt-in-residential-evictions-in-communities-with-substantial-or-high-transmission-of.
- Alabama Association of Realtors v Department of Health and Human Services, decided August 26, 2021.
- California v Texas, decided June 17, 2021.
- Brief of Amici Curiae American Medical Association, American Academy of Allergy, Asthma and Immunology, Aerospace Medical Association, American Academy of Family Physicians, American Academy of Pediatrics, American College of Cardiology, American College of Emergency Physicians, American College of Medical Genetics and Genomics, American College of Obstetricians and Gynecologists, American College of Physicians, American College of Radiation Oncology, American College of Radiology, American Psychiatric Association, American Society of Gastrointestinal Endoscopy, American Society of Hematology, American Society of Metabolic and Bariatric Surgery, Endocrine Society, GLMA: Health Professionals Advancing LGBTQ Equality, Renal Physicians Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology in Support of Petitioners, in California v. Texas. May 13, 2020. https://www.supremecourt.gov/DocketPDF/19/19-840/143469/20200513150051995_19-840%20Amici%20Brief%20AMA.pdf. Accessed October 9, 2021.
- Rutledge v Pharmaceutical Care Management Association, decided December 10, 2020.
- Brief of the American Medical Association, The Arkansas Medical Society, and The Litigation Center of the American Medical Association and the State Medical Societies as Amici Curiae in Support of Petitioner in Rutledge v Pharmaceutical Care Management Association. March 2, 2020. https://www.supremecourt.gov/DocketPDF/18/18-540/134670/20200302163622018_Rutledge%20v.%20PCMA%20Amicus%20Brief%20of%20AMA%20et%20al.pdf. Accessed October 9, 2021.
- Apple quietly settles patent lawsuit, promptly gets hit with another one. TechCrunch website. Published July 30, 2010. https://techcrunch.com/2010/07/30/apple-minerva-emblaze/. Accessed October 9, 2021.
- Minerva Surgical, Inc. v Hologic, Inc., decided June 29, 2021.
- Stat pack. SCOTUS Blog website. Published July 6, 2021. https://www.scotusblog.com/wp-content/uploads/2021/07/Final-Stat-Pack-7.6.21.pdf. Accessed October 9, 2021.
- Dobbs v Jackson Women’s Health Organization, No. 19-1392.
- Cameron v. EMW Women’s Surgical Center, https://www.scotusblog.com/case-files/cases/cameron-v-emw-womens-surgical-center-p-s-c/. Accessed August 28, 2021.
- American Hospital Association v Becerra, No. 20-1114.
- Becerra v Empire Health Foundation, No. 20-1312.
- Gallardo v Marstiller, No. 20-1263.
- New York State Rifle & Pistol Association Inc. v Corlett, No. 20-843.
- Students for Fair Admissions v President & Fellows of Harvard College, No. 20-1199.
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 others2,3 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 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. Reference Am. Coll. of Obstetricians & Gynecologists v. United States FDA, 467 F. Supp. 3d 282, 284 (D. Md. 2020).
Reference
1. Am. Coll. of Obstetricians & Gynecologists v. United States FDA, 467 F. Supp. 3d 282, 284 (D. Md. 2020).
The “Shadow Docket”
The ACOG mifepristone decisions do not appear on the Supreme Court’s “Court Opinions” website.1 They appear in what has become known in recent years as “The Shadow Docket,” an informal term that includes many orders of the Court and statements of individual justices regarding some cases.2 There are hundreds of orders by the Court each Term, there is nothing particularly shadowy about any of these items—they are all publicly available on the Court’s website and later in paper format. It is, however, a little harder to find and much harder to sort through than the major opinions. In some cases, it is not possible to tell what the vote was, how each justice voted, and what the reasoning of the Court was. In a few cases it is difficult to know exactly what the Court was holding or otherwise leaves some confusion about what the law actually is.3
The part of the Shadow Docket that is most intriguing for commentators, and where the ACOG cases appear, is the “Opinions Relating to Orders.”4 These are a variety of opinions, some written by the Court and many by individual justices. It also includes the action of the Court in some cases in which there was not full briefing or oral argument. The statements by justices often are to dissent from the denial of cert of decisions of the Court. These opinions have become much more common over the years. In this past term, there were approximately 60 such opinions related to about 50 cases. In part, this relates to the number of pandemic cases that could not wait for a Court decision going through the extended ordinary process. Although the Shadow Docket has been of interest to academic observers and Court watchers for years, this year it has attracted the attention of Congress.5
References
1. Opinions of the Court. Supreme Court website. https://www.supremecourt.gov/opinions/slipopinion/20#list. Accessed October 10, 2021.
2. Baude W. Foreword: the Supreme Court’s Shadow Docket, 9 N.Y.U. J.L. & Liberty 1 (2015).
3. Vladeck SI. The Solicitor General and the Shadow Docket, 133 Harvard Law Review. 123 (2019).
4. Opinions relating to orders. Supreme Court website. https://www.supremecourt.gov/opinions/relatingtoorders/20#list. Accessed October 10, 2021.
5. The Supreme Court’s Shadow Docket: Hearing Before the Subcommittee on Courts, Intellectual Property and the Internet of the H. Committee on the Judiciary, 117th Congress (2021).
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 others2,3 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 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. Reference Am. Coll. of Obstetricians & Gynecologists v. United States FDA, 467 F. Supp. 3d 282, 284 (D. Md. 2020).
Reference
1. Am. Coll. of Obstetricians & Gynecologists v. United States FDA, 467 F. Supp. 3d 282, 284 (D. Md. 2020).
The “Shadow Docket”
The ACOG mifepristone decisions do not appear on the Supreme Court’s “Court Opinions” website.1 They appear in what has become known in recent years as “The Shadow Docket,” an informal term that includes many orders of the Court and statements of individual justices regarding some cases.2 There are hundreds of orders by the Court each Term, there is nothing particularly shadowy about any of these items—they are all publicly available on the Court’s website and later in paper format. It is, however, a little harder to find and much harder to sort through than the major opinions. In some cases, it is not possible to tell what the vote was, how each justice voted, and what the reasoning of the Court was. In a few cases it is difficult to know exactly what the Court was holding or otherwise leaves some confusion about what the law actually is.3
The part of the Shadow Docket that is most intriguing for commentators, and where the ACOG cases appear, is the “Opinions Relating to Orders.”4 These are a variety of opinions, some written by the Court and many by individual justices. It also includes the action of the Court in some cases in which there was not full briefing or oral argument. The statements by justices often are to dissent from the denial of cert of decisions of the Court. These opinions have become much more common over the years. In this past term, there were approximately 60 such opinions related to about 50 cases. In part, this relates to the number of pandemic cases that could not wait for a Court decision going through the extended ordinary process. Although the Shadow Docket has been of interest to academic observers and Court watchers for years, this year it has attracted the attention of Congress.5
References
1. Opinions of the Court. Supreme Court website. https://www.supremecourt.gov/opinions/slipopinion/20#list. Accessed October 10, 2021.
2. Baude W. Foreword: the Supreme Court’s Shadow Docket, 9 N.Y.U. J.L. & Liberty 1 (2015).
3. Vladeck SI. The Solicitor General and the Shadow Docket, 133 Harvard Law Review. 123 (2019).
4. Opinions relating to orders. Supreme Court website. https://www.supremecourt.gov/opinions/relatingtoorders/20#list. Accessed October 10, 2021.
5. The Supreme Court’s Shadow Docket: Hearing Before the Subcommittee on Courts, Intellectual Property and the Internet of the H. Committee on the Judiciary, 117th Congress (2021).
- American College of Obstetricians & Gynecologists v. United States FDA, 472 F. Supp. 3d 183 (D. Md. 2020).
- Michael Kunzelman, Doctors Sue to Block FDA Abortion Pill Rule During Pandemic, (May 29, 2020).
- ACLU, American College Of Obstetricians And Gynecologists V. U.S. Food And Drug Administration, https://www.aclu.org/cases/american-college-obstetricians-and-gynecologists-v-us-food-and-drug-administration. Updated February 12, 2021. Accessed August 27, 2021.
- Whole Woman’s Health v Hellerstedt, 579 US ___ (2016), 136 S Ct 2292.
- 2016 Clinical Review at 39, 47, 49, Opp’n Mot. PI Ex. 19, ECF No. 62-11.
- American College of Obstetricians and Gynecologists v FDA (I), decided October 8, 2020.
- October 8, 2020, dissenting opinion by Justice Alito.
- January 12, 2021, dissenting opinion by Justice Sotomayor.
- Questions and answers on Mifeprex. U.S. Food and Drug Administration website. Published April 13, 2021. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex. Accessed October 9, 2021.
- Whole Woman’s Health v Jackson, decided September 1, 2021.
- Texas Senate Bill 8, relating to abortion, including abortions after detection of unborn child’s heartbeat; authorizing a private civil right of action. LegiScan website. https://legiscan.com/TX/text/SB8/id/2395961. Accessed October 9, 2021.
- Planned Parenthood of Southeastern Pennsylvania v Casey, 505 U. S. 833 (1992); Roe v Wade, 410 U. S. 113 (1973).
- Dobbs v Jackson Women’s Health Organization, No. 19-1392.
- Roman Catholic Diocese of Brooklyn v Cuomo, decided November 25, 2020.
- Alabama Association of Realtors v Department of Health and Human Services, decided June 29, 2021.
- Temporary halt in residential evictions in communities with substantial or high levels of community transmission of COVID-19 to prevent the further spread of COVID-19. August 6, 2021. https://www.federalregister.gov/documents/2021/08/06/2021-16945/temporary-halt-in-residential-evictions-in-communities-with-substantial-or-high-transmission-of.
- Alabama Association of Realtors v Department of Health and Human Services, decided August 26, 2021.
- California v Texas, decided June 17, 2021.
- Brief of Amici Curiae American Medical Association, American Academy of Allergy, Asthma and Immunology, Aerospace Medical Association, American Academy of Family Physicians, American Academy of Pediatrics, American College of Cardiology, American College of Emergency Physicians, American College of Medical Genetics and Genomics, American College of Obstetricians and Gynecologists, American College of Physicians, American College of Radiation Oncology, American College of Radiology, American Psychiatric Association, American Society of Gastrointestinal Endoscopy, American Society of Hematology, American Society of Metabolic and Bariatric Surgery, Endocrine Society, GLMA: Health Professionals Advancing LGBTQ Equality, Renal Physicians Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology in Support of Petitioners, in California v. Texas. May 13, 2020. https://www.supremecourt.gov/DocketPDF/19/19-840/143469/20200513150051995_19-840%20Amici%20Brief%20AMA.pdf. Accessed October 9, 2021.
- Rutledge v Pharmaceutical Care Management Association, decided December 10, 2020.
- Brief of the American Medical Association, The Arkansas Medical Society, and The Litigation Center of the American Medical Association and the State Medical Societies as Amici Curiae in Support of Petitioner in Rutledge v Pharmaceutical Care Management Association. March 2, 2020. https://www.supremecourt.gov/DocketPDF/18/18-540/134670/20200302163622018_Rutledge%20v.%20PCMA%20Amicus%20Brief%20of%20AMA%20et%20al.pdf. Accessed October 9, 2021.
- Apple quietly settles patent lawsuit, promptly gets hit with another one. TechCrunch website. Published July 30, 2010. https://techcrunch.com/2010/07/30/apple-minerva-emblaze/. Accessed October 9, 2021.
- Minerva Surgical, Inc. v Hologic, Inc., decided June 29, 2021.
- Stat pack. SCOTUS Blog website. Published July 6, 2021. https://www.scotusblog.com/wp-content/uploads/2021/07/Final-Stat-Pack-7.6.21.pdf. Accessed October 9, 2021.
- Dobbs v Jackson Women’s Health Organization, No. 19-1392.
- Cameron v. EMW Women’s Surgical Center, https://www.scotusblog.com/case-files/cases/cameron-v-emw-womens-surgical-center-p-s-c/. Accessed August 28, 2021.
- American Hospital Association v Becerra, No. 20-1114.
- Becerra v Empire Health Foundation, No. 20-1312.
- Gallardo v Marstiller, No. 20-1263.
- New York State Rifle & Pistol Association Inc. v Corlett, No. 20-843.
- Students for Fair Admissions v President & Fellows of Harvard College, No. 20-1199.
- American College of Obstetricians & Gynecologists v. United States FDA, 472 F. Supp. 3d 183 (D. Md. 2020).
- Michael Kunzelman, Doctors Sue to Block FDA Abortion Pill Rule During Pandemic, (May 29, 2020).
- ACLU, American College Of Obstetricians And Gynecologists V. U.S. Food And Drug Administration, https://www.aclu.org/cases/american-college-obstetricians-and-gynecologists-v-us-food-and-drug-administration. Updated February 12, 2021. Accessed August 27, 2021.
- Whole Woman’s Health v Hellerstedt, 579 US ___ (2016), 136 S Ct 2292.
- 2016 Clinical Review at 39, 47, 49, Opp’n Mot. PI Ex. 19, ECF No. 62-11.
- American College of Obstetricians and Gynecologists v FDA (I), decided October 8, 2020.
- October 8, 2020, dissenting opinion by Justice Alito.
- January 12, 2021, dissenting opinion by Justice Sotomayor.
- Questions and answers on Mifeprex. U.S. Food and Drug Administration website. Published April 13, 2021. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex. Accessed October 9, 2021.
- Whole Woman’s Health v Jackson, decided September 1, 2021.
- Texas Senate Bill 8, relating to abortion, including abortions after detection of unborn child’s heartbeat; authorizing a private civil right of action. LegiScan website. https://legiscan.com/TX/text/SB8/id/2395961. Accessed October 9, 2021.
- Planned Parenthood of Southeastern Pennsylvania v Casey, 505 U. S. 833 (1992); Roe v Wade, 410 U. S. 113 (1973).
- Dobbs v Jackson Women’s Health Organization, No. 19-1392.
- Roman Catholic Diocese of Brooklyn v Cuomo, decided November 25, 2020.
- Alabama Association of Realtors v Department of Health and Human Services, decided June 29, 2021.
- Temporary halt in residential evictions in communities with substantial or high levels of community transmission of COVID-19 to prevent the further spread of COVID-19. August 6, 2021. https://www.federalregister.gov/documents/2021/08/06/2021-16945/temporary-halt-in-residential-evictions-in-communities-with-substantial-or-high-transmission-of.
- Alabama Association of Realtors v Department of Health and Human Services, decided August 26, 2021.
- California v Texas, decided June 17, 2021.
- Brief of Amici Curiae American Medical Association, American Academy of Allergy, Asthma and Immunology, Aerospace Medical Association, American Academy of Family Physicians, American Academy of Pediatrics, American College of Cardiology, American College of Emergency Physicians, American College of Medical Genetics and Genomics, American College of Obstetricians and Gynecologists, American College of Physicians, American College of Radiation Oncology, American College of Radiology, American Psychiatric Association, American Society of Gastrointestinal Endoscopy, American Society of Hematology, American Society of Metabolic and Bariatric Surgery, Endocrine Society, GLMA: Health Professionals Advancing LGBTQ Equality, Renal Physicians Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology in Support of Petitioners, in California v. Texas. May 13, 2020. https://www.supremecourt.gov/DocketPDF/19/19-840/143469/20200513150051995_19-840%20Amici%20Brief%20AMA.pdf. Accessed October 9, 2021.
- Rutledge v Pharmaceutical Care Management Association, decided December 10, 2020.
- Brief of the American Medical Association, The Arkansas Medical Society, and The Litigation Center of the American Medical Association and the State Medical Societies as Amici Curiae in Support of Petitioner in Rutledge v Pharmaceutical Care Management Association. March 2, 2020. https://www.supremecourt.gov/DocketPDF/18/18-540/134670/20200302163622018_Rutledge%20v.%20PCMA%20Amicus%20Brief%20of%20AMA%20et%20al.pdf. Accessed October 9, 2021.
- Apple quietly settles patent lawsuit, promptly gets hit with another one. TechCrunch website. Published July 30, 2010. https://techcrunch.com/2010/07/30/apple-minerva-emblaze/. Accessed October 9, 2021.
- Minerva Surgical, Inc. v Hologic, Inc., decided June 29, 2021.
- Stat pack. SCOTUS Blog website. Published July 6, 2021. https://www.scotusblog.com/wp-content/uploads/2021/07/Final-Stat-Pack-7.6.21.pdf. Accessed October 9, 2021.
- Dobbs v Jackson Women’s Health Organization, No. 19-1392.
- Cameron v. EMW Women’s Surgical Center, https://www.scotusblog.com/case-files/cases/cameron-v-emw-womens-surgical-center-p-s-c/. Accessed August 28, 2021.
- American Hospital Association v Becerra, No. 20-1114.
- Becerra v Empire Health Foundation, No. 20-1312.
- Gallardo v Marstiller, No. 20-1263.
- New York State Rifle & Pistol Association Inc. v Corlett, No. 20-843.
- Students for Fair Admissions v President & Fellows of Harvard College, No. 20-1199.
Advocacy Update: Is Your Practice Equipped to Handle Looming Changes in Dermatopathology?
The proposed 2022 Medicare physician fee schedule and quality payment program (QPP) regulations were released on July 13, 2021.1 Final regulations are expected to be released on or around November 1, 2021, but they may be delayed. Multiple national medical organizations, including the College of American Pathologists (CAP), the American Society of Dermatopathology, the American Academy of Dermatology Association (AADA), and the American Medical Association (AMA) Physicians’ Grassroots Network all work together to engage with the Centers for Medicare & Medicaid Services (CMS) to influence these regulations. Stated advocacy priorities include protecting the value of dermatopathology services, mobilizing dermatopathologists for political action, ensuring dermatopathologists can participate in new payment models, strengthening the profession with advocacy on a state level, and conducting socioeconomic research. Is your practice aware and prepared to handle the changes coming in 2022?
The recent revisions and revaluations of the outpatient evaluation and management (E/M) codes2 resulted in a considerable redistribution of Medicare dollars in 2021, negatively impacting dermatopathologists and other specialties and services due to budget neutrality required by law (Figure). Important steps were taken to mitigate the 2021 Medicare cuts for all non–office-based dermatopathology services (eg, pathology, surgical services, emergency department).1,3 Direct engagement by the CAP, American Society of Dermatopathology, and AADA, along with the AMA Physicians’ Grassroots Network resulted in legislative action on December 27, 2020, which directed Medicare to make a 3.75% positive adjustment to the 2021 physician payments. Additionally, the CMS updated the 2021 physician conversion factor to $34.8931, a 3.3% reduction from the 2020 conversion factor rather than $32.41, or a 10.20% decrease. The 2% payment adjustment (sequestration) through December 21, 2021, also was suspended, and Congress and the Biden administration mandated delayed implementation of the inherent complexity add-on code for E/M services (G2211) until 2024.1,3
Threat of Medicare Cuts in 2022
Based on dermatopathology utilization data, the overall impact on reimbursement for 2022 represents an approximately 5% decrease from 2021 dermatopathology payments (Table 1).1,4 This represents a 3.75% cut from revaluation of E/M services, and a 1% cut due to changes in practice expense pricing. The estimated change in reimbursement for independent laboratories is a 6% decrease. Advocacy groups have been working to mitigate the 2022 cuts by engaging with Congress and urging them to act before these changes go into effect next year. Keep in mind that approximately half of all pathology Current Procedural Terminology (CPT) codes have been targeted for evaluation by the CMS since 2006.1,4
The current clinical pathology consultation services (CPT codes 80500 and 80502) previously were identified as potentially misvalued for review by the AMA Relative Value Scale Update Committee’s (RUC’s) relativity assessment workgroup.4 Consequently, the CAP worked with the AMA’s CPT Editorial Panel to delete codes 80500 and 80502, as well as to modernize and create the 4 new clinical pathology consultation codes: 80XX0, 80XX1, 80XX2, and 80XX3. Then the CAP worked with the RUC to develop physician work and practice expense values for the new clinical pathology consultation codes. Once the fee schedule is finalized, pathologists can begin using the new codes to bill these services in 2022 (Table 2).4
According to CPT, clinical pathology consultation services may be reported when the following criteria have been met: (1) the pathologist renders a clinical pathology consultation at the request of a physician or qualified health care professional at the same or another institution; (2) the pathology clinical consultation request relating to pathology and laboratory findings or other relevant clinical or diagnostic information requiring additional medical interpretative judgment is made; and (3) these codes are not reported in conjunction with codes 88321, 88323, and 88325.4
Proposed 2022 Medicare QPP Requirements
On July 13, 2021, the CMS also published its proposed 2022 QPP proposals that will take effect next year.4 According to the proposed regulation, nearly all dermatopathologists will be required to participate in Medicare’s QPP, either through advanced alternative payment models (APMs) or the Merit-based Incentive Payment System (MIPS). The CAP has long advocated for reducing MIPS reporting burdens for dermatopathologists. In this regulation, the CMS is proposing key program changes that move the program forward but also introduce additional complexities; for example, the CMS will move forward with a new participation pathway called MIPS Value Pathways (MVPs). The CMS proposed 7 specific MVPs that align with certain clinical topics; however, it will not implement these MVPs until the 2023 MIPS performance period.
In 2022, dermatopathologists who are eligible for MIPS will have to take action to avoid penalties that reduce future Medicare Part B payments for their services. Performance in MIPS in 2022 affects Medicare Part B payments in 2024 by an increase of 9% to a decrease of 9%.
In its proposed 2022 QPP regulations, the CMS proposed an increase of the performance threshold from 60 MIPS points to 75 MIPS points. It also proposed an increase of the exceptional Performance Threshold from 85 MIPS points to 89 MIPS points.
The CMS also proposed notable scoring changes for quality measures, including removing the 3-point floor for measures that can be scored against a benchmark. These measures would receive 1 to 10 points. Measures without a benchmark or that do not meet case requirements would earn 0 points, with an exception for small practices. The CMS also proposed removing bonus points for reporting additional outcomes and high-priority measures beyond the 1 that is required, as well as establishing a 5-point floor for the first 2 performance periods for new measures, which is in line with the CAP’s advocacy.
The Pathology Specialty Measure Set will remain the same as the 2021 set containing 6 quality measures, including the AADA-stewarded quality measure #440 (skin cancer: biopsy reporting time—pathologist to clinician). Although the CAP recognizes the importance of prompt turnaround of biopsy reports, it also is working with the CMS and the AADA to mitigate the operational challenges dermatopathologists encounter when using this measure.
Due to advocacy from the CAP, the CMS included a CAP-proposed improvement activity on implementation of a laboratory preparedness plan to support continued or expanded patient care during the COVID-19 pandemic or another public health emergency. This plan should address how the laboratory would maintain or expand access to improve beneficiary health outcomes and reduce health care disparities.
The CAP has actively worked with the CMS to demonstrate the need for more appropriate and alternative measures and improvement activities so that pathologists can more fully participate in MIPS.
Alternative Payment Models—For those dermatopathologists who practice in an APM, the proposed 2022 QPP makes minimal changes to the advanced APM track while adding transition time for accountable care organizations in the Medicare Shared Savings Program to report on certain quality measures and increasing flexibility related to the program’s quality performance standard.
Cures Act 2021: To Do No Harm
The 21st Century Cures Act (Cures Act) was signed into federal law in 2016. The Office of the National Coordinator for Health Information Technology (ONC) laid the groundwork for patients to have easier access to and control of their health information.5 The ONC’s final rule, which went into effect on April 5, 2021, requires that all providers make their office notes, laboratory results, and other diagnostic reports (including dermatopathology reports) available to patients as soon as the physician’s office receives an electronic copy. Penalty for noncompliance has not been determined.
There are information-blocking exceptions, but delaying access to a patient’s report so that a provider can review the result before the patient receives it is not considered an exception.6 The exceptions are situational and must be evaluated by the referring clinician or their employer. Documentation of the exception is critical. The specific facts and circumstances associated with your decision to use an exception will be important to include in your documentation. Information blocking necessary to prevent “harm” to a patient or another person requires a reasonable belief that the practice will substantially reduce the risk of harm.6
The AMA passed a resolution in June 2021 calling for changes to this rule to allow for a delay of pathology results, advocating to the Office for Civil Rights to revise the harm exception to include psychological distress.6 In August 2021, the AADA met with senior officials at the ONC also asking to revise its definition of harm, sharing examples of emotional strain that resulted from receiving results without clinical context.7 California enacted a law requiring a delay before a patient receives the result of a malignant diagnosis, giving the clinician time to contact the patient before they see their report.8
The Cures Act requirements are about patients accessing their health care information. Always consider what is best for the patient and ensure that your policies and procedures reflect this.5
Final Thoughts
It is important to learn and support advocacy priorities and efforts and to join forces to protect your practice. Physician advocacy is no longer an elective pursuit. We need to be involved and engaged through our medical societies to help patients, communities, and ourselves.
- Centers for Medicare & Medicaid Services. Calendar Year (CY) 2022 Medicare Physician Fee Schedule Proposed Rule. Published July 13, 2021. Accessed October 22, 2021. https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2022-medicare-physician-fee-schedule-proposed-rule
- Healthcare spending and the Medicare program. Medicare Payment Advisory Commission; July 2020. Accessed October 25, 2021.http://www.medpac.gov/docs/default-source/data-book/july2020_databook_entirereport_sec.pdf
- Frieden J. 2021 Medicare fee schedule includes 10.2% cut in conversion factor. MedPage Today website. Published December 2, 2020. Accessed October 22, 2021. https://www.medpagetoday.com/practicemanagement/reimbursement/89970
- Advocacy. College of American Pathologists website. Accessed October 13, 2021. https://www.cap.org/advocacy
- ONC’s Cures Act Final Rule. The Office of the National Coordinator for Health Information Technology website. Accessed October 13, 2021. https://www.healthit.gov/curesrule/
- Nelson H. Delegates call AMA to advocate for provider info-blocking flexibility. Published June 18, 2021. Accessed October 13, 2021. https://ehrintelligence.com/news/delegates-call-ama-to-advocate-for-provider-info-blocking-flexibility
- Rosamilia LL. Immediate Pathology report release to patients—is the 21st Century Cures Act worse than the disease? American Academy of Dermatology website. Published August 25, 2021. Accessed October 22, 2021. https://www.aad.org/dw/dw-insights-and-inquiries/archive/2021/cures-act-immediate-pathology-report-release-to-patients
- Purington K, Alfreds ST, Pritts J, et al; The National Academy for State Health Policy. Electronic release of clinical laboratory results: a review of state and federal policy. Published January 2010. Accessed October 13, 2021. https://www.nashp.org/wp-content/uploads/2010/02/ElectronicLabResultsExchangePolicy.pdf
The proposed 2022 Medicare physician fee schedule and quality payment program (QPP) regulations were released on July 13, 2021.1 Final regulations are expected to be released on or around November 1, 2021, but they may be delayed. Multiple national medical organizations, including the College of American Pathologists (CAP), the American Society of Dermatopathology, the American Academy of Dermatology Association (AADA), and the American Medical Association (AMA) Physicians’ Grassroots Network all work together to engage with the Centers for Medicare & Medicaid Services (CMS) to influence these regulations. Stated advocacy priorities include protecting the value of dermatopathology services, mobilizing dermatopathologists for political action, ensuring dermatopathologists can participate in new payment models, strengthening the profession with advocacy on a state level, and conducting socioeconomic research. Is your practice aware and prepared to handle the changes coming in 2022?
The recent revisions and revaluations of the outpatient evaluation and management (E/M) codes2 resulted in a considerable redistribution of Medicare dollars in 2021, negatively impacting dermatopathologists and other specialties and services due to budget neutrality required by law (Figure). Important steps were taken to mitigate the 2021 Medicare cuts for all non–office-based dermatopathology services (eg, pathology, surgical services, emergency department).1,3 Direct engagement by the CAP, American Society of Dermatopathology, and AADA, along with the AMA Physicians’ Grassroots Network resulted in legislative action on December 27, 2020, which directed Medicare to make a 3.75% positive adjustment to the 2021 physician payments. Additionally, the CMS updated the 2021 physician conversion factor to $34.8931, a 3.3% reduction from the 2020 conversion factor rather than $32.41, or a 10.20% decrease. The 2% payment adjustment (sequestration) through December 21, 2021, also was suspended, and Congress and the Biden administration mandated delayed implementation of the inherent complexity add-on code for E/M services (G2211) until 2024.1,3
Threat of Medicare Cuts in 2022
Based on dermatopathology utilization data, the overall impact on reimbursement for 2022 represents an approximately 5% decrease from 2021 dermatopathology payments (Table 1).1,4 This represents a 3.75% cut from revaluation of E/M services, and a 1% cut due to changes in practice expense pricing. The estimated change in reimbursement for independent laboratories is a 6% decrease. Advocacy groups have been working to mitigate the 2022 cuts by engaging with Congress and urging them to act before these changes go into effect next year. Keep in mind that approximately half of all pathology Current Procedural Terminology (CPT) codes have been targeted for evaluation by the CMS since 2006.1,4
The current clinical pathology consultation services (CPT codes 80500 and 80502) previously were identified as potentially misvalued for review by the AMA Relative Value Scale Update Committee’s (RUC’s) relativity assessment workgroup.4 Consequently, the CAP worked with the AMA’s CPT Editorial Panel to delete codes 80500 and 80502, as well as to modernize and create the 4 new clinical pathology consultation codes: 80XX0, 80XX1, 80XX2, and 80XX3. Then the CAP worked with the RUC to develop physician work and practice expense values for the new clinical pathology consultation codes. Once the fee schedule is finalized, pathologists can begin using the new codes to bill these services in 2022 (Table 2).4
According to CPT, clinical pathology consultation services may be reported when the following criteria have been met: (1) the pathologist renders a clinical pathology consultation at the request of a physician or qualified health care professional at the same or another institution; (2) the pathology clinical consultation request relating to pathology and laboratory findings or other relevant clinical or diagnostic information requiring additional medical interpretative judgment is made; and (3) these codes are not reported in conjunction with codes 88321, 88323, and 88325.4
Proposed 2022 Medicare QPP Requirements
On July 13, 2021, the CMS also published its proposed 2022 QPP proposals that will take effect next year.4 According to the proposed regulation, nearly all dermatopathologists will be required to participate in Medicare’s QPP, either through advanced alternative payment models (APMs) or the Merit-based Incentive Payment System (MIPS). The CAP has long advocated for reducing MIPS reporting burdens for dermatopathologists. In this regulation, the CMS is proposing key program changes that move the program forward but also introduce additional complexities; for example, the CMS will move forward with a new participation pathway called MIPS Value Pathways (MVPs). The CMS proposed 7 specific MVPs that align with certain clinical topics; however, it will not implement these MVPs until the 2023 MIPS performance period.
In 2022, dermatopathologists who are eligible for MIPS will have to take action to avoid penalties that reduce future Medicare Part B payments for their services. Performance in MIPS in 2022 affects Medicare Part B payments in 2024 by an increase of 9% to a decrease of 9%.
In its proposed 2022 QPP regulations, the CMS proposed an increase of the performance threshold from 60 MIPS points to 75 MIPS points. It also proposed an increase of the exceptional Performance Threshold from 85 MIPS points to 89 MIPS points.
The CMS also proposed notable scoring changes for quality measures, including removing the 3-point floor for measures that can be scored against a benchmark. These measures would receive 1 to 10 points. Measures without a benchmark or that do not meet case requirements would earn 0 points, with an exception for small practices. The CMS also proposed removing bonus points for reporting additional outcomes and high-priority measures beyond the 1 that is required, as well as establishing a 5-point floor for the first 2 performance periods for new measures, which is in line with the CAP’s advocacy.
The Pathology Specialty Measure Set will remain the same as the 2021 set containing 6 quality measures, including the AADA-stewarded quality measure #440 (skin cancer: biopsy reporting time—pathologist to clinician). Although the CAP recognizes the importance of prompt turnaround of biopsy reports, it also is working with the CMS and the AADA to mitigate the operational challenges dermatopathologists encounter when using this measure.
Due to advocacy from the CAP, the CMS included a CAP-proposed improvement activity on implementation of a laboratory preparedness plan to support continued or expanded patient care during the COVID-19 pandemic or another public health emergency. This plan should address how the laboratory would maintain or expand access to improve beneficiary health outcomes and reduce health care disparities.
The CAP has actively worked with the CMS to demonstrate the need for more appropriate and alternative measures and improvement activities so that pathologists can more fully participate in MIPS.
Alternative Payment Models—For those dermatopathologists who practice in an APM, the proposed 2022 QPP makes minimal changes to the advanced APM track while adding transition time for accountable care organizations in the Medicare Shared Savings Program to report on certain quality measures and increasing flexibility related to the program’s quality performance standard.
Cures Act 2021: To Do No Harm
The 21st Century Cures Act (Cures Act) was signed into federal law in 2016. The Office of the National Coordinator for Health Information Technology (ONC) laid the groundwork for patients to have easier access to and control of their health information.5 The ONC’s final rule, which went into effect on April 5, 2021, requires that all providers make their office notes, laboratory results, and other diagnostic reports (including dermatopathology reports) available to patients as soon as the physician’s office receives an electronic copy. Penalty for noncompliance has not been determined.
There are information-blocking exceptions, but delaying access to a patient’s report so that a provider can review the result before the patient receives it is not considered an exception.6 The exceptions are situational and must be evaluated by the referring clinician or their employer. Documentation of the exception is critical. The specific facts and circumstances associated with your decision to use an exception will be important to include in your documentation. Information blocking necessary to prevent “harm” to a patient or another person requires a reasonable belief that the practice will substantially reduce the risk of harm.6
The AMA passed a resolution in June 2021 calling for changes to this rule to allow for a delay of pathology results, advocating to the Office for Civil Rights to revise the harm exception to include psychological distress.6 In August 2021, the AADA met with senior officials at the ONC also asking to revise its definition of harm, sharing examples of emotional strain that resulted from receiving results without clinical context.7 California enacted a law requiring a delay before a patient receives the result of a malignant diagnosis, giving the clinician time to contact the patient before they see their report.8
The Cures Act requirements are about patients accessing their health care information. Always consider what is best for the patient and ensure that your policies and procedures reflect this.5
Final Thoughts
It is important to learn and support advocacy priorities and efforts and to join forces to protect your practice. Physician advocacy is no longer an elective pursuit. We need to be involved and engaged through our medical societies to help patients, communities, and ourselves.
The proposed 2022 Medicare physician fee schedule and quality payment program (QPP) regulations were released on July 13, 2021.1 Final regulations are expected to be released on or around November 1, 2021, but they may be delayed. Multiple national medical organizations, including the College of American Pathologists (CAP), the American Society of Dermatopathology, the American Academy of Dermatology Association (AADA), and the American Medical Association (AMA) Physicians’ Grassroots Network all work together to engage with the Centers for Medicare & Medicaid Services (CMS) to influence these regulations. Stated advocacy priorities include protecting the value of dermatopathology services, mobilizing dermatopathologists for political action, ensuring dermatopathologists can participate in new payment models, strengthening the profession with advocacy on a state level, and conducting socioeconomic research. Is your practice aware and prepared to handle the changes coming in 2022?
The recent revisions and revaluations of the outpatient evaluation and management (E/M) codes2 resulted in a considerable redistribution of Medicare dollars in 2021, negatively impacting dermatopathologists and other specialties and services due to budget neutrality required by law (Figure). Important steps were taken to mitigate the 2021 Medicare cuts for all non–office-based dermatopathology services (eg, pathology, surgical services, emergency department).1,3 Direct engagement by the CAP, American Society of Dermatopathology, and AADA, along with the AMA Physicians’ Grassroots Network resulted in legislative action on December 27, 2020, which directed Medicare to make a 3.75% positive adjustment to the 2021 physician payments. Additionally, the CMS updated the 2021 physician conversion factor to $34.8931, a 3.3% reduction from the 2020 conversion factor rather than $32.41, or a 10.20% decrease. The 2% payment adjustment (sequestration) through December 21, 2021, also was suspended, and Congress and the Biden administration mandated delayed implementation of the inherent complexity add-on code for E/M services (G2211) until 2024.1,3
Threat of Medicare Cuts in 2022
Based on dermatopathology utilization data, the overall impact on reimbursement for 2022 represents an approximately 5% decrease from 2021 dermatopathology payments (Table 1).1,4 This represents a 3.75% cut from revaluation of E/M services, and a 1% cut due to changes in practice expense pricing. The estimated change in reimbursement for independent laboratories is a 6% decrease. Advocacy groups have been working to mitigate the 2022 cuts by engaging with Congress and urging them to act before these changes go into effect next year. Keep in mind that approximately half of all pathology Current Procedural Terminology (CPT) codes have been targeted for evaluation by the CMS since 2006.1,4
The current clinical pathology consultation services (CPT codes 80500 and 80502) previously were identified as potentially misvalued for review by the AMA Relative Value Scale Update Committee’s (RUC’s) relativity assessment workgroup.4 Consequently, the CAP worked with the AMA’s CPT Editorial Panel to delete codes 80500 and 80502, as well as to modernize and create the 4 new clinical pathology consultation codes: 80XX0, 80XX1, 80XX2, and 80XX3. Then the CAP worked with the RUC to develop physician work and practice expense values for the new clinical pathology consultation codes. Once the fee schedule is finalized, pathologists can begin using the new codes to bill these services in 2022 (Table 2).4
According to CPT, clinical pathology consultation services may be reported when the following criteria have been met: (1) the pathologist renders a clinical pathology consultation at the request of a physician or qualified health care professional at the same or another institution; (2) the pathology clinical consultation request relating to pathology and laboratory findings or other relevant clinical or diagnostic information requiring additional medical interpretative judgment is made; and (3) these codes are not reported in conjunction with codes 88321, 88323, and 88325.4
Proposed 2022 Medicare QPP Requirements
On July 13, 2021, the CMS also published its proposed 2022 QPP proposals that will take effect next year.4 According to the proposed regulation, nearly all dermatopathologists will be required to participate in Medicare’s QPP, either through advanced alternative payment models (APMs) or the Merit-based Incentive Payment System (MIPS). The CAP has long advocated for reducing MIPS reporting burdens for dermatopathologists. In this regulation, the CMS is proposing key program changes that move the program forward but also introduce additional complexities; for example, the CMS will move forward with a new participation pathway called MIPS Value Pathways (MVPs). The CMS proposed 7 specific MVPs that align with certain clinical topics; however, it will not implement these MVPs until the 2023 MIPS performance period.
In 2022, dermatopathologists who are eligible for MIPS will have to take action to avoid penalties that reduce future Medicare Part B payments for their services. Performance in MIPS in 2022 affects Medicare Part B payments in 2024 by an increase of 9% to a decrease of 9%.
In its proposed 2022 QPP regulations, the CMS proposed an increase of the performance threshold from 60 MIPS points to 75 MIPS points. It also proposed an increase of the exceptional Performance Threshold from 85 MIPS points to 89 MIPS points.
The CMS also proposed notable scoring changes for quality measures, including removing the 3-point floor for measures that can be scored against a benchmark. These measures would receive 1 to 10 points. Measures without a benchmark or that do not meet case requirements would earn 0 points, with an exception for small practices. The CMS also proposed removing bonus points for reporting additional outcomes and high-priority measures beyond the 1 that is required, as well as establishing a 5-point floor for the first 2 performance periods for new measures, which is in line with the CAP’s advocacy.
The Pathology Specialty Measure Set will remain the same as the 2021 set containing 6 quality measures, including the AADA-stewarded quality measure #440 (skin cancer: biopsy reporting time—pathologist to clinician). Although the CAP recognizes the importance of prompt turnaround of biopsy reports, it also is working with the CMS and the AADA to mitigate the operational challenges dermatopathologists encounter when using this measure.
Due to advocacy from the CAP, the CMS included a CAP-proposed improvement activity on implementation of a laboratory preparedness plan to support continued or expanded patient care during the COVID-19 pandemic or another public health emergency. This plan should address how the laboratory would maintain or expand access to improve beneficiary health outcomes and reduce health care disparities.
The CAP has actively worked with the CMS to demonstrate the need for more appropriate and alternative measures and improvement activities so that pathologists can more fully participate in MIPS.
Alternative Payment Models—For those dermatopathologists who practice in an APM, the proposed 2022 QPP makes minimal changes to the advanced APM track while adding transition time for accountable care organizations in the Medicare Shared Savings Program to report on certain quality measures and increasing flexibility related to the program’s quality performance standard.
Cures Act 2021: To Do No Harm
The 21st Century Cures Act (Cures Act) was signed into federal law in 2016. The Office of the National Coordinator for Health Information Technology (ONC) laid the groundwork for patients to have easier access to and control of their health information.5 The ONC’s final rule, which went into effect on April 5, 2021, requires that all providers make their office notes, laboratory results, and other diagnostic reports (including dermatopathology reports) available to patients as soon as the physician’s office receives an electronic copy. Penalty for noncompliance has not been determined.
There are information-blocking exceptions, but delaying access to a patient’s report so that a provider can review the result before the patient receives it is not considered an exception.6 The exceptions are situational and must be evaluated by the referring clinician or their employer. Documentation of the exception is critical. The specific facts and circumstances associated with your decision to use an exception will be important to include in your documentation. Information blocking necessary to prevent “harm” to a patient or another person requires a reasonable belief that the practice will substantially reduce the risk of harm.6
The AMA passed a resolution in June 2021 calling for changes to this rule to allow for a delay of pathology results, advocating to the Office for Civil Rights to revise the harm exception to include psychological distress.6 In August 2021, the AADA met with senior officials at the ONC also asking to revise its definition of harm, sharing examples of emotional strain that resulted from receiving results without clinical context.7 California enacted a law requiring a delay before a patient receives the result of a malignant diagnosis, giving the clinician time to contact the patient before they see their report.8
The Cures Act requirements are about patients accessing their health care information. Always consider what is best for the patient and ensure that your policies and procedures reflect this.5
Final Thoughts
It is important to learn and support advocacy priorities and efforts and to join forces to protect your practice. Physician advocacy is no longer an elective pursuit. We need to be involved and engaged through our medical societies to help patients, communities, and ourselves.
- Centers for Medicare & Medicaid Services. Calendar Year (CY) 2022 Medicare Physician Fee Schedule Proposed Rule. Published July 13, 2021. Accessed October 22, 2021. https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2022-medicare-physician-fee-schedule-proposed-rule
- Healthcare spending and the Medicare program. Medicare Payment Advisory Commission; July 2020. Accessed October 25, 2021.http://www.medpac.gov/docs/default-source/data-book/july2020_databook_entirereport_sec.pdf
- Frieden J. 2021 Medicare fee schedule includes 10.2% cut in conversion factor. MedPage Today website. Published December 2, 2020. Accessed October 22, 2021. https://www.medpagetoday.com/practicemanagement/reimbursement/89970
- Advocacy. College of American Pathologists website. Accessed October 13, 2021. https://www.cap.org/advocacy
- ONC’s Cures Act Final Rule. The Office of the National Coordinator for Health Information Technology website. Accessed October 13, 2021. https://www.healthit.gov/curesrule/
- Nelson H. Delegates call AMA to advocate for provider info-blocking flexibility. Published June 18, 2021. Accessed October 13, 2021. https://ehrintelligence.com/news/delegates-call-ama-to-advocate-for-provider-info-blocking-flexibility
- Rosamilia LL. Immediate Pathology report release to patients—is the 21st Century Cures Act worse than the disease? American Academy of Dermatology website. Published August 25, 2021. Accessed October 22, 2021. https://www.aad.org/dw/dw-insights-and-inquiries/archive/2021/cures-act-immediate-pathology-report-release-to-patients
- Purington K, Alfreds ST, Pritts J, et al; The National Academy for State Health Policy. Electronic release of clinical laboratory results: a review of state and federal policy. Published January 2010. Accessed October 13, 2021. https://www.nashp.org/wp-content/uploads/2010/02/ElectronicLabResultsExchangePolicy.pdf
- Centers for Medicare & Medicaid Services. Calendar Year (CY) 2022 Medicare Physician Fee Schedule Proposed Rule. Published July 13, 2021. Accessed October 22, 2021. https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2022-medicare-physician-fee-schedule-proposed-rule
- Healthcare spending and the Medicare program. Medicare Payment Advisory Commission; July 2020. Accessed October 25, 2021.http://www.medpac.gov/docs/default-source/data-book/july2020_databook_entirereport_sec.pdf
- Frieden J. 2021 Medicare fee schedule includes 10.2% cut in conversion factor. MedPage Today website. Published December 2, 2020. Accessed October 22, 2021. https://www.medpagetoday.com/practicemanagement/reimbursement/89970
- Advocacy. College of American Pathologists website. Accessed October 13, 2021. https://www.cap.org/advocacy
- ONC’s Cures Act Final Rule. The Office of the National Coordinator for Health Information Technology website. Accessed October 13, 2021. https://www.healthit.gov/curesrule/
- Nelson H. Delegates call AMA to advocate for provider info-blocking flexibility. Published June 18, 2021. Accessed October 13, 2021. https://ehrintelligence.com/news/delegates-call-ama-to-advocate-for-provider-info-blocking-flexibility
- Rosamilia LL. Immediate Pathology report release to patients—is the 21st Century Cures Act worse than the disease? American Academy of Dermatology website. Published August 25, 2021. Accessed October 22, 2021. https://www.aad.org/dw/dw-insights-and-inquiries/archive/2021/cures-act-immediate-pathology-report-release-to-patients
- Purington K, Alfreds ST, Pritts J, et al; The National Academy for State Health Policy. Electronic release of clinical laboratory results: a review of state and federal policy. Published January 2010. Accessed October 13, 2021. https://www.nashp.org/wp-content/uploads/2010/02/ElectronicLabResultsExchangePolicy.pdf
Practice Points
- A proposed 2022 fee schedule negatively impacting dermatopathology practices has been published by the Centers for Medicare & Medicaid Services (CMS) in July 2021.
- New pathology consultation codes with new payment rates proposed by CMS can be used starting January 1, 2022.
- The 21st Century Cures Act Final Rule has information blocking provisions.