Health Policy

Insurers Target Modifier -25

Modifier -25 allows reporting of both a minor procedure (ie, one with a 0- or 10-day global period) and a separate and distinct evaluation and management (E/M) service on the same date of service.¹ Because of the multicomplaint nature of dermatology, the ability to report a same-day procedure and an E/M service is critical for efficient, cost-effective, and patient-centered dermatologic care. However, it is well known that the use of modifier -25 has been under notable insurer scrutiny and is a common reason for medical record audits.^2,3 Some insurers have responded to increased utilization of modifier -25 by cutting reimbursement for claims that include both a procedure and an E/M service or by denying one of the services altogether.^4-6 The Centers for Medicare and Medicaid Services also have expressed concern about this coding combination with proposed cuts to reimbursement.⁷ Moreover, the Office of Inspector General has announced a work plan to investigate the frequent utilization of E/M codes and minor procedures by dermatologists.⁸ Clearly, modifier -25 is a continued target by insurers and regulators; therefore, dermatologists will want to make sure their coding and documentation meet all requirements and are updated for the new E/M codes for 2021.

The American Medical Association’s Current Procedural Terminology indicates that modifier -25 allows reporting of a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of a procedure or other service.”¹ Given that dermatology patients typically present with multiple concerns, dermatologists commonly evaluate and treat numerous conditions during one visit. Understanding what constitutes a separately identifiable E/M service is critical to bill accurately and to pass insurer audits.

Global Surgical Package

To appropriately bill both a procedure and an E/M service, the physician must indicate that the patient’s condition required an E/M service above and beyond the usual work of the procedure. The compilation of evaluation and work included in the payment for a procedure is called the global surgical package.⁹ In general, the global surgical package includes local or topical anesthesia; the surgical service/procedure itself; immediate postoperative care, including dictating the operative note; meeting/discussing the patient’s procedure with family and other physicians; and writing orders for the patient. For minor procedures (ie, those with either 0- or 10-day global periods), the surgical package also includes same-day E/M services associated with the decision to perform surgery. An appropriate history and physical examination as well as a discussion of the differential diagnosis, treatment options, and risk and benefits of treatment are all included in the payment of a minor procedure itself. Therefore, an evaluation to discuss a patient’s condition or change in condition, alternatives to treatment, or next steps after a diagnosis related to a treatment or diagnostic procedure should not be separately reported. Moreover, the fact that the patient is new to the physician is not in itself sufficient to allow reporting of an E/M service with these minor procedures. For major procedures (ie, those with 90-day postoperative periods), the decision for surgery is excluded from the global surgical package.

2021 E/M Codes Simplify Documentation

The biggest coding change of 2021 was the new E/M codes.¹⁰ Prior to this year, the descriptors of E/M services recognized 7 components to define the levels of E/M services¹¹: history and nature of the presenting problem; physical examination; medical decision-making (MDM); counseling; coordination of care; and time. Furthermore, history, physical examination, and MDM were all broken down into more granular elements that were summed to determine the level for each component; for example, the history of the presenting problem was defined as a chronological description of the development of the patient’s present illness, including the following elements: location, quality, severity, duration, timing, context, modifying factors, and associated signs and symptoms. Each of these categories would constitute bullet points to be summed to determine the level of history. Physical examination and MDM bullet points also would be summed to determine a proper coding level.¹¹ Understandably, this coding scheme was complicated and burdensome to medical providers.

The redefinition of the E/M codes for 2021 substantially simplified the determination of coding level and documentation.¹⁰ The revisions to the E/M office visit code descriptors and documentation standards are now centered around how physicians think and take care of patients and not on mandatory standards and checking boxes. The main changes involve MDM as the prime determinant of the coding level. Elements of MDM affecting coding for an outpatient or office visit now include only 3 components: the number and complexity of problems addressed in the encounter, the amount or complexity of data to be reviewed and analyzed, and the risk of complications or morbidity of patient management. Gone are the requirements from the earlier criteria requiring so many bullet points for the history, physical examination, and MDM.

Dermatologists may ask, “How does the new E/M coding structure affect reporting and documenting an E/M and a procedure on the same day?” The answer is that the determination of separate and distinct is basically unchanged with the new E/M codes; however, the documentation requirements for modifier -25 using the new E/M codes are simplified.

As always, the key to determining whether a separate and distinct E/M service was provided and subsequently documented is to deconstruct the medical note. All evaluation services associated with the procedure—making a clinical diagnosis or differential diagnosis, decision to perform surgery, and discussion of alternative treatments—should be removed from one’s documentation as shown in the example below. If a complete E/M service still exists, then an E/M may be billed in addition to the procedure. Physical examination of the treatment area is included in the surgical package. With the prior E/M criteria, physical examination of the procedural area could not be used again as a bullet point to count for the E/M level. However, with the new 2021 coding requirements, the documentation of a separate MDM will be sufficient to meet criteria because documentation of physical examination is not a requirement.

Modifier -25 Examples

Let’s examine a typical dermatologist medical note. An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. The patient also complains of a growing tender lesion on the left elbow of 2 months’ duration. Physical examination reveals a linear vesicular eruption on the left wrist and a tender hyperkeratotic papule on the left elbow. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed. The decision is made to perform a tangential biopsy of the lesion on the left elbow because of the suspicion for malignancy. The biopsy is performed the same day.

This case clearly illustrates performance of an E/M service in the treatment of rhus dermatitis, which is separate and distinct from the biopsy procedure; however, in evaluating whether the case meets the documentation requirements for modifier -25, the information in the medical note inclusive to the procedure’s global surgical package, including history associated with establishing the diagnosis, physical examination of the procedure area(s), and discussion of treatment options, is eliminated, leaving the following notes: An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed.

Because the physical examination of the body part (left arm) is included in the procedure’s global surgical package, the examination of the left wrist cannot be used as coding support for the E/M service. This makes a difference for coding level in the prior E/M coding requirements, which required examination bullet points. However, with the 2021 E/M codes, documentation of physical examination bullet points is irrelevant to the coding level. Therefore, qualifying for a modifier -25 claim is more straightforward in this case with the new code set. Because bullet points are not integral to the 2021 E/M codes, qualifying and properly documenting for a higher level of service will likely be more common in dermatology.

Final Thoughts

Frequent use of modifier -25 is a critical part of a high-quality and cost-effective dermatology practice. Same-day performance of minor procedures and E/M services allows for more rapid and efficient diagnosis and treatment of various conditions as well as minimizing unnecessary office visits. The new E/M codes for 2021 actually make the documentation of a separate and distinct E/M service less complicated because the bullet point requirements associated with the old E/M codes have been eliminated. Understanding how the new E/M code descriptors affect modifier -25 reporting and clear documentation of separate, distinct, and medically necessary E/M services will be needed due to increased insurer scrutiny and audits.

Insurers Target Modifier -25

Modifier -25 allows reporting of both a minor procedure (ie, one with a 0- or 10-day global period) and a separate and distinct evaluation and management (E/M) service on the same date of service.¹ Because of the multicomplaint nature of dermatology, the ability to report a same-day procedure and an E/M service is critical for efficient, cost-effective, and patient-centered dermatologic care. However, it is well known that the use of modifier -25 has been under notable insurer scrutiny and is a common reason for medical record audits.^2,3 Some insurers have responded to increased utilization of modifier -25 by cutting reimbursement for claims that include both a procedure and an E/M service or by denying one of the services altogether.^4-6 The Centers for Medicare and Medicaid Services also have expressed concern about this coding combination with proposed cuts to reimbursement.⁷ Moreover, the Office of Inspector General has announced a work plan to investigate the frequent utilization of E/M codes and minor procedures by dermatologists.⁸ Clearly, modifier -25 is a continued target by insurers and regulators; therefore, dermatologists will want to make sure their coding and documentation meet all requirements and are updated for the new E/M codes for 2021.

The American Medical Association’s Current Procedural Terminology indicates that modifier -25 allows reporting of a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of a procedure or other service.”¹ Given that dermatology patients typically present with multiple concerns, dermatologists commonly evaluate and treat numerous conditions during one visit. Understanding what constitutes a separately identifiable E/M service is critical to bill accurately and to pass insurer audits.

Global Surgical Package

To appropriately bill both a procedure and an E/M service, the physician must indicate that the patient’s condition required an E/M service above and beyond the usual work of the procedure. The compilation of evaluation and work included in the payment for a procedure is called the global surgical package.⁹ In general, the global surgical package includes local or topical anesthesia; the surgical service/procedure itself; immediate postoperative care, including dictating the operative note; meeting/discussing the patient’s procedure with family and other physicians; and writing orders for the patient. For minor procedures (ie, those with either 0- or 10-day global periods), the surgical package also includes same-day E/M services associated with the decision to perform surgery. An appropriate history and physical examination as well as a discussion of the differential diagnosis, treatment options, and risk and benefits of treatment are all included in the payment of a minor procedure itself. Therefore, an evaluation to discuss a patient’s condition or change in condition, alternatives to treatment, or next steps after a diagnosis related to a treatment or diagnostic procedure should not be separately reported. Moreover, the fact that the patient is new to the physician is not in itself sufficient to allow reporting of an E/M service with these minor procedures. For major procedures (ie, those with 90-day postoperative periods), the decision for surgery is excluded from the global surgical package.

2021 E/M Codes Simplify Documentation

The biggest coding change of 2021 was the new E/M codes.¹⁰ Prior to this year, the descriptors of E/M services recognized 7 components to define the levels of E/M services¹¹: history and nature of the presenting problem; physical examination; medical decision-making (MDM); counseling; coordination of care; and time. Furthermore, history, physical examination, and MDM were all broken down into more granular elements that were summed to determine the level for each component; for example, the history of the presenting problem was defined as a chronological description of the development of the patient’s present illness, including the following elements: location, quality, severity, duration, timing, context, modifying factors, and associated signs and symptoms. Each of these categories would constitute bullet points to be summed to determine the level of history. Physical examination and MDM bullet points also would be summed to determine a proper coding level.¹¹ Understandably, this coding scheme was complicated and burdensome to medical providers.

The redefinition of the E/M codes for 2021 substantially simplified the determination of coding level and documentation.¹⁰ The revisions to the E/M office visit code descriptors and documentation standards are now centered around how physicians think and take care of patients and not on mandatory standards and checking boxes. The main changes involve MDM as the prime determinant of the coding level. Elements of MDM affecting coding for an outpatient or office visit now include only 3 components: the number and complexity of problems addressed in the encounter, the amount or complexity of data to be reviewed and analyzed, and the risk of complications or morbidity of patient management. Gone are the requirements from the earlier criteria requiring so many bullet points for the history, physical examination, and MDM.

Dermatologists may ask, “How does the new E/M coding structure affect reporting and documenting an E/M and a procedure on the same day?” The answer is that the determination of separate and distinct is basically unchanged with the new E/M codes; however, the documentation requirements for modifier -25 using the new E/M codes are simplified.

As always, the key to determining whether a separate and distinct E/M service was provided and subsequently documented is to deconstruct the medical note. All evaluation services associated with the procedure—making a clinical diagnosis or differential diagnosis, decision to perform surgery, and discussion of alternative treatments—should be removed from one’s documentation as shown in the example below. If a complete E/M service still exists, then an E/M may be billed in addition to the procedure. Physical examination of the treatment area is included in the surgical package. With the prior E/M criteria, physical examination of the procedural area could not be used again as a bullet point to count for the E/M level. However, with the new 2021 coding requirements, the documentation of a separate MDM will be sufficient to meet criteria because documentation of physical examination is not a requirement.

Modifier -25 Examples

Let’s examine a typical dermatologist medical note. An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. The patient also complains of a growing tender lesion on the left elbow of 2 months’ duration. Physical examination reveals a linear vesicular eruption on the left wrist and a tender hyperkeratotic papule on the left elbow. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed. The decision is made to perform a tangential biopsy of the lesion on the left elbow because of the suspicion for malignancy. The biopsy is performed the same day.

This case clearly illustrates performance of an E/M service in the treatment of rhus dermatitis, which is separate and distinct from the biopsy procedure; however, in evaluating whether the case meets the documentation requirements for modifier -25, the information in the medical note inclusive to the procedure’s global surgical package, including history associated with establishing the diagnosis, physical examination of the procedure area(s), and discussion of treatment options, is eliminated, leaving the following notes: An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed.

Because the physical examination of the body part (left arm) is included in the procedure’s global surgical package, the examination of the left wrist cannot be used as coding support for the E/M service. This makes a difference for coding level in the prior E/M coding requirements, which required examination bullet points. However, with the 2021 E/M codes, documentation of physical examination bullet points is irrelevant to the coding level. Therefore, qualifying for a modifier -25 claim is more straightforward in this case with the new code set. Because bullet points are not integral to the 2021 E/M codes, qualifying and properly documenting for a higher level of service will likely be more common in dermatology.

Final Thoughts

Frequent use of modifier -25 is a critical part of a high-quality and cost-effective dermatology practice. Same-day performance of minor procedures and E/M services allows for more rapid and efficient diagnosis and treatment of various conditions as well as minimizing unnecessary office visits. The new E/M codes for 2021 actually make the documentation of a separate and distinct E/M service less complicated because the bullet point requirements associated with the old E/M codes have been eliminated. Understanding how the new E/M code descriptors affect modifier -25 reporting and clear documentation of separate, distinct, and medically necessary E/M services will be needed due to increased insurer scrutiny and audits.

Insurers Target Modifier -25

Modifier -25 allows reporting of both a minor procedure (ie, one with a 0- or 10-day global period) and a separate and distinct evaluation and management (E/M) service on the same date of service.¹ Because of the multicomplaint nature of dermatology, the ability to report a same-day procedure and an E/M service is critical for efficient, cost-effective, and patient-centered dermatologic care. However, it is well known that the use of modifier -25 has been under notable insurer scrutiny and is a common reason for medical record audits.^2,3 Some insurers have responded to increased utilization of modifier -25 by cutting reimbursement for claims that include both a procedure and an E/M service or by denying one of the services altogether.^4-6 The Centers for Medicare and Medicaid Services also have expressed concern about this coding combination with proposed cuts to reimbursement.⁷ Moreover, the Office of Inspector General has announced a work plan to investigate the frequent utilization of E/M codes and minor procedures by dermatologists.⁸ Clearly, modifier -25 is a continued target by insurers and regulators; therefore, dermatologists will want to make sure their coding and documentation meet all requirements and are updated for the new E/M codes for 2021.

The American Medical Association’s Current Procedural Terminology indicates that modifier -25 allows reporting of a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of a procedure or other service.”¹ Given that dermatology patients typically present with multiple concerns, dermatologists commonly evaluate and treat numerous conditions during one visit. Understanding what constitutes a separately identifiable E/M service is critical to bill accurately and to pass insurer audits.

Global Surgical Package

To appropriately bill both a procedure and an E/M service, the physician must indicate that the patient’s condition required an E/M service above and beyond the usual work of the procedure. The compilation of evaluation and work included in the payment for a procedure is called the global surgical package.⁹ In general, the global surgical package includes local or topical anesthesia; the surgical service/procedure itself; immediate postoperative care, including dictating the operative note; meeting/discussing the patient’s procedure with family and other physicians; and writing orders for the patient. For minor procedures (ie, those with either 0- or 10-day global periods), the surgical package also includes same-day E/M services associated with the decision to perform surgery. An appropriate history and physical examination as well as a discussion of the differential diagnosis, treatment options, and risk and benefits of treatment are all included in the payment of a minor procedure itself. Therefore, an evaluation to discuss a patient’s condition or change in condition, alternatives to treatment, or next steps after a diagnosis related to a treatment or diagnostic procedure should not be separately reported. Moreover, the fact that the patient is new to the physician is not in itself sufficient to allow reporting of an E/M service with these minor procedures. For major procedures (ie, those with 90-day postoperative periods), the decision for surgery is excluded from the global surgical package.

2021 E/M Codes Simplify Documentation

The biggest coding change of 2021 was the new E/M codes.¹⁰ Prior to this year, the descriptors of E/M services recognized 7 components to define the levels of E/M services¹¹: history and nature of the presenting problem; physical examination; medical decision-making (MDM); counseling; coordination of care; and time. Furthermore, history, physical examination, and MDM were all broken down into more granular elements that were summed to determine the level for each component; for example, the history of the presenting problem was defined as a chronological description of the development of the patient’s present illness, including the following elements: location, quality, severity, duration, timing, context, modifying factors, and associated signs and symptoms. Each of these categories would constitute bullet points to be summed to determine the level of history. Physical examination and MDM bullet points also would be summed to determine a proper coding level.¹¹ Understandably, this coding scheme was complicated and burdensome to medical providers.

The redefinition of the E/M codes for 2021 substantially simplified the determination of coding level and documentation.¹⁰ The revisions to the E/M office visit code descriptors and documentation standards are now centered around how physicians think and take care of patients and not on mandatory standards and checking boxes. The main changes involve MDM as the prime determinant of the coding level. Elements of MDM affecting coding for an outpatient or office visit now include only 3 components: the number and complexity of problems addressed in the encounter, the amount or complexity of data to be reviewed and analyzed, and the risk of complications or morbidity of patient management. Gone are the requirements from the earlier criteria requiring so many bullet points for the history, physical examination, and MDM.

Dermatologists may ask, “How does the new E/M coding structure affect reporting and documenting an E/M and a procedure on the same day?” The answer is that the determination of separate and distinct is basically unchanged with the new E/M codes; however, the documentation requirements for modifier -25 using the new E/M codes are simplified.

As always, the key to determining whether a separate and distinct E/M service was provided and subsequently documented is to deconstruct the medical note. All evaluation services associated with the procedure—making a clinical diagnosis or differential diagnosis, decision to perform surgery, and discussion of alternative treatments—should be removed from one’s documentation as shown in the example below. If a complete E/M service still exists, then an E/M may be billed in addition to the procedure. Physical examination of the treatment area is included in the surgical package. With the prior E/M criteria, physical examination of the procedural area could not be used again as a bullet point to count for the E/M level. However, with the new 2021 coding requirements, the documentation of a separate MDM will be sufficient to meet criteria because documentation of physical examination is not a requirement.

Modifier -25 Examples

Let’s examine a typical dermatologist medical note. An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. The patient also complains of a growing tender lesion on the left elbow of 2 months’ duration. Physical examination reveals a linear vesicular eruption on the left wrist and a tender hyperkeratotic papule on the left elbow. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed. The decision is made to perform a tangential biopsy of the lesion on the left elbow because of the suspicion for malignancy. The biopsy is performed the same day.

This case clearly illustrates performance of an E/M service in the treatment of rhus dermatitis, which is separate and distinct from the biopsy procedure; however, in evaluating whether the case meets the documentation requirements for modifier -25, the information in the medical note inclusive to the procedure’s global surgical package, including history associated with establishing the diagnosis, physical examination of the procedure area(s), and discussion of treatment options, is eliminated, leaving the following notes: An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed.

Because the physical examination of the body part (left arm) is included in the procedure’s global surgical package, the examination of the left wrist cannot be used as coding support for the E/M service. This makes a difference for coding level in the prior E/M coding requirements, which required examination bullet points. However, with the 2021 E/M codes, documentation of physical examination bullet points is irrelevant to the coding level. Therefore, qualifying for a modifier -25 claim is more straightforward in this case with the new code set. Because bullet points are not integral to the 2021 E/M codes, qualifying and properly documenting for a higher level of service will likely be more common in dermatology.

Final Thoughts

Frequent use of modifier -25 is a critical part of a high-quality and cost-effective dermatology practice. Same-day performance of minor procedures and E/M services allows for more rapid and efficient diagnosis and treatment of various conditions as well as minimizing unnecessary office visits. The new E/M codes for 2021 actually make the documentation of a separate and distinct E/M service less complicated because the bullet point requirements associated with the old E/M codes have been eliminated. Understanding how the new E/M code descriptors affect modifier -25 reporting and clear documentation of separate, distinct, and medically necessary E/M services will be needed due to increased insurer scrutiny and audits.

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

SCOTUS and abortion rights

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

Dobbs v Jackson

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

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

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

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

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

 

 

Potential outcome of Dobbs v Jackson

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

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

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

Action items

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

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

SCOTUS and abortion rights

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

Dobbs v Jackson

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

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

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

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

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

 

 

Potential outcome of Dobbs v Jackson

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

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

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

Action items

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

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

SCOTUS and abortion rights

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

Dobbs v Jackson

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

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

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

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

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

 

 

Potential outcome of Dobbs v Jackson

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

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

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

Action items

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

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.

New policy hopes to be in line with full FDA approval expected in September. When the largest employer in the world makes any significant decision, everyone sits up and takes notice.

That’s what happened when Secretary of Defense Lloyd Austin III sent out a memo to all US Department of Defense (DoD) employees saying he was seeking President Biden’s approval to make COVID-19 vaccines mandatory. His decision affects not only the 3.2 million employees on the payroll, but their families, communities, and states. Florida, for instance, where approximately 40% of the population remains unvaccinated has about 55,000 active duty service members and 36,000 reservists.

Vaccination rates in the military have lagged behind other populations, especially among Black and Hispanic service members. An April study published in Medical Surveillance Monthly Report found that “non-Hispanic Blacks, as well as those who were female, younger, of lower rank, with lower education levels, and those serving in the Army were less likely to initiate COVID-19 vaccination after adjusting for other factors.”

The decision had been in the offing for some time but when cases of the Delta variant of the virus began to spike in July, President Biden asked Sec. Austin to consider how and when the COVID vaccine could be added to the list of required vaccines for service members. It’s a long list already: Depending on their location, service members can get as many as 17 vaccines. It also folllows on the heals of the decision by the US Department of Veterans Affairs to require vaccinations for frontline health care workers.

Austin promised to “not let grass grow.” He consulted with Army Gen. Mark Milley, the Joint Chiefs of Staff, service chiefs, service secretaries, and medical professionals. Based on those discussions, he decided to ask for approval to make the vaccines mandatory no later than mid-September or immediately upon FDA licensure, whichever comes first.

However, he added, “[t]o defend this Nation, we need a healthy and ready force. I strongly encourage all DoD military and civilian personnel—as well as contractor personnel—to get vaccinated now and for military Service members to not wait for the mandate.” Currently, 73% of active-duty personnel have had at least one dose of the vaccine.

Leaping upon the news—and based on the wording in the memo—some in the media were reporting that it meant all troops have to be vaccinated by mid-September. “He’ll make the request by mid-September, unless or until FDA licensure occurs before that time, at which point the Secretary has the authority he needs…to make whatever vaccine is then given that license mandatory.”  That’s not the case, said Pentagon press secretary John Kirby in a briefing. Some voices also have called on the DoD to do more to dispel vaccine hesitancy among the troops.

In the meantime, Kirby said, “[T]wo things are going to happen. One, the services are going to be tasked to come back to the Secretary with implementation plans for how they’re going to get this moving.” Noting that mid-September isn’t far away, he pointed out that the services have a “fair but limited amount of time” to arrange their implementation plans. “I have every confidence that service leadership and your commanders will implement this new vaccination program with professionalism, skill, and compassion,” Austin wrote in his memo.

The second thing, Kirby said, was that DoD would be developing policies that comply with the President’s direction that the unvaccinated will have to be subjected to “certain requirements and restrictions.” The Delta variant is hitting the unvaccinated hardest. Austin said the DoD will keep a close eye on infection rates “and the impact these rates might have on our readiness. I will not hesitate to act sooner or recommend a different course to the President if I feel the need to do so.”

Kirby said he didn’t have all the details for that yet, but the department is “working hard” on a policy directive that will clarify what those requirements and restrictions might be.

President Biden replied almost immediately to Austin’s message. “I strongly support Secretary Austin’s message to the force today…. Secretary Austin and I share an unshakeable commitment to making sure our troops have every tool they need to do their jobs as safely as possible. These vaccines will save lives. Period.”

“All FDA-authorized COVID-19 vaccines are safe and highly effective,” Austin said in the close to his memo. “They will protect you and your family. They will protect your unit, your ship, and your co-workers. …Get the shot. Stay healthy. Stay ready.”

New policy hopes to be in line with full FDA approval expected in September. When the largest employer in the world makes any significant decision, everyone sits up and takes notice.

That’s what happened when Secretary of Defense Lloyd Austin III sent out a memo to all US Department of Defense (DoD) employees saying he was seeking President Biden’s approval to make COVID-19 vaccines mandatory. His decision affects not only the 3.2 million employees on the payroll, but their families, communities, and states. Florida, for instance, where approximately 40% of the population remains unvaccinated has about 55,000 active duty service members and 36,000 reservists.

Vaccination rates in the military have lagged behind other populations, especially among Black and Hispanic service members. An April study published in Medical Surveillance Monthly Report found that “non-Hispanic Blacks, as well as those who were female, younger, of lower rank, with lower education levels, and those serving in the Army were less likely to initiate COVID-19 vaccination after adjusting for other factors.”

The decision had been in the offing for some time but when cases of the Delta variant of the virus began to spike in July, President Biden asked Sec. Austin to consider how and when the COVID vaccine could be added to the list of required vaccines for service members. It’s a long list already: Depending on their location, service members can get as many as 17 vaccines. It also folllows on the heals of the decision by the US Department of Veterans Affairs to require vaccinations for frontline health care workers.

Austin promised to “not let grass grow.” He consulted with Army Gen. Mark Milley, the Joint Chiefs of Staff, service chiefs, service secretaries, and medical professionals. Based on those discussions, he decided to ask for approval to make the vaccines mandatory no later than mid-September or immediately upon FDA licensure, whichever comes first.

However, he added, “[t]o defend this Nation, we need a healthy and ready force. I strongly encourage all DoD military and civilian personnel—as well as contractor personnel—to get vaccinated now and for military Service members to not wait for the mandate.” Currently, 73% of active-duty personnel have had at least one dose of the vaccine.

Leaping upon the news—and based on the wording in the memo—some in the media were reporting that it meant all troops have to be vaccinated by mid-September. “He’ll make the request by mid-September, unless or until FDA licensure occurs before that time, at which point the Secretary has the authority he needs…to make whatever vaccine is then given that license mandatory.”  That’s not the case, said Pentagon press secretary John Kirby in a briefing. Some voices also have called on the DoD to do more to dispel vaccine hesitancy among the troops.

In the meantime, Kirby said, “[T]wo things are going to happen. One, the services are going to be tasked to come back to the Secretary with implementation plans for how they’re going to get this moving.” Noting that mid-September isn’t far away, he pointed out that the services have a “fair but limited amount of time” to arrange their implementation plans. “I have every confidence that service leadership and your commanders will implement this new vaccination program with professionalism, skill, and compassion,” Austin wrote in his memo.

The second thing, Kirby said, was that DoD would be developing policies that comply with the President’s direction that the unvaccinated will have to be subjected to “certain requirements and restrictions.” The Delta variant is hitting the unvaccinated hardest. Austin said the DoD will keep a close eye on infection rates “and the impact these rates might have on our readiness. I will not hesitate to act sooner or recommend a different course to the President if I feel the need to do so.”

Kirby said he didn’t have all the details for that yet, but the department is “working hard” on a policy directive that will clarify what those requirements and restrictions might be.

President Biden replied almost immediately to Austin’s message. “I strongly support Secretary Austin’s message to the force today…. Secretary Austin and I share an unshakeable commitment to making sure our troops have every tool they need to do their jobs as safely as possible. These vaccines will save lives. Period.”

“All FDA-authorized COVID-19 vaccines are safe and highly effective,” Austin said in the close to his memo. “They will protect you and your family. They will protect your unit, your ship, and your co-workers. …Get the shot. Stay healthy. Stay ready.”

New policy hopes to be in line with full FDA approval expected in September. When the largest employer in the world makes any significant decision, everyone sits up and takes notice.

That’s what happened when Secretary of Defense Lloyd Austin III sent out a memo to all US Department of Defense (DoD) employees saying he was seeking President Biden’s approval to make COVID-19 vaccines mandatory. His decision affects not only the 3.2 million employees on the payroll, but their families, communities, and states. Florida, for instance, where approximately 40% of the population remains unvaccinated has about 55,000 active duty service members and 36,000 reservists.

Vaccination rates in the military have lagged behind other populations, especially among Black and Hispanic service members. An April study published in Medical Surveillance Monthly Report found that “non-Hispanic Blacks, as well as those who were female, younger, of lower rank, with lower education levels, and those serving in the Army were less likely to initiate COVID-19 vaccination after adjusting for other factors.”

The decision had been in the offing for some time but when cases of the Delta variant of the virus began to spike in July, President Biden asked Sec. Austin to consider how and when the COVID vaccine could be added to the list of required vaccines for service members. It’s a long list already: Depending on their location, service members can get as many as 17 vaccines. It also folllows on the heals of the decision by the US Department of Veterans Affairs to require vaccinations for frontline health care workers.

Austin promised to “not let grass grow.” He consulted with Army Gen. Mark Milley, the Joint Chiefs of Staff, service chiefs, service secretaries, and medical professionals. Based on those discussions, he decided to ask for approval to make the vaccines mandatory no later than mid-September or immediately upon FDA licensure, whichever comes first.

However, he added, “[t]o defend this Nation, we need a healthy and ready force. I strongly encourage all DoD military and civilian personnel—as well as contractor personnel—to get vaccinated now and for military Service members to not wait for the mandate.” Currently, 73% of active-duty personnel have had at least one dose of the vaccine.

Leaping upon the news—and based on the wording in the memo—some in the media were reporting that it meant all troops have to be vaccinated by mid-September. “He’ll make the request by mid-September, unless or until FDA licensure occurs before that time, at which point the Secretary has the authority he needs…to make whatever vaccine is then given that license mandatory.”  That’s not the case, said Pentagon press secretary John Kirby in a briefing. Some voices also have called on the DoD to do more to dispel vaccine hesitancy among the troops.

In the meantime, Kirby said, “[T]wo things are going to happen. One, the services are going to be tasked to come back to the Secretary with implementation plans for how they’re going to get this moving.” Noting that mid-September isn’t far away, he pointed out that the services have a “fair but limited amount of time” to arrange their implementation plans. “I have every confidence that service leadership and your commanders will implement this new vaccination program with professionalism, skill, and compassion,” Austin wrote in his memo.

The second thing, Kirby said, was that DoD would be developing policies that comply with the President’s direction that the unvaccinated will have to be subjected to “certain requirements and restrictions.” The Delta variant is hitting the unvaccinated hardest. Austin said the DoD will keep a close eye on infection rates “and the impact these rates might have on our readiness. I will not hesitate to act sooner or recommend a different course to the President if I feel the need to do so.”

Kirby said he didn’t have all the details for that yet, but the department is “working hard” on a policy directive that will clarify what those requirements and restrictions might be.

President Biden replied almost immediately to Austin’s message. “I strongly support Secretary Austin’s message to the force today…. Secretary Austin and I share an unshakeable commitment to making sure our troops have every tool they need to do their jobs as safely as possible. These vaccines will save lives. Period.”

“All FDA-authorized COVID-19 vaccines are safe and highly effective,” Austin said in the close to his memo. “They will protect you and your family. They will protect your unit, your ship, and your co-workers. …Get the shot. Stay healthy. Stay ready.”

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

• Receiving treatment for solid tumors or blood cancers
• Taking immunosuppressing medications after a solid organ transplant
• Within 2 years of receiving CAR-T therapy or a stem cell transplant
• Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
• With advanced or untreated 
• Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
• With certain chronic medical conditions, such as  or asplenia – living without a spleen
• Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

• Receiving treatment for solid tumors or blood cancers
• Taking immunosuppressing medications after a solid organ transplant
• Within 2 years of receiving CAR-T therapy or a stem cell transplant
• Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
• With advanced or untreated 
• Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
• With certain chronic medical conditions, such as  or asplenia – living without a spleen
• Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, has officially signed off on a recommendation by an independent panel of 11 experts to allow people with weakened immune function to get a third dose of certain COVID-19 vaccines.

The decision follows a unanimous vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which in turn came hours after the U.S. Food and Drug Administration updated its Emergency Use Authorization (EUA) for the Pfizer and Moderna mRNA vaccines.

About 7 million adults in the United States have moderately to severely impaired immune function because of a medical condition they live with or a medication they take to manage a health condition.

People who fall into this category are at higher risk of being hospitalized or dying if they get COVID-19. They are also more likely to transmit the infection. About 40% of vaccinated patients who are hospitalized with breakthrough cases are immunocompromised.

Recent studies have shown that between one-third and one-half of immunocompromised people who didn’t develop antibodies after two doses of a vaccine do get some level of protection after a third dose.

Even then, however, the protection immunocompromised people get from vaccines is not as robust as someone who has healthy immune function, and some panel members were concerned that a third dose might come with a false sense of security.

“My only concern with adding a third dose for the immunocompromised is the impression that our immunocompromised population [will] then be safe,” said ACIP member Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.

“I think the reality is they’ll be safer but still at incredibly high risk for severe disease and death,” she said.

In updating its EUA, the FDA stressed that, even after a third dose, people who are immunocompromised will still need to wear a mask indoors, socially distance, and avoid large crowds. In addition, family members and other close contacts should be fully vaccinated to protect these vulnerable individuals.
 

Johnson & Johnson not in the mix

The boosters will be available to children as young as 12 years of age who’ve had a Pfizer vaccine or those ages 18 and older who’ve gotten the Moderna vaccine.

For now, people who’ve had the one-dose Johnson & Johnson vaccine have not been cleared to get a second dose of any vaccine.

FDA experts acknowledged the gap but said that people who had received the Johnson & Johnson vaccine represented a small slice of vaccinated Americans, and said they couldn’t act before the FDA had updated its authorization for that vaccine, which the agency is actively exploring.

“We had to do what we’re doing based on the data we have in hand,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA, the division of the agency that regulates vaccines.

“We think at least there is a solution here for the very large majority of immunocompromised individuals, and we believe we will probably have a solution for the remainder in the not-too-distant future,” Dr. Marks said.

In its updated EUA, the FDA said that the third shots were intended for people who had undergone solid organ transplants or have an “equivalent level of immunocompromise.”
 

The details

Clinical experts on the CDC panel spent a good deal of time trying to suss out exactly what conditions might fall under the FDA’s umbrella for a third dose.

In a presentation to the committee, Neela Goswami, MD, PhD, an assistant professor of infectious diseases at Emory University School of Medicine and of epidemiology at the Emory Rollins School of Public Health, Atlanta, stressed that the shots are intended for patients who are moderately or severely immunocompromised, in close consultation with their doctors, but that people who should qualify would include those:

• Receiving treatment for solid tumors or blood cancers
• Taking immunosuppressing medications after a solid organ transplant
• Within 2 years of receiving CAR-T therapy or a stem cell transplant
• Who have primary immunodeficiencies – rare genetic disorders that prevent the immune system from working properly
• With advanced or untreated 
• Taking high-dose corticosteroids (more than 20 milligrams of  or its equivalent daily), alkylating agents, antimetabolites, chemotherapy, TNF blockers, or other immunomodulating or immunosuppressing biologics
• With certain chronic medical conditions, such as  or asplenia – living without a spleen
• Receiving dialysis

In discussion, CDC experts clarified that these third doses were not intended for people whose immune function had waned with age, such as elderly residents of long-term care facilities or people with chronic diseases like diabetes.

The idea is to try to get a third dose of the vaccine they’ve already had – Moderna or Pfizer – but if that’s not feasible, it’s fine for the third dose to be different from what someone has had before. The third dose should be given at least 28 days after a second dose, and, ideally, before the initiation of immunosuppressive therapy.

Participants in the meeting said that the CDC would post updated materials on its website to help guide physicians on exactly who should receive third doses.

Ultimately, however, the extra doses will be given on an honor system; no prescriptions or other kinds of clinical documentation will be required for people to get a third dose of these shots.

Tests to measure neutralizing antibodies are also not recommended before the shots are given because of differences in the types of tests used to measure these antibodies and the difficulty in interpreting them. It’s unclear right now what level of neutralizing antibodies is needed for protection.
 

‘Peace of mind’

In public testimony, Heather Braaten, a 44-year-old being treated for ovarian cancer, said she was grateful to have gotten two shots of the Pfizer vaccine last winter, in between rounds of chemotherapy, but she knew she was probably not well protected. She said she’d become obsessive over the past few months reading medical studies and trying to understand her risk.

“I have felt distraught over the situation. My prognosis is poor. I most likely have about two to three years left to live, so everything counts,” Ms. Braaten said.

She said her life ambitions were humble. She wants to visit with friends and family and not have to worry that she’ll be a breakthrough case. She wants to go grocery shopping again and “not panic and leave the store after five minutes.” She’d love to feel free to travel, she said.

“While I understand I still need to be cautious, I am hopeful for the peace of mind and greater freedom a third shot can provide,” Ms. Braaten said.
 

More boosters on the way?

In the second half of the meeting, the CDC also signaled that it was considering the use of boosters for people whose immunity might have waned in the months since they had completed their vaccine series, particularly seniors. About 75% of people hospitalized with vaccine breakthrough cases are over age 65, according to CDC data.

Those considerations are becoming more urgent as the Delta variant continues to pummel less vaccinated states and counties.

In its presentation to the ACIP, Heather Scobie, PhD, MPH, a member of the CDC’s COVID Response Team, highlighted data from Canada, Israel, Qatar, and the United Kingdom showing that, while the Pfizer vaccine was still highly effective at preventing hospitalizations and death, it’s far less likely when faced with Delta to prevent an infection that causes symptoms.

In Israel, Pfizer’s vaccine prevented symptoms an average of 41% of the time. In Qatar, which is also using the Moderna vaccine, Pfizer’s prevented symptomatic infections with Delta about 54% of the time compared with 85% with Moderna’s.

Dr. Scobie noted that Pfizer’s waning efficacy may have something to do with the fact that it uses a lower dosage than Moderna’s. Pfizer’s recommended dosing interval is also shorter – 3 weeks compared with 4 weeks for Moderna’s. Stretching the time between shots has been shown to boost vaccine effectiveness, she said.

New data from the Mayo clinic, published ahead of peer review, also suggest that Pfizer’s protection may be fading more quickly than Moderna’s. 

In February, both shots were nearly 100% effective at preventing the SARS-CoV-2 infection, but by July, against Delta, Pfizer’s efficacy had dropped to somewhere between 13% and 62%, while Moderna’s was still effective at preventing infection between 58% and 87% of the time.

In July, Pfizer’s was between 24% and 94% effective at preventing hospitalization with a COVID-19 infection and Moderna’s was between 33% and 96% effective at preventing hospitalization.

While that may sound like cause for concern, Dr. Scobie noted that, as of August 2, severe COVD-19 outcomes after vaccination are still very rare. Among 164 million fully vaccinated people in the United States there have been about 7,000 hospitalizations and 1,500 deaths; nearly three out of four of these have been in people over the age of 65.

The ACIP will next meet on August 24 to focus solely on the COVID-19 vaccines.

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

The American Society for Clinical Pathology (ASCP), which represents over 100,000 pathologists and medical laboratory professionals, has called for a nationwide vaccination mandate. It is the first medical specialty society to do so, ASCP chief executive officer Blair Holladay, PhD, said in an interview.

However, the American Lung Association this week said it supports President Biden’s call for businesses to require their employees to be vaccinated. In addition, more than 50 medical societies, including ASCP, recently said they support vaccination mandates for health care workers.

In a position statement released Wednesday, ASCP recommended that every eligible American be vaccinated. “The U.S. Food and Drug Administration is soon expected to fully approve at least one COVID-19 vaccine, and when it does, we urge that vaccination requirements become the norm,” the society said.

Second, ASCP noted that at least 16 states have enacted some form of a ban on COVID-19 vaccine mandates or related requirements. These include blocking employment-based mandates, school vaccination or mask requirements, and vaccine passport requirements.

“These laws prolong the pandemic and threaten the health and safety of every American. They should be repealed or overturned immediately,” the association stated.

Third, ASCP said, it supports the guidance of the Centers for Disease Control and Prevention that masks should be worn indoors in public places in areas of substantial or high COVID-19 transmission.

“Before more people die, our elected leaders need to take serious and aggressive action to ensure that Americans get vaccinated, so we can end the pandemic, end patient and family suffering, end the fatalities, and get back to the lives we had before COVID-19,” the statement concluded.
 

Laboratories have to focus on COVID again

In his interview, Dr. Holladay noted that the eruption of the Delta variant across the country has again forced laboratories to focus on COVID-19 testing at the expense of necessary tests related to other diseases.

“Because 7 of 10 medical decisions depend on the laboratory, anything that interferes with that interferes with the needs of patient care, including preventive, chronic, and acute care services,” he said.

This is a major reason, he said, for ASCP to support a national vaccination mandate. “People have postponed treatment because of the inability to access medical care [for other conditions],” he noted. The same is true for preventive or diagnostic care such as biopsies for breast cancer and colonoscopies, he added.

“In many parts of the country, the throughput of COVID tests made it difficult for us to focus on tests for other acute conditions. It overwhelmed the laboratory personnel in terms of the number of tests being run.”
 

Returning to the ‘dark days’

This was a significant issue in the earlier part of the pandemic, Dr. Holladay recalled. The shortage of non-COVID lab capacity eased in the spring and early summer of 2021, when COVID-19 vaccines became widely available.

“But with the Delta variant, we’re going back to those dark days and creating the same bottleneck that we saw in the beginning,” he said.

Although the situation is worse in some states than others, Dr. Holladay added, some of the hardest-hit states like Florida and Texas have very large populations.

“This is not just about doctors, nurses, pathologists, and laboratory personnel being exhausted,” commented Kimberly Sanford, MD, president of ASCP, in a press release. “Laboratory medicine is absolutely necessary for accurate and timely diagnosis of disease, infection control, and effective treatment planning. It is an essential part of the health care system and often overwhelmed by the increasing number of coronavirus tests requiring immediate analysis.

“Such testing takes time and disproportionately consumes scarce equipment and other resources. It means those with cancer and other life-threatening conditions face serious delays in diagnosis and treatment. It delays medical diagnoses, erects barriers to preventative care, and prevents us from focusing on the significant health care needs of the population at large.”

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

The American Society for Clinical Pathology (ASCP), which represents over 100,000 pathologists and medical laboratory professionals, has called for a nationwide vaccination mandate. It is the first medical specialty society to do so, ASCP chief executive officer Blair Holladay, PhD, said in an interview.

However, the American Lung Association this week said it supports President Biden’s call for businesses to require their employees to be vaccinated. In addition, more than 50 medical societies, including ASCP, recently said they support vaccination mandates for health care workers.

In a position statement released Wednesday, ASCP recommended that every eligible American be vaccinated. “The U.S. Food and Drug Administration is soon expected to fully approve at least one COVID-19 vaccine, and when it does, we urge that vaccination requirements become the norm,” the society said.

Second, ASCP noted that at least 16 states have enacted some form of a ban on COVID-19 vaccine mandates or related requirements. These include blocking employment-based mandates, school vaccination or mask requirements, and vaccine passport requirements.

“These laws prolong the pandemic and threaten the health and safety of every American. They should be repealed or overturned immediately,” the association stated.

Third, ASCP said, it supports the guidance of the Centers for Disease Control and Prevention that masks should be worn indoors in public places in areas of substantial or high COVID-19 transmission.

“Before more people die, our elected leaders need to take serious and aggressive action to ensure that Americans get vaccinated, so we can end the pandemic, end patient and family suffering, end the fatalities, and get back to the lives we had before COVID-19,” the statement concluded.
 

Laboratories have to focus on COVID again

In his interview, Dr. Holladay noted that the eruption of the Delta variant across the country has again forced laboratories to focus on COVID-19 testing at the expense of necessary tests related to other diseases.

“Because 7 of 10 medical decisions depend on the laboratory, anything that interferes with that interferes with the needs of patient care, including preventive, chronic, and acute care services,” he said.

This is a major reason, he said, for ASCP to support a national vaccination mandate. “People have postponed treatment because of the inability to access medical care [for other conditions],” he noted. The same is true for preventive or diagnostic care such as biopsies for breast cancer and colonoscopies, he added.

“In many parts of the country, the throughput of COVID tests made it difficult for us to focus on tests for other acute conditions. It overwhelmed the laboratory personnel in terms of the number of tests being run.”
 

Returning to the ‘dark days’

This was a significant issue in the earlier part of the pandemic, Dr. Holladay recalled. The shortage of non-COVID lab capacity eased in the spring and early summer of 2021, when COVID-19 vaccines became widely available.

“But with the Delta variant, we’re going back to those dark days and creating the same bottleneck that we saw in the beginning,” he said.

Although the situation is worse in some states than others, Dr. Holladay added, some of the hardest-hit states like Florida and Texas have very large populations.

“This is not just about doctors, nurses, pathologists, and laboratory personnel being exhausted,” commented Kimberly Sanford, MD, president of ASCP, in a press release. “Laboratory medicine is absolutely necessary for accurate and timely diagnosis of disease, infection control, and effective treatment planning. It is an essential part of the health care system and often overwhelmed by the increasing number of coronavirus tests requiring immediate analysis.

“Such testing takes time and disproportionately consumes scarce equipment and other resources. It means those with cancer and other life-threatening conditions face serious delays in diagnosis and treatment. It delays medical diagnoses, erects barriers to preventative care, and prevents us from focusing on the significant health care needs of the population at large.”

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

The American Society for Clinical Pathology (ASCP), which represents over 100,000 pathologists and medical laboratory professionals, has called for a nationwide vaccination mandate. It is the first medical specialty society to do so, ASCP chief executive officer Blair Holladay, PhD, said in an interview.

However, the American Lung Association this week said it supports President Biden’s call for businesses to require their employees to be vaccinated. In addition, more than 50 medical societies, including ASCP, recently said they support vaccination mandates for health care workers.

In a position statement released Wednesday, ASCP recommended that every eligible American be vaccinated. “The U.S. Food and Drug Administration is soon expected to fully approve at least one COVID-19 vaccine, and when it does, we urge that vaccination requirements become the norm,” the society said.

Second, ASCP noted that at least 16 states have enacted some form of a ban on COVID-19 vaccine mandates or related requirements. These include blocking employment-based mandates, school vaccination or mask requirements, and vaccine passport requirements.

“These laws prolong the pandemic and threaten the health and safety of every American. They should be repealed or overturned immediately,” the association stated.

Third, ASCP said, it supports the guidance of the Centers for Disease Control and Prevention that masks should be worn indoors in public places in areas of substantial or high COVID-19 transmission.

“Before more people die, our elected leaders need to take serious and aggressive action to ensure that Americans get vaccinated, so we can end the pandemic, end patient and family suffering, end the fatalities, and get back to the lives we had before COVID-19,” the statement concluded.
 

Laboratories have to focus on COVID again

In his interview, Dr. Holladay noted that the eruption of the Delta variant across the country has again forced laboratories to focus on COVID-19 testing at the expense of necessary tests related to other diseases.

“Because 7 of 10 medical decisions depend on the laboratory, anything that interferes with that interferes with the needs of patient care, including preventive, chronic, and acute care services,” he said.

This is a major reason, he said, for ASCP to support a national vaccination mandate. “People have postponed treatment because of the inability to access medical care [for other conditions],” he noted. The same is true for preventive or diagnostic care such as biopsies for breast cancer and colonoscopies, he added.

“In many parts of the country, the throughput of COVID tests made it difficult for us to focus on tests for other acute conditions. It overwhelmed the laboratory personnel in terms of the number of tests being run.”
 

Returning to the ‘dark days’

This was a significant issue in the earlier part of the pandemic, Dr. Holladay recalled. The shortage of non-COVID lab capacity eased in the spring and early summer of 2021, when COVID-19 vaccines became widely available.

“But with the Delta variant, we’re going back to those dark days and creating the same bottleneck that we saw in the beginning,” he said.

Although the situation is worse in some states than others, Dr. Holladay added, some of the hardest-hit states like Florida and Texas have very large populations.

“This is not just about doctors, nurses, pathologists, and laboratory personnel being exhausted,” commented Kimberly Sanford, MD, president of ASCP, in a press release. “Laboratory medicine is absolutely necessary for accurate and timely diagnosis of disease, infection control, and effective treatment planning. It is an essential part of the health care system and often overwhelmed by the increasing number of coronavirus tests requiring immediate analysis.

“Such testing takes time and disproportionately consumes scarce equipment and other resources. It means those with cancer and other life-threatening conditions face serious delays in diagnosis and treatment. It delays medical diagnoses, erects barriers to preventative care, and prevents us from focusing on the significant health care needs of the population at large.”

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

The U.S. Food and Drug Administration (FDA) could green-light a booster dose of the COVID-19 mRNA vaccines for people with weakened immune systems within the next two days, according to multiple media reports.

The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.

About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis. 

Immune function also wanes with age, so the FDA could consider boosters for the elderly.

New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose. 

A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”

It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.

The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.

The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.

The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.

The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.

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

The U.S. Food and Drug Administration (FDA) could green-light a booster dose of the COVID-19 mRNA vaccines for people with weakened immune systems within the next two days, according to multiple media reports.

The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.

About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis. 

Immune function also wanes with age, so the FDA could consider boosters for the elderly.

New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose. 

A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”

It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.

The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.

The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.

The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.

The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.

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

The U.S. Food and Drug Administration (FDA) could green-light a booster dose of the COVID-19 mRNA vaccines for people with weakened immune systems within the next two days, according to multiple media reports.

The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.

About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis. 

Immune function also wanes with age, so the FDA could consider boosters for the elderly.

New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose. 

A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”

It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.

The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.

The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.

The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.

The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.

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

State laws capping initial opioid prescriptions to 7 days or less have led to a reduction in opioid prescribing, a new analysis of Medicare data shows.

While overall opioid prescribing has decreased, the reduction in states with legislation restricting opioid prescribing was “significantly greater than in states without such legislation,” study investigator Michael Brenner, MD, University of Michigan, Ann Arbor, said in an interview.

The study was published online August 9 in JAMA Internal Medicine.
 

Significant but limited effect

Because of rising concern around the opioid crisis, 23 states representing 43% of the U.S. population passed laws from 2016 through 2018 limiting initial opioid prescription to 7 days or less.

Using Medicare data from 2013 through 2018, Dr. Brenner and colleagues conducted a before-and-after study to assess the effect of these laws.

They found that on average, the number of days an opioid was prescribed for each Medicare beneficiary decreased by 11.6 days (from 44.2 days in 2013 to 32.7 days in 2018) in states that imposed duration limits, compared with 10.1 days in states without these laws (from 43.4 days in 2013 to 33.3 days in 2018).

Prior to the start of duration limits in 2016, days an opioid was prescribed were comparable among states.

After adjusting for state-level differences in race, urbanization, median income, tobacco and alcohol use, serious mental illness, and other factors, state laws limiting opioid prescriptions to 7 days or less were associated with a reduction in prescribing of 1.7 days per enrollee, “suggesting a significant but limited outcome” for these laws, the researchers note.

The largest decrease in opioid prescribing occurred in primary care, but this was not significantly different in states with limit laws versus those without. However, state laws limiting duration led to a significant reduction in days of opioid prescribed among surgeons, dentists, pain specialists, and other specialists.
 

Inadequate pain control?

The researchers note the study was limited to Medicare beneficiaries; however, excess opioid prescribing is prevalent across all patient populations.

In addition, it’s not possible to tell from the data whether acute pain was adequately controlled with fewer pills.

“The question of adequacy of pain control is a crucial one that has been investigated extensively in prior work but was not possible to evaluate in this particular study,” said Dr. Brenner.

However, “ample evidence supports a role for reducing opioid prescribing and that such reduction can be achieved while ensuring that pain is adequately controlled with fewer pills,” he noted.

“A persistent misconception is that opioids are uniquely powerful and effective for controlling pain. Patients may perceive that effective analgesia is being withheld when opioids are not included in a regimen,” Dr. Brenner added.

“Yet, the evidence from meta-analyses derived from large numbers of randomized clinical trials finds that [nonsteroidal anti-inflammatory drugs] NSAIDS combined with acetaminophen provide similar or improved acute pain when compared to commonly prescribed opioid regimens, based on number-needed-to-treat analyses,” he added.

In a related editorial, Deborah Grady, MD, MPH, with University of California, San Francisco, and Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, say the decrease in opioid prescribing with duration limits was “small but probably meaningful.” 

Restricting initial prescriptions to seven or fewer days is “reasonable because patients with new onset of pain should be re-evaluated in a week if the pain continues,” they write. 

However, Dr. Grady and Dr. Katz “worry” that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as has occurred in six states, “may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief.”

In their view, the data from this study suggest that limiting initial prescriptions to seven or fewer days is “helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

The study had no specific funding. Dr. Brenner, Dr. Grady, and Dr. Katz have disclosed no relevant financial relationships.

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

State laws capping initial opioid prescriptions to 7 days or less have led to a reduction in opioid prescribing, a new analysis of Medicare data shows.

While overall opioid prescribing has decreased, the reduction in states with legislation restricting opioid prescribing was “significantly greater than in states without such legislation,” study investigator Michael Brenner, MD, University of Michigan, Ann Arbor, said in an interview.

The study was published online August 9 in JAMA Internal Medicine.
 

Significant but limited effect

Because of rising concern around the opioid crisis, 23 states representing 43% of the U.S. population passed laws from 2016 through 2018 limiting initial opioid prescription to 7 days or less.

Using Medicare data from 2013 through 2018, Dr. Brenner and colleagues conducted a before-and-after study to assess the effect of these laws.

They found that on average, the number of days an opioid was prescribed for each Medicare beneficiary decreased by 11.6 days (from 44.2 days in 2013 to 32.7 days in 2018) in states that imposed duration limits, compared with 10.1 days in states without these laws (from 43.4 days in 2013 to 33.3 days in 2018).

Prior to the start of duration limits in 2016, days an opioid was prescribed were comparable among states.

After adjusting for state-level differences in race, urbanization, median income, tobacco and alcohol use, serious mental illness, and other factors, state laws limiting opioid prescriptions to 7 days or less were associated with a reduction in prescribing of 1.7 days per enrollee, “suggesting a significant but limited outcome” for these laws, the researchers note.

The largest decrease in opioid prescribing occurred in primary care, but this was not significantly different in states with limit laws versus those without. However, state laws limiting duration led to a significant reduction in days of opioid prescribed among surgeons, dentists, pain specialists, and other specialists.
 

Inadequate pain control?

The researchers note the study was limited to Medicare beneficiaries; however, excess opioid prescribing is prevalent across all patient populations.

In addition, it’s not possible to tell from the data whether acute pain was adequately controlled with fewer pills.

“The question of adequacy of pain control is a crucial one that has been investigated extensively in prior work but was not possible to evaluate in this particular study,” said Dr. Brenner.

However, “ample evidence supports a role for reducing opioid prescribing and that such reduction can be achieved while ensuring that pain is adequately controlled with fewer pills,” he noted.

“A persistent misconception is that opioids are uniquely powerful and effective for controlling pain. Patients may perceive that effective analgesia is being withheld when opioids are not included in a regimen,” Dr. Brenner added.

“Yet, the evidence from meta-analyses derived from large numbers of randomized clinical trials finds that [nonsteroidal anti-inflammatory drugs] NSAIDS combined with acetaminophen provide similar or improved acute pain when compared to commonly prescribed opioid regimens, based on number-needed-to-treat analyses,” he added.

In a related editorial, Deborah Grady, MD, MPH, with University of California, San Francisco, and Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, say the decrease in opioid prescribing with duration limits was “small but probably meaningful.” 

Restricting initial prescriptions to seven or fewer days is “reasonable because patients with new onset of pain should be re-evaluated in a week if the pain continues,” they write. 

However, Dr. Grady and Dr. Katz “worry” that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as has occurred in six states, “may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief.”

In their view, the data from this study suggest that limiting initial prescriptions to seven or fewer days is “helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

The study had no specific funding. Dr. Brenner, Dr. Grady, and Dr. Katz have disclosed no relevant financial relationships.

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

State laws capping initial opioid prescriptions to 7 days or less have led to a reduction in opioid prescribing, a new analysis of Medicare data shows.

While overall opioid prescribing has decreased, the reduction in states with legislation restricting opioid prescribing was “significantly greater than in states without such legislation,” study investigator Michael Brenner, MD, University of Michigan, Ann Arbor, said in an interview.

The study was published online August 9 in JAMA Internal Medicine.
 

Significant but limited effect

Because of rising concern around the opioid crisis, 23 states representing 43% of the U.S. population passed laws from 2016 through 2018 limiting initial opioid prescription to 7 days or less.

Using Medicare data from 2013 through 2018, Dr. Brenner and colleagues conducted a before-and-after study to assess the effect of these laws.

They found that on average, the number of days an opioid was prescribed for each Medicare beneficiary decreased by 11.6 days (from 44.2 days in 2013 to 32.7 days in 2018) in states that imposed duration limits, compared with 10.1 days in states without these laws (from 43.4 days in 2013 to 33.3 days in 2018).

Prior to the start of duration limits in 2016, days an opioid was prescribed were comparable among states.

After adjusting for state-level differences in race, urbanization, median income, tobacco and alcohol use, serious mental illness, and other factors, state laws limiting opioid prescriptions to 7 days or less were associated with a reduction in prescribing of 1.7 days per enrollee, “suggesting a significant but limited outcome” for these laws, the researchers note.

The largest decrease in opioid prescribing occurred in primary care, but this was not significantly different in states with limit laws versus those without. However, state laws limiting duration led to a significant reduction in days of opioid prescribed among surgeons, dentists, pain specialists, and other specialists.
 

Inadequate pain control?

The researchers note the study was limited to Medicare beneficiaries; however, excess opioid prescribing is prevalent across all patient populations.

In addition, it’s not possible to tell from the data whether acute pain was adequately controlled with fewer pills.

“The question of adequacy of pain control is a crucial one that has been investigated extensively in prior work but was not possible to evaluate in this particular study,” said Dr. Brenner.

However, “ample evidence supports a role for reducing opioid prescribing and that such reduction can be achieved while ensuring that pain is adequately controlled with fewer pills,” he noted.

“A persistent misconception is that opioids are uniquely powerful and effective for controlling pain. Patients may perceive that effective analgesia is being withheld when opioids are not included in a regimen,” Dr. Brenner added.

“Yet, the evidence from meta-analyses derived from large numbers of randomized clinical trials finds that [nonsteroidal anti-inflammatory drugs] NSAIDS combined with acetaminophen provide similar or improved acute pain when compared to commonly prescribed opioid regimens, based on number-needed-to-treat analyses,” he added.

In a related editorial, Deborah Grady, MD, MPH, with University of California, San Francisco, and Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, say the decrease in opioid prescribing with duration limits was “small but probably meaningful.” 

Restricting initial prescriptions to seven or fewer days is “reasonable because patients with new onset of pain should be re-evaluated in a week if the pain continues,” they write. 

However, Dr. Grady and Dr. Katz “worry” that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as has occurred in six states, “may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief.”

In their view, the data from this study suggest that limiting initial prescriptions to seven or fewer days is “helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

The study had no specific funding. Dr. Brenner, Dr. Grady, and Dr. Katz have disclosed no relevant financial relationships.

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

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

Study Overview

Objective. To compare the risk of subsequent fractures after an initial traumatic or nontraumatic fracture in postmenopausal women.

Design. A prospective observational study utilizing data from the Women’s Health Initiative (WHI) Study, WHI Clinical Trials (WHI-CT), and WHI Bone Density Substudy to evaluate rates at which patients who suffered a traumatic fracture vs nontraumatic fracture develop a subsequent fracture.

Setting and participants. The WHI study, implemented at 40 United States clinical sites, enrolled 161 808 postmenopausal women aged 50 to 79 years at baseline between 1993 and 1998. The study cohort consisted of 75 335 patients who had self-reported fractures from September 1994 to December 1998 that were confirmed by the WHI Bone Density Substudy and WHI-CT. Of these participants, 253 (0.3%) were excluded because of a lack of follow-up information regarding incident fractures, and 8208 (10.9%) were excluded due to incomplete information on covariates, thus resulting in an analytic sample of 66 874 (88.8%) participants. Prospective fracture ascertainment with participants was conducted at least annually and the mechanism of fracture was assessed to differentiate traumatic vs nontraumatic incident fractures. Traumatic fractures were defined as fractures caused by motor vehicle collisions, falls from a height, falls downstairs, or sports injury. Nontraumatic fractures were defined as fractures caused by a trip and fall.

Main outcome measures. The primary outcome was an incident fracture at an anatomically distinct body part. Fractures were classified as upper extremity (carpal, elbow, lower or upper end of humerus, shaft of humerus, upper radius/ulna, or radius/ulna), lower extremity (ankle, hip, patella, pelvis, shaft of femur, tibia/fibula, or tibial plateau), or spine (lumbar and/or thoracic spine). Self-reported fractures were verified via medical chart review by WHI study physicians; hip fractures were confirmed by review of written reports of radiographic studies; and nonhip fractures were confirmed by review of radiography reports or clinical documentations.

Main results. In total, 66 874 women in the study (mean [SD] age) 63.1 (7.0) years without clinical fracture and 65.3 (7.2) years with clinical fracture at baseline were followed for 8.1 (1.6) years. Of these participants, 7142 (10.7%) experienced incident fracture during the study follow-up period (13.9 per 1000 person-years), and 721 (10.1%) of whom had a subsequent fracture. The adjusted hazard ratio (aHR) of subsequent fracture after an initial fracture was 1.49 (95% CI, 1.38-1.61, P < .001). Covariates adjusted were age, race, ethnicity, body mass index, treated diabetes, frequency of falls in the previous year, and physical function and activity. In women with initial traumatic fracture, the association between initial and subsequent fracture was increased (aHR, 1.25; 95% CI, 1.06-1.48, P = .01). Among women with initial nontraumatic fracture, the association between initial and subsequent fracture was also increased (aHR, 1.52; 95% CI, 1.37-1.68, P < .001). The confidence intervals for the 2 preceding associations for traumatic and nontraumatic initial fracture strata were overlapping.

Conclusion. Fractures, regardless of mechanism of injury, are similarly associated with an increased risk of subsequent fractures in postmenopausal women aged 50 years and older. Findings from this study provide evidence to support reevaluation of current clinical guidelines to include traumatic fracture as a trigger for osteoporosis screening.

Commentary

Osteoporosis is one of the most common age-associated disease that affects 1 in 4 women and 1 in 20 men over the age of 65.¹ It increases the risk of fracture, and its clinical sequelae include reduced mobility, health decline, and increased all-cause mortality. The high prevalence of osteoporosis poses a clinical challenge as the global population continues to age. Pharmacological treatments such as bisphosphonates are highly effective in preventing or slowing bone mineral density (BMD) loss and reducing risk of fragility fractures (eg, nontraumatic fractures of the vertebra, hip, and femur) and are commonly used to mitigate adverse effects of degenerative bone changes secondary to osteoporosis.¹

The high prevalence of osteoporosis and effectiveness of bisphosphonates raises the question of how to optimally identify adults at risk for osteoporosis so that pharmacologic therapy can be promptly initiated to prevent disease progression. Multiple osteoporosis screening guidelines, including those from the United States Preventive Services Task Force (USPSTF), American Association of Family Physicians, and National Osteoporosis Foundation, are widely used in the clinical setting to address this important clinical question. In general, the prevailing wisdom is to screen osteoporosis in postmenopausal women over the age of 65, women under the age of 65 who have a significant 10-year fracture risk, or women over the age of 50 who have experienced a fragility fracture.¹ In the study reported by Crandall et al, it was shown that the risks of having subsequent fractures were similar after an initial traumatic or nontraumatic (fragility) fracture in postmenopausal women aged 50 years and older.² This finding brings into question whether traumatic fractures should be viewed any differently than nontraumatic fractures in women over the age of 50 in light of evaluation for osteoporosis. Furthermore, these results suggest that most fractures in postmenopausal women may indicate decreased bone integrity, thus adding to the rationale that osteoporosis screening needs to be considered and expanded to include postmenopausal women under the age of 65 who endured a traumatic fracture.

Per current guidelines, a woman under the age of 65 is recommended for osteoporosis screening only if she has an increased 10-year fracture risk compared to women aged 65 years and older. This risk is calculated based on the World Health Organization fracture-risk algorithm (WHO FRAX) tool which uses multiple factors such as age, weight, and history of fragility fractures to predict whether an individual is at risk of developing a fracture in the next 10 years. The WHO FRAX tool does not include traumatic fractures in its risk calculation and current clinical guidelines do not account for traumatic fractures as a red flag to initiate osteoporosis screening. Therefore, postmenopausal women under the age of 65 are less likely to be screened for osteoporosis when they experience a traumatic fracture compared to a fragility fracture, despite being at a demonstrably higher risk for subsequent fracture. As an unintended consequence, this may lead to the under diagnosis of osteoporosis in postmenopausal women under the age of 65. Thus, Crandall et al conclude that a fracture due to any cause warrants follow up evaluation for osteoporosis including BMD testing in women older than 50 years of age.

Older men constitute another population who are commonly under screened for osteoporosis. The current USPSTF guidelines indicate that there is an insufficient body of evidence to screen men for osteoporosis given its lower prevalence.¹ However, it is important to note that men have significantly increased mortality after a hip fracture, are less likely to be on pharmacological treatment for osteoporosis, and are under diagnosed for osteoporosis.³ Consistent with findings from the current study, Leslie et al showed that high-trauma and low-trauma fractures have similarly elevated subsequent fracture risk in both men and women over the age of 40 in a Canadian study.⁴ Moreover, in the same study, BMD was decreased in both men and women who suffered a fracture regardless of the injury mechanism. This finding further underscores a need to consider traumatic fractures as a risk factor for osteoporosis. Taken together, given that men are under screened and treated for osteoporosis but have increased mortality post-fracture, considerations to initiate osteoporosis evaluation should be similarly given to men who endured a traumatic fracture.

The study conducted by Crandall et al has several strengths. It is noteworthy for the large size of the WHI cohort with participants from across the United States which enables the capture of a wider range of age groups as women under the age of 65 are not common participants of osteoporosis studies. Additionally, data ascertainment and outcome adjudication utilizing medical records and physician review assure data quality. A limitation of the study is that the study cohort consists exclusively of women and therefore the findings are not generalizable to men. However, findings from this study echo those from other studies that investigate the relationship between fracture mechanisms and subsequent fracture risk in men and women.^3,4 Collectively, these comparable findings highlight the need for additional research to validate traumatic fracture as a risk factor for osteoporosis and to incorporate it into clinical guidelines for osteoporosis screening.

Applications for Clinical Practice

The findings from the current study indicate that traumatic and fragility fractures may be more alike than previously recognized in regards to bone health and subsequent fracture prevention in postmenopausal women. If validated, these results may lead to changes in clinical practice whereby all fractures in postmenopausal women could trigger osteoporosis screening, assessment, and treatment if indicated for the secondary prevention of fractures.

Study Overview

Objective. To compare the risk of subsequent fractures after an initial traumatic or nontraumatic fracture in postmenopausal women.

Design. A prospective observational study utilizing data from the Women’s Health Initiative (WHI) Study, WHI Clinical Trials (WHI-CT), and WHI Bone Density Substudy to evaluate rates at which patients who suffered a traumatic fracture vs nontraumatic fracture develop a subsequent fracture.

Setting and participants. The WHI study, implemented at 40 United States clinical sites, enrolled 161 808 postmenopausal women aged 50 to 79 years at baseline between 1993 and 1998. The study cohort consisted of 75 335 patients who had self-reported fractures from September 1994 to December 1998 that were confirmed by the WHI Bone Density Substudy and WHI-CT. Of these participants, 253 (0.3%) were excluded because of a lack of follow-up information regarding incident fractures, and 8208 (10.9%) were excluded due to incomplete information on covariates, thus resulting in an analytic sample of 66 874 (88.8%) participants. Prospective fracture ascertainment with participants was conducted at least annually and the mechanism of fracture was assessed to differentiate traumatic vs nontraumatic incident fractures. Traumatic fractures were defined as fractures caused by motor vehicle collisions, falls from a height, falls downstairs, or sports injury. Nontraumatic fractures were defined as fractures caused by a trip and fall.

Main outcome measures. The primary outcome was an incident fracture at an anatomically distinct body part. Fractures were classified as upper extremity (carpal, elbow, lower or upper end of humerus, shaft of humerus, upper radius/ulna, or radius/ulna), lower extremity (ankle, hip, patella, pelvis, shaft of femur, tibia/fibula, or tibial plateau), or spine (lumbar and/or thoracic spine). Self-reported fractures were verified via medical chart review by WHI study physicians; hip fractures were confirmed by review of written reports of radiographic studies; and nonhip fractures were confirmed by review of radiography reports or clinical documentations.

Main results. In total, 66 874 women in the study (mean [SD] age) 63.1 (7.0) years without clinical fracture and 65.3 (7.2) years with clinical fracture at baseline were followed for 8.1 (1.6) years. Of these participants, 7142 (10.7%) experienced incident fracture during the study follow-up period (13.9 per 1000 person-years), and 721 (10.1%) of whom had a subsequent fracture. The adjusted hazard ratio (aHR) of subsequent fracture after an initial fracture was 1.49 (95% CI, 1.38-1.61, P < .001). Covariates adjusted were age, race, ethnicity, body mass index, treated diabetes, frequency of falls in the previous year, and physical function and activity. In women with initial traumatic fracture, the association between initial and subsequent fracture was increased (aHR, 1.25; 95% CI, 1.06-1.48, P = .01). Among women with initial nontraumatic fracture, the association between initial and subsequent fracture was also increased (aHR, 1.52; 95% CI, 1.37-1.68, P < .001). The confidence intervals for the 2 preceding associations for traumatic and nontraumatic initial fracture strata were overlapping.

Conclusion. Fractures, regardless of mechanism of injury, are similarly associated with an increased risk of subsequent fractures in postmenopausal women aged 50 years and older. Findings from this study provide evidence to support reevaluation of current clinical guidelines to include traumatic fracture as a trigger for osteoporosis screening.

Commentary

Osteoporosis is one of the most common age-associated disease that affects 1 in 4 women and 1 in 20 men over the age of 65.¹ It increases the risk of fracture, and its clinical sequelae include reduced mobility, health decline, and increased all-cause mortality. The high prevalence of osteoporosis poses a clinical challenge as the global population continues to age. Pharmacological treatments such as bisphosphonates are highly effective in preventing or slowing bone mineral density (BMD) loss and reducing risk of fragility fractures (eg, nontraumatic fractures of the vertebra, hip, and femur) and are commonly used to mitigate adverse effects of degenerative bone changes secondary to osteoporosis.¹

The high prevalence of osteoporosis and effectiveness of bisphosphonates raises the question of how to optimally identify adults at risk for osteoporosis so that pharmacologic therapy can be promptly initiated to prevent disease progression. Multiple osteoporosis screening guidelines, including those from the United States Preventive Services Task Force (USPSTF), American Association of Family Physicians, and National Osteoporosis Foundation, are widely used in the clinical setting to address this important clinical question. In general, the prevailing wisdom is to screen osteoporosis in postmenopausal women over the age of 65, women under the age of 65 who have a significant 10-year fracture risk, or women over the age of 50 who have experienced a fragility fracture.¹ In the study reported by Crandall et al, it was shown that the risks of having subsequent fractures were similar after an initial traumatic or nontraumatic (fragility) fracture in postmenopausal women aged 50 years and older.² This finding brings into question whether traumatic fractures should be viewed any differently than nontraumatic fractures in women over the age of 50 in light of evaluation for osteoporosis. Furthermore, these results suggest that most fractures in postmenopausal women may indicate decreased bone integrity, thus adding to the rationale that osteoporosis screening needs to be considered and expanded to include postmenopausal women under the age of 65 who endured a traumatic fracture.

Per current guidelines, a woman under the age of 65 is recommended for osteoporosis screening only if she has an increased 10-year fracture risk compared to women aged 65 years and older. This risk is calculated based on the World Health Organization fracture-risk algorithm (WHO FRAX) tool which uses multiple factors such as age, weight, and history of fragility fractures to predict whether an individual is at risk of developing a fracture in the next 10 years. The WHO FRAX tool does not include traumatic fractures in its risk calculation and current clinical guidelines do not account for traumatic fractures as a red flag to initiate osteoporosis screening. Therefore, postmenopausal women under the age of 65 are less likely to be screened for osteoporosis when they experience a traumatic fracture compared to a fragility fracture, despite being at a demonstrably higher risk for subsequent fracture. As an unintended consequence, this may lead to the under diagnosis of osteoporosis in postmenopausal women under the age of 65. Thus, Crandall et al conclude that a fracture due to any cause warrants follow up evaluation for osteoporosis including BMD testing in women older than 50 years of age.

Older men constitute another population who are commonly under screened for osteoporosis. The current USPSTF guidelines indicate that there is an insufficient body of evidence to screen men for osteoporosis given its lower prevalence.¹ However, it is important to note that men have significantly increased mortality after a hip fracture, are less likely to be on pharmacological treatment for osteoporosis, and are under diagnosed for osteoporosis.³ Consistent with findings from the current study, Leslie et al showed that high-trauma and low-trauma fractures have similarly elevated subsequent fracture risk in both men and women over the age of 40 in a Canadian study.⁴ Moreover, in the same study, BMD was decreased in both men and women who suffered a fracture regardless of the injury mechanism. This finding further underscores a need to consider traumatic fractures as a risk factor for osteoporosis. Taken together, given that men are under screened and treated for osteoporosis but have increased mortality post-fracture, considerations to initiate osteoporosis evaluation should be similarly given to men who endured a traumatic fracture.

The study conducted by Crandall et al has several strengths. It is noteworthy for the large size of the WHI cohort with participants from across the United States which enables the capture of a wider range of age groups as women under the age of 65 are not common participants of osteoporosis studies. Additionally, data ascertainment and outcome adjudication utilizing medical records and physician review assure data quality. A limitation of the study is that the study cohort consists exclusively of women and therefore the findings are not generalizable to men. However, findings from this study echo those from other studies that investigate the relationship between fracture mechanisms and subsequent fracture risk in men and women.^3,4 Collectively, these comparable findings highlight the need for additional research to validate traumatic fracture as a risk factor for osteoporosis and to incorporate it into clinical guidelines for osteoporosis screening.

Applications for Clinical Practice

The findings from the current study indicate that traumatic and fragility fractures may be more alike than previously recognized in regards to bone health and subsequent fracture prevention in postmenopausal women. If validated, these results may lead to changes in clinical practice whereby all fractures in postmenopausal women could trigger osteoporosis screening, assessment, and treatment if indicated for the secondary prevention of fractures.

Study Overview

Objective. To compare the risk of subsequent fractures after an initial traumatic or nontraumatic fracture in postmenopausal women.

Design. A prospective observational study utilizing data from the Women’s Health Initiative (WHI) Study, WHI Clinical Trials (WHI-CT), and WHI Bone Density Substudy to evaluate rates at which patients who suffered a traumatic fracture vs nontraumatic fracture develop a subsequent fracture.

Setting and participants. The WHI study, implemented at 40 United States clinical sites, enrolled 161 808 postmenopausal women aged 50 to 79 years at baseline between 1993 and 1998. The study cohort consisted of 75 335 patients who had self-reported fractures from September 1994 to December 1998 that were confirmed by the WHI Bone Density Substudy and WHI-CT. Of these participants, 253 (0.3%) were excluded because of a lack of follow-up information regarding incident fractures, and 8208 (10.9%) were excluded due to incomplete information on covariates, thus resulting in an analytic sample of 66 874 (88.8%) participants. Prospective fracture ascertainment with participants was conducted at least annually and the mechanism of fracture was assessed to differentiate traumatic vs nontraumatic incident fractures. Traumatic fractures were defined as fractures caused by motor vehicle collisions, falls from a height, falls downstairs, or sports injury. Nontraumatic fractures were defined as fractures caused by a trip and fall.

Main outcome measures. The primary outcome was an incident fracture at an anatomically distinct body part. Fractures were classified as upper extremity (carpal, elbow, lower or upper end of humerus, shaft of humerus, upper radius/ulna, or radius/ulna), lower extremity (ankle, hip, patella, pelvis, shaft of femur, tibia/fibula, or tibial plateau), or spine (lumbar and/or thoracic spine). Self-reported fractures were verified via medical chart review by WHI study physicians; hip fractures were confirmed by review of written reports of radiographic studies; and nonhip fractures were confirmed by review of radiography reports or clinical documentations.

Main results. In total, 66 874 women in the study (mean [SD] age) 63.1 (7.0) years without clinical fracture and 65.3 (7.2) years with clinical fracture at baseline were followed for 8.1 (1.6) years. Of these participants, 7142 (10.7%) experienced incident fracture during the study follow-up period (13.9 per 1000 person-years), and 721 (10.1%) of whom had a subsequent fracture. The adjusted hazard ratio (aHR) of subsequent fracture after an initial fracture was 1.49 (95% CI, 1.38-1.61, P < .001). Covariates adjusted were age, race, ethnicity, body mass index, treated diabetes, frequency of falls in the previous year, and physical function and activity. In women with initial traumatic fracture, the association between initial and subsequent fracture was increased (aHR, 1.25; 95% CI, 1.06-1.48, P = .01). Among women with initial nontraumatic fracture, the association between initial and subsequent fracture was also increased (aHR, 1.52; 95% CI, 1.37-1.68, P < .001). The confidence intervals for the 2 preceding associations for traumatic and nontraumatic initial fracture strata were overlapping.

Conclusion. Fractures, regardless of mechanism of injury, are similarly associated with an increased risk of subsequent fractures in postmenopausal women aged 50 years and older. Findings from this study provide evidence to support reevaluation of current clinical guidelines to include traumatic fracture as a trigger for osteoporosis screening.

Commentary

Osteoporosis is one of the most common age-associated disease that affects 1 in 4 women and 1 in 20 men over the age of 65.¹ It increases the risk of fracture, and its clinical sequelae include reduced mobility, health decline, and increased all-cause mortality. The high prevalence of osteoporosis poses a clinical challenge as the global population continues to age. Pharmacological treatments such as bisphosphonates are highly effective in preventing or slowing bone mineral density (BMD) loss and reducing risk of fragility fractures (eg, nontraumatic fractures of the vertebra, hip, and femur) and are commonly used to mitigate adverse effects of degenerative bone changes secondary to osteoporosis.¹

The high prevalence of osteoporosis and effectiveness of bisphosphonates raises the question of how to optimally identify adults at risk for osteoporosis so that pharmacologic therapy can be promptly initiated to prevent disease progression. Multiple osteoporosis screening guidelines, including those from the United States Preventive Services Task Force (USPSTF), American Association of Family Physicians, and National Osteoporosis Foundation, are widely used in the clinical setting to address this important clinical question. In general, the prevailing wisdom is to screen osteoporosis in postmenopausal women over the age of 65, women under the age of 65 who have a significant 10-year fracture risk, or women over the age of 50 who have experienced a fragility fracture.¹ In the study reported by Crandall et al, it was shown that the risks of having subsequent fractures were similar after an initial traumatic or nontraumatic (fragility) fracture in postmenopausal women aged 50 years and older.² This finding brings into question whether traumatic fractures should be viewed any differently than nontraumatic fractures in women over the age of 50 in light of evaluation for osteoporosis. Furthermore, these results suggest that most fractures in postmenopausal women may indicate decreased bone integrity, thus adding to the rationale that osteoporosis screening needs to be considered and expanded to include postmenopausal women under the age of 65 who endured a traumatic fracture.

Per current guidelines, a woman under the age of 65 is recommended for osteoporosis screening only if she has an increased 10-year fracture risk compared to women aged 65 years and older. This risk is calculated based on the World Health Organization fracture-risk algorithm (WHO FRAX) tool which uses multiple factors such as age, weight, and history of fragility fractures to predict whether an individual is at risk of developing a fracture in the next 10 years. The WHO FRAX tool does not include traumatic fractures in its risk calculation and current clinical guidelines do not account for traumatic fractures as a red flag to initiate osteoporosis screening. Therefore, postmenopausal women under the age of 65 are less likely to be screened for osteoporosis when they experience a traumatic fracture compared to a fragility fracture, despite being at a demonstrably higher risk for subsequent fracture. As an unintended consequence, this may lead to the under diagnosis of osteoporosis in postmenopausal women under the age of 65. Thus, Crandall et al conclude that a fracture due to any cause warrants follow up evaluation for osteoporosis including BMD testing in women older than 50 years of age.

Older men constitute another population who are commonly under screened for osteoporosis. The current USPSTF guidelines indicate that there is an insufficient body of evidence to screen men for osteoporosis given its lower prevalence.¹ However, it is important to note that men have significantly increased mortality after a hip fracture, are less likely to be on pharmacological treatment for osteoporosis, and are under diagnosed for osteoporosis.³ Consistent with findings from the current study, Leslie et al showed that high-trauma and low-trauma fractures have similarly elevated subsequent fracture risk in both men and women over the age of 40 in a Canadian study.⁴ Moreover, in the same study, BMD was decreased in both men and women who suffered a fracture regardless of the injury mechanism. This finding further underscores a need to consider traumatic fractures as a risk factor for osteoporosis. Taken together, given that men are under screened and treated for osteoporosis but have increased mortality post-fracture, considerations to initiate osteoporosis evaluation should be similarly given to men who endured a traumatic fracture.

The study conducted by Crandall et al has several strengths. It is noteworthy for the large size of the WHI cohort with participants from across the United States which enables the capture of a wider range of age groups as women under the age of 65 are not common participants of osteoporosis studies. Additionally, data ascertainment and outcome adjudication utilizing medical records and physician review assure data quality. A limitation of the study is that the study cohort consists exclusively of women and therefore the findings are not generalizable to men. However, findings from this study echo those from other studies that investigate the relationship between fracture mechanisms and subsequent fracture risk in men and women.^3,4 Collectively, these comparable findings highlight the need for additional research to validate traumatic fracture as a risk factor for osteoporosis and to incorporate it into clinical guidelines for osteoporosis screening.

Applications for Clinical Practice

The findings from the current study indicate that traumatic and fragility fractures may be more alike than previously recognized in regards to bone health and subsequent fracture prevention in postmenopausal women. If validated, these results may lead to changes in clinical practice whereby all fractures in postmenopausal women could trigger osteoporosis screening, assessment, and treatment if indicated for the secondary prevention of fractures.