TOPLINE:

A meta-analysis supports the use of mobile mental health apps, both as a standalone and added to conventional treatment, for adults with moderate to severe depression.

METHODOLOGY:

Mobile mental health apps have proliferated but data on their effectiveness in different patient populations is lacking.

To investigate, researchers conducted a systematic review and meta-analysis of 13 randomized clinical trials assessing treatment efficacy of mobile mental health apps in 1470 adults with moderate to severe depression.

The primary outcome was change in depression symptoms from pre- to post-treatment; secondary outcomes included patient-level factors associated with app efficacy.

TAKEAWAY: 

Mobile app interventions were associated with significantly reduced depressive symptoms vs both active and inactive control groups, with a medium effect size (standardized mean difference [SMD] 0.50).

App interventions delivered for < 8 weeks had a significantly greater effect size than those delivered for 8+ weeks (SMD 0.77 vs 0.43). Apps were more effective in patients not on medication or in therapy. Apps offering rewards or incentives also appeared to be more effective.

Interventions with in-app notifications were associated with significantly lower treatment outcomes (SMD 0.45) than interventions without (SMD 0.45 vs 0.71).

IN PRACTICE:

“The significant treatment efficacy of app-based interventions compared with active and inactive controls suggests the potential of mobile app interventions as an alternative to conventional psychotherapy, with further merits in accessibility, financial affordability, and safety from stigma,” the authors write.

SOURCE:

The study, with first author Hayoung Bae, BA, with Korea University School of Psychology, Seoul, South Korea, was published online November 20 in JAMA Network Open .

LIMITATIONS:

The findings are based on a small number of trials, with significant heterogeneity among the included trials. The analysis included only English-language publications. Using summary data for the subgroup analyses might have prevented a detailed understanding of the moderating associations of individual participant characteristics.

DISCLOSURES:

The study was supported by a grant from the National Research Foundation funded by the Korean government. The authors report no relevant financial relationships.

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

TOPLINE:

A meta-analysis supports the use of mobile mental health apps, both as a standalone and added to conventional treatment, for adults with moderate to severe depression.

METHODOLOGY:

Mobile mental health apps have proliferated but data on their effectiveness in different patient populations is lacking.

To investigate, researchers conducted a systematic review and meta-analysis of 13 randomized clinical trials assessing treatment efficacy of mobile mental health apps in 1470 adults with moderate to severe depression.

The primary outcome was change in depression symptoms from pre- to post-treatment; secondary outcomes included patient-level factors associated with app efficacy.

TAKEAWAY: 

Mobile app interventions were associated with significantly reduced depressive symptoms vs both active and inactive control groups, with a medium effect size (standardized mean difference [SMD] 0.50).

App interventions delivered for < 8 weeks had a significantly greater effect size than those delivered for 8+ weeks (SMD 0.77 vs 0.43). Apps were more effective in patients not on medication or in therapy. Apps offering rewards or incentives also appeared to be more effective.

Interventions with in-app notifications were associated with significantly lower treatment outcomes (SMD 0.45) than interventions without (SMD 0.45 vs 0.71).

IN PRACTICE:

“The significant treatment efficacy of app-based interventions compared with active and inactive controls suggests the potential of mobile app interventions as an alternative to conventional psychotherapy, with further merits in accessibility, financial affordability, and safety from stigma,” the authors write.

SOURCE:

The study, with first author Hayoung Bae, BA, with Korea University School of Psychology, Seoul, South Korea, was published online November 20 in JAMA Network Open .

LIMITATIONS:

The findings are based on a small number of trials, with significant heterogeneity among the included trials. The analysis included only English-language publications. Using summary data for the subgroup analyses might have prevented a detailed understanding of the moderating associations of individual participant characteristics.

DISCLOSURES:

The study was supported by a grant from the National Research Foundation funded by the Korean government. The authors report no relevant financial relationships.

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

TOPLINE:

A meta-analysis supports the use of mobile mental health apps, both as a standalone and added to conventional treatment, for adults with moderate to severe depression.

METHODOLOGY:

Mobile mental health apps have proliferated but data on their effectiveness in different patient populations is lacking.

To investigate, researchers conducted a systematic review and meta-analysis of 13 randomized clinical trials assessing treatment efficacy of mobile mental health apps in 1470 adults with moderate to severe depression.

The primary outcome was change in depression symptoms from pre- to post-treatment; secondary outcomes included patient-level factors associated with app efficacy.

TAKEAWAY: 

Mobile app interventions were associated with significantly reduced depressive symptoms vs both active and inactive control groups, with a medium effect size (standardized mean difference [SMD] 0.50).

App interventions delivered for < 8 weeks had a significantly greater effect size than those delivered for 8+ weeks (SMD 0.77 vs 0.43). Apps were more effective in patients not on medication or in therapy. Apps offering rewards or incentives also appeared to be more effective.

Interventions with in-app notifications were associated with significantly lower treatment outcomes (SMD 0.45) than interventions without (SMD 0.45 vs 0.71).

IN PRACTICE:

“The significant treatment efficacy of app-based interventions compared with active and inactive controls suggests the potential of mobile app interventions as an alternative to conventional psychotherapy, with further merits in accessibility, financial affordability, and safety from stigma,” the authors write.

SOURCE:

The study, with first author Hayoung Bae, BA, with Korea University School of Psychology, Seoul, South Korea, was published online November 20 in JAMA Network Open .

LIMITATIONS:

The findings are based on a small number of trials, with significant heterogeneity among the included trials. The analysis included only English-language publications. Using summary data for the subgroup analyses might have prevented a detailed understanding of the moderating associations of individual participant characteristics.

DISCLOSURES:

The study was supported by a grant from the National Research Foundation funded by the Korean government. The authors report no relevant financial relationships.

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

TOPLINE:

Salivary microbiota changes caused by cigarette smoking may affect metabolic pathways and increase disease risk.

METHODOLOGY:

The researchers analyzed health information and data on the composition of salivary microbiota from 1601 adult participants in the Cooperative Health Research in South Tyrol (CHRIS) microbiome study (CHRISMB); CHRIS is an ongoing study in Italy.

The average age of the study population was 45 years; 53% were female, and 45% were current or former smokers.

The researchers hypothesized that changes in salivary microbial composition would be associated with smoking, with more nitrate-reducing bacteria present, and that nitrate reduction pathways would be reduced in smokers.

TAKEAWAY:

The researchers identified 44 genera that differed in the salivary microbiota of current smokers and nonsmokers. In smokers, seven genera in the phylum Proteobacteria were decreased and six in the phylum Actinobacteria were increased compared with nonsmokers; these phyla contain primarily aerobic and anaerobic taxa, respectively.

Some microbiota changes were significantly associated with daily smoking intensity; genera from the classes Betaproteobacteria (Lautropia or Neisseria), Gammaproteobacteria (Cardiobacterium), and Flavobacteriia (Capnocytophaga) decreased significantly with increased grams of tobacco smoked per day, measured in 5-g increments.

Smoking was associated with changes in the salivary microbiota; the nitrate reduction pathway was significantly lower in smokers compared with nonsmokers, and these decreases were consistent with previous studies of decreased cardiovascular events in former smokers.

However, the salivary microbiota of smokers who had quit for at least 5 years resembled that of individuals who had never smoked.

IN PRACTICE:

“Decreased microbial nitrate reduction pathway abundance in smokers may provide an additional explanation for the effect of smoking on cardiovascular and periodontal diseases risk, a hypothesis which should be tested in future studies,” the researchers wrote.

SOURCE:

The lead author of the study was Giacomo Antonello, MD, of Eurac Research, Affiliated Institute of the University of Lübeck, Bolzano, Italy. The study was published online in Scientific Reports (a Nature journal) on November 2, 2023.

LIMITATIONS:

The cross-sectional design and lack of professional assessment of tooth and gum health were limiting factors, as were potential confounding factors including medication use, diet, and alcohol intake.

DISCLOSURES:

The study was supported by the Department of Innovation, Research and University of the Autonomous Province of Bolzano-South Tyrol and by the European Regional Development Fund. The CHRISMB microbiota data generation was funded by the National Institute of Dental and Craniofacial Research. The researchers had no financial conflicts to disclose.

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

TOPLINE:

Salivary microbiota changes caused by cigarette smoking may affect metabolic pathways and increase disease risk.

METHODOLOGY:

The researchers analyzed health information and data on the composition of salivary microbiota from 1601 adult participants in the Cooperative Health Research in South Tyrol (CHRIS) microbiome study (CHRISMB); CHRIS is an ongoing study in Italy.

The average age of the study population was 45 years; 53% were female, and 45% were current or former smokers.

The researchers hypothesized that changes in salivary microbial composition would be associated with smoking, with more nitrate-reducing bacteria present, and that nitrate reduction pathways would be reduced in smokers.

TAKEAWAY:

The researchers identified 44 genera that differed in the salivary microbiota of current smokers and nonsmokers. In smokers, seven genera in the phylum Proteobacteria were decreased and six in the phylum Actinobacteria were increased compared with nonsmokers; these phyla contain primarily aerobic and anaerobic taxa, respectively.

Some microbiota changes were significantly associated with daily smoking intensity; genera from the classes Betaproteobacteria (Lautropia or Neisseria), Gammaproteobacteria (Cardiobacterium), and Flavobacteriia (Capnocytophaga) decreased significantly with increased grams of tobacco smoked per day, measured in 5-g increments.

Smoking was associated with changes in the salivary microbiota; the nitrate reduction pathway was significantly lower in smokers compared with nonsmokers, and these decreases were consistent with previous studies of decreased cardiovascular events in former smokers.

However, the salivary microbiota of smokers who had quit for at least 5 years resembled that of individuals who had never smoked.

IN PRACTICE:

“Decreased microbial nitrate reduction pathway abundance in smokers may provide an additional explanation for the effect of smoking on cardiovascular and periodontal diseases risk, a hypothesis which should be tested in future studies,” the researchers wrote.

SOURCE:

The lead author of the study was Giacomo Antonello, MD, of Eurac Research, Affiliated Institute of the University of Lübeck, Bolzano, Italy. The study was published online in Scientific Reports (a Nature journal) on November 2, 2023.

LIMITATIONS:

The cross-sectional design and lack of professional assessment of tooth and gum health were limiting factors, as were potential confounding factors including medication use, diet, and alcohol intake.

DISCLOSURES:

The study was supported by the Department of Innovation, Research and University of the Autonomous Province of Bolzano-South Tyrol and by the European Regional Development Fund. The CHRISMB microbiota data generation was funded by the National Institute of Dental and Craniofacial Research. The researchers had no financial conflicts to disclose.

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

TOPLINE:

Salivary microbiota changes caused by cigarette smoking may affect metabolic pathways and increase disease risk.

METHODOLOGY:

The researchers analyzed health information and data on the composition of salivary microbiota from 1601 adult participants in the Cooperative Health Research in South Tyrol (CHRIS) microbiome study (CHRISMB); CHRIS is an ongoing study in Italy.

The average age of the study population was 45 years; 53% were female, and 45% were current or former smokers.

The researchers hypothesized that changes in salivary microbial composition would be associated with smoking, with more nitrate-reducing bacteria present, and that nitrate reduction pathways would be reduced in smokers.

TAKEAWAY:

The researchers identified 44 genera that differed in the salivary microbiota of current smokers and nonsmokers. In smokers, seven genera in the phylum Proteobacteria were decreased and six in the phylum Actinobacteria were increased compared with nonsmokers; these phyla contain primarily aerobic and anaerobic taxa, respectively.

Some microbiota changes were significantly associated with daily smoking intensity; genera from the classes Betaproteobacteria (Lautropia or Neisseria), Gammaproteobacteria (Cardiobacterium), and Flavobacteriia (Capnocytophaga) decreased significantly with increased grams of tobacco smoked per day, measured in 5-g increments.

Smoking was associated with changes in the salivary microbiota; the nitrate reduction pathway was significantly lower in smokers compared with nonsmokers, and these decreases were consistent with previous studies of decreased cardiovascular events in former smokers.

However, the salivary microbiota of smokers who had quit for at least 5 years resembled that of individuals who had never smoked.

IN PRACTICE:

“Decreased microbial nitrate reduction pathway abundance in smokers may provide an additional explanation for the effect of smoking on cardiovascular and periodontal diseases risk, a hypothesis which should be tested in future studies,” the researchers wrote.

SOURCE:

The lead author of the study was Giacomo Antonello, MD, of Eurac Research, Affiliated Institute of the University of Lübeck, Bolzano, Italy. The study was published online in Scientific Reports (a Nature journal) on November 2, 2023.

LIMITATIONS:

The cross-sectional design and lack of professional assessment of tooth and gum health were limiting factors, as were potential confounding factors including medication use, diet, and alcohol intake.

DISCLOSURES:

The study was supported by the Department of Innovation, Research and University of the Autonomous Province of Bolzano-South Tyrol and by the European Regional Development Fund. The CHRISMB microbiota data generation was funded by the National Institute of Dental and Craniofacial Research. The researchers had no financial conflicts to disclose.

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

The 2024 updates to the Medicare Physician Fee Schedule (MPFS) and the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) final rules represent a mixed bag for gastroenterologists.

Medicare Physician Fee Schedule (MPFS) Final Rule

Cuts to physician payments continue: The final calendar year (CY) 2024 MPFS conversion factor will be $32.7442, a cut of approximately 3.4% from CY 2023, unless Congress acts. The reduction is the result of several factors, including the statutory base payment update of 0 percent, the reduction in assistance provided by the Consolidated Appropriations Act, 2023 (from 2.5% for 2023 to 1.25% for 2024), and budget neutrality adjustments of –2.18 percent resulting from CMS’ finalized policies.

New add-on code for complex care: CMS is finalizing complexity add-on code, G2211 (Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious condition or a complex condition), that it originally proposed in 2018 rulemaking. CMS noted that G2211 cannot be used with an office and outpatient E/M procedure reported with modifier –25. CMS further clarified that the add-on code “is not intended for use by a professional whose relationship with the patient is of a discrete, routine, or time-limited nature ...” CMS further stated, “The inherent complexity that this code (G2211) captures is not in the clinical condition itself ... but rather the cognitive load of the continued responsibility of being the focal point for all needed services for this patient.” For gastroenterologists, it is reasonable to assume G2211 could be reported for care of patients with complex, chronic conditions such as inflammatory bowel disease (IBD), celiac disease, and/or chronic liver disease.

CMS to align split (or shared) visit policy with CPT rules: Originally, CMS proposed to again delay “through at least December 31, 2024” its planned implementation of defining the “substantive portion” of a split/shared visit as more than half of the total time. However, after the American Medical Association’s CPT Editorial Panel, the body responsible for maintaining the CPT code set, issued new guidelines for split (or shared) services CMS decided to finalize the following policy to align with those guidelines: “Substantive portion means more than half of the total time spent by the physician and nonphysician practitioner performing the split (or shared) visit, or a substantive part of the medical decision making except as otherwise provided in this paragraph. For critical care visits, substantive portion means more than half of the total time spent by the physician and nonphysician practitioner performing the split (or shared) visit.”

While the CPT guidance states, “If code selection is based on total time on the date of the encounter, the service is reported by the professional who spent the majority of the face-to-face or non-face-to-face time performing the service,” this direction does not appear in the finalized CMS language.

CMS has extended Telehealth flexibility provisions through Dec. 31, 2024:

• Reporting of Home Address — CMS will continue to permit distant site practitioners to use their currently enrolled practice location instead of their home address when providing telehealth services from their home through CY 2024.
• Place of Service (POS) for Medicare Telehealth Services — Beginning in CY 2024, claims billed with POS 10 (Telehealth Provided in Patient’s Home) will be paid at the non-facility rate, and claims billed with POS 02 (Telehealth Provided Other than in Patient’s Home) will be paid at the facility rate. CMS also clarified that modifier –95 should be used when the clinician is in the hospital and the patient is at home.
• Direct Supervision with Virtual Presence — CMS will continue to define direct supervision to permit the presence and “immediate availability” of the supervising practitioner through real-time audio and visual interactive telecommunications through CY 2024.
• Supervision of Residents in Teaching Settings — CMS will allow teaching physicians to have a virtual presence (to continue to include real-time audio and video observation by the teaching physician) in all teaching settings, but only in clinical instances when the service is furnished virtually, through CY 2024.
• Telephone E/M Services — CMS will continue to pay for CPT codes for telephone assessment and management services (99441-99443) through CY 2024.

Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) Final Rule

Hospital and ASC payments will increase: Conversion factors will increase 3.1% to $87.38 for hospitals and $53.51 for ASCs that meet applicable quality reporting requirements.

Hospital payments for Peroral Endoscopic Myotomy (POEM) increase: The GI societies successfully advocated for a 67% increase to the facility payment for POEM. To better align with the procedure’s cost, CMS will place CPT code 43497 for POEM into a higher-level Ambulatory Payment Classification (APC) (5331 — Complex GI procedures) with a facility payment of $5,435.83.

Cuts to hospital payments for some Level 3 upper GI procedures: CMS has finalized moving the following GI CPT codes that had previously been assigned to APC 5303 (Level 3 Upper GI Procedures — $3,260.69) to APC 5302 (Level 2 Upper GI Procedures — $1,814.88) without explanation and against advice from AGA and the GI societies. This will result in payment cuts of 44% to hospitals.

• 43252 (EGD, flexible transoral with optical microscopy)
• 43263 (ERCP with pressure measurement, sphincter of Oddi)
• 43275 (ERCP, remove foreign body/stent biliary/pancreatic duct)

GI Comprehensive APC complexity adjustments: Based on a cost and volume threshold, CMS sometimes makes payment adjustments for Comprehensive APCs when two procedures are performed together. In response to comments received, CMS is adding the following procedures to the list of code combinations eligible for an increased payment via the Complexity Adjustment.

• CPT 43270 (EGD, ablate tumor polyp/lesion with dilation and wire)
• CPT 43252 (EGD, flexible transoral with optical microscopy)

For more information, see 2024 the payment rules summary and payment tables at https://gastro.org/practice-resources/reimbursement.

The Coverage and Reimbursement Subcommittee members have no conflicts of interest.

The 2024 updates to the Medicare Physician Fee Schedule (MPFS) and the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) final rules represent a mixed bag for gastroenterologists.

Medicare Physician Fee Schedule (MPFS) Final Rule

Cuts to physician payments continue: The final calendar year (CY) 2024 MPFS conversion factor will be $32.7442, a cut of approximately 3.4% from CY 2023, unless Congress acts. The reduction is the result of several factors, including the statutory base payment update of 0 percent, the reduction in assistance provided by the Consolidated Appropriations Act, 2023 (from 2.5% for 2023 to 1.25% for 2024), and budget neutrality adjustments of –2.18 percent resulting from CMS’ finalized policies.

New add-on code for complex care: CMS is finalizing complexity add-on code, G2211 (Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious condition or a complex condition), that it originally proposed in 2018 rulemaking. CMS noted that G2211 cannot be used with an office and outpatient E/M procedure reported with modifier –25. CMS further clarified that the add-on code “is not intended for use by a professional whose relationship with the patient is of a discrete, routine, or time-limited nature ...” CMS further stated, “The inherent complexity that this code (G2211) captures is not in the clinical condition itself ... but rather the cognitive load of the continued responsibility of being the focal point for all needed services for this patient.” For gastroenterologists, it is reasonable to assume G2211 could be reported for care of patients with complex, chronic conditions such as inflammatory bowel disease (IBD), celiac disease, and/or chronic liver disease.

CMS to align split (or shared) visit policy with CPT rules: Originally, CMS proposed to again delay “through at least December 31, 2024” its planned implementation of defining the “substantive portion” of a split/shared visit as more than half of the total time. However, after the American Medical Association’s CPT Editorial Panel, the body responsible for maintaining the CPT code set, issued new guidelines for split (or shared) services CMS decided to finalize the following policy to align with those guidelines: “Substantive portion means more than half of the total time spent by the physician and nonphysician practitioner performing the split (or shared) visit, or a substantive part of the medical decision making except as otherwise provided in this paragraph. For critical care visits, substantive portion means more than half of the total time spent by the physician and nonphysician practitioner performing the split (or shared) visit.”

While the CPT guidance states, “If code selection is based on total time on the date of the encounter, the service is reported by the professional who spent the majority of the face-to-face or non-face-to-face time performing the service,” this direction does not appear in the finalized CMS language.

CMS has extended Telehealth flexibility provisions through Dec. 31, 2024:

• Reporting of Home Address — CMS will continue to permit distant site practitioners to use their currently enrolled practice location instead of their home address when providing telehealth services from their home through CY 2024.
• Place of Service (POS) for Medicare Telehealth Services — Beginning in CY 2024, claims billed with POS 10 (Telehealth Provided in Patient’s Home) will be paid at the non-facility rate, and claims billed with POS 02 (Telehealth Provided Other than in Patient’s Home) will be paid at the facility rate. CMS also clarified that modifier –95 should be used when the clinician is in the hospital and the patient is at home.
• Direct Supervision with Virtual Presence — CMS will continue to define direct supervision to permit the presence and “immediate availability” of the supervising practitioner through real-time audio and visual interactive telecommunications through CY 2024.
• Supervision of Residents in Teaching Settings — CMS will allow teaching physicians to have a virtual presence (to continue to include real-time audio and video observation by the teaching physician) in all teaching settings, but only in clinical instances when the service is furnished virtually, through CY 2024.
• Telephone E/M Services — CMS will continue to pay for CPT codes for telephone assessment and management services (99441-99443) through CY 2024.

Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) Final Rule

Hospital and ASC payments will increase: Conversion factors will increase 3.1% to $87.38 for hospitals and $53.51 for ASCs that meet applicable quality reporting requirements.

Hospital payments for Peroral Endoscopic Myotomy (POEM) increase: The GI societies successfully advocated for a 67% increase to the facility payment for POEM. To better align with the procedure’s cost, CMS will place CPT code 43497 for POEM into a higher-level Ambulatory Payment Classification (APC) (5331 — Complex GI procedures) with a facility payment of $5,435.83.

Cuts to hospital payments for some Level 3 upper GI procedures: CMS has finalized moving the following GI CPT codes that had previously been assigned to APC 5303 (Level 3 Upper GI Procedures — $3,260.69) to APC 5302 (Level 2 Upper GI Procedures — $1,814.88) without explanation and against advice from AGA and the GI societies. This will result in payment cuts of 44% to hospitals.

• 43252 (EGD, flexible transoral with optical microscopy)
• 43263 (ERCP with pressure measurement, sphincter of Oddi)
• 43275 (ERCP, remove foreign body/stent biliary/pancreatic duct)

GI Comprehensive APC complexity adjustments: Based on a cost and volume threshold, CMS sometimes makes payment adjustments for Comprehensive APCs when two procedures are performed together. In response to comments received, CMS is adding the following procedures to the list of code combinations eligible for an increased payment via the Complexity Adjustment.

• CPT 43270 (EGD, ablate tumor polyp/lesion with dilation and wire)
• CPT 43252 (EGD, flexible transoral with optical microscopy)

For more information, see 2024 the payment rules summary and payment tables at https://gastro.org/practice-resources/reimbursement.

The Coverage and Reimbursement Subcommittee members have no conflicts of interest.

The 2024 updates to the Medicare Physician Fee Schedule (MPFS) and the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) final rules represent a mixed bag for gastroenterologists.

Medicare Physician Fee Schedule (MPFS) Final Rule

Cuts to physician payments continue: The final calendar year (CY) 2024 MPFS conversion factor will be $32.7442, a cut of approximately 3.4% from CY 2023, unless Congress acts. The reduction is the result of several factors, including the statutory base payment update of 0 percent, the reduction in assistance provided by the Consolidated Appropriations Act, 2023 (from 2.5% for 2023 to 1.25% for 2024), and budget neutrality adjustments of –2.18 percent resulting from CMS’ finalized policies.

New add-on code for complex care: CMS is finalizing complexity add-on code, G2211 (Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious condition or a complex condition), that it originally proposed in 2018 rulemaking. CMS noted that G2211 cannot be used with an office and outpatient E/M procedure reported with modifier –25. CMS further clarified that the add-on code “is not intended for use by a professional whose relationship with the patient is of a discrete, routine, or time-limited nature ...” CMS further stated, “The inherent complexity that this code (G2211) captures is not in the clinical condition itself ... but rather the cognitive load of the continued responsibility of being the focal point for all needed services for this patient.” For gastroenterologists, it is reasonable to assume G2211 could be reported for care of patients with complex, chronic conditions such as inflammatory bowel disease (IBD), celiac disease, and/or chronic liver disease.

CMS to align split (or shared) visit policy with CPT rules: Originally, CMS proposed to again delay “through at least December 31, 2024” its planned implementation of defining the “substantive portion” of a split/shared visit as more than half of the total time. However, after the American Medical Association’s CPT Editorial Panel, the body responsible for maintaining the CPT code set, issued new guidelines for split (or shared) services CMS decided to finalize the following policy to align with those guidelines: “Substantive portion means more than half of the total time spent by the physician and nonphysician practitioner performing the split (or shared) visit, or a substantive part of the medical decision making except as otherwise provided in this paragraph. For critical care visits, substantive portion means more than half of the total time spent by the physician and nonphysician practitioner performing the split (or shared) visit.”

While the CPT guidance states, “If code selection is based on total time on the date of the encounter, the service is reported by the professional who spent the majority of the face-to-face or non-face-to-face time performing the service,” this direction does not appear in the finalized CMS language.

CMS has extended Telehealth flexibility provisions through Dec. 31, 2024:

• Reporting of Home Address — CMS will continue to permit distant site practitioners to use their currently enrolled practice location instead of their home address when providing telehealth services from their home through CY 2024.
• Place of Service (POS) for Medicare Telehealth Services — Beginning in CY 2024, claims billed with POS 10 (Telehealth Provided in Patient’s Home) will be paid at the non-facility rate, and claims billed with POS 02 (Telehealth Provided Other than in Patient’s Home) will be paid at the facility rate. CMS also clarified that modifier –95 should be used when the clinician is in the hospital and the patient is at home.
• Direct Supervision with Virtual Presence — CMS will continue to define direct supervision to permit the presence and “immediate availability” of the supervising practitioner through real-time audio and visual interactive telecommunications through CY 2024.
• Supervision of Residents in Teaching Settings — CMS will allow teaching physicians to have a virtual presence (to continue to include real-time audio and video observation by the teaching physician) in all teaching settings, but only in clinical instances when the service is furnished virtually, through CY 2024.
• Telephone E/M Services — CMS will continue to pay for CPT codes for telephone assessment and management services (99441-99443) through CY 2024.

Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) Final Rule

Hospital and ASC payments will increase: Conversion factors will increase 3.1% to $87.38 for hospitals and $53.51 for ASCs that meet applicable quality reporting requirements.

Hospital payments for Peroral Endoscopic Myotomy (POEM) increase: The GI societies successfully advocated for a 67% increase to the facility payment for POEM. To better align with the procedure’s cost, CMS will place CPT code 43497 for POEM into a higher-level Ambulatory Payment Classification (APC) (5331 — Complex GI procedures) with a facility payment of $5,435.83.

Cuts to hospital payments for some Level 3 upper GI procedures: CMS has finalized moving the following GI CPT codes that had previously been assigned to APC 5303 (Level 3 Upper GI Procedures — $3,260.69) to APC 5302 (Level 2 Upper GI Procedures — $1,814.88) without explanation and against advice from AGA and the GI societies. This will result in payment cuts of 44% to hospitals.

• 43252 (EGD, flexible transoral with optical microscopy)
• 43263 (ERCP with pressure measurement, sphincter of Oddi)
• 43275 (ERCP, remove foreign body/stent biliary/pancreatic duct)

GI Comprehensive APC complexity adjustments: Based on a cost and volume threshold, CMS sometimes makes payment adjustments for Comprehensive APCs when two procedures are performed together. In response to comments received, CMS is adding the following procedures to the list of code combinations eligible for an increased payment via the Complexity Adjustment.

• CPT 43270 (EGD, ablate tumor polyp/lesion with dilation and wire)
• CPT 43252 (EGD, flexible transoral with optical microscopy)

For more information, see 2024 the payment rules summary and payment tables at https://gastro.org/practice-resources/reimbursement.

The Coverage and Reimbursement Subcommittee members have no conflicts of interest.

The Diagnosis: Merkel Cell Carcinoma

Multiple diagnoses should be considered for a small, round, blue cell neoplasm of the skin, including both primary and metastatic entities. In our patient, histopathology revealed sheets and nests of infiltrative neoplastic cells with dispersed chromatin, minimal cytoplasm, and multiple mitoses (quiz image 1).¹ The lesional cells were in the dermis and superficial subcutaneous tissue but did not appear to be arising from the epidermis. Lymphovascular invasion also was evident on additional sections. Metastatic disease was identified in 3 sentinel lymph nodes from the right inguinal and right iliac regions. These features were compatible with a diagnosis of Merkel cell carcinoma (MCC).

Merkel cell carcinoma is a rare malignant neuroendocrine cutaneous tumor with a worldwide incidence of 0.1 to 1.6 cases per 100,000 individuals annually.² The typical patient is older than 75 years with fair skin and a history of extensive sun exposure. Immunocompromised individuals are predisposed and more susceptible to infection with the Merkel cell polyomavirus, which promotes oncogenesis in the majority of MCCs. Our patient’s history of combined variable immunodeficiency likely explains her presentation at a younger age.

The prognosis in patients with MCC is poor, with 5-year survival rates of 51% for local disease, 35% for nodal disease, and 14% for systemic metastases. Survival also is reduced in cases with head/ neck primary tumors and polyomavirus-negative tumors, as well as in immunocompromised patients.² Treatment of resectable MCC consists of Mohs micrographic surgery or wide local excision depending on the patient’s cosmetic concerns. Radiation therapy is recommended for cases with increased risk for recurrence or positive surgical margins, as well as when additional resection is impossible. A study investigating immunotherapy with nivolumab demonstrated complete pathologic response and radiographic tumor regression in nearly half of patients when given 4 weeks prior to surgery.³

Immunohistochemistry is essential in discerning MCC from other small blue cell tumors. Most MCC cases show positive expression of neuroendocrine markers such as synaptophysin, chromogranin, and insulinomaassociated protein 1. Perinuclear dotlike staining with cytokeratin (CK) 20 (quiz image 2) commonly is seen, but up to 15% of cases may be CK20 negative. Many of these CK20-negative cases also express CK7. This tumor also may stain with paired box 5 (PAX-5), CD99, terminal deoxynucleotidyl transferase, Ber-EP4, and CD117^1,4; melanoma stains (ie, human melanoma black [HMB] 45, SRYrelated HMB-box 10 [SOX-10], S-100, melanoma antigen recognized by T-cells 1 [MART-1]) should be negative. However, PAX-5 expression may be a potential pitfall given that B-cell lymphomas also would express that marker and could mimic MCC histologically. Therefore, other universal lymphoid markers such as CD45 should be ordered to rule out this entity. Even with one or a few aberrant stains, a diagnosis of MCC still can be rendered using the histomorphology and the overall staining profile.⁴ Of prognostic significance, p63 expression is associated with more aggressive tumors, while Bcl-2 expression is favorable, as it offers an additional targeted treatment option.^5,6

Basal cell carcinoma (BCC) is linked to excessive sun exposure and is the most common skin cancer. Similar to MCC, it typically is mitotically active and hyperchromatic; however, lymphovascular invasion or metastasis almost never is observed in BCC, whereas approximately one-third of MCC cases have metastasized by the time of diagnosis. Additionally, BCC lacks the perinuclear dotlike staining seen with CK20.^2,7 Features present in BCC that are unusual for MCC include peripheral nuclear palisading, mucin, and retraction artifact on paraffin-embedded sections (Figure 1).⁷

Leukemia cutis (or cutaneous infiltrates of leukemia) commonly displays a perivascular and periadnexal pattern in the dermis and subcutis. These infiltrates of neoplastic leukocytes can congregate into sheets, sometimes with an overlying Grenz zone, or form single-file infiltrates (Figure 2).^1,4 The neoplastic cells can be monomorphic or atypical and commonly are susceptible to crush artifact.⁴ Although the immunohistochemical profile varies depending on the etiology of the underlying leukemia, broad hematologic markers such as CD43 and CD45 are helpful to discern these malignancies from MCC.⁴

Being neuroendocrine in origin, metastatic small cell carcinoma (Figure 3) strongly mimics MCC histologically and usually stains with synaptophysin, chromogranin, and insulinoma-associated protein 1. Both tumor cells typically exhibit nuclear molding and high mitotic rates. Although small cell carcinoma is more likely to stain with high-molecular-weight cytokeratins (ie, CK7), it is not uncommon for these tumors to express lowmolecular- weight cytokeratins such as CK20. Because most cases originate from the lungs, these lesions should be positive for thyroid transcription factor 1 and negative for PAX-5, whereas MCC would show the reverse for those stains.¹ Ultimately, however, clinical correlation with imaging results is the single best methodology for differentiation.

Small cell melanoma, a variant of nevoid melanoma, can strongly resemble an MCC or a lymphoma. Usually located on the scalp or arising from a congenital nevus, small cell melanomas are aggressive and confer an unfavorable prognosis. Histologically, they consist of nests to sheets of atypical cells within the epidermis and dermis. These cells typically exhibit hyperchromatic nuclei, minimal cytoplasm, and frequent mitoses (Figure 4). Furthermore, the cells do not display maturation based on depth.⁸ These tumors usually are positive for HMB45, S-100, MART-1, SOX-10, and tyrosinase, all of which are extremely unlikely to stain an MCC.¹

The Diagnosis: Merkel Cell Carcinoma

Multiple diagnoses should be considered for a small, round, blue cell neoplasm of the skin, including both primary and metastatic entities. In our patient, histopathology revealed sheets and nests of infiltrative neoplastic cells with dispersed chromatin, minimal cytoplasm, and multiple mitoses (quiz image 1).¹ The lesional cells were in the dermis and superficial subcutaneous tissue but did not appear to be arising from the epidermis. Lymphovascular invasion also was evident on additional sections. Metastatic disease was identified in 3 sentinel lymph nodes from the right inguinal and right iliac regions. These features were compatible with a diagnosis of Merkel cell carcinoma (MCC).

Merkel cell carcinoma is a rare malignant neuroendocrine cutaneous tumor with a worldwide incidence of 0.1 to 1.6 cases per 100,000 individuals annually.² The typical patient is older than 75 years with fair skin and a history of extensive sun exposure. Immunocompromised individuals are predisposed and more susceptible to infection with the Merkel cell polyomavirus, which promotes oncogenesis in the majority of MCCs. Our patient’s history of combined variable immunodeficiency likely explains her presentation at a younger age.

The prognosis in patients with MCC is poor, with 5-year survival rates of 51% for local disease, 35% for nodal disease, and 14% for systemic metastases. Survival also is reduced in cases with head/ neck primary tumors and polyomavirus-negative tumors, as well as in immunocompromised patients.² Treatment of resectable MCC consists of Mohs micrographic surgery or wide local excision depending on the patient’s cosmetic concerns. Radiation therapy is recommended for cases with increased risk for recurrence or positive surgical margins, as well as when additional resection is impossible. A study investigating immunotherapy with nivolumab demonstrated complete pathologic response and radiographic tumor regression in nearly half of patients when given 4 weeks prior to surgery.³

Immunohistochemistry is essential in discerning MCC from other small blue cell tumors. Most MCC cases show positive expression of neuroendocrine markers such as synaptophysin, chromogranin, and insulinomaassociated protein 1. Perinuclear dotlike staining with cytokeratin (CK) 20 (quiz image 2) commonly is seen, but up to 15% of cases may be CK20 negative. Many of these CK20-negative cases also express CK7. This tumor also may stain with paired box 5 (PAX-5), CD99, terminal deoxynucleotidyl transferase, Ber-EP4, and CD117^1,4; melanoma stains (ie, human melanoma black [HMB] 45, SRYrelated HMB-box 10 [SOX-10], S-100, melanoma antigen recognized by T-cells 1 [MART-1]) should be negative. However, PAX-5 expression may be a potential pitfall given that B-cell lymphomas also would express that marker and could mimic MCC histologically. Therefore, other universal lymphoid markers such as CD45 should be ordered to rule out this entity. Even with one or a few aberrant stains, a diagnosis of MCC still can be rendered using the histomorphology and the overall staining profile.⁴ Of prognostic significance, p63 expression is associated with more aggressive tumors, while Bcl-2 expression is favorable, as it offers an additional targeted treatment option.^5,6

Basal cell carcinoma (BCC) is linked to excessive sun exposure and is the most common skin cancer. Similar to MCC, it typically is mitotically active and hyperchromatic; however, lymphovascular invasion or metastasis almost never is observed in BCC, whereas approximately one-third of MCC cases have metastasized by the time of diagnosis. Additionally, BCC lacks the perinuclear dotlike staining seen with CK20.^2,7 Features present in BCC that are unusual for MCC include peripheral nuclear palisading, mucin, and retraction artifact on paraffin-embedded sections (Figure 1).⁷

Leukemia cutis (or cutaneous infiltrates of leukemia) commonly displays a perivascular and periadnexal pattern in the dermis and subcutis. These infiltrates of neoplastic leukocytes can congregate into sheets, sometimes with an overlying Grenz zone, or form single-file infiltrates (Figure 2).^1,4 The neoplastic cells can be monomorphic or atypical and commonly are susceptible to crush artifact.⁴ Although the immunohistochemical profile varies depending on the etiology of the underlying leukemia, broad hematologic markers such as CD43 and CD45 are helpful to discern these malignancies from MCC.⁴

Being neuroendocrine in origin, metastatic small cell carcinoma (Figure 3) strongly mimics MCC histologically and usually stains with synaptophysin, chromogranin, and insulinoma-associated protein 1. Both tumor cells typically exhibit nuclear molding and high mitotic rates. Although small cell carcinoma is more likely to stain with high-molecular-weight cytokeratins (ie, CK7), it is not uncommon for these tumors to express lowmolecular- weight cytokeratins such as CK20. Because most cases originate from the lungs, these lesions should be positive for thyroid transcription factor 1 and negative for PAX-5, whereas MCC would show the reverse for those stains.¹ Ultimately, however, clinical correlation with imaging results is the single best methodology for differentiation.

Small cell melanoma, a variant of nevoid melanoma, can strongly resemble an MCC or a lymphoma. Usually located on the scalp or arising from a congenital nevus, small cell melanomas are aggressive and confer an unfavorable prognosis. Histologically, they consist of nests to sheets of atypical cells within the epidermis and dermis. These cells typically exhibit hyperchromatic nuclei, minimal cytoplasm, and frequent mitoses (Figure 4). Furthermore, the cells do not display maturation based on depth.⁸ These tumors usually are positive for HMB45, S-100, MART-1, SOX-10, and tyrosinase, all of which are extremely unlikely to stain an MCC.¹

The Diagnosis: Merkel Cell Carcinoma

Multiple diagnoses should be considered for a small, round, blue cell neoplasm of the skin, including both primary and metastatic entities. In our patient, histopathology revealed sheets and nests of infiltrative neoplastic cells with dispersed chromatin, minimal cytoplasm, and multiple mitoses (quiz image 1).¹ The lesional cells were in the dermis and superficial subcutaneous tissue but did not appear to be arising from the epidermis. Lymphovascular invasion also was evident on additional sections. Metastatic disease was identified in 3 sentinel lymph nodes from the right inguinal and right iliac regions. These features were compatible with a diagnosis of Merkel cell carcinoma (MCC).

Merkel cell carcinoma is a rare malignant neuroendocrine cutaneous tumor with a worldwide incidence of 0.1 to 1.6 cases per 100,000 individuals annually.² The typical patient is older than 75 years with fair skin and a history of extensive sun exposure. Immunocompromised individuals are predisposed and more susceptible to infection with the Merkel cell polyomavirus, which promotes oncogenesis in the majority of MCCs. Our patient’s history of combined variable immunodeficiency likely explains her presentation at a younger age.

The prognosis in patients with MCC is poor, with 5-year survival rates of 51% for local disease, 35% for nodal disease, and 14% for systemic metastases. Survival also is reduced in cases with head/ neck primary tumors and polyomavirus-negative tumors, as well as in immunocompromised patients.² Treatment of resectable MCC consists of Mohs micrographic surgery or wide local excision depending on the patient’s cosmetic concerns. Radiation therapy is recommended for cases with increased risk for recurrence or positive surgical margins, as well as when additional resection is impossible. A study investigating immunotherapy with nivolumab demonstrated complete pathologic response and radiographic tumor regression in nearly half of patients when given 4 weeks prior to surgery.³

Immunohistochemistry is essential in discerning MCC from other small blue cell tumors. Most MCC cases show positive expression of neuroendocrine markers such as synaptophysin, chromogranin, and insulinomaassociated protein 1. Perinuclear dotlike staining with cytokeratin (CK) 20 (quiz image 2) commonly is seen, but up to 15% of cases may be CK20 negative. Many of these CK20-negative cases also express CK7. This tumor also may stain with paired box 5 (PAX-5), CD99, terminal deoxynucleotidyl transferase, Ber-EP4, and CD117^1,4; melanoma stains (ie, human melanoma black [HMB] 45, SRYrelated HMB-box 10 [SOX-10], S-100, melanoma antigen recognized by T-cells 1 [MART-1]) should be negative. However, PAX-5 expression may be a potential pitfall given that B-cell lymphomas also would express that marker and could mimic MCC histologically. Therefore, other universal lymphoid markers such as CD45 should be ordered to rule out this entity. Even with one or a few aberrant stains, a diagnosis of MCC still can be rendered using the histomorphology and the overall staining profile.⁴ Of prognostic significance, p63 expression is associated with more aggressive tumors, while Bcl-2 expression is favorable, as it offers an additional targeted treatment option.^5,6

Basal cell carcinoma (BCC) is linked to excessive sun exposure and is the most common skin cancer. Similar to MCC, it typically is mitotically active and hyperchromatic; however, lymphovascular invasion or metastasis almost never is observed in BCC, whereas approximately one-third of MCC cases have metastasized by the time of diagnosis. Additionally, BCC lacks the perinuclear dotlike staining seen with CK20.^2,7 Features present in BCC that are unusual for MCC include peripheral nuclear palisading, mucin, and retraction artifact on paraffin-embedded sections (Figure 1).⁷

Leukemia cutis (or cutaneous infiltrates of leukemia) commonly displays a perivascular and periadnexal pattern in the dermis and subcutis. These infiltrates of neoplastic leukocytes can congregate into sheets, sometimes with an overlying Grenz zone, or form single-file infiltrates (Figure 2).^1,4 The neoplastic cells can be monomorphic or atypical and commonly are susceptible to crush artifact.⁴ Although the immunohistochemical profile varies depending on the etiology of the underlying leukemia, broad hematologic markers such as CD43 and CD45 are helpful to discern these malignancies from MCC.⁴

Being neuroendocrine in origin, metastatic small cell carcinoma (Figure 3) strongly mimics MCC histologically and usually stains with synaptophysin, chromogranin, and insulinoma-associated protein 1. Both tumor cells typically exhibit nuclear molding and high mitotic rates. Although small cell carcinoma is more likely to stain with high-molecular-weight cytokeratins (ie, CK7), it is not uncommon for these tumors to express lowmolecular- weight cytokeratins such as CK20. Because most cases originate from the lungs, these lesions should be positive for thyroid transcription factor 1 and negative for PAX-5, whereas MCC would show the reverse for those stains.¹ Ultimately, however, clinical correlation with imaging results is the single best methodology for differentiation.

Small cell melanoma, a variant of nevoid melanoma, can strongly resemble an MCC or a lymphoma. Usually located on the scalp or arising from a congenital nevus, small cell melanomas are aggressive and confer an unfavorable prognosis. Histologically, they consist of nests to sheets of atypical cells within the epidermis and dermis. These cells typically exhibit hyperchromatic nuclei, minimal cytoplasm, and frequent mitoses (Figure 4). Furthermore, the cells do not display maturation based on depth.⁸ These tumors usually are positive for HMB45, S-100, MART-1, SOX-10, and tyrosinase, all of which are extremely unlikely to stain an MCC.¹

Did you know you can honor a family member, friend, or colleague and support the AGA Research Awards Program, while giving you a tax benefit? Any charitable gift can be made in honor or memory of someone.

• A gift today. An outright gift will help fund the AGA Research Awards Program. Your gift will assist in furthering basic digestive disease research which can ultimately advance research into all digestive diseases. The financial benefits include an income tax deduction and possible elimination of capital gains tax.
• A gift through your will or living trust. You can include a bequest in your will or living trust stating that a specific asset, certain dollar amount, or more commonly a percentage of your estate will pass to the AGA Research Foundation in honor of your loved one.
• AGA Institute program naming opportunities. Individuals interested in receiving name recognition for selected AGA Institute program can do so by contributing a new, unrestricted gift totaling a designated amount to the AGA Research Foundation.

Your next step

An honorary gift is a wonderful way to acknowledge someone’s vision for the future. To learn more about ways to recognize your honoree, visit our website at www.foundation.gastro.org.

Did you know you can honor a family member, friend, or colleague and support the AGA Research Awards Program, while giving you a tax benefit? Any charitable gift can be made in honor or memory of someone.

• A gift today. An outright gift will help fund the AGA Research Awards Program. Your gift will assist in furthering basic digestive disease research which can ultimately advance research into all digestive diseases. The financial benefits include an income tax deduction and possible elimination of capital gains tax.
• A gift through your will or living trust. You can include a bequest in your will or living trust stating that a specific asset, certain dollar amount, or more commonly a percentage of your estate will pass to the AGA Research Foundation in honor of your loved one.
• AGA Institute program naming opportunities. Individuals interested in receiving name recognition for selected AGA Institute program can do so by contributing a new, unrestricted gift totaling a designated amount to the AGA Research Foundation.

Your next step

An honorary gift is a wonderful way to acknowledge someone’s vision for the future. To learn more about ways to recognize your honoree, visit our website at www.foundation.gastro.org.

Did you know you can honor a family member, friend, or colleague and support the AGA Research Awards Program, while giving you a tax benefit? Any charitable gift can be made in honor or memory of someone.

• A gift today. An outright gift will help fund the AGA Research Awards Program. Your gift will assist in furthering basic digestive disease research which can ultimately advance research into all digestive diseases. The financial benefits include an income tax deduction and possible elimination of capital gains tax.
• A gift through your will or living trust. You can include a bequest in your will or living trust stating that a specific asset, certain dollar amount, or more commonly a percentage of your estate will pass to the AGA Research Foundation in honor of your loved one.
• AGA Institute program naming opportunities. Individuals interested in receiving name recognition for selected AGA Institute program can do so by contributing a new, unrestricted gift totaling a designated amount to the AGA Research Foundation.

Your next step

An honorary gift is a wonderful way to acknowledge someone’s vision for the future. To learn more about ways to recognize your honoree, visit our website at www.foundation.gastro.org.

Persistent chemotherapy-related amenorrhea (CRA) after treatment for breast cancer was common and associated with worse long-term quality of life among premenopausal women in a large multicenter French cohort study.

The findings, which showed a particularly increased risk of persistent CRA in older women and those who received adjuvant tamoxifen, can help inform communication, personalized counseling, and supportive care, according to the investigators.

At 1 year after treatment, CRA occurred in 1242 of 1497 women (83.0%) from the prospective, longitudinal Cancers Toxicity Study (CANTO). The rates at years 2 and 4 after treatment were 72.5% and 66.1%, respectively, Rayan Kabirian, MD, of Gustave Roussy, Villejuif, France, and Sorbonne University, Paris, and colleagues reported.

In a quality-of-life analysis conducted among 729 women from the cohort, 416 (57.1%) had persistent CRA, although 11 of 21 women aged 18-34 years who had no menses at year 2 had late menses recovery between years 2 and 4. Those with persistent CRA at year 4, compared with those who had menses recovery at any time, had significantly worse insomnia (mean difference, 9.9 points), worse systemic therapy-related adverse effects (mean difference, 3.0 points), and worse sexual functioning (mean difference, -9.2 points).

Factors associated with greater risk of persistent CRA included receipt versus non-receipt of adjuvant tamoxifen (adjusted odds ratio, 1.97), and hot flashes at diagnosis (aOR, 1.83, and older age versus age 18-34 (aORs, 1.84 for those aged 35-39 years; 5.90 for those aged 40-44 years, and 21.29 for those 45 or older).

The findings were published online November 16 in JAMA Network Open.

The study cohort included 1636 women under age 50 years (mean age of 42.2 years) at the time of diagnosis of stage I to III breast cancer. Outcomes at up to 4 years after diagnosis and enrollment between 2012 and 2017 were reported. QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires c30 and br23.

“Breast cancer is the most commonly diagnosed tumor in women, and approximately 20% of women with breast cancer are younger than 50 years at diagnosis,” the investigators note, explaining that younger survivors have higher risk of cancer-related symptoms and quality-of-life deterioration. “In particular, treatment-related symptoms linked to the menopausal transition (ie, vasomotor symptoms and sexual problems) represent an important source of distress during and after treatment, highlighting a need to monitor and address survivorship-related problems that are specific to this population.”

The current analysis “helps answer several clinical questions about long-term trajectories of CRA and menses recovery rates by age and about factors associated with higher likelihood of CRA,” they added, noting that the findings have several clinical implications.

For example, premenopausal women should be made aware of the risks associated with chemotherapy-related premature ovarian failure and persistent CRA, and should and receive systematic oncofertility counseling, they argue.

“In addition, in light of data showing possible late [menses] recoveries, contraceptive options should also be clearly discussed,” and “[d]edicated gynecological counseling may help patients who have an inaccurate perception of infertility due to previous exposure to chemotherapy and long-term absence of menses.”

Given that a late menses recovery pattern was also observed in older age groups in the cohort, the investigators noted that choosing the optimal adjuvant endocrine treatment can pose a challenge.

“The absence of menses after completion of chemotherapy should not be used as a proxy for permanent transition to menopause, because it does not represent a reliable surrogate of gonadotoxicity,” they warned. “Adjuvant endocrine treatment choices should be based on a more thorough and comprehensive evaluation, combining absence of menses, assessments of circulating hormone levels, and gynecological ultrasonographic imaging.”

These findings “can inform personalized care pathways targeting patients at higher risk of QOL deterioration associated with a permanent menopausal transition,” they noted, concluding that “[r]isk and duration of CRA, including potential late resumption of menses and its downstream implications for QOL, should be approached using a coordinated biopsychosocial model addressing multiple dimensions of physical, psychological, and social health.

“Proactive management of premenopausal women with early breast cancer undergoing chemotherapy should also include adapted strategies for risk communication, as well as personalized counseling and early supportive care referrals.”

The CANTO study is supported by the French government under the Investment for the Future program managed by the National Research Agency, the Prism project, and the MYPROBE Program. Dr. Kabirian reported having no disclosures.

Persistent chemotherapy-related amenorrhea (CRA) after treatment for breast cancer was common and associated with worse long-term quality of life among premenopausal women in a large multicenter French cohort study.

The findings, which showed a particularly increased risk of persistent CRA in older women and those who received adjuvant tamoxifen, can help inform communication, personalized counseling, and supportive care, according to the investigators.

At 1 year after treatment, CRA occurred in 1242 of 1497 women (83.0%) from the prospective, longitudinal Cancers Toxicity Study (CANTO). The rates at years 2 and 4 after treatment were 72.5% and 66.1%, respectively, Rayan Kabirian, MD, of Gustave Roussy, Villejuif, France, and Sorbonne University, Paris, and colleagues reported.

In a quality-of-life analysis conducted among 729 women from the cohort, 416 (57.1%) had persistent CRA, although 11 of 21 women aged 18-34 years who had no menses at year 2 had late menses recovery between years 2 and 4. Those with persistent CRA at year 4, compared with those who had menses recovery at any time, had significantly worse insomnia (mean difference, 9.9 points), worse systemic therapy-related adverse effects (mean difference, 3.0 points), and worse sexual functioning (mean difference, -9.2 points).

Factors associated with greater risk of persistent CRA included receipt versus non-receipt of adjuvant tamoxifen (adjusted odds ratio, 1.97), and hot flashes at diagnosis (aOR, 1.83, and older age versus age 18-34 (aORs, 1.84 for those aged 35-39 years; 5.90 for those aged 40-44 years, and 21.29 for those 45 or older).

The findings were published online November 16 in JAMA Network Open.

The study cohort included 1636 women under age 50 years (mean age of 42.2 years) at the time of diagnosis of stage I to III breast cancer. Outcomes at up to 4 years after diagnosis and enrollment between 2012 and 2017 were reported. QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires c30 and br23.

“Breast cancer is the most commonly diagnosed tumor in women, and approximately 20% of women with breast cancer are younger than 50 years at diagnosis,” the investigators note, explaining that younger survivors have higher risk of cancer-related symptoms and quality-of-life deterioration. “In particular, treatment-related symptoms linked to the menopausal transition (ie, vasomotor symptoms and sexual problems) represent an important source of distress during and after treatment, highlighting a need to monitor and address survivorship-related problems that are specific to this population.”

The current analysis “helps answer several clinical questions about long-term trajectories of CRA and menses recovery rates by age and about factors associated with higher likelihood of CRA,” they added, noting that the findings have several clinical implications.

For example, premenopausal women should be made aware of the risks associated with chemotherapy-related premature ovarian failure and persistent CRA, and should and receive systematic oncofertility counseling, they argue.

“In addition, in light of data showing possible late [menses] recoveries, contraceptive options should also be clearly discussed,” and “[d]edicated gynecological counseling may help patients who have an inaccurate perception of infertility due to previous exposure to chemotherapy and long-term absence of menses.”

Given that a late menses recovery pattern was also observed in older age groups in the cohort, the investigators noted that choosing the optimal adjuvant endocrine treatment can pose a challenge.

“The absence of menses after completion of chemotherapy should not be used as a proxy for permanent transition to menopause, because it does not represent a reliable surrogate of gonadotoxicity,” they warned. “Adjuvant endocrine treatment choices should be based on a more thorough and comprehensive evaluation, combining absence of menses, assessments of circulating hormone levels, and gynecological ultrasonographic imaging.”

These findings “can inform personalized care pathways targeting patients at higher risk of QOL deterioration associated with a permanent menopausal transition,” they noted, concluding that “[r]isk and duration of CRA, including potential late resumption of menses and its downstream implications for QOL, should be approached using a coordinated biopsychosocial model addressing multiple dimensions of physical, psychological, and social health.

“Proactive management of premenopausal women with early breast cancer undergoing chemotherapy should also include adapted strategies for risk communication, as well as personalized counseling and early supportive care referrals.”

The CANTO study is supported by the French government under the Investment for the Future program managed by the National Research Agency, the Prism project, and the MYPROBE Program. Dr. Kabirian reported having no disclosures.

Persistent chemotherapy-related amenorrhea (CRA) after treatment for breast cancer was common and associated with worse long-term quality of life among premenopausal women in a large multicenter French cohort study.

The findings, which showed a particularly increased risk of persistent CRA in older women and those who received adjuvant tamoxifen, can help inform communication, personalized counseling, and supportive care, according to the investigators.

At 1 year after treatment, CRA occurred in 1242 of 1497 women (83.0%) from the prospective, longitudinal Cancers Toxicity Study (CANTO). The rates at years 2 and 4 after treatment were 72.5% and 66.1%, respectively, Rayan Kabirian, MD, of Gustave Roussy, Villejuif, France, and Sorbonne University, Paris, and colleagues reported.

In a quality-of-life analysis conducted among 729 women from the cohort, 416 (57.1%) had persistent CRA, although 11 of 21 women aged 18-34 years who had no menses at year 2 had late menses recovery between years 2 and 4. Those with persistent CRA at year 4, compared with those who had menses recovery at any time, had significantly worse insomnia (mean difference, 9.9 points), worse systemic therapy-related adverse effects (mean difference, 3.0 points), and worse sexual functioning (mean difference, -9.2 points).

Factors associated with greater risk of persistent CRA included receipt versus non-receipt of adjuvant tamoxifen (adjusted odds ratio, 1.97), and hot flashes at diagnosis (aOR, 1.83, and older age versus age 18-34 (aORs, 1.84 for those aged 35-39 years; 5.90 for those aged 40-44 years, and 21.29 for those 45 or older).

The findings were published online November 16 in JAMA Network Open.

The study cohort included 1636 women under age 50 years (mean age of 42.2 years) at the time of diagnosis of stage I to III breast cancer. Outcomes at up to 4 years after diagnosis and enrollment between 2012 and 2017 were reported. QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires c30 and br23.

“Breast cancer is the most commonly diagnosed tumor in women, and approximately 20% of women with breast cancer are younger than 50 years at diagnosis,” the investigators note, explaining that younger survivors have higher risk of cancer-related symptoms and quality-of-life deterioration. “In particular, treatment-related symptoms linked to the menopausal transition (ie, vasomotor symptoms and sexual problems) represent an important source of distress during and after treatment, highlighting a need to monitor and address survivorship-related problems that are specific to this population.”

The current analysis “helps answer several clinical questions about long-term trajectories of CRA and menses recovery rates by age and about factors associated with higher likelihood of CRA,” they added, noting that the findings have several clinical implications.

For example, premenopausal women should be made aware of the risks associated with chemotherapy-related premature ovarian failure and persistent CRA, and should and receive systematic oncofertility counseling, they argue.

“In addition, in light of data showing possible late [menses] recoveries, contraceptive options should also be clearly discussed,” and “[d]edicated gynecological counseling may help patients who have an inaccurate perception of infertility due to previous exposure to chemotherapy and long-term absence of menses.”

Given that a late menses recovery pattern was also observed in older age groups in the cohort, the investigators noted that choosing the optimal adjuvant endocrine treatment can pose a challenge.

“The absence of menses after completion of chemotherapy should not be used as a proxy for permanent transition to menopause, because it does not represent a reliable surrogate of gonadotoxicity,” they warned. “Adjuvant endocrine treatment choices should be based on a more thorough and comprehensive evaluation, combining absence of menses, assessments of circulating hormone levels, and gynecological ultrasonographic imaging.”

These findings “can inform personalized care pathways targeting patients at higher risk of QOL deterioration associated with a permanent menopausal transition,” they noted, concluding that “[r]isk and duration of CRA, including potential late resumption of menses and its downstream implications for QOL, should be approached using a coordinated biopsychosocial model addressing multiple dimensions of physical, psychological, and social health.

“Proactive management of premenopausal women with early breast cancer undergoing chemotherapy should also include adapted strategies for risk communication, as well as personalized counseling and early supportive care referrals.”

The CANTO study is supported by the French government under the Investment for the Future program managed by the National Research Agency, the Prism project, and the MYPROBE Program. Dr. Kabirian reported having no disclosures.

Compared with premenopausal women, postmenopausal women experienced greater improvement in pain following interventions such as physical therapy despite being prescribed fewer medications, a new study shows.

“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.

Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.   

For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.

According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.

Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.

“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.  

The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.

While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.

“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.  

Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”

Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”

Dr. Yu and Dr. Wenham report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Compared with premenopausal women, postmenopausal women experienced greater improvement in pain following interventions such as physical therapy despite being prescribed fewer medications, a new study shows.

“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.

Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.   

For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.

According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.

Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.

“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.  

The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.

While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.

“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.  

Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”

Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”

Dr. Yu and Dr. Wenham report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Compared with premenopausal women, postmenopausal women experienced greater improvement in pain following interventions such as physical therapy despite being prescribed fewer medications, a new study shows.

“This study provides us a better understanding of pain management strategies for pre versus postmenopausal women,” said Tian Yu, MD, who presented the research at the annual pain medicine meeting of the American Society of Regional Anesthesia and Pain Medicine. “With our postmenopausal patients, we may no longer jump the gun and give them a lot of medications; we may first turn to physical therapy or procedural intervention, which they seem to benefit much more from than pharmacological therapy.”Pain perception is a multifaceted phenomenon influenced by age, gender, individual variations, and hormonal changes. Pain management in women, particularly in the context of menopausal status, still lacks consensus.

Menopause primarily results from diminished production of estrogen by the ovaries, leading to spinal and joint pain, hot flashes, night sweats, chronic fatigue, increased osteoclastic activity with a heightened risk for osteoporosis, psychological symptoms, and elevated risk for cardiovascular disease.   

For their retrospective cohort study, Dr. Yu, department of anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, Illinois, and his colleagues looked at 1215 women who had been treated for different chronic pain conditions for at least 3 months. The researchers used a predefined age cutoff of 51 years (considered the national average) to categorize participants as either premenopausal (n = 248) or postmenopausal (n = 967). Pain scores and subjective improvement were assessed after pharmacological and procedural interventions.

According to Dr. Yu, the results revealed distinct patterns in pain scores and response to interventions between the two groups.

Although postmenopausal women initially reported higher mean pain scores upon presentation (8.037 vs 7.613 in premenopausal women), they reported more improvement following intervention (63% vs 59%; P = .029). They responded more favorably to both procedural and pharmacological interventions, but were prescribed muscle relaxants, tricyclic antidepressants, and benzodiazepines less frequently than premenopausal women, Dr. Yu’s group found.

“So even though postmenopausal women had a higher initial pain score, they had better pain improvement after procedural intervention, although they were prescribed fewer pharmacological interventions,” Dr. Yu said.  

The fact that postmenopausal women typically are older than women who have not reached menopause could act as a confounding factor in this study in terms of disease prevalence and intervention, Dr. Yu said. Additionally, the study’s reliance on a broad menopausal age cutoff of 51 years may limit the true characterization of menopausal status.

While acknowledging study limitations, the findings suggest a potential shift toward prioritizing nonpharmacological interventions in postmenopausal women. Further investigation into physical therapy and other approaches could provide a more comprehensive understanding of pain management strategies in this population.

“We hope to take these findings into consideration during our practice to better individualize care,” Yu said.  

Robert Wenham, MD, MS, chair of gynecologic oncology, Moffitt Cancer Center, Tampa, Florida, who was not involved in the study, said: “Despite the many methodological challenges it has, including using age as a surrogate for menopause, I applaud the authors for investigating how pain and pain management may be individualized for women.”

Dr. Wenham added that he hoped the findings would prompt additional studies “that specifically address populations based on hormonal status and other confounding factors, so that interventional avenues may be identified for clinical trials.”

Dr. Yu and Dr. Wenham report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Antireflux surgery may be no more effective than antireflux medication for reducing risk of esophageal adenocarcinoma (EAC) among patients with Barrett’s esophagus, according to a Nordic retrospective study.

Risk of EAC was higher among patients who underwent surgery, and risk appeared to increase over time, suggesting that postoperative patients should continue to participate in surveillance programs, reported lead author Jesper Lagergren, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues.

Karolinska Institutet

“Antireflux surgery with fundoplication increases the ability of the gastroesophageal anatomic and physiological barrier to prevent reflux, and can thus prevent any carcinogenic gastric content from reaching the esophagus, including both acid and bile,” the investigators wrote in Gastroenterology, noting that surgery reduces esophageal acid exposure to a greater degree than medication. “Antireflux surgery may thus prevent esophageal adenocarcinoma better than antireflux medication.”

Three meta-analyses to date, however, have failed to provide consistent support for this hypothesis.

“Most of the studies included in these meta-analyses came from single centers, were of small sample size, examined only one treatment arm, and had a short or incomplete follow-up, and ... were hampered by heterogeneity among the included studies,” they noted.

For the present study, Dr. Lagergren and colleagues analyzed national registry data from 33,939 patients with Barrett’s esophagus in Denmark, Finland, Norway, and Sweden. Out of this group, 542 patients (1.6%) had undergone antireflux surgery, while the remainder were managed with antireflux medication.

In both groups, approximately two-thirds of the patients were men. The median age at enrollment was about a decade higher in the medication group (66 vs. 54 years), and this group also tended to have more comorbidities.

After a follow-up period as long as 32 years, the absolute rates of EAC were 1.3% and 2.6% in the medication and surgery groups, respectively. Multivariate analysis, with adjustments for sex, age, year, comorbidities, and age, revealed that postsurgical patients had a 90% increased risk of EAC (hazard ratio [HR], 1.9; 95% CI, 1.1-3.5), versus patients treated with antireflux medication alone.

The relatively higher risk of EAC appeared to increase over time, based on a nonsignificant hazard ratio of 1.8 during the 1- to 4-year follow-up period (HR, 1.8; 95% CI, 0.6-5.0), versus a significant, fourfold risk elevation during the 10- to 32-year follow-up period (HR, 4.4; 95% CI, 1.4-13.5).

“In this cohort of patients with Barrett’s esophagus, the risk of esophageal adenocarcinoma did not decrease after antireflux surgery compared with antireflux medication,” the investigators wrote. “Instead, the risk was increased throughout the follow-up among patients having undergone antireflux surgery.”

Dr. Lagergren and colleagues suggested that the reason for relatively higher cancer risk in the group that underwent surgery likely stems from early and prolonged acid exposure.

“[P]erforming antireflux surgery after years of GERD may be too late to enable a cancer-preventative effect, and most of the patients first diagnosed with Barrett’s esophagus reported a history of many years of GERD symptoms,” they wrote, suggesting that carcinogenic processes had already been set in motion by the time surgery was performed.

“[P]atients with Barrett’s esophagus who undergo antireflux surgery remain at an increased risk of esophageal adenocarcinoma and should continue taking part in surveillance programs,” the investigators concluded.

The study was funded by the Swedish Cancer Society, Swedish Research Council, and Stockholm County Council. The investigators disclosed no conflicts of interest.

Antireflux surgery may be no more effective than antireflux medication for reducing risk of esophageal adenocarcinoma (EAC) among patients with Barrett’s esophagus, according to a Nordic retrospective study.

Risk of EAC was higher among patients who underwent surgery, and risk appeared to increase over time, suggesting that postoperative patients should continue to participate in surveillance programs, reported lead author Jesper Lagergren, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues.

Karolinska Institutet

“Antireflux surgery with fundoplication increases the ability of the gastroesophageal anatomic and physiological barrier to prevent reflux, and can thus prevent any carcinogenic gastric content from reaching the esophagus, including both acid and bile,” the investigators wrote in Gastroenterology, noting that surgery reduces esophageal acid exposure to a greater degree than medication. “Antireflux surgery may thus prevent esophageal adenocarcinoma better than antireflux medication.”

Three meta-analyses to date, however, have failed to provide consistent support for this hypothesis.

“Most of the studies included in these meta-analyses came from single centers, were of small sample size, examined only one treatment arm, and had a short or incomplete follow-up, and ... were hampered by heterogeneity among the included studies,” they noted.

For the present study, Dr. Lagergren and colleagues analyzed national registry data from 33,939 patients with Barrett’s esophagus in Denmark, Finland, Norway, and Sweden. Out of this group, 542 patients (1.6%) had undergone antireflux surgery, while the remainder were managed with antireflux medication.

In both groups, approximately two-thirds of the patients were men. The median age at enrollment was about a decade higher in the medication group (66 vs. 54 years), and this group also tended to have more comorbidities.

After a follow-up period as long as 32 years, the absolute rates of EAC were 1.3% and 2.6% in the medication and surgery groups, respectively. Multivariate analysis, with adjustments for sex, age, year, comorbidities, and age, revealed that postsurgical patients had a 90% increased risk of EAC (hazard ratio [HR], 1.9; 95% CI, 1.1-3.5), versus patients treated with antireflux medication alone.

The relatively higher risk of EAC appeared to increase over time, based on a nonsignificant hazard ratio of 1.8 during the 1- to 4-year follow-up period (HR, 1.8; 95% CI, 0.6-5.0), versus a significant, fourfold risk elevation during the 10- to 32-year follow-up period (HR, 4.4; 95% CI, 1.4-13.5).

“In this cohort of patients with Barrett’s esophagus, the risk of esophageal adenocarcinoma did not decrease after antireflux surgery compared with antireflux medication,” the investigators wrote. “Instead, the risk was increased throughout the follow-up among patients having undergone antireflux surgery.”

Dr. Lagergren and colleagues suggested that the reason for relatively higher cancer risk in the group that underwent surgery likely stems from early and prolonged acid exposure.

“[P]erforming antireflux surgery after years of GERD may be too late to enable a cancer-preventative effect, and most of the patients first diagnosed with Barrett’s esophagus reported a history of many years of GERD symptoms,” they wrote, suggesting that carcinogenic processes had already been set in motion by the time surgery was performed.

“[P]atients with Barrett’s esophagus who undergo antireflux surgery remain at an increased risk of esophageal adenocarcinoma and should continue taking part in surveillance programs,” the investigators concluded.

The study was funded by the Swedish Cancer Society, Swedish Research Council, and Stockholm County Council. The investigators disclosed no conflicts of interest.

Antireflux surgery may be no more effective than antireflux medication for reducing risk of esophageal adenocarcinoma (EAC) among patients with Barrett’s esophagus, according to a Nordic retrospective study.

Risk of EAC was higher among patients who underwent surgery, and risk appeared to increase over time, suggesting that postoperative patients should continue to participate in surveillance programs, reported lead author Jesper Lagergren, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues.

Karolinska Institutet

“Antireflux surgery with fundoplication increases the ability of the gastroesophageal anatomic and physiological barrier to prevent reflux, and can thus prevent any carcinogenic gastric content from reaching the esophagus, including both acid and bile,” the investigators wrote in Gastroenterology, noting that surgery reduces esophageal acid exposure to a greater degree than medication. “Antireflux surgery may thus prevent esophageal adenocarcinoma better than antireflux medication.”

Three meta-analyses to date, however, have failed to provide consistent support for this hypothesis.

“Most of the studies included in these meta-analyses came from single centers, were of small sample size, examined only one treatment arm, and had a short or incomplete follow-up, and ... were hampered by heterogeneity among the included studies,” they noted.

For the present study, Dr. Lagergren and colleagues analyzed national registry data from 33,939 patients with Barrett’s esophagus in Denmark, Finland, Norway, and Sweden. Out of this group, 542 patients (1.6%) had undergone antireflux surgery, while the remainder were managed with antireflux medication.

In both groups, approximately two-thirds of the patients were men. The median age at enrollment was about a decade higher in the medication group (66 vs. 54 years), and this group also tended to have more comorbidities.

After a follow-up period as long as 32 years, the absolute rates of EAC were 1.3% and 2.6% in the medication and surgery groups, respectively. Multivariate analysis, with adjustments for sex, age, year, comorbidities, and age, revealed that postsurgical patients had a 90% increased risk of EAC (hazard ratio [HR], 1.9; 95% CI, 1.1-3.5), versus patients treated with antireflux medication alone.

The relatively higher risk of EAC appeared to increase over time, based on a nonsignificant hazard ratio of 1.8 during the 1- to 4-year follow-up period (HR, 1.8; 95% CI, 0.6-5.0), versus a significant, fourfold risk elevation during the 10- to 32-year follow-up period (HR, 4.4; 95% CI, 1.4-13.5).

“In this cohort of patients with Barrett’s esophagus, the risk of esophageal adenocarcinoma did not decrease after antireflux surgery compared with antireflux medication,” the investigators wrote. “Instead, the risk was increased throughout the follow-up among patients having undergone antireflux surgery.”

Dr. Lagergren and colleagues suggested that the reason for relatively higher cancer risk in the group that underwent surgery likely stems from early and prolonged acid exposure.

“[P]erforming antireflux surgery after years of GERD may be too late to enable a cancer-preventative effect, and most of the patients first diagnosed with Barrett’s esophagus reported a history of many years of GERD symptoms,” they wrote, suggesting that carcinogenic processes had already been set in motion by the time surgery was performed.

“[P]atients with Barrett’s esophagus who undergo antireflux surgery remain at an increased risk of esophageal adenocarcinoma and should continue taking part in surveillance programs,” the investigators concluded.

The study was funded by the Swedish Cancer Society, Swedish Research Council, and Stockholm County Council. The investigators disclosed no conflicts of interest.

Pseudofolliculitis barbae (PFB)(also referred to as razor bumps) is a skin disease of the face and neck caused by shaving and remains prevalent in the US Military. As the sharpened ends of curly hair strands penetrate back into the epidermis, they can trigger inflammatory reactions, leading to papules and pustules as well as hyperpigmentation and scarring.¹ Although anyone with thick curly hair can develop PFB, Black individuals are disproportionately affected, with 45% to 83% reporting PFB symptoms compared with 18% of White individuals.² In this article, we review the treatments and current policies on PFB in the military.

Treatment Options

Shaving Guidelines—Daily shaving remains the grooming standard for US service members who are encouraged to follow prescribed grooming techniques to prevent mild cases of PFB, defined as having “few, scattered papules with scant hair growth of the beard area,” according to the technical bulletin of the US Army, which provides the most detailed guidelines among the branches.³ The bulletin recommends hydrating the face with warm water, followed by a preshave lotion and shaving with a single pass superiorly to inferiorly. Following shaving, postrazor hydration lotion is recommended. Single-bladed razors are preferred, as there is less trauma to existing PFB and less potential for hair retraction under the epidermis, though multibladed razors can be used with adequate preshave and postrazor hydration.⁴ Shaving can be undertaken in the evening to ensure adequate time for preshave preparation and postshave hydration. Waterless shaving uses waterless soaps or lotions containing α-hydroxy acid just prior to shaving in lieu of preshaving and postshaving procedures.⁴

Topical Medications—For PFB cases that are recalcitrant to management by changes in shaving, topical retinoids are commonly prescribed, as they reduce follicular hyperkeratosis that may lead to PFB.⁵ The Army medical bulletin recommends a pea-sized amount of tretinoin cream or gel 0.025%, 0.05%, or 0.1% for moderate cases, defined as “heavier beard growth, more scattered papules, no evidence of pustules or denudation.”³ Adapalene cream 0.1% may be used instead of tretinoin for sensitive skin. Oral doxycycline or topical benzoyl peroxide–clindamycin may be added for secondary bacterial skin infections. Clinical trials have demonstrated that combination benzoyl peroxide–clindamycin significantly reduces papules and pustules in up to 63% of patients with PFB (P<.029).⁶ Azelaic acid can be prescribed for prominent postinflammatory hyperpigmentation. The bulletin also suggests depilatories such as barium sulfide to obtund the hair ends and make them less likely to re-enter the skin surface, though it notes low compliance rates due to strong sulfur odor, messy application, and irritation and reactions to ingredients in the preparations.⁴

Shaving Waivers and Laser Hair Removal—The definitive treatment of PFB is to not shave, and a shaving waiver or laser hair removal (LHR) are the best options for severe PFB or PFB refractory to other treatments. A shaving waiver (or shaving profile) allows for growth of up to 0.25 inches of facial hair with maintenance of the length using clippers. The shaving profile typically is issued by the referring primary care manager (PCM) but also can be recommended by a dermatologist. Each military branch implements different regulations on shaving profiles, which complicates care delivery at joint-service military treatment facilities (MTFs). The Table provides guidelines that govern the management of PFB by the US Army, Air Force, Navy, and Marine Corps. The issuance and duration of shaving waivers vary by service.

Laser hair removal therapy uses high-wavelength lasers that largely bypass the melanocyte-containing basal layer and selectively target hair follicles located deeper in the skin, which results in precise hair reduction with relative sparing of the epidermis.¹⁶ Clinical trials at military clinics have demonstrated that treatments with the 1064-nm long-pulse Nd:YAG laser generally are safe and effective in impeding hair growth in Fitzpatrick skin types IV, V, and VI.¹⁷ This laser, along with the Alexandrite 755-nm long-pulse laser for Fitzpatrick skin types I to III, is widely available and used for LHR at MTFs that house dermatologists. Eflornithine cream 13.9%, which is approved by the US Food and Drug Administration to treat hirsutism, can be used as monotherapy for treatment of PFB and has a synergistic depilatory effect in PFB patients when used in conjunction with LHR.^18,19 Laser hair removal treatments can induce a permanent change in facial hair density and pattern of growth. Side effects and complications of LHR include discomfort during treatment and, in rare instances, blistering and dyspigmentation of the skin as well as paradoxical hair growth.¹⁷

TRICARE, the uniformed health care program, covers LHR in the civilian sector if the following criteria are met: candidates must work in an environment that may require breathing protection, and they must have failed conservative therapy; an MTF dermatologist must evaluate each case and attempt LHR at an MTF to limit outside referrals; and the MTF dermatologist must process each outside referral claim to completion and ensure that the LHR is rendered by a civilian dermatologist and is consistent with branch-specific policies.²⁰

Service Policies on PFB

Army—The Army technical bulletin breaks down the treatment of PFB based on mild, moderate, and severe conditions.³ For mild conditions, a trial of shaving every 2 or 3 days until resolution is recommended. For moderate PFB, topical tretinoin as well as shaving every 2 to 3 days is recommended. For severe conditions, temporary beard growth with issuance of a temporary shaving profile up to 90 days is authorized.³

The technical bulletin also allows a permanent shaving profile for soldiers who demonstrate a severe adverse reaction to treatment or progression of the disease despite a trial of all these methods.³ The regulation stipulates that 0.125 to 0.25 inches of beard growth usually is sufficient to prevent PFB. Patients on profiles must be re-evaluated by a PCM or a dermatologist at least once a year.³

Air Force—Air Force Instruction 44-102 delegates PFB treatment and management strategies to each individual MTF, which allows for decentralized management of PFB, resulting in treatment protocols that can differ from one MTF to another.⁷ Since 2020, waivers have been valid for 5 years regardless of deployment or permanent change of station location. Previously, shaving profiles required annual renewals.⁷ Special duties, such as Honor Guard, Thunderbirds, Special Warfare Mission Support, recruiters, and the Air Force Band, often follow the professional appearance standards more strictly. Until recently, the Honor Guard used to reassign those with long-term medical shaving waivers but now allows airmen with shaving profiles to serve with exceptions (eg, shaving before ceremonies).²¹

Navy—BUPERS (Bureau of Naval Personnel) Instruction 1000.22C divides PFB severity into 2 categories.⁸ For mild to moderate PFB cases, topical tretinoin and adapalene are recommended, along with improved shaving hygiene practices. As an alternative to topical steroids, topical eflornithine monotherapy can be used twice daily for 60 days. For moderate to severe PFB cases, continued grooming modifications and LHR at military clinics with dermatologic services are expected.⁸

Naval administrative memorandum NAVADMIN 064/22 (released in 2022) no longer requires sailors with a shaving “chit,” or shaving waiver, to fully grow out their beards.⁹ Sailors may now outline or edge their beards as long as doing so does not trigger a skin irritation or outbreak. Furthermore, sailors are no longer required to carry a physical copy of their shaving chit at all times. Laser hair removal for sailors with PFB is now considered optional, whereas sailors with severe PFB were previously expected to receive LHR.⁹

Marine Corps—The Marine Corps endorses a 4-phase treatment algorithm (Table). As of January 2022, permanent shaving chits are authorized. Marines no longer need to carry physical copies of their chits at all times and cannot be separated from service because of PFB.¹⁰ New updates explicitly state that medical officers, not the commanding officers, now have final authority for granting shaving chits.¹¹

Final Thoughts

The Army provides the most detailed bulletin, which defines the clinical features and treatments expected for each stage of PFB. All 4 service branches permit temporary profiles, albeit for different lengths of time. However, only the Army and the Marine Corps currently authorize permanent shaving waivers if all treatments mentioned in their respective bulletins have failed.

The Air Force has adopted the most decentralized approach, in which each MTF is responsible for implementing its own treatment protocols and definitions. Air Force regulations now authorize a 5-year shaving profile for medical reasons, including PFB. The Air Force also has spearheaded efforts to create more inclusive policies. A study of 10,000 active-duty male Air Force members conducted by Air Force physicians found that shaving waivers were associated with longer times to promotion. Although self-identified race was not independently linked to longer promotion times, more Black service members were affected because of a higher prevalence of PFB and shaving profiles.²²

The Navy has outlined the most specific timeline for therapy for PFB. The regulations allow a 60-day temporary shaving chit that expires on the day of the appointment with the dermatologist or PCM. Although sailors were previously mandated to fully grow out their beards without modifications during the 60-day shaving chit period, Navy leadership recently overturned these requirements. However, permanent shaving chits are still not authorized in the Navy.

Service members are trying to destigmatize shaving profiles and facial hair in our military. A Facebook group called DoD Beard Action Initiative has more than 17,000 members and was created in 2021 to compile testimonies and data regarding the effects of PFB on airmen.²³ Soldiers also have petitioned for growing beards in the garrison environment with more than 100,000 signatures, citing that North Atlantic Treaty Organization allied nations permit beard growth in their respective ranks.²⁴ A Sikh marine captain recently won a lawsuit against the US Department of the Navy to maintain a beard with a turban in uniform on religious grounds.²⁵

The clean-shaven look remains standard across the military, not only for uniformity of appearance but also for safety concerns. The Naval Safety Center’s ALSAFE report concluded that any facial hair impedes a tight fit of gas masks, which can be lethal in chemical warfare. However, the report did not explore how different hair lengths would affect the seal of gas masks.²⁶ It remains unknown how 0.25 inch of facial hair, the maximum hair length authorized for most PFB patients, affects the seal. Department of Defense occupational health researchers currently are assessing how each specific facial hair length diminishes the effectiveness of gas masks.²⁷

Furthermore, the COVID-19 pandemic has led to frequent N95 respirator wear in the military. It is likely that growing a long beard disrupts the fitting of N95 respirators and could endanger service members, especially in clinical settings. However, one study confirmed that 0.125 inch of facial hair still results in 98% effectiveness in filtering particles for the respirator wearers.²⁸ Although unverified, it is surmisable that 0.25 inch of facial hair will likely not render all respirators useless. However, current Occupational Safety and Health Administration guidelines require fit tests to be conducted only on clean-shaven faces.²⁹ Effectively, service members with facial hair cannot be fit-tested for N95 respirators.

More research is needed to optimize treatment protocols and regulations for PFB in our military. As long as the current grooming standards remain in place, treatment of PFB will be a controversial topic. Guidelines will need to be continuously updated to balance the needs of our service members and to minimize risk to unit safety and mission success. Department of Defense Instruction 6130.03, Volume 1, revised in late 2022, now no longer designates PFB as a condition that disqualifies a candidate from entering service in any military branch.³⁰ The Department of Defense is demonstrating active research and adoption of policies regarding PFB that will benefit our service members.

Pseudofolliculitis barbae (PFB)(also referred to as razor bumps) is a skin disease of the face and neck caused by shaving and remains prevalent in the US Military. As the sharpened ends of curly hair strands penetrate back into the epidermis, they can trigger inflammatory reactions, leading to papules and pustules as well as hyperpigmentation and scarring.¹ Although anyone with thick curly hair can develop PFB, Black individuals are disproportionately affected, with 45% to 83% reporting PFB symptoms compared with 18% of White individuals.² In this article, we review the treatments and current policies on PFB in the military.

Treatment Options

Shaving Guidelines—Daily shaving remains the grooming standard for US service members who are encouraged to follow prescribed grooming techniques to prevent mild cases of PFB, defined as having “few, scattered papules with scant hair growth of the beard area,” according to the technical bulletin of the US Army, which provides the most detailed guidelines among the branches.³ The bulletin recommends hydrating the face with warm water, followed by a preshave lotion and shaving with a single pass superiorly to inferiorly. Following shaving, postrazor hydration lotion is recommended. Single-bladed razors are preferred, as there is less trauma to existing PFB and less potential for hair retraction under the epidermis, though multibladed razors can be used with adequate preshave and postrazor hydration.⁴ Shaving can be undertaken in the evening to ensure adequate time for preshave preparation and postshave hydration. Waterless shaving uses waterless soaps or lotions containing α-hydroxy acid just prior to shaving in lieu of preshaving and postshaving procedures.⁴

Topical Medications—For PFB cases that are recalcitrant to management by changes in shaving, topical retinoids are commonly prescribed, as they reduce follicular hyperkeratosis that may lead to PFB.⁵ The Army medical bulletin recommends a pea-sized amount of tretinoin cream or gel 0.025%, 0.05%, or 0.1% for moderate cases, defined as “heavier beard growth, more scattered papules, no evidence of pustules or denudation.”³ Adapalene cream 0.1% may be used instead of tretinoin for sensitive skin. Oral doxycycline or topical benzoyl peroxide–clindamycin may be added for secondary bacterial skin infections. Clinical trials have demonstrated that combination benzoyl peroxide–clindamycin significantly reduces papules and pustules in up to 63% of patients with PFB (P<.029).⁶ Azelaic acid can be prescribed for prominent postinflammatory hyperpigmentation. The bulletin also suggests depilatories such as barium sulfide to obtund the hair ends and make them less likely to re-enter the skin surface, though it notes low compliance rates due to strong sulfur odor, messy application, and irritation and reactions to ingredients in the preparations.⁴

Shaving Waivers and Laser Hair Removal—The definitive treatment of PFB is to not shave, and a shaving waiver or laser hair removal (LHR) are the best options for severe PFB or PFB refractory to other treatments. A shaving waiver (or shaving profile) allows for growth of up to 0.25 inches of facial hair with maintenance of the length using clippers. The shaving profile typically is issued by the referring primary care manager (PCM) but also can be recommended by a dermatologist. Each military branch implements different regulations on shaving profiles, which complicates care delivery at joint-service military treatment facilities (MTFs). The Table provides guidelines that govern the management of PFB by the US Army, Air Force, Navy, and Marine Corps. The issuance and duration of shaving waivers vary by service.

Laser hair removal therapy uses high-wavelength lasers that largely bypass the melanocyte-containing basal layer and selectively target hair follicles located deeper in the skin, which results in precise hair reduction with relative sparing of the epidermis.¹⁶ Clinical trials at military clinics have demonstrated that treatments with the 1064-nm long-pulse Nd:YAG laser generally are safe and effective in impeding hair growth in Fitzpatrick skin types IV, V, and VI.¹⁷ This laser, along with the Alexandrite 755-nm long-pulse laser for Fitzpatrick skin types I to III, is widely available and used for LHR at MTFs that house dermatologists. Eflornithine cream 13.9%, which is approved by the US Food and Drug Administration to treat hirsutism, can be used as monotherapy for treatment of PFB and has a synergistic depilatory effect in PFB patients when used in conjunction with LHR.^18,19 Laser hair removal treatments can induce a permanent change in facial hair density and pattern of growth. Side effects and complications of LHR include discomfort during treatment and, in rare instances, blistering and dyspigmentation of the skin as well as paradoxical hair growth.¹⁷

TRICARE, the uniformed health care program, covers LHR in the civilian sector if the following criteria are met: candidates must work in an environment that may require breathing protection, and they must have failed conservative therapy; an MTF dermatologist must evaluate each case and attempt LHR at an MTF to limit outside referrals; and the MTF dermatologist must process each outside referral claim to completion and ensure that the LHR is rendered by a civilian dermatologist and is consistent with branch-specific policies.²⁰

Service Policies on PFB

Army—The Army technical bulletin breaks down the treatment of PFB based on mild, moderate, and severe conditions.³ For mild conditions, a trial of shaving every 2 or 3 days until resolution is recommended. For moderate PFB, topical tretinoin as well as shaving every 2 to 3 days is recommended. For severe conditions, temporary beard growth with issuance of a temporary shaving profile up to 90 days is authorized.³

The technical bulletin also allows a permanent shaving profile for soldiers who demonstrate a severe adverse reaction to treatment or progression of the disease despite a trial of all these methods.³ The regulation stipulates that 0.125 to 0.25 inches of beard growth usually is sufficient to prevent PFB. Patients on profiles must be re-evaluated by a PCM or a dermatologist at least once a year.³

Air Force—Air Force Instruction 44-102 delegates PFB treatment and management strategies to each individual MTF, which allows for decentralized management of PFB, resulting in treatment protocols that can differ from one MTF to another.⁷ Since 2020, waivers have been valid for 5 years regardless of deployment or permanent change of station location. Previously, shaving profiles required annual renewals.⁷ Special duties, such as Honor Guard, Thunderbirds, Special Warfare Mission Support, recruiters, and the Air Force Band, often follow the professional appearance standards more strictly. Until recently, the Honor Guard used to reassign those with long-term medical shaving waivers but now allows airmen with shaving profiles to serve with exceptions (eg, shaving before ceremonies).²¹

Navy—BUPERS (Bureau of Naval Personnel) Instruction 1000.22C divides PFB severity into 2 categories.⁸ For mild to moderate PFB cases, topical tretinoin and adapalene are recommended, along with improved shaving hygiene practices. As an alternative to topical steroids, topical eflornithine monotherapy can be used twice daily for 60 days. For moderate to severe PFB cases, continued grooming modifications and LHR at military clinics with dermatologic services are expected.⁸

Naval administrative memorandum NAVADMIN 064/22 (released in 2022) no longer requires sailors with a shaving “chit,” or shaving waiver, to fully grow out their beards.⁹ Sailors may now outline or edge their beards as long as doing so does not trigger a skin irritation or outbreak. Furthermore, sailors are no longer required to carry a physical copy of their shaving chit at all times. Laser hair removal for sailors with PFB is now considered optional, whereas sailors with severe PFB were previously expected to receive LHR.⁹

Marine Corps—The Marine Corps endorses a 4-phase treatment algorithm (Table). As of January 2022, permanent shaving chits are authorized. Marines no longer need to carry physical copies of their chits at all times and cannot be separated from service because of PFB.¹⁰ New updates explicitly state that medical officers, not the commanding officers, now have final authority for granting shaving chits.¹¹

Final Thoughts

The Army provides the most detailed bulletin, which defines the clinical features and treatments expected for each stage of PFB. All 4 service branches permit temporary profiles, albeit for different lengths of time. However, only the Army and the Marine Corps currently authorize permanent shaving waivers if all treatments mentioned in their respective bulletins have failed.

The Air Force has adopted the most decentralized approach, in which each MTF is responsible for implementing its own treatment protocols and definitions. Air Force regulations now authorize a 5-year shaving profile for medical reasons, including PFB. The Air Force also has spearheaded efforts to create more inclusive policies. A study of 10,000 active-duty male Air Force members conducted by Air Force physicians found that shaving waivers were associated with longer times to promotion. Although self-identified race was not independently linked to longer promotion times, more Black service members were affected because of a higher prevalence of PFB and shaving profiles.²²

The Navy has outlined the most specific timeline for therapy for PFB. The regulations allow a 60-day temporary shaving chit that expires on the day of the appointment with the dermatologist or PCM. Although sailors were previously mandated to fully grow out their beards without modifications during the 60-day shaving chit period, Navy leadership recently overturned these requirements. However, permanent shaving chits are still not authorized in the Navy.

Service members are trying to destigmatize shaving profiles and facial hair in our military. A Facebook group called DoD Beard Action Initiative has more than 17,000 members and was created in 2021 to compile testimonies and data regarding the effects of PFB on airmen.²³ Soldiers also have petitioned for growing beards in the garrison environment with more than 100,000 signatures, citing that North Atlantic Treaty Organization allied nations permit beard growth in their respective ranks.²⁴ A Sikh marine captain recently won a lawsuit against the US Department of the Navy to maintain a beard with a turban in uniform on religious grounds.²⁵

The clean-shaven look remains standard across the military, not only for uniformity of appearance but also for safety concerns. The Naval Safety Center’s ALSAFE report concluded that any facial hair impedes a tight fit of gas masks, which can be lethal in chemical warfare. However, the report did not explore how different hair lengths would affect the seal of gas masks.²⁶ It remains unknown how 0.25 inch of facial hair, the maximum hair length authorized for most PFB patients, affects the seal. Department of Defense occupational health researchers currently are assessing how each specific facial hair length diminishes the effectiveness of gas masks.²⁷

Furthermore, the COVID-19 pandemic has led to frequent N95 respirator wear in the military. It is likely that growing a long beard disrupts the fitting of N95 respirators and could endanger service members, especially in clinical settings. However, one study confirmed that 0.125 inch of facial hair still results in 98% effectiveness in filtering particles for the respirator wearers.²⁸ Although unverified, it is surmisable that 0.25 inch of facial hair will likely not render all respirators useless. However, current Occupational Safety and Health Administration guidelines require fit tests to be conducted only on clean-shaven faces.²⁹ Effectively, service members with facial hair cannot be fit-tested for N95 respirators.

More research is needed to optimize treatment protocols and regulations for PFB in our military. As long as the current grooming standards remain in place, treatment of PFB will be a controversial topic. Guidelines will need to be continuously updated to balance the needs of our service members and to minimize risk to unit safety and mission success. Department of Defense Instruction 6130.03, Volume 1, revised in late 2022, now no longer designates PFB as a condition that disqualifies a candidate from entering service in any military branch.³⁰ The Department of Defense is demonstrating active research and adoption of policies regarding PFB that will benefit our service members.

Pseudofolliculitis barbae (PFB)(also referred to as razor bumps) is a skin disease of the face and neck caused by shaving and remains prevalent in the US Military. As the sharpened ends of curly hair strands penetrate back into the epidermis, they can trigger inflammatory reactions, leading to papules and pustules as well as hyperpigmentation and scarring.¹ Although anyone with thick curly hair can develop PFB, Black individuals are disproportionately affected, with 45% to 83% reporting PFB symptoms compared with 18% of White individuals.² In this article, we review the treatments and current policies on PFB in the military.

Treatment Options

Shaving Guidelines—Daily shaving remains the grooming standard for US service members who are encouraged to follow prescribed grooming techniques to prevent mild cases of PFB, defined as having “few, scattered papules with scant hair growth of the beard area,” according to the technical bulletin of the US Army, which provides the most detailed guidelines among the branches.³ The bulletin recommends hydrating the face with warm water, followed by a preshave lotion and shaving with a single pass superiorly to inferiorly. Following shaving, postrazor hydration lotion is recommended. Single-bladed razors are preferred, as there is less trauma to existing PFB and less potential for hair retraction under the epidermis, though multibladed razors can be used with adequate preshave and postrazor hydration.⁴ Shaving can be undertaken in the evening to ensure adequate time for preshave preparation and postshave hydration. Waterless shaving uses waterless soaps or lotions containing α-hydroxy acid just prior to shaving in lieu of preshaving and postshaving procedures.⁴

Topical Medications—For PFB cases that are recalcitrant to management by changes in shaving, topical retinoids are commonly prescribed, as they reduce follicular hyperkeratosis that may lead to PFB.⁵ The Army medical bulletin recommends a pea-sized amount of tretinoin cream or gel 0.025%, 0.05%, or 0.1% for moderate cases, defined as “heavier beard growth, more scattered papules, no evidence of pustules or denudation.”³ Adapalene cream 0.1% may be used instead of tretinoin for sensitive skin. Oral doxycycline or topical benzoyl peroxide–clindamycin may be added for secondary bacterial skin infections. Clinical trials have demonstrated that combination benzoyl peroxide–clindamycin significantly reduces papules and pustules in up to 63% of patients with PFB (P<.029).⁶ Azelaic acid can be prescribed for prominent postinflammatory hyperpigmentation. The bulletin also suggests depilatories such as barium sulfide to obtund the hair ends and make them less likely to re-enter the skin surface, though it notes low compliance rates due to strong sulfur odor, messy application, and irritation and reactions to ingredients in the preparations.⁴

Shaving Waivers and Laser Hair Removal—The definitive treatment of PFB is to not shave, and a shaving waiver or laser hair removal (LHR) are the best options for severe PFB or PFB refractory to other treatments. A shaving waiver (or shaving profile) allows for growth of up to 0.25 inches of facial hair with maintenance of the length using clippers. The shaving profile typically is issued by the referring primary care manager (PCM) but also can be recommended by a dermatologist. Each military branch implements different regulations on shaving profiles, which complicates care delivery at joint-service military treatment facilities (MTFs). The Table provides guidelines that govern the management of PFB by the US Army, Air Force, Navy, and Marine Corps. The issuance and duration of shaving waivers vary by service.

Laser hair removal therapy uses high-wavelength lasers that largely bypass the melanocyte-containing basal layer and selectively target hair follicles located deeper in the skin, which results in precise hair reduction with relative sparing of the epidermis.¹⁶ Clinical trials at military clinics have demonstrated that treatments with the 1064-nm long-pulse Nd:YAG laser generally are safe and effective in impeding hair growth in Fitzpatrick skin types IV, V, and VI.¹⁷ This laser, along with the Alexandrite 755-nm long-pulse laser for Fitzpatrick skin types I to III, is widely available and used for LHR at MTFs that house dermatologists. Eflornithine cream 13.9%, which is approved by the US Food and Drug Administration to treat hirsutism, can be used as monotherapy for treatment of PFB and has a synergistic depilatory effect in PFB patients when used in conjunction with LHR.^18,19 Laser hair removal treatments can induce a permanent change in facial hair density and pattern of growth. Side effects and complications of LHR include discomfort during treatment and, in rare instances, blistering and dyspigmentation of the skin as well as paradoxical hair growth.¹⁷

TRICARE, the uniformed health care program, covers LHR in the civilian sector if the following criteria are met: candidates must work in an environment that may require breathing protection, and they must have failed conservative therapy; an MTF dermatologist must evaluate each case and attempt LHR at an MTF to limit outside referrals; and the MTF dermatologist must process each outside referral claim to completion and ensure that the LHR is rendered by a civilian dermatologist and is consistent with branch-specific policies.²⁰

Service Policies on PFB

Army—The Army technical bulletin breaks down the treatment of PFB based on mild, moderate, and severe conditions.³ For mild conditions, a trial of shaving every 2 or 3 days until resolution is recommended. For moderate PFB, topical tretinoin as well as shaving every 2 to 3 days is recommended. For severe conditions, temporary beard growth with issuance of a temporary shaving profile up to 90 days is authorized.³

The technical bulletin also allows a permanent shaving profile for soldiers who demonstrate a severe adverse reaction to treatment or progression of the disease despite a trial of all these methods.³ The regulation stipulates that 0.125 to 0.25 inches of beard growth usually is sufficient to prevent PFB. Patients on profiles must be re-evaluated by a PCM or a dermatologist at least once a year.³

Air Force—Air Force Instruction 44-102 delegates PFB treatment and management strategies to each individual MTF, which allows for decentralized management of PFB, resulting in treatment protocols that can differ from one MTF to another.⁷ Since 2020, waivers have been valid for 5 years regardless of deployment or permanent change of station location. Previously, shaving profiles required annual renewals.⁷ Special duties, such as Honor Guard, Thunderbirds, Special Warfare Mission Support, recruiters, and the Air Force Band, often follow the professional appearance standards more strictly. Until recently, the Honor Guard used to reassign those with long-term medical shaving waivers but now allows airmen with shaving profiles to serve with exceptions (eg, shaving before ceremonies).²¹

Navy—BUPERS (Bureau of Naval Personnel) Instruction 1000.22C divides PFB severity into 2 categories.⁸ For mild to moderate PFB cases, topical tretinoin and adapalene are recommended, along with improved shaving hygiene practices. As an alternative to topical steroids, topical eflornithine monotherapy can be used twice daily for 60 days. For moderate to severe PFB cases, continued grooming modifications and LHR at military clinics with dermatologic services are expected.⁸

Naval administrative memorandum NAVADMIN 064/22 (released in 2022) no longer requires sailors with a shaving “chit,” or shaving waiver, to fully grow out their beards.⁹ Sailors may now outline or edge their beards as long as doing so does not trigger a skin irritation or outbreak. Furthermore, sailors are no longer required to carry a physical copy of their shaving chit at all times. Laser hair removal for sailors with PFB is now considered optional, whereas sailors with severe PFB were previously expected to receive LHR.⁹

Marine Corps—The Marine Corps endorses a 4-phase treatment algorithm (Table). As of January 2022, permanent shaving chits are authorized. Marines no longer need to carry physical copies of their chits at all times and cannot be separated from service because of PFB.¹⁰ New updates explicitly state that medical officers, not the commanding officers, now have final authority for granting shaving chits.¹¹

Final Thoughts

The Army provides the most detailed bulletin, which defines the clinical features and treatments expected for each stage of PFB. All 4 service branches permit temporary profiles, albeit for different lengths of time. However, only the Army and the Marine Corps currently authorize permanent shaving waivers if all treatments mentioned in their respective bulletins have failed.

The Air Force has adopted the most decentralized approach, in which each MTF is responsible for implementing its own treatment protocols and definitions. Air Force regulations now authorize a 5-year shaving profile for medical reasons, including PFB. The Air Force also has spearheaded efforts to create more inclusive policies. A study of 10,000 active-duty male Air Force members conducted by Air Force physicians found that shaving waivers were associated with longer times to promotion. Although self-identified race was not independently linked to longer promotion times, more Black service members were affected because of a higher prevalence of PFB and shaving profiles.²²

The Navy has outlined the most specific timeline for therapy for PFB. The regulations allow a 60-day temporary shaving chit that expires on the day of the appointment with the dermatologist or PCM. Although sailors were previously mandated to fully grow out their beards without modifications during the 60-day shaving chit period, Navy leadership recently overturned these requirements. However, permanent shaving chits are still not authorized in the Navy.

Service members are trying to destigmatize shaving profiles and facial hair in our military. A Facebook group called DoD Beard Action Initiative has more than 17,000 members and was created in 2021 to compile testimonies and data regarding the effects of PFB on airmen.²³ Soldiers also have petitioned for growing beards in the garrison environment with more than 100,000 signatures, citing that North Atlantic Treaty Organization allied nations permit beard growth in their respective ranks.²⁴ A Sikh marine captain recently won a lawsuit against the US Department of the Navy to maintain a beard with a turban in uniform on religious grounds.²⁵

The clean-shaven look remains standard across the military, not only for uniformity of appearance but also for safety concerns. The Naval Safety Center’s ALSAFE report concluded that any facial hair impedes a tight fit of gas masks, which can be lethal in chemical warfare. However, the report did not explore how different hair lengths would affect the seal of gas masks.²⁶ It remains unknown how 0.25 inch of facial hair, the maximum hair length authorized for most PFB patients, affects the seal. Department of Defense occupational health researchers currently are assessing how each specific facial hair length diminishes the effectiveness of gas masks.²⁷

Furthermore, the COVID-19 pandemic has led to frequent N95 respirator wear in the military. It is likely that growing a long beard disrupts the fitting of N95 respirators and could endanger service members, especially in clinical settings. However, one study confirmed that 0.125 inch of facial hair still results in 98% effectiveness in filtering particles for the respirator wearers.²⁸ Although unverified, it is surmisable that 0.25 inch of facial hair will likely not render all respirators useless. However, current Occupational Safety and Health Administration guidelines require fit tests to be conducted only on clean-shaven faces.²⁹ Effectively, service members with facial hair cannot be fit-tested for N95 respirators.

More research is needed to optimize treatment protocols and regulations for PFB in our military. As long as the current grooming standards remain in place, treatment of PFB will be a controversial topic. Guidelines will need to be continuously updated to balance the needs of our service members and to minimize risk to unit safety and mission success. Department of Defense Instruction 6130.03, Volume 1, revised in late 2022, now no longer designates PFB as a condition that disqualifies a candidate from entering service in any military branch.³⁰ The Department of Defense is demonstrating active research and adoption of policies regarding PFB that will benefit our service members.