Mixed Topics

THE DIAGNOSIS: Pedunculated Lipofibroma

Histopathology confirmed a pedunculated/polypoid lesion with intradermal lobules of adipocytes/mature adipose tissue admixed with connective tissue bundles and vascular ectasias. Overlying epidermal acanthosis with slight papillomatosis and hyperkeratosis was present (Figure 1). Masson trichrome staining highlighted admixed collagen bundles (Figure 2). Verhoeff–van Gieson staining showed marked reduction in elastic fibers (Figure 3). Immunostaining was negative for smooth muscle actin and desmin. A diagnosis of pedunculated lipofibroma on the nose was made based on both clinical and histopathologic findings.

Pedunculated lipofibroma (or solitary lipofibroma) is the solitary form of nevus lipomatosus cutaneous superficialis (NLCS).⁷ First described by Hoffmann and Zurhelle¹ in 1921, NLCS is an uncommon benign hamartomatous cutaneous lesion/connective tissue nevus that also has a classic multiple form.^1-13 The etiology of NLCS remains unclear, but several theories have been proposed to explain its pathogenesis, including deposition of adipocytes secondary to degenerative changes in dermal connective tissue, focal/local heterotopic development of adipose tissue, and derivation from differentiating lipoblasts (preadipose tissue) originating from precursor vascular or perivascular cells.^2-13

Pedunculated lipofibroma usually develops during the third to sixth decades of life and manifests as a single cutaneous lesion with a smooth surface, often on a non–pelvic girdle location.^7-13 No particular predilection sites are noted, with lesions reported on the arm, axilla, back, upper thigh, knee, and sole.^5,12 There are rare reports of this type of NLCS on the ear, scalp, forehead, or eyelid.^7-11

In the classic form of NLCS, multiple cutaneous lesions are present at birth or develop within the first 2 to 3 decades of life.^2-6 Lesions consist of soft, nontender, pedunculated, flesh-colored or yellowish papules and nodules with a verrucoid or cerebriform surface that may later coalesce to form plaques.^2-6 Predilection sites include the pelvic girdle, buttocks, sacral and coccygeal regions, and upper posterior thighs, with a linear or zosteriform pattern of distribution.^2-6 Rarely, the classic form can arise in elderly patients and/or at an atypical anatomic location (eg, clitoris,³ shoulder,⁵ thorax,⁵ abdomen⁵) and can demonstrate extension of lesions across the midline.⁴ Rare cases of classic NLCS on the scalp² and face^3-6 have been reported, including lesions localized to the nose³ and chin⁴ and others extending from the right mandible to the neck⁵ and right lower lip to the submandibular/posteriorateral cervical region.⁶ In some cases, lesions clinically resemble plane xanthoma⁴ and localized scleroderma.⁶

Adotama et al¹³ proposed a set of clinical features to differentiate classic NLCS, pedunculated lipofibroma (solitary NLCS), and fibroepithelial polyp with adipocytes (distinguished by their furrowed surface, hyperpigmentation, and anatomic predilection for the neck and axilla). Lesions are asymptomatic in both forms of NLCS.^2-13 Family history or predominant sex involvement have not been reported in either clinical type.^2-13 Reported associations with NLCS include a number of endocrinologic conditions including diabetes.⁷ Other coexisting skin findings can include café-au-lait macules, leukodermic (white) spots, overlying hypertrichosis, comedolike alterations, angiokeratoma, hemangioma, and folliculosebaceous cystic hamartoma.⁴ None of these were evident in our patient.

Lesions from both types of NLCS are indistinguishable on histopathology, characterized by the presence of a central core of ectopic mature adipocytes in the papillary/reticular dermis.^2-13 Additional light microscopic features (some seen in our case) have been described, including thickened collagen bundles, reduction of elastic fibers, increased numbers of fibroblasts and/or mast cells, increased (small-vessel) vascularity, focal mucin deposition/myxoid degeneration, a mild perivascular lymphocytic infiltrate, attenuation of adnexal structures, and abnormalities of the epidermis (eg, surface ulceration).^2-13

Prior to biopsy, the differential diagnosis in our patient included angiofibroma, pyogenic granuloma, and basal cell carcinoma given the exophytic, pink, papular appearance of the lesion; however, the histopathologic differential diagnosis included angiofibroma, angiomyolipoma, lymphangioma, nevus sebaceus, and spindle cell lipoma (SCL). In angiofibroma, a dermal proliferation of stellate fibroblasts, dilated blood vessels, and collagenous stroma are seen. Cutaneous angiomyolipoma demonstrates smooth muscle bundles in addition to thickened blood vessels and variable proportions of mature adipocytes. Lymphangioma is characterized by dilated lymph channels lined by flat endothelial cells. Nevus sebaceus shows superficial immature and abnormally formed pilosebaceous units, with epidermal papillomatosis.

Rare cases of SCL on the nose have been described.¹⁴ Similar to pedunculated lipofibroma, reported examples demonstrate mature univacuolar adipocytes with thick collagen fibers and bland uniform spindle cells. Unlike the lesion seen in our patient, nasal SCL may be clinically mobile and typically is localized to the subcutaneous tissue, although dermal tumors also occur.¹⁴ Variably reported histopathologic findings in nasal SCL include circumscription/encapsulation, spindle cells arranged in short fascicles with nuclear palisading, a myxoid/mucinous interstitial matrix, and/or multinucleated giant cells—all light microscopic features that were not identified in our case; however, variable proportions of adipocytic, fibrous, and myxoid components among reported examples of SCL on the nose¹⁴ can make distinction from pedunculated lipofibroma difficult, as both are benign lipomatous tumor variants.

Clinically, pedunculated lipofibroma may be confused with more common benign cutaneous lesions and must be distinguished from other fibrolipomatous lesions on the nose. Specifically, the differential diagnosis includes benign cutaneous papillomas such as acrochordon, angiofibroma, melanocytic nevi, neurofibroma, nevus sebaceus, lymphangioma, and eccrine poroma.^7-13 These all can be readily excluded on histopathology. Pedunculated lipofibroma on the nose, as in our patient, must be distinguished from fibrolipoma¹⁵ and dendritic myxofibrolipoma.¹⁶ Fibrolipoma is a subcutaneous proliferation of mature adipose tissue and fibrous tissue and comprises 1.6% of all facial lipomas reported worldwide.¹⁵ Dendritic myxofibrolipoma is a recently described benign soft-tissue tumor characterized by an admixture of mature adipose tissue, spindle and stellate cells, and an abundant myxoid stroma with prominent collagenization.¹⁶

Treatment of pedunculated lipofibroma on the nose is not indicated except for cosmetic reasons, in which case simple surgical excision would be considered satisfactory. Following biopsy, no further treatment was pursued in our patient.

THE DIAGNOSIS: Pedunculated Lipofibroma

Histopathology confirmed a pedunculated/polypoid lesion with intradermal lobules of adipocytes/mature adipose tissue admixed with connective tissue bundles and vascular ectasias. Overlying epidermal acanthosis with slight papillomatosis and hyperkeratosis was present (Figure 1). Masson trichrome staining highlighted admixed collagen bundles (Figure 2). Verhoeff–van Gieson staining showed marked reduction in elastic fibers (Figure 3). Immunostaining was negative for smooth muscle actin and desmin. A diagnosis of pedunculated lipofibroma on the nose was made based on both clinical and histopathologic findings.

Pedunculated lipofibroma (or solitary lipofibroma) is the solitary form of nevus lipomatosus cutaneous superficialis (NLCS).⁷ First described by Hoffmann and Zurhelle¹ in 1921, NLCS is an uncommon benign hamartomatous cutaneous lesion/connective tissue nevus that also has a classic multiple form.^1-13 The etiology of NLCS remains unclear, but several theories have been proposed to explain its pathogenesis, including deposition of adipocytes secondary to degenerative changes in dermal connective tissue, focal/local heterotopic development of adipose tissue, and derivation from differentiating lipoblasts (preadipose tissue) originating from precursor vascular or perivascular cells.^2-13

Pedunculated lipofibroma usually develops during the third to sixth decades of life and manifests as a single cutaneous lesion with a smooth surface, often on a non–pelvic girdle location.^7-13 No particular predilection sites are noted, with lesions reported on the arm, axilla, back, upper thigh, knee, and sole.^5,12 There are rare reports of this type of NLCS on the ear, scalp, forehead, or eyelid.^7-11

In the classic form of NLCS, multiple cutaneous lesions are present at birth or develop within the first 2 to 3 decades of life.^2-6 Lesions consist of soft, nontender, pedunculated, flesh-colored or yellowish papules and nodules with a verrucoid or cerebriform surface that may later coalesce to form plaques.^2-6 Predilection sites include the pelvic girdle, buttocks, sacral and coccygeal regions, and upper posterior thighs, with a linear or zosteriform pattern of distribution.^2-6 Rarely, the classic form can arise in elderly patients and/or at an atypical anatomic location (eg, clitoris,³ shoulder,⁵ thorax,⁵ abdomen⁵) and can demonstrate extension of lesions across the midline.⁴ Rare cases of classic NLCS on the scalp² and face^3-6 have been reported, including lesions localized to the nose³ and chin⁴ and others extending from the right mandible to the neck⁵ and right lower lip to the submandibular/posteriorateral cervical region.⁶ In some cases, lesions clinically resemble plane xanthoma⁴ and localized scleroderma.⁶

Adotama et al¹³ proposed a set of clinical features to differentiate classic NLCS, pedunculated lipofibroma (solitary NLCS), and fibroepithelial polyp with adipocytes (distinguished by their furrowed surface, hyperpigmentation, and anatomic predilection for the neck and axilla). Lesions are asymptomatic in both forms of NLCS.^2-13 Family history or predominant sex involvement have not been reported in either clinical type.^2-13 Reported associations with NLCS include a number of endocrinologic conditions including diabetes.⁷ Other coexisting skin findings can include café-au-lait macules, leukodermic (white) spots, overlying hypertrichosis, comedolike alterations, angiokeratoma, hemangioma, and folliculosebaceous cystic hamartoma.⁴ None of these were evident in our patient.

Lesions from both types of NLCS are indistinguishable on histopathology, characterized by the presence of a central core of ectopic mature adipocytes in the papillary/reticular dermis.^2-13 Additional light microscopic features (some seen in our case) have been described, including thickened collagen bundles, reduction of elastic fibers, increased numbers of fibroblasts and/or mast cells, increased (small-vessel) vascularity, focal mucin deposition/myxoid degeneration, a mild perivascular lymphocytic infiltrate, attenuation of adnexal structures, and abnormalities of the epidermis (eg, surface ulceration).^2-13

Prior to biopsy, the differential diagnosis in our patient included angiofibroma, pyogenic granuloma, and basal cell carcinoma given the exophytic, pink, papular appearance of the lesion; however, the histopathologic differential diagnosis included angiofibroma, angiomyolipoma, lymphangioma, nevus sebaceus, and spindle cell lipoma (SCL). In angiofibroma, a dermal proliferation of stellate fibroblasts, dilated blood vessels, and collagenous stroma are seen. Cutaneous angiomyolipoma demonstrates smooth muscle bundles in addition to thickened blood vessels and variable proportions of mature adipocytes. Lymphangioma is characterized by dilated lymph channels lined by flat endothelial cells. Nevus sebaceus shows superficial immature and abnormally formed pilosebaceous units, with epidermal papillomatosis.

Rare cases of SCL on the nose have been described.¹⁴ Similar to pedunculated lipofibroma, reported examples demonstrate mature univacuolar adipocytes with thick collagen fibers and bland uniform spindle cells. Unlike the lesion seen in our patient, nasal SCL may be clinically mobile and typically is localized to the subcutaneous tissue, although dermal tumors also occur.¹⁴ Variably reported histopathologic findings in nasal SCL include circumscription/encapsulation, spindle cells arranged in short fascicles with nuclear palisading, a myxoid/mucinous interstitial matrix, and/or multinucleated giant cells—all light microscopic features that were not identified in our case; however, variable proportions of adipocytic, fibrous, and myxoid components among reported examples of SCL on the nose¹⁴ can make distinction from pedunculated lipofibroma difficult, as both are benign lipomatous tumor variants.

Clinically, pedunculated lipofibroma may be confused with more common benign cutaneous lesions and must be distinguished from other fibrolipomatous lesions on the nose. Specifically, the differential diagnosis includes benign cutaneous papillomas such as acrochordon, angiofibroma, melanocytic nevi, neurofibroma, nevus sebaceus, lymphangioma, and eccrine poroma.^7-13 These all can be readily excluded on histopathology. Pedunculated lipofibroma on the nose, as in our patient, must be distinguished from fibrolipoma¹⁵ and dendritic myxofibrolipoma.¹⁶ Fibrolipoma is a subcutaneous proliferation of mature adipose tissue and fibrous tissue and comprises 1.6% of all facial lipomas reported worldwide.¹⁵ Dendritic myxofibrolipoma is a recently described benign soft-tissue tumor characterized by an admixture of mature adipose tissue, spindle and stellate cells, and an abundant myxoid stroma with prominent collagenization.¹⁶

Treatment of pedunculated lipofibroma on the nose is not indicated except for cosmetic reasons, in which case simple surgical excision would be considered satisfactory. Following biopsy, no further treatment was pursued in our patient.

THE DIAGNOSIS: Pedunculated Lipofibroma

Histopathology confirmed a pedunculated/polypoid lesion with intradermal lobules of adipocytes/mature adipose tissue admixed with connective tissue bundles and vascular ectasias. Overlying epidermal acanthosis with slight papillomatosis and hyperkeratosis was present (Figure 1). Masson trichrome staining highlighted admixed collagen bundles (Figure 2). Verhoeff–van Gieson staining showed marked reduction in elastic fibers (Figure 3). Immunostaining was negative for smooth muscle actin and desmin. A diagnosis of pedunculated lipofibroma on the nose was made based on both clinical and histopathologic findings.

Pedunculated lipofibroma (or solitary lipofibroma) is the solitary form of nevus lipomatosus cutaneous superficialis (NLCS).⁷ First described by Hoffmann and Zurhelle¹ in 1921, NLCS is an uncommon benign hamartomatous cutaneous lesion/connective tissue nevus that also has a classic multiple form.^1-13 The etiology of NLCS remains unclear, but several theories have been proposed to explain its pathogenesis, including deposition of adipocytes secondary to degenerative changes in dermal connective tissue, focal/local heterotopic development of adipose tissue, and derivation from differentiating lipoblasts (preadipose tissue) originating from precursor vascular or perivascular cells.^2-13

Pedunculated lipofibroma usually develops during the third to sixth decades of life and manifests as a single cutaneous lesion with a smooth surface, often on a non–pelvic girdle location.^7-13 No particular predilection sites are noted, with lesions reported on the arm, axilla, back, upper thigh, knee, and sole.^5,12 There are rare reports of this type of NLCS on the ear, scalp, forehead, or eyelid.^7-11

In the classic form of NLCS, multiple cutaneous lesions are present at birth or develop within the first 2 to 3 decades of life.^2-6 Lesions consist of soft, nontender, pedunculated, flesh-colored or yellowish papules and nodules with a verrucoid or cerebriform surface that may later coalesce to form plaques.^2-6 Predilection sites include the pelvic girdle, buttocks, sacral and coccygeal regions, and upper posterior thighs, with a linear or zosteriform pattern of distribution.^2-6 Rarely, the classic form can arise in elderly patients and/or at an atypical anatomic location (eg, clitoris,³ shoulder,⁵ thorax,⁵ abdomen⁵) and can demonstrate extension of lesions across the midline.⁴ Rare cases of classic NLCS on the scalp² and face^3-6 have been reported, including lesions localized to the nose³ and chin⁴ and others extending from the right mandible to the neck⁵ and right lower lip to the submandibular/posteriorateral cervical region.⁶ In some cases, lesions clinically resemble plane xanthoma⁴ and localized scleroderma.⁶

Adotama et al¹³ proposed a set of clinical features to differentiate classic NLCS, pedunculated lipofibroma (solitary NLCS), and fibroepithelial polyp with adipocytes (distinguished by their furrowed surface, hyperpigmentation, and anatomic predilection for the neck and axilla). Lesions are asymptomatic in both forms of NLCS.^2-13 Family history or predominant sex involvement have not been reported in either clinical type.^2-13 Reported associations with NLCS include a number of endocrinologic conditions including diabetes.⁷ Other coexisting skin findings can include café-au-lait macules, leukodermic (white) spots, overlying hypertrichosis, comedolike alterations, angiokeratoma, hemangioma, and folliculosebaceous cystic hamartoma.⁴ None of these were evident in our patient.

Lesions from both types of NLCS are indistinguishable on histopathology, characterized by the presence of a central core of ectopic mature adipocytes in the papillary/reticular dermis.^2-13 Additional light microscopic features (some seen in our case) have been described, including thickened collagen bundles, reduction of elastic fibers, increased numbers of fibroblasts and/or mast cells, increased (small-vessel) vascularity, focal mucin deposition/myxoid degeneration, a mild perivascular lymphocytic infiltrate, attenuation of adnexal structures, and abnormalities of the epidermis (eg, surface ulceration).^2-13

Prior to biopsy, the differential diagnosis in our patient included angiofibroma, pyogenic granuloma, and basal cell carcinoma given the exophytic, pink, papular appearance of the lesion; however, the histopathologic differential diagnosis included angiofibroma, angiomyolipoma, lymphangioma, nevus sebaceus, and spindle cell lipoma (SCL). In angiofibroma, a dermal proliferation of stellate fibroblasts, dilated blood vessels, and collagenous stroma are seen. Cutaneous angiomyolipoma demonstrates smooth muscle bundles in addition to thickened blood vessels and variable proportions of mature adipocytes. Lymphangioma is characterized by dilated lymph channels lined by flat endothelial cells. Nevus sebaceus shows superficial immature and abnormally formed pilosebaceous units, with epidermal papillomatosis.

Rare cases of SCL on the nose have been described.¹⁴ Similar to pedunculated lipofibroma, reported examples demonstrate mature univacuolar adipocytes with thick collagen fibers and bland uniform spindle cells. Unlike the lesion seen in our patient, nasal SCL may be clinically mobile and typically is localized to the subcutaneous tissue, although dermal tumors also occur.¹⁴ Variably reported histopathologic findings in nasal SCL include circumscription/encapsulation, spindle cells arranged in short fascicles with nuclear palisading, a myxoid/mucinous interstitial matrix, and/or multinucleated giant cells—all light microscopic features that were not identified in our case; however, variable proportions of adipocytic, fibrous, and myxoid components among reported examples of SCL on the nose¹⁴ can make distinction from pedunculated lipofibroma difficult, as both are benign lipomatous tumor variants.

Clinically, pedunculated lipofibroma may be confused with more common benign cutaneous lesions and must be distinguished from other fibrolipomatous lesions on the nose. Specifically, the differential diagnosis includes benign cutaneous papillomas such as acrochordon, angiofibroma, melanocytic nevi, neurofibroma, nevus sebaceus, lymphangioma, and eccrine poroma.^7-13 These all can be readily excluded on histopathology. Pedunculated lipofibroma on the nose, as in our patient, must be distinguished from fibrolipoma¹⁵ and dendritic myxofibrolipoma.¹⁶ Fibrolipoma is a subcutaneous proliferation of mature adipose tissue and fibrous tissue and comprises 1.6% of all facial lipomas reported worldwide.¹⁵ Dendritic myxofibrolipoma is a recently described benign soft-tissue tumor characterized by an admixture of mature adipose tissue, spindle and stellate cells, and an abundant myxoid stroma with prominent collagenization.¹⁶

Treatment of pedunculated lipofibroma on the nose is not indicated except for cosmetic reasons, in which case simple surgical excision would be considered satisfactory. Following biopsy, no further treatment was pursued in our patient.

Caring messages to veterans at risk for suicide come in many forms: cards, letters, phone calls, email, and text messages. Each message can have a major impact on the veteran’s mental health and their decision to use health care provided by the US Department of Veterans Affairs (VA). A recent study outlined ways to centralize that impact, ensuring the caring message reaches those who need it most.

The study examined the impact of the VA Veterans Crisis Line (VCL) caring letters intervention among veterans at increased psychiatric risk. It focused on veterans with ≥ 2 Veterans Health Administration (VHA) health service encounters within 24 months prior to VCL contact. The primary outcome was suicide-related events (SRE), including suicide attempts, intentional self-harm, and suicidal self-directed violence. Secondary outcomes included VHA health care use (all-cause inpatient and outpatient, mental health outpatient, mental health inpatient, and emergency department). 

Of 186,514 VCL callers, 8.3% had a psychiatric hospitalization, 4.8% were flagged as high-risk by the REACH VET program, 6.2% had an SRE, and 12.9% met any of these criteria in the year prior to initial VCL contact. There was no association between caring letters and all-cause mortality or SRE, even though caring letters is one of the only interventions to demonstrate a reduction in suicide mortality as a randomized controlled trial.

While reducing suicide has not been the expected result, caring letters have consistently been associated with increased use of outpatient mental health services. The analysis found that veterans with and without indicators of elevated psychiatric risk were using services more. That, the researchers suggest, is more evidence that caring letters might prompt engagement with VHA care, even among veterans not identified as high risk.

Psychiatrist Jerome A. Motto, MD believed long-term supportive but nondemanding contact could reduce a suicidal person’s sense of isolation and enhance feelings of connectedness. His 1976 intervention established a plan to “exert a suicide prevention influence on high-risk persons who decline to enter the health care system.” In Motto’s 5-year follow-up study of 3,006 psychiatric inpatients, half of those who were not following their postdischarge treatment plan received calls or letters expressing interest in their well-being. Suicidal deaths were found to “diverge progressively,” leading Motto to claim the study showed “tentative evidence” that a high-risk population for suicide can be identified and that risk might be reduced through a systematic approach.

Despite those findings, the results of studies on repeated follow-up contact have been mixed. One review outlined how 5 studies showed a statistically significant reduction in suicidal behavior, 4 showed mixed results with trends toward a preventive effect, and 2 studies did not show a preventive effect.

In 2020, the VA launched an intervention for veterans who contacted the VCL. In the first 12 months, CLs were sent to > 100,000 veterans. In feedback interviews, participants described feeling appreciated, cared for, encouraged, and connected. They also said that the CLs helped them engage with community resources and made them more likely to seek VA care. Even veterans who were skeptical of the utility of the caring letters sometimes admitted keeping them.

Finding effective ways to prevent suicide among veterans has been a top priority for the VA. In 2021, then-US Surgeon General Jerome Adams issued a Call to Action that recommended using caring letters when gaps in care may exist, including following crisis line calls.

Caring messages to veterans at risk for suicide come in many forms: cards, letters, phone calls, email, and text messages. Each message can have a major impact on the veteran’s mental health and their decision to use health care provided by the US Department of Veterans Affairs (VA). A recent study outlined ways to centralize that impact, ensuring the caring message reaches those who need it most.

The study examined the impact of the VA Veterans Crisis Line (VCL) caring letters intervention among veterans at increased psychiatric risk. It focused on veterans with ≥ 2 Veterans Health Administration (VHA) health service encounters within 24 months prior to VCL contact. The primary outcome was suicide-related events (SRE), including suicide attempts, intentional self-harm, and suicidal self-directed violence. Secondary outcomes included VHA health care use (all-cause inpatient and outpatient, mental health outpatient, mental health inpatient, and emergency department). 

Of 186,514 VCL callers, 8.3% had a psychiatric hospitalization, 4.8% were flagged as high-risk by the REACH VET program, 6.2% had an SRE, and 12.9% met any of these criteria in the year prior to initial VCL contact. There was no association between caring letters and all-cause mortality or SRE, even though caring letters is one of the only interventions to demonstrate a reduction in suicide mortality as a randomized controlled trial.

While reducing suicide has not been the expected result, caring letters have consistently been associated with increased use of outpatient mental health services. The analysis found that veterans with and without indicators of elevated psychiatric risk were using services more. That, the researchers suggest, is more evidence that caring letters might prompt engagement with VHA care, even among veterans not identified as high risk.

Psychiatrist Jerome A. Motto, MD believed long-term supportive but nondemanding contact could reduce a suicidal person’s sense of isolation and enhance feelings of connectedness. His 1976 intervention established a plan to “exert a suicide prevention influence on high-risk persons who decline to enter the health care system.” In Motto’s 5-year follow-up study of 3,006 psychiatric inpatients, half of those who were not following their postdischarge treatment plan received calls or letters expressing interest in their well-being. Suicidal deaths were found to “diverge progressively,” leading Motto to claim the study showed “tentative evidence” that a high-risk population for suicide can be identified and that risk might be reduced through a systematic approach.

Despite those findings, the results of studies on repeated follow-up contact have been mixed. One review outlined how 5 studies showed a statistically significant reduction in suicidal behavior, 4 showed mixed results with trends toward a preventive effect, and 2 studies did not show a preventive effect.

In 2020, the VA launched an intervention for veterans who contacted the VCL. In the first 12 months, CLs were sent to > 100,000 veterans. In feedback interviews, participants described feeling appreciated, cared for, encouraged, and connected. They also said that the CLs helped them engage with community resources and made them more likely to seek VA care. Even veterans who were skeptical of the utility of the caring letters sometimes admitted keeping them.

Finding effective ways to prevent suicide among veterans has been a top priority for the VA. In 2021, then-US Surgeon General Jerome Adams issued a Call to Action that recommended using caring letters when gaps in care may exist, including following crisis line calls.

Caring messages to veterans at risk for suicide come in many forms: cards, letters, phone calls, email, and text messages. Each message can have a major impact on the veteran’s mental health and their decision to use health care provided by the US Department of Veterans Affairs (VA). A recent study outlined ways to centralize that impact, ensuring the caring message reaches those who need it most.

The study examined the impact of the VA Veterans Crisis Line (VCL) caring letters intervention among veterans at increased psychiatric risk. It focused on veterans with ≥ 2 Veterans Health Administration (VHA) health service encounters within 24 months prior to VCL contact. The primary outcome was suicide-related events (SRE), including suicide attempts, intentional self-harm, and suicidal self-directed violence. Secondary outcomes included VHA health care use (all-cause inpatient and outpatient, mental health outpatient, mental health inpatient, and emergency department). 

Of 186,514 VCL callers, 8.3% had a psychiatric hospitalization, 4.8% were flagged as high-risk by the REACH VET program, 6.2% had an SRE, and 12.9% met any of these criteria in the year prior to initial VCL contact. There was no association between caring letters and all-cause mortality or SRE, even though caring letters is one of the only interventions to demonstrate a reduction in suicide mortality as a randomized controlled trial.

While reducing suicide has not been the expected result, caring letters have consistently been associated with increased use of outpatient mental health services. The analysis found that veterans with and without indicators of elevated psychiatric risk were using services more. That, the researchers suggest, is more evidence that caring letters might prompt engagement with VHA care, even among veterans not identified as high risk.

Psychiatrist Jerome A. Motto, MD believed long-term supportive but nondemanding contact could reduce a suicidal person’s sense of isolation and enhance feelings of connectedness. His 1976 intervention established a plan to “exert a suicide prevention influence on high-risk persons who decline to enter the health care system.” In Motto’s 5-year follow-up study of 3,006 psychiatric inpatients, half of those who were not following their postdischarge treatment plan received calls or letters expressing interest in their well-being. Suicidal deaths were found to “diverge progressively,” leading Motto to claim the study showed “tentative evidence” that a high-risk population for suicide can be identified and that risk might be reduced through a systematic approach.

Despite those findings, the results of studies on repeated follow-up contact have been mixed. One review outlined how 5 studies showed a statistically significant reduction in suicidal behavior, 4 showed mixed results with trends toward a preventive effect, and 2 studies did not show a preventive effect.

In 2020, the VA launched an intervention for veterans who contacted the VCL. In the first 12 months, CLs were sent to > 100,000 veterans. In feedback interviews, participants described feeling appreciated, cared for, encouraged, and connected. They also said that the CLs helped them engage with community resources and made them more likely to seek VA care. Even veterans who were skeptical of the utility of the caring letters sometimes admitted keeping them.

Finding effective ways to prevent suicide among veterans has been a top priority for the VA. In 2021, then-US Surgeon General Jerome Adams issued a Call to Action that recommended using caring letters when gaps in care may exist, including following crisis line calls.

Traumatic and environmental exposures during military service may put women veterans at risk for early menopause, a recent longitudinal analysis of data from 668 women in the Gulf War Era Cohort Study found.

The study examined associations between possible early menopause (aged < 45 years) and participants’ Gulf War deployment, military environmental exposures (MEEs), Gulf War Illness, military sexual trauma (MST) and posttraumatic stress disorder (PTSD). 

Of 384 Gulf War–deployed veterans, 63% reported MEEs and 26% reported MST during deployment. More than half (57%) of study participants (both Gulf War veterans and nondeployed veterans) met criteria for Gulf War Illness, and 23% met criteria for probable PTSD. 

At follow-up, 15% of the women had possible early menopause—higher than population estimates for early menopause in the US, which range from 5% to 10%.

Gulf War deployment, Gulf War–related environmental exposures, and MST during deployment were not significantly associated with early menopause. However, both Gulf War Illness (odds ratio [OR], 1.83; 95% CI, 1.14 to 2.95) and probable PTSD (OR, 2.45; 95% CI, 1.54 to 3.90) were strongly associated with early menopause. Women with probable PTSD at baseline had more than double the odds of possible early menopause.

Previous research suggests that deployment, MEEs, and Gulf War Illness are broadly associated with adverse reproductive health conditions in women veterans. Exposure to persistent organic pollutants and combustion byproducts (eg, from industrial processes and burn pits) have been linked to ovarian dysfunction and oocyte destruction presumed to contribute to accelerated ovarian aging.

The average age for menopause in the US is 52 years. About 5% of women go through early menopause naturally. Early and premature (< 40 years) menopause may also result from a medical or surgical cause, such as a hysterectomy. Regardless the cause, early menopause can have a profound impact on a woman’s physical, emotional, and mental health. It is associated with premature mortality, poor bone health, sexual dysfunction, a 50% increased risk of cardiovascular disease, and 2-fold increased odds of depression.

“Sometimes we talk about menopause symptoms thinking that they're just sort of 1 brief point in time, but we're also talking about things that may affect women's health and functioning for a third or half of a lifespan,” Carolyn Gibson, PhD, MPH, said at the 2024 Spotlight on Women's Health Cyberseminar Series.

Gibson, a staff psychologist at the San Francisco Veterans Affairs (VA) Women’s Mental Health Program and lead author on the recent early-menopause study, pointed to some of the chronic physical health issues that might develop, such as cardiovascular disease, but also the psychological effects.

“It's just important,” she said during the Cyberseminar Series. “To think about the number of things that women in midlife tend to be juggling and managing, all of which may turn up the volume on symptom experience, effect of vulnerability to health and mental health challenges during this period.”

The findings of the study have clinical implications. Midlife women veterans (aged 45 to 64 years) are the largest group of women veterans enrolled in VA health care. Early menopause brings additional age-related care considerations. The authors advise prioritizing support for routine screening for menopause status and symptoms as well as gender-sensitive training, resources, and staffing to provide comprehensive, trauma-informed, evidence-based menopause care for women at any age.

Traumatic and environmental exposures during military service may put women veterans at risk for early menopause, a recent longitudinal analysis of data from 668 women in the Gulf War Era Cohort Study found.

The study examined associations between possible early menopause (aged < 45 years) and participants’ Gulf War deployment, military environmental exposures (MEEs), Gulf War Illness, military sexual trauma (MST) and posttraumatic stress disorder (PTSD). 

Of 384 Gulf War–deployed veterans, 63% reported MEEs and 26% reported MST during deployment. More than half (57%) of study participants (both Gulf War veterans and nondeployed veterans) met criteria for Gulf War Illness, and 23% met criteria for probable PTSD. 

At follow-up, 15% of the women had possible early menopause—higher than population estimates for early menopause in the US, which range from 5% to 10%.

Gulf War deployment, Gulf War–related environmental exposures, and MST during deployment were not significantly associated with early menopause. However, both Gulf War Illness (odds ratio [OR], 1.83; 95% CI, 1.14 to 2.95) and probable PTSD (OR, 2.45; 95% CI, 1.54 to 3.90) were strongly associated with early menopause. Women with probable PTSD at baseline had more than double the odds of possible early menopause.

Previous research suggests that deployment, MEEs, and Gulf War Illness are broadly associated with adverse reproductive health conditions in women veterans. Exposure to persistent organic pollutants and combustion byproducts (eg, from industrial processes and burn pits) have been linked to ovarian dysfunction and oocyte destruction presumed to contribute to accelerated ovarian aging.

The average age for menopause in the US is 52 years. About 5% of women go through early menopause naturally. Early and premature (< 40 years) menopause may also result from a medical or surgical cause, such as a hysterectomy. Regardless the cause, early menopause can have a profound impact on a woman’s physical, emotional, and mental health. It is associated with premature mortality, poor bone health, sexual dysfunction, a 50% increased risk of cardiovascular disease, and 2-fold increased odds of depression.

“Sometimes we talk about menopause symptoms thinking that they're just sort of 1 brief point in time, but we're also talking about things that may affect women's health and functioning for a third or half of a lifespan,” Carolyn Gibson, PhD, MPH, said at the 2024 Spotlight on Women's Health Cyberseminar Series.

Gibson, a staff psychologist at the San Francisco Veterans Affairs (VA) Women’s Mental Health Program and lead author on the recent early-menopause study, pointed to some of the chronic physical health issues that might develop, such as cardiovascular disease, but also the psychological effects.

“It's just important,” she said during the Cyberseminar Series. “To think about the number of things that women in midlife tend to be juggling and managing, all of which may turn up the volume on symptom experience, effect of vulnerability to health and mental health challenges during this period.”

The findings of the study have clinical implications. Midlife women veterans (aged 45 to 64 years) are the largest group of women veterans enrolled in VA health care. Early menopause brings additional age-related care considerations. The authors advise prioritizing support for routine screening for menopause status and symptoms as well as gender-sensitive training, resources, and staffing to provide comprehensive, trauma-informed, evidence-based menopause care for women at any age.

Traumatic and environmental exposures during military service may put women veterans at risk for early menopause, a recent longitudinal analysis of data from 668 women in the Gulf War Era Cohort Study found.

The study examined associations between possible early menopause (aged < 45 years) and participants’ Gulf War deployment, military environmental exposures (MEEs), Gulf War Illness, military sexual trauma (MST) and posttraumatic stress disorder (PTSD). 

Of 384 Gulf War–deployed veterans, 63% reported MEEs and 26% reported MST during deployment. More than half (57%) of study participants (both Gulf War veterans and nondeployed veterans) met criteria for Gulf War Illness, and 23% met criteria for probable PTSD. 

At follow-up, 15% of the women had possible early menopause—higher than population estimates for early menopause in the US, which range from 5% to 10%.

Gulf War deployment, Gulf War–related environmental exposures, and MST during deployment were not significantly associated with early menopause. However, both Gulf War Illness (odds ratio [OR], 1.83; 95% CI, 1.14 to 2.95) and probable PTSD (OR, 2.45; 95% CI, 1.54 to 3.90) were strongly associated with early menopause. Women with probable PTSD at baseline had more than double the odds of possible early menopause.

Previous research suggests that deployment, MEEs, and Gulf War Illness are broadly associated with adverse reproductive health conditions in women veterans. Exposure to persistent organic pollutants and combustion byproducts (eg, from industrial processes and burn pits) have been linked to ovarian dysfunction and oocyte destruction presumed to contribute to accelerated ovarian aging.

The average age for menopause in the US is 52 years. About 5% of women go through early menopause naturally. Early and premature (< 40 years) menopause may also result from a medical or surgical cause, such as a hysterectomy. Regardless the cause, early menopause can have a profound impact on a woman’s physical, emotional, and mental health. It is associated with premature mortality, poor bone health, sexual dysfunction, a 50% increased risk of cardiovascular disease, and 2-fold increased odds of depression.

“Sometimes we talk about menopause symptoms thinking that they're just sort of 1 brief point in time, but we're also talking about things that may affect women's health and functioning for a third or half of a lifespan,” Carolyn Gibson, PhD, MPH, said at the 2024 Spotlight on Women's Health Cyberseminar Series.

Gibson, a staff psychologist at the San Francisco Veterans Affairs (VA) Women’s Mental Health Program and lead author on the recent early-menopause study, pointed to some of the chronic physical health issues that might develop, such as cardiovascular disease, but also the psychological effects.

“It's just important,” she said during the Cyberseminar Series. “To think about the number of things that women in midlife tend to be juggling and managing, all of which may turn up the volume on symptom experience, effect of vulnerability to health and mental health challenges during this period.”

The findings of the study have clinical implications. Midlife women veterans (aged 45 to 64 years) are the largest group of women veterans enrolled in VA health care. Early menopause brings additional age-related care considerations. The authors advise prioritizing support for routine screening for menopause status and symptoms as well as gender-sensitive training, resources, and staffing to provide comprehensive, trauma-informed, evidence-based menopause care for women at any age.

To the Editor:

Drug-induced hyperpigmentation is a common cause of an acquired increase in pigmentation. Belumosudil is an oral selective inhibitor of Rho-associated coiled-coil containing protein kinase (ROCK2) that is approved for the treatment of chronic graft-vs-host disease (GVHD). We describe a patient who developed diffuse skin bronzing 3 weeks after initiation of belumosudil treatment.

A 64-year-old fair-skinned woman presented to the dermatology clinic with bronzing of the skin and dystrophic nails 3 weeks after starting belumosudil for treatment of chronic GVHD. Six months prior to presentation, the patient had received a bone marrow transplant for chronic lymphoid leukemia. She presented to dermatology 6 months after the transplant with a new-onset rash that was suspicious for GVHD. Physical examination revealed pruritic pink papules diffusely scattered on the legs and forearms (Figure 1). The patient declined biopsy at that time and later followed up with oncology. The patient’s oncologist supported a diagnosis of GVHD, and the patient began treatment with belumosudil 200 mg/d which was intended to be taken until treatment failure due to progression of chronic GVHD.

Three weeks after starting belumosudil, the patient developed diffuse bronzing of the skin and brown, evenly colored patches scattered on the trunk, back, and upper and lower extremities on a background of the presumed GVHD rash (Figure 2). The hyperpigmentation was abrupt, starting on the chest and spreading to the abdomen, extremities, and back (Figure 3).

Again, the patient was offered biopsy for the new-onset pigmentation but declined. During this time, she had no notable sun exposure and primarily stayed indoors despite living in a region with a sunny semi-arid climate. Her medication and supplement list were reviewed and included acalabrutinib, a multivitamin, lutein, biotin, and a fish oil supplement. A compete blood cell count as well as ferritin, transferrin, cortisol, and adrenocorticotropic hormone levels were unremarkable.

The patient continued to take belumosudil for treatment of GVHD. The hyperpigmentation faded slightly by a 2-month follow-up visit but persisted and was stable. She has not tried other treatments for GVHD to manage the hyperpigmentation.

Conditions known to cause diffuse bronzing of the skin include Addison disease, hemochromatosis, Cushing disease, and medication adverse events. Our patient presented with an absence of systemic symptoms, normal laboratory results, and no clinical indicators suggesting alternate causes. Given that the onset of the hyperpigmentation was 3 weeks after she started a new medication, we hypothesized that the bronzing was an adverse effect of the belumosudil—though this correlation cannot be definitively proven by this case.

The most common offending agents for drug-induced skin hyperpigmentation are nonsteroidal anti- inflammatory drugs, antimalarials, amiodarone, cytotoxic drugs, and tetracyclines.^1,2 Our patient’s medication list included the cytotoxic agent acalabrutinib, a Bruton tyrosine kinase inhibitor used for the treatment of non-Hodgkin lymphoma. It has been associated with dermatologic findings of ecchymosis, bruising, panniculitis, and cellulitis, but there are no known reports of hyperpigmentation.³ Our patient had been taking acalabrutinib for 6 months when the GVHD rash developed. At the time, she also was taking a multivitamin and lutein, biotin, and fish oil supplements, none of which have been associated with hyperpigmentation.

Polypharmacy adds a layer of difficulty in identifying the inciting cause of pigmentary change. In our case, symptoms began 3 weeks after the initiation of belumosudil. There were no cutaneous reactions observed in the ROCKstar study of belumosudil; the most common adverse events were upper respiratory tract infection, diarrhea, fatigue, nausea, increased liver enzymes, and dyspnea.^4,5 Patients on belumosudil have developed aggressive cutaneous squamous cell carcinoma.⁶ However, a search of PubMed articles indexed for MEDLINE using the search terms acalabrutinib or belumosudil with hyperpigmentation or cutaneous reaction returned no reports of these medications causing hyperpigmentation or cutaneous deposits.

Treatment of drug-induced hyperpigmentation is difficult because discontinuation of the offending agent typically confirms diagnosis, but interruption of treatment is not always possible, as in our patient. The skin changes can fade over time, but effects typically are long lasting.

Dermatologists play a key role in the identification of drug-induced skin hyperpigmentation. After endocrine or metabolic causes of skin hyperpigmentation have been ruled out, a thorough review of the patient’s medication list should be done to assess for a drug-induced cause. Treatment is limited to sun avoidance, as interruption of treatment may not be possible, and lesions typically do fade over time. These chronic skin changes can have a psychosocial effect on patients and regular follow-up is recommended.

To the Editor:

Drug-induced hyperpigmentation is a common cause of an acquired increase in pigmentation. Belumosudil is an oral selective inhibitor of Rho-associated coiled-coil containing protein kinase (ROCK2) that is approved for the treatment of chronic graft-vs-host disease (GVHD). We describe a patient who developed diffuse skin bronzing 3 weeks after initiation of belumosudil treatment.

A 64-year-old fair-skinned woman presented to the dermatology clinic with bronzing of the skin and dystrophic nails 3 weeks after starting belumosudil for treatment of chronic GVHD. Six months prior to presentation, the patient had received a bone marrow transplant for chronic lymphoid leukemia. She presented to dermatology 6 months after the transplant with a new-onset rash that was suspicious for GVHD. Physical examination revealed pruritic pink papules diffusely scattered on the legs and forearms (Figure 1). The patient declined biopsy at that time and later followed up with oncology. The patient’s oncologist supported a diagnosis of GVHD, and the patient began treatment with belumosudil 200 mg/d which was intended to be taken until treatment failure due to progression of chronic GVHD.

Three weeks after starting belumosudil, the patient developed diffuse bronzing of the skin and brown, evenly colored patches scattered on the trunk, back, and upper and lower extremities on a background of the presumed GVHD rash (Figure 2). The hyperpigmentation was abrupt, starting on the chest and spreading to the abdomen, extremities, and back (Figure 3).

Again, the patient was offered biopsy for the new-onset pigmentation but declined. During this time, she had no notable sun exposure and primarily stayed indoors despite living in a region with a sunny semi-arid climate. Her medication and supplement list were reviewed and included acalabrutinib, a multivitamin, lutein, biotin, and a fish oil supplement. A compete blood cell count as well as ferritin, transferrin, cortisol, and adrenocorticotropic hormone levels were unremarkable.

The patient continued to take belumosudil for treatment of GVHD. The hyperpigmentation faded slightly by a 2-month follow-up visit but persisted and was stable. She has not tried other treatments for GVHD to manage the hyperpigmentation.

Conditions known to cause diffuse bronzing of the skin include Addison disease, hemochromatosis, Cushing disease, and medication adverse events. Our patient presented with an absence of systemic symptoms, normal laboratory results, and no clinical indicators suggesting alternate causes. Given that the onset of the hyperpigmentation was 3 weeks after she started a new medication, we hypothesized that the bronzing was an adverse effect of the belumosudil—though this correlation cannot be definitively proven by this case.

The most common offending agents for drug-induced skin hyperpigmentation are nonsteroidal anti- inflammatory drugs, antimalarials, amiodarone, cytotoxic drugs, and tetracyclines.^1,2 Our patient’s medication list included the cytotoxic agent acalabrutinib, a Bruton tyrosine kinase inhibitor used for the treatment of non-Hodgkin lymphoma. It has been associated with dermatologic findings of ecchymosis, bruising, panniculitis, and cellulitis, but there are no known reports of hyperpigmentation.³ Our patient had been taking acalabrutinib for 6 months when the GVHD rash developed. At the time, she also was taking a multivitamin and lutein, biotin, and fish oil supplements, none of which have been associated with hyperpigmentation.

Polypharmacy adds a layer of difficulty in identifying the inciting cause of pigmentary change. In our case, symptoms began 3 weeks after the initiation of belumosudil. There were no cutaneous reactions observed in the ROCKstar study of belumosudil; the most common adverse events were upper respiratory tract infection, diarrhea, fatigue, nausea, increased liver enzymes, and dyspnea.^4,5 Patients on belumosudil have developed aggressive cutaneous squamous cell carcinoma.⁶ However, a search of PubMed articles indexed for MEDLINE using the search terms acalabrutinib or belumosudil with hyperpigmentation or cutaneous reaction returned no reports of these medications causing hyperpigmentation or cutaneous deposits.

Treatment of drug-induced hyperpigmentation is difficult because discontinuation of the offending agent typically confirms diagnosis, but interruption of treatment is not always possible, as in our patient. The skin changes can fade over time, but effects typically are long lasting.

Dermatologists play a key role in the identification of drug-induced skin hyperpigmentation. After endocrine or metabolic causes of skin hyperpigmentation have been ruled out, a thorough review of the patient’s medication list should be done to assess for a drug-induced cause. Treatment is limited to sun avoidance, as interruption of treatment may not be possible, and lesions typically do fade over time. These chronic skin changes can have a psychosocial effect on patients and regular follow-up is recommended.

To the Editor:

Drug-induced hyperpigmentation is a common cause of an acquired increase in pigmentation. Belumosudil is an oral selective inhibitor of Rho-associated coiled-coil containing protein kinase (ROCK2) that is approved for the treatment of chronic graft-vs-host disease (GVHD). We describe a patient who developed diffuse skin bronzing 3 weeks after initiation of belumosudil treatment.

A 64-year-old fair-skinned woman presented to the dermatology clinic with bronzing of the skin and dystrophic nails 3 weeks after starting belumosudil for treatment of chronic GVHD. Six months prior to presentation, the patient had received a bone marrow transplant for chronic lymphoid leukemia. She presented to dermatology 6 months after the transplant with a new-onset rash that was suspicious for GVHD. Physical examination revealed pruritic pink papules diffusely scattered on the legs and forearms (Figure 1). The patient declined biopsy at that time and later followed up with oncology. The patient’s oncologist supported a diagnosis of GVHD, and the patient began treatment with belumosudil 200 mg/d which was intended to be taken until treatment failure due to progression of chronic GVHD.

Three weeks after starting belumosudil, the patient developed diffuse bronzing of the skin and brown, evenly colored patches scattered on the trunk, back, and upper and lower extremities on a background of the presumed GVHD rash (Figure 2). The hyperpigmentation was abrupt, starting on the chest and spreading to the abdomen, extremities, and back (Figure 3).

Again, the patient was offered biopsy for the new-onset pigmentation but declined. During this time, she had no notable sun exposure and primarily stayed indoors despite living in a region with a sunny semi-arid climate. Her medication and supplement list were reviewed and included acalabrutinib, a multivitamin, lutein, biotin, and a fish oil supplement. A compete blood cell count as well as ferritin, transferrin, cortisol, and adrenocorticotropic hormone levels were unremarkable.

The patient continued to take belumosudil for treatment of GVHD. The hyperpigmentation faded slightly by a 2-month follow-up visit but persisted and was stable. She has not tried other treatments for GVHD to manage the hyperpigmentation.

Conditions known to cause diffuse bronzing of the skin include Addison disease, hemochromatosis, Cushing disease, and medication adverse events. Our patient presented with an absence of systemic symptoms, normal laboratory results, and no clinical indicators suggesting alternate causes. Given that the onset of the hyperpigmentation was 3 weeks after she started a new medication, we hypothesized that the bronzing was an adverse effect of the belumosudil—though this correlation cannot be definitively proven by this case.

The most common offending agents for drug-induced skin hyperpigmentation are nonsteroidal anti- inflammatory drugs, antimalarials, amiodarone, cytotoxic drugs, and tetracyclines.^1,2 Our patient’s medication list included the cytotoxic agent acalabrutinib, a Bruton tyrosine kinase inhibitor used for the treatment of non-Hodgkin lymphoma. It has been associated with dermatologic findings of ecchymosis, bruising, panniculitis, and cellulitis, but there are no known reports of hyperpigmentation.³ Our patient had been taking acalabrutinib for 6 months when the GVHD rash developed. At the time, she also was taking a multivitamin and lutein, biotin, and fish oil supplements, none of which have been associated with hyperpigmentation.

Polypharmacy adds a layer of difficulty in identifying the inciting cause of pigmentary change. In our case, symptoms began 3 weeks after the initiation of belumosudil. There were no cutaneous reactions observed in the ROCKstar study of belumosudil; the most common adverse events were upper respiratory tract infection, diarrhea, fatigue, nausea, increased liver enzymes, and dyspnea.^4,5 Patients on belumosudil have developed aggressive cutaneous squamous cell carcinoma.⁶ However, a search of PubMed articles indexed for MEDLINE using the search terms acalabrutinib or belumosudil with hyperpigmentation or cutaneous reaction returned no reports of these medications causing hyperpigmentation or cutaneous deposits.

Treatment of drug-induced hyperpigmentation is difficult because discontinuation of the offending agent typically confirms diagnosis, but interruption of treatment is not always possible, as in our patient. The skin changes can fade over time, but effects typically are long lasting.

Dermatologists play a key role in the identification of drug-induced skin hyperpigmentation. After endocrine or metabolic causes of skin hyperpigmentation have been ruled out, a thorough review of the patient’s medication list should be done to assess for a drug-induced cause. Treatment is limited to sun avoidance, as interruption of treatment may not be possible, and lesions typically do fade over time. These chronic skin changes can have a psychosocial effect on patients and regular follow-up is recommended.

In our June issue, I highlighted the potentially seismic clinical implications of the U.S. Supreme Court’s then-pending decision in the Kennedy vs. Braidwood Management, Inc., case. That ruling, recently released at the conclusion of the Court’s term, ultimately affirmed the Affordable Care Act’s mandate requiring insurers to cover certain preventive services, including colorectal cancer screening tests, without cost-sharing.

In doing so, however, the court determined that members of the U.S. Preventive Services Task Force (USPSTF), which recommends these services, are “inferior officers” appropriately appointed by the Secretary of Health and Human Services (HHS), rather than needing Senate confirmation. Thus, the decision reinforced the HHS Secretary’s authority to oversee and potentially influence USPSTF recommendations in the future. While the decision represented a victory in upholding a key provision of the ACA, it also signaled a potential threat to the scientific independence of the body charged with making those preventive care recommendations in a scientifically rigorous, unbiased manner. 

As anticipated, the HHS Secretary responded to the Supreme Court’s ruling by abruptly canceling the USPSTF’s scheduled July meeting. This decision, coupled with his recent disbanding of the entire 17-member Advisory Committee on Immunization Practices — the group responsible for shaping evidence-based vaccine policy — has raised serious concerns across the healthcare field. On July 9th, AGA joined a coalition of 104 health organizations in submitting a letter to the Chair and Ranking Members of the Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce, urging them to protect the integrity of the USPSTF.

The fight to protect science-based health policy is far from over — effective advocacy necessitates that clinicians use their professional platforms to push back against the politicization of science – not only for the integrity of the medical profession, but for the health and future of the patients we serve. At a time when medical misinformation runs rampant, undermining the independence of scientific bodies risks sowing confusion, eroding public trust, and compromising patient care for years to come.

Megan A. Adams, MD, JD, MSc 

Editor in Chief

In our June issue, I highlighted the potentially seismic clinical implications of the U.S. Supreme Court’s then-pending decision in the Kennedy vs. Braidwood Management, Inc., case. That ruling, recently released at the conclusion of the Court’s term, ultimately affirmed the Affordable Care Act’s mandate requiring insurers to cover certain preventive services, including colorectal cancer screening tests, without cost-sharing.

In doing so, however, the court determined that members of the U.S. Preventive Services Task Force (USPSTF), which recommends these services, are “inferior officers” appropriately appointed by the Secretary of Health and Human Services (HHS), rather than needing Senate confirmation. Thus, the decision reinforced the HHS Secretary’s authority to oversee and potentially influence USPSTF recommendations in the future. While the decision represented a victory in upholding a key provision of the ACA, it also signaled a potential threat to the scientific independence of the body charged with making those preventive care recommendations in a scientifically rigorous, unbiased manner. 

As anticipated, the HHS Secretary responded to the Supreme Court’s ruling by abruptly canceling the USPSTF’s scheduled July meeting. This decision, coupled with his recent disbanding of the entire 17-member Advisory Committee on Immunization Practices — the group responsible for shaping evidence-based vaccine policy — has raised serious concerns across the healthcare field. On July 9th, AGA joined a coalition of 104 health organizations in submitting a letter to the Chair and Ranking Members of the Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce, urging them to protect the integrity of the USPSTF.

The fight to protect science-based health policy is far from over — effective advocacy necessitates that clinicians use their professional platforms to push back against the politicization of science – not only for the integrity of the medical profession, but for the health and future of the patients we serve. At a time when medical misinformation runs rampant, undermining the independence of scientific bodies risks sowing confusion, eroding public trust, and compromising patient care for years to come.

Megan A. Adams, MD, JD, MSc 

Editor in Chief

In our June issue, I highlighted the potentially seismic clinical implications of the U.S. Supreme Court’s then-pending decision in the Kennedy vs. Braidwood Management, Inc., case. That ruling, recently released at the conclusion of the Court’s term, ultimately affirmed the Affordable Care Act’s mandate requiring insurers to cover certain preventive services, including colorectal cancer screening tests, without cost-sharing.

In doing so, however, the court determined that members of the U.S. Preventive Services Task Force (USPSTF), which recommends these services, are “inferior officers” appropriately appointed by the Secretary of Health and Human Services (HHS), rather than needing Senate confirmation. Thus, the decision reinforced the HHS Secretary’s authority to oversee and potentially influence USPSTF recommendations in the future. While the decision represented a victory in upholding a key provision of the ACA, it also signaled a potential threat to the scientific independence of the body charged with making those preventive care recommendations in a scientifically rigorous, unbiased manner. 

As anticipated, the HHS Secretary responded to the Supreme Court’s ruling by abruptly canceling the USPSTF’s scheduled July meeting. This decision, coupled with his recent disbanding of the entire 17-member Advisory Committee on Immunization Practices — the group responsible for shaping evidence-based vaccine policy — has raised serious concerns across the healthcare field. On July 9th, AGA joined a coalition of 104 health organizations in submitting a letter to the Chair and Ranking Members of the Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce, urging them to protect the integrity of the USPSTF.

The fight to protect science-based health policy is far from over — effective advocacy necessitates that clinicians use their professional platforms to push back against the politicization of science – not only for the integrity of the medical profession, but for the health and future of the patients we serve. At a time when medical misinformation runs rampant, undermining the independence of scientific bodies risks sowing confusion, eroding public trust, and compromising patient care for years to come.

Megan A. Adams, MD, JD, MSc 

Editor in Chief

Primary care clinicians across the US are warning cuts to Medicaid in the Trump Administration’s new budget bill could push many of them out of practice and deepen access gaps for patients.

In a recent survey by researchers at the Green Center at Virginia Commonwealth University, in Richmond, Virginia, more than 1 in 4 physicians (26%) said their practice would suffer financially, and those figures were higher for rural doctors (31%) and those working at federally qualified health centers (FQHCs; 60%).

Nearly 70% of the physicians surveyed said the legislation’s tighter eligibility rules would worsen their administrative burdens, according to a June survey of 379 primary care physicians. That figure jumped to 87% among clinicians at FQHCs.

Only 13% of primary care clinicians said the proposed changes to the program were unlikely to affect their practice or patients.

“It’s sobering,” said Rebecca Etz, PhD, a professor of family medicine at Virginia Commonwealth and co-director of the Green Center. “Frontline clinicians are letting us know that reductions in Medicaid, they predict, will severely constrain access — which is already constrained in the US”

For Amy Ellingson, MD, a primary care physician at Three Rivers Family Medicine in Brewster, Washington, those numbers are not abstract.

Medicaid cuts “will seriously hurt our hospital and clinic’s viability since our payer mix is 31% Medicaid,” Ellingson told this news organization. “We are already on the edge due to low reimbursement, and this will only make things worse. It will also reduce patient volumes.”

Her greatest fear, however, is not just for her clinic but also for her patients.

“We don’t have any further cuts to services that we can make,” she said. “So our situation would be about our survival. In the clinic, we are already seeing people get cut from Medicaid due to an increase in paperwork burden. If they don’t have Medicaid, they can’t seek care. This will land them in the ER [emergency room], as all studies have shown.”

That cycle — from loss of primary care to overuse of emergency care to hospital debt — puts institutions like hers on a dangerous path.

“An increase in ER visits with people who are uninsured will then be part of a cycle of bad debt, leaving the hospital further at risk,” she said.

 

Primary Care at Particular Risk

The survey findings came in the wake of the passage in May of the House version of the “One Big Beautiful Bill,” which included more than $800 billion in Medicaid cuts over the next decade. The final version, which passed the Senate by one vote, cut the program by more than $1 trillion between now and 2034 and included monthly work or community service requirements and frequent eligibility verifications.

The Congressional Budget Office estimated roughly 12 million Americans would lose their health care coverage under the bill.

Medicaid currently covers more than 70 million Americans, including low-income families, children, seniors, pregnant women, and people with disabilities. Provisions in the bill would cap state-directed payments to hospitals and nursing facilities, reducing them 10% annually and stripping funding for staffing, patient outreach and care delivery.

Sumana Reddy, MD, a primary care clinician at Acacia Family Medical Group, Salinas, California, said the changes could upend care for the region’s farmworker community.

Requalification requirements for eligibility “will be a real challenge for my patients, many of whom are farmworkers,” Reddy said. “Primary care practices like ours already do a lot of this work, which is unreimbursed. There may be patients who lose Medicaid entirely and will really struggle with their untreated conditions.”

Her practice serves entire families, including young children, parents, and older adults who rely on Medicaid for preventive care, management of chronic diseases, prescriptions, and long-term care.

“This move will adversely affect the health of our community,” Reddy said. “Work requirements may leave elderly uncared for. Everyone will be affected.”

Yalda Jabbarpour, MD, director of the Robert Graham Center for Policy Studies and a practicing family physician in Washington, DC, said the cuts reflect a “deeply concerning trend” in health policy: the “systematic underinvestment” in primary care.

“At a time when more than a third of adults and 15% of children lack a usual source of care, we should be expanding access — not restricting it,” she said.

 

Maternal and Rural Practice in Jeopardy

Midwife Jennifer Seymour, CNM, operates an accredited freestanding birth center in rural New York, where 60% of births are covered by Medicaid. She said any threat to Medicaid funding puts entire communities at risk.

“New York already has too many maternity care deserts as hospitals close because they can’t be financially viable,” said Seymour, founder of Cocoon Wellness and Birth Center in Waverly, New York, about 85 miles south of Syracuse. “If 60% of births are not getting paid for, perinatal deaths of moms and babies will skyrocket over our already abysmal numbers.”

“Where will anyone go for their medical needs when that happens?” she added.

In a Green Center survey conducted in May, 34.7% of clinicians said their practice would become financially unviable if Medicaid reimbursements were cut. Nearly 40% said at least 10% of their patients would likely forgo preventive care.

Etz said while FQHCs and pediatric practices are often hit hardest by Medicaid policy shifts, the data show the financial stress is widespread.

“I was surprised at the large variety of demographics among those who said they’d lose their financial viability,” she said. “It really was small and large practices, hospital-owned, insurance-owned, direct primary care — everybody was predicting an impact.”

 

Ripple Effects Across the System

In the June survey, 74% of respondents predicted an increase in the use of high-cost emergency care by uninsured patients — a number that jumped to 95% among FQHCs.

“What you’re looking at is a reduction in access to primary care, and the ripple effect across the health care system is tremendous,” Etz said. “That means an influx of uninsured patients into hospitals already struggling to repair after the pandemic — patients who are often more complex and expensive to care for.”

Etz cited studies showing the life-and-death stakes of continuous access to primary care.

“A little investment in primary care can yield strong health outcomes,” she said. “When that access is lost, even briefly, mortality rates for manageable conditions like diabetes or Alzheimer’s can skyrocket.”

Jabbarpour agreed.

“In high-cost urban areas like Washington, DC, access to primary care is already strained due to low Medicaid reimbursement rates and provider shortages,” she said. “Cutting Medicaid further will push more patients to delay care until conditions worsen, when treatment becomes more complex and costly.”

 

Clinician Well-Being and the Future Workforce

Clinicians themselves are also under mounting pressure. In the June Green Center survey, 55% of clinicians reported high levels of burnout or moral injury — a number that rose to 68% among FQHC providers.

“Burnout suggests the problem is with the individual. Moral injury is about functioning in an inhumane system, seeing wrong things happen that you could fix, if only someone would let you,” Etz said.

Jabbarpour said the toll on the clinical workforce could be long-lasting.

“Medicaid cuts send a clear signal to early-career physicians: Choosing primary care, especially in underserved communities, comes with greater financial instability and fewer resources to care for patients effectively,” Jabbarpour said. “If we want to retain a new generation of mission-driven doctors, we have to invest in the systems and safety nets that support them.”

Reddy said her practice will likely cease to exist in the long run if reductions restrict what they have done for the past 27 years. “We try to see everyone in the community and provide continuity for our patients,” said Reddy. “It will be emotionally wrenching to have to turn away Medicaid patients we’ve seen for years. So far, we’ve never done that.”

 

A Systemic Warning

Ellingson was blunt about what is at stake.

“Rural hospitals and clinics are at extreme risk of closure should these cuts be put in place,” she said, leading to more health care “deserts.” “Mortality and morbidity in these communities, tragically, will increase quickly if this happens.”

Despite the threat, Etz said many clinicians remain deeply committed to their work.

“Even as they report all the sad things, 77% also reported high professional fulfillment,” she said. “They’re saying, ‘You’re making this hard — but I’ve never felt my work was more important.’”

The sources cited in this story reported having no relevant disclosures.

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

Primary care clinicians across the US are warning cuts to Medicaid in the Trump Administration’s new budget bill could push many of them out of practice and deepen access gaps for patients.

In a recent survey by researchers at the Green Center at Virginia Commonwealth University, in Richmond, Virginia, more than 1 in 4 physicians (26%) said their practice would suffer financially, and those figures were higher for rural doctors (31%) and those working at federally qualified health centers (FQHCs; 60%).

Nearly 70% of the physicians surveyed said the legislation’s tighter eligibility rules would worsen their administrative burdens, according to a June survey of 379 primary care physicians. That figure jumped to 87% among clinicians at FQHCs.

Only 13% of primary care clinicians said the proposed changes to the program were unlikely to affect their practice or patients.

“It’s sobering,” said Rebecca Etz, PhD, a professor of family medicine at Virginia Commonwealth and co-director of the Green Center. “Frontline clinicians are letting us know that reductions in Medicaid, they predict, will severely constrain access — which is already constrained in the US”

For Amy Ellingson, MD, a primary care physician at Three Rivers Family Medicine in Brewster, Washington, those numbers are not abstract.

Medicaid cuts “will seriously hurt our hospital and clinic’s viability since our payer mix is 31% Medicaid,” Ellingson told this news organization. “We are already on the edge due to low reimbursement, and this will only make things worse. It will also reduce patient volumes.”

Her greatest fear, however, is not just for her clinic but also for her patients.

“We don’t have any further cuts to services that we can make,” she said. “So our situation would be about our survival. In the clinic, we are already seeing people get cut from Medicaid due to an increase in paperwork burden. If they don’t have Medicaid, they can’t seek care. This will land them in the ER [emergency room], as all studies have shown.”

That cycle — from loss of primary care to overuse of emergency care to hospital debt — puts institutions like hers on a dangerous path.

“An increase in ER visits with people who are uninsured will then be part of a cycle of bad debt, leaving the hospital further at risk,” she said.

 

Primary Care at Particular Risk

The survey findings came in the wake of the passage in May of the House version of the “One Big Beautiful Bill,” which included more than $800 billion in Medicaid cuts over the next decade. The final version, which passed the Senate by one vote, cut the program by more than $1 trillion between now and 2034 and included monthly work or community service requirements and frequent eligibility verifications.

The Congressional Budget Office estimated roughly 12 million Americans would lose their health care coverage under the bill.

Medicaid currently covers more than 70 million Americans, including low-income families, children, seniors, pregnant women, and people with disabilities. Provisions in the bill would cap state-directed payments to hospitals and nursing facilities, reducing them 10% annually and stripping funding for staffing, patient outreach and care delivery.

Sumana Reddy, MD, a primary care clinician at Acacia Family Medical Group, Salinas, California, said the changes could upend care for the region’s farmworker community.

Requalification requirements for eligibility “will be a real challenge for my patients, many of whom are farmworkers,” Reddy said. “Primary care practices like ours already do a lot of this work, which is unreimbursed. There may be patients who lose Medicaid entirely and will really struggle with their untreated conditions.”

Her practice serves entire families, including young children, parents, and older adults who rely on Medicaid for preventive care, management of chronic diseases, prescriptions, and long-term care.

“This move will adversely affect the health of our community,” Reddy said. “Work requirements may leave elderly uncared for. Everyone will be affected.”

Yalda Jabbarpour, MD, director of the Robert Graham Center for Policy Studies and a practicing family physician in Washington, DC, said the cuts reflect a “deeply concerning trend” in health policy: the “systematic underinvestment” in primary care.

“At a time when more than a third of adults and 15% of children lack a usual source of care, we should be expanding access — not restricting it,” she said.

 

Maternal and Rural Practice in Jeopardy

Midwife Jennifer Seymour, CNM, operates an accredited freestanding birth center in rural New York, where 60% of births are covered by Medicaid. She said any threat to Medicaid funding puts entire communities at risk.

“New York already has too many maternity care deserts as hospitals close because they can’t be financially viable,” said Seymour, founder of Cocoon Wellness and Birth Center in Waverly, New York, about 85 miles south of Syracuse. “If 60% of births are not getting paid for, perinatal deaths of moms and babies will skyrocket over our already abysmal numbers.”

“Where will anyone go for their medical needs when that happens?” she added.

In a Green Center survey conducted in May, 34.7% of clinicians said their practice would become financially unviable if Medicaid reimbursements were cut. Nearly 40% said at least 10% of their patients would likely forgo preventive care.

Etz said while FQHCs and pediatric practices are often hit hardest by Medicaid policy shifts, the data show the financial stress is widespread.

“I was surprised at the large variety of demographics among those who said they’d lose their financial viability,” she said. “It really was small and large practices, hospital-owned, insurance-owned, direct primary care — everybody was predicting an impact.”

 

Ripple Effects Across the System

In the June survey, 74% of respondents predicted an increase in the use of high-cost emergency care by uninsured patients — a number that jumped to 95% among FQHCs.

“What you’re looking at is a reduction in access to primary care, and the ripple effect across the health care system is tremendous,” Etz said. “That means an influx of uninsured patients into hospitals already struggling to repair after the pandemic — patients who are often more complex and expensive to care for.”

Etz cited studies showing the life-and-death stakes of continuous access to primary care.

“A little investment in primary care can yield strong health outcomes,” she said. “When that access is lost, even briefly, mortality rates for manageable conditions like diabetes or Alzheimer’s can skyrocket.”

Jabbarpour agreed.

“In high-cost urban areas like Washington, DC, access to primary care is already strained due to low Medicaid reimbursement rates and provider shortages,” she said. “Cutting Medicaid further will push more patients to delay care until conditions worsen, when treatment becomes more complex and costly.”

 

Clinician Well-Being and the Future Workforce

Clinicians themselves are also under mounting pressure. In the June Green Center survey, 55% of clinicians reported high levels of burnout or moral injury — a number that rose to 68% among FQHC providers.

“Burnout suggests the problem is with the individual. Moral injury is about functioning in an inhumane system, seeing wrong things happen that you could fix, if only someone would let you,” Etz said.

Jabbarpour said the toll on the clinical workforce could be long-lasting.

“Medicaid cuts send a clear signal to early-career physicians: Choosing primary care, especially in underserved communities, comes with greater financial instability and fewer resources to care for patients effectively,” Jabbarpour said. “If we want to retain a new generation of mission-driven doctors, we have to invest in the systems and safety nets that support them.”

Reddy said her practice will likely cease to exist in the long run if reductions restrict what they have done for the past 27 years. “We try to see everyone in the community and provide continuity for our patients,” said Reddy. “It will be emotionally wrenching to have to turn away Medicaid patients we’ve seen for years. So far, we’ve never done that.”

 

A Systemic Warning

Ellingson was blunt about what is at stake.

“Rural hospitals and clinics are at extreme risk of closure should these cuts be put in place,” she said, leading to more health care “deserts.” “Mortality and morbidity in these communities, tragically, will increase quickly if this happens.”

Despite the threat, Etz said many clinicians remain deeply committed to their work.

“Even as they report all the sad things, 77% also reported high professional fulfillment,” she said. “They’re saying, ‘You’re making this hard — but I’ve never felt my work was more important.’”

The sources cited in this story reported having no relevant disclosures.

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

Primary care clinicians across the US are warning cuts to Medicaid in the Trump Administration’s new budget bill could push many of them out of practice and deepen access gaps for patients.

In a recent survey by researchers at the Green Center at Virginia Commonwealth University, in Richmond, Virginia, more than 1 in 4 physicians (26%) said their practice would suffer financially, and those figures were higher for rural doctors (31%) and those working at federally qualified health centers (FQHCs; 60%).

Nearly 70% of the physicians surveyed said the legislation’s tighter eligibility rules would worsen their administrative burdens, according to a June survey of 379 primary care physicians. That figure jumped to 87% among clinicians at FQHCs.

Only 13% of primary care clinicians said the proposed changes to the program were unlikely to affect their practice or patients.

“It’s sobering,” said Rebecca Etz, PhD, a professor of family medicine at Virginia Commonwealth and co-director of the Green Center. “Frontline clinicians are letting us know that reductions in Medicaid, they predict, will severely constrain access — which is already constrained in the US”

For Amy Ellingson, MD, a primary care physician at Three Rivers Family Medicine in Brewster, Washington, those numbers are not abstract.

Medicaid cuts “will seriously hurt our hospital and clinic’s viability since our payer mix is 31% Medicaid,” Ellingson told this news organization. “We are already on the edge due to low reimbursement, and this will only make things worse. It will also reduce patient volumes.”

Her greatest fear, however, is not just for her clinic but also for her patients.

“We don’t have any further cuts to services that we can make,” she said. “So our situation would be about our survival. In the clinic, we are already seeing people get cut from Medicaid due to an increase in paperwork burden. If they don’t have Medicaid, they can’t seek care. This will land them in the ER [emergency room], as all studies have shown.”

That cycle — from loss of primary care to overuse of emergency care to hospital debt — puts institutions like hers on a dangerous path.

“An increase in ER visits with people who are uninsured will then be part of a cycle of bad debt, leaving the hospital further at risk,” she said.

 

Primary Care at Particular Risk

The survey findings came in the wake of the passage in May of the House version of the “One Big Beautiful Bill,” which included more than $800 billion in Medicaid cuts over the next decade. The final version, which passed the Senate by one vote, cut the program by more than $1 trillion between now and 2034 and included monthly work or community service requirements and frequent eligibility verifications.

The Congressional Budget Office estimated roughly 12 million Americans would lose their health care coverage under the bill.

Medicaid currently covers more than 70 million Americans, including low-income families, children, seniors, pregnant women, and people with disabilities. Provisions in the bill would cap state-directed payments to hospitals and nursing facilities, reducing them 10% annually and stripping funding for staffing, patient outreach and care delivery.

Sumana Reddy, MD, a primary care clinician at Acacia Family Medical Group, Salinas, California, said the changes could upend care for the region’s farmworker community.

Requalification requirements for eligibility “will be a real challenge for my patients, many of whom are farmworkers,” Reddy said. “Primary care practices like ours already do a lot of this work, which is unreimbursed. There may be patients who lose Medicaid entirely and will really struggle with their untreated conditions.”

Her practice serves entire families, including young children, parents, and older adults who rely on Medicaid for preventive care, management of chronic diseases, prescriptions, and long-term care.

“This move will adversely affect the health of our community,” Reddy said. “Work requirements may leave elderly uncared for. Everyone will be affected.”

Yalda Jabbarpour, MD, director of the Robert Graham Center for Policy Studies and a practicing family physician in Washington, DC, said the cuts reflect a “deeply concerning trend” in health policy: the “systematic underinvestment” in primary care.

“At a time when more than a third of adults and 15% of children lack a usual source of care, we should be expanding access — not restricting it,” she said.

 

Maternal and Rural Practice in Jeopardy

Midwife Jennifer Seymour, CNM, operates an accredited freestanding birth center in rural New York, where 60% of births are covered by Medicaid. She said any threat to Medicaid funding puts entire communities at risk.

“New York already has too many maternity care deserts as hospitals close because they can’t be financially viable,” said Seymour, founder of Cocoon Wellness and Birth Center in Waverly, New York, about 85 miles south of Syracuse. “If 60% of births are not getting paid for, perinatal deaths of moms and babies will skyrocket over our already abysmal numbers.”

“Where will anyone go for their medical needs when that happens?” she added.

In a Green Center survey conducted in May, 34.7% of clinicians said their practice would become financially unviable if Medicaid reimbursements were cut. Nearly 40% said at least 10% of their patients would likely forgo preventive care.

Etz said while FQHCs and pediatric practices are often hit hardest by Medicaid policy shifts, the data show the financial stress is widespread.

“I was surprised at the large variety of demographics among those who said they’d lose their financial viability,” she said. “It really was small and large practices, hospital-owned, insurance-owned, direct primary care — everybody was predicting an impact.”

 

Ripple Effects Across the System

In the June survey, 74% of respondents predicted an increase in the use of high-cost emergency care by uninsured patients — a number that jumped to 95% among FQHCs.

“What you’re looking at is a reduction in access to primary care, and the ripple effect across the health care system is tremendous,” Etz said. “That means an influx of uninsured patients into hospitals already struggling to repair after the pandemic — patients who are often more complex and expensive to care for.”

Etz cited studies showing the life-and-death stakes of continuous access to primary care.

“A little investment in primary care can yield strong health outcomes,” she said. “When that access is lost, even briefly, mortality rates for manageable conditions like diabetes or Alzheimer’s can skyrocket.”

Jabbarpour agreed.

“In high-cost urban areas like Washington, DC, access to primary care is already strained due to low Medicaid reimbursement rates and provider shortages,” she said. “Cutting Medicaid further will push more patients to delay care until conditions worsen, when treatment becomes more complex and costly.”

 

Clinician Well-Being and the Future Workforce

Clinicians themselves are also under mounting pressure. In the June Green Center survey, 55% of clinicians reported high levels of burnout or moral injury — a number that rose to 68% among FQHC providers.

“Burnout suggests the problem is with the individual. Moral injury is about functioning in an inhumane system, seeing wrong things happen that you could fix, if only someone would let you,” Etz said.

Jabbarpour said the toll on the clinical workforce could be long-lasting.

“Medicaid cuts send a clear signal to early-career physicians: Choosing primary care, especially in underserved communities, comes with greater financial instability and fewer resources to care for patients effectively,” Jabbarpour said. “If we want to retain a new generation of mission-driven doctors, we have to invest in the systems and safety nets that support them.”

Reddy said her practice will likely cease to exist in the long run if reductions restrict what they have done for the past 27 years. “We try to see everyone in the community and provide continuity for our patients,” said Reddy. “It will be emotionally wrenching to have to turn away Medicaid patients we’ve seen for years. So far, we’ve never done that.”

 

A Systemic Warning

Ellingson was blunt about what is at stake.

“Rural hospitals and clinics are at extreme risk of closure should these cuts be put in place,” she said, leading to more health care “deserts.” “Mortality and morbidity in these communities, tragically, will increase quickly if this happens.”

Despite the threat, Etz said many clinicians remain deeply committed to their work.

“Even as they report all the sad things, 77% also reported high professional fulfillment,” she said. “They’re saying, ‘You’re making this hard — but I’ve never felt my work was more important.’”

The sources cited in this story reported having no relevant disclosures.

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

The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a supplemental new drug application for brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in combination with sertraline, for the treatment of adults with posttraumatic stress disorder (PTSD).

If approved, it would be the first new treatment for PTSD in more than 20 years.

“It is my hope that the FDA does approve this treatment for two related reasons — the data look positive and compelling, and there’s a tremendous unmet need in PTSD,” Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the Mood Disorders Psychopharmacology Unit, University of Toronto, Toronto, Ontario, Canada, told this news organization.

 

What’s in the Treatment Toolbox Now?

PTSD is a “common, severe, and nonremitting condition,” McIntyre noted. According to the National Center for PTSD, the condition affects roughly 13 million adults in the US in any given year. This represents about 5% of the adult population.

PTSD can develop following exposure to traumatic events such as combat, assault, disasters, or severe accidents. Core symptoms of PTSD include intrusive memories and flashbacks, avoidance behaviors, negative alterations in mood and cognition, and hyperarousal.

Currently, the selective serotonin reuptake inhibitors (SSRI), sertraline and paroxetine, are the only FDA-approved medications for PTSD, and while these medications can be effective, many patients fail to achieve remission or discontinue treatment due to adverse effects or lack of response.

Other medications used off-label to treat PTSD — including prazosin, mirtazapine, atypical antipsychotics, and mood stabilizers — have shown variable efficacy. 

There has not been a new FDA-approved drug for PTSD in over two decades, underscoring the need for better therapeutic options, particularly for patients who do not fully respond to SSRI alone.

 

Why Brexpiprazole Plus Sertraline?

Brexpiprazole is an atypical antipsychotic currently approved as adjunctive treatment of major depressive disorder (MDD) in adults; treatment of schizophrenia in adults and adolescents aged 13 years or older; and treatment of agitation associated with Alzheimer’s dementia.

The combination of brexpiprazole and sertraline could address the limitations of SSRI alone by working synergistically to treat PTSD.

Sertraline increases serotonin levels in the brain to improve mood and reduce anxiety. Brexpiprazole has a complex mechanism of action involving multiple neurotransmitter systems, including but not limited to serotonin and dopamine.

Together, they may target different aspects of PTSD, potentially leading to a more comprehensive reduction in symptoms.

 

What Do the Phase 3 Data Show?

In a pivotal, double-blind, randomized controlled, phase 3 trial, brexpiprazole plus sertraline provided significantly greater relief of PTSD symptoms than sertraline plus placebo.

The results were published late last year in JAMA Psychiatry and reported by this news organization at that time.

The trial enrolled 416 adults (mean age, 37 years; 75% women) aged 18-65 years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of PTSD and symptoms for at least 6 months prior to screening.

At baseline, participants had a mean Clinician Administered PTSD Scale (CAPS-5) for DSM-5 total score of 38.4, indicating moderate to high severity PTSD. The average time from the index traumatic event was 4 years, and three fourths had no prior exposure to PTSD prescription medications.

Participants underwent a 1-week placebo run-in period followed by randomization to daily oral brexpiprazole 2-3 mg plus sertraline 150 mg or daily sertraline 150 mg plus placebo for 11 weeks.

At week 10, brexpiprazole plus sertraline demonstrated statistically significant greater improvement in the CAPS-5 total score (primary outcome) than sertraline plus placebo (mean change, -19.2 points vs -13.6 points; P < .001).

Brexpiprazole plus sertraline also led to statistically significant greater improvement on all key secondary and other efficacy endpoints, both clinician-reported and patient-reported, including measures of anxiety, depression, intrusive symptoms, hyperarousal, and overall functioning.

Combining an atypical antipsychotic with an antidepressant for PTSD “builds on what we’ve been doing in depression,” Elspeth Ritchie, MD, chair of Psychiatry, MedStar Washington Hospital Center, Washington, DC, noted in an interview with this news organization.

“We have found that a combination of a low-dose antipsychotic and an antidepressant is helpful for depression, so it makes sense that it will be helpful for PTSD. However, this has been mostly based on clinical decisions, without a heavy research background. Good science is always helpful to support those clinical decisions,” Ritchie told this news organization.

 

What About Safety?

In the phase 3 trial, brexpiprazole plus sertraline had a safety profile consistent with that of brexpiprazole in approved indications. The rate of discontinuation due to adverse events was low (3.9% for brexpiprazole plus sertraline vs 10.2% for sertraline plus placebo), indicating that most participants tolerated the brexpiprazole and sertraline combination treatment, the study team said.

In both treatment groups, the only treatment-emergent adverse event (TEAE) with incidence greater than 10% was nausea, a known adverse effect of sertraline treatment.

Weight gain was greater in participants receiving the combination. At the last visit, a weight gain of 7% or greater from week 1 was experienced by 8% of participants taking brexpiprazole with the sertraline group and 5% of those taking the sertraline plus placebo. Previous analyses in schizophrenia and MDD show that brexpiprazole is associated with moderate weight gain (+3 to 4 kg over 1 year).

The incidence of sedating TEAEs (a concern with some antipsychotics) was generally low, although fatigue (7% vs 4%) and somnolence (5% vs 3%) were more common with brexpiprazole plus sertraline than with sertraline alone.

There were no clinically meaningful between-group differences in changes in laboratory test parameters, vital signs, or ECG and participant-reported TEAEs related to suicidality.

 

Potential Concerns

As with any new drug application, several questions and issues are likely to be raised by the advisory committee. They could include whether the clinical benefit is substantial enough to warrant approval and how the observed effect sizes compare to existing approved therapies and evidence-based psychotherapies.

McIntyre told this news organization what’s particularly noteworthy is that the magnitude of the improvement in PTSD symptoms with brexpiprazole plus sertraline is greater than with sertraline alone. “That’s a very important statement. And this high level of efficacy was consistent on the secondary outcome measures, and the overall tolerability and safety seemed very acceptable,” he said.

What’s equally important, said McIntyre, is that most people with PTSD have depression and anxiety, and the brexpiprazole plus sertraline combination was more helpful than sertraline alone on the measures of anxiety and depression. “This is really important, especially in light of the fact that this medication [brexpiprazole] is already approved for adults living with major depressive disorder and inadequate response to antidepressants,” McIntyre said.

McIntyre added he suspects some questions the committee may have could relate to the extent to which it’s the case that brexpiprazole is effective in PTSD regardless of the antidepressant that is prescribed with it.

“There also will be the inevitable questions about the absence of long-term data which I think will need to be addressed given how chronic and relapse prone this condition is,” McIntyre said.

The committee may ask how trauma and PTSD will be screened in primary care and how outcomes related to this therapy will be evaluated in everyday clinical practice, McIntyre said.

Overall, McIntyre said brexpiprazole plus sertraline in PTSD is a “very positive” development for the field.

“PTSD is a terrible condition. It’s so darn common, and we just don’t have enough treatments for it. The data look good for my perspective. My fingers are crossed for the patients with PTSD and their families,” said McIntyre.

Ritchie reported having no relevant disclosures. McIntyre received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and atai Life Sciences. McIntyre is a CEO of Braxia Scientific Corp.

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

The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a supplemental new drug application for brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in combination with sertraline, for the treatment of adults with posttraumatic stress disorder (PTSD).

If approved, it would be the first new treatment for PTSD in more than 20 years.

“It is my hope that the FDA does approve this treatment for two related reasons — the data look positive and compelling, and there’s a tremendous unmet need in PTSD,” Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the Mood Disorders Psychopharmacology Unit, University of Toronto, Toronto, Ontario, Canada, told this news organization.

 

What’s in the Treatment Toolbox Now?

PTSD is a “common, severe, and nonremitting condition,” McIntyre noted. According to the National Center for PTSD, the condition affects roughly 13 million adults in the US in any given year. This represents about 5% of the adult population.

PTSD can develop following exposure to traumatic events such as combat, assault, disasters, or severe accidents. Core symptoms of PTSD include intrusive memories and flashbacks, avoidance behaviors, negative alterations in mood and cognition, and hyperarousal.

Currently, the selective serotonin reuptake inhibitors (SSRI), sertraline and paroxetine, are the only FDA-approved medications for PTSD, and while these medications can be effective, many patients fail to achieve remission or discontinue treatment due to adverse effects or lack of response.

Other medications used off-label to treat PTSD — including prazosin, mirtazapine, atypical antipsychotics, and mood stabilizers — have shown variable efficacy. 

There has not been a new FDA-approved drug for PTSD in over two decades, underscoring the need for better therapeutic options, particularly for patients who do not fully respond to SSRI alone.

 

Why Brexpiprazole Plus Sertraline?

Brexpiprazole is an atypical antipsychotic currently approved as adjunctive treatment of major depressive disorder (MDD) in adults; treatment of schizophrenia in adults and adolescents aged 13 years or older; and treatment of agitation associated with Alzheimer’s dementia.

The combination of brexpiprazole and sertraline could address the limitations of SSRI alone by working synergistically to treat PTSD.

Sertraline increases serotonin levels in the brain to improve mood and reduce anxiety. Brexpiprazole has a complex mechanism of action involving multiple neurotransmitter systems, including but not limited to serotonin and dopamine.

Together, they may target different aspects of PTSD, potentially leading to a more comprehensive reduction in symptoms.

 

What Do the Phase 3 Data Show?

In a pivotal, double-blind, randomized controlled, phase 3 trial, brexpiprazole plus sertraline provided significantly greater relief of PTSD symptoms than sertraline plus placebo.

The results were published late last year in JAMA Psychiatry and reported by this news organization at that time.

The trial enrolled 416 adults (mean age, 37 years; 75% women) aged 18-65 years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of PTSD and symptoms for at least 6 months prior to screening.

At baseline, participants had a mean Clinician Administered PTSD Scale (CAPS-5) for DSM-5 total score of 38.4, indicating moderate to high severity PTSD. The average time from the index traumatic event was 4 years, and three fourths had no prior exposure to PTSD prescription medications.

Participants underwent a 1-week placebo run-in period followed by randomization to daily oral brexpiprazole 2-3 mg plus sertraline 150 mg or daily sertraline 150 mg plus placebo for 11 weeks.

At week 10, brexpiprazole plus sertraline demonstrated statistically significant greater improvement in the CAPS-5 total score (primary outcome) than sertraline plus placebo (mean change, -19.2 points vs -13.6 points; P < .001).

Brexpiprazole plus sertraline also led to statistically significant greater improvement on all key secondary and other efficacy endpoints, both clinician-reported and patient-reported, including measures of anxiety, depression, intrusive symptoms, hyperarousal, and overall functioning.

Combining an atypical antipsychotic with an antidepressant for PTSD “builds on what we’ve been doing in depression,” Elspeth Ritchie, MD, chair of Psychiatry, MedStar Washington Hospital Center, Washington, DC, noted in an interview with this news organization.

“We have found that a combination of a low-dose antipsychotic and an antidepressant is helpful for depression, so it makes sense that it will be helpful for PTSD. However, this has been mostly based on clinical decisions, without a heavy research background. Good science is always helpful to support those clinical decisions,” Ritchie told this news organization.

 

What About Safety?

In the phase 3 trial, brexpiprazole plus sertraline had a safety profile consistent with that of brexpiprazole in approved indications. The rate of discontinuation due to adverse events was low (3.9% for brexpiprazole plus sertraline vs 10.2% for sertraline plus placebo), indicating that most participants tolerated the brexpiprazole and sertraline combination treatment, the study team said.

In both treatment groups, the only treatment-emergent adverse event (TEAE) with incidence greater than 10% was nausea, a known adverse effect of sertraline treatment.

Weight gain was greater in participants receiving the combination. At the last visit, a weight gain of 7% or greater from week 1 was experienced by 8% of participants taking brexpiprazole with the sertraline group and 5% of those taking the sertraline plus placebo. Previous analyses in schizophrenia and MDD show that brexpiprazole is associated with moderate weight gain (+3 to 4 kg over 1 year).

The incidence of sedating TEAEs (a concern with some antipsychotics) was generally low, although fatigue (7% vs 4%) and somnolence (5% vs 3%) were more common with brexpiprazole plus sertraline than with sertraline alone.

There were no clinically meaningful between-group differences in changes in laboratory test parameters, vital signs, or ECG and participant-reported TEAEs related to suicidality.

 

Potential Concerns

As with any new drug application, several questions and issues are likely to be raised by the advisory committee. They could include whether the clinical benefit is substantial enough to warrant approval and how the observed effect sizes compare to existing approved therapies and evidence-based psychotherapies.

McIntyre told this news organization what’s particularly noteworthy is that the magnitude of the improvement in PTSD symptoms with brexpiprazole plus sertraline is greater than with sertraline alone. “That’s a very important statement. And this high level of efficacy was consistent on the secondary outcome measures, and the overall tolerability and safety seemed very acceptable,” he said.

What’s equally important, said McIntyre, is that most people with PTSD have depression and anxiety, and the brexpiprazole plus sertraline combination was more helpful than sertraline alone on the measures of anxiety and depression. “This is really important, especially in light of the fact that this medication [brexpiprazole] is already approved for adults living with major depressive disorder and inadequate response to antidepressants,” McIntyre said.

McIntyre added he suspects some questions the committee may have could relate to the extent to which it’s the case that brexpiprazole is effective in PTSD regardless of the antidepressant that is prescribed with it.

“There also will be the inevitable questions about the absence of long-term data which I think will need to be addressed given how chronic and relapse prone this condition is,” McIntyre said.

The committee may ask how trauma and PTSD will be screened in primary care and how outcomes related to this therapy will be evaluated in everyday clinical practice, McIntyre said.

Overall, McIntyre said brexpiprazole plus sertraline in PTSD is a “very positive” development for the field.

“PTSD is a terrible condition. It’s so darn common, and we just don’t have enough treatments for it. The data look good for my perspective. My fingers are crossed for the patients with PTSD and their families,” said McIntyre.

Ritchie reported having no relevant disclosures. McIntyre received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and atai Life Sciences. McIntyre is a CEO of Braxia Scientific Corp.

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

The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a supplemental new drug application for brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in combination with sertraline, for the treatment of adults with posttraumatic stress disorder (PTSD).

If approved, it would be the first new treatment for PTSD in more than 20 years.

“It is my hope that the FDA does approve this treatment for two related reasons — the data look positive and compelling, and there’s a tremendous unmet need in PTSD,” Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the Mood Disorders Psychopharmacology Unit, University of Toronto, Toronto, Ontario, Canada, told this news organization.

 

What’s in the Treatment Toolbox Now?

PTSD is a “common, severe, and nonremitting condition,” McIntyre noted. According to the National Center for PTSD, the condition affects roughly 13 million adults in the US in any given year. This represents about 5% of the adult population.

PTSD can develop following exposure to traumatic events such as combat, assault, disasters, or severe accidents. Core symptoms of PTSD include intrusive memories and flashbacks, avoidance behaviors, negative alterations in mood and cognition, and hyperarousal.

Currently, the selective serotonin reuptake inhibitors (SSRI), sertraline and paroxetine, are the only FDA-approved medications for PTSD, and while these medications can be effective, many patients fail to achieve remission or discontinue treatment due to adverse effects or lack of response.

Other medications used off-label to treat PTSD — including prazosin, mirtazapine, atypical antipsychotics, and mood stabilizers — have shown variable efficacy. 

There has not been a new FDA-approved drug for PTSD in over two decades, underscoring the need for better therapeutic options, particularly for patients who do not fully respond to SSRI alone.

 

Why Brexpiprazole Plus Sertraline?

Brexpiprazole is an atypical antipsychotic currently approved as adjunctive treatment of major depressive disorder (MDD) in adults; treatment of schizophrenia in adults and adolescents aged 13 years or older; and treatment of agitation associated with Alzheimer’s dementia.

The combination of brexpiprazole and sertraline could address the limitations of SSRI alone by working synergistically to treat PTSD.

Sertraline increases serotonin levels in the brain to improve mood and reduce anxiety. Brexpiprazole has a complex mechanism of action involving multiple neurotransmitter systems, including but not limited to serotonin and dopamine.

Together, they may target different aspects of PTSD, potentially leading to a more comprehensive reduction in symptoms.

 

What Do the Phase 3 Data Show?

In a pivotal, double-blind, randomized controlled, phase 3 trial, brexpiprazole plus sertraline provided significantly greater relief of PTSD symptoms than sertraline plus placebo.

The results were published late last year in JAMA Psychiatry and reported by this news organization at that time.

The trial enrolled 416 adults (mean age, 37 years; 75% women) aged 18-65 years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of PTSD and symptoms for at least 6 months prior to screening.

At baseline, participants had a mean Clinician Administered PTSD Scale (CAPS-5) for DSM-5 total score of 38.4, indicating moderate to high severity PTSD. The average time from the index traumatic event was 4 years, and three fourths had no prior exposure to PTSD prescription medications.

Participants underwent a 1-week placebo run-in period followed by randomization to daily oral brexpiprazole 2-3 mg plus sertraline 150 mg or daily sertraline 150 mg plus placebo for 11 weeks.

At week 10, brexpiprazole plus sertraline demonstrated statistically significant greater improvement in the CAPS-5 total score (primary outcome) than sertraline plus placebo (mean change, -19.2 points vs -13.6 points; P < .001).

Brexpiprazole plus sertraline also led to statistically significant greater improvement on all key secondary and other efficacy endpoints, both clinician-reported and patient-reported, including measures of anxiety, depression, intrusive symptoms, hyperarousal, and overall functioning.

Combining an atypical antipsychotic with an antidepressant for PTSD “builds on what we’ve been doing in depression,” Elspeth Ritchie, MD, chair of Psychiatry, MedStar Washington Hospital Center, Washington, DC, noted in an interview with this news organization.

“We have found that a combination of a low-dose antipsychotic and an antidepressant is helpful for depression, so it makes sense that it will be helpful for PTSD. However, this has been mostly based on clinical decisions, without a heavy research background. Good science is always helpful to support those clinical decisions,” Ritchie told this news organization.

 

What About Safety?

In the phase 3 trial, brexpiprazole plus sertraline had a safety profile consistent with that of brexpiprazole in approved indications. The rate of discontinuation due to adverse events was low (3.9% for brexpiprazole plus sertraline vs 10.2% for sertraline plus placebo), indicating that most participants tolerated the brexpiprazole and sertraline combination treatment, the study team said.

In both treatment groups, the only treatment-emergent adverse event (TEAE) with incidence greater than 10% was nausea, a known adverse effect of sertraline treatment.

Weight gain was greater in participants receiving the combination. At the last visit, a weight gain of 7% or greater from week 1 was experienced by 8% of participants taking brexpiprazole with the sertraline group and 5% of those taking the sertraline plus placebo. Previous analyses in schizophrenia and MDD show that brexpiprazole is associated with moderate weight gain (+3 to 4 kg over 1 year).

The incidence of sedating TEAEs (a concern with some antipsychotics) was generally low, although fatigue (7% vs 4%) and somnolence (5% vs 3%) were more common with brexpiprazole plus sertraline than with sertraline alone.

There were no clinically meaningful between-group differences in changes in laboratory test parameters, vital signs, or ECG and participant-reported TEAEs related to suicidality.

 

Potential Concerns

As with any new drug application, several questions and issues are likely to be raised by the advisory committee. They could include whether the clinical benefit is substantial enough to warrant approval and how the observed effect sizes compare to existing approved therapies and evidence-based psychotherapies.

McIntyre told this news organization what’s particularly noteworthy is that the magnitude of the improvement in PTSD symptoms with brexpiprazole plus sertraline is greater than with sertraline alone. “That’s a very important statement. And this high level of efficacy was consistent on the secondary outcome measures, and the overall tolerability and safety seemed very acceptable,” he said.

What’s equally important, said McIntyre, is that most people with PTSD have depression and anxiety, and the brexpiprazole plus sertraline combination was more helpful than sertraline alone on the measures of anxiety and depression. “This is really important, especially in light of the fact that this medication [brexpiprazole] is already approved for adults living with major depressive disorder and inadequate response to antidepressants,” McIntyre said.

McIntyre added he suspects some questions the committee may have could relate to the extent to which it’s the case that brexpiprazole is effective in PTSD regardless of the antidepressant that is prescribed with it.

“There also will be the inevitable questions about the absence of long-term data which I think will need to be addressed given how chronic and relapse prone this condition is,” McIntyre said.

The committee may ask how trauma and PTSD will be screened in primary care and how outcomes related to this therapy will be evaluated in everyday clinical practice, McIntyre said.

Overall, McIntyre said brexpiprazole plus sertraline in PTSD is a “very positive” development for the field.

“PTSD is a terrible condition. It’s so darn common, and we just don’t have enough treatments for it. The data look good for my perspective. My fingers are crossed for the patients with PTSD and their families,” said McIntyre.

Ritchie reported having no relevant disclosures. McIntyre received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and atai Life Sciences. McIntyre is a CEO of Braxia Scientific Corp.

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

“Gold card” programs were supposed to make it easier for frustrated physicians to deal with insurers’ burdensome prior authorization demands.

The idea: Insurers would reward doctors whose past prior authorization requests were typically approved by exempting them from red tape in the future.

At least 10 states have required insurers to establish gold card programs amid mounting concerns nationwide that overuse of prior authorization jeopardizes patient health. Last month, leading insurers joined with the White House in a voluntary pledge to reduce their use of the practice, which they contend is necessary to control costs and minimize unnecessary care.

But Texas’ experience with gold card programs may signal the limits of that approach.

 

Only 3% of Clinicians Qualified

The Lone Star State was an early adopter, passing a 2021 law enabling health providers with a high prior authorization success rate to earn a “gold card” exemption from insurers.

But statewide, only 3% of providers met that bar, according to a testimony provided by the Texas Department of Insurance earlier this year.

“I think it’s safe to say that the impact of this law on prior authorizations for our physicians is underwhelming,” said Ezequiel “Zeke” Silva III, MD, a San Antonio-based interventional radiologist who chairs the Texas Medical Association’s Council on Legislation. “We would have hoped for a greater percentage of our physicians to have been granted the ‘gold card’ status.”

At least nine other states have enacted gold card laws, according to the National Conference of State Legislatures (NCSL).

 

Care Delayed and Denied

Physicians maintain that excessive prior authorization paperwork impedes timely patient care, with clinicians and staffers devoting 13 hours weekly to documentation, according to a 2024 American Medical Association survey.

Insurers view the review as a guardrail against unnecessary care driving up costs. Studies show that restricting prior authorization could boost premiums by 5.6%-16.7%, a Texas Association of Health Plans official testified during the legislative session.

In June, Texas Gov. Greg Abbott signed a revised version of the state’s “gold card” law — part of an emerging national attempt to streamline the prior review process. Cigna, Humana, UnitedHealthcare, and other large insurers have voluntarily committed to reducing the scope of claims involved, according to the America’s Health Insurance Plans trade group.

Meanwhile, federal officials have finalized requirements that direct some insurers, including Medicaid and Medicare Advantage programs, to speed up responses to prior authorization requests, among other measures. Some of those requirements begin in 2026.

 

Gold Card Designs

As in other states, Texas’ “gold card” legislation applies only to state-regulated insurers, which comprise about one fifth of the state’s market. Under HB 3812, which takes effect on September 1, insurers will evaluate health providers based on a year of prior authorization requests rather than 6 months under the 2021 law.

To be evaluated, providers must have submitted at least five requests for a specific health service during that period. To achieve “gold card” status, insurers must approve at least 90% of requests, the same threshold as set by the 2021 law. But the new law stipulates that insurers review a broader pool of requests, including those made directly to the health plan as well as any related affiliates, according to the Texas Department of Insurance. 

The new law continues to limit exemptions only to “top-performing physicians” who repeatedly provide cost-effective care, said Blake Hutson, director of public affairs at the Texas Association of Health Plans. “Even with the change to 1 year, and the bill also adds in a broader array of claims that will be looked at, you still have to meet 90%.”

A key addition requires insurers to release an annual report detailing how many exemptions they have granted or denied, making decisions more transparent to the public, Silva said. “Not just what’s being approved and what’s not being approved, but to potentially evaluate for trends that presently we just have no ability to evaluate,” he said.

Gold card laws vary from state to state, and some exclude prescription drugs, according to an NCSL legislative summary. Other states with gold card programs include Arkansas, Colorado, Illinois, Louisiana, Michigan, New Mexico, Vermont, West Virginia, and Wyoming.

In Illinois, legislation passed last year targeted hospital services for Medicaid patients, as denial rates were routinely higher in that population, said Dave Gross, senior vice president of Government Relations and Communications at the Illinois Health and Hospital Association, Naperville, Illinois. “We’re not seeing this problem in the commercial space,” he noted.

 

Real-World Implications

To some degree, the “gold card” concept makes intuitive sense, recognizing physicians who have a track record of getting their medical care requests approved, said Ravi Gupta, MD, an assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, who has studied prior authorization patterns.

But Gupta raised equity concerns. Physicians in large medical groups and hospital systems will have access to staff and other resources to better navigate the prior approval process than those in smaller private practices.

Plus, he added, there’s the potential that physicians who achieve exemptions may become “more indiscriminate” about the services that they recommend.

Insurers’ stated aim is to reduce unnecessary and low-value medical care through prior authorization gatekeeping, Gupta said. But a study he helped conduct, assessing policies across five Medicare Advantage insurers, found a significant lack of consensus on what treatments should be included. Treatments comprising only 12% of Medicare spending would have required prior authorization by all five insurers. Most of that consensus, he wrote, “was devoted to a small number of costly services.”

The administrative burdens affect patients as well. Two thirds of patients with cancer in one 2023 study become personally involved, including calling the insurer or appealing a denial. The patients also reported less trust in insurers and the health system overall, which could have worrisome downstream effects, Fumiko Chino, MD, the study’s lead author and an assistant professor of radiation oncology at Houston’s MD Anderson Cancer Center, said.

“If you don’t trust healthcare,” she said, “why on earth would you get a vaccine or get cancer screening or get your blood pressure checked?”

 

More Than X Percent?

Gupta views the leading health insurers’ pledge as encouraging in concept — but he notes that they are voluntary commitments without any accountability.

In the interim, gold carding remains no more than a workaround, he said.

“Gold cards aren’t really fixing that [prior authorization] problem,” he said. “They’re just rewarding certain clinicians who can demonstrate that they have been able to get through the prior authorization process successfully for X amount of time before they’re rewarded with a gold card.”

In Illinois, regulators are still hashing out gold card rules, including whether the required 90% approval threshold will be based on a specific hospital service or a broader pool of services, Gross said. The hospital association also will closely watch whether Illinois’ experience begins to mirror that in Texas, he said.

“We have some of the best hospitals in the country here in Chicago,” he said. “If we end up with a 3% approval rating of gold cards, we’re going to have to go back to the legislature.”

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

“Gold card” programs were supposed to make it easier for frustrated physicians to deal with insurers’ burdensome prior authorization demands.

The idea: Insurers would reward doctors whose past prior authorization requests were typically approved by exempting them from red tape in the future.

At least 10 states have required insurers to establish gold card programs amid mounting concerns nationwide that overuse of prior authorization jeopardizes patient health. Last month, leading insurers joined with the White House in a voluntary pledge to reduce their use of the practice, which they contend is necessary to control costs and minimize unnecessary care.

But Texas’ experience with gold card programs may signal the limits of that approach.

 

Only 3% of Clinicians Qualified

The Lone Star State was an early adopter, passing a 2021 law enabling health providers with a high prior authorization success rate to earn a “gold card” exemption from insurers.

But statewide, only 3% of providers met that bar, according to a testimony provided by the Texas Department of Insurance earlier this year.

“I think it’s safe to say that the impact of this law on prior authorizations for our physicians is underwhelming,” said Ezequiel “Zeke” Silva III, MD, a San Antonio-based interventional radiologist who chairs the Texas Medical Association’s Council on Legislation. “We would have hoped for a greater percentage of our physicians to have been granted the ‘gold card’ status.”

At least nine other states have enacted gold card laws, according to the National Conference of State Legislatures (NCSL).

 

Care Delayed and Denied

Physicians maintain that excessive prior authorization paperwork impedes timely patient care, with clinicians and staffers devoting 13 hours weekly to documentation, according to a 2024 American Medical Association survey.

Insurers view the review as a guardrail against unnecessary care driving up costs. Studies show that restricting prior authorization could boost premiums by 5.6%-16.7%, a Texas Association of Health Plans official testified during the legislative session.

In June, Texas Gov. Greg Abbott signed a revised version of the state’s “gold card” law — part of an emerging national attempt to streamline the prior review process. Cigna, Humana, UnitedHealthcare, and other large insurers have voluntarily committed to reducing the scope of claims involved, according to the America’s Health Insurance Plans trade group.

Meanwhile, federal officials have finalized requirements that direct some insurers, including Medicaid and Medicare Advantage programs, to speed up responses to prior authorization requests, among other measures. Some of those requirements begin in 2026.

 

Gold Card Designs

As in other states, Texas’ “gold card” legislation applies only to state-regulated insurers, which comprise about one fifth of the state’s market. Under HB 3812, which takes effect on September 1, insurers will evaluate health providers based on a year of prior authorization requests rather than 6 months under the 2021 law.

To be evaluated, providers must have submitted at least five requests for a specific health service during that period. To achieve “gold card” status, insurers must approve at least 90% of requests, the same threshold as set by the 2021 law. But the new law stipulates that insurers review a broader pool of requests, including those made directly to the health plan as well as any related affiliates, according to the Texas Department of Insurance. 

The new law continues to limit exemptions only to “top-performing physicians” who repeatedly provide cost-effective care, said Blake Hutson, director of public affairs at the Texas Association of Health Plans. “Even with the change to 1 year, and the bill also adds in a broader array of claims that will be looked at, you still have to meet 90%.”

A key addition requires insurers to release an annual report detailing how many exemptions they have granted or denied, making decisions more transparent to the public, Silva said. “Not just what’s being approved and what’s not being approved, but to potentially evaluate for trends that presently we just have no ability to evaluate,” he said.

Gold card laws vary from state to state, and some exclude prescription drugs, according to an NCSL legislative summary. Other states with gold card programs include Arkansas, Colorado, Illinois, Louisiana, Michigan, New Mexico, Vermont, West Virginia, and Wyoming.

In Illinois, legislation passed last year targeted hospital services for Medicaid patients, as denial rates were routinely higher in that population, said Dave Gross, senior vice president of Government Relations and Communications at the Illinois Health and Hospital Association, Naperville, Illinois. “We’re not seeing this problem in the commercial space,” he noted.

 

Real-World Implications

To some degree, the “gold card” concept makes intuitive sense, recognizing physicians who have a track record of getting their medical care requests approved, said Ravi Gupta, MD, an assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, who has studied prior authorization patterns.

But Gupta raised equity concerns. Physicians in large medical groups and hospital systems will have access to staff and other resources to better navigate the prior approval process than those in smaller private practices.

Plus, he added, there’s the potential that physicians who achieve exemptions may become “more indiscriminate” about the services that they recommend.

Insurers’ stated aim is to reduce unnecessary and low-value medical care through prior authorization gatekeeping, Gupta said. But a study he helped conduct, assessing policies across five Medicare Advantage insurers, found a significant lack of consensus on what treatments should be included. Treatments comprising only 12% of Medicare spending would have required prior authorization by all five insurers. Most of that consensus, he wrote, “was devoted to a small number of costly services.”

The administrative burdens affect patients as well. Two thirds of patients with cancer in one 2023 study become personally involved, including calling the insurer or appealing a denial. The patients also reported less trust in insurers and the health system overall, which could have worrisome downstream effects, Fumiko Chino, MD, the study’s lead author and an assistant professor of radiation oncology at Houston’s MD Anderson Cancer Center, said.

“If you don’t trust healthcare,” she said, “why on earth would you get a vaccine or get cancer screening or get your blood pressure checked?”

 

More Than X Percent?

Gupta views the leading health insurers’ pledge as encouraging in concept — but he notes that they are voluntary commitments without any accountability.

In the interim, gold carding remains no more than a workaround, he said.

“Gold cards aren’t really fixing that [prior authorization] problem,” he said. “They’re just rewarding certain clinicians who can demonstrate that they have been able to get through the prior authorization process successfully for X amount of time before they’re rewarded with a gold card.”

In Illinois, regulators are still hashing out gold card rules, including whether the required 90% approval threshold will be based on a specific hospital service or a broader pool of services, Gross said. The hospital association also will closely watch whether Illinois’ experience begins to mirror that in Texas, he said.

“We have some of the best hospitals in the country here in Chicago,” he said. “If we end up with a 3% approval rating of gold cards, we’re going to have to go back to the legislature.”

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

“Gold card” programs were supposed to make it easier for frustrated physicians to deal with insurers’ burdensome prior authorization demands.

The idea: Insurers would reward doctors whose past prior authorization requests were typically approved by exempting them from red tape in the future.

At least 10 states have required insurers to establish gold card programs amid mounting concerns nationwide that overuse of prior authorization jeopardizes patient health. Last month, leading insurers joined with the White House in a voluntary pledge to reduce their use of the practice, which they contend is necessary to control costs and minimize unnecessary care.

But Texas’ experience with gold card programs may signal the limits of that approach.

 

Only 3% of Clinicians Qualified

The Lone Star State was an early adopter, passing a 2021 law enabling health providers with a high prior authorization success rate to earn a “gold card” exemption from insurers.

But statewide, only 3% of providers met that bar, according to a testimony provided by the Texas Department of Insurance earlier this year.

“I think it’s safe to say that the impact of this law on prior authorizations for our physicians is underwhelming,” said Ezequiel “Zeke” Silva III, MD, a San Antonio-based interventional radiologist who chairs the Texas Medical Association’s Council on Legislation. “We would have hoped for a greater percentage of our physicians to have been granted the ‘gold card’ status.”

At least nine other states have enacted gold card laws, according to the National Conference of State Legislatures (NCSL).

 

Care Delayed and Denied

Physicians maintain that excessive prior authorization paperwork impedes timely patient care, with clinicians and staffers devoting 13 hours weekly to documentation, according to a 2024 American Medical Association survey.

Insurers view the review as a guardrail against unnecessary care driving up costs. Studies show that restricting prior authorization could boost premiums by 5.6%-16.7%, a Texas Association of Health Plans official testified during the legislative session.

In June, Texas Gov. Greg Abbott signed a revised version of the state’s “gold card” law — part of an emerging national attempt to streamline the prior review process. Cigna, Humana, UnitedHealthcare, and other large insurers have voluntarily committed to reducing the scope of claims involved, according to the America’s Health Insurance Plans trade group.

Meanwhile, federal officials have finalized requirements that direct some insurers, including Medicaid and Medicare Advantage programs, to speed up responses to prior authorization requests, among other measures. Some of those requirements begin in 2026.

 

Gold Card Designs

As in other states, Texas’ “gold card” legislation applies only to state-regulated insurers, which comprise about one fifth of the state’s market. Under HB 3812, which takes effect on September 1, insurers will evaluate health providers based on a year of prior authorization requests rather than 6 months under the 2021 law.

To be evaluated, providers must have submitted at least five requests for a specific health service during that period. To achieve “gold card” status, insurers must approve at least 90% of requests, the same threshold as set by the 2021 law. But the new law stipulates that insurers review a broader pool of requests, including those made directly to the health plan as well as any related affiliates, according to the Texas Department of Insurance. 

The new law continues to limit exemptions only to “top-performing physicians” who repeatedly provide cost-effective care, said Blake Hutson, director of public affairs at the Texas Association of Health Plans. “Even with the change to 1 year, and the bill also adds in a broader array of claims that will be looked at, you still have to meet 90%.”

A key addition requires insurers to release an annual report detailing how many exemptions they have granted or denied, making decisions more transparent to the public, Silva said. “Not just what’s being approved and what’s not being approved, but to potentially evaluate for trends that presently we just have no ability to evaluate,” he said.

Gold card laws vary from state to state, and some exclude prescription drugs, according to an NCSL legislative summary. Other states with gold card programs include Arkansas, Colorado, Illinois, Louisiana, Michigan, New Mexico, Vermont, West Virginia, and Wyoming.

In Illinois, legislation passed last year targeted hospital services for Medicaid patients, as denial rates were routinely higher in that population, said Dave Gross, senior vice president of Government Relations and Communications at the Illinois Health and Hospital Association, Naperville, Illinois. “We’re not seeing this problem in the commercial space,” he noted.

 

Real-World Implications

To some degree, the “gold card” concept makes intuitive sense, recognizing physicians who have a track record of getting their medical care requests approved, said Ravi Gupta, MD, an assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, who has studied prior authorization patterns.

But Gupta raised equity concerns. Physicians in large medical groups and hospital systems will have access to staff and other resources to better navigate the prior approval process than those in smaller private practices.

Plus, he added, there’s the potential that physicians who achieve exemptions may become “more indiscriminate” about the services that they recommend.

Insurers’ stated aim is to reduce unnecessary and low-value medical care through prior authorization gatekeeping, Gupta said. But a study he helped conduct, assessing policies across five Medicare Advantage insurers, found a significant lack of consensus on what treatments should be included. Treatments comprising only 12% of Medicare spending would have required prior authorization by all five insurers. Most of that consensus, he wrote, “was devoted to a small number of costly services.”

The administrative burdens affect patients as well. Two thirds of patients with cancer in one 2023 study become personally involved, including calling the insurer or appealing a denial. The patients also reported less trust in insurers and the health system overall, which could have worrisome downstream effects, Fumiko Chino, MD, the study’s lead author and an assistant professor of radiation oncology at Houston’s MD Anderson Cancer Center, said.

“If you don’t trust healthcare,” she said, “why on earth would you get a vaccine or get cancer screening or get your blood pressure checked?”

 

More Than X Percent?

Gupta views the leading health insurers’ pledge as encouraging in concept — but he notes that they are voluntary commitments without any accountability.

In the interim, gold carding remains no more than a workaround, he said.

“Gold cards aren’t really fixing that [prior authorization] problem,” he said. “They’re just rewarding certain clinicians who can demonstrate that they have been able to get through the prior authorization process successfully for X amount of time before they’re rewarded with a gold card.”

In Illinois, regulators are still hashing out gold card rules, including whether the required 90% approval threshold will be based on a specific hospital service or a broader pool of services, Gross said. The hospital association also will closely watch whether Illinois’ experience begins to mirror that in Texas, he said.

“We have some of the best hospitals in the country here in Chicago,” he said. “If we end up with a 3% approval rating of gold cards, we’re going to have to go back to the legislature.”

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