The dentition of head and neck cancer patients is of utmost importance when they receive radiation therapy, especially because patients are living longer after a course of head and neck radiation. Good communication among the oncology team members (the radiation and medical oncologists, the maxillofacial prosthodontist/dental oncologist, otolaryngologist, reconstructive surgeon, nursing support) and the patient is essential initially, and subsequently including the general dentist as well. The aim of this primer for all those caring for patients with head and neck cancer is to underscore the important role of the dental oncologist during all phases of radiation therapy, and to provide guidelines to minimize and prevent dental complications such as radiation-induced caries and ORN.

Click on the PDF icon at the top of this introduction to read the full article.

The dentition of head and neck cancer patients is of utmost importance when they receive radiation therapy, especially because patients are living longer after a course of head and neck radiation. Good communication among the oncology team members (the radiation and medical oncologists, the maxillofacial prosthodontist/dental oncologist, otolaryngologist, reconstructive surgeon, nursing support) and the patient is essential initially, and subsequently including the general dentist as well. The aim of this primer for all those caring for patients with head and neck cancer is to underscore the important role of the dental oncologist during all phases of radiation therapy, and to provide guidelines to minimize and prevent dental complications such as radiation-induced caries and ORN.

Click on the PDF icon at the top of this introduction to read the full article.

The dentition of head and neck cancer patients is of utmost importance when they receive radiation therapy, especially because patients are living longer after a course of head and neck radiation. Good communication among the oncology team members (the radiation and medical oncologists, the maxillofacial prosthodontist/dental oncologist, otolaryngologist, reconstructive surgeon, nursing support) and the patient is essential initially, and subsequently including the general dentist as well. The aim of this primer for all those caring for patients with head and neck cancer is to underscore the important role of the dental oncologist during all phases of radiation therapy, and to provide guidelines to minimize and prevent dental complications such as radiation-induced caries and ORN.

Click on the PDF icon at the top of this introduction to read the full article.

As 2016 winds down, we are already gearing up for the 2019 implementation of the Medicare Access and CHIP Reauthorization Act, or MACRA. The bipartisan 2015 legislation will replace the current sustainable growth rate as well as streamline the existing quality reporting programs and redirect us from the current volume-based Medicare payments to value- and performance-based payments. On page 394 of this issue, two community- based colleagues, JCSO Editor Dr Linda Bosserman and Dr Robin Zon, a community oncologist and chair of the American Society of Clinical Oncology’s Task Force on Clinical Pathways, discuss the ins and outs of MACRA – what it is, what it replaces, how it will work, and what we need to be doing to prepare for its implementation in 2019.

Click on the PDF icon at the top of this introduction to read the full article.

As 2016 winds down, we are already gearing up for the 2019 implementation of the Medicare Access and CHIP Reauthorization Act, or MACRA. The bipartisan 2015 legislation will replace the current sustainable growth rate as well as streamline the existing quality reporting programs and redirect us from the current volume-based Medicare payments to value- and performance-based payments. On page 394 of this issue, two community- based colleagues, JCSO Editor Dr Linda Bosserman and Dr Robin Zon, a community oncologist and chair of the American Society of Clinical Oncology’s Task Force on Clinical Pathways, discuss the ins and outs of MACRA – what it is, what it replaces, how it will work, and what we need to be doing to prepare for its implementation in 2019.

Click on the PDF icon at the top of this introduction to read the full article.

As 2016 winds down, we are already gearing up for the 2019 implementation of the Medicare Access and CHIP Reauthorization Act, or MACRA. The bipartisan 2015 legislation will replace the current sustainable growth rate as well as streamline the existing quality reporting programs and redirect us from the current volume-based Medicare payments to value- and performance-based payments. On page 394 of this issue, two community- based colleagues, JCSO Editor Dr Linda Bosserman and Dr Robin Zon, a community oncologist and chair of the American Society of Clinical Oncology’s Task Force on Clinical Pathways, discuss the ins and outs of MACRA – what it is, what it replaces, how it will work, and what we need to be doing to prepare for its implementation in 2019.

Click on the PDF icon at the top of this introduction to read the full article.

HILTON HEAD—Multiple sclerosis (MS) is the most common demyelinating disease, and its mimics are rare, according to an overview provided at the 39th Annual Contemporary Clinical Neurology Symposium. Given that the treatments and outcomes for MS and its mimics are so different, neurologists should take care to establish a diagnosis early, said Sid Pawate, MD, Assistant Professor of Neurology at Vanderbilt University School of Medicine in Nashville.

Because of the varied clinical presentation of MS, a wide variety of conditions enter the differential diagnosis. Because of the central role that MRI plays in MS diagnosis, imaging mimics that cause white matter lesions also need to be considered, said Dr. Pawate. Typically, the white matter lesions seen in MS are periventricular, juxtacortical, and callososeptal in location. Infratentorially, cerebellar peduncles are a common site. The lesions tend to be ovoid, are 3 mm to 5 mm or larger, and appear hyperintense on T2 and FLAIR sequences. Acute lesions may show restricted diffusion or enhancement after the administration of gadolinium contrast.

Typical Presentations of MS

The three most common presentations of MS are transverse myelitis, optic neuritis, and brainstem–cerebellar dysfunction. Acute partial transverse myelitis is “the most classic” form of transverse myelitis among patients with MS, said Dr. Pawate. Acute complete transverse myelitis, on the other hand, may be postinfectious or idiopathic, or seen as part of acute disseminated encephalomyelitis (ADEM). Similarly, longitudinally extensive transverse myelitis is more suggestive of neuromyelitis optica spectrum disorders (NMOSD) than MS.

The most typical presentation of MS optic neuritis is unilateral and has acute or subacute onset. Patients often have retrobulbar, “gritty” pain when they move their eye. Complete blindness is unusual, and complete recovery occurs in nearly all patients. Hyperacute onset suggests a vascular process rather than optic neuritis, said Dr. Pawate. Slow, insidious onset may indicate an infiltrative process such as neoplasm or sarcoidosis. Painless vision loss may indicate ischemic optic neuropathy, and severe blindness without recovery may result from NMOSD.

The most pathognomonic brainstem dysfunction in MS is intranuclear ophthalmoplegia (INO), especially when it is bilateral. Other brainstem symptoms typical of MS include ataxia, painless diplopia, facial numbness, and trigeminal neuralgia in a young patient. Hyperacute or insidious onset of brainstem symptoms is unlikely to indicate MS. Symptoms that localize to a vascular territory usually result from a stroke. In addition, multiple cranial neuropathy is more suggestive of infections such as Lyme disease, sarcoidosis, or carcinomic ulcers.

Unusual Presentations of MS

Certain variants of MS do not present with the typical periventricular ovoid lesions. Tumefactive MS often presents with a large (ie, larger than 2 cm), solitary demyelinating lesion. These lesions usually are biopsied. Treatment with steroids usually brings improvement. After this first manifestation, the patient’s course is typical of relapsing-remitting MS. “Rarely do patients have tumefactive lesions in the middle of their MS course,” said Dr. Pawate.

Another unusual presentation is concentric rings of demyelination, sometimes with mass effect. This variant is called Balo’s concentric sclerosis, and the patient may have typical MS lesions in addition to the rings. “Historically, Balo’s concentric sclerosis was thought to be a severe disease with a poor prognosis,” said Dr. Pawate. “With the advent of MRI, we know that these [rings] are more common than we initially thought, and more benign—not much different from any other MS lesions.”

Patients also may present with multiple large lesions and aggressive disease onset. Such patients need early treatment. “When I see something like this, I treat aggressively using plasma exchange and IV steroids,” said Dr. Pawate. This treatment may be followed by natalizumab infusions, and the patients may make a good recovery. “Historically, this aggressive MS onset was called Marburg variant and was fatal,” said Dr. Pawate.

MS Mimics

ADEM is more common in children than in adults, and imaging can distinguish it from MS. One distinguishing feature of ADEM is that the patient has many lesions that appear to be of the same age. Lesions may appear on the basal ganglia and the thalamus, which is atypical for MS. Spinal cord lesions tend to be longer in ADEM, compared with those in MS. ADEM tends to have a monophasic course, and patients usually present with encephalopathy, headaches, and vomiting. Patients often have a history of preceding vaccination or infection.

Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) also can mimic MS on MRI. What distinguishes it from MS are lacunar infarcts, involvement in sites like the thalamus and basal ganglia, and gray matter involvement. CADASIL affects middle-aged adults and leads to disability and dementia.

If a patient referred for suspected MS has bilaterally symmetric confluent lesions, “think more in terms of leukodystrophies,” said Dr. Pawate. The absence of gadolinium enhancement is typical in leukodystrophies. The disorders may involve the U-fibers, the brainstem, or the cerebellum, and patients may present with cognitive decline.

Susac’s syndrome is a triad of branch retinal artery occlusion, sensorineural hearing loss, and encephalopathy. The syndrome is associated with a characteristic MRI that includes “spokes” (ie, linear lesions) and “snowballs” (ie, globular lesions) in the corpus callosum, as well as a “string of pearls” (ie, microinfarcts) in the internal capsule. In the eye, the most pathognomonic finding is hyperfluorescence of the arterial wall on fluorescein angiogram. Early treatment can produce good outcomes, but missing the diagnosis may quickly result in dementia, vision loss, and hearing loss.

Lupus can cause CNS manifestations, including cerebritis, vasculitis, and myelitis. “Primary CNS vasculitis can mimic MS on MRI sometimes, but the red flags are that the patient may have headache and infarcts on MRI, which are not seen in MS,” said Dr. Pawate. The white matter lesions in neurosarcoidosis can be similar to those in MS, but neurosarcoidosis also causes leptomeningeal enhancement and cranial nerve enhancement, which are not seen in MS.

—Erik Greb

Suggested Reading

Costello DJ, Eichler AF, Eichler FS. Leukodystrophies: classification, diagnosis, and treatment. Neurologist. 2009;15(6):319-328.

Kleinfeld K, Mobley B, Hedera P, et al. Adult-onset leukoencephalopathy with neuroaxonal spheroids and pigmented glia: report of five cases and a new mutation. J Neurol. 2013;260(2):558-571.

Pawate S, Agarwal A, Moses H, Sriram S. The spectrum of Susac’s syndrome. Neurol Sci. 2009;30(1):59-64.

HILTON HEAD—Multiple sclerosis (MS) is the most common demyelinating disease, and its mimics are rare, according to an overview provided at the 39th Annual Contemporary Clinical Neurology Symposium. Given that the treatments and outcomes for MS and its mimics are so different, neurologists should take care to establish a diagnosis early, said Sid Pawate, MD, Assistant Professor of Neurology at Vanderbilt University School of Medicine in Nashville.

Because of the varied clinical presentation of MS, a wide variety of conditions enter the differential diagnosis. Because of the central role that MRI plays in MS diagnosis, imaging mimics that cause white matter lesions also need to be considered, said Dr. Pawate. Typically, the white matter lesions seen in MS are periventricular, juxtacortical, and callososeptal in location. Infratentorially, cerebellar peduncles are a common site. The lesions tend to be ovoid, are 3 mm to 5 mm or larger, and appear hyperintense on T2 and FLAIR sequences. Acute lesions may show restricted diffusion or enhancement after the administration of gadolinium contrast.

Typical Presentations of MS

The three most common presentations of MS are transverse myelitis, optic neuritis, and brainstem–cerebellar dysfunction. Acute partial transverse myelitis is “the most classic” form of transverse myelitis among patients with MS, said Dr. Pawate. Acute complete transverse myelitis, on the other hand, may be postinfectious or idiopathic, or seen as part of acute disseminated encephalomyelitis (ADEM). Similarly, longitudinally extensive transverse myelitis is more suggestive of neuromyelitis optica spectrum disorders (NMOSD) than MS.

The most typical presentation of MS optic neuritis is unilateral and has acute or subacute onset. Patients often have retrobulbar, “gritty” pain when they move their eye. Complete blindness is unusual, and complete recovery occurs in nearly all patients. Hyperacute onset suggests a vascular process rather than optic neuritis, said Dr. Pawate. Slow, insidious onset may indicate an infiltrative process such as neoplasm or sarcoidosis. Painless vision loss may indicate ischemic optic neuropathy, and severe blindness without recovery may result from NMOSD.

The most pathognomonic brainstem dysfunction in MS is intranuclear ophthalmoplegia (INO), especially when it is bilateral. Other brainstem symptoms typical of MS include ataxia, painless diplopia, facial numbness, and trigeminal neuralgia in a young patient. Hyperacute or insidious onset of brainstem symptoms is unlikely to indicate MS. Symptoms that localize to a vascular territory usually result from a stroke. In addition, multiple cranial neuropathy is more suggestive of infections such as Lyme disease, sarcoidosis, or carcinomic ulcers.

Unusual Presentations of MS

Certain variants of MS do not present with the typical periventricular ovoid lesions. Tumefactive MS often presents with a large (ie, larger than 2 cm), solitary demyelinating lesion. These lesions usually are biopsied. Treatment with steroids usually brings improvement. After this first manifestation, the patient’s course is typical of relapsing-remitting MS. “Rarely do patients have tumefactive lesions in the middle of their MS course,” said Dr. Pawate.

Another unusual presentation is concentric rings of demyelination, sometimes with mass effect. This variant is called Balo’s concentric sclerosis, and the patient may have typical MS lesions in addition to the rings. “Historically, Balo’s concentric sclerosis was thought to be a severe disease with a poor prognosis,” said Dr. Pawate. “With the advent of MRI, we know that these [rings] are more common than we initially thought, and more benign—not much different from any other MS lesions.”

Patients also may present with multiple large lesions and aggressive disease onset. Such patients need early treatment. “When I see something like this, I treat aggressively using plasma exchange and IV steroids,” said Dr. Pawate. This treatment may be followed by natalizumab infusions, and the patients may make a good recovery. “Historically, this aggressive MS onset was called Marburg variant and was fatal,” said Dr. Pawate.

MS Mimics

ADEM is more common in children than in adults, and imaging can distinguish it from MS. One distinguishing feature of ADEM is that the patient has many lesions that appear to be of the same age. Lesions may appear on the basal ganglia and the thalamus, which is atypical for MS. Spinal cord lesions tend to be longer in ADEM, compared with those in MS. ADEM tends to have a monophasic course, and patients usually present with encephalopathy, headaches, and vomiting. Patients often have a history of preceding vaccination or infection.

Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) also can mimic MS on MRI. What distinguishes it from MS are lacunar infarcts, involvement in sites like the thalamus and basal ganglia, and gray matter involvement. CADASIL affects middle-aged adults and leads to disability and dementia.

If a patient referred for suspected MS has bilaterally symmetric confluent lesions, “think more in terms of leukodystrophies,” said Dr. Pawate. The absence of gadolinium enhancement is typical in leukodystrophies. The disorders may involve the U-fibers, the brainstem, or the cerebellum, and patients may present with cognitive decline.

Susac’s syndrome is a triad of branch retinal artery occlusion, sensorineural hearing loss, and encephalopathy. The syndrome is associated with a characteristic MRI that includes “spokes” (ie, linear lesions) and “snowballs” (ie, globular lesions) in the corpus callosum, as well as a “string of pearls” (ie, microinfarcts) in the internal capsule. In the eye, the most pathognomonic finding is hyperfluorescence of the arterial wall on fluorescein angiogram. Early treatment can produce good outcomes, but missing the diagnosis may quickly result in dementia, vision loss, and hearing loss.

Lupus can cause CNS manifestations, including cerebritis, vasculitis, and myelitis. “Primary CNS vasculitis can mimic MS on MRI sometimes, but the red flags are that the patient may have headache and infarcts on MRI, which are not seen in MS,” said Dr. Pawate. The white matter lesions in neurosarcoidosis can be similar to those in MS, but neurosarcoidosis also causes leptomeningeal enhancement and cranial nerve enhancement, which are not seen in MS.

—Erik Greb

Suggested Reading

Costello DJ, Eichler AF, Eichler FS. Leukodystrophies: classification, diagnosis, and treatment. Neurologist. 2009;15(6):319-328.

Kleinfeld K, Mobley B, Hedera P, et al. Adult-onset leukoencephalopathy with neuroaxonal spheroids and pigmented glia: report of five cases and a new mutation. J Neurol. 2013;260(2):558-571.

Pawate S, Agarwal A, Moses H, Sriram S. The spectrum of Susac’s syndrome. Neurol Sci. 2009;30(1):59-64.

HILTON HEAD—Multiple sclerosis (MS) is the most common demyelinating disease, and its mimics are rare, according to an overview provided at the 39th Annual Contemporary Clinical Neurology Symposium. Given that the treatments and outcomes for MS and its mimics are so different, neurologists should take care to establish a diagnosis early, said Sid Pawate, MD, Assistant Professor of Neurology at Vanderbilt University School of Medicine in Nashville.

Because of the varied clinical presentation of MS, a wide variety of conditions enter the differential diagnosis. Because of the central role that MRI plays in MS diagnosis, imaging mimics that cause white matter lesions also need to be considered, said Dr. Pawate. Typically, the white matter lesions seen in MS are periventricular, juxtacortical, and callososeptal in location. Infratentorially, cerebellar peduncles are a common site. The lesions tend to be ovoid, are 3 mm to 5 mm or larger, and appear hyperintense on T2 and FLAIR sequences. Acute lesions may show restricted diffusion or enhancement after the administration of gadolinium contrast.

Typical Presentations of MS

The three most common presentations of MS are transverse myelitis, optic neuritis, and brainstem–cerebellar dysfunction. Acute partial transverse myelitis is “the most classic” form of transverse myelitis among patients with MS, said Dr. Pawate. Acute complete transverse myelitis, on the other hand, may be postinfectious or idiopathic, or seen as part of acute disseminated encephalomyelitis (ADEM). Similarly, longitudinally extensive transverse myelitis is more suggestive of neuromyelitis optica spectrum disorders (NMOSD) than MS.

The most typical presentation of MS optic neuritis is unilateral and has acute or subacute onset. Patients often have retrobulbar, “gritty” pain when they move their eye. Complete blindness is unusual, and complete recovery occurs in nearly all patients. Hyperacute onset suggests a vascular process rather than optic neuritis, said Dr. Pawate. Slow, insidious onset may indicate an infiltrative process such as neoplasm or sarcoidosis. Painless vision loss may indicate ischemic optic neuropathy, and severe blindness without recovery may result from NMOSD.

The most pathognomonic brainstem dysfunction in MS is intranuclear ophthalmoplegia (INO), especially when it is bilateral. Other brainstem symptoms typical of MS include ataxia, painless diplopia, facial numbness, and trigeminal neuralgia in a young patient. Hyperacute or insidious onset of brainstem symptoms is unlikely to indicate MS. Symptoms that localize to a vascular territory usually result from a stroke. In addition, multiple cranial neuropathy is more suggestive of infections such as Lyme disease, sarcoidosis, or carcinomic ulcers.

Unusual Presentations of MS

Certain variants of MS do not present with the typical periventricular ovoid lesions. Tumefactive MS often presents with a large (ie, larger than 2 cm), solitary demyelinating lesion. These lesions usually are biopsied. Treatment with steroids usually brings improvement. After this first manifestation, the patient’s course is typical of relapsing-remitting MS. “Rarely do patients have tumefactive lesions in the middle of their MS course,” said Dr. Pawate.

Another unusual presentation is concentric rings of demyelination, sometimes with mass effect. This variant is called Balo’s concentric sclerosis, and the patient may have typical MS lesions in addition to the rings. “Historically, Balo’s concentric sclerosis was thought to be a severe disease with a poor prognosis,” said Dr. Pawate. “With the advent of MRI, we know that these [rings] are more common than we initially thought, and more benign—not much different from any other MS lesions.”

Patients also may present with multiple large lesions and aggressive disease onset. Such patients need early treatment. “When I see something like this, I treat aggressively using plasma exchange and IV steroids,” said Dr. Pawate. This treatment may be followed by natalizumab infusions, and the patients may make a good recovery. “Historically, this aggressive MS onset was called Marburg variant and was fatal,” said Dr. Pawate.

MS Mimics

ADEM is more common in children than in adults, and imaging can distinguish it from MS. One distinguishing feature of ADEM is that the patient has many lesions that appear to be of the same age. Lesions may appear on the basal ganglia and the thalamus, which is atypical for MS. Spinal cord lesions tend to be longer in ADEM, compared with those in MS. ADEM tends to have a monophasic course, and patients usually present with encephalopathy, headaches, and vomiting. Patients often have a history of preceding vaccination or infection.

Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) also can mimic MS on MRI. What distinguishes it from MS are lacunar infarcts, involvement in sites like the thalamus and basal ganglia, and gray matter involvement. CADASIL affects middle-aged adults and leads to disability and dementia.

If a patient referred for suspected MS has bilaterally symmetric confluent lesions, “think more in terms of leukodystrophies,” said Dr. Pawate. The absence of gadolinium enhancement is typical in leukodystrophies. The disorders may involve the U-fibers, the brainstem, or the cerebellum, and patients may present with cognitive decline.

Susac’s syndrome is a triad of branch retinal artery occlusion, sensorineural hearing loss, and encephalopathy. The syndrome is associated with a characteristic MRI that includes “spokes” (ie, linear lesions) and “snowballs” (ie, globular lesions) in the corpus callosum, as well as a “string of pearls” (ie, microinfarcts) in the internal capsule. In the eye, the most pathognomonic finding is hyperfluorescence of the arterial wall on fluorescein angiogram. Early treatment can produce good outcomes, but missing the diagnosis may quickly result in dementia, vision loss, and hearing loss.

Lupus can cause CNS manifestations, including cerebritis, vasculitis, and myelitis. “Primary CNS vasculitis can mimic MS on MRI sometimes, but the red flags are that the patient may have headache and infarcts on MRI, which are not seen in MS,” said Dr. Pawate. The white matter lesions in neurosarcoidosis can be similar to those in MS, but neurosarcoidosis also causes leptomeningeal enhancement and cranial nerve enhancement, which are not seen in MS.

—Erik Greb

Suggested Reading

Costello DJ, Eichler AF, Eichler FS. Leukodystrophies: classification, diagnosis, and treatment. Neurologist. 2009;15(6):319-328.

Kleinfeld K, Mobley B, Hedera P, et al. Adult-onset leukoencephalopathy with neuroaxonal spheroids and pigmented glia: report of five cases and a new mutation. J Neurol. 2013;260(2):558-571.

Pawate S, Agarwal A, Moses H, Sriram S. The spectrum of Susac’s syndrome. Neurol Sci. 2009;30(1):59-64.

LAS VEGAS – Dermatologists need to be alert for amyotrophic dermatomyositis in patients with rash where lupus might be considered, because of the need for vigilant surveillance for cancer and lung disease in this population.

Ruth Ann Vleugels, MD, walked attendees through a series of dermatomyositis diagnostic pearls at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.

“When a patient has dermatomyositis but doesn’t have muscle disease, you really have to rely on the skin findings,” since you’re lacking the tipoff of muscle disease at presentation, Dr. Vleugels, professor of dermatology at Brigham and Women’s Hospital, Boston, said in an interview. This is especially true because, on biopsy, “the pathological findings are identical to that of lupus,” she said.

Dr. Vleugels emphasized that it’s important not to miss a more subtle, less violaceous heliotrope eruption, especially in lighter-skinned patients; similarly, Gottron’s papules are not always papular and limited to the knuckle pads, but can be more macular and linear, with psoriasiform scaling. Nail findings such as dilated capillary loops with dystrophic and hypertrophied cuticles are also a big clue. Photodistributed erythema – the “shawl sign” – can be subtle, but offers additional support for a dermatomyositis diagnosis.

Though the erythematous midface rash of lupus resembles a dermatomyositis rash in many ways, there’s a critical differentiator of the two rashes, Dr. Vleugels said. “In dermatomyositis patients, it very classically hugs, or involves, the nasolabial folds, whereas in our systemic lupus patients, the erythema of the cheeks spares the nasolabial folds.”

Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

On Twitter @karioakes

LAS VEGAS – Dermatologists need to be alert for amyotrophic dermatomyositis in patients with rash where lupus might be considered, because of the need for vigilant surveillance for cancer and lung disease in this population.

Ruth Ann Vleugels, MD, walked attendees through a series of dermatomyositis diagnostic pearls at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.

“When a patient has dermatomyositis but doesn’t have muscle disease, you really have to rely on the skin findings,” since you’re lacking the tipoff of muscle disease at presentation, Dr. Vleugels, professor of dermatology at Brigham and Women’s Hospital, Boston, said in an interview. This is especially true because, on biopsy, “the pathological findings are identical to that of lupus,” she said.

Dr. Vleugels emphasized that it’s important not to miss a more subtle, less violaceous heliotrope eruption, especially in lighter-skinned patients; similarly, Gottron’s papules are not always papular and limited to the knuckle pads, but can be more macular and linear, with psoriasiform scaling. Nail findings such as dilated capillary loops with dystrophic and hypertrophied cuticles are also a big clue. Photodistributed erythema – the “shawl sign” – can be subtle, but offers additional support for a dermatomyositis diagnosis.

Though the erythematous midface rash of lupus resembles a dermatomyositis rash in many ways, there’s a critical differentiator of the two rashes, Dr. Vleugels said. “In dermatomyositis patients, it very classically hugs, or involves, the nasolabial folds, whereas in our systemic lupus patients, the erythema of the cheeks spares the nasolabial folds.”

Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

On Twitter @karioakes

LAS VEGAS – Dermatologists need to be alert for amyotrophic dermatomyositis in patients with rash where lupus might be considered, because of the need for vigilant surveillance for cancer and lung disease in this population.

Ruth Ann Vleugels, MD, walked attendees through a series of dermatomyositis diagnostic pearls at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.

“When a patient has dermatomyositis but doesn’t have muscle disease, you really have to rely on the skin findings,” since you’re lacking the tipoff of muscle disease at presentation, Dr. Vleugels, professor of dermatology at Brigham and Women’s Hospital, Boston, said in an interview. This is especially true because, on biopsy, “the pathological findings are identical to that of lupus,” she said.

Dr. Vleugels emphasized that it’s important not to miss a more subtle, less violaceous heliotrope eruption, especially in lighter-skinned patients; similarly, Gottron’s papules are not always papular and limited to the knuckle pads, but can be more macular and linear, with psoriasiform scaling. Nail findings such as dilated capillary loops with dystrophic and hypertrophied cuticles are also a big clue. Photodistributed erythema – the “shawl sign” – can be subtle, but offers additional support for a dermatomyositis diagnosis.

Though the erythematous midface rash of lupus resembles a dermatomyositis rash in many ways, there’s a critical differentiator of the two rashes, Dr. Vleugels said. “In dermatomyositis patients, it very classically hugs, or involves, the nasolabial folds, whereas in our systemic lupus patients, the erythema of the cheeks spares the nasolabial folds.”

Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

On Twitter @karioakes

LAS VEGAS – When genetic risk and lifestyle risk factors collide with the baseline systemic inflammation of rheumatoid arthritis (RA), cardiovascular risk increases significantly. Helping patients to manage risk for cardiovascular disease (CVD) requires getting comfortable in making risk assessments and counseling patients about medication and lifestyle options, especially for patients who are not actively being managed by primary care physicians.

Jon Giles, MD, said that a large portion of the elevated risk for CVD in patients with RA is “driven by the fact that [RA] patients have more atherosclerosis.”

Dr. Giles, professor of medicine at Columbia University, New York, said that other CVD risk factors can boost the risk further. “If you have diabetes, smoking, high blood pressure, elevated lipids in your blood – if you have a combination of those plus inflammation, it makes that risk even higher,” Dr. Giles said at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.

“There’s definitely a lot of data that suggests that, as rheumatologists, we’re not doing a very good job of screening and treating for cardiovascular disease and risk,” Dr. Giles said in an interview at the meeting. He suggests that his fellow rheumatologists become comfortable with screening and treatment guidelines for cardiovascular disease. For selected patients, coronary CT or carotid ultrasound may be valuable in guiding decision making, since very low LDL cholesterol may be correlated with an increased risk of CVD for some patients with RA.

Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

On Twitter @karioakes

LAS VEGAS – When genetic risk and lifestyle risk factors collide with the baseline systemic inflammation of rheumatoid arthritis (RA), cardiovascular risk increases significantly. Helping patients to manage risk for cardiovascular disease (CVD) requires getting comfortable in making risk assessments and counseling patients about medication and lifestyle options, especially for patients who are not actively being managed by primary care physicians.

Jon Giles, MD, said that a large portion of the elevated risk for CVD in patients with RA is “driven by the fact that [RA] patients have more atherosclerosis.”

Dr. Giles, professor of medicine at Columbia University, New York, said that other CVD risk factors can boost the risk further. “If you have diabetes, smoking, high blood pressure, elevated lipids in your blood – if you have a combination of those plus inflammation, it makes that risk even higher,” Dr. Giles said at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.

“There’s definitely a lot of data that suggests that, as rheumatologists, we’re not doing a very good job of screening and treating for cardiovascular disease and risk,” Dr. Giles said in an interview at the meeting. He suggests that his fellow rheumatologists become comfortable with screening and treatment guidelines for cardiovascular disease. For selected patients, coronary CT or carotid ultrasound may be valuable in guiding decision making, since very low LDL cholesterol may be correlated with an increased risk of CVD for some patients with RA.

Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

On Twitter @karioakes

LAS VEGAS – When genetic risk and lifestyle risk factors collide with the baseline systemic inflammation of rheumatoid arthritis (RA), cardiovascular risk increases significantly. Helping patients to manage risk for cardiovascular disease (CVD) requires getting comfortable in making risk assessments and counseling patients about medication and lifestyle options, especially for patients who are not actively being managed by primary care physicians.

Jon Giles, MD, said that a large portion of the elevated risk for CVD in patients with RA is “driven by the fact that [RA] patients have more atherosclerosis.”

Dr. Giles, professor of medicine at Columbia University, New York, said that other CVD risk factors can boost the risk further. “If you have diabetes, smoking, high blood pressure, elevated lipids in your blood – if you have a combination of those plus inflammation, it makes that risk even higher,” Dr. Giles said at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.

“There’s definitely a lot of data that suggests that, as rheumatologists, we’re not doing a very good job of screening and treating for cardiovascular disease and risk,” Dr. Giles said in an interview at the meeting. He suggests that his fellow rheumatologists become comfortable with screening and treatment guidelines for cardiovascular disease. For selected patients, coronary CT or carotid ultrasound may be valuable in guiding decision making, since very low LDL cholesterol may be correlated with an increased risk of CVD for some patients with RA.

Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

On Twitter @karioakes

Editor's Note: Listen to Dr. Smith share more of his views on the State of Hospital Medicine report.

Hospitalist groups and their stakeholders must continually adapt to evolving reimbursement models and their attendant financial foci on quality. Even in the midst of care models that rely less heavily on volume of care as a marker for reimbursement, the use of criteria by insurers to separate hospital stays into inpatient or observation status remains widespread. Hospitalist groups vary in the reimbursement model environment they work in, and different reimbursement models can drive hospitalist group behavior in different ways.

SHM’s 2016 State of Hospital Medicine Report revisits the issue of observation status utilization raised in previous surveys.1 The 2012 survey’s methodology reports admissions classified as observation status based on CPT coding.2 The 2016 survey continues the 2014 survey methodology of using discharges classified as observation status based on CPT coding, along with same-day admission and discharge reported as a third hospitalization status category. In groups serving adults only, observation discharges accounted for 21.2% of all discharges, which represents an increase from 16.1% in the 2014 survey3 and a general return to the 2012-reported percentage of 20%. If same-day admissions and discharges, many of which are likely classified as observation status, are added, then observation status use in the 2016 survey may be as high as 24% of all admissions. This represents a considerable increase from the combined 19.6% rate in 2014.

Changes in non-academic status hospitalist groups largely account for this increase. Academic hospitalist groups reported an observation status utilization rate of 15.3% of admissions in 2012 and 19.4% in 2014, with a subsequent decrease to 17.5% reported in the 2016 survey. Inclusion of same-day admission and discharge with reported observation status use also reveals a decrease from 22.8% in 2014 to 20.8% in the new survey. In contrast, non-academic hospitalist groups now report a substantial change in observation status utilization, up to 21.4% in the 2016 survey from 15.6% in 2014 and similar to the 2012 level of 20.4%. When same-day admission and discharge codes are also included, the totals for non-academic hospitalist groups also evidence an increase, to 24.3% in the new survey from 19.2% in 2014.

I postulated in 2015 that the comparative increase in observation status utilization by academic groups as compared with non-academic groups in the 2014 survey may have been associated with greater proficiency in documentation and related billing inherent in a bedside clinical workforce entirely composed of physicians who have completed postgraduate training. Other phenomena may now potentially explain the increase in observation status use we see in the 2016 survey. These include adoption of the two-midnight rule by the Centers for Medicare & Medicaid Services, use of readmission rates in hospitalist group incentive structures, sharing of cost savings between hospitalist groups and healthcare organizations mutually engaged in third-party bundled payment arrangements, or risk-avoidant strategies executed by clinicians and institutional coders perhaps in excess of their institutions’ needs for risk avoidance. For many of these events, the 2016 State of Hospital Medicine Report provides further benchmark data, in a national and regional context, to inform understanding for hospitalist groups facing challenges associated with observation status utilization.

G. Randy Smith Jr., MD, MS, FRCP(Edin), SFHM, is an assistant professor in the Division of Hospital Medicine at Northwestern University Feinberg School of Medicine in Chicago.

References

1. 2016 State of Hospital Medicine Report. Society of Hospital Medicine website. Accessed September 11, 2016.
2. 2012 State of Hospital Medicine Report. Society of Hospital Medicine website. Accessed September 11, 2016.
3. 2014 State of Hospital Medicine Report. Society of Hospital Medicine website.

   Accessed September 11, 2016.

Editor's Note: Listen to Dr. Smith share more of his views on the State of Hospital Medicine report.

Hospitalist groups and their stakeholders must continually adapt to evolving reimbursement models and their attendant financial foci on quality. Even in the midst of care models that rely less heavily on volume of care as a marker for reimbursement, the use of criteria by insurers to separate hospital stays into inpatient or observation status remains widespread. Hospitalist groups vary in the reimbursement model environment they work in, and different reimbursement models can drive hospitalist group behavior in different ways.

SHM’s 2016 State of Hospital Medicine Report revisits the issue of observation status utilization raised in previous surveys.1 The 2012 survey’s methodology reports admissions classified as observation status based on CPT coding.2 The 2016 survey continues the 2014 survey methodology of using discharges classified as observation status based on CPT coding, along with same-day admission and discharge reported as a third hospitalization status category. In groups serving adults only, observation discharges accounted for 21.2% of all discharges, which represents an increase from 16.1% in the 2014 survey3 and a general return to the 2012-reported percentage of 20%. If same-day admissions and discharges, many of which are likely classified as observation status, are added, then observation status use in the 2016 survey may be as high as 24% of all admissions. This represents a considerable increase from the combined 19.6% rate in 2014.

Changes in non-academic status hospitalist groups largely account for this increase. Academic hospitalist groups reported an observation status utilization rate of 15.3% of admissions in 2012 and 19.4% in 2014, with a subsequent decrease to 17.5% reported in the 2016 survey. Inclusion of same-day admission and discharge with reported observation status use also reveals a decrease from 22.8% in 2014 to 20.8% in the new survey. In contrast, non-academic hospitalist groups now report a substantial change in observation status utilization, up to 21.4% in the 2016 survey from 15.6% in 2014 and similar to the 2012 level of 20.4%. When same-day admission and discharge codes are also included, the totals for non-academic hospitalist groups also evidence an increase, to 24.3% in the new survey from 19.2% in 2014.

I postulated in 2015 that the comparative increase in observation status utilization by academic groups as compared with non-academic groups in the 2014 survey may have been associated with greater proficiency in documentation and related billing inherent in a bedside clinical workforce entirely composed of physicians who have completed postgraduate training. Other phenomena may now potentially explain the increase in observation status use we see in the 2016 survey. These include adoption of the two-midnight rule by the Centers for Medicare & Medicaid Services, use of readmission rates in hospitalist group incentive structures, sharing of cost savings between hospitalist groups and healthcare organizations mutually engaged in third-party bundled payment arrangements, or risk-avoidant strategies executed by clinicians and institutional coders perhaps in excess of their institutions’ needs for risk avoidance. For many of these events, the 2016 State of Hospital Medicine Report provides further benchmark data, in a national and regional context, to inform understanding for hospitalist groups facing challenges associated with observation status utilization.

G. Randy Smith Jr., MD, MS, FRCP(Edin), SFHM, is an assistant professor in the Division of Hospital Medicine at Northwestern University Feinberg School of Medicine in Chicago.

References

1. 2016 State of Hospital Medicine Report. Society of Hospital Medicine website. Accessed September 11, 2016.
2. 2012 State of Hospital Medicine Report. Society of Hospital Medicine website. Accessed September 11, 2016.
3. 2014 State of Hospital Medicine Report. Society of Hospital Medicine website.

   Accessed September 11, 2016.

Editor's Note: Listen to Dr. Smith share more of his views on the State of Hospital Medicine report.

Hospitalist groups and their stakeholders must continually adapt to evolving reimbursement models and their attendant financial foci on quality. Even in the midst of care models that rely less heavily on volume of care as a marker for reimbursement, the use of criteria by insurers to separate hospital stays into inpatient or observation status remains widespread. Hospitalist groups vary in the reimbursement model environment they work in, and different reimbursement models can drive hospitalist group behavior in different ways.

SHM’s 2016 State of Hospital Medicine Report revisits the issue of observation status utilization raised in previous surveys.1 The 2012 survey’s methodology reports admissions classified as observation status based on CPT coding.2 The 2016 survey continues the 2014 survey methodology of using discharges classified as observation status based on CPT coding, along with same-day admission and discharge reported as a third hospitalization status category. In groups serving adults only, observation discharges accounted for 21.2% of all discharges, which represents an increase from 16.1% in the 2014 survey3 and a general return to the 2012-reported percentage of 20%. If same-day admissions and discharges, many of which are likely classified as observation status, are added, then observation status use in the 2016 survey may be as high as 24% of all admissions. This represents a considerable increase from the combined 19.6% rate in 2014.

Changes in non-academic status hospitalist groups largely account for this increase. Academic hospitalist groups reported an observation status utilization rate of 15.3% of admissions in 2012 and 19.4% in 2014, with a subsequent decrease to 17.5% reported in the 2016 survey. Inclusion of same-day admission and discharge with reported observation status use also reveals a decrease from 22.8% in 2014 to 20.8% in the new survey. In contrast, non-academic hospitalist groups now report a substantial change in observation status utilization, up to 21.4% in the 2016 survey from 15.6% in 2014 and similar to the 2012 level of 20.4%. When same-day admission and discharge codes are also included, the totals for non-academic hospitalist groups also evidence an increase, to 24.3% in the new survey from 19.2% in 2014.

I postulated in 2015 that the comparative increase in observation status utilization by academic groups as compared with non-academic groups in the 2014 survey may have been associated with greater proficiency in documentation and related billing inherent in a bedside clinical workforce entirely composed of physicians who have completed postgraduate training. Other phenomena may now potentially explain the increase in observation status use we see in the 2016 survey. These include adoption of the two-midnight rule by the Centers for Medicare & Medicaid Services, use of readmission rates in hospitalist group incentive structures, sharing of cost savings between hospitalist groups and healthcare organizations mutually engaged in third-party bundled payment arrangements, or risk-avoidant strategies executed by clinicians and institutional coders perhaps in excess of their institutions’ needs for risk avoidance. For many of these events, the 2016 State of Hospital Medicine Report provides further benchmark data, in a national and regional context, to inform understanding for hospitalist groups facing challenges associated with observation status utilization.

G. Randy Smith Jr., MD, MS, FRCP(Edin), SFHM, is an assistant professor in the Division of Hospital Medicine at Northwestern University Feinberg School of Medicine in Chicago.

References

1. 2016 State of Hospital Medicine Report. Society of Hospital Medicine website. Accessed September 11, 2016.
2. 2012 State of Hospital Medicine Report. Society of Hospital Medicine website. Accessed September 11, 2016.
3. 2014 State of Hospital Medicine Report. Society of Hospital Medicine website.

   Accessed September 11, 2016.

(Reuters Health) - The proportion of U.S. babies born suffering from withdrawal syndrome after exposure to heroin or prescription opiates in utero has more than doubled in less than a decade, a study suggests.

Nationally, the rate of neonatal abstinence syndrome involving mothers' use of opiates - which includes heroin as well as prescription narcotics like codeine and Vicodin - surged from 2.8 cases for every 1,000 births in 2009 to 7.3 cases for every 1,000 births in 2013, the study found.

At least some of this surge in the case count is due to drug policies designed to crack down on prescription drug abuse and combat the methamphetamine epidemic, said lead study author Dr. Joshua Brown, a pharmacy researcher at the University of Kentucky in Lexington.

"The drug policies of the early 2000s were effective in reducing supply - we have seen a decrease in methamphetamine abuse and there have been reductions in some aspects of prescription drug abuse," Brown said by email. "However, the indirect results, mainly the increase in heroin abuse, were likely not anticipated and we are just starting to see these."

The findings of the current study add to a growing body of evidence pointing to a surge in births of babies suffering from opiate withdrawal. One report last month from the U.S. Centers for Disease Control and Prevention found an even bigger spike over a longer period, from 1.5 cases for every 1,000 births in 1999 to 6 cases per 1,000 in 2013.

CDC researchers also found wide variation in neonatal abstinence syndrome by state, ranging in 2013 from 0.7 cases for every 1,000 births in Hawaii to 33.4 cases per 1,000 in West Virginia.

"We know that certain states are harder hit by the opioid/heroin abuse epidemic, with about 10 states contributing half of all neonatal abstinence syndrome cases," Brown said. "These states are often more rural and impoverished areas of the U.S. such as Mississippi, Alabama, and West Virginia."

Brown and colleagues looked at Kentucky in particular. Here, the rate of neonatal abstinence syndrome climbed from 5 cases for every 1,000 births in 2008 to 21.2 cases per 1,000 births in 2014, researchers report in JAMA Pediatrics, online September 26.

While the study didn't look at health outcomes for babies born suffering from drug withdrawal, these infants often require intensive medical care. (See Reuters' 2015 special report "Helpless and Hooked" here.)

These babies may have central nervous system issues like seizures and tremors, gastrointestinal problems and feeding difficulties, breathing challenges, as well as unstable body temperatures.

Typically, they remain in the hospital for several weeks after birth and receive low doses of methadone, Brown said.

Treatment can ease withdrawal symptoms in newborns, but can't necessarily address developmental problems these infants may have later on, said Dr. William Carey, a pediatrics researcher at pediatrics at Mayo Clinic Children's Center in Rochester, Minnesota.

"While abuse of prescription opiates has declined, the use of illicit opiates has increased such that there may be a zero-sum game at best," Carey, who wasn't involved in the study, said by email. "Since maternal use of either prescription opiates or illicit opiates is associated with withdrawal in newborns, it is reasonable to think that any increase in the overall use of opiates would be linked to an increase in the rate of neonatal abstinence syndrome."

(Reuters Health) - The proportion of U.S. babies born suffering from withdrawal syndrome after exposure to heroin or prescription opiates in utero has more than doubled in less than a decade, a study suggests.

Nationally, the rate of neonatal abstinence syndrome involving mothers' use of opiates - which includes heroin as well as prescription narcotics like codeine and Vicodin - surged from 2.8 cases for every 1,000 births in 2009 to 7.3 cases for every 1,000 births in 2013, the study found.

At least some of this surge in the case count is due to drug policies designed to crack down on prescription drug abuse and combat the methamphetamine epidemic, said lead study author Dr. Joshua Brown, a pharmacy researcher at the University of Kentucky in Lexington.

"The drug policies of the early 2000s were effective in reducing supply - we have seen a decrease in methamphetamine abuse and there have been reductions in some aspects of prescription drug abuse," Brown said by email. "However, the indirect results, mainly the increase in heroin abuse, were likely not anticipated and we are just starting to see these."

The findings of the current study add to a growing body of evidence pointing to a surge in births of babies suffering from opiate withdrawal. One report last month from the U.S. Centers for Disease Control and Prevention found an even bigger spike over a longer period, from 1.5 cases for every 1,000 births in 1999 to 6 cases per 1,000 in 2013.

CDC researchers also found wide variation in neonatal abstinence syndrome by state, ranging in 2013 from 0.7 cases for every 1,000 births in Hawaii to 33.4 cases per 1,000 in West Virginia.

"We know that certain states are harder hit by the opioid/heroin abuse epidemic, with about 10 states contributing half of all neonatal abstinence syndrome cases," Brown said. "These states are often more rural and impoverished areas of the U.S. such as Mississippi, Alabama, and West Virginia."

Brown and colleagues looked at Kentucky in particular. Here, the rate of neonatal abstinence syndrome climbed from 5 cases for every 1,000 births in 2008 to 21.2 cases per 1,000 births in 2014, researchers report in JAMA Pediatrics, online September 26.

While the study didn't look at health outcomes for babies born suffering from drug withdrawal, these infants often require intensive medical care. (See Reuters' 2015 special report "Helpless and Hooked" here.)

These babies may have central nervous system issues like seizures and tremors, gastrointestinal problems and feeding difficulties, breathing challenges, as well as unstable body temperatures.

Typically, they remain in the hospital for several weeks after birth and receive low doses of methadone, Brown said.

Treatment can ease withdrawal symptoms in newborns, but can't necessarily address developmental problems these infants may have later on, said Dr. William Carey, a pediatrics researcher at pediatrics at Mayo Clinic Children's Center in Rochester, Minnesota.

"While abuse of prescription opiates has declined, the use of illicit opiates has increased such that there may be a zero-sum game at best," Carey, who wasn't involved in the study, said by email. "Since maternal use of either prescription opiates or illicit opiates is associated with withdrawal in newborns, it is reasonable to think that any increase in the overall use of opiates would be linked to an increase in the rate of neonatal abstinence syndrome."

(Reuters Health) - The proportion of U.S. babies born suffering from withdrawal syndrome after exposure to heroin or prescription opiates in utero has more than doubled in less than a decade, a study suggests.

Nationally, the rate of neonatal abstinence syndrome involving mothers' use of opiates - which includes heroin as well as prescription narcotics like codeine and Vicodin - surged from 2.8 cases for every 1,000 births in 2009 to 7.3 cases for every 1,000 births in 2013, the study found.

At least some of this surge in the case count is due to drug policies designed to crack down on prescription drug abuse and combat the methamphetamine epidemic, said lead study author Dr. Joshua Brown, a pharmacy researcher at the University of Kentucky in Lexington.

"The drug policies of the early 2000s were effective in reducing supply - we have seen a decrease in methamphetamine abuse and there have been reductions in some aspects of prescription drug abuse," Brown said by email. "However, the indirect results, mainly the increase in heroin abuse, were likely not anticipated and we are just starting to see these."

The findings of the current study add to a growing body of evidence pointing to a surge in births of babies suffering from opiate withdrawal. One report last month from the U.S. Centers for Disease Control and Prevention found an even bigger spike over a longer period, from 1.5 cases for every 1,000 births in 1999 to 6 cases per 1,000 in 2013.

CDC researchers also found wide variation in neonatal abstinence syndrome by state, ranging in 2013 from 0.7 cases for every 1,000 births in Hawaii to 33.4 cases per 1,000 in West Virginia.

"We know that certain states are harder hit by the opioid/heroin abuse epidemic, with about 10 states contributing half of all neonatal abstinence syndrome cases," Brown said. "These states are often more rural and impoverished areas of the U.S. such as Mississippi, Alabama, and West Virginia."

Brown and colleagues looked at Kentucky in particular. Here, the rate of neonatal abstinence syndrome climbed from 5 cases for every 1,000 births in 2008 to 21.2 cases per 1,000 births in 2014, researchers report in JAMA Pediatrics, online September 26.

While the study didn't look at health outcomes for babies born suffering from drug withdrawal, these infants often require intensive medical care. (See Reuters' 2015 special report "Helpless and Hooked" here.)

These babies may have central nervous system issues like seizures and tremors, gastrointestinal problems and feeding difficulties, breathing challenges, as well as unstable body temperatures.

Typically, they remain in the hospital for several weeks after birth and receive low doses of methadone, Brown said.

Treatment can ease withdrawal symptoms in newborns, but can't necessarily address developmental problems these infants may have later on, said Dr. William Carey, a pediatrics researcher at pediatrics at Mayo Clinic Children's Center in Rochester, Minnesota.

"While abuse of prescription opiates has declined, the use of illicit opiates has increased such that there may be a zero-sum game at best," Carey, who wasn't involved in the study, said by email. "Since maternal use of either prescription opiates or illicit opiates is associated with withdrawal in newborns, it is reasonable to think that any increase in the overall use of opiates would be linked to an increase in the rate of neonatal abstinence syndrome."

Diagnostic testing needed to confirm cfDNA results for aneuploidy and microdeletions, finds retrospective study

Researchers at the David Geffen School of Medicine at the University of California-Los Angeles, found a 73.5% positive predictive value (95% CI, 63%-82%) for cfDNA screening for autosomal aneuploidy, a lower-than-reported rate. The positive predictive value for microdeletion testing was found to be 0%.

This was a retrospective cohort study published in June in the American Journal of Obstetrics and Gynecology. It included 105 patients with abnormal or nonreportable cfDNA results for trisomies 21, 18, or 13, and 26 patients with positive or nonreportable microdeletions. Of the 105 patients with abnormal results for the trisomies, 92 results (87.6%) were positive for trisomy 21 (48, 52.2%), trisomy 18 (22, 23.9%), trisomy 13 (17, 18.5%), triploidy (2, 2.2%) and positive for >1 parameter (3, 3.3%). An additional 13 results (12.4%) were nonreportable.

Abnormal cfDNA results were associated with positive serum screening (by group: trisomy 21 [17/48]; trisomy 18 [7/22]; trisomy 13 [3/17]; nonreportable [2/13]; P = .004), and abnormal first-trimester ultrasound (trisomy 21 [25/45]; trisomy 18 [13/20]; trisomy 13 [6/14]; nonreportable [1/13]; P = .003). There was no association between false-positive rates and testing platform, but there was a difference between the 4 laboratories included in the study (P = .018).

In all, 26 patients had positive (n = 9) or nonreportable (n = 17) microdeletion results. Seven of 9 screens positive for microdeletions underwent confirmatory testing; all were false positives.

Access study in AJOG

When is NIPT appropriate for use as a diagnostic tool? Large-scale systematic review evaluates the answer.

Many systematic reviews and meta-analyses evaluating the accuracy of cell-free fetal (cf) DNA−based testing have been published. This May 2016 study in the British Journal of Obstetrics and Gynecology was the most comprehensive of singleton pregnancies to date, say researchers, who aimed to reduce analysis bias by including only cohort studies (117 analyzed), undertaking bivariate meta-analysis when possible, and including all indications for antenatal use, which allowed for a uniform comparison of NIPT use in actual clinical practice.

The researchers concluded that cell-free fetal (cf) DNA−based NIPT is diagnostic for fetal sex and rhesus D (RHD) status. For trisomies 21, 18, and 13, however, they concluded that the lower sensitivities and specificities found and disease prevalence, combined with the biological influence of confined placental mosaicism, designates NIPT as a screening test (with invasive testing required to confirm a positive test result). They advised that these factors be considered not only when clinicians are counseling patients but also in the overall assessment of the cost of introducing NIPT into routine care.

Visit BJOG study

2016 update on NIPT from the American College of Medical Genetics and Genomics

The American College of Medical Genetics and Genomics (ACMG) has published an updated position statement in Genetics in Medicine in July 2016 that replaces its 2013 statement. Among its recommendations, the ACMG advocates:

• providing up-to-date, balanced, and accurate information early in gestation to optimize patient decision making, independent of the screening approach used
• that laboratories work with public health officials, policymakers, and private payers to make NIPT, including the pretest and posttest education and counseling, accessible to all pregnant women
• informing all pregnant women that diagnostic testing (chorionic villus sampling or amniocentesis) is an option for the detection of chromosome abnormalities and clinically significant copy-number variants.

ACMG also recommends:

• informing all pregnant women that noninvasive prenatal screening (NIPS) is the most sensitive screening option for traditionally screened aneuploidies
• referring patients to a trained genetics professional when an increased risk of aneuploidy is reported after NIPS
• offering diagnostic testing when a positive screening test result is reported after NIPS
• laboratories provide readily visible and clearly stated detection rate (DR), clinical specificity (SPEC), and positive predictive values (PPV), and negative predictive values (NPVs) for conditions being screened
• laboratories not offer screening for Patau, Edwards, and Down syndromes if they cannot report DR, SPEC, and PPV values for these conditions.

ACMG does not recommend:

• NIPS to screen for autosomal aneuploidies other than those involving chromosomes 13, 18, and 21.

Visit full recommendations

Public health perspective: Long-term study concludes implementing cfDNA in high-risk women could be cost-effective

Researchers in Italy retrospectively analyzed the performance of first-trimester screening (FTS) test in a general obstetrics population, including a cost-benefit analysis of a hypothetical model that implemented universal FTS testing using cfDNA. A 2-step strategy based on nuchal translucency, serum screening, and ultrasound assessment of the nasal bone was applied when analyzing the FTS results of 6,679 women. The researchers identified 3 groups: high-risk: >1:250; intermediate-risk: 1:251-1:999; and low-risk group: <1:1000. Women at intermediate-risk underwent NB assessment and recalculation of individual risk. All women at high-risk were offered fetal karyotyping.

The investigators concluded that the Italian public health system would not be able to sustain the cost of universal cfDNA testing in women undergoing FTS. However, a possible scenario based on use of cfDNA FTS in women at high-risk would result in a 6-fold reduction in the number of invasive procedures. It would also avoid 2 false-negative results (trisomy 21) diagnosed in women with intermediate-risk using the current screening strategy of combined invasive and noninvasive testing.

Access JECP study

Diagnostic testing needed to confirm cfDNA results for aneuploidy and microdeletions, finds retrospective study

Researchers at the David Geffen School of Medicine at the University of California-Los Angeles, found a 73.5% positive predictive value (95% CI, 63%-82%) for cfDNA screening for autosomal aneuploidy, a lower-than-reported rate. The positive predictive value for microdeletion testing was found to be 0%.

This was a retrospective cohort study published in June in the American Journal of Obstetrics and Gynecology. It included 105 patients with abnormal or nonreportable cfDNA results for trisomies 21, 18, or 13, and 26 patients with positive or nonreportable microdeletions. Of the 105 patients with abnormal results for the trisomies, 92 results (87.6%) were positive for trisomy 21 (48, 52.2%), trisomy 18 (22, 23.9%), trisomy 13 (17, 18.5%), triploidy (2, 2.2%) and positive for >1 parameter (3, 3.3%). An additional 13 results (12.4%) were nonreportable.

Abnormal cfDNA results were associated with positive serum screening (by group: trisomy 21 [17/48]; trisomy 18 [7/22]; trisomy 13 [3/17]; nonreportable [2/13]; P = .004), and abnormal first-trimester ultrasound (trisomy 21 [25/45]; trisomy 18 [13/20]; trisomy 13 [6/14]; nonreportable [1/13]; P = .003). There was no association between false-positive rates and testing platform, but there was a difference between the 4 laboratories included in the study (P = .018).

In all, 26 patients had positive (n = 9) or nonreportable (n = 17) microdeletion results. Seven of 9 screens positive for microdeletions underwent confirmatory testing; all were false positives.

Access study in AJOG

When is NIPT appropriate for use as a diagnostic tool? Large-scale systematic review evaluates the answer.

Many systematic reviews and meta-analyses evaluating the accuracy of cell-free fetal (cf) DNA−based testing have been published. This May 2016 study in the British Journal of Obstetrics and Gynecology was the most comprehensive of singleton pregnancies to date, say researchers, who aimed to reduce analysis bias by including only cohort studies (117 analyzed), undertaking bivariate meta-analysis when possible, and including all indications for antenatal use, which allowed for a uniform comparison of NIPT use in actual clinical practice.

The researchers concluded that cell-free fetal (cf) DNA−based NIPT is diagnostic for fetal sex and rhesus D (RHD) status. For trisomies 21, 18, and 13, however, they concluded that the lower sensitivities and specificities found and disease prevalence, combined with the biological influence of confined placental mosaicism, designates NIPT as a screening test (with invasive testing required to confirm a positive test result). They advised that these factors be considered not only when clinicians are counseling patients but also in the overall assessment of the cost of introducing NIPT into routine care.

Visit BJOG study

2016 update on NIPT from the American College of Medical Genetics and Genomics

The American College of Medical Genetics and Genomics (ACMG) has published an updated position statement in Genetics in Medicine in July 2016 that replaces its 2013 statement. Among its recommendations, the ACMG advocates:

• providing up-to-date, balanced, and accurate information early in gestation to optimize patient decision making, independent of the screening approach used
• that laboratories work with public health officials, policymakers, and private payers to make NIPT, including the pretest and posttest education and counseling, accessible to all pregnant women
• informing all pregnant women that diagnostic testing (chorionic villus sampling or amniocentesis) is an option for the detection of chromosome abnormalities and clinically significant copy-number variants.

ACMG also recommends:

• informing all pregnant women that noninvasive prenatal screening (NIPS) is the most sensitive screening option for traditionally screened aneuploidies
• referring patients to a trained genetics professional when an increased risk of aneuploidy is reported after NIPS
• offering diagnostic testing when a positive screening test result is reported after NIPS
• laboratories provide readily visible and clearly stated detection rate (DR), clinical specificity (SPEC), and positive predictive values (PPV), and negative predictive values (NPVs) for conditions being screened
• laboratories not offer screening for Patau, Edwards, and Down syndromes if they cannot report DR, SPEC, and PPV values for these conditions.

ACMG does not recommend:

• NIPS to screen for autosomal aneuploidies other than those involving chromosomes 13, 18, and 21.

Visit full recommendations

Public health perspective: Long-term study concludes implementing cfDNA in high-risk women could be cost-effective

Researchers in Italy retrospectively analyzed the performance of first-trimester screening (FTS) test in a general obstetrics population, including a cost-benefit analysis of a hypothetical model that implemented universal FTS testing using cfDNA. A 2-step strategy based on nuchal translucency, serum screening, and ultrasound assessment of the nasal bone was applied when analyzing the FTS results of 6,679 women. The researchers identified 3 groups: high-risk: >1:250; intermediate-risk: 1:251-1:999; and low-risk group: <1:1000. Women at intermediate-risk underwent NB assessment and recalculation of individual risk. All women at high-risk were offered fetal karyotyping.

The investigators concluded that the Italian public health system would not be able to sustain the cost of universal cfDNA testing in women undergoing FTS. However, a possible scenario based on use of cfDNA FTS in women at high-risk would result in a 6-fold reduction in the number of invasive procedures. It would also avoid 2 false-negative results (trisomy 21) diagnosed in women with intermediate-risk using the current screening strategy of combined invasive and noninvasive testing.

Access JECP study

Diagnostic testing needed to confirm cfDNA results for aneuploidy and microdeletions, finds retrospective study

Researchers at the David Geffen School of Medicine at the University of California-Los Angeles, found a 73.5% positive predictive value (95% CI, 63%-82%) for cfDNA screening for autosomal aneuploidy, a lower-than-reported rate. The positive predictive value for microdeletion testing was found to be 0%.

This was a retrospective cohort study published in June in the American Journal of Obstetrics and Gynecology. It included 105 patients with abnormal or nonreportable cfDNA results for trisomies 21, 18, or 13, and 26 patients with positive or nonreportable microdeletions. Of the 105 patients with abnormal results for the trisomies, 92 results (87.6%) were positive for trisomy 21 (48, 52.2%), trisomy 18 (22, 23.9%), trisomy 13 (17, 18.5%), triploidy (2, 2.2%) and positive for >1 parameter (3, 3.3%). An additional 13 results (12.4%) were nonreportable.

Abnormal cfDNA results were associated with positive serum screening (by group: trisomy 21 [17/48]; trisomy 18 [7/22]; trisomy 13 [3/17]; nonreportable [2/13]; P = .004), and abnormal first-trimester ultrasound (trisomy 21 [25/45]; trisomy 18 [13/20]; trisomy 13 [6/14]; nonreportable [1/13]; P = .003). There was no association between false-positive rates and testing platform, but there was a difference between the 4 laboratories included in the study (P = .018).

In all, 26 patients had positive (n = 9) or nonreportable (n = 17) microdeletion results. Seven of 9 screens positive for microdeletions underwent confirmatory testing; all were false positives.

Access study in AJOG

When is NIPT appropriate for use as a diagnostic tool? Large-scale systematic review evaluates the answer.

Many systematic reviews and meta-analyses evaluating the accuracy of cell-free fetal (cf) DNA−based testing have been published. This May 2016 study in the British Journal of Obstetrics and Gynecology was the most comprehensive of singleton pregnancies to date, say researchers, who aimed to reduce analysis bias by including only cohort studies (117 analyzed), undertaking bivariate meta-analysis when possible, and including all indications for antenatal use, which allowed for a uniform comparison of NIPT use in actual clinical practice.

The researchers concluded that cell-free fetal (cf) DNA−based NIPT is diagnostic for fetal sex and rhesus D (RHD) status. For trisomies 21, 18, and 13, however, they concluded that the lower sensitivities and specificities found and disease prevalence, combined with the biological influence of confined placental mosaicism, designates NIPT as a screening test (with invasive testing required to confirm a positive test result). They advised that these factors be considered not only when clinicians are counseling patients but also in the overall assessment of the cost of introducing NIPT into routine care.

Visit BJOG study

2016 update on NIPT from the American College of Medical Genetics and Genomics

The American College of Medical Genetics and Genomics (ACMG) has published an updated position statement in Genetics in Medicine in July 2016 that replaces its 2013 statement. Among its recommendations, the ACMG advocates:

• providing up-to-date, balanced, and accurate information early in gestation to optimize patient decision making, independent of the screening approach used
• that laboratories work with public health officials, policymakers, and private payers to make NIPT, including the pretest and posttest education and counseling, accessible to all pregnant women
• informing all pregnant women that diagnostic testing (chorionic villus sampling or amniocentesis) is an option for the detection of chromosome abnormalities and clinically significant copy-number variants.

ACMG also recommends:

• informing all pregnant women that noninvasive prenatal screening (NIPS) is the most sensitive screening option for traditionally screened aneuploidies
• referring patients to a trained genetics professional when an increased risk of aneuploidy is reported after NIPS
• offering diagnostic testing when a positive screening test result is reported after NIPS
• laboratories provide readily visible and clearly stated detection rate (DR), clinical specificity (SPEC), and positive predictive values (PPV), and negative predictive values (NPVs) for conditions being screened
• laboratories not offer screening for Patau, Edwards, and Down syndromes if they cannot report DR, SPEC, and PPV values for these conditions.

ACMG does not recommend:

• NIPS to screen for autosomal aneuploidies other than those involving chromosomes 13, 18, and 21.

Visit full recommendations

Public health perspective: Long-term study concludes implementing cfDNA in high-risk women could be cost-effective

Researchers in Italy retrospectively analyzed the performance of first-trimester screening (FTS) test in a general obstetrics population, including a cost-benefit analysis of a hypothetical model that implemented universal FTS testing using cfDNA. A 2-step strategy based on nuchal translucency, serum screening, and ultrasound assessment of the nasal bone was applied when analyzing the FTS results of 6,679 women. The researchers identified 3 groups: high-risk: >1:250; intermediate-risk: 1:251-1:999; and low-risk group: <1:1000. Women at intermediate-risk underwent NB assessment and recalculation of individual risk. All women at high-risk were offered fetal karyotyping.

The investigators concluded that the Italian public health system would not be able to sustain the cost of universal cfDNA testing in women undergoing FTS. However, a possible scenario based on use of cfDNA FTS in women at high-risk would result in a 6-fold reduction in the number of invasive procedures. It would also avoid 2 false-negative results (trisomy 21) diagnosed in women with intermediate-risk using the current screening strategy of combined invasive and noninvasive testing.

Access JECP study

VIENNA – Early-onset idiopathic epilepsy occurring before age 7 years nearly doubles the likelihood that a child with autism spectrum disorder will later develop comorbid attention-deficit/hyperactivity disorder, Johnny Downs, MD, reported at the annual congress of the European College of Neuropsychopharmacology.

Comorbid ADHD is common in the setting of autism spectrum disorder (ASD). In a search for risk factors for the comorbid condition, he and his coinvestigators reviewed the physical health records prior to age 7 years of 3,032 patients with ASD referred at ages 3-17 years to child and adolescent mental health services clinics serving South London.

Bruce Jancin/Frontline Medical News

“That’s information that often doesn’t make it into the clinical psychiatric record,” noted Dr. Downs, a child psychiatrist at King’s College London.

Half of the 3,032 subjects were diagnosed with ASD at age 6-12 years and another 39% at age 13-17. During 5 years of prospective follow-up after being diagnosed with ASD in this longitudinal observational study, 25.5% of patients were diagnosed with comorbid ADHD. Looking back through the early physical health records, 114 (3.76%) of study participants had experienced early-onset epilepsy before age 7 years.

This large sample size allowed for robust multivariate adjustment for potential confounders. In a multivariate analysis, ASD patients with a history of early-onset epilepsy were at a significant 1.75-fold increased risk for subsequent comorbid ADHD. The analysis was adjusted for family history of epilepsy, sociodemographic factors, intellectual disability, previous head injury, perinatal complications, central nervous system tumors, early meningitis, and other confounders.

“The take-home message would be if you’ve got social and communication difficulties in a young child appearing at the age of 5, 6, or 7 [years], and there’s a history of seizures, we are seeing from observational data that the child is at increased risk of ADHD over the age of 7,” Dr. Downs said in an interview.

Compared with white subjects with ASD, the risk of developing comorbid ADHD was reduced by 37% in black and by 52% in Asian patients with ASD.

He plans further studies aimed at determining whether conventional ADHD management strategies have the same risk/benefit ratios in children with ASD and comorbid ADHD as in those with ADHD alone.

Dr. Downs reported having no financial conflicts of interest regarding his study, which was conducted free of commercial support.

[email protected]

VIENNA – Early-onset idiopathic epilepsy occurring before age 7 years nearly doubles the likelihood that a child with autism spectrum disorder will later develop comorbid attention-deficit/hyperactivity disorder, Johnny Downs, MD, reported at the annual congress of the European College of Neuropsychopharmacology.

Comorbid ADHD is common in the setting of autism spectrum disorder (ASD). In a search for risk factors for the comorbid condition, he and his coinvestigators reviewed the physical health records prior to age 7 years of 3,032 patients with ASD referred at ages 3-17 years to child and adolescent mental health services clinics serving South London.

Bruce Jancin/Frontline Medical News

“That’s information that often doesn’t make it into the clinical psychiatric record,” noted Dr. Downs, a child psychiatrist at King’s College London.

Half of the 3,032 subjects were diagnosed with ASD at age 6-12 years and another 39% at age 13-17. During 5 years of prospective follow-up after being diagnosed with ASD in this longitudinal observational study, 25.5% of patients were diagnosed with comorbid ADHD. Looking back through the early physical health records, 114 (3.76%) of study participants had experienced early-onset epilepsy before age 7 years.

This large sample size allowed for robust multivariate adjustment for potential confounders. In a multivariate analysis, ASD patients with a history of early-onset epilepsy were at a significant 1.75-fold increased risk for subsequent comorbid ADHD. The analysis was adjusted for family history of epilepsy, sociodemographic factors, intellectual disability, previous head injury, perinatal complications, central nervous system tumors, early meningitis, and other confounders.

“The take-home message would be if you’ve got social and communication difficulties in a young child appearing at the age of 5, 6, or 7 [years], and there’s a history of seizures, we are seeing from observational data that the child is at increased risk of ADHD over the age of 7,” Dr. Downs said in an interview.

Compared with white subjects with ASD, the risk of developing comorbid ADHD was reduced by 37% in black and by 52% in Asian patients with ASD.

He plans further studies aimed at determining whether conventional ADHD management strategies have the same risk/benefit ratios in children with ASD and comorbid ADHD as in those with ADHD alone.

Dr. Downs reported having no financial conflicts of interest regarding his study, which was conducted free of commercial support.

[email protected]

VIENNA – Early-onset idiopathic epilepsy occurring before age 7 years nearly doubles the likelihood that a child with autism spectrum disorder will later develop comorbid attention-deficit/hyperactivity disorder, Johnny Downs, MD, reported at the annual congress of the European College of Neuropsychopharmacology.

Comorbid ADHD is common in the setting of autism spectrum disorder (ASD). In a search for risk factors for the comorbid condition, he and his coinvestigators reviewed the physical health records prior to age 7 years of 3,032 patients with ASD referred at ages 3-17 years to child and adolescent mental health services clinics serving South London.

Bruce Jancin/Frontline Medical News

“That’s information that often doesn’t make it into the clinical psychiatric record,” noted Dr. Downs, a child psychiatrist at King’s College London.

Half of the 3,032 subjects were diagnosed with ASD at age 6-12 years and another 39% at age 13-17. During 5 years of prospective follow-up after being diagnosed with ASD in this longitudinal observational study, 25.5% of patients were diagnosed with comorbid ADHD. Looking back through the early physical health records, 114 (3.76%) of study participants had experienced early-onset epilepsy before age 7 years.

This large sample size allowed for robust multivariate adjustment for potential confounders. In a multivariate analysis, ASD patients with a history of early-onset epilepsy were at a significant 1.75-fold increased risk for subsequent comorbid ADHD. The analysis was adjusted for family history of epilepsy, sociodemographic factors, intellectual disability, previous head injury, perinatal complications, central nervous system tumors, early meningitis, and other confounders.

“The take-home message would be if you’ve got social and communication difficulties in a young child appearing at the age of 5, 6, or 7 [years], and there’s a history of seizures, we are seeing from observational data that the child is at increased risk of ADHD over the age of 7,” Dr. Downs said in an interview.

Compared with white subjects with ASD, the risk of developing comorbid ADHD was reduced by 37% in black and by 52% in Asian patients with ASD.

He plans further studies aimed at determining whether conventional ADHD management strategies have the same risk/benefit ratios in children with ASD and comorbid ADHD as in those with ADHD alone.

Dr. Downs reported having no financial conflicts of interest regarding his study, which was conducted free of commercial support.

[email protected]

ORLANDO – Use of sacubitril/valsartan to treat patients with heart failure with reduced ejection fraction (HFrEF) became a class I recommendation in both the U.S. and European heart failure guidelines in May 2016, but virtually all U.S. health insurers continue to regard the potent and effective sacubitril/valsartan formulation as a second-line treatment that needs special preauthorization before patients receive reimbursement for the prescription.

“What is really morally sad is that U.S. payers are requiring physicians to fill out extensive, patient-by-patient paperwork” to allow patients with HFrEF to receive health insurance coverage for sacubitril/valsartan (Entresto), Milton Packer, MD, said at the annual scientific meeting of the Heart Failure Society of America.

Mitchel L. Zoler/Frontline Medical News

“It is very difficult to understand why third-party payers would intentionally try to slow adoption of this life-saving drug simply because it is considered expensive. It is much cheaper than many drugs they cover for patients with cancer that don’t work half as well,” said Dr. Packer, a cardiologist and heart failure specialist at Baylor University Medical Center in Dallas.

The “excessive paperwork” for insurers when starting patients on sacubitril/valsartan is a “new and unique phenomenon among the cardiovascular drugs I prescribe,” agreed Nancy K. Sweitzer, MD, PhD, professor and chief of cardiology at the University of Arizona in Tuscon. “This approach by insurers seems based on cost; they do not want to pay” for sacubitril/valsartan, and to successfully arrange for coverage patients need to exactly match the enrollment criteria used in the PARADIGM-HF (Prospective Comparison of ARNI [Angiotensin Receptor – Neprilysin Inhibitor] with ACEI [Angiotensin-Converting Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial ), the pivotal study that supplied the evidence base for making sacubitril/valsartan a class I agent for treating HFrEF.

“I don’t put some HFrEF patients on sacubitil/valsartan just because they don’t meet the trial’s entry criteria,” Dr. Sweitzer said in an interview. “Insurers seem to scrutinize every single parameter to make sure patients match the PARADIGM-HF patients. Coverage is denied if their BNP [brain natriuretic peptide] level is too low.” Dr. Sweitzer added that in one instance she had to submit a second preauthorization to simply uptitrate the dosage of sacubitril/valsartan she wanted a patient to receive.

“Based on the data it seems like you could easily identify HFrEF patients who are good candidates for sacubitril/valsartan, but your hands are tied by payers because you can’t prescribe it until you’ve first tried something else, and even then you still need to deal with a lot of paperwork,” agreed Robert O. Bonow, MD, professor of medicine at Northwestern University in Chicago. “The paperwork burden is really cumbersome for physicians with busy practices; it impedes taking care of patients,” Dr. Bonow said in an interview.

Sales figures for sacubitril/valsartan that the drug’s manufacturer, Novartis, has reported since the agent received U.S. marketing approval a little over a year ago reflect these challenges in prescribing the compound to patients. During the first quarter of 2016, Novartis reported $17 million in worldwide sales of the agent, followed by $32 million in worldwide sales during the second quarter of 2016, through June 30. With a total of $49 million in sacubitril/valsartan sales during the first 6 months of 2016, it seems like Novartis may be challenged to meet its stated target of $200 million in total sales of the compound during 2016. In April, one commentator called the $17 million sales figure for first quarter 2016 “an astonishingly small amount for a drug that was widely expected to be a blockbuster.”

Dr. Packer has in the past been a consultant to Novartis and was one of the lead investigators for the PARADIGM-HF trial. He said that currently he has no financial relationship with Novartis but he does serve as a consultant to several other drug companies. Dr. Sweitzer has received research support from Novartis and was an investigator for PARADIGM-HF. Dr. Bonow has been a consultant to Gilead.

[email protected]

On Twitter @mitchelzoler

ORLANDO – Use of sacubitril/valsartan to treat patients with heart failure with reduced ejection fraction (HFrEF) became a class I recommendation in both the U.S. and European heart failure guidelines in May 2016, but virtually all U.S. health insurers continue to regard the potent and effective sacubitril/valsartan formulation as a second-line treatment that needs special preauthorization before patients receive reimbursement for the prescription.

“What is really morally sad is that U.S. payers are requiring physicians to fill out extensive, patient-by-patient paperwork” to allow patients with HFrEF to receive health insurance coverage for sacubitril/valsartan (Entresto), Milton Packer, MD, said at the annual scientific meeting of the Heart Failure Society of America.

Mitchel L. Zoler/Frontline Medical News

“It is very difficult to understand why third-party payers would intentionally try to slow adoption of this life-saving drug simply because it is considered expensive. It is much cheaper than many drugs they cover for patients with cancer that don’t work half as well,” said Dr. Packer, a cardiologist and heart failure specialist at Baylor University Medical Center in Dallas.

The “excessive paperwork” for insurers when starting patients on sacubitril/valsartan is a “new and unique phenomenon among the cardiovascular drugs I prescribe,” agreed Nancy K. Sweitzer, MD, PhD, professor and chief of cardiology at the University of Arizona in Tuscon. “This approach by insurers seems based on cost; they do not want to pay” for sacubitril/valsartan, and to successfully arrange for coverage patients need to exactly match the enrollment criteria used in the PARADIGM-HF (Prospective Comparison of ARNI [Angiotensin Receptor – Neprilysin Inhibitor] with ACEI [Angiotensin-Converting Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial ), the pivotal study that supplied the evidence base for making sacubitril/valsartan a class I agent for treating HFrEF.

“I don’t put some HFrEF patients on sacubitil/valsartan just because they don’t meet the trial’s entry criteria,” Dr. Sweitzer said in an interview. “Insurers seem to scrutinize every single parameter to make sure patients match the PARADIGM-HF patients. Coverage is denied if their BNP [brain natriuretic peptide] level is too low.” Dr. Sweitzer added that in one instance she had to submit a second preauthorization to simply uptitrate the dosage of sacubitril/valsartan she wanted a patient to receive.

“Based on the data it seems like you could easily identify HFrEF patients who are good candidates for sacubitril/valsartan, but your hands are tied by payers because you can’t prescribe it until you’ve first tried something else, and even then you still need to deal with a lot of paperwork,” agreed Robert O. Bonow, MD, professor of medicine at Northwestern University in Chicago. “The paperwork burden is really cumbersome for physicians with busy practices; it impedes taking care of patients,” Dr. Bonow said in an interview.

Sales figures for sacubitril/valsartan that the drug’s manufacturer, Novartis, has reported since the agent received U.S. marketing approval a little over a year ago reflect these challenges in prescribing the compound to patients. During the first quarter of 2016, Novartis reported $17 million in worldwide sales of the agent, followed by $32 million in worldwide sales during the second quarter of 2016, through June 30. With a total of $49 million in sacubitril/valsartan sales during the first 6 months of 2016, it seems like Novartis may be challenged to meet its stated target of $200 million in total sales of the compound during 2016. In April, one commentator called the $17 million sales figure for first quarter 2016 “an astonishingly small amount for a drug that was widely expected to be a blockbuster.”

Dr. Packer has in the past been a consultant to Novartis and was one of the lead investigators for the PARADIGM-HF trial. He said that currently he has no financial relationship with Novartis but he does serve as a consultant to several other drug companies. Dr. Sweitzer has received research support from Novartis and was an investigator for PARADIGM-HF. Dr. Bonow has been a consultant to Gilead.

[email protected]

On Twitter @mitchelzoler

ORLANDO – Use of sacubitril/valsartan to treat patients with heart failure with reduced ejection fraction (HFrEF) became a class I recommendation in both the U.S. and European heart failure guidelines in May 2016, but virtually all U.S. health insurers continue to regard the potent and effective sacubitril/valsartan formulation as a second-line treatment that needs special preauthorization before patients receive reimbursement for the prescription.

“What is really morally sad is that U.S. payers are requiring physicians to fill out extensive, patient-by-patient paperwork” to allow patients with HFrEF to receive health insurance coverage for sacubitril/valsartan (Entresto), Milton Packer, MD, said at the annual scientific meeting of the Heart Failure Society of America.

Mitchel L. Zoler/Frontline Medical News

“It is very difficult to understand why third-party payers would intentionally try to slow adoption of this life-saving drug simply because it is considered expensive. It is much cheaper than many drugs they cover for patients with cancer that don’t work half as well,” said Dr. Packer, a cardiologist and heart failure specialist at Baylor University Medical Center in Dallas.

The “excessive paperwork” for insurers when starting patients on sacubitril/valsartan is a “new and unique phenomenon among the cardiovascular drugs I prescribe,” agreed Nancy K. Sweitzer, MD, PhD, professor and chief of cardiology at the University of Arizona in Tuscon. “This approach by insurers seems based on cost; they do not want to pay” for sacubitril/valsartan, and to successfully arrange for coverage patients need to exactly match the enrollment criteria used in the PARADIGM-HF (Prospective Comparison of ARNI [Angiotensin Receptor – Neprilysin Inhibitor] with ACEI [Angiotensin-Converting Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial ), the pivotal study that supplied the evidence base for making sacubitril/valsartan a class I agent for treating HFrEF.

“I don’t put some HFrEF patients on sacubitil/valsartan just because they don’t meet the trial’s entry criteria,” Dr. Sweitzer said in an interview. “Insurers seem to scrutinize every single parameter to make sure patients match the PARADIGM-HF patients. Coverage is denied if their BNP [brain natriuretic peptide] level is too low.” Dr. Sweitzer added that in one instance she had to submit a second preauthorization to simply uptitrate the dosage of sacubitril/valsartan she wanted a patient to receive.

“Based on the data it seems like you could easily identify HFrEF patients who are good candidates for sacubitril/valsartan, but your hands are tied by payers because you can’t prescribe it until you’ve first tried something else, and even then you still need to deal with a lot of paperwork,” agreed Robert O. Bonow, MD, professor of medicine at Northwestern University in Chicago. “The paperwork burden is really cumbersome for physicians with busy practices; it impedes taking care of patients,” Dr. Bonow said in an interview.

Sales figures for sacubitril/valsartan that the drug’s manufacturer, Novartis, has reported since the agent received U.S. marketing approval a little over a year ago reflect these challenges in prescribing the compound to patients. During the first quarter of 2016, Novartis reported $17 million in worldwide sales of the agent, followed by $32 million in worldwide sales during the second quarter of 2016, through June 30. With a total of $49 million in sacubitril/valsartan sales during the first 6 months of 2016, it seems like Novartis may be challenged to meet its stated target of $200 million in total sales of the compound during 2016. In April, one commentator called the $17 million sales figure for first quarter 2016 “an astonishingly small amount for a drug that was widely expected to be a blockbuster.”

Dr. Packer has in the past been a consultant to Novartis and was one of the lead investigators for the PARADIGM-HF trial. He said that currently he has no financial relationship with Novartis but he does serve as a consultant to several other drug companies. Dr. Sweitzer has received research support from Novartis and was an investigator for PARADIGM-HF. Dr. Bonow has been a consultant to Gilead.

[email protected]

On Twitter @mitchelzoler