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COVID-19: Frequently asked clinical questions
Question
How should patients on immunosuppressive therapy be advised during the COVID-19 pandemic?
Answer
In general, those patients who have not tested positive, have not been exposed, and are asymptomatic should continue their medications as prescribed.
The American College of Rheumatology issued a statement on April 14, recommending that stable patients continue their medications. Those with known exposure but without confirmed infection may continue hydroxychloroquine, sulfasalazine, and NSAIDs.
Immunosuppressants, non–IL-6 biologics, and JAK inhibitors should be stopped temporarily, pending a negative test or after two weeks without symptoms. In patients with confirmed positive COVID-19 infection, sulfasalazine, methotrexate, leflunomide, immunosuppressants, non-IL-6 biologics, and JAK inhibitors should be stopped temporarily, pending a negative test or after two weeks without symptoms. In patients with confirmed positive COVID-19 infection, sulfasalazine, methotrexate, leflunomide, immunosuppressants, non-IL-6 biologics, and JAK inhibitors should be stopped temporarily. Anti-malarial therapies (hydroxycholoroquine and chloroquine) may be continued and IL-6 inhibitors may be continued in select circumstances.1
The American Academy of Dermatology recommends that the discussion of continuation of biologics be based on a case-by-case basis, citing insufficient evidence to recommend against discontinuation at this time in those patients who have not tested positive. In patients who have tested positive for COVID-19 it is recommended that biologic therapy be suspended until symptoms have resolved.2
Question
Should I continue preventive services during peak COVID-19?
Answer
The Centers for Disease Control and Prevention recommends delaying all elective ambulatory provider visits. In general, preventative services, such as adult immunizations, lipid screening, and cancer screenings, should be delayed. Additionally, the CDC recommends reaching out to patients who are at high risk for complications from respiratory diseases to ensure medication adherence and provide resources if these patients become ill. Facilities can reduce transmission of COVID-19 by triaging and assessing patients through virtual visits through phone calls, video conferences, text-monitoring systems, and other telemedicine tools. Physicians should try to provide routine and chronic care through virtual visits when possible over in-person visits.3
Question
Should I continue to vaccinate my pediatric population during peak COVID-19?
Answer
Practices that schedule separate well visits and sick visits in different sessions or locations can continue to provide well child visits. A practice could, for example, schedule well visits in the morning and sick visits in the afternoon if a single facility is used. These practices should prioritize newborn care and vaccinations of children, especially for those under the age of 24 months.4
Question
Can physicians use telehealth (phone only or audiovisual) to conduct visits with Medicare patients even if they are new patients?
Answer
Effective March 1 through the duration of the pandemic, Medicare will pay physicians for telehealth services at the same rate as an in-office visit. On March 30th, the Centers for Medicare & Medcaid Services announced new policies for physicians and hospitals during the COVID-19 pandemic. These guidelines were updated on April 9.
Audio-only visits are now permitted and the limit on the number of these kinds of visits allowed per month has been waived. Controlled substances can be prescribed via telehealth; however, complying with each state’s individual laws is still required.
Use of any two-way, audiovisual device is permitted. The level of service billed for visits with both audio and visual components is the same as an in-office visit. Telemedicine can be used for both new and existing patients.5
A list of services that may be rendered via telehealth are available on the CMS website.6
It will be important to regularly check the references given, as information on some of these topics is updated frequently.
Dr. Chuong is a second-year resident in the family medicine residency, Dr. Flanagan is a third-year resident, and Dr. Matthews is an intern, all at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
References
1. ACR issues COVID-19 treatment guidance for rheumatic disease patients.
2. American Academy of Dermatology: Guidance on the use of biologic agents during COVID-19 outbreak.
3. Centers for Disease Control and Prevention. Actions to take in response to community transmission of COVID-19.
4. Centers for Disease Control and Prevention. Maintaining childhood immunizations during COVID19 pandemic.
5. Centers for Medicare & Medcaid Services. COVID-19 frequently asked questions (FAQs) on Medicare Fee-for-Service (FFS) billing.
6. Centers for Medicare & Medcaid Services. List of telehealth services.
Question
How should patients on immunosuppressive therapy be advised during the COVID-19 pandemic?
Answer
In general, those patients who have not tested positive, have not been exposed, and are asymptomatic should continue their medications as prescribed.
The American College of Rheumatology issued a statement on April 14, recommending that stable patients continue their medications. Those with known exposure but without confirmed infection may continue hydroxychloroquine, sulfasalazine, and NSAIDs.
Immunosuppressants, non–IL-6 biologics, and JAK inhibitors should be stopped temporarily, pending a negative test or after two weeks without symptoms. In patients with confirmed positive COVID-19 infection, sulfasalazine, methotrexate, leflunomide, immunosuppressants, non-IL-6 biologics, and JAK inhibitors should be stopped temporarily, pending a negative test or after two weeks without symptoms. In patients with confirmed positive COVID-19 infection, sulfasalazine, methotrexate, leflunomide, immunosuppressants, non-IL-6 biologics, and JAK inhibitors should be stopped temporarily. Anti-malarial therapies (hydroxycholoroquine and chloroquine) may be continued and IL-6 inhibitors may be continued in select circumstances.1
The American Academy of Dermatology recommends that the discussion of continuation of biologics be based on a case-by-case basis, citing insufficient evidence to recommend against discontinuation at this time in those patients who have not tested positive. In patients who have tested positive for COVID-19 it is recommended that biologic therapy be suspended until symptoms have resolved.2
Question
Should I continue preventive services during peak COVID-19?
Answer
The Centers for Disease Control and Prevention recommends delaying all elective ambulatory provider visits. In general, preventative services, such as adult immunizations, lipid screening, and cancer screenings, should be delayed. Additionally, the CDC recommends reaching out to patients who are at high risk for complications from respiratory diseases to ensure medication adherence and provide resources if these patients become ill. Facilities can reduce transmission of COVID-19 by triaging and assessing patients through virtual visits through phone calls, video conferences, text-monitoring systems, and other telemedicine tools. Physicians should try to provide routine and chronic care through virtual visits when possible over in-person visits.3
Question
Should I continue to vaccinate my pediatric population during peak COVID-19?
Answer
Practices that schedule separate well visits and sick visits in different sessions or locations can continue to provide well child visits. A practice could, for example, schedule well visits in the morning and sick visits in the afternoon if a single facility is used. These practices should prioritize newborn care and vaccinations of children, especially for those under the age of 24 months.4
Question
Can physicians use telehealth (phone only or audiovisual) to conduct visits with Medicare patients even if they are new patients?
Answer
Effective March 1 through the duration of the pandemic, Medicare will pay physicians for telehealth services at the same rate as an in-office visit. On March 30th, the Centers for Medicare & Medcaid Services announced new policies for physicians and hospitals during the COVID-19 pandemic. These guidelines were updated on April 9.
Audio-only visits are now permitted and the limit on the number of these kinds of visits allowed per month has been waived. Controlled substances can be prescribed via telehealth; however, complying with each state’s individual laws is still required.
Use of any two-way, audiovisual device is permitted. The level of service billed for visits with both audio and visual components is the same as an in-office visit. Telemedicine can be used for both new and existing patients.5
A list of services that may be rendered via telehealth are available on the CMS website.6
It will be important to regularly check the references given, as information on some of these topics is updated frequently.
Dr. Chuong is a second-year resident in the family medicine residency, Dr. Flanagan is a third-year resident, and Dr. Matthews is an intern, all at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
References
1. ACR issues COVID-19 treatment guidance for rheumatic disease patients.
2. American Academy of Dermatology: Guidance on the use of biologic agents during COVID-19 outbreak.
3. Centers for Disease Control and Prevention. Actions to take in response to community transmission of COVID-19.
4. Centers for Disease Control and Prevention. Maintaining childhood immunizations during COVID19 pandemic.
5. Centers for Medicare & Medcaid Services. COVID-19 frequently asked questions (FAQs) on Medicare Fee-for-Service (FFS) billing.
6. Centers for Medicare & Medcaid Services. List of telehealth services.
Question
How should patients on immunosuppressive therapy be advised during the COVID-19 pandemic?
Answer
In general, those patients who have not tested positive, have not been exposed, and are asymptomatic should continue their medications as prescribed.
The American College of Rheumatology issued a statement on April 14, recommending that stable patients continue their medications. Those with known exposure but without confirmed infection may continue hydroxychloroquine, sulfasalazine, and NSAIDs.
Immunosuppressants, non–IL-6 biologics, and JAK inhibitors should be stopped temporarily, pending a negative test or after two weeks without symptoms. In patients with confirmed positive COVID-19 infection, sulfasalazine, methotrexate, leflunomide, immunosuppressants, non-IL-6 biologics, and JAK inhibitors should be stopped temporarily, pending a negative test or after two weeks without symptoms. In patients with confirmed positive COVID-19 infection, sulfasalazine, methotrexate, leflunomide, immunosuppressants, non-IL-6 biologics, and JAK inhibitors should be stopped temporarily. Anti-malarial therapies (hydroxycholoroquine and chloroquine) may be continued and IL-6 inhibitors may be continued in select circumstances.1
The American Academy of Dermatology recommends that the discussion of continuation of biologics be based on a case-by-case basis, citing insufficient evidence to recommend against discontinuation at this time in those patients who have not tested positive. In patients who have tested positive for COVID-19 it is recommended that biologic therapy be suspended until symptoms have resolved.2
Question
Should I continue preventive services during peak COVID-19?
Answer
The Centers for Disease Control and Prevention recommends delaying all elective ambulatory provider visits. In general, preventative services, such as adult immunizations, lipid screening, and cancer screenings, should be delayed. Additionally, the CDC recommends reaching out to patients who are at high risk for complications from respiratory diseases to ensure medication adherence and provide resources if these patients become ill. Facilities can reduce transmission of COVID-19 by triaging and assessing patients through virtual visits through phone calls, video conferences, text-monitoring systems, and other telemedicine tools. Physicians should try to provide routine and chronic care through virtual visits when possible over in-person visits.3
Question
Should I continue to vaccinate my pediatric population during peak COVID-19?
Answer
Practices that schedule separate well visits and sick visits in different sessions or locations can continue to provide well child visits. A practice could, for example, schedule well visits in the morning and sick visits in the afternoon if a single facility is used. These practices should prioritize newborn care and vaccinations of children, especially for those under the age of 24 months.4
Question
Can physicians use telehealth (phone only or audiovisual) to conduct visits with Medicare patients even if they are new patients?
Answer
Effective March 1 through the duration of the pandemic, Medicare will pay physicians for telehealth services at the same rate as an in-office visit. On March 30th, the Centers for Medicare & Medcaid Services announced new policies for physicians and hospitals during the COVID-19 pandemic. These guidelines were updated on April 9.
Audio-only visits are now permitted and the limit on the number of these kinds of visits allowed per month has been waived. Controlled substances can be prescribed via telehealth; however, complying with each state’s individual laws is still required.
Use of any two-way, audiovisual device is permitted. The level of service billed for visits with both audio and visual components is the same as an in-office visit. Telemedicine can be used for both new and existing patients.5
A list of services that may be rendered via telehealth are available on the CMS website.6
It will be important to regularly check the references given, as information on some of these topics is updated frequently.
Dr. Chuong is a second-year resident in the family medicine residency, Dr. Flanagan is a third-year resident, and Dr. Matthews is an intern, all at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
References
1. ACR issues COVID-19 treatment guidance for rheumatic disease patients.
2. American Academy of Dermatology: Guidance on the use of biologic agents during COVID-19 outbreak.
3. Centers for Disease Control and Prevention. Actions to take in response to community transmission of COVID-19.
4. Centers for Disease Control and Prevention. Maintaining childhood immunizations during COVID19 pandemic.
5. Centers for Medicare & Medcaid Services. COVID-19 frequently asked questions (FAQs) on Medicare Fee-for-Service (FFS) billing.
6. Centers for Medicare & Medcaid Services. List of telehealth services.
Itchy bumps on back
This patient had prurigo nodularis (PN). The diagnosis usually is made clinically by the appearance of the lesions and the cycle of severe pruritus and scratching. In this case, the patient had acutely excoriated lesions in addition to more chronic lesions that had become hyperpigmented nodules. The distribution pattern on his back was typical and highlighted the clinical course of PN. There were no lesions present where the patient was unable to scratch; however, lesions were present where he could reach, hence the term Picker’s nodules. Often, these patients have a history of atopic dermatitis, and anxiety may play a role in patients nervously scratching the lesions.
Biopsy is indicated if there is suspicion of bullous pemphigoid or cutaneous T-cell lymphoma. Pathology of PN shows increased density of nerve fibers in the dermis along with an increased number of T cells, mast cells, and eosinophilic granulocytes. Most patients do not require biopsy unless the diagnosis is in doubt.
Treatment can be difficult due to the severe pruritis and subsequent scratching that appears to prolong the chronic cycle of inflammation. Daily use of nonsedating antihistamines (eg, loratadine, cetirizine) may help reduce pruritus and break the cycle. Sedating antihistamines (eg, diphenhydramine, hydroxyzine) can be used cautiously at bedtime; cotton gloves worn while sleeping may reduce nocturnal scratching and excoriations.
Topical steroids (eg, triamcinolone, betamethasone) can reduce the itching and local inflammation. Emollients can help with associated dyshidrosis and eczema, if present.
Second line therapies include topical calcineurin inhibitors (eg, tacrolimus, pimecrolimus), calcipotriene, and narrow beam UVB therapy.
This patient had done reasonably well with cetirizine and triamcinolone in the past, so treatment was restarted. He was counseled regarding the nature and chronicity of his PN and told that if he could achieve symptom control and stop scratching the lesions, his condition might resolve.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Zeidler C, Yosipovitch G, Ständer S. Prurigo nodularis and its management. Dermatol Clin. 2018;36:189-197.
This patient had prurigo nodularis (PN). The diagnosis usually is made clinically by the appearance of the lesions and the cycle of severe pruritus and scratching. In this case, the patient had acutely excoriated lesions in addition to more chronic lesions that had become hyperpigmented nodules. The distribution pattern on his back was typical and highlighted the clinical course of PN. There were no lesions present where the patient was unable to scratch; however, lesions were present where he could reach, hence the term Picker’s nodules. Often, these patients have a history of atopic dermatitis, and anxiety may play a role in patients nervously scratching the lesions.
Biopsy is indicated if there is suspicion of bullous pemphigoid or cutaneous T-cell lymphoma. Pathology of PN shows increased density of nerve fibers in the dermis along with an increased number of T cells, mast cells, and eosinophilic granulocytes. Most patients do not require biopsy unless the diagnosis is in doubt.
Treatment can be difficult due to the severe pruritis and subsequent scratching that appears to prolong the chronic cycle of inflammation. Daily use of nonsedating antihistamines (eg, loratadine, cetirizine) may help reduce pruritus and break the cycle. Sedating antihistamines (eg, diphenhydramine, hydroxyzine) can be used cautiously at bedtime; cotton gloves worn while sleeping may reduce nocturnal scratching and excoriations.
Topical steroids (eg, triamcinolone, betamethasone) can reduce the itching and local inflammation. Emollients can help with associated dyshidrosis and eczema, if present.
Second line therapies include topical calcineurin inhibitors (eg, tacrolimus, pimecrolimus), calcipotriene, and narrow beam UVB therapy.
This patient had done reasonably well with cetirizine and triamcinolone in the past, so treatment was restarted. He was counseled regarding the nature and chronicity of his PN and told that if he could achieve symptom control and stop scratching the lesions, his condition might resolve.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
This patient had prurigo nodularis (PN). The diagnosis usually is made clinically by the appearance of the lesions and the cycle of severe pruritus and scratching. In this case, the patient had acutely excoriated lesions in addition to more chronic lesions that had become hyperpigmented nodules. The distribution pattern on his back was typical and highlighted the clinical course of PN. There were no lesions present where the patient was unable to scratch; however, lesions were present where he could reach, hence the term Picker’s nodules. Often, these patients have a history of atopic dermatitis, and anxiety may play a role in patients nervously scratching the lesions.
Biopsy is indicated if there is suspicion of bullous pemphigoid or cutaneous T-cell lymphoma. Pathology of PN shows increased density of nerve fibers in the dermis along with an increased number of T cells, mast cells, and eosinophilic granulocytes. Most patients do not require biopsy unless the diagnosis is in doubt.
Treatment can be difficult due to the severe pruritis and subsequent scratching that appears to prolong the chronic cycle of inflammation. Daily use of nonsedating antihistamines (eg, loratadine, cetirizine) may help reduce pruritus and break the cycle. Sedating antihistamines (eg, diphenhydramine, hydroxyzine) can be used cautiously at bedtime; cotton gloves worn while sleeping may reduce nocturnal scratching and excoriations.
Topical steroids (eg, triamcinolone, betamethasone) can reduce the itching and local inflammation. Emollients can help with associated dyshidrosis and eczema, if present.
Second line therapies include topical calcineurin inhibitors (eg, tacrolimus, pimecrolimus), calcipotriene, and narrow beam UVB therapy.
This patient had done reasonably well with cetirizine and triamcinolone in the past, so treatment was restarted. He was counseled regarding the nature and chronicity of his PN and told that if he could achieve symptom control and stop scratching the lesions, his condition might resolve.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Zeidler C, Yosipovitch G, Ständer S. Prurigo nodularis and its management. Dermatol Clin. 2018;36:189-197.
Zeidler C, Yosipovitch G, Ständer S. Prurigo nodularis and its management. Dermatol Clin. 2018;36:189-197.
EU panel review supports decision to pull Picato from market
Picato was cleared for marketing in the European Union in November 2012. The European Commission requested a safety review of the drug in September 2019 after data suggested a higher number of skin cancer cases, including cases of squamous cell carcinoma, in patients using it, as reported by Medscape Medical News.
In January 2020, use of Picato was suspended as a precaution while the PRAC review was underway. One month later, marketing authorization was withdrawn at the request of Leo Laboratories Ltd, which marketed the medicine.
The PRAC has now concluded its review of all available data on the risk for skin cancer in patients using Picato, including results of a study that compared Picato with imiquimod.
The review found “a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod,” the EMA said Friday in a news release.
“The committee also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis,” the EMA said.
The agency recommends that patients who have used Picato watch for unusual skin changes or growths, which may occur weeks to months after use, and seek medical advice if any occur.
Picato continues to be available in the United States, although the US Food and Drug Administration is also looking into its safety and risks.
This article first appeared on Medscape.com.
Picato was cleared for marketing in the European Union in November 2012. The European Commission requested a safety review of the drug in September 2019 after data suggested a higher number of skin cancer cases, including cases of squamous cell carcinoma, in patients using it, as reported by Medscape Medical News.
In January 2020, use of Picato was suspended as a precaution while the PRAC review was underway. One month later, marketing authorization was withdrawn at the request of Leo Laboratories Ltd, which marketed the medicine.
The PRAC has now concluded its review of all available data on the risk for skin cancer in patients using Picato, including results of a study that compared Picato with imiquimod.
The review found “a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod,” the EMA said Friday in a news release.
“The committee also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis,” the EMA said.
The agency recommends that patients who have used Picato watch for unusual skin changes or growths, which may occur weeks to months after use, and seek medical advice if any occur.
Picato continues to be available in the United States, although the US Food and Drug Administration is also looking into its safety and risks.
This article first appeared on Medscape.com.
Picato was cleared for marketing in the European Union in November 2012. The European Commission requested a safety review of the drug in September 2019 after data suggested a higher number of skin cancer cases, including cases of squamous cell carcinoma, in patients using it, as reported by Medscape Medical News.
In January 2020, use of Picato was suspended as a precaution while the PRAC review was underway. One month later, marketing authorization was withdrawn at the request of Leo Laboratories Ltd, which marketed the medicine.
The PRAC has now concluded its review of all available data on the risk for skin cancer in patients using Picato, including results of a study that compared Picato with imiquimod.
The review found “a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod,” the EMA said Friday in a news release.
“The committee also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis,” the EMA said.
The agency recommends that patients who have used Picato watch for unusual skin changes or growths, which may occur weeks to months after use, and seek medical advice if any occur.
Picato continues to be available in the United States, although the US Food and Drug Administration is also looking into its safety and risks.
This article first appeared on Medscape.com.
Lesion Has Been Giving Him an Earful
ANSWER
The correct answer is gouty tophus (choice “b”).
DISCUSSION
Gout is a defect of purine metabolism, usually caused by underexcretion of uric acid. Diet and heredity also play parts in gout’s development. Gouty tophi usually develop after years of hyperuricemia. As uric acid builds up in the bloodstream over time, it can then begin to be deposited into joints—most commonly the first metatarsal-phalangeal—as well as cartilage or even bones.
On further questioning, the patient recalled having been told on several occasions that his serum uric acid was elevated. In retrospect, his arthritis was most likely gouty in nature.
In terms of the differential, BCC (choice “a”) is common on helical rims, but it would not have contained the type of material found in this patient’s lesion. Also, it would not have waxed and waned as this lesion had done.
Epidermal cysts (choice “c”) can certainly come and go in prominence, but they are filled with a cheesy, pasty material—not the dry crystalline substance found in this lesion. Moreover, most epidermal cysts will have a small comedonal punctum over the center of the lesion. Dystrophic calcification (choice “d”) can mimic gouty tophi, but it is usually rough, firm, and fixed. It certainly would not be coming and going as it pleases.
TREATMENT
Surgical excision of the tophus was offered, but the patient was content with knowing the correct diagnosis. His PCP had previously explained therapeutic options—such as medication and dietary changes—that could address the overall problem. The patient elected to pursue treatment with his PCP.
ANSWER
The correct answer is gouty tophus (choice “b”).
DISCUSSION
Gout is a defect of purine metabolism, usually caused by underexcretion of uric acid. Diet and heredity also play parts in gout’s development. Gouty tophi usually develop after years of hyperuricemia. As uric acid builds up in the bloodstream over time, it can then begin to be deposited into joints—most commonly the first metatarsal-phalangeal—as well as cartilage or even bones.
On further questioning, the patient recalled having been told on several occasions that his serum uric acid was elevated. In retrospect, his arthritis was most likely gouty in nature.
In terms of the differential, BCC (choice “a”) is common on helical rims, but it would not have contained the type of material found in this patient’s lesion. Also, it would not have waxed and waned as this lesion had done.
Epidermal cysts (choice “c”) can certainly come and go in prominence, but they are filled with a cheesy, pasty material—not the dry crystalline substance found in this lesion. Moreover, most epidermal cysts will have a small comedonal punctum over the center of the lesion. Dystrophic calcification (choice “d”) can mimic gouty tophi, but it is usually rough, firm, and fixed. It certainly would not be coming and going as it pleases.
TREATMENT
Surgical excision of the tophus was offered, but the patient was content with knowing the correct diagnosis. His PCP had previously explained therapeutic options—such as medication and dietary changes—that could address the overall problem. The patient elected to pursue treatment with his PCP.
ANSWER
The correct answer is gouty tophus (choice “b”).
DISCUSSION
Gout is a defect of purine metabolism, usually caused by underexcretion of uric acid. Diet and heredity also play parts in gout’s development. Gouty tophi usually develop after years of hyperuricemia. As uric acid builds up in the bloodstream over time, it can then begin to be deposited into joints—most commonly the first metatarsal-phalangeal—as well as cartilage or even bones.
On further questioning, the patient recalled having been told on several occasions that his serum uric acid was elevated. In retrospect, his arthritis was most likely gouty in nature.
In terms of the differential, BCC (choice “a”) is common on helical rims, but it would not have contained the type of material found in this patient’s lesion. Also, it would not have waxed and waned as this lesion had done.
Epidermal cysts (choice “c”) can certainly come and go in prominence, but they are filled with a cheesy, pasty material—not the dry crystalline substance found in this lesion. Moreover, most epidermal cysts will have a small comedonal punctum over the center of the lesion. Dystrophic calcification (choice “d”) can mimic gouty tophi, but it is usually rough, firm, and fixed. It certainly would not be coming and going as it pleases.
TREATMENT
Surgical excision of the tophus was offered, but the patient was content with knowing the correct diagnosis. His PCP had previously explained therapeutic options—such as medication and dietary changes—that could address the overall problem. The patient elected to pursue treatment with his PCP.
Over the years, the lesion on this 49-year-old man’s right ear has waxed and waned in prominence. Although it never causes pain, its unrelenting existence coupled with a history of basal cell carcinoma (BCC) on his face has caused him to worry. He has had no other lesions and is in otherwise good health, except for occasional bouts of arthritis, for which he takes ibuprofen, with good results.
While his family had suggested that the lesion could be a cyst, his primary care provider (PCP) disagreed and referred him to dermatology.
A 5-mm firm papule is located at the right helical crest. The lesion is skin-colored, with no redness, and nontender on palpation, although it is moderately firm and mobile. No punctum is noted.
The surrounding skin has no signs of sun damage, although the patient is quite fair. As a young man, he had far too much sun exposure, burning easily and tanning only with difficulty.
After consultation with the patient, the decision is made to incise the lesion using a #11 blade to examine its contents. The incision reveals a dry crystalline substance, which is easily cleared with brief curettage. This effectively leads to a flattening of the lesion.
Protean manifestations of COVID-19: “Our ignorance is profound”
Although a cause-and-effect relationship is unknown, people with the virus have presented with or developed heart disease, acute liver injury, ongoing GI issues, skin manifestations, neurologic damage, and other problems, especially among sicker people.
For example, French physicians described an association with encephalopathy, agitation, confusion, and corticospinal tract signs among 58 people hospitalized with acute respiratory distress (N Engl J Med. 2020 Apr 15. doi: 10.1056/NEJMc2008597).
In particular, Yale New Haven (Conn.) Hospital is dealing with unexpected complications up close. Almost half of the beds there are occupied by COVID-19 patients. Over 100 people are in the ICU, and almost 70 intubated. Of the more than 750 COVID admissions so far, only about 350 have been discharged. “Even in a bad flu season, you never see something like this; it’s just unheard of,” said Harlan Krumholz, MD, a Yale cardiologist and professor of medicine helping lead the efforts there.
Kidney injuries prominent
“When they get to the ICU, we are seeing lots of people with acute kidney injuries; lots of people developing endocrine problems; people having blood sugar control issues, coagulation issues, blood clots. We are just waking up to the wide range of ways this virus can affect people. Our ignorance is profound,” Dr. Krumholz said, but physicians “recognize that this thing has the capability of attacking almost every single organ system, and it may or may not present with respiratory symptoms.”
It’s a similar story at Mt. Sinai South Nassau, a hospital in Oceanside, N.Y. “We’ve seen a lot of renal injury in people having complications, a lot of acute dialysis,” but it’s unclear how much is caused by the virus and how much is simply because people are so sick, said Aaron Glatt, MD, infectious disease professor and chair of medicine at the hospital. However, he said things are looking brighter than at Yale.
“We are not seeing the same level of increase in cases that we had previously, and we are starting to see extubations and discharges. We’ve treated a number of patients with plasma therapy, and hopefully that will be of benefit. We’ve seen some response to” the immunosuppressive “tocilizumab [Actemra], and a lot of response to very good respiratory therapy. I think we are starting to flatten the curve,” Dr. Glatt said.
“Look for tricky symptoms”
The growing awareness of COVID’s protean manifestations is evident in Medscape’s Consult forum, an online community where physicians and medical students share information and seek advice; there’s been over 200 COVID-19 cases and questions since January.
Early on, traffic was mostly about typical pulmonary presentations, but lately it’s shifted to nonrespiratory involvement. Physicians want to know if what they are seeing is related to the virus, and if other people are seeing the same things.
There’s a case on Consult of a 37-year-old man with stomach pain, vomiting, and diarrhea, but no respiratory symptoms and a positive COVID test. A chest CT incidental to his abdominal scan revealed significant bilateral lung involvement.
A 69-year-old woman with a history of laparotomy and new onset intestinal subocclusion had only adhesions on a subsequent exploratory laparotomy, and was doing okay otherwise. She suddenly went into respiratory failure with progressive bradycardia and died 3 days later. Aspiration pneumonia, pulmonary embolism, and MI had been ruled out. “The pattern of cardiovascular failure was in favor of myocarditis, but we don’t have any other clue,” the physician said after describing a second similar case.
Another doctor on the forum reported elevated cardiac enzymes without coronary artery obstruction in a positive patient who went into shock, with an ejection fraction of 40% and markedly increased heart wall thickness, but no lung involvement. There are also two cases of idiopathic thrombocytopenia without fever of hypoxia.
An Italian gastroenterologist said: “Look for tricky symptoms.” Expand “patient history, asking about the sudden occurrence of dysgeusia and/or anosmia. These symptoms have become my guiding diagnostic light” in Verona. “Most patients become nauseated, [and] the taste of any food is unbearable. When I find these symptoms by history, the patient is COVID positive 100%.”
‘Make sure that they didn’t die in vain’
There was interest in those and other reports on Consult, and comments from physicians who have theories, but no certain answers about what is, and is not, caused by the virus.
Direct viral attack is likely a part of it, said Stanley Perlman, MD, PhD, a professor of microbiology and immunology at the University of Iowa, Iowa City.
The ACE2 receptor the virus uses to enter cells is common in many organs, plus there were extrapulmonary manifestations with severe acute respiratory syndrome (SARS), another pandemic caused by a zoonotic coronavirus almost 20 years ago. At least with SARS, “many organs were infected when examined at autopsy,” he said.
The body’s inflammatory response is almost certainly also in play. Progressive derangements in inflammatory markers – C-reactive protein, D-dimer, ferritin – correlate with worse prognosis, and “the cytokine storm that occurs in these patients can lead to a degree of encephalopathy, myocarditis, liver impairment, and kidney impairment; multiorgan dysfunction, in other words,” said William Shaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.
But in some cases, the virus might simply be a bystander to an unrelated disease process; in others, the experimental treatments being used might cause problems. Indeed, cardiology groups recently warned of torsade de pointes – a dangerously abnormal heart rhythm – with hydroxychloroquine and azithromycin.
“We think it’s some combination,” but don’t really know, Dr. Krumholz said. In the meantime, “we are forced to treat patients by instinct and first principles,” and long-term sequelae are unknown. “We don’t want to be in this position for long.”
To that end, he said, “this is the time for us all to hold hands and be together because we need to learn rapidly from each other. Our job is both to care for the people in front of us and make sure that they didn’t die in vain, that the experience they had is funneled into a larger set of data to make sure the next person is better off.”
Although a cause-and-effect relationship is unknown, people with the virus have presented with or developed heart disease, acute liver injury, ongoing GI issues, skin manifestations, neurologic damage, and other problems, especially among sicker people.
For example, French physicians described an association with encephalopathy, agitation, confusion, and corticospinal tract signs among 58 people hospitalized with acute respiratory distress (N Engl J Med. 2020 Apr 15. doi: 10.1056/NEJMc2008597).
In particular, Yale New Haven (Conn.) Hospital is dealing with unexpected complications up close. Almost half of the beds there are occupied by COVID-19 patients. Over 100 people are in the ICU, and almost 70 intubated. Of the more than 750 COVID admissions so far, only about 350 have been discharged. “Even in a bad flu season, you never see something like this; it’s just unheard of,” said Harlan Krumholz, MD, a Yale cardiologist and professor of medicine helping lead the efforts there.
Kidney injuries prominent
“When they get to the ICU, we are seeing lots of people with acute kidney injuries; lots of people developing endocrine problems; people having blood sugar control issues, coagulation issues, blood clots. We are just waking up to the wide range of ways this virus can affect people. Our ignorance is profound,” Dr. Krumholz said, but physicians “recognize that this thing has the capability of attacking almost every single organ system, and it may or may not present with respiratory symptoms.”
It’s a similar story at Mt. Sinai South Nassau, a hospital in Oceanside, N.Y. “We’ve seen a lot of renal injury in people having complications, a lot of acute dialysis,” but it’s unclear how much is caused by the virus and how much is simply because people are so sick, said Aaron Glatt, MD, infectious disease professor and chair of medicine at the hospital. However, he said things are looking brighter than at Yale.
“We are not seeing the same level of increase in cases that we had previously, and we are starting to see extubations and discharges. We’ve treated a number of patients with plasma therapy, and hopefully that will be of benefit. We’ve seen some response to” the immunosuppressive “tocilizumab [Actemra], and a lot of response to very good respiratory therapy. I think we are starting to flatten the curve,” Dr. Glatt said.
“Look for tricky symptoms”
The growing awareness of COVID’s protean manifestations is evident in Medscape’s Consult forum, an online community where physicians and medical students share information and seek advice; there’s been over 200 COVID-19 cases and questions since January.
Early on, traffic was mostly about typical pulmonary presentations, but lately it’s shifted to nonrespiratory involvement. Physicians want to know if what they are seeing is related to the virus, and if other people are seeing the same things.
There’s a case on Consult of a 37-year-old man with stomach pain, vomiting, and diarrhea, but no respiratory symptoms and a positive COVID test. A chest CT incidental to his abdominal scan revealed significant bilateral lung involvement.
A 69-year-old woman with a history of laparotomy and new onset intestinal subocclusion had only adhesions on a subsequent exploratory laparotomy, and was doing okay otherwise. She suddenly went into respiratory failure with progressive bradycardia and died 3 days later. Aspiration pneumonia, pulmonary embolism, and MI had been ruled out. “The pattern of cardiovascular failure was in favor of myocarditis, but we don’t have any other clue,” the physician said after describing a second similar case.
Another doctor on the forum reported elevated cardiac enzymes without coronary artery obstruction in a positive patient who went into shock, with an ejection fraction of 40% and markedly increased heart wall thickness, but no lung involvement. There are also two cases of idiopathic thrombocytopenia without fever of hypoxia.
An Italian gastroenterologist said: “Look for tricky symptoms.” Expand “patient history, asking about the sudden occurrence of dysgeusia and/or anosmia. These symptoms have become my guiding diagnostic light” in Verona. “Most patients become nauseated, [and] the taste of any food is unbearable. When I find these symptoms by history, the patient is COVID positive 100%.”
‘Make sure that they didn’t die in vain’
There was interest in those and other reports on Consult, and comments from physicians who have theories, but no certain answers about what is, and is not, caused by the virus.
Direct viral attack is likely a part of it, said Stanley Perlman, MD, PhD, a professor of microbiology and immunology at the University of Iowa, Iowa City.
The ACE2 receptor the virus uses to enter cells is common in many organs, plus there were extrapulmonary manifestations with severe acute respiratory syndrome (SARS), another pandemic caused by a zoonotic coronavirus almost 20 years ago. At least with SARS, “many organs were infected when examined at autopsy,” he said.
The body’s inflammatory response is almost certainly also in play. Progressive derangements in inflammatory markers – C-reactive protein, D-dimer, ferritin – correlate with worse prognosis, and “the cytokine storm that occurs in these patients can lead to a degree of encephalopathy, myocarditis, liver impairment, and kidney impairment; multiorgan dysfunction, in other words,” said William Shaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.
But in some cases, the virus might simply be a bystander to an unrelated disease process; in others, the experimental treatments being used might cause problems. Indeed, cardiology groups recently warned of torsade de pointes – a dangerously abnormal heart rhythm – with hydroxychloroquine and azithromycin.
“We think it’s some combination,” but don’t really know, Dr. Krumholz said. In the meantime, “we are forced to treat patients by instinct and first principles,” and long-term sequelae are unknown. “We don’t want to be in this position for long.”
To that end, he said, “this is the time for us all to hold hands and be together because we need to learn rapidly from each other. Our job is both to care for the people in front of us and make sure that they didn’t die in vain, that the experience they had is funneled into a larger set of data to make sure the next person is better off.”
Although a cause-and-effect relationship is unknown, people with the virus have presented with or developed heart disease, acute liver injury, ongoing GI issues, skin manifestations, neurologic damage, and other problems, especially among sicker people.
For example, French physicians described an association with encephalopathy, agitation, confusion, and corticospinal tract signs among 58 people hospitalized with acute respiratory distress (N Engl J Med. 2020 Apr 15. doi: 10.1056/NEJMc2008597).
In particular, Yale New Haven (Conn.) Hospital is dealing with unexpected complications up close. Almost half of the beds there are occupied by COVID-19 patients. Over 100 people are in the ICU, and almost 70 intubated. Of the more than 750 COVID admissions so far, only about 350 have been discharged. “Even in a bad flu season, you never see something like this; it’s just unheard of,” said Harlan Krumholz, MD, a Yale cardiologist and professor of medicine helping lead the efforts there.
Kidney injuries prominent
“When they get to the ICU, we are seeing lots of people with acute kidney injuries; lots of people developing endocrine problems; people having blood sugar control issues, coagulation issues, blood clots. We are just waking up to the wide range of ways this virus can affect people. Our ignorance is profound,” Dr. Krumholz said, but physicians “recognize that this thing has the capability of attacking almost every single organ system, and it may or may not present with respiratory symptoms.”
It’s a similar story at Mt. Sinai South Nassau, a hospital in Oceanside, N.Y. “We’ve seen a lot of renal injury in people having complications, a lot of acute dialysis,” but it’s unclear how much is caused by the virus and how much is simply because people are so sick, said Aaron Glatt, MD, infectious disease professor and chair of medicine at the hospital. However, he said things are looking brighter than at Yale.
“We are not seeing the same level of increase in cases that we had previously, and we are starting to see extubations and discharges. We’ve treated a number of patients with plasma therapy, and hopefully that will be of benefit. We’ve seen some response to” the immunosuppressive “tocilizumab [Actemra], and a lot of response to very good respiratory therapy. I think we are starting to flatten the curve,” Dr. Glatt said.
“Look for tricky symptoms”
The growing awareness of COVID’s protean manifestations is evident in Medscape’s Consult forum, an online community where physicians and medical students share information and seek advice; there’s been over 200 COVID-19 cases and questions since January.
Early on, traffic was mostly about typical pulmonary presentations, but lately it’s shifted to nonrespiratory involvement. Physicians want to know if what they are seeing is related to the virus, and if other people are seeing the same things.
There’s a case on Consult of a 37-year-old man with stomach pain, vomiting, and diarrhea, but no respiratory symptoms and a positive COVID test. A chest CT incidental to his abdominal scan revealed significant bilateral lung involvement.
A 69-year-old woman with a history of laparotomy and new onset intestinal subocclusion had only adhesions on a subsequent exploratory laparotomy, and was doing okay otherwise. She suddenly went into respiratory failure with progressive bradycardia and died 3 days later. Aspiration pneumonia, pulmonary embolism, and MI had been ruled out. “The pattern of cardiovascular failure was in favor of myocarditis, but we don’t have any other clue,” the physician said after describing a second similar case.
Another doctor on the forum reported elevated cardiac enzymes without coronary artery obstruction in a positive patient who went into shock, with an ejection fraction of 40% and markedly increased heart wall thickness, but no lung involvement. There are also two cases of idiopathic thrombocytopenia without fever of hypoxia.
An Italian gastroenterologist said: “Look for tricky symptoms.” Expand “patient history, asking about the sudden occurrence of dysgeusia and/or anosmia. These symptoms have become my guiding diagnostic light” in Verona. “Most patients become nauseated, [and] the taste of any food is unbearable. When I find these symptoms by history, the patient is COVID positive 100%.”
‘Make sure that they didn’t die in vain’
There was interest in those and other reports on Consult, and comments from physicians who have theories, but no certain answers about what is, and is not, caused by the virus.
Direct viral attack is likely a part of it, said Stanley Perlman, MD, PhD, a professor of microbiology and immunology at the University of Iowa, Iowa City.
The ACE2 receptor the virus uses to enter cells is common in many organs, plus there were extrapulmonary manifestations with severe acute respiratory syndrome (SARS), another pandemic caused by a zoonotic coronavirus almost 20 years ago. At least with SARS, “many organs were infected when examined at autopsy,” he said.
The body’s inflammatory response is almost certainly also in play. Progressive derangements in inflammatory markers – C-reactive protein, D-dimer, ferritin – correlate with worse prognosis, and “the cytokine storm that occurs in these patients can lead to a degree of encephalopathy, myocarditis, liver impairment, and kidney impairment; multiorgan dysfunction, in other words,” said William Shaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.
But in some cases, the virus might simply be a bystander to an unrelated disease process; in others, the experimental treatments being used might cause problems. Indeed, cardiology groups recently warned of torsade de pointes – a dangerously abnormal heart rhythm – with hydroxychloroquine and azithromycin.
“We think it’s some combination,” but don’t really know, Dr. Krumholz said. In the meantime, “we are forced to treat patients by instinct and first principles,” and long-term sequelae are unknown. “We don’t want to be in this position for long.”
To that end, he said, “this is the time for us all to hold hands and be together because we need to learn rapidly from each other. Our job is both to care for the people in front of us and make sure that they didn’t die in vain, that the experience they had is funneled into a larger set of data to make sure the next person is better off.”
Financial incentives affect the adoption of biosimilars
during the same time period in 2015-2019, according to an analysis published in Arthritis and Rheumatology.
The use of the biosimilars also was associated with cost savings at the VAMC, but not at the academic medical center, which illustrates that insufficient financial incentives can delay the adoption of biosimilars and the health care system’s realization of cost savings, according to the authors.
Medicare, which is not allowed to negotiate drug prices, is one of the largest payers for infused therapies. Medicare reimbursement for infused therapies is based on the latter’s average selling price (ASP) during the previous quarter. Institutions may negotiate purchase prices with drug manufacturers and receive Medicare reimbursement. Biosimilars generally have lower ASPs than their corresponding reference therapies, and biosimilar manufacturers may have less room to negotiate prices than reference therapy manufacturers. Consequently, a given institution might have a greater incentive to use reference products than to use biosimilars.
An examination of pharmacy data
The VA negotiates drug prices for all of its medical centers and has mandated that clinicians prefer biosimilars to their corresponding reference therapies, so Joshua F. Baker, MD, of the University of Pennsylvania and the Corporal Michael J. Crescenz VAMC, both in Philadelphia, and his colleagues hypothesized that the adoption of biosimilars had proceeded more quickly at a VAMC than at a nearby academic medical center.
The investigators examined pharmacy data from the University of Pennsylvania Health System (UPHS) electronic medical record and the Corporal Michael J. Crescenz VAMC to compare the frequency of prescribing biosimilars at these sites between Jan. 1, 2015, and May 31, 2019. Dr. Baker and his associates focused specifically on reference infliximab (Remicade) and the reference noninfusion therapies filgrastim (Neupogen) and pegfilgrastim (Neulasta) and on biosimilars of these therapies (infliximab-dyyb [Inflectra], infliximab-abda [Renflexis], filgrastim-sndz [Zarxio], and pegfilgrastim-jmdb [Fulphila]).
Because Medicare was the predominant payer, the researchers estimated reimbursement for reference and biosimilar infliximabs according to the Medicare Part B reimbursement policy. They defined an institution’s incentive to use a given therapy as the difference between the reimbursement and acquisition cost for that therapy. Dr. Baker and colleagues compared the incentives for UPHS with those for the VAMC.
VAMC saved 81% of reference product cost
The researchers identified 15,761 infusions of infliximab at UPHS and 446 at the VAMC during the study period. The proportion of infusions that used the reference product was 99% at UPHS and 62% at the VAMC. ASPs for biosimilar infliximab have been consistently lower than those for the reference product since July 2017. In December 2017, the VAMC switched to the biosimilar infliximab.
Institutional incentives based on Medicare Part B reimbursement and acquisitions costs for reference and biosimilar infliximab have been similar since 2018. In 2019, the institutional incentive favored the reference product by $49-$64 per 100-mg vial. But at the VAMC, the cost per 100-mg vial was $623.48 for the reference product and $115.58 for the biosimilar Renflexis. Purchasing the biosimilar thus yielded a savings of 81%. The current costs for the therapies are $546 and $116, respectively.
In addition, Dr. Baker and colleagues identified 46,683 orders for filgrastim or pegfilgrastim at UPHS. Approximately 90% of the orders were for either of the two reference products despite the ASP of biosimilar filgrastim being approximately 40% lower than that of its reference product. At the VAMC, about 88% of orders were for the reference products. Biosimilars became available in 2016. UPHS began using them at a modest rate, but their adoption was greater at the VAMC, which designated them as preferred products.
Tendering and a nationwide policy mandating use of biosimilars have resulted in financial savings for the VAMC, wrote Dr. Baker and colleagues. “These data suggest that, with current Medicare Part B reimbursement policy, the absence of financial incentives to encourage use of infliximab biosimilars has resulted in slower uptake of biosimilar use at institutions outside of the VA system. The implications of this are a slower reduction in costs to the health care system, since decreases in ASP over time are predicated on negotiations at the institutional level, which have been gradual and stepwise. ...
“Although some of our results may not be applicable to other geographical regions of the U.S., the comparison of two affiliated institutions in geographical proximity and with shared health care providers is a strength,” they continued. “Our findings should be replicated using national VAMC data or data from other health care systems.”
The researchers said that their findings may not apply to noninfused therapies, which are not covered under Medicare Part B, and they did not directly study the impact of pharmacy benefit managers. However, they noted that their data on filgrastim and pegfilgrastim support the hypothesis that pharmacy benefit managers receive “incentives that continue to promote the use of reference products that have higher manufacturer’s list prices, which likely will limit the uptake of both infused and injectable biosimilar therapies over time.” They said that “this finding has important implications for when noninfused biosimilars (e.g. etanercept and adalimumab) are eventually introduced to the U.S. market.”
European governments incentivize use of biosimilars
Government and institutional incentives have increased the adoption of biosimilars in Europe, wrote Guro Lovik Goll, MD, and Tore Kristian Kvien, MD, of the department of rheumatology at Diakonhjemmet Hospital in Oslo, in an accompanying editorial. Norway and Denmark have annual national tender systems in which biosimilars and reference products compete. The price of infliximab biosimilar was 39% lower than the reference product in 2014 and 69% lower in 2015. “Competition has caused dramatically lower prices both for biosimilars and also for the originator drugs competing with them,” wrote the authors.
In 2015, the government of Denmark mandated that patients on infliximab be switched to a biosimilar, and patients in Norway also have been switched to biosimilars. The use of etanercept in Norway increased by 40% from 2016 to 2019, and the use of infliximab has increased by more than threefold since 2015. “In Norway, the consequence of competition, national tenders, and availability of biosimilars have led to better access to therapy for more people in need of biologic drugs, while at the same time showing a total cost reduction of biologics for use in rheumatology, gastroenterology, and dermatology,” wrote the authors.
Health care costs $10,000 per capita in the United States, compared with $5,300 for other wealthy countries in the Organization for Economic Cooperation and Development. Low life expectancy and high infant mortality in the U.S. indicate that high costs are not associated with better outcomes. “As Americans seem to lose out on the cost-cutting potential of biosimilars, this missed opportunity is set to get even more expensive,” the authors concluded.
The U.S. Department of Veterans Affairs, the National Institutes of Health, and the American Diabetes Association contributed funding for the study. Dr. Baker reported receiving consulting fees from Bristol-Myers Squibb and Gilead, and another author reported receiving research support paid to his institution by Pfizer and UCB, as well as receiving consulting fees from nine pharmaceutical companies. Dr. Goll and Dr. Kvien both reported receiving fees for speaking and/or consulting from numerous pharmaceutical companies, including Pfizer.
SOURCES: Baker JF et al. Arthritis Rheumatol. 2020 Apr 6. doi: 10.1002/art.41277.
during the same time period in 2015-2019, according to an analysis published in Arthritis and Rheumatology.
The use of the biosimilars also was associated with cost savings at the VAMC, but not at the academic medical center, which illustrates that insufficient financial incentives can delay the adoption of biosimilars and the health care system’s realization of cost savings, according to the authors.
Medicare, which is not allowed to negotiate drug prices, is one of the largest payers for infused therapies. Medicare reimbursement for infused therapies is based on the latter’s average selling price (ASP) during the previous quarter. Institutions may negotiate purchase prices with drug manufacturers and receive Medicare reimbursement. Biosimilars generally have lower ASPs than their corresponding reference therapies, and biosimilar manufacturers may have less room to negotiate prices than reference therapy manufacturers. Consequently, a given institution might have a greater incentive to use reference products than to use biosimilars.
An examination of pharmacy data
The VA negotiates drug prices for all of its medical centers and has mandated that clinicians prefer biosimilars to their corresponding reference therapies, so Joshua F. Baker, MD, of the University of Pennsylvania and the Corporal Michael J. Crescenz VAMC, both in Philadelphia, and his colleagues hypothesized that the adoption of biosimilars had proceeded more quickly at a VAMC than at a nearby academic medical center.
The investigators examined pharmacy data from the University of Pennsylvania Health System (UPHS) electronic medical record and the Corporal Michael J. Crescenz VAMC to compare the frequency of prescribing biosimilars at these sites between Jan. 1, 2015, and May 31, 2019. Dr. Baker and his associates focused specifically on reference infliximab (Remicade) and the reference noninfusion therapies filgrastim (Neupogen) and pegfilgrastim (Neulasta) and on biosimilars of these therapies (infliximab-dyyb [Inflectra], infliximab-abda [Renflexis], filgrastim-sndz [Zarxio], and pegfilgrastim-jmdb [Fulphila]).
Because Medicare was the predominant payer, the researchers estimated reimbursement for reference and biosimilar infliximabs according to the Medicare Part B reimbursement policy. They defined an institution’s incentive to use a given therapy as the difference between the reimbursement and acquisition cost for that therapy. Dr. Baker and colleagues compared the incentives for UPHS with those for the VAMC.
VAMC saved 81% of reference product cost
The researchers identified 15,761 infusions of infliximab at UPHS and 446 at the VAMC during the study period. The proportion of infusions that used the reference product was 99% at UPHS and 62% at the VAMC. ASPs for biosimilar infliximab have been consistently lower than those for the reference product since July 2017. In December 2017, the VAMC switched to the biosimilar infliximab.
Institutional incentives based on Medicare Part B reimbursement and acquisitions costs for reference and biosimilar infliximab have been similar since 2018. In 2019, the institutional incentive favored the reference product by $49-$64 per 100-mg vial. But at the VAMC, the cost per 100-mg vial was $623.48 for the reference product and $115.58 for the biosimilar Renflexis. Purchasing the biosimilar thus yielded a savings of 81%. The current costs for the therapies are $546 and $116, respectively.
In addition, Dr. Baker and colleagues identified 46,683 orders for filgrastim or pegfilgrastim at UPHS. Approximately 90% of the orders were for either of the two reference products despite the ASP of biosimilar filgrastim being approximately 40% lower than that of its reference product. At the VAMC, about 88% of orders were for the reference products. Biosimilars became available in 2016. UPHS began using them at a modest rate, but their adoption was greater at the VAMC, which designated them as preferred products.
Tendering and a nationwide policy mandating use of biosimilars have resulted in financial savings for the VAMC, wrote Dr. Baker and colleagues. “These data suggest that, with current Medicare Part B reimbursement policy, the absence of financial incentives to encourage use of infliximab biosimilars has resulted in slower uptake of biosimilar use at institutions outside of the VA system. The implications of this are a slower reduction in costs to the health care system, since decreases in ASP over time are predicated on negotiations at the institutional level, which have been gradual and stepwise. ...
“Although some of our results may not be applicable to other geographical regions of the U.S., the comparison of two affiliated institutions in geographical proximity and with shared health care providers is a strength,” they continued. “Our findings should be replicated using national VAMC data or data from other health care systems.”
The researchers said that their findings may not apply to noninfused therapies, which are not covered under Medicare Part B, and they did not directly study the impact of pharmacy benefit managers. However, they noted that their data on filgrastim and pegfilgrastim support the hypothesis that pharmacy benefit managers receive “incentives that continue to promote the use of reference products that have higher manufacturer’s list prices, which likely will limit the uptake of both infused and injectable biosimilar therapies over time.” They said that “this finding has important implications for when noninfused biosimilars (e.g. etanercept and adalimumab) are eventually introduced to the U.S. market.”
European governments incentivize use of biosimilars
Government and institutional incentives have increased the adoption of biosimilars in Europe, wrote Guro Lovik Goll, MD, and Tore Kristian Kvien, MD, of the department of rheumatology at Diakonhjemmet Hospital in Oslo, in an accompanying editorial. Norway and Denmark have annual national tender systems in which biosimilars and reference products compete. The price of infliximab biosimilar was 39% lower than the reference product in 2014 and 69% lower in 2015. “Competition has caused dramatically lower prices both for biosimilars and also for the originator drugs competing with them,” wrote the authors.
In 2015, the government of Denmark mandated that patients on infliximab be switched to a biosimilar, and patients in Norway also have been switched to biosimilars. The use of etanercept in Norway increased by 40% from 2016 to 2019, and the use of infliximab has increased by more than threefold since 2015. “In Norway, the consequence of competition, national tenders, and availability of biosimilars have led to better access to therapy for more people in need of biologic drugs, while at the same time showing a total cost reduction of biologics for use in rheumatology, gastroenterology, and dermatology,” wrote the authors.
Health care costs $10,000 per capita in the United States, compared with $5,300 for other wealthy countries in the Organization for Economic Cooperation and Development. Low life expectancy and high infant mortality in the U.S. indicate that high costs are not associated with better outcomes. “As Americans seem to lose out on the cost-cutting potential of biosimilars, this missed opportunity is set to get even more expensive,” the authors concluded.
The U.S. Department of Veterans Affairs, the National Institutes of Health, and the American Diabetes Association contributed funding for the study. Dr. Baker reported receiving consulting fees from Bristol-Myers Squibb and Gilead, and another author reported receiving research support paid to his institution by Pfizer and UCB, as well as receiving consulting fees from nine pharmaceutical companies. Dr. Goll and Dr. Kvien both reported receiving fees for speaking and/or consulting from numerous pharmaceutical companies, including Pfizer.
SOURCES: Baker JF et al. Arthritis Rheumatol. 2020 Apr 6. doi: 10.1002/art.41277.
during the same time period in 2015-2019, according to an analysis published in Arthritis and Rheumatology.
The use of the biosimilars also was associated with cost savings at the VAMC, but not at the academic medical center, which illustrates that insufficient financial incentives can delay the adoption of biosimilars and the health care system’s realization of cost savings, according to the authors.
Medicare, which is not allowed to negotiate drug prices, is one of the largest payers for infused therapies. Medicare reimbursement for infused therapies is based on the latter’s average selling price (ASP) during the previous quarter. Institutions may negotiate purchase prices with drug manufacturers and receive Medicare reimbursement. Biosimilars generally have lower ASPs than their corresponding reference therapies, and biosimilar manufacturers may have less room to negotiate prices than reference therapy manufacturers. Consequently, a given institution might have a greater incentive to use reference products than to use biosimilars.
An examination of pharmacy data
The VA negotiates drug prices for all of its medical centers and has mandated that clinicians prefer biosimilars to their corresponding reference therapies, so Joshua F. Baker, MD, of the University of Pennsylvania and the Corporal Michael J. Crescenz VAMC, both in Philadelphia, and his colleagues hypothesized that the adoption of biosimilars had proceeded more quickly at a VAMC than at a nearby academic medical center.
The investigators examined pharmacy data from the University of Pennsylvania Health System (UPHS) electronic medical record and the Corporal Michael J. Crescenz VAMC to compare the frequency of prescribing biosimilars at these sites between Jan. 1, 2015, and May 31, 2019. Dr. Baker and his associates focused specifically on reference infliximab (Remicade) and the reference noninfusion therapies filgrastim (Neupogen) and pegfilgrastim (Neulasta) and on biosimilars of these therapies (infliximab-dyyb [Inflectra], infliximab-abda [Renflexis], filgrastim-sndz [Zarxio], and pegfilgrastim-jmdb [Fulphila]).
Because Medicare was the predominant payer, the researchers estimated reimbursement for reference and biosimilar infliximabs according to the Medicare Part B reimbursement policy. They defined an institution’s incentive to use a given therapy as the difference between the reimbursement and acquisition cost for that therapy. Dr. Baker and colleagues compared the incentives for UPHS with those for the VAMC.
VAMC saved 81% of reference product cost
The researchers identified 15,761 infusions of infliximab at UPHS and 446 at the VAMC during the study period. The proportion of infusions that used the reference product was 99% at UPHS and 62% at the VAMC. ASPs for biosimilar infliximab have been consistently lower than those for the reference product since July 2017. In December 2017, the VAMC switched to the biosimilar infliximab.
Institutional incentives based on Medicare Part B reimbursement and acquisitions costs for reference and biosimilar infliximab have been similar since 2018. In 2019, the institutional incentive favored the reference product by $49-$64 per 100-mg vial. But at the VAMC, the cost per 100-mg vial was $623.48 for the reference product and $115.58 for the biosimilar Renflexis. Purchasing the biosimilar thus yielded a savings of 81%. The current costs for the therapies are $546 and $116, respectively.
In addition, Dr. Baker and colleagues identified 46,683 orders for filgrastim or pegfilgrastim at UPHS. Approximately 90% of the orders were for either of the two reference products despite the ASP of biosimilar filgrastim being approximately 40% lower than that of its reference product. At the VAMC, about 88% of orders were for the reference products. Biosimilars became available in 2016. UPHS began using them at a modest rate, but their adoption was greater at the VAMC, which designated them as preferred products.
Tendering and a nationwide policy mandating use of biosimilars have resulted in financial savings for the VAMC, wrote Dr. Baker and colleagues. “These data suggest that, with current Medicare Part B reimbursement policy, the absence of financial incentives to encourage use of infliximab biosimilars has resulted in slower uptake of biosimilar use at institutions outside of the VA system. The implications of this are a slower reduction in costs to the health care system, since decreases in ASP over time are predicated on negotiations at the institutional level, which have been gradual and stepwise. ...
“Although some of our results may not be applicable to other geographical regions of the U.S., the comparison of two affiliated institutions in geographical proximity and with shared health care providers is a strength,” they continued. “Our findings should be replicated using national VAMC data or data from other health care systems.”
The researchers said that their findings may not apply to noninfused therapies, which are not covered under Medicare Part B, and they did not directly study the impact of pharmacy benefit managers. However, they noted that their data on filgrastim and pegfilgrastim support the hypothesis that pharmacy benefit managers receive “incentives that continue to promote the use of reference products that have higher manufacturer’s list prices, which likely will limit the uptake of both infused and injectable biosimilar therapies over time.” They said that “this finding has important implications for when noninfused biosimilars (e.g. etanercept and adalimumab) are eventually introduced to the U.S. market.”
European governments incentivize use of biosimilars
Government and institutional incentives have increased the adoption of biosimilars in Europe, wrote Guro Lovik Goll, MD, and Tore Kristian Kvien, MD, of the department of rheumatology at Diakonhjemmet Hospital in Oslo, in an accompanying editorial. Norway and Denmark have annual national tender systems in which biosimilars and reference products compete. The price of infliximab biosimilar was 39% lower than the reference product in 2014 and 69% lower in 2015. “Competition has caused dramatically lower prices both for biosimilars and also for the originator drugs competing with them,” wrote the authors.
In 2015, the government of Denmark mandated that patients on infliximab be switched to a biosimilar, and patients in Norway also have been switched to biosimilars. The use of etanercept in Norway increased by 40% from 2016 to 2019, and the use of infliximab has increased by more than threefold since 2015. “In Norway, the consequence of competition, national tenders, and availability of biosimilars have led to better access to therapy for more people in need of biologic drugs, while at the same time showing a total cost reduction of biologics for use in rheumatology, gastroenterology, and dermatology,” wrote the authors.
Health care costs $10,000 per capita in the United States, compared with $5,300 for other wealthy countries in the Organization for Economic Cooperation and Development. Low life expectancy and high infant mortality in the U.S. indicate that high costs are not associated with better outcomes. “As Americans seem to lose out on the cost-cutting potential of biosimilars, this missed opportunity is set to get even more expensive,” the authors concluded.
The U.S. Department of Veterans Affairs, the National Institutes of Health, and the American Diabetes Association contributed funding for the study. Dr. Baker reported receiving consulting fees from Bristol-Myers Squibb and Gilead, and another author reported receiving research support paid to his institution by Pfizer and UCB, as well as receiving consulting fees from nine pharmaceutical companies. Dr. Goll and Dr. Kvien both reported receiving fees for speaking and/or consulting from numerous pharmaceutical companies, including Pfizer.
SOURCES: Baker JF et al. Arthritis Rheumatol. 2020 Apr 6. doi: 10.1002/art.41277.
FROM ARTHRITIS & RHEUMATOLOGY
COVID-19 PPE-related skin effects described in survey of Chinese doctors, nurses
Almost 75% of doctors and nurses in and around Wuhan, China, where the outbreak first emerged, reported skin problems during a single week in early February 2020, in a survey of health care workers (HCW) caring for COVID-19 patients at five university and five regional hospitals. Hands, cheeks, and the nasal bridge were the most commonly affected areas, with skin dryness, maceration, papules, and erythema the most common problems, according to research published in the British Journal of Dermatology.
In New York City, masks in particular are “really an issue,” said Ellen Marmur, MD, a dermatologist in private practice and an associate clinical professor at the Mount Sinai School of Medicine, New York.
She’s dealing with patients who have abrasions and skin infections at the tip of the nose, bruising from the metal strap that goes across the bridge of the nose, and skin irritation from the straps. “Rosacea is [also] definitely flaring up, [and] people’s acne is definitely flaring up, not only because of the stress, but because of the sweat and humidity” that builds up under the masks, she said.
“It’s not a life-threatening thing, but it’s definitely something we’ve been helping people with,” she said. This includes her husband, a cardiologist pulling 12-hour shifts in a New York City hospital wearing an N95 mask; when he comes home, the tip of his nose is red and abraded.
Treatment entails first aid skin care: a dab of a gentle ointment like Aquaphor to prevent abrasions while the mask is on and to help them heal after it’s off, and bacitracin if infection is a worry. For acne and rosacea flares, a course of minocycline or topical clindamycin might help, Dr. Marmur said.
Although almost 75% of the doctors and nurses in the Chinese study reported skin problems, the response rate was low, just 376 of the 1,000 surveyed (37.6%). That might have tilted the results to providers who actually ran into problems, wrote the investigators, led by Ping Lin of the department of dermatology and venereology at Peking University First Hospital, Beijing.
Still, 280 (74.5%) reported adverse skin reactions from caring for COVID-19 patients. “Of note, this rate was much higher than the rate of occupational contact dermatitis (31.5%) in HCWs under normal working condition[s], and that of adverse skin reactions (21.4%-35.5%)” during the outbreak of another coronavirus in 2003, severe acute respiratory syndrome, they wrote.
Most providers in the study washed their hands more than 10 times a day, but only about 22% applied hand cream afterwards, they reported.
On multivariate analysis, working in hospitals harder hit by the pandemic (odds ratio, 2.41; P = .001), working on inpatient wards (OR, 2.44; P = .003), wearing full-body personal protective equipment over 6 hours (OR, 4.26; P < .001), and female sex (OR, 1.87; P = .038) increased the risk of adverse skin reactions. The team suggested moisturizers would help to protect against hand dermatitis, and alcohol-based products instead of soaps “as the former show high antimicrobial activity and low risks of skin damage.” Also, “restricting duration of wearing” of protection gear “to no more than 6 hours would help.”
The study investigators reported that they had no conflicts of interest.
SOURCE: Lin P et al. Br J Dermatol. 2020 Apr 7. doi: 10.1111/bjd.19089.
Almost 75% of doctors and nurses in and around Wuhan, China, where the outbreak first emerged, reported skin problems during a single week in early February 2020, in a survey of health care workers (HCW) caring for COVID-19 patients at five university and five regional hospitals. Hands, cheeks, and the nasal bridge were the most commonly affected areas, with skin dryness, maceration, papules, and erythema the most common problems, according to research published in the British Journal of Dermatology.
In New York City, masks in particular are “really an issue,” said Ellen Marmur, MD, a dermatologist in private practice and an associate clinical professor at the Mount Sinai School of Medicine, New York.
She’s dealing with patients who have abrasions and skin infections at the tip of the nose, bruising from the metal strap that goes across the bridge of the nose, and skin irritation from the straps. “Rosacea is [also] definitely flaring up, [and] people’s acne is definitely flaring up, not only because of the stress, but because of the sweat and humidity” that builds up under the masks, she said.
“It’s not a life-threatening thing, but it’s definitely something we’ve been helping people with,” she said. This includes her husband, a cardiologist pulling 12-hour shifts in a New York City hospital wearing an N95 mask; when he comes home, the tip of his nose is red and abraded.
Treatment entails first aid skin care: a dab of a gentle ointment like Aquaphor to prevent abrasions while the mask is on and to help them heal after it’s off, and bacitracin if infection is a worry. For acne and rosacea flares, a course of minocycline or topical clindamycin might help, Dr. Marmur said.
Although almost 75% of the doctors and nurses in the Chinese study reported skin problems, the response rate was low, just 376 of the 1,000 surveyed (37.6%). That might have tilted the results to providers who actually ran into problems, wrote the investigators, led by Ping Lin of the department of dermatology and venereology at Peking University First Hospital, Beijing.
Still, 280 (74.5%) reported adverse skin reactions from caring for COVID-19 patients. “Of note, this rate was much higher than the rate of occupational contact dermatitis (31.5%) in HCWs under normal working condition[s], and that of adverse skin reactions (21.4%-35.5%)” during the outbreak of another coronavirus in 2003, severe acute respiratory syndrome, they wrote.
Most providers in the study washed their hands more than 10 times a day, but only about 22% applied hand cream afterwards, they reported.
On multivariate analysis, working in hospitals harder hit by the pandemic (odds ratio, 2.41; P = .001), working on inpatient wards (OR, 2.44; P = .003), wearing full-body personal protective equipment over 6 hours (OR, 4.26; P < .001), and female sex (OR, 1.87; P = .038) increased the risk of adverse skin reactions. The team suggested moisturizers would help to protect against hand dermatitis, and alcohol-based products instead of soaps “as the former show high antimicrobial activity and low risks of skin damage.” Also, “restricting duration of wearing” of protection gear “to no more than 6 hours would help.”
The study investigators reported that they had no conflicts of interest.
SOURCE: Lin P et al. Br J Dermatol. 2020 Apr 7. doi: 10.1111/bjd.19089.
Almost 75% of doctors and nurses in and around Wuhan, China, where the outbreak first emerged, reported skin problems during a single week in early February 2020, in a survey of health care workers (HCW) caring for COVID-19 patients at five university and five regional hospitals. Hands, cheeks, and the nasal bridge were the most commonly affected areas, with skin dryness, maceration, papules, and erythema the most common problems, according to research published in the British Journal of Dermatology.
In New York City, masks in particular are “really an issue,” said Ellen Marmur, MD, a dermatologist in private practice and an associate clinical professor at the Mount Sinai School of Medicine, New York.
She’s dealing with patients who have abrasions and skin infections at the tip of the nose, bruising from the metal strap that goes across the bridge of the nose, and skin irritation from the straps. “Rosacea is [also] definitely flaring up, [and] people’s acne is definitely flaring up, not only because of the stress, but because of the sweat and humidity” that builds up under the masks, she said.
“It’s not a life-threatening thing, but it’s definitely something we’ve been helping people with,” she said. This includes her husband, a cardiologist pulling 12-hour shifts in a New York City hospital wearing an N95 mask; when he comes home, the tip of his nose is red and abraded.
Treatment entails first aid skin care: a dab of a gentle ointment like Aquaphor to prevent abrasions while the mask is on and to help them heal after it’s off, and bacitracin if infection is a worry. For acne and rosacea flares, a course of minocycline or topical clindamycin might help, Dr. Marmur said.
Although almost 75% of the doctors and nurses in the Chinese study reported skin problems, the response rate was low, just 376 of the 1,000 surveyed (37.6%). That might have tilted the results to providers who actually ran into problems, wrote the investigators, led by Ping Lin of the department of dermatology and venereology at Peking University First Hospital, Beijing.
Still, 280 (74.5%) reported adverse skin reactions from caring for COVID-19 patients. “Of note, this rate was much higher than the rate of occupational contact dermatitis (31.5%) in HCWs under normal working condition[s], and that of adverse skin reactions (21.4%-35.5%)” during the outbreak of another coronavirus in 2003, severe acute respiratory syndrome, they wrote.
Most providers in the study washed their hands more than 10 times a day, but only about 22% applied hand cream afterwards, they reported.
On multivariate analysis, working in hospitals harder hit by the pandemic (odds ratio, 2.41; P = .001), working on inpatient wards (OR, 2.44; P = .003), wearing full-body personal protective equipment over 6 hours (OR, 4.26; P < .001), and female sex (OR, 1.87; P = .038) increased the risk of adverse skin reactions. The team suggested moisturizers would help to protect against hand dermatitis, and alcohol-based products instead of soaps “as the former show high antimicrobial activity and low risks of skin damage.” Also, “restricting duration of wearing” of protection gear “to no more than 6 hours would help.”
The study investigators reported that they had no conflicts of interest.
SOURCE: Lin P et al. Br J Dermatol. 2020 Apr 7. doi: 10.1111/bjd.19089.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
What's your diagnosis?
A punch biopsy of one of the lesions showed a superficial and deep mixed inflammatory cell infiltrate, including neutrophils and eosinophils. There was also vasculitis, karyorrhexis and extravasated red blood cells. The findings are those of leukocytoclastic vasculitis, suggestive of acute hemorrhagic edema of infancy. Direct immunofluorescence was positive for IgM, C3, and fibrinogen, but negative for IgA.
Acute hemorrhagic edema of infancy (AHEI), also known as Finkelstein disease, is form of leukocytoclastic vasculitis that occurs in infants and toddlers aged between4 months and 3 years.
The lesions start as petechiae or edematous, erythematous to violaceous nodules that later coalesce and form “cockade”-like plaques with a central clearing on the face and extremities. Gastrointestinal, renal, and joint involvement are rare.1 AHEI follows a benign course with resolution of the lesions and symptoms within days to weeks. The etiology of this condition is not known but infection triggers have been reported including coronavirus infections, coxsackie virus infections, Escherichia coli urinary tract infections, herpes simplex virus stomatitis, and pneumococcal bacteremia.2,3 Our patient had a prior history of pneumococcal pneumonia and metapneumovirus infection. MMR vaccine also has been reported as a possible trigger, as well as some medications.
Laboratory results are usually normal, but some patients may have elevated inflammatory markers (C-reactive protein and erythrocyte sedimentation rate), as noted in our patient, and leukocytosis, thrombocytosis, and eosinophilia. Microscopic analysis demonstrates leukocytoclastic vasculitis of small vessels with associated karyorrhexis and extravasated red blood cells.
The differential diagnosis includes other vasculitic conditions, primarily Henoch-Schönlein purpura (HSP). Patients with HSP tend to be older in age and the lesions described as palpable purpura commonly affect the lower extremities and buttocks. These patients can present with abdominal pain and arthritis; renal compromise also can occur. Direct immunofluorescence can commonly be positive for IgA, which was negative in our patient.
AHEI and HSP are considered different entities, but both present with leukocytoclastic vasculitis.1 Another condition to consider in patients with fever, rash, and edema is Kawasaki disease, also a form of vasculitis, that affects small- and medium-size muscular vessels with predilection for the coronary arteries. Patients with Kawasaki disease present with fever (usually longer than 5 days), facial and extremity edema (similar to AHEI), skin lesions (which may have multiple presentations, the most common being macular, papular and erythematous, and urticarial eruptions), but also lymphadenopathy and conjunctivitis. These patients appear sicker than children with AHEI. Their laboratory results show leukocytosis, thrombocytosis or thrombocytopenia, elevated inflammatory markers, and sterile pyuria.4
Patients with erythema nodosum present with tender erythematous nodules, which can look like early AHEI lesions. The most common location is the lower extremities, but in children erythema nodosum can occur on the face, trunk, and arms. The lesions can occur secondary to infections such as streptococcus, mycoplasma, tuberculosis, coccidioidomycosis, and sarcoidosis, as well as to malignancy or medications. These patients do not appear sick, are not febrile, and are rarely seen under 2 years of age.5
Acute febrile neutrophilic dermatosis – Sweets’ syndrome – also should be considered in a patient with tender nodules, fever, and leukocytosis. The skin lesions in Sweets’ syndrome, compared with those in AHEI, are painful and can present as papules, nodules, and bullae on the face and extremities. A prior history of an upper respiratory infection is commonly described in children with Sweets’ syndrome. These patients present with fever, which may start days to weeks prior to the lesions starting. Children with Sweets’ syndrome also can have conjunctivitis, myalgias, polyarthritis, and in severe cases septic shock and multiorgan dysfunction. Sweets’ syndrome can be seen in patients with inflammatory bowel disease, systemic lupus erythematosus, chronic multifocal osteomyelitis, and malignancy; it also may be induced by certain medications.6
As mentioned above, the course of AHEI is benign, and the condition resolves within days to weeks. Treatment is supportive.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. She had no relevant financial disclosures. Email Dr. Matiz at pdnews@mdedge.com.
References
1. F1000Res. 2019;8:1771.
2. Pediatr Dermatol. 2006 Jul-Aug;23(4):361-4.
3. Pediatr Dermatol. 2015 Nov-Dec;32(6):e309-11.
4. Clin Dermatol. 2017 Nov-Dec;35(6):530-40.
5. Yonsei Med J. 2019 Mar;60(3):312-4.
6. Pediatr Dermatol. 2015 Jul-Aug;32(4):437-46.
A punch biopsy of one of the lesions showed a superficial and deep mixed inflammatory cell infiltrate, including neutrophils and eosinophils. There was also vasculitis, karyorrhexis and extravasated red blood cells. The findings are those of leukocytoclastic vasculitis, suggestive of acute hemorrhagic edema of infancy. Direct immunofluorescence was positive for IgM, C3, and fibrinogen, but negative for IgA.
Acute hemorrhagic edema of infancy (AHEI), also known as Finkelstein disease, is form of leukocytoclastic vasculitis that occurs in infants and toddlers aged between4 months and 3 years.
The lesions start as petechiae or edematous, erythematous to violaceous nodules that later coalesce and form “cockade”-like plaques with a central clearing on the face and extremities. Gastrointestinal, renal, and joint involvement are rare.1 AHEI follows a benign course with resolution of the lesions and symptoms within days to weeks. The etiology of this condition is not known but infection triggers have been reported including coronavirus infections, coxsackie virus infections, Escherichia coli urinary tract infections, herpes simplex virus stomatitis, and pneumococcal bacteremia.2,3 Our patient had a prior history of pneumococcal pneumonia and metapneumovirus infection. MMR vaccine also has been reported as a possible trigger, as well as some medications.
Laboratory results are usually normal, but some patients may have elevated inflammatory markers (C-reactive protein and erythrocyte sedimentation rate), as noted in our patient, and leukocytosis, thrombocytosis, and eosinophilia. Microscopic analysis demonstrates leukocytoclastic vasculitis of small vessels with associated karyorrhexis and extravasated red blood cells.
The differential diagnosis includes other vasculitic conditions, primarily Henoch-Schönlein purpura (HSP). Patients with HSP tend to be older in age and the lesions described as palpable purpura commonly affect the lower extremities and buttocks. These patients can present with abdominal pain and arthritis; renal compromise also can occur. Direct immunofluorescence can commonly be positive for IgA, which was negative in our patient.
AHEI and HSP are considered different entities, but both present with leukocytoclastic vasculitis.1 Another condition to consider in patients with fever, rash, and edema is Kawasaki disease, also a form of vasculitis, that affects small- and medium-size muscular vessels with predilection for the coronary arteries. Patients with Kawasaki disease present with fever (usually longer than 5 days), facial and extremity edema (similar to AHEI), skin lesions (which may have multiple presentations, the most common being macular, papular and erythematous, and urticarial eruptions), but also lymphadenopathy and conjunctivitis. These patients appear sicker than children with AHEI. Their laboratory results show leukocytosis, thrombocytosis or thrombocytopenia, elevated inflammatory markers, and sterile pyuria.4
Patients with erythema nodosum present with tender erythematous nodules, which can look like early AHEI lesions. The most common location is the lower extremities, but in children erythema nodosum can occur on the face, trunk, and arms. The lesions can occur secondary to infections such as streptococcus, mycoplasma, tuberculosis, coccidioidomycosis, and sarcoidosis, as well as to malignancy or medications. These patients do not appear sick, are not febrile, and are rarely seen under 2 years of age.5
Acute febrile neutrophilic dermatosis – Sweets’ syndrome – also should be considered in a patient with tender nodules, fever, and leukocytosis. The skin lesions in Sweets’ syndrome, compared with those in AHEI, are painful and can present as papules, nodules, and bullae on the face and extremities. A prior history of an upper respiratory infection is commonly described in children with Sweets’ syndrome. These patients present with fever, which may start days to weeks prior to the lesions starting. Children with Sweets’ syndrome also can have conjunctivitis, myalgias, polyarthritis, and in severe cases septic shock and multiorgan dysfunction. Sweets’ syndrome can be seen in patients with inflammatory bowel disease, systemic lupus erythematosus, chronic multifocal osteomyelitis, and malignancy; it also may be induced by certain medications.6
As mentioned above, the course of AHEI is benign, and the condition resolves within days to weeks. Treatment is supportive.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. She had no relevant financial disclosures. Email Dr. Matiz at pdnews@mdedge.com.
References
1. F1000Res. 2019;8:1771.
2. Pediatr Dermatol. 2006 Jul-Aug;23(4):361-4.
3. Pediatr Dermatol. 2015 Nov-Dec;32(6):e309-11.
4. Clin Dermatol. 2017 Nov-Dec;35(6):530-40.
5. Yonsei Med J. 2019 Mar;60(3):312-4.
6. Pediatr Dermatol. 2015 Jul-Aug;32(4):437-46.
A punch biopsy of one of the lesions showed a superficial and deep mixed inflammatory cell infiltrate, including neutrophils and eosinophils. There was also vasculitis, karyorrhexis and extravasated red blood cells. The findings are those of leukocytoclastic vasculitis, suggestive of acute hemorrhagic edema of infancy. Direct immunofluorescence was positive for IgM, C3, and fibrinogen, but negative for IgA.
Acute hemorrhagic edema of infancy (AHEI), also known as Finkelstein disease, is form of leukocytoclastic vasculitis that occurs in infants and toddlers aged between4 months and 3 years.
The lesions start as petechiae or edematous, erythematous to violaceous nodules that later coalesce and form “cockade”-like plaques with a central clearing on the face and extremities. Gastrointestinal, renal, and joint involvement are rare.1 AHEI follows a benign course with resolution of the lesions and symptoms within days to weeks. The etiology of this condition is not known but infection triggers have been reported including coronavirus infections, coxsackie virus infections, Escherichia coli urinary tract infections, herpes simplex virus stomatitis, and pneumococcal bacteremia.2,3 Our patient had a prior history of pneumococcal pneumonia and metapneumovirus infection. MMR vaccine also has been reported as a possible trigger, as well as some medications.
Laboratory results are usually normal, but some patients may have elevated inflammatory markers (C-reactive protein and erythrocyte sedimentation rate), as noted in our patient, and leukocytosis, thrombocytosis, and eosinophilia. Microscopic analysis demonstrates leukocytoclastic vasculitis of small vessels with associated karyorrhexis and extravasated red blood cells.
The differential diagnosis includes other vasculitic conditions, primarily Henoch-Schönlein purpura (HSP). Patients with HSP tend to be older in age and the lesions described as palpable purpura commonly affect the lower extremities and buttocks. These patients can present with abdominal pain and arthritis; renal compromise also can occur. Direct immunofluorescence can commonly be positive for IgA, which was negative in our patient.
AHEI and HSP are considered different entities, but both present with leukocytoclastic vasculitis.1 Another condition to consider in patients with fever, rash, and edema is Kawasaki disease, also a form of vasculitis, that affects small- and medium-size muscular vessels with predilection for the coronary arteries. Patients with Kawasaki disease present with fever (usually longer than 5 days), facial and extremity edema (similar to AHEI), skin lesions (which may have multiple presentations, the most common being macular, papular and erythematous, and urticarial eruptions), but also lymphadenopathy and conjunctivitis. These patients appear sicker than children with AHEI. Their laboratory results show leukocytosis, thrombocytosis or thrombocytopenia, elevated inflammatory markers, and sterile pyuria.4
Patients with erythema nodosum present with tender erythematous nodules, which can look like early AHEI lesions. The most common location is the lower extremities, but in children erythema nodosum can occur on the face, trunk, and arms. The lesions can occur secondary to infections such as streptococcus, mycoplasma, tuberculosis, coccidioidomycosis, and sarcoidosis, as well as to malignancy or medications. These patients do not appear sick, are not febrile, and are rarely seen under 2 years of age.5
Acute febrile neutrophilic dermatosis – Sweets’ syndrome – also should be considered in a patient with tender nodules, fever, and leukocytosis. The skin lesions in Sweets’ syndrome, compared with those in AHEI, are painful and can present as papules, nodules, and bullae on the face and extremities. A prior history of an upper respiratory infection is commonly described in children with Sweets’ syndrome. These patients present with fever, which may start days to weeks prior to the lesions starting. Children with Sweets’ syndrome also can have conjunctivitis, myalgias, polyarthritis, and in severe cases septic shock and multiorgan dysfunction. Sweets’ syndrome can be seen in patients with inflammatory bowel disease, systemic lupus erythematosus, chronic multifocal osteomyelitis, and malignancy; it also may be induced by certain medications.6
As mentioned above, the course of AHEI is benign, and the condition resolves within days to weeks. Treatment is supportive.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. She had no relevant financial disclosures. Email Dr. Matiz at pdnews@mdedge.com.
References
1. F1000Res. 2019;8:1771.
2. Pediatr Dermatol. 2006 Jul-Aug;23(4):361-4.
3. Pediatr Dermatol. 2015 Nov-Dec;32(6):e309-11.
4. Clin Dermatol. 2017 Nov-Dec;35(6):530-40.
5. Yonsei Med J. 2019 Mar;60(3):312-4.
6. Pediatr Dermatol. 2015 Jul-Aug;32(4):437-46.
At 3 a.m., you receive a call from the ED for a baby with a new rash on the arms, legs, and face. Some of the lesions appear to be tender. He has a mild fever of 38.4° C (101.1° F) and is not in acute distress. He is drinking, but not eating much.
The parents also have noted some swelling on the hands and the feet. He has no upper respiratory or gastrointestinal symptoms. He is not walking yet.
He was admitted to the hospital 3 weeks prior for streptococcal pneumonia and metapneumovirus infection. He was treated with ceftriaxone, supportive respiratory care, and an albuterol inhaler. Influenza and respiratory syncytial virus tests were negative.
On physical exam, the child is tired and sleeping in his mom's arms. He has red and some purpuric papules on the face. On the arms and legs, he has purpuric papules and nodules. There is some edema on the face, hands, and feet. His conjunctiva is normal, and he has no oral lesions. He has no lymphadenopathy or hepatosplenomegaly.
Blood work shows normal complete blood count, coagulation tests, comprehensive metabolic panel, and urinalysis, but he has an elevated C-reactive protein of 114 mg/L and an elevated erythrocyte sedimentation rate of 71 mm/hour.
Receding hairline
This patient had frontal fibrosing alopecia (FFA), a subtype of lichen planopilaris (LPP), or follicular lichen planus. LPP causes cicatricial (scarring) alopecia where the follicular epithelium is replaced with connective tissue and the hair follicle is permanently lost. LPP is caused by lymphocytic inflammation that initially presents as perifollicular erythema, with scale and keratotic plugs, and later progresses to scarring. If there is uncertainty in the diagnosis, biopsy can be helpful.
The LPP subtype, FFA, usually occurs in postmenopausal women. It follows a distinctive pattern, as in this patient, where the hair is progressively lost along the frontoparietal hair line (and sometimes the eyebrows). A careful physical examination reveals smooth skin where follicles are lost and there is erythema around the base of the hairs due to active inflammation and keratotic plugging. The specific mechanism of FFA is poorly understood, and hormones may play a role, in addition to the inflammatory response.
The goal of treatment is to arrest the progression of additional hair loss (which usually is permanent). Intralesional steroid injections, which also are used for alopecia areata, are the most common therapy. Triamcinolone 2.5 to 5 mg/mL is injected in the affected dermal layer of the scalp. Oral finasteride (a 5-alpha-reductase inhibitor to decrease androgens) 1 mg/d can be helpful, as can oral hydroxychloroquine 200 mg bid.
Once the inflammation has subsided, treatment can be discontinued. Hair transplantation has been used, but often fails due to the inflammatory scarring process. Our patient noted that her disease process had been stable and declined treatment.
Photo courtesy of Daniel Stulberg, MD, FAAFP. Text courtesy of Rory Aufderheide, MD, and Daniel Stulberg, MD, FAAFP. Drs. Stulberg and Aufderheide are from the Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
To D, Beecker J. Frontal fibrosing alopecia: update and review of challenges and successes. J Cutan Med Surg. 2018;22:182-189.
This patient had frontal fibrosing alopecia (FFA), a subtype of lichen planopilaris (LPP), or follicular lichen planus. LPP causes cicatricial (scarring) alopecia where the follicular epithelium is replaced with connective tissue and the hair follicle is permanently lost. LPP is caused by lymphocytic inflammation that initially presents as perifollicular erythema, with scale and keratotic plugs, and later progresses to scarring. If there is uncertainty in the diagnosis, biopsy can be helpful.
The LPP subtype, FFA, usually occurs in postmenopausal women. It follows a distinctive pattern, as in this patient, where the hair is progressively lost along the frontoparietal hair line (and sometimes the eyebrows). A careful physical examination reveals smooth skin where follicles are lost and there is erythema around the base of the hairs due to active inflammation and keratotic plugging. The specific mechanism of FFA is poorly understood, and hormones may play a role, in addition to the inflammatory response.
The goal of treatment is to arrest the progression of additional hair loss (which usually is permanent). Intralesional steroid injections, which also are used for alopecia areata, are the most common therapy. Triamcinolone 2.5 to 5 mg/mL is injected in the affected dermal layer of the scalp. Oral finasteride (a 5-alpha-reductase inhibitor to decrease androgens) 1 mg/d can be helpful, as can oral hydroxychloroquine 200 mg bid.
Once the inflammation has subsided, treatment can be discontinued. Hair transplantation has been used, but often fails due to the inflammatory scarring process. Our patient noted that her disease process had been stable and declined treatment.
Photo courtesy of Daniel Stulberg, MD, FAAFP. Text courtesy of Rory Aufderheide, MD, and Daniel Stulberg, MD, FAAFP. Drs. Stulberg and Aufderheide are from the Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
This patient had frontal fibrosing alopecia (FFA), a subtype of lichen planopilaris (LPP), or follicular lichen planus. LPP causes cicatricial (scarring) alopecia where the follicular epithelium is replaced with connective tissue and the hair follicle is permanently lost. LPP is caused by lymphocytic inflammation that initially presents as perifollicular erythema, with scale and keratotic plugs, and later progresses to scarring. If there is uncertainty in the diagnosis, biopsy can be helpful.
The LPP subtype, FFA, usually occurs in postmenopausal women. It follows a distinctive pattern, as in this patient, where the hair is progressively lost along the frontoparietal hair line (and sometimes the eyebrows). A careful physical examination reveals smooth skin where follicles are lost and there is erythema around the base of the hairs due to active inflammation and keratotic plugging. The specific mechanism of FFA is poorly understood, and hormones may play a role, in addition to the inflammatory response.
The goal of treatment is to arrest the progression of additional hair loss (which usually is permanent). Intralesional steroid injections, which also are used for alopecia areata, are the most common therapy. Triamcinolone 2.5 to 5 mg/mL is injected in the affected dermal layer of the scalp. Oral finasteride (a 5-alpha-reductase inhibitor to decrease androgens) 1 mg/d can be helpful, as can oral hydroxychloroquine 200 mg bid.
Once the inflammation has subsided, treatment can be discontinued. Hair transplantation has been used, but often fails due to the inflammatory scarring process. Our patient noted that her disease process had been stable and declined treatment.
Photo courtesy of Daniel Stulberg, MD, FAAFP. Text courtesy of Rory Aufderheide, MD, and Daniel Stulberg, MD, FAAFP. Drs. Stulberg and Aufderheide are from the Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
To D, Beecker J. Frontal fibrosing alopecia: update and review of challenges and successes. J Cutan Med Surg. 2018;22:182-189.
To D, Beecker J. Frontal fibrosing alopecia: update and review of challenges and successes. J Cutan Med Surg. 2018;22:182-189.
Most e-consults not followed by specialist visit
Studies have shown that e-consults increase access to specialist care and primary care physician (PCP) education, according to research published in the Annals of Internal Medicine (2020. Apr 14. doi: 10.7326/M19-3852) by Salman Ahmed, MD, and colleagues.
These resources are already being frequently used by physicians, but more often by general internists and hospitalists than by subspecialists, according to a recent survey by the American College of Physicians. That survey found that 42% of its respondents are using e-consults and that subspecialists’ use is less common primarily because of the lack of access to e-consult technology.
What hasn’t been widely researched are the effects of large-scale e-consult programs, said Dr. Ahmed, who is associate physician in the renal division at Brigham and Women’s Hospital, Boston, in an interview.
For frontline providers such as PCPs, e-consults are a way to quickly seek out answers to clinical questions from specialists. In turn, the specialist can help a wider pool of participants, he noted.
The findings of Dr. Ahmed’s study, which included several academic centers and hospitals affiliated with Partners HealthCare System, a nonprofit network in eastern Massachusetts that includes Brigham and Women’s Hospital, used several metrics to analyze the appropriateness and utility of e-consults across a range of specialties. An e-consult was considered useful if it resulted in the avoidance of a visit to a specialist, which was defined as the absence of an in-person visit to the type of specialist consulted electronically for 120 days. An e-consult was considered appropriate if it met the following four criteria.
- It could not be answered by referring to society guidelines or widely available, evidence-based summary sources.
- It did not seek logistic information, such as where to have a specific laboratory test done.
- It did not include a question of high urgency.
- The medical complexity of the clinical situation was not substantial enough to warrant an in-person consultation.
The investigators examined e-consult inquiries to mostly physician health care providers in five specialties – hematology, infectious disease, dermatology, rheumatology, and psychiatry – over a year.
High rates of appropriateness
The search spanned 6,512 eligible e-consults from 1,096 referring providers to 121 specialist consultants. Narrowing their search to 741 records with complete data, the investigators found that 70.2% of these consults met the criteria for appropriateness. In an analysis of four reviewers blinded to each other’s results, raters agreed on the appropriateness of 94% of e-consults.
Across specialties, more than 81% of e-consults were associated with avoided in-person visits.
The reasons for most e-consults were to seek answers to questions about diagnosis, therapeutics, or patient inquiries, or to request further education by PCPs.
“Across all specialties, the most common reasons an e-consult was not considered appropriate were failing the point-of-care resource test and asking a question of inappropriately high complexity,” the authors summarized.
Physicians and PCPs from tertiary care practices made up the majority of referring providers, with turnaround time for consults averaging 24 hours across specialties.
Rates of appropriateness, content, patient demographics, and timeliness of e-consult responses varied among the four specialties. Those with high avoidance of visits rates tended to have high appropriateness rates, indicating that some specialties may be more conducive to e-consults than others, the authors noted. Psychiatry and hematology had the highest proportion of appropriate e-consults (77.9% and 73.3% respectively). Rheumatology had the lowest proportion of appropriate e-consults and one of the lowest rates of avoided in-person visits, and dermatology had the lowest rate of avoided in-person visits, at 61.9%.
The majority (93%) of e-consults sought in psychiatry were therapy related, whereas 88.4% of the e-consult questions in rheumatology related to diagnosis.
“Questions about diagnosis were less likely to be answerable via e-consult, which suggests that to provide diagnoses, consultants may wish to engage with the patient directly,” Dr. Ahmed said in an interview.
Infectious disease specialists seemed to be the fastest responders, with nearly 90% of their consultations having been answered within a day. Dermatology specialists had the distinction of having the youngest e-consult patients (mean age, 38.6 years).
PCPs weigh in on results
Physicians said in interviews that the study data reflects their own positive experiences with e-consults.
“Although I don’t always think [an e-consult] is able to fully prevent the specialist visit, it does allow the specialist to provide recommendations for work-up that can be done prior to the specialist visit,” said Santina Wheat MD, a family physician at Erie Family Health Center in Chicago. This reduces the time in which the consult is placed to when effective treatment can take place.
Patients who may have to wait months or even years to see a specialty doctor, benefit from e-consults, said Dr. Wheat, who is also a member of the editorial advisory board of Family Practice News. “As part of an organization that does e-consults to another hospital with a different electronic medical record, the e-consult increases the likelihood that all of the clinical information reaches the specialists and prevents tests from being repeated.”
Starting an e-consult may also increase the likelihood that the patient quickly sees a specialist at the contracted hospital, she added.
Sarah G. Candler, MD, said in an interview that she also sees e-consults as an essential tool. “When patients present with rare, complex, or atypical pictures, I find it helpful to have specialists weigh in. The e-consult helps me ensure that I work to the top of my abilities as an internist,” said Dr. Candler, who is practice medical director and physician director of academic relations at Iora Primary Care, Northside Clinic, Houston. However, she did not agree with the study’s avoided in-person visits metric for assessing utility.
“In some cases, the end result of an e-consult is a referral for an in-person evaluation, and the role of the e-consult is to ensure that I have done my due diligence as a primary care doctor asking the correct questions, getting the appropriate work-up completed, and referring to the appropriate specialty for next steps, when necessary,” noted Dr. Candler, who also serves on the editorial advisory board of Internal Medicine News.
Financial considerations
The study’s authors suggested taking a closer look at standardizing payment for the use of e-consults and developing appropriateness criteria for them.
Health systems could use such criteria to study what makes an e-consult useful and how to best utilize this tool, Dr. Ahmed said in an interview.
“Compensation models that promote high-quality, effective, and efficient e-consults are needed to reinforce the ability of health systems to optimize the mix of e-consults and in-person visits,” Dr. Ahmed and colleagues suggested.
Because not all patient care requires e-consults, the model makes the most sense in practices that already participate in value-based payment programs. In these types of programs, the cost can be shared according to the variable risk and patient need for the service, Dr. Candler explained.
“I have been fortunate to work in two different systems that function in this way, which means that e-consults have been readily available and encouraged-both to improve patient care and decrease overall cost by decreasing unnecessary testing or specialist referral,” she said.
Dr. Wheat said that the managed care organization affiliated with her practice seems to be saving money with e-consults, as it decreases the need to pay for specialist visits in some instances and for repeated work-ups.
Future studies
The study’s cohort represented just one large health care system with a shared electronic health record. “Single-system descriptive studies, such as that of Ahmed and colleagues, are particularly useful for local evaluation and quality improvement efforts,” Varsha G. Vimalananda, MD, and B. Graeme Fincke, MD, both of the Center for Healthcare Organization and Implementation Research at Bedford (Mass.) Veterans Affairs Hospital, wrote in a related editorial.
“However, we need innovative approaches to evaluation that estimate the effect of e-consults on quality and cost of care across health care systems and over time. Implementation studies can help to identify key contributors to success,” the editorialists wrote.
One of the study authors, reported receiving personal fees from Bayer outside the submitted work. The other authors of the paper and the authors of the editorial reported no conflicts of interest. Dr. Candler said her employer contracts with an e-consult service, but that she is not compensated for use of the service. She is also a coeditor of Annals of Internal Medicine’s blog, “Fresh Look.”
SOURCE: Ahmed S et al. Ann Intern Med. 2020 Apr 14. doi: 10.7326/M19-3852.
Studies have shown that e-consults increase access to specialist care and primary care physician (PCP) education, according to research published in the Annals of Internal Medicine (2020. Apr 14. doi: 10.7326/M19-3852) by Salman Ahmed, MD, and colleagues.
These resources are already being frequently used by physicians, but more often by general internists and hospitalists than by subspecialists, according to a recent survey by the American College of Physicians. That survey found that 42% of its respondents are using e-consults and that subspecialists’ use is less common primarily because of the lack of access to e-consult technology.
What hasn’t been widely researched are the effects of large-scale e-consult programs, said Dr. Ahmed, who is associate physician in the renal division at Brigham and Women’s Hospital, Boston, in an interview.
For frontline providers such as PCPs, e-consults are a way to quickly seek out answers to clinical questions from specialists. In turn, the specialist can help a wider pool of participants, he noted.
The findings of Dr. Ahmed’s study, which included several academic centers and hospitals affiliated with Partners HealthCare System, a nonprofit network in eastern Massachusetts that includes Brigham and Women’s Hospital, used several metrics to analyze the appropriateness and utility of e-consults across a range of specialties. An e-consult was considered useful if it resulted in the avoidance of a visit to a specialist, which was defined as the absence of an in-person visit to the type of specialist consulted electronically for 120 days. An e-consult was considered appropriate if it met the following four criteria.
- It could not be answered by referring to society guidelines or widely available, evidence-based summary sources.
- It did not seek logistic information, such as where to have a specific laboratory test done.
- It did not include a question of high urgency.
- The medical complexity of the clinical situation was not substantial enough to warrant an in-person consultation.
The investigators examined e-consult inquiries to mostly physician health care providers in five specialties – hematology, infectious disease, dermatology, rheumatology, and psychiatry – over a year.
High rates of appropriateness
The search spanned 6,512 eligible e-consults from 1,096 referring providers to 121 specialist consultants. Narrowing their search to 741 records with complete data, the investigators found that 70.2% of these consults met the criteria for appropriateness. In an analysis of four reviewers blinded to each other’s results, raters agreed on the appropriateness of 94% of e-consults.
Across specialties, more than 81% of e-consults were associated with avoided in-person visits.
The reasons for most e-consults were to seek answers to questions about diagnosis, therapeutics, or patient inquiries, or to request further education by PCPs.
“Across all specialties, the most common reasons an e-consult was not considered appropriate were failing the point-of-care resource test and asking a question of inappropriately high complexity,” the authors summarized.
Physicians and PCPs from tertiary care practices made up the majority of referring providers, with turnaround time for consults averaging 24 hours across specialties.
Rates of appropriateness, content, patient demographics, and timeliness of e-consult responses varied among the four specialties. Those with high avoidance of visits rates tended to have high appropriateness rates, indicating that some specialties may be more conducive to e-consults than others, the authors noted. Psychiatry and hematology had the highest proportion of appropriate e-consults (77.9% and 73.3% respectively). Rheumatology had the lowest proportion of appropriate e-consults and one of the lowest rates of avoided in-person visits, and dermatology had the lowest rate of avoided in-person visits, at 61.9%.
The majority (93%) of e-consults sought in psychiatry were therapy related, whereas 88.4% of the e-consult questions in rheumatology related to diagnosis.
“Questions about diagnosis were less likely to be answerable via e-consult, which suggests that to provide diagnoses, consultants may wish to engage with the patient directly,” Dr. Ahmed said in an interview.
Infectious disease specialists seemed to be the fastest responders, with nearly 90% of their consultations having been answered within a day. Dermatology specialists had the distinction of having the youngest e-consult patients (mean age, 38.6 years).
PCPs weigh in on results
Physicians said in interviews that the study data reflects their own positive experiences with e-consults.
“Although I don’t always think [an e-consult] is able to fully prevent the specialist visit, it does allow the specialist to provide recommendations for work-up that can be done prior to the specialist visit,” said Santina Wheat MD, a family physician at Erie Family Health Center in Chicago. This reduces the time in which the consult is placed to when effective treatment can take place.
Patients who may have to wait months or even years to see a specialty doctor, benefit from e-consults, said Dr. Wheat, who is also a member of the editorial advisory board of Family Practice News. “As part of an organization that does e-consults to another hospital with a different electronic medical record, the e-consult increases the likelihood that all of the clinical information reaches the specialists and prevents tests from being repeated.”
Starting an e-consult may also increase the likelihood that the patient quickly sees a specialist at the contracted hospital, she added.
Sarah G. Candler, MD, said in an interview that she also sees e-consults as an essential tool. “When patients present with rare, complex, or atypical pictures, I find it helpful to have specialists weigh in. The e-consult helps me ensure that I work to the top of my abilities as an internist,” said Dr. Candler, who is practice medical director and physician director of academic relations at Iora Primary Care, Northside Clinic, Houston. However, she did not agree with the study’s avoided in-person visits metric for assessing utility.
“In some cases, the end result of an e-consult is a referral for an in-person evaluation, and the role of the e-consult is to ensure that I have done my due diligence as a primary care doctor asking the correct questions, getting the appropriate work-up completed, and referring to the appropriate specialty for next steps, when necessary,” noted Dr. Candler, who also serves on the editorial advisory board of Internal Medicine News.
Financial considerations
The study’s authors suggested taking a closer look at standardizing payment for the use of e-consults and developing appropriateness criteria for them.
Health systems could use such criteria to study what makes an e-consult useful and how to best utilize this tool, Dr. Ahmed said in an interview.
“Compensation models that promote high-quality, effective, and efficient e-consults are needed to reinforce the ability of health systems to optimize the mix of e-consults and in-person visits,” Dr. Ahmed and colleagues suggested.
Because not all patient care requires e-consults, the model makes the most sense in practices that already participate in value-based payment programs. In these types of programs, the cost can be shared according to the variable risk and patient need for the service, Dr. Candler explained.
“I have been fortunate to work in two different systems that function in this way, which means that e-consults have been readily available and encouraged-both to improve patient care and decrease overall cost by decreasing unnecessary testing or specialist referral,” she said.
Dr. Wheat said that the managed care organization affiliated with her practice seems to be saving money with e-consults, as it decreases the need to pay for specialist visits in some instances and for repeated work-ups.
Future studies
The study’s cohort represented just one large health care system with a shared electronic health record. “Single-system descriptive studies, such as that of Ahmed and colleagues, are particularly useful for local evaluation and quality improvement efforts,” Varsha G. Vimalananda, MD, and B. Graeme Fincke, MD, both of the Center for Healthcare Organization and Implementation Research at Bedford (Mass.) Veterans Affairs Hospital, wrote in a related editorial.
“However, we need innovative approaches to evaluation that estimate the effect of e-consults on quality and cost of care across health care systems and over time. Implementation studies can help to identify key contributors to success,” the editorialists wrote.
One of the study authors, reported receiving personal fees from Bayer outside the submitted work. The other authors of the paper and the authors of the editorial reported no conflicts of interest. Dr. Candler said her employer contracts with an e-consult service, but that she is not compensated for use of the service. She is also a coeditor of Annals of Internal Medicine’s blog, “Fresh Look.”
SOURCE: Ahmed S et al. Ann Intern Med. 2020 Apr 14. doi: 10.7326/M19-3852.
Studies have shown that e-consults increase access to specialist care and primary care physician (PCP) education, according to research published in the Annals of Internal Medicine (2020. Apr 14. doi: 10.7326/M19-3852) by Salman Ahmed, MD, and colleagues.
These resources are already being frequently used by physicians, but more often by general internists and hospitalists than by subspecialists, according to a recent survey by the American College of Physicians. That survey found that 42% of its respondents are using e-consults and that subspecialists’ use is less common primarily because of the lack of access to e-consult technology.
What hasn’t been widely researched are the effects of large-scale e-consult programs, said Dr. Ahmed, who is associate physician in the renal division at Brigham and Women’s Hospital, Boston, in an interview.
For frontline providers such as PCPs, e-consults are a way to quickly seek out answers to clinical questions from specialists. In turn, the specialist can help a wider pool of participants, he noted.
The findings of Dr. Ahmed’s study, which included several academic centers and hospitals affiliated with Partners HealthCare System, a nonprofit network in eastern Massachusetts that includes Brigham and Women’s Hospital, used several metrics to analyze the appropriateness and utility of e-consults across a range of specialties. An e-consult was considered useful if it resulted in the avoidance of a visit to a specialist, which was defined as the absence of an in-person visit to the type of specialist consulted electronically for 120 days. An e-consult was considered appropriate if it met the following four criteria.
- It could not be answered by referring to society guidelines or widely available, evidence-based summary sources.
- It did not seek logistic information, such as where to have a specific laboratory test done.
- It did not include a question of high urgency.
- The medical complexity of the clinical situation was not substantial enough to warrant an in-person consultation.
The investigators examined e-consult inquiries to mostly physician health care providers in five specialties – hematology, infectious disease, dermatology, rheumatology, and psychiatry – over a year.
High rates of appropriateness
The search spanned 6,512 eligible e-consults from 1,096 referring providers to 121 specialist consultants. Narrowing their search to 741 records with complete data, the investigators found that 70.2% of these consults met the criteria for appropriateness. In an analysis of four reviewers blinded to each other’s results, raters agreed on the appropriateness of 94% of e-consults.
Across specialties, more than 81% of e-consults were associated with avoided in-person visits.
The reasons for most e-consults were to seek answers to questions about diagnosis, therapeutics, or patient inquiries, or to request further education by PCPs.
“Across all specialties, the most common reasons an e-consult was not considered appropriate were failing the point-of-care resource test and asking a question of inappropriately high complexity,” the authors summarized.
Physicians and PCPs from tertiary care practices made up the majority of referring providers, with turnaround time for consults averaging 24 hours across specialties.
Rates of appropriateness, content, patient demographics, and timeliness of e-consult responses varied among the four specialties. Those with high avoidance of visits rates tended to have high appropriateness rates, indicating that some specialties may be more conducive to e-consults than others, the authors noted. Psychiatry and hematology had the highest proportion of appropriate e-consults (77.9% and 73.3% respectively). Rheumatology had the lowest proportion of appropriate e-consults and one of the lowest rates of avoided in-person visits, and dermatology had the lowest rate of avoided in-person visits, at 61.9%.
The majority (93%) of e-consults sought in psychiatry were therapy related, whereas 88.4% of the e-consult questions in rheumatology related to diagnosis.
“Questions about diagnosis were less likely to be answerable via e-consult, which suggests that to provide diagnoses, consultants may wish to engage with the patient directly,” Dr. Ahmed said in an interview.
Infectious disease specialists seemed to be the fastest responders, with nearly 90% of their consultations having been answered within a day. Dermatology specialists had the distinction of having the youngest e-consult patients (mean age, 38.6 years).
PCPs weigh in on results
Physicians said in interviews that the study data reflects their own positive experiences with e-consults.
“Although I don’t always think [an e-consult] is able to fully prevent the specialist visit, it does allow the specialist to provide recommendations for work-up that can be done prior to the specialist visit,” said Santina Wheat MD, a family physician at Erie Family Health Center in Chicago. This reduces the time in which the consult is placed to when effective treatment can take place.
Patients who may have to wait months or even years to see a specialty doctor, benefit from e-consults, said Dr. Wheat, who is also a member of the editorial advisory board of Family Practice News. “As part of an organization that does e-consults to another hospital with a different electronic medical record, the e-consult increases the likelihood that all of the clinical information reaches the specialists and prevents tests from being repeated.”
Starting an e-consult may also increase the likelihood that the patient quickly sees a specialist at the contracted hospital, she added.
Sarah G. Candler, MD, said in an interview that she also sees e-consults as an essential tool. “When patients present with rare, complex, or atypical pictures, I find it helpful to have specialists weigh in. The e-consult helps me ensure that I work to the top of my abilities as an internist,” said Dr. Candler, who is practice medical director and physician director of academic relations at Iora Primary Care, Northside Clinic, Houston. However, she did not agree with the study’s avoided in-person visits metric for assessing utility.
“In some cases, the end result of an e-consult is a referral for an in-person evaluation, and the role of the e-consult is to ensure that I have done my due diligence as a primary care doctor asking the correct questions, getting the appropriate work-up completed, and referring to the appropriate specialty for next steps, when necessary,” noted Dr. Candler, who also serves on the editorial advisory board of Internal Medicine News.
Financial considerations
The study’s authors suggested taking a closer look at standardizing payment for the use of e-consults and developing appropriateness criteria for them.
Health systems could use such criteria to study what makes an e-consult useful and how to best utilize this tool, Dr. Ahmed said in an interview.
“Compensation models that promote high-quality, effective, and efficient e-consults are needed to reinforce the ability of health systems to optimize the mix of e-consults and in-person visits,” Dr. Ahmed and colleagues suggested.
Because not all patient care requires e-consults, the model makes the most sense in practices that already participate in value-based payment programs. In these types of programs, the cost can be shared according to the variable risk and patient need for the service, Dr. Candler explained.
“I have been fortunate to work in two different systems that function in this way, which means that e-consults have been readily available and encouraged-both to improve patient care and decrease overall cost by decreasing unnecessary testing or specialist referral,” she said.
Dr. Wheat said that the managed care organization affiliated with her practice seems to be saving money with e-consults, as it decreases the need to pay for specialist visits in some instances and for repeated work-ups.
Future studies
The study’s cohort represented just one large health care system with a shared electronic health record. “Single-system descriptive studies, such as that of Ahmed and colleagues, are particularly useful for local evaluation and quality improvement efforts,” Varsha G. Vimalananda, MD, and B. Graeme Fincke, MD, both of the Center for Healthcare Organization and Implementation Research at Bedford (Mass.) Veterans Affairs Hospital, wrote in a related editorial.
“However, we need innovative approaches to evaluation that estimate the effect of e-consults on quality and cost of care across health care systems and over time. Implementation studies can help to identify key contributors to success,” the editorialists wrote.
One of the study authors, reported receiving personal fees from Bayer outside the submitted work. The other authors of the paper and the authors of the editorial reported no conflicts of interest. Dr. Candler said her employer contracts with an e-consult service, but that she is not compensated for use of the service. She is also a coeditor of Annals of Internal Medicine’s blog, “Fresh Look.”
SOURCE: Ahmed S et al. Ann Intern Med. 2020 Apr 14. doi: 10.7326/M19-3852.
FROM ANNALS OF INTERNAL MEDICINE