Trends in Patch Testing in the Medicare Part B Fee-for-Service Population.

BACKGROUND: Patch testing is a vital component of the workup for allergic contact dermatitis. There are limited data on changes of patch testing use among Medicare providers, as well as patch testing reimbursement rates. OBJECTIVE: The aim of the study was to evaluate trends in the use of patch testing among various Medicare providers and Medicare patch testing reimbursement. DESIGN: A longitudinal analysis of patch testing claims was performed with the Medicare Part B Physician/Supplier Procedure Summary files from 2010 to 2018. The primary outcomes were the total number and change in the number of submitted patch testing services from 2010 to 2018 by 3 provider groups: dermatology physicians, nondermatology physicians, and nonphysician providers. Secondary outcome measures included Medicare reimbursement amounts and changes in reimbursement amounts for patch test services (total and per 1000 enrollees) from 2010 to 2018 for the 3 provider groups, as well as per patch test service. RESULTS: From 2010 to 2018, submitted patch testing services per 1000 enrollees grew by 89.0%. The annual trend estimate for submitted services relative to 2010 was +10.1% (95% confidence interval [CI] = 8.1 to 12.0) for physicians and +34.1% (95% CI = 32.1 to 36.0) for nonphysician providers (physician assistants and nurse practitioners). Among physicians, the annual trend estimate for submitted services was +5.1% (95% CI = -11.3 to 21.5) for dermatologists and +31.40% (95% CI = 15.00 to 47.81) for allergists. CONCLUSIONS: Patch testing increased in the US Medicare population from 2010 to 2018, and this increase was largely driven by nonphysician providers and allergists.

Chemical Identification and Confirmation of Contact Allergens.

Identification of the etiological chemical agent(s) associated with a case(s) of allergic contact dermatitis (ACD) is important for both patient management and public health surveillance. Traditional patch testing can identify chemical allergens to which the patient is allergic. Confirmation of allergen presence in the causative ACD-associated material is presently dependent on labeling information, which may not list the allergenic chemical on the product label or safety data sheet. Dermatologists have expressed concern over the lack of laboratory support for chemical allergen identification and possibly quantification from patients' ACD-associated products. The aim of this review was to provide the clinician a primer to better understand the analytical chemistry of contact allergen confirmation and unknown identification, including types of analyses, required instrumentation, identification levels of confidence decision tree, limitations, and costs.

Skin Sensitization Induction Risk Assessment of Common Ingredients in Commercially Available Cleansing Conditioners.

BACKGROUND: An essential step in ensuring the toxicological safety of cosmetic or personal care products is the evaluation of the skin sensitizing potential of product ingredients. OBJECTIVE: We used a standardized protocol from cosmetic trade industry and consumer safety groups to evaluate the sensitization potential of ingredients in 3 commercially available cleansing conditioners. METHODS: A total of 33 ingredients were evaluated. Each ingredient underwent (1) dermatological evaluation, (2) in silico analysis for irritation and sensitization potential, and (3) a literature evaluation to determine risk of sensitization. Consumer exposure level was compared with the weight-of-evidence no-expected sensitization induction level for the constituent. If a no-expected sensitization induction level for a specific ingredient was not available, the dermal sensitization threshold approach was used. A margin of safety was calculated for each constituent. RESULTS: The margins of safety for all evaluated ingredients in the cleansing conditioners were greater than 1. CONCLUSIONS: This analysis indicates that exposure to the individual ingredients present in these cleansing conditioners would not be expected to induce dermal sensitization in a consumer under the examined exposure scenario.

Risk Assessment of the Skin Sensitization Induction Potential of Kathon CG in Rinse-off and Leave-on Personal Care and Cosmetic Products.

BACKGROUND: Kathon CG is a commonly used cosmetic-grade preservative that contains active ingredients methylchloroisothiazolinone (MCI) and methylisothiazolinone (MI). OBJECTIVE: The aim of the study was to perform a skin sensitization induction risk assessment of daily exposure to Kathon CG after use of various personal care and cosmetic products. METHODS: We calculated an estimated daily consumer exposure level for rinse-off and leave-on products using the amount of product applied per application, number of applications per day, a retention factor, the MCI/MI concentration, and body surface area values. We assumed that the products contained the maximum recommended safe concentration of MCI/MI: 15 ppm in rinse-off products and 7.5 ppm in leave-on products. We compared estimated consumer exposure levels with the no expected sensitization induction level for MCI/MI and applied sensitization assessment factors to calculate product-specific margins of safety (MOSs). CONCLUSIONS: The MOSs for rinse-off products ranged from 5 to 63, whereas the MOSs for leave-on products ranged from 0.03 to 1.49. Overall, our results provide evidence that some leave-on products containing the maximum recommended safe concentration of Kathon CG may increase the risk of sensitization induction due to exposure to MCI/MI. In contrast, rinse-off products were not associated with a potential increased risk of skin sensitization induction.

Cost and Utility Analysis of a Store-and-Forward Teledermatology Referral System: A Randomized Clinical Trial.

IMPORTANCE: The costs and utility of teledermatology are important features of implementation. Such an analysis requires a description of the perspective of the entity that will bear the cost. OBJECTIVE: To assess the costs and utility of a store-and-forward teledermatology referral process compared with a conventional referral process from the perspectives of the Department of Veterans Affairs (VA) and society. DESIGN, SETTING, AND PARTICIPANTS: Three hundred ninety-one randomized participants were referred from remote sites of primary care to the dermatology services of 2 VA medical facilities for ambulatory skin conditions from December 2008 through June 2010, and follow-up was completed in March 2011. The time trade-off utility measures and costs were collected during a 9-month period among participants in a 2-site parallel group randomized clinical trial. The perspectives of the VA and society were evaluated. The multiple imputation procedure or weighted means were used for missing data elements. Data were analyzed from January to July 2014. INTERVENTIONS: Referrals were managed using store-and-forward teledermatology or a conventional text-based referral process. MAIN OUTCOMES AND MEASURES: Total costs from the perspectives of the VA and society incurred during the 9-month follow-up were used to derive per-participant costs. Utility, using the time trade-off method, was the measure of effectiveness. RESULTS: From the VA perspective, the total cost for conventional referrals was $66 145 (minimum, $58 697; maximum, $71 635), or $338 (SD, $291) per participant (196 participants); the total cost for teledermatology referrals was $59 917 (mimimum, $51 794; maximum, $70 398), or $308 (SD, $298) per participant (195 participants). The $30 difference in per-participant cost was not statistically significant (95% CI, -$79 to $20). From the societal perspective, the total cost for conventional referrals was $106 194 (minimum, $98 746; maximum, $111 684), or $542 (SD, $403) per participant (196 participants); the total cost for teledermatology referrals was $89 523 (minimum, $81 400; maximum, $100 400) or $460 (SD, $428) per participant. This $82 difference in per-participant cost was statistically significant (95% CI, -$12 to -$152). From baseline to the 9-month follow-up, the time trade-off utility value improved by 0.02 in the conventional referral group and 0.03 in the teledermatology group. This difference was not statistically significant (P = .50). CONCLUSIONS AND RELEVANCE: Compared with conventional referrals, store-and-forward teledermatology referrals were performed at a comparable cost (VA perspective) or at a lower cost (societal perspective) with no evidence of a difference in utility as measured by the time trade-off method. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00488293.

Adverse reactions to sunscreen agents: epidemiology, responsible irritants and allergens, clinical characteristics, and management.

Sunscreen is a key component in the preventive measures recommended by dermatologists and public health campaigns aimed at reducing sunburn, early skin aging, and skin cancer. To maximize compliance, adverse reactions to sunscreens should be minimized. Although inactive ingredients cause many of these reactions, it is important for dermatologists to be aware of reactions to active ultraviolet filters. There are approximately 120 chemicals that can function as ultraviolet (UV) filters. This review focuses on the 36 most common filters in commercial and historical use. Of these, 16 are approved for use by the US Food and Drug Administration. The benzophenones and dibenzoylmethanes are the most commonly implicated UV filters causing allergic and photoallergic contact dermatitis (PACD) reactions; benzophenone-3 is the leading allergen and photoallergen within this class. When clinically indicated, patch and photopatch testing should be performed to common UV filters.

Allergy to methyldibromoglutaronitrile/phenoxyethanol (Euxyl k 400): regulatory issues, epidemiology, clinical characteristics, and management.

Methyldibromoglutaronitrile/phenoxyethanol (Euxyl K 400) is a preservative found in both personal care products and industrial sources. Although Euxyl K 400 initially appeared to have low sensitizing potential, increased prevalence of contact allergy to Euxyl K 400 led to regulatory intervention. This review summarizes the history, epidemiology, and management of contact allergy to Euxyl K 400. Issues related to patch-test preparations are also discussed.

Allergic contact dermatitis to topical antibiotics: Epidemiology, responsible allergens, and management.

UNLABELLED: Topical antibiotics are widely used to treat cutaneous, ocular, and otic infections. Allergic contact dermatitis to topical antibiotics is a rare but well-documented side effect, especially in at-risk populations. The purpose of this article is to review the epidemiology, responsible allergens, and management of allergic contact dermatitis to topical antibiotics. LEARNING OBJECTIVE: After completing this learning activity, participants should be able to describe the epidemiology of allergic contact dermatitis related to topical antibiotics; show knowledge of the most common allergenic topical antibiotics; and understand the allergenic cross-reactivity pattern amongst topical antibiotics.

Toenail onychomycosis: current and future treatment options.

Onychomycosis is a common disease affecting as much as 8% of the general population. Treatment of onychomycosis is challenging, complicated by low cure rates and relatively high relapse rates. This paper reviews the efficacy of current oral, topical, and surgical treatment options. Currently, the treatment of choice for toenail onychomycosis is oral terbinafine because of its high efficacy, low relapse rates, and cost-effectiveness. Oral itraconazole or fluconazole could be considered for infections caused by Candida. Topical therapies may be a useful adjunct to these systemic therapies, but are less effective when used alone. More research is needed to determine the best measures for preventing reinfection.

Cost-effectiveness of diagnostic tests for toenail onychomycosis: a repeated-measure, single-blinded, cross-sectional evaluation of 7 diagnostic tests.

OBJECTIVE: Our purpose was to estimate and compare the cost-effectiveness of the most commonly used diagnostic tests for onychomycosis: potassium hydroxide preparation (KOH), interpreted both by a dermatologist (KOH-CLINIC) and a laboratory technician (KOH-LAB); KOH with dimethyl sulfoxide (KOH-DMSO) and with chlorazol black E (KOH-CBE), interpreted by a dermatologist; culture using dermatophyte test medium, culture with Mycobiotic and Inhibitory Mold Agar (Cx); and histopathologic analysis using periodic acid-Schiff stain (PAS). METHODS: This was a repeated-measure, blinded, cross-sectional study conducted at the Minneapolis Veterans Affairs Medical Center. Inclusion criteria included: at least one toenail with 25% or more clinical disease, which was defined as subungual debris with onycholysis and/or onychauxis. Exclusion criteria included other nail dystrophies, use of oral antifungal medication for 2 months or longer within the past year, or topical ciclopirox lacquer within 6 weeks of enrollment. The main outcome measure was the cost-effectiveness (Medicare and non-Medicare costs) of 7 diagnostic tests. Sensitivity (at least 3 positive tests) was the unit of effectiveness. RESULTS: Two hundred four participants were enrolled; their average age was 69.5 years and 95.5% were male. PAS was the most sensitive test (98.8%); it was statistically significantly more sensitive than all other diagnostic tests except KOH-CBE (94.3%). Dermatophye test medium was the least sensitive test (57.3%). KOH-CBE was statistically significantly more cost effective than any other test, with the exception of KOH-CLINIC and KOH-LAB. PAS was the least cost effective. LIMITATIONS: Test specificities were not evaluated. CONCLUSION: KOH-CBE should be the test of choice for practitioners confident in interpreting KOH preparations because of its combination of high sensitivity and cost-effectiveness.

Evaluating costs for onychomycosis treatments: a practitioner's perspective.

Onychomycosis is a common problem. The desired outcome of treatment for patients and clinicians is complete cure (negative culture and negative potassium hydroxide examination results plus a completely normal nail). This cost analysis sought to determine the cost-effectiveness of treatments for onychomycosis using complete cure as a unit of effectiveness. A simplified cost-effectiveness analysis was conducted using complete cure rates from randomized, blinded clinical trials involving at least 50 participants. Trials were identified by searching the literature, manually searching for review articles, and reviewing medication package inserts. For each trial that met the entry criteria, three levels of cost were used to calculate medication cost per complete cure: commercial price, average wholesale price, and Veterans Affairs pharmacy price. In addition, a computerized economic model was used to determine total cost per complete cure, including all medical costs. The most cost-effective treatments were those that involved terbinafine: pulse, continuous, or in combination with other agents. Itraconazole, griseofulvin, and fluconazole were less cost-effective. Ciclopirox nail lacquer was at least three times more expensive than all other agents when evaluating total costs per complete cure. Overall, the lowest cost per complete cure resulted from terbinafine treatment, with most evidence supporting 3 months of continuous therapy.