IMPORTANT INFORMATION ABOUT CODING AND BILLING FOR ONYCHOMYCOSIS

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IMPORTANT INFORMATION ABOUT CODING AND BILLING FOR ONYCHOMYCOSIS This guide provides information about coding and billing to help you prepare patient paperwork so that you are appropriately reimbursed for the diagnosis of onychomycosis. Below are 3 crucial tips to keep in mind, but be sure to read on for additional detailed information. Quality is critical Keep in mind that a quality medical record is essential to support the medical necessity and performance of a separately identifiable evaluation/ management (E/M) service. 1 Consistent coding matters Remember that E/M services are especially vulnerable to record requests, due to multiple coding level options and documentation requirements. 2 Evidence is essential Be sure to provide detailed documentation to strengthen and support the evidence of onychomycosis. 1,3,4 To learn more about JUBLIA, visit: INDICATION JUBLIA (efinaconazole) topical solution, 10% is indicated for the topical treatment of onychomycosis (tinea unguium) of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. IMPORTANT SAFETY INFORMATION JUBLIA is for topical use only and is not for oral, ophthalmic, or intravaginal use.

Evaluation and management coding E/M coding physical workup, medical record documentation of salient points, and management plan provides a uniform language to health care insurance companies through the use of CPT* codes. 1 A quality medical record is essential to support the medical necessity and performance of a separately identifiable E/M service. 1 Payers and auditors will look to see if E/M services are billed separately or with other services performed on the same day. 1,5 Examination of claims and records reveals: Whether the primary service was cognitive (ie, an evaluation and management service), palliative (eg, debridement of mycotic nails), or a combination of both 1,4-6 Whether the E/M service represents the workup of a new complaint unrelated to any palliative service performed on the same day, or an unsupported E/M service on the claim 1,4-6 Whether an independent E/M service was documented and coded to the proper level 1 Payers determine eligibility for reimbursement based on the policy benefits, medical necessity, correct coding, and standard of care; so always check with the payers in question for their requirements. *Current Procedural Terminology American Medical Association. IMPORTANT SAFETY INFORMATION (continued ) Patients should be instructed to contact their health care professional if a reaction suggesting sensitivity or severe irritation occurs.

Careful coding is key Requests for records or audits of claims are common and should be considered a cost of doing business in a medical practice. 2 E/M services are especially vulnerable to record requests because of multiple coding level options, documentation requirements, and expectations for a level of uniformity. 2 Failure to document the relevant elements needed to support the level of E/M service billed can result in a request for a refund. 2 Ignorance of E/M service coding or improper use of modifiers is not a defense. 2 IMPORTANT SAFETY INFORMATION (continued ) The most common adverse reactions (incidence >1%) were (vs vehicle): ingrown toenail (2.3% vs 0.7%), application-site dermatitis (2.2% vs 0.2%), application-site vesicles (1.6% vs 0%), and application-site pain (1.1% vs 0.2%). To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Documenting onychomycosis Always refer to local and national Medicare or non-medicare policies on onychomycosis for additional documentation requirements. Infections are included in Chapter B, Certain Infectious and Parasitic Diseases of the ICD-10 tabular section. 3,7 Category B35 includes the onychomycosis subcategory (B35.1* tinea unguium). 3,7 The inclusion terms for B35.1 include dermatophytic onychia, dermatophytosis of the nail, ringworm of the nails, and the commonly used term onychomycosis. 7 * The ICD-10 code provided is for informational purposes only. It is the treating physician s responsibility to determine the applicable ICD-10 code. Ortho Dermatologics does not guarantee coverage or reimbursement for the product. In the case of documenting onychomycosis, the medical record should include Clinical findings that support the diagnosis coding included on the claim form 3 The medical necessity for the service or procedure 3 The location of each nail with onychomycosis (eg, right hallux nail; left second, third, and fourth toenail; bilateral great toenails) 3 A notation of the degree of onychomycosis involvement in each affected nail plate (eg, distal third of the right hallux nail; entire left great toenail) 3 A characteristic description of each pathologic nail plate (eg, thick, normal, or thin; incurvated, loose, discolored [other than normal color], brittle, crumbling, pitted, splitting, etc) 3 Any reported symptoms specific to one or more individually identified infected toenail 4 Illustrations or photos will strengthen the evidence of pathology. JUBLIA is indicated for onychomychosis of the toenail. 8 IMPORTANT SAFETY INFORMATION (continued ) JUBLIA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and should be used with caution in nursing women. The safety and effectiveness in pediatric patients have not been established.

Additional documentation notes Basic ICD-10 guidelines* direct coders to include all relevant ICD-10 codes on the claim that match supportive documentation in the medical record. For example, if a patient has both a thickened, curved nail with a confirmed diagnosis of onychomycosis, the coding would be 1,4 : B35.1 (onychomycosis) 4,9 L60.2 (onychogryphosis) 4,9 If the patient reports pain, the doctor should include pain in foot and toes (M79.674 [right toe(s)] and/or M79.675 [left toe(s)]) to the list of diagnoses on the claim. 9 * The ICD-10 code provided is for informational purposes only. It is the treating physician s responsibility to determine the applicable ICD-10 code. Ortho Dermatologics does not guarantee coverage or reimbursement for the product. 2016 Medicare data of all CPT codes billed by podiatrists. Frequently billed codes These E/M services, in order of frequency billed, are some of the most commonly used CPT codes submitted by podiatrists 10,11 : 99213 office visit, established 99212 office visit, established 99203 office visit, initial 99202 office visit, initial 99307 nursing facility, established 99308 nursing facility, established 99214 office visit, established 99348 home visit, established

Additional documentation notes Billing codes with a modifier Use of coding modifiers further describes a service or procedure code without changing the definition of the code. The addition of a -25 modifier a significant, separate identifiable service to an E/M code when performing a minor procedure during the same encounter may raise red flags regarding whether or not there was a need for the addition of an E/M code. Red flags lead to medical records requests or outright denials, forcing the practice to appeal. It is the doctor s responsibility to understand the proper use of E/M codes, including coding modifiers when submitting claims. 4,12 Disclaimer E/M levels may change with additional relevant documented information impacting the management of the patient s presenting illness(es). Refer to Evaluation and Management Services, a guideline published by the Department of Health and Human Services Centers for Medicare & Medicaid Services, for further information. References: 1. Department of Health and Human Services: Centers for Medicare & Medicaid Services. Evaluation and Management Services. https://www.cms.gov/outreach-and- Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf. Accessed December 20, 2017. 2. Block, Barry H. Avoiding That Medicare Audit. Podiatry Management Online. http://www.podiatrym.com/pm%5cavoid.pdf. Accessed December 20, 2017. 3. Centers for Medicare & Medicaid Services. Local Coverage Determination (LCD): Surgery: Routine Foot Care (L34944). https://www.cms.gov/medicare-coverage-database/details/lcd-detailsaspx?lcdid=34944&ver=22&cntrctrselected=385*1& Cntrctr=385&s=2&DocType=Active&bc=AAgAAAIAIAAAAA%3d%3d&. Accessed December 20, 2017. 4. Centers for Medicare & Medicaid Services. Local Coverage Determination (LCD): Routine Foot Care and Debridement of Nails (L34246). https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?lcdid=34246&ver=11&cntrctrselected=238*2& Cntrctr=238&name=CGS+Administrators%2c+LLC+(15202%2c+MAC+-+Part+B)&DocType=Active&s=42&bc=AggAAAIAIAAAAA%3d%3d&. Accessed December 20, 2017. 5. Department of Health and Human Services. Medicare Payments for Nail Debridement Services. https://oig.hhs.gov/oei/reports/oei-04-99-00460.pdf. Accessed December 20, 2017.

INDICATION JUBLIA (efinaconazole) topical solution, 10% is indicated for the topical treatment of onychomycosis (tinea unguium) of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. IMPORTANT SAFETY INFORMATION JUBLIA is for topical use only and is not for oral, ophthalmic, or intravaginal use. Patients should be instructed to contact their health care professional if a reaction suggesting sensitivity or severe irritation occurs. The most common adverse reactions (incidence >1%) were (vs vehicle): ingrown toenail (2.3% vs 0.7%), application-site dermatitis (2.2% vs 0.2%), application-site vesicles (1.6% vs 0%), and application-site pain (1.1% vs 0.2%). JUBLIA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and should be used with caution in nursing women. The safety and effectiveness in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. References (continued): 6. Centers for Medicare & Medicaid Services. Local Coverage Determination (LCD): Debridement of Mycotic Nails (L35013). https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?lcdid=35013&ver=10&cntrctrselected=327*1&cntrctr=327&s=3&doctype=active&bc=aggaaaiacaaaaa%3d%3d&. Accessed December 20, 2017. 7. Centers for Medicare & Medicaid Services. ICD-10-CM tabular list of diseases and injuries. https://www.cms.gov/medicare/coding/icd10/downloads/6_i10tab2010.pdf. Accessed December 20, 2017. 8. JUBLIA [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC. 9. Centers for Medicare & Medicaid Services. Local Coverage Determination (LCD): Routine Foot Care and Debridement of Nails (L33636). https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?lcdid=33636&ver=42&cntrctrselected= 299*1&Cntrctr=299&s=9&DocType=Active&bc=AggAAAIAIAAAAA%3d%3d&. Accessed December 20, 2017. 10. Department of Health and Human Services. Coding trends of Medicare evaluation and management service. https://oig.hhs.gov/oei/reports/oei-04-10-00180.pdf. Accessed December 20, 2017. 11. Data on file. Department of Health and Human Services: Centers for Medicare & Medicaid Services. 12. Department of Health and Human Services. Use of modifier 25. https://oig.hhs.gov/oei/reports/oei-07-03-00470.pdf. Accessed December 20, 2017. JUBLIA is a trademark of Ortho Dermatologics, Inc. or its affiliates. 2018 All Rights Reserved JUB.0072.USA.17