Summary Of Evidence

N/A

Analysis of Evidence

N/A

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

As with other Medicare covered services, Mycotic Nail Debridement must be reasonable and necessary for the treatment of an illness or injury or to improve the functioning of a malformed body member; refer to CMS IOM Publication 100-08, Program Integrity Manual, Chapter 13 for more information. Medicare payment generally may be made for mycotic nail debridement in the two following circumstances:

1. As "routine foot care" under Medicare's national "Exceptions to Routine Foot Care Exclusions" provision when there is clinical evidence of mycosis of the toenail and the services and patient conditions meet national requirements for that exception.
   
   
2. When, whether or not the services and patient conditions meet national requirements for routine foot care, there is clinical evidence of mycosis of the toenail, and the patient has marked limitation of ambulation due solely to discomfort caused by the nails, (patients who are non-ambulatory for other reasons must have severe pain or impairment of some aspect of ADL) or has secondary soft tissue infection resulting from the thickening and dystrophy of the infected nail plate. The treatment of symptomatic mycotic nails in the absence of a qualifying covered systemic condition will not be covered after the acute symptoms caused by mycosis have abated. In the absence of a qualifying systemic condition, debridement of six or more nails in a single encounter is not payable without medical review of records associated with the service.

Onychomycosis may present as one or more nail findings, including hypertrophy/thickening, lysis, discoloration, brittleness or loosening of the nail plate. Fungal disease of the toenails is usually a relatively benign condition and may produce little or no symptoms beyond white opacities on the nails. Confirmation of mycotic nail infections by laboratory tests such as fungal cultures and/or stains is not necessary for Medicare coverage of debridement when clinical findings are strongly supportive of the diagnosis and treatment is not contraindicated. For coverage of mycotic nail debridement, mycologic confirmation by culture, potassium hydroxide examination, or dermatophyte testing is expected to differentiate fungal disease from other nail pathology in certain circumstances including but not limited to the following conditions: previous unsatisfactory treatment results (recurrent nail disease, unsuccessful treatment with FDA approved antifungal medications, long term - beyond 12 debridements per 24 months, etc.) and for patients whose debridement is prescribed absent of concomitant pharmacologic therapy.

Definitive treatment of mycotic nails involves the appropriate use of effective antifungal pharmacologic agents with or without periodic debridement of dystrophic nail plates to lessen the fungal load. Medicare will cover debridement of mycotic nails as an adjunct to pharmacologic treatment with a prescription antifungal agent indicated per its Food and Drug Administration (FDA) label for the treatment of fungal nail infections.

Debridement of nails, whether by electric grinder or manual method, is a temporary reduction in the length and thickness (short of avulsion) of an abnormal nail plate. This is usually performed without anesthesia. The debridement code should not be used if the only part of the nail removed is the distal nail border or other portion of nail not attached to the nailbed. Medicare expects debridement services reported for Medicare payment to include removal of maximal nail material possible (in consideration of the clinical condition of the nail and the patient's degree of comfort during the procedure) required for control of symptoms or infection.

It is performed most commonly without anesthesia to accomplish any or all of the following objectives:

• Relief of pain
• Treatment of infection (bacterial, fungal, and viral)
• Temporary removal of an anatomic deformity such as onychauxis (thickened nail), or certain types of onychocryptosis (ingrown nail)
• Exposure of subungual conditions for the purpose of treatment as well as diagnosis (biopsy, culture, etc.)
• As a prophylactic measure to prevent further problems, such as a subungual ulceration in an insensate patient with onychauxis

Debridement of asymptomatic mycotic nails is considered to be routine foot care and not a covered service unless submitted with documentation of the complicating factor or condition required for Medicare reimbursement. 

Covered Indications

Whether by manual method or by electrical grinder, debridement is a modality used as part of the definitive antifungal treatment of onychomycosis.

Payment may be made for the debridement of a mycotic nail (whether by manual method or by electrical grinder) when definitive antifungal treatment options have been reviewed and discussed with the patient at the initial visit and the requirements outlined in the CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 290 Foot Care are met.

For patients with a systemic condition and clinical evidence of mycosis of the toenail, but who do not meet the above criteria, refer to Local Coverage Determination (LCD) L35138, Routine Foot Care.

Medicare does not routinely cover fungus cultures, KOH preparations, or dermatophyte testing performed on toenail clippings in the doctor's office. Identification of cultures of fungi, potassium hydroxide examination, or dermatophyte testing of the toenail clippings is medically necessary only:

• When it is required to differentiate fungal disease from psoriatic nails or other nail pathology.
• When a definitive treatment for a prolonged period of time is being planned involving the use of a prescription medication which could pose health issues.

Debridement of nails is considered reasonable and necessary when performed by physicians, doctors of osteopathy, podiatrists and non-physician practitioners (NPPs) when performed within their state scope of practice or when performed under the direction of a qualified provider.

Limitations

Whirlpool treatment prior to the debridement of mycotic nails to soften the nails or the skin is not eligible for separate reimbursement.

Debridement codes should not be used to report the simple trimming, cutting, or clipping of the distal nail plate.

This LCD imposes frequency limitations. For frequency limitations please refer to the Utilization Guidelines section below.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. Refer to Billing and Coding: Debridement of Mycotic Nails, A56640, for applicable CPT codes and diagnosis codes.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.