Local Coverage Determination (LCD)

Surgical Treatment of Nails

L39258

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Contractor Information

LCD Information

Document Information

LCD ID
L39258
LCD Title
Surgical Treatment of Nails
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL39258
Original Effective Date
For services performed on or after 03/05/2023
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
01/19/2023
Notice Period End Date
03/04/2023
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Issue

Issue Description

The Surgical Treatment of Nails L39258 LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.

Issue - Explanation of Change Between Proposed LCD and Final LCD

The Limitations and Documentation Requirements sections were updated with a statement indicating that medically necessary repeat nail avulsions or nail excisions would be considered on redetermination. The medical record documentation must be specific as to the indication.

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, §1862(a)(7) excludes routine physical examinations.

Title XVIII of the Social Security Act, §1862(a)(13)(C) addresses routine foot care.

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §290 Foot Care

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 1, §70.2.1 Services Provided for the Diagnosis and Treatment of Diabetic Sensory Neuropathy with Loss of Protective Sensation (aka Diabetic Peripheral Neuropathy)

CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.4 Reasonable and Necessary Provisions in LCDs

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Nail surgery is often performed to remove benign and malignant nail tumors, relieve pain caused by ingrown and traumatized nails, manage disease processes, and diagnose challenging lesions and dystrophies.8

An ingrown nail (onychocryptosis) is a condition which results in the growth of the nail edge into the surrounding soft tissue. Ingrown toenails present with a varying degree of inflammation and edema of the nail folds. This often results in a draining, foul-smelling lesion with hypertrophy of the involved nail fold; however, the most common accompanying symptom is pain. This condition most commonly occurs in the great toes and may require surgical treatment in moderate to severe cases.7,10,13 Ingrown toenails account for approximately 20% of foot problems presenting to primary care.13

Other conditions may also require avulsion of part or all the nail. These conditions may include but are not limited to onychomycosis, subungual hematoma, trauma, onychogryphosis, psoriasis, lichen planus, congenital nail dystrophies, and tumors.1,2,5,12,14 Onychauxis, which can result from nail fungus, psoriasis, or other conditions, may cause onycholysis (separation of the nail plate from the nail bed). In the case of a moderate to severe symptomatic dystrophic nail plate, surgical intervention may be needed.5,7,12 This LCD addresses the conditions for which nail avulsion may be considered reasonable and necessary.

Surgical techniques for the treatment of nail pathology include complete or partial nail avulsion. Nail avulsion requires adequate anesthesia for optimal results.11 Generally, this procedure is performed under local anesthesia and involves the separation and removal of a border of the nail or removal of the entire nail from the nail bed to the eponychium.8 When possible, partial nail plate avulsion is preferred to complete avulsion, because it minimizes trauma to the adjacent tissues.3 Nail avulsions usually offer only temporary relief for ingrown toenails. The nail often grows back to its original thickness, and the offending margin again may become problematic, resulting in a need for another nail avulsion. Often, the preferred course of treatment may be a partial or complete nail avulsion performed with a matrixectomy, which is destruction or permanent removal of the matrix to prevent the nail from regrowing.6,9,13,17 The matrixectomy can be performed either chemically or surgically. When nail avulsion is performed without matrixectomy, the nail will regrow from the matrix.4 A fingernail takes approximately 4–6 months to regrow, and a toenail takes approximately 8–12 months to regrow.1,13,14,16

Wedge excision of skin of the nail fold is a procedure designed to relieve pressure on the nail/soft tissue and requires an excision of a wedge of the soft granulation tissue and ingrown nail from the affected side (medial and/or lateral) of the toe or finger.

Services will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the provider’s professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting.

Covered Indications

Surgical treatment of nails is covered for the following indications:

  • Symptomatic onychocryptosis (ingrown fingernails or toenails)6,7,10,13,15,17;

  • Subungual abscess and/or hematoma after a failed puncture aspiration;
  • Complicated injury of the toes or fingers involving the nail component that is severe enough to require removal of the nail to evaluate the stability of the nail bed or to release a subungual hematoma14;

  • Severe or recurrent fungal nail infection that has failed to respond to usual, less invasive treatment (e.g., pharmacological treatment, debridement);

  • Onychogryphosis or onychauxis1;

  • Congenital or acquired nail dystrophies that jeopardize the integrity of the finger or toe1,8;

  • Diagnosis of suspected lichen planus or psoriasis of the fingernail or toenail1;

  • Subungual and periungual tumors5

Limitations

The following indications are non-covered and are considered not medically reasonable and necessary:

  • Trimming, cutting, clipping or debridement of nails;

  • Removing small chips or wedges of the nail or skin that does not require local anesthesia does not constitute surgical treatment of a nail1,13;

  • Simple treatment of ingrown toenails (e.g., trimming, cutting, clipping of the distal unattached nail margins) does not constitute surgical treatment of nails;

  • Surgical treatment of asymptomatic conditions1;

  • Repeat nail excision on the same toenail or fingernail following a complete nail excision for permanent removal;

  • When a complete nail avulsion is performed, a repeat nail avulsion of the same toenail or fingernail performed more often than every 32 weeks (8 months) for toenails or every 16 weeks (4 months) for fingernails, is considered to be not medically reasonable and necessary.1,13,14,16

NOTE: A medically necessary repeat nail avulsion on the same finger less than 16 weeks or the same toe less than 32 weeks following a previous avulsion will be considered on a redetermination. A medically necessary repeat excision of the nail and nail matrix for permanent removal on the same finger or the same toe following a previous excision of the nail and nail matrix for permanent removal will be considered on a redetermination. The medical record documentation must be specific as to the indication, such as ingrown nail of the opposite border or new significant pathology on the same border recently treated.

Summary of Evidence

Abdullah and Abbas published a clinical literature review presenting common nail alterations and disorders that occur in the elderly population and their management options.1 The elderly are at an increased risk of nail alterations, including normal age-related changes and nail disorders that are more common in this specific population. Secondary factors that may contribute to pathologic nail changes include impaired circulation at the distal extremities, faulty biomechanics, infections, neoplasms, and skin or systemic diseases with nail manifestations. These factors can affect the nail plate or involve other components of the nail unit (e.g., matrix, nail bed, hyponychium, or nail folds). These nail changes can impair the daily activities of this older population whose activities might already be restricted. Common nail disorders in this population include onychauxis, onychocryptosis, infections (e.g., onychomycosis), subungual hematoma, and malignancies of the nail apparatus.

Tos et al published a review article, which addressed the surgical treatment of acute fingernail injuries.14 This review focused on several nail-bed and fingertip injuries. One such injury reviewed was that of a subungual hematoma. The authors suggested that when >50% involvement of the nail plate is associated with a fracture of the distal phalanx, examination of the nail bed is recommended. The fingernail should be detached, the hematoma drained, and the nail lesions should be identified and eventually treated.

Multiple publications (Eekhof et al; Geizhals et al; Kline; Mayeaux et al; Vlahovic) describe the ingrown nail (onychocryptosis) and potential approaches to treatment.6,7,10,13,15 Eekhof et al updated the Cochrane review 'Surgical treatments for ingrowing toenails’ in order to evaluate the effects of non-surgical and surgical interventions in a medical setting for ingrowing toenails.6 Two authors independently selected studies that included randomized control trials (RCT) of non-surgical and surgical interventions for ingrowing toenails, assessed methodological quality, and extracted data from the selected studies. The group then analyzed outcomes as risk ratios (RR) with 95% confidence intervals (CI). This update included 24 RCT studies, with a total of 2,826 participants, 7 of the studies were included in a previous review. Five studies were on non-surgical interventions, and 19 were on surgical interventions. The goal of surgical treatment is to remove the interaction between the nail plate and the nail fold to eliminate the local trauma and inflammatory reaction. These approaches are superior to non-surgical ones for preventing recurrence. In the Cochrane review, 1 study demonstrated no significant difference in recurrence with nail-edge excision and total avulsion of the nail. Less recur­rence was noted after 12 months with wedge resection (risk ratio = 0.19; 95% CI, 0.05 to 0.80) and radical excision of the nail fold (risk ratio = 0.17; 95% CI, 0.04 to 0.72) than with the rotational flap technique of the nail fold. Prevention of recurrence between wedge resection and radical excision of the nail fold showed no significant difference after 12 months.

The most common, and preferred, surgical approach is partial avulsion of the lateral edge of the nail plate (Collins et al)3 often followed by lateral horn matrixectomy by phenolization or surgical excision of the lateral horn of the nail matrix. Both approaches appear equally effective. The recurrence rate, for ingrown toenail, with a simple partial nail avulsion is approximately 70%.15 A Cochrane systematic review6 found that partial nail avulsion combined with phenolization is more effective at preventing symptomatic recurrence than surgical excision without phenolization (1 in 25 patients vs. 8 in 21 patients respectively). Electrosurgical or laser ablation of the matrix are also suc­cessful alternatives.

Kouba et al published evidence-based clinical recommendations to address the clinical use and safety of local anesthesia for dermatologic office-based procedures.11 Two hundred one studies were collated, each study was reviewed and ranked based on relevance and the level of evidence for specific clinical questions. Evidence tables were generated for these studies and used by the authors in developing clinical recommendations. This review supports the recommendations for the use of topical anesthesia for office-based procedures. Local infiltrative anesthesia is safe and recommended for office-based dermatologic procedures including, but not limited to, obtaining a biopsy specimen, excision, wound closure, tissue rearrangement, skin grafting, cauterization, nonablative laser, and ablative skin resurfacing. Also, nerve blocks should be considered as an alternative or, in addition to, infiltrative anesthesia for procedures on the face, hands, feet, and digits.

A study conducted by Yaemsiri et al was performed to estimate the average growth rate of fingernails and toenails.16 Prior to this study, the authors explain that only a few observational studies had been conducted, all prior to 1980. Twenty-two healthy American young adults marked their nails close to the proximal nail fold following a standardized protocol and recorded the date and the distance from the proximal nail fold to the mark. Participants recorded the date and distance from the proximal nail fold to the mark again in 1-3 months. Nail growth rate was calculated based on recorded distance and time between the 2 measurements. The authors found that the average fingernail growth rate was faster than that of toenails (3.47 vs. 1.62 mm⁄month, P < 0.01). Younger age, male gender, and onychophagia were associated with faster nail growth rate; however, the differences were not statistically significant.

According to the literature review by Abdullah et al, with advancing age, normal characteristic changes in the growth rate and morphology of the nail plate occur.1 Although not completely understood, the underlying mechanisms for these changes might be related to dysfunctional blood circulation at the distal extremities or to the effects of ultraviolet radiation. Tos et al notes that an injured nail will be pushed off by the new nail and reach complete growth at 4-6 months after trauma.14 Nail plate growth rates of fingernails and toenails normally average 3.0 and 1.0 mm/month, respectively. As patients age, starting at the age of 25 years, this rate tends to decrease by approximately 0.5% per year.1

Analysis of Evidence (Rationale for Determination)

Published peer-reviewed literature has shown that surgical treatment of nails is recommended in moderate to severe onychocryptosis, subungual abscess/hematoma, complicated injury of the toes or fingers involving the nail component, severe or recurrent fungal nail infection that has failed less invasive treatment, onychogryphosis, onychauxis, congenital or acquired nail dystrophies that jeopardize the integrity of the finger or toe, diagnosis of suspected lichen planus or psoriasis of the fingernail or toenail, and treatment of subungual or periungual tumors. Surgical treatment of nails should be considered, especially in circumstances where more conservative measures of treatment have failed.

In addition, when consideration is being given for a repeat nail avulsion on the same toe or finger, studies show that complete regrowth of an avulsed toenail may require up to 8-12 months, while an avulsed fingernail usually requires 4-6 months. This data assists in supporting the utilization parameters outlined in this LCD.

General Information

Associated Information

Documentation Requirements

  1. The record must include the appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.

  1. Documentation should support the criteria for coverage as set forth in the Coverage Indications, Limitations and/or Medical Necessity section of this LCD. The physical exam should document the severity of the nail infection, injury, or deformity, and the assessment and plan should document detailed rationale as to why surgical treatment of the nails is being performed as the proposed treatment over other treatment options.

  1. Surgical treatment of nails, in general, requires the use of local anesthesia. The medical record must indicate the anesthesia used (digital, local, or topical). If digital or local anesthesia is not used, the medical record must justify why digital or local anesthesia was not used (e.g., "patient requested topical anesthesia", "patient allergic to lidocaine", or "patient has neuropathy precluding need for anesthesia", etc.).

  1. It is inappropriate to state "no anesthesia used due to a possible anesthetic reaction" without indicating the patient's allergies in the medical record.

  1. An operative report or complete detailed description of the procedure being performed is required. Documentation must support the medical necessity and the frequency of the service. Failure to include the following information in the patient's medical record could result in denial of the claim.

    • The patient's chief complaint
    • Procedure being performed
    • Method of obtaining anesthesia (if not used, the reason for not using it)
    • A complete detailed description of the procedure
    • Postoperative observation and treatment of the surgical site (e.g. minimal bleeding, sterile dressing applied)
    • Postoperative instructions given to the patient and any follow-up care (e.g., soaks, antibiotics, follow-up appointments)

  1. For a medically necessary repeat nail avulsion on the same toenail less than 32 weeks or the same fingernail less than 16 weeks following a previous avulsion, or for a medically necessary repeat excision of the nail and nail matrix for permanent removal on the same finger or the same toe following a previous excision of the nail and nail matrix for permanent removal, the medical record documentation must be specific as to the indication (e.g., ingrown nail of the opposite border or new significant pathology on the same border recently treated). These repeat procedures will be considered on redetermination.

Documentation supporting medical necessity should be legible, maintained in the patient's medical record, and must be made available to the A/B MAC upon request.

Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in Centers for Medicare and Medicaid Services (CMS) payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

Sources of Information

Other Contractor’s policies

Bibliography
  1. Abdullah l, Abbas O. Common nail changes and disorders in older people. Can Fam Physician. 2011;57:173-181.

  1. Baswan S, Kasting GB, Li SK, et.al. Understanding the formidable nail barrier: A review of the nail microstructure, composition and diseases. Mycoses. 2017;60(5):284-295.

  1. Collins SC, Cordova K, Jellinek NJ. Alternatives to complete nail plate avulsion. J Am Acad Dermatol. 2008;59:619-626.

  1. Dabrowski M, Litowinska A. Recurrence and satisfaction with sutured surgical treatment of an ingrown toenail. Annals of Medicine and Surgery. 2020;56:152-160.

  1. Dooley TP, Kindt KE, Baratz ME. Subungual tumors. Hand. 2012;7:252-258.

  1. Eekhof JAH, Van Wijk B, Knuistingh Neven A, van der Wouden JC. Interventions for ingrowing toenails. Cochrane Database of Systematic Reviews. 2012;(4). Art. No.: CD001541.

  1. Geizhals S, Lipner S. Review of onychocryptosis: epidemiology, pathogenesis, risk factors, diagnosis and treatment. eScholarship.org. Dermatology Online Journal. 2019;25(9):1-8. Accessed 12/12/22.

  1. Haneke E. Surgical anatomy of the nail apparatus. Dermatol Clin. 2006;24:291-296.

  1. Karaca N, Dereli T. Treatment of ingrown toenail with proximolateral matrix partial excision and matrix phenolization. Ann Fam Med. 2012;10(6):556-559.

  1. Kline A, Onychocryptosis: A simple classification system. The Foot and Ankle Journal. 2008;1(5):6.

  1. Kouba DJ, LoPiccolo MC, Alam M, et al. Guidelines for the use of local anesthesia in office-based dermatologic surgery. J Am Acad Dermatol. 2016;74:1201-1219.

  1. Lee DJR, Arbache ST, Quaresma MV, Nico MMS, Gabbi TVB. Nail apparatus melanoma: Experience of 10 years in a single institution. Skin Appendage Disord. 2019;5:20-26.

  1. Mayeaux EJ Jr, Carter C, Murphy TE. Ingrown toenail management. Am Fam Physician. 2019;100(3):158-164.

  1. Tos P, Titolo P, Chirila NL, et al. Surgical treatment of acute fingernail injuries. J Orthopaed Traumatol. 2012;13(2):57-62.

  1. Vlahovic TC, Current concepts in nail surgery. Podiatry Today. 2016;29(7):72-75.

  1. Yaemsiri S, Hou N, Slining MM, He K. Growth rate of human fingernails and toenails in healthy American young adults. JEADV. 2010;24(4):420-423.

  1. Zuber T. Ingrown toenail removal. Am Family Physician. 2002;65(12):2547-2550.

Revision History Information

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Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
01/13/2023 03/05/2023 - N/A Currently in Effect You are here

Keywords

  • onychocryptosis
  • ingrown nail
  • onychomycosis
  • onychogryphosis
  • subungual hematoma
  • onychauxis
  • lichen planus
  • psoriasis

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