Surgical Treatment of Nails

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

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.¹

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.^2,3,4 Ingrown toenails account for approximately 20% of foot problems presenting to primary care.⁴

Other conditions may also require avulsion of part or all of the nail. These conditions may include, but are not limited to, onychomycosis, subungual hematoma, trauma, onychogryphosis, psoriasis, lichen planus, congenital nail dystrophies, and tumors.^5,6,7,8,9 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.^2,7,8 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.¹⁰ 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.¹ When possible, partial nail plate avulsion is preferred to complete avulsion, because it minimizes trauma to the adjacent tissues.¹¹ 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.^4,12,13,14 The matrixectomy can be performed either chemically or surgically. When nail avulsion is performed without matrixectomy, the nail will regrow from the matrix.¹⁵ A fingernail takes approximately 4–6 months to regrow, and a toenail takes approximately 8–12 months to regrow.^4,5,9,16

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);^{2,3,4,12,14,17}

• 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 hematoma;⁹

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

• Onychogryphosis or onychauxis;⁵

• Congenital or acquired nail dystrophies that jeopardize the integrity of the finger or toe;^1,5

• Diagnosis of suspected lichen planus or psoriasis of the fingernail or toenail;⁵

• Subungual and periungual tumors;⁷

• For a medically reasonable and necessary repeat nail excision on the same finger or toe. 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;

• For a medically reasonable and necessary 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. 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.^4,5,9,16

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 do not require local anesthesia does not constitute surgical treatment of a nail;^4,5

• 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 conditions⁵

Background

Common conditions affecting both fingernails and toenails include onychocryptosis, retronychia, subungual hematomas, paronychia, infections (especially onychomycosis), onychogryphosis, and onychauxis. Trauma, pathological, and congenital factors can affect both the nail plate and other components of the nail unit (matrix, nail bed, nail folds, etc.). Older populations are at an increased risk of nail alterations and disorders. Throughout the aging process, fingernails and toenails are exposed to physiologic and pathological processes that leave them vulnerable to developing an array of disorders, including physiologic, traumatic, infectious, and inflammatory conditions. In addition, impaired peripheral circulation and alterations in elastic and connective tissues may contribute to nail abnormalities in older adults.^5,18 The rate of regrowth in nails from the nail bed is also affected by these factors and slows by approximately 0.5% per year.¹⁹

Nail avulsion is the most common surgical intervention for treatment of the nail unit,²⁰ especially for conditions in which part of the nail plate grows into surrounding tissue and causes recurrent symptoms.²¹ It may be done for both therapeutic and diagnostic purposes. The most common use of nail avulsion is in the treatment of ingrown and incurved nails. Avulsion is also an option in the treatment of other nail disorders, particularly when removal of infected keratin and increased surface area for topical applications are expected to improve therapeutic response.²¹ Nail avulsions may be partial or complete, depending on the extent of the nail unit that is symptomatic. Nail avulsions involve the removal of the nail plate from the nail bed, either laterally or from the free edge of the nail. Often paired with nail avulsion is removal or ablation of the nail matrix, a matrixectomy, to prevent nail regrowth. Matrixectomies can be performed surgically, chemically with a caustic liquid, or electrosurgically through a variety of treatment options.¹² Nail avulsion with matrixectomy is often the preferred method of treatment for conditions requiring removal of the nail plate to reduce symptom recurrence from nail regrowth.¹²

Methods

The primary aim of this summary of evidence is to review and assess the clinical utility, efficacy, and safety of surgical nail interventions across a range of nail disorders. This summary of evidence has been formatted by indication, which may be grouped when nail abnormalities become symptomatic through a similar mechanism of action. The literature analysis draws from primary studies when applicable, as well as clinical literature reviews and consensus guidelines representative of standard practice in treatment.

Literature Review

Onychocryptosis, or ingrown nails, occurs when part of the nail plate pierces the lateral nail fold²² and can be debilitating in elderly patients. Ingrown nails are classified by severity into stages I, II, and III, based on the extent of symptoms, including erythema, edema, pain, and progressive drainage. Stage I ingrown toenails often resolve with conservative, non-surgical treatment methods, while stage II and III ingrown nails are associated with more severe symptoms and therefore are better suited for surgical treatment.^12,14 The 2012 Cochrane Review, Interventions for Ingrowing Toenails, updated an earlier review published in 2005 and assessed the evidence supporting available medical interventions for ingrowing toenails. Two authors independently selected studies that included randomized controlled trials (RCTs) of non-surgical and surgical interventions for ingrown toenails, assessed methodological quality, and extracted data from the resulting 24 selected RCTs spanning 2,826 participants. Across the 24 studies, 19 involved surgical interventions and seven had been included in the previous Cochrane review. The review concluded that surgical interventions addressing the interaction between the nail plate and the nail fold to eliminate trauma and inflammatory reaction are more effective than non-surgical interventions in preventing recurrence. One study included in the review compared partial nail avulsion with matrix excision to the same surgical intervention with chemical ablation by phenol. With 117 participants, the study found phenol to be significantly more effective in preventing recurrence than surgical intervention alone (14% versus 41%, respectively; risk ratio [RR] 0.34). Partial nail avulsion with chemical matrixectomy performed with phenol is the most widely used treatment for severe distal-lateral onychocryptosis, although other chemical, laser, and electrosurgical ablation methods of the matrix are also successful alternatives. In another systematic review and meta-analysis by Exley et al., the authors conducted a review of surgical methods for treating ingrown toenails, finding overall low-quality evidence regarding the use of phenol with nail avulsion versus nail avulsion alone.²³ In the review, two studies compared nail avulsion alone with avulsion and phenol matrixectomy, finding a significant reduction in recurrence in favor of phenol matrixectomy (95% confidence interval [CI] 0.06 to 0.27, RR 0.13). The findings of both systematic reviews are consistent with current medical guidelines from the Association of American Family Physicians, which recommend lateral (partial) nail avulsion and matrixectomy as best practice in the treatment of ingrown nails.

Retronychia is an incomplete form of nail shedding in which the nail plate becomes embedded within the proximal nail fold, resulting in inflammation through a mechanism similar to that seen in onychocryptosis. In a systematic review of retronychia and its treatment modalities conducted by Sechi et al., 24 studies including 231 participants were collated and reviewed by treatment type. Avulsion of the nail, either chemical or surgical, had a cure rate of 71.2%, and surgical avulsion of the nail plate alone had the highest cure rate of any treatment (78.2%); however, it was accompanied by long-term sequelae in 9.6% of cases.²⁵ Avulsion of the nail plate is generally considered curative in the treatment of retronychia.

Subungual hematomas are commonly caused by direct injuries to the nail,²² causing the accumulation of blood from the nail bed under the nail plate. Etiologies may also include anticoagulant therapy and hallux rigidus/valgus.^18,22 This accumulating pressure can lead to pain, nail discoloration, and visible blood accumulation.²⁶ While smaller hematomas can be allowed to progressively migrate to the free edge of the nail plate, nail bed visualization may be justified for subungual hematomas with associated distal phalanx fracture; in these cases, nail avulsion may be performed to drain the hematoma and examine the nail bed and any present nail lesions. Avulsion of the nail plate may be used in cases of traumatic nail injury to evaluate the stability of the nail bed or release a subungual hematoma after failed aspiration.²⁰

Paronychia is defined as inflammation or infection of the proximal lateral nail folds involving a breach in the protective barrier provided by the nail fold.²⁷ Paronychia can be acute, chronic, or secondary to environmental and pharmaceutical factors. Depending on the severity of the infection, it is possible for an abscess to form and to spread to adjacent nail folds and the subungual region. Chronic paronychia can also cause a nail plate deformity, manifesting as multiple transverse ridges.²² For cases with subungual abscesses, complete nail avulsion is recommended.²⁷ Similarly, nail avulsion and eponychial marsupialization (a wedge excision of eponychial nail fold skin) are recommended for the management of chronic paronychia when more conservative treatments fail. The Association of American Family Physicians published guidelines outlining the role of surgical intervention in the treatment of paronychia, both chronic and acute. The guidelines recommend surgical intervention for paronychia when an abscess is present, and for cases when drainage does not manage the infection, a partial nail avulsion can be performed for rapid relief and more sustained drainage.²⁸ Regarding the surgical treatment of chronic paronychia, two studies conducted by Bednar and Lane, and Grover et al., examined the use of nail avulsion in tandem with other surgical approaches to the treatment of paronychia.^29,30 Bednar and Lane conducted a retrospective study of 25 patients involving 28 consecutive fingers with chronic paronychia. Twenty-three fingers had nail irregularities; of these, the first 7 were treated with eponychial marsupialization alone, while the next 16 were treated with eponychial marsupialization plus nail removal. ²⁹ The authors found rates of recurrence dropped from 28.6% with marsupialization alone to zero incidence of recurrence with the addition of nail avulsion to the procedure (p<0.05). Grover et al.’s RCT of 30 patients treated with en bloc excision of the proximal nail fold, which included 15 patients with the procedure alone and 15 with the addition of nail plate removal, yielded similar results.³⁰ Within the group treated with en bloc excision and nail avulsion, 70% of patients who completed treatment protocols were cured (13 of 15 patients), whereas only 41% of patients who were treated with en bloc excision and completed the treatment protocol (12 of 15 patients) were cured. Across both studies, the addition of nail avulsion to another surgical treatment modality for chronic paronychia, in the absence of chemical or pharmaceutical interventions, improved patient outcomes for chronic paronychia.

Onychomycosis is a fungal infection of the nail unit characterized by nail dystrophy, discoloration, and subungual hyperkeratosis (nail thickening).³¹ A majority of onychomycosis cases require lengthy treatment plans due to slow growth of the nail. Chronic, untreated onychomycosis can lead to permanent damage of the nail plate, pain, local spread of infection, and cellulitis. Onychomycosis also exhibits high rates of reinfection (20%-25% after successful treatment).³¹ A 2014 British Association of Dermatologists (BAD) guideline on onychomycosis management found evidentiary support for surgical avulsion with topical treatment. Specifically for nondermatophyte onychomycosis, avulsion with antifungals resulted in a higher cure rate (60%) than topical monotherapies without avulsion (20%-40%).³² Multiple reviews and BAD guidelines reference an RCT conducted by Grover et al. for its application to surgical interventions in the treatment of onychomycosis. In the trial comparing the efficacy of avulsion with differing topical treatments, Grover et al. randomly assigned 40 patients with single-nail onychomycosis to four treatment groups. Each treatment group received nail avulsion and a specific topical antifungal. The authors intended to establish comparative efficacy of avulsion techniques used with topical treatments and also performed a pooled cure-rate analysis across all treated patients. Cure rates varied across treatment groups; however, a 56% cure rate was achieved across all interventions. The study was noted to have important limitations, including small sample size, high attrition rate, poor patient compliance, and lack of a nail-avulsion-only treatment group.³³ A clinical literature review conducted by Yousefian et al. identifies surgical procedures, such as avulsions or matrixectomies, as treatment options following multiple therapeutic failures.³¹ These surgical procedures are often administered concurrently with other treatments to optimize clinical benefits, as the nail bed can be better penetrated after the procedure.

Subungual hyperkeratosis is a marked symptom of some common nail disorders, including onychauxis, onychogryphosis, lichen planus, and nail psoriasis.^22,34 These conditions are characterized in part by the buildup of keratin material under the nail plate, leading to thickening, pain, and separation from the nail bed. When subungual hyperkeratosis produces pain, onycholysis, secondary onychomycosis, or impaired ambulation refractory to conservative debridement, nail avulsion with or without matrixectomy is indicated to remove the offending nail plate.¹⁸ In cases of psoriasis, lichen planus, and nail unit tumors, nail avulsion can be used to uncover aspects of the nail for further analysis or biopsy. ²⁰ A systematic review of the impact of nail psoriasis and its treatment on quality of life was conducted by Stewart et al.³⁴ The authors' review affirms that nail psoriasis is both physically and emotionally distressing, with nail involvement occurring in at least 80% of psoriasis patients and an estimated 10% having isolated nail psoriasis. Two clinical conditions, onychauxis and onychogryphosis, were described in a review by Cohen and Scher.²² Onychauxis was described as local hypertrophy of the nail plate, with possible complications including distal onycholysis and increased risk of onychomycosis. Onychogryphosis is an onychodystrophy characterized by exaggerated enlargement of the nail and poses an added risk of subungual gangrene development in patients with peripheral vascular disease or diabetes mellitus. For both conditions, the review proposed surgical avulsion of the nail plate. In cases of onychauxis with significant morbidity and complications, avulsion with matrixectomy was recommended. For onychogryphosis, nail avulsion was explicitly outlined for patients with preserved vascular supply to the digit, as it may be the preferred aggressive treatment.²²

Tumors affecting the nail unit can vary widely in etiology; common examples include human papilloma virus warts, glomus tumors, Bowen disease (Squamous Cell Carcinoma in situ), and nail apparatus melanoma.³⁵ Iorizzo, et al. conducted a literature review of malignant epithelial nail unit tumors, synthesizing the evidence base of these tumors and providing insight into clinical presentations of nail unit tumors.³⁶ Nail tumors often present clinically benign; however, a tumor should be suspected in the presence of single-digit dystrophy, ulceration/bleeding, pain, and nail plate color changes. The glomus tumor can present with indications for nail surgery, and is described by its features, diagnostic conditions, and treatment in Dooley, et al.’s review.⁷ The treatment described for glomus tumors is surgical excision, sometimes involving complete nail removal, split nail technique, and lateral approaches.

Two studies can be used to estimate the average growth rate of fingernails and toenails. Yaemsiri et al. conducted an observational study to estimate the average growth rate of fingernails and toenails in healthy American young adults.¹⁶ Twenty-two participants were included; all had their nails marked 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 fold to the mark again in 1-3 months. Nail growth rate was calculated based on recorded distance and time between the 2 measurements. Using similar methodology, a study conducted by Orentreich, Markofsky, and Vogelman included 271 participants aged 10-100 years, and examined nail growth rate and its decline throughout the aging process.¹⁹ Across the two studies, nail growth rate can be averaged at an approximate range of 3.47-3.60mm/month for fingernails and approximately 1.62 mm/month for toenails, with an average decline of 0.5% per year after 25 years old.^16,19 In a review of fingertip injuries, Tos et al. states that after a trauma a new nail will reach complete growth, pushing off the affected area of the unit, after 4-6 months.⁹

The evidence base evaluating surgical treatment of nail disorders is limited and consists primarily of descriptive studies, case series, reviews, and clinical practice guidelines rather than comparative trials of intervention. Across most indications considered in this LCD, the literature generally focuses on the clinical circumstances prompting surgical intervention and the consequences of delayed or inadequate management, rather than the use of surgical intervention alone. Although comparative evidence is limited, the consistency of reported clinical experience and concurrent guidelines supports the use of surgical nail procedures for select coverage criteria. Under the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, this evidentiary pattern is consistent with a good practice statement, in which a substantial body of indirect evidence supports a particular course of action, and formal comparative synthesis would provide little additional value or may be unreasonable from a patient care perspective.^37,38 In these circumstances, the rationale for intervention is based on the clear relationship between treatment and the prevention of clinically important adverse outcomes.

This framework is applicable across several conditions addressed in this policy. For subungual abscesses, hematomas, and traumatic injuries involving the nail unit, the literature consistently describes drainage of collections under pressure, evaluation and repair of nail bed injuries, and the avoidance of complications associated with the underlying pathology. Similarly, for subungual and periungual tumors, the literature is descriptive and emphasizes the importance of timely diagnosis and treatment. The clinical presentation of some nail tumors mimics that of benign conditions and as a result diagnosis of the appropriate condition can be delayed.³⁶ The primary consequence of diagnostic delay is stage progression, meaning a formal comparative synthesis of surgical treatment modalities would be an inefficient use of resources and unreasonable regarding patient well-being. In both settings, published evidence supports intervention based on well-established clinical principles despite the absence of extensive comparative studies in order to prioritize patient outcomes.

The literature regarding surgical treatment of onychomycosis is limited. Available studies primarily evaluate surgical procedures in combination with topical or systemic antifungal therapies, interventions that are outside the scope of this policy. A study evaluating nail avulsion alone for the treatment of onychomycosis was not identified within the literature search. Rather, surgical treatment is typically considered to relieve symptoms, address structural abnormalities, facilitate diagnosis, or manage conditions that have not responded adequately to conservative measures.³¹

The evidence supporting surgical treatment of hyperkeratotic nail conditions, including onychogryphosis, onychauxis, lichen planus, and nail psoriasis, was limited and consisted primarily of descriptive reviews and reports rather than comparative studies of intervention. The available literature consistently describes surgical nail procedures as treatment options for patients with symptomatic disease when conservative measures have proven inadequate, particularly in the presence of pain, nail deformity, secondary complications, or functional impairment. Although direct comparative evidence is lacking, the reported clinical experience demonstrates an association between surgical intervention and the alleviation of clinically significant symptoms attributable to the underlying condition. Consistent with GRADE principles regarding good practice statements,^37,38 the available body of evidence supports coverage of surgical procedures for select hyperkeratotic nail disorders when symptoms, complications, or functional limitations warrant intervention.

Published peer-reviewed literature supports surgical treatment of nail abnormalities with specific clinical indications present. These indications include moderate to severe onychocryptosis, subungual abscess or hematoma with failed aspiration, complicated injuries involving the nail unit, severe or recurrent fungal nail infection that has failed conservative treatment, onychogryphosis, onychauxis, congenital or acquired nail dystrophies, diagnostic evaluation of suspected nail manifestations of lichen planus or psoriasis, and treatment of subungual or periungual tumors. While the supporting evidence is frequently indirect, it demonstrates consistent clinical utility and supports coverage of surgical intervention when medically necessary, particularly when conservative treatment has failed or when delay in treatment may reasonably be expected to worsen clinical outcomes.

In addition, when repeat nail avulsion is being considered on the same toe or finger, available evidence indicates that complete regrowth of an avulsed toenail may require approximately 8 to 12 months, while regrowth of an avulsed fingernail generally requires 4 to 6 months. These timelines support the utilization parameters outlined in this LCD and help ensure that repeat procedures are performed only when clinically appropriate.

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• Creation of Uniform LCDs With Other MAC Jurisdiction