Summary Of Evidence

The content of this LCD is supported through an evidence-based literature search of articles and publications through PubMed. Articles were identified based on a key word search for: indications for the surgical treatment of nails, ingrown toenails. The literature search was filtered to find articles within 5 to 10 years. Also included were full text articles, clinical trials, randomized controlled trials, and systematic reviews. Below is a summary of evidence to support the medically reasonable and necessary indications for the surgical treatment of nails and explanation of limitations.

Yaemsiri et al conducted a study of human nail clippings for epidemiological studies as a biomarker for assessing diet and environmental exposure to trace elements or other chemical compounds. To the authors knowledge at the time of this study, little was known about toenail and fingernail growth rates so the purpose of the study was to estimate the average growth rate of fingernails and toenails and to examine factors that may influence nail growth rate. Study participants were twenty-two healthy American young adults. The participants marked their nails close to the proximal nail fold with a provided nail file using a standardized protocol. Participants recorded the date and distance from the proximal nail fold to the mark at one to three months with the average time frame between baseline and final measurement as 64 days (range: 33 to 89 days). Nail growth was calculated based on the study participants recorded distance and time between the measurements of date and the distance from the proximal nail fold to the mark. The results were reported in millimeters per month, a month was defined as 30 days. Information was obtained on the nail growth rate of 195 fingernails and 188 toenails from twenty-two participants. With this study, it was observed that the “average fingernail growth rate 3.47 mm/month) was over twice as fast as that of toenails (1.62 mm/month), P < 0.01.” Also, it was determined that, “Younger age, male gender, and onychophagia were associated with faster nail growth rate; however, the differences were not statistically significant.”¹² There were some limitations noted. Study participants were young adults and therefore results were not generalizable to children or the elderly. Another limitation was that, as shown in previous studies, nail growth rate may be modified by other factors such as race, pregnancy, and disease status. Additionally, the small sample size limited the ability to measure the differences in factors noted above and nail growth rate based on self-measurements may have inherent errors. Lastly, follow-up time was short and limited the ability to determine the possible variation in nail growth rate across seasons and climates as compared in previous studies.

Eekhof et al updated the Cochrane review 'Surgical treatments for ingrowing toenails.' Two authors independently selected studies that included randomized control trials (RCT) of non-surgical and surgical interventions for ingrowing toenails. Search of the databases to January 2010 included Cochrane Skin Group Specialized Register, CENTRAL in The Cochrane Library, MEDLINE, and EMBASE. In addition, searches of CINAHL, WEB of SCIENCE, ongoing trials databases, and the reference articles were updated. Methodological quality, and data were extracted from the selected studies. This update included 24 RCT studies, with a total of 2,826 participants, 7 of the studies were included in the previous review. Five studies were on non-surgical interventions, and 19 were on surgical interventions.

The comparison of non-surgical interventions with surgical interventions revealed that surgical interventions are more effective in preventing the recurrence of an ingrowing toenail and surgical interventions are most likely to be of use when the ingrowing toenail is at a more severe stage of development (stage II and stage Ill). In the studies comparing a surgical intervention to a surgical intervention with the application of phenol, (phenolization), authors determined that the addition of phenol is probably more effective in preventing recurrence and regrowth of the ingrowing toenail.¹¹ One limitation noted is there is only one study in which the surgical interventions in both study arms were equal, thereby more studies must be done to confirm these outcomes. Also, although there are different non-surgical and surgical interventions for ingrowing toenails that are available, there is no agreement about a standard first choice treatment.

The recurrence rate, for ingrown toenail, with a simple partial nail avulsion is approximately 70 percent.⁸ A study by Khan et al revealed that at follow-up at one and six months 5% of the patients had spike formation and all of them belonged to the partial nail avulsion alone group. Between the groups studied, patients with surgery with phenolization and patients without phenolization, the p-value for recurrent disease was 0.027 considered significant and showed that partial avulsion with phenol application had better outcome compared to partial nail avulsion without the application of phenol.¹³ Other studies have shown that the surgical technique of partial lateral nail avulsion and matrixectomy has been shown to achieve success in the treatment of ingrown nails.¹⁴

Avulsion of the nail plate may be initially performed to allow full exposure of the nail matrix to visualize the nail bed and nail matrix in order to look for pathologies originating in either the nail bed or the nail matrix, which may include inflammatory dermatoses, (e.g., chronic plaque psoriasis), infections, connective tissue diseases (e.g., systemic sclerosis, lupus erythematosus (SLE), dermatomyositis (DM), primary Sjogren’s syndrome), and tumors.¹ Avulsion of the nail plate may also be performed in order to obtain a biopsy on the nail bed or matrix for diseases with nail deformities associated with dermatologic conditions, like psoriasis and lichen planus nail dystrophy, as well as, nail unit tumors, nevi, suspected malignant melanoma, longitudinal melanonychia and pachyonychia congenita.^2,7,9,10 Total nail avulsion is a method to examine and treat various nail unit pathologies; (Chronic onychomycosis and periungual warts) however, the literature notes that partial avulsion procedure, due to its simplicity and fewer postoperative complications, is often found to be preferred. Also noted, careful patient selection and maintenance of asepsis during and after the procedure and gentle handling of the matrix and nail folds are noted to promote positive outcomes of the procedure. Nail generation depends on a patient’s age, gender, and habits. Complete regrowth of an avulsed fingernail usually requires 4 to 5 months, whereas the toenail may require up to 10 to 12 months.^7,10

A partial nail avulsion, used to treat a symptomatic infected ingrown toenail is a temporary relief for ingrown toenails as the nail matrix often grows back to its original thickness and the offending margin may again become a problem, resulting in another ingrown nail. When a nail avulsion is done, the matrix is not typically destroyed, thus leading to regrowth of the spicule or nail plate.^13,14 For those patients who have failed conservative therapy or have a symptomatic presentation of an ingrown toenail that is moderate to severe³; a surgical intervention such as removal of granulation tissue of the affected nail fold and a partial nail avulsion of the affected nail edge and with the application of a chemical, surgical, or electrocautery matrixectomy to prevent recurrences, may be required.¹³ A Cochrane systematic review found that a partial nail avulsion combined with phenolization is more effective at preventing symptomatic recurrence of an ingrown nail than surgical excision/removal without phenolization (one in 25 patients with recurrence versus eight in 21 without phenolization).¹¹ In a 2019 publication, the American Academy of Family Physicians reported that matrixectomy prevents recurrence of an ingrown nail and can be performed through surgical, chemical, or electrosurgical means.

The American Academy of Dermatology (AAD) Association Administrative Regulations for Evidence-based Clinical Practice Guidelines addresses the safety of the clinical use of some of the more commonly used local anesthetics (i.e., topical, infiltrative, nerve blocks, and infiltrative tumescent) in dermatologic surgeries in the office setting. One hundred sixty-five abstracts were retained and used. A secondary manual search identified 36 additional relevant studies. Once the full data set of 201 studies was made in proper order and categorized, each study was reviewed and ranked based on relevance, then the level of evidence for the clinical questions were determined by the workgroup.

Clinical recommendations per the workgroup were developed based on the best available evidence. The strength of recommendation was ranked as A, B, or C. Where documented evidence-based data were not available, or showed inconsistent or limited conclusion, expert opinion and medical consensus were also considered.¹⁵

This study supports the recommendations for the use of topical anesthesia in dermatologic surgery. Infiltrative anesthesia is considered 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 is a strength of recommendation of “C” and a level of evidence of “III” referenced by expert opinion.¹⁵

Nail trephination or releasing the hematoma is a technique to relieve painful pressure by draining the blood beneath the nail. Onumah et al describes the management of subungual hematomas which depends on their size, location, and presentation. A hematoma that occupies 25% or more of the nail bed is evacuated by creating one or two small puncture holes through the nail plate, to allow drainage of the hematoma.⁷ Tos et al describe strategies in treating nail bed and fingertip injuries. If the hematoma is 50% or more of the underlying nail area, depending on the type and degree of injury, the nail plate may need to be surgically removed. When there is greater than 50% involvement of the nail plate and associated fracture of the distal phalanx, the authors suggest the examination of the complete nail bed. Although studies show that it may be necessary to have the nail removed to examine the nail bed for injury, and subsequent repair, the authors noted that this is no longer a routine practice if the nail edges or margins are intact.

Analysis of Evidence

Partial or complete avulsion of the nail plate with the use of a local anesthetic may be performed to allow the exposure of the nail matrix for examination of the nail bed enabling visualization of the nail bed and nail matrix in order to look for pathologies originating in either the nail bed or the nail matrix. Studies have shown that partial or complete nail avulsion is considered medically reasonable and necessary for the examination of the nail bed and for the treatment of traumatic nail injury, subungual abscess and/or hematoma, subungual tumors, onychogryphosis, onychauxis, onycholysis, symptomatic congenital nail dystrophies or nail deformities associated with dermatologic conditions. Studies have shown that complete regrowth of an avulsed fingernail usually requires 4 to 5 months, and the toenail may require up to 8 to 12 months. Based on these studies, a repeat nail avulsion on the same toe or finger following a complete nail avulsion performed more frequently than every 8 months (32 weeks) for toenails or 4 months (16 weeks) for fingernails is considered not medically reasonable and necessary.

For those patients who have failed conservative therapy or have a symptomatic presentation of an ingrown toenail that is too severe for a non-surgical intervention, a surgical intervention, such as removal of granulation tissue of the affected nail fold and a partial nail avulsion of the affected nail edge either with or without the application of a chemical, surgical, or electrocautery matrixectomy may be considered medically reasonable and necessary for the treatment of a symptomatic ingrown toenail or fingernail.

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

History/Background and/or General Information

There are a number of indications for surgical exploration of the nail unit of the fingers and toes. Surgical nail avulsion may be performed to aid in diagnosis by allowing for the full examination and exploration of the nail bed, the nail matrix, the proximal nail fold (the soft tissue that protects the emerging nail plate), the lateral nail fold (LNF) (extension of the proximal nail fold that protects each side of the nail plate), and the nail grooves for the presence of pathology or as a preliminary step before performing a biopsy on the nail bed and the nail matrix. Indications such as subungual hematomas and tumors, benign or malignant neoplasms and trauma may require access and visualization of the nail bed. Surgical nail avulsion may also be performed for therapeutic management of disease processes, to relieve pain or to correct or prevent anatomical deformities of the nail. Symptomatic disease processes affecting the nail complex that may be managed with surgical intervention include infections, inflammation, onychomycosis (i.e., fungal infection), onychocryptosis (i.e., ingrown nails), onychogryphosis (i.e., hornlike hypertrophy of the nail plate), and onychauxis (i.e., thickened nails), as well as psoriasis, lichen planus, congenital nail dystrophies,¹ and tumors.²

Nail treatment and surgical options must be individualized based on the nail condition and careful consideration should be taken when selecting patients for surgical nail procedures. Factors to consider when determining appropriate treatment include the extent of disease, type of organism, and medical comorbidities.¹ Patients with factors that predispose them to infection include but are not limited to those with uncontrolled diabetes mellitus, prior infection with methicillin-resistant Staphylococcus aureus, and immunosuppression.

Medical conditions that impede blood flow or depress immunity may increase the risk of fungal nail infection. Diabetes and circulatory disorders may impair blood flow to the nail beds, increasing the chance of fungal infection. Prevalence in the general population ranges from 2.5% - 5% and is more common in diabetics (13% - 32%). Diabetics, and others suffering from impaired arterial circulation and decreased sensation, may present with more severe cases (i.e., secondary infection, gangrene).^3,4,5

Ingrown toenails account for approximately 20% of foot problems presented in the primary care setting.⁶ An ingrown nail is a condition which results in the growth of the nail edge into the surrounding soft tissue that may result in pain, inflammation, or infection. This condition, although not very often, may involve the fingernails, and is noted in the literature to commonly occur in the great toes.^1,6 No consensus has been reached for the best treatment approach, but ingrown nails may be treated non-surgically or surgically. Non-surgical treatments are typically used for mild to moderate ingrown nails, whereas surgical treatments are typically used in moderate and severe cases.^1,3,6

Blood underneath a fingernail or toenail or a subungual hematoma, generates pressure between the nail bed and the nail plate where the blood collects and may cause pain. Treatment of a subungual hematoma depends on the type of injury and patient comorbidities or risk factors for complications. A small not too painful hematoma is incorporated into the nail and progressively migrates outward to the free edge of the nail plate as the nail grows out.

In traumatic nail injuries, surgical nail avulsion may be used to evaluate the stability of the nail bed or to release a subungual hematoma after a failed puncture aspiration. Injury of a fingernail may be treated with avulsion with surgical repair of the nail bed.^1,10 For toenail avulsions, a nonadherent, highly absorbent dressing is ideal.¹⁰ A reattachment of the avulsed fingernail or a fingernail substitute, intended to protect the nail bed during the healing process, will adhere to the nail bed within 1 to 3 months and will be pushed off by the new nail, and as noted in this situation, will reach complete growth in 4 to 6 months.⁸

The thickening of the nail plate may be a symptom of nail fungus, psoriasis or other conditions. This thickening (Onychauxis) may force the nail plate to separate from the nail bed (Onycholysis). This condition may last for several months because the finger or toenail will not reattach to its nail bed. Non-surgical treatment consists of clipping off the affected separated portion at the distal end of the of the nail plate and treating the underlying cause. In the case of moderate or severe symptomatic dystrophic nail plate, a surgical intervention may be required.^1,3,6

A partial or complete avulsion of a nail plate is generally performed under local anesthesia. This surgical procedure involves the separation and a partial removal of a border of the nail plate or removal of the entire nail plate from the nail bed to the eponychium; the surgical removal of the body of the nail plate from its primary attachments, the nail bed ventrally and the proximal nail fold dorsally.

Excision of nail plate and nail matrix is performed under local anesthesia and requires removal of the full length or the entire nail plate, with destruction or permanent removal of the matrix (matrixectomy). Matrixectomy can be performed surgically, chemically, electrosurgically, or with radiofrequency ablation. All are effective options when treating ingrown toenails.⁶ Partial matrixectomies may be performed in the management of persistent onycholysis and onychocryptosis. When performed without matrixectomy, in most cases, the nail will regrow from the area under the cuticle (the matrix). A fingernail takes about 4 to 6 months to grow back. A toenail takes about 8 to 12 months to grow back.^7,8

Wedge excision of skin of the nail fold is designed to relieve pressure on the nail/soft tissue and is an excision of the skin from the involved, medial and/or lateral, side of the toe or finger. The technique of wedge excision often fails to remove the nail spicule. Nail removal without destroying the matrix of the nail that produces nail growth can permit the nail to regrow beneath the nail fold, producing another ingrown nail. The purpose of partial or complete removal of a nail is to decrease the width of the nail plate at the offending border to relieve pain and pressure. This procedure could include removal/destruction of the nail matrix, either surgically or chemically, to cause long-term narrowing of the nail plate.^3,6

Covered Indications

Avulsion of the nail plate, excision of the nail and nail matrix, and wedge excision of the skin of the nail fold are considered medically reasonable and necessary for the following indications:

1. Symptomatic onychocryptosis (ingrown fingernails or toenails)^1,4,7,8
2. Subungual abscess and/or hematoma^7,9,10
3. Subungual and periungual tumors^2,9
4. Injury of the toes or fingers involving the nail component to evaluate the stability of the nail bed or to release a subungual hematoma after a failed puncture aspiration^1,7,11
5. Severe or recurrent fungal nail infection that has failed to respond to usual, less invasive treatment (for example, pharmacological treatment, debridement)
6. For diagnosis of suspected lichen planus or psoriasis of the fingernail or toenail^{2, 9,10}
7. Onychogryphosis or onychauxis¹
8. Congenital or acquired nail dystrophies that jeopardize the integrity of the finger or toe^1,2,10

Limitations

The following are considered not medically reasonable and necessary:

1. Nail debridement or removing small chips or wedges of the nail and/or skin that does not require local anesthesia does not constitute surgical treatment of a nail^3,6,11
2. Trimming, cutting, or clipping of the distal unattached nail margins does not constitute surgical treatment of a nail^3,6,11
3. Surgical treatment of asymptomatic conditions^3,6
4. Repeat nail avulsion on the same toe or finger following a complete nail avulsion performed more frequently than every 8 months (32 weeks) for toenails or 4 months (16 weeks) for fingernails^7,10
5. Repeat nail excision on the same toe or finger following a complete nail excision for permanent removal

Provider Qualifications

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.

Notice: 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 CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.