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 hematoma7,9,10
  3. Subungual and periungual tumors2,9
  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 aspiration1,7,11
  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 toenail2, 9,10
  7. Onychogryphosis or onychauxis1
  8. Congenital or acquired nail dystrophies that jeopardize the integrity of the finger or toe1,2,10

**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 nail3,6,11
  2. Trimming, cutting, or clipping of the distal unattached nail margins does not constitute surgical treatment of a nail3,6,11
  3. Surgical treatment of asymptomatic conditions3,6
  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 fingernails7,10
  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.

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.

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.