Pending Policies - Surgery


Foot Care Services

Number:SUR701.006

Effective Date:01-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Routine foot care for patients with comorbidities (e.g., arteriosclerosis obliterans, peripheral artery or vascular disease, Buerger’s disease, diabetes mellitus) which can impede healing and can jeopardize life or limb may be considered medically necessary when the following criteria are met:

Services are delivered by a qualified provider of foot care services (a qualified provider is one who is licensed and is performing within the scope of licensure), AND

Services are considered specific, effective, and reasonable for the patient’s diagnosis and condition.

Routine foot care, (hygiene and preventive maintenance such as trimming of corns, calluses, or nails), for patients without comorbidities does not usually require the skills of a qualified provider of foot care services, and is considered not medically necessary.

Manual debridement and electric grinding procedures of the toenails may be considered medically necessary, when performed by a qualified provider, for the following conditions:

Onychomycosis (mycotic nails), when confirmed by positive culture or by documented signs and symptoms, which substantiate difficulty in wearing shoes or in ambulation.

Onychauxis (club nail), onychodystrophy (deformed nail), and onychogryposis (thickened nail), when such conditions result in paronychia or pain from gross distortions of the nail, as well as difficulty in wearing shoes or in ambulation.

Laser treatment of onychomycosis is considered experimental, investigational and/or unproven; lasers used include, but are not limited to, Noveon™ by Nomir Medical Technologies, Inc. and PinPointe™FootLaser™ by PinPointe USA, Inc.

Near-infrared spectroscopy studies for evaluation of oxyhemoglobin measurement is considered experimental investigational and/or unproven for all indications, including but not limited to diabetic foot ulcers.

NOTE: Treatment of medical conditions and symptomatic diseases of the feet is not routine foot care. These conditions may include but are not limited to the following examples: bunion, hammer toe, plantar fasciitis, neuroma and plantar warts.

Description:

Foot care services include the examination, diagnosis, and medical or surgical treatment of conditions and dysfunctions of the foot.

Routine Foot Care may include the following:

The cutting or removal of corns, calluses or plantar keratosis,

The trimming of nails, (including mycotic nails),

Other hygienic and preventive/maintenance care in the realm of self-care, such as cleaning and soaking the feet and the use of skin creams to maintain skin tone of both ambulatory and bedfast patients, AND/OR

Any services performed in the absence of localized illness, injury or symptoms involving the foot.

The following are increased risk factors for ulcers or amputations:

Diabetes mellitus,

Vision impairment,

Diabetic nephropathy, (especially patients on dialysis)

Poor glycemic control,

Cigarette smoking,

Peripheral neuropathy with loss of protective sensation,

Altered biomechanics (in the presence of neuropathy),

Evidence of increased pressure (erythema, hemorrhage under a callus),

Foot or bony deformity,

Peripheral vascular disease (decreased or absent pulses),

History of ulcers or amputation,

Severe nail pathology,

Arteriosclerosis obliterans, AND/OR

Buerger’s disease.

Symptoms associated with comorbidities may include:

Ischemic ulcer,

Intermittent claudication or other ischemic-type pain,

Non-palpable pedal pulses,

Decreased hair growth in the leg,

Nail overgrowth,

Abnormal skin texture (thinning),

Abnormal skin color,

Abnormal skin temperature (i.e., cold feet), AND/OR

Pigmentation changes.

In most situations, a family member or nursing staff may perform these services. However, in patients with conditions associated with inadequate circulation to the extremities, routine foot services may require the services of a professional (for example, a podiatrist or physician) in order to limit the potential complications of impaired wound healing and infection.

Preventive foot-care practice, such as annual foot examination by multidisciplinary health care providers, can substantially reduce the risk in patients with foot problems caused by underlying disease, foot deformities, and alteration in the normal perfusion to the lower leg and foot.

If an infection, such as onychomycosis, occurs to the nails, conventional medical treatment requires pharmacological therapy, mechanical intervention or surgical treatment.

Foot ulcers and amputations are a major cause of morbidity, disability, as well as emotional and physical costs for patients with high-risk foot related conditions. Early recognition and management of independent risk factors can prevent or delay the onset of adverse outcomes.

Onychomycosis

Onychomycosis is a common chronic fungal infection of the nail. It is estimated to cause up to 50% of all nail disease and 33% of cutaneous fungal infections. (1) The diagnosis of onychomycosis can be confirmed by potassium hydroxide preparation, culture or histology. Treatments for onychomycosis include topical antifungals such as nail paints containing ciclopirox (ciclopiroxolamine) or amorolfine, and oral antifungals such as terbinafine and itraconazole. These generally have low to moderate efficacy and a high relapse rate. Topical antifungals and some long-available oral medications such as griseofulvin require a long course of treatment, which presents issues for patient compliance. Moreover, oral antifungal medications have been associated with adverse effects such as a risk of hepatotoxicity.

Several types of device-based therapies are under investigation for treatment of onychomycosis, including ultrasound, iontophoresis, photodynamic therapy, and laser systems. A potential advantage of lasers is that they have greater tissue penetration than antifungal medication and thus may be more effective at treating infection embedded within the nail. Another potential advantage is that laser treatments are provided in a clinical setting in only 1 or several sessions, and thus, long-term patient compliance is less of an issue than with medications.

Laser treatment of onychomycosis uses the principle of selective photothermolysis. This is defined as the precise targeting of a tissue using a specific wavelength of light. The premise is that light is absorbed into the target area and heat generated by that energy is sufficient to damage the target area while sparing the surrounding area. The aim of laser treatment of onychomycosis is to heat the nail bed to temperatures required to disrupt fungal growth (approximately 40º-60ºC) and at the same time avoid pain and necrosis to surrounding tissues. (5)

A number of laser systems for treating onychomycosis have been cleared for marketing by the Food and Drug Administration (FDA). FDA-cleared indications are for the temporary increase of clear nail; they are not cleared as a cure for onychomycosis.

Near-infrared spectroscopy

The measurement of oxyhemoglobin using a near-infrared spectroscopy study is being investigated as a diagnostic tool to evaluate a patient’s response to a diabetic ulcer treatment within 4 weeks of starting the current therapy. Emunamedica, a diagnostics company, has developed a patented device to address this issue and improve patient wound care. (15) This device in not currently FDA approved.

Regulatory Status

Multiple Nd:YAG laser systems have been cleared by the FDA for marketing for the temporary increase of clear nail in patients with onychomycosis (product code: GEX). The FDA determined that these devices were substantially equivalent to existing devices. Cleared devices and year of the FDA decision are as follows:

Nd:YAG 1064 nm laser systems (FDA product code: GEX):

PinPointe FootLaser (PinPointe USA acquired by NuvoLase in 2011): 2010

GenesisPlus™ (Cutera): 2011

VARIABreeze™ (CoolTouch): 2011

JOULE ClearSense™ (Sciton): 2011

Dual wavelength Nd:YAG 1064 nm and 532 nm laser system (FDA product code: PDX):

Q-Clear™ (Light Age): 2011

Rationale:

The policy was originally created in 1994 and has been updated with scientific literature review through April 15, 2015. This section of the current policy has been substantially revised. Following is a summary of the key literature to date.

Preventive foot-care practice, such as annual foot examination by multidisciplinary professionals, can substantially reduce the risk in patients with foot problems caused by underlying disease, foot deformities, and alteration in the normal perfusion to the lower leg and foot.

Laser Treatment of Onychomycosis

The main question for review is whether laser treatment is an efficacious treatment for onychomycosis and whether it is at least as effective as alternatives. Randomized controlled trials (RCTs) with appropriate comparison groups are the best study design to answer this question. The most important outcomes for this review are clinical cure of onychomycosis, i.e., complete clearing without recurrence and mycological cure. Other useful outcomes would be symptoms and functional measures related to onychomycosis. Partial healing and accelerated nail growth are intermediate outcomes that may or may not be associated with the ultimate cure rate. The most appropriate comparison interventions are sham laser treatment or best alternative care (e.g., topical antifungals).

Systematic Reviews

A 2014 systematic review by Bristow et al. identified 12 published studies on laser treatment for onychomycosis. (6) Two were RCTs, 4 were nonrandomized comparative studies, and the other 6 were case series. The authors did not pool study findings but concluded that the evidence was limited and of poor methodologic quality. Representative RCTs with the largest sample sizes that compare laser treatment to placebo or to a different intervention are described next.

Randomized Controlled Trials

In 2015, El-Tatawy et al. in Egypt reported on 40 patients with toenail onychomycosis randomized to receive 4 sessions of treatment with a 1064 nm Nd:YAG laser (n=20) or topical terbinafine twice daily for 6 months (n=20). (7) The laser was a Dualis SP device (Fontona, Slovenia). The clinical efficacy outcome measure categorized patients into those with marked improvement (>75%), moderate improvement (50%- 75%), mild improvement (25%-50%) or no improvement (<25%). The authors did not state that outcome assessment was blinded. At the end of the 6 months, 100% of patients in the laser group and none in the medication group showed marked improvement (p<0.002). In the medication group, 8 patients had mild improvement, 2 had moderate improvement, and 10 had no improvement. However, at the 6-month evaluation, none of the patients in either group had positive fungal cultures. Lack of blinding could have introduced bias in the clinical assessment of patients.

A 2014 trial by Xu et al. in China randomized 53 patients with toenail onychomycosis to 1 of 3 treatment groups: 250 mg daily oral terbinafine, weekly long-pulsed 1064 nm Nd:YAG laser (Luminis One), or the combination of the 2 therapies. (8) The medication only group included 16 patients with 30 infected nails, the laser group included 18 patients with 31 infected nails, and the combination treatment group included 16 patients with 29 infected nails. Analysis was done on a per nail basis. All patients completed the 24-month follow-up. At this final evaluation point, the clinical clearance rate (defined as ≤5% nail plate involvement in onychomycosis) was 22 of 30 nails (73.3%) in the medication only group, 20 of 31 nails (64.5%) in the laser group, and 28 of 29 nails (96.6%) in the combination treatment group. The rate was significantly higher in the combined treatment group compared with either treatment alone; clinical clearance in the medication versus laser group did not differ significantly. Findings were similar for the mycological clearance rate. A limitation of the study was reporting outcomes on a per nail basis, which does not account for correlated measurements.

In 2010, an industry-sponsored study by Landsman et al. used a dual-wavelength near-infrared diode laser that has not been cleared by the U.S. Food and Drug Administration for treatment of onychomycosis. (9) The study included 36 patients with mycologically confirmed onychomycosis. Patients were randomized to receive actual laser treatment (n=26) or sham treatment (n=10). The sham treatment group received the same number of sessions, but the laser power was set to zero. A total of 34 of 36 patients (94%) completed the study. The 34 patients had a total of 59 toes treated with an active or sham laser. Thirty-seven of the toes met all of the clinical eligibility criteria (26 in the active treatment group, 11 in the control group).

The primary study outcomes were the proportion of patients who had at least 3 mm of clear nail growth and attainment of a negative mycologic finding. As assessed by the blinded expert panel, at 180 days, 17 of 26 toes (65%) in the active treatment group and 1 of 11 (9%) in the control group attained at least 3 mm of clear lineal nail growth. The difference between groups was statistically significant, favoring the active treatment group (p=0.011). Moreover, 10 of 26 toes (39%) in the active treatment group and 1 of 11 (9%) in the control group had both a negative mycologic culture and at least 3 mm of clear nail growth at 180 days; the difference between groups was not statistically significant (p=0.119).

In the subjective clinical visual assessment of improvement at 180 days, the investigators judged 5 of 26 (19%) toes in the active treatment group and 2 of 11 (18%) in the control group to be markedly improved. No toes were judged by the investigators to be completely cleared. Reviewing photographs, the expert panel judged 1 toe (4%) in the active treatment group and 2 toes (18%) in the control group to be markedly improved and 1 toe (4%) in the active treatment group to be completely cleared. (Statistical comparisons of the treatment vs sham group were not reported for the visual assessment outcome.)

In 2012, Landsman and Robbins reported 270-day results in 36 of 40 treated toes. (10) (This included clinically eligible toes, as well as companion toes.) When photographs of 34 toes were evaluated, 35% were considered to have continued improvement, 38% were considered not to have changed since 180 days and 20% were considered to have worsened. The authors did not report 270-day findings in patients assigned to the sham control group.

Limitations of the Landsman et al. study include that the outcome measures used, such as 3 mm of clear lineal nail growth, are intermediate outcomes of uncertain clinical significance. In addition, the investigators randomized patients to the treatment and control group, yet presented their findings on a per nail basis which does not account for correlated measurements. Three of the 34 patients (9%) evaluated at 180 days contributed data from 2 toes to the analysis.

Summary of Evidence

In most situations, routine foot care to a patient without comorbidities can be performed by a family member or nursing staff. However, in patients with conditions associated with inadequate circulation to the extremities, routine foot services may require the services of a professional (for example, a podiatrist or physician) in order to limit the potential complications of impaired wound healing and infection.

The published evidence to date is insufficient to determine whether laser treatment improves health outcomes in patients with onychomycosis. A few small randomized controlled trials (RCTs) report improvements in clinical outcomes with laser treatment, but the available trials have methodologic limitations. Clinical and mycological outcomes sometimes differed in the trials, which may be due in part to lack of consistent blinding of outcome assessment. Additional well-designed and conducted RCTs are needed that include sufficient numbers of patients and that follow patients for an adequate amount of time. Thus, laser treatment for onychomycosis is considered experimental, investigational and/or unproven.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

11055, 11056, 11057, 11719, 11720, 11721, 11730, 11732, 11740, 17999, 0493T

HCPCS Codes

G0127, G0245, G0246, G0247, S0390

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Rodgers P, Bassler M. Treating onychomycosis. Am Fam Physician. Feb 15 2001; 63(4):663-672, 677-668. PMID 11237081

2. Boyko EJ, Ahroni JH, Cohen V, et al. Prediction of diabetic foot ulcer occurrence using commonly available clinical information: the Seattle Diabetic Foot Study. Diabetes Care. Jun 2006; 29(6):1202-1207. PMID 16731996

3. Drake LA, Scher RK, Smith EB, et al. Effect of onychomycosis on quality of life. J Am Acad Dermatol. May 1998; 38(5 Pt 1):702-704. PMID 9591814

4. Elewski BE. Onychomycosis. Treatment, quality of life, and economic issues. Am J Clin Dermatol. Jan-Feb 2000; 1(1):19-26. PMID 11702301

5. Gupta A, Simpson F. Device-based therapies for onychomycosis treatment. Skin Therapy Lett. Oct 2012; 17(9):4- 9. PMID 23032936

6. Bristow IR. The effectiveness of lasers in the treatment of onychomycosis: a systematic review. J Foot Ankle Res. 2014; 7:34. PMID 25104974

7. El-Tatawy RA, Abd El-Naby NM, El-Hawary EE, et al. A comparative clinical and mycological study of Nd-YAG laser versus topical terbinafine in the treatment of onychomycosis. J Dermatolog Treat. Feb 11 2015:1-4. PMID 25669435

8. Xu Y, Miao X, Zhou B, et al. Combined oral terbinafine and long-pulsed 1,064-nm Nd: YAG laser treatment is more effective for onychomycosis than either treatment alone. Dermatol Surg. Nov 2014; 40(11):1201-1207. PMID 25322165

9. Landsman AS, Robbins AH, Angelini PF, et al. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure. J Am Podiatr Med Assoc. May-Jun 2010; 100(3):166-177. PMID 20479446

10. Landsman AS, Robbins AH. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure: some follow-up observations at 270 days. J Am Podiatr Med Assoc. Mar-Apr 2012; 102(2):169- 171. PMID 22461276

11. Laser Treatment of Onychomycosis. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2015 May) Medical Policies 2.01.89.

12. Warner, I. Nursing and long-term care concerns of foot care in the elderly. Clinics in Podiatric Medicine and Surgery (2003 July) 32:S13-61.

13. Blume, P., Wilkinson, J., et al. Treating difficult nails in diabetic patients. Podiatry Today (2006 March 1) Volume 3.

14. Foot Care Services - Archived. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 February) Miscellaneous Policies 9.01.01.

15. Emunamedica Quantitative Wound Diagnostics getting off the wrong therapy sooner and onto the right therapy faster. Available at <http://emunamedica.com> (accessed November 8, 2017).

Policy History:

DateReason
1/1/2018 Document updated with literature review. The following change was made to Coverage: 1) Added “Near-infrared spectroscopy studies for evaluation of oxyhemoglobin measurement is considered experimental investigational and/or unproven for all indications, including but not limited to diabetic foot ulcers.”
4/15/2017 Reviewed. No changes.
5/1/2016 Document updated with literature review. Coverage unchanged. Rationale substantially revised.
7/15/2015 Reviewed. No changes.
2/1/2014 Document updated with literature review. Coverage unchanged.
9/15/2009 Revised/Updated entire document. Added: Laser treatment for onychomycosis is experimental, investigational and unproven.
9/1/2007 Revised/Updated Entire Document, this policy is no longer scheduled for routine literature review and update
8/1/2005 Revised/Updated Entire Document
2/1/2002 Revised/Updated Entire Document
1/1/1998 Revised/Updated Entire Document
5/1/1996 Revised/Updated Entire Document
4/1/1994 New Medical Document

Archived Document(s):

Title:Effective Date:End Date:
Foot Care Services08-01-201910-14-2020
Foot Care Services01-01-201807-31-2019
Foot Care Services04-15-201712-31-2017
Foot Care Services05-01-201604-14-2017
Foot Care Services07-15-201504-30-2016
Foot Care Services02-01-201407-14-2015
Foot Care Services09-15-200901-31-2014
Routine Foot Care Services09-01-200709-14-2009
Routine Foot Care Services01-01-200708-31-2007
Routine Foot Care Services08-01-200512-31-2006
Foot Care Services02-01-200207-31-2005
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