Clinical UM Guideline

This document addresses the following foot care services: cutting or removal of corns or calluses, trimming, cutting, clipping or debriding of nails (including mycotic and ingrown toenails), and cleaning and soaking of the feet.

Note: Benefit language supersedes this document. Foot care services are not a covered benefit under all member contracts/certificates. Please see the text in the footnote of this document regarding Federal and State mandates and contract language, as these requirements or documents may specifically address the topic of foot care services.

Medically Necessary:

Foot care services including cutting or removal of corns or calluses, or trimming, cutting, clipping or debriding of nails are considered medically necessary when the following criteria are met:

1. The individual has a systemic condition resulting in circulatory insufficiency or desensitization of the lower extremity including, but not limited to, one or more of the conditions listed below:
   1. Arteriosclerosis; or
   2. Chronic thrombophlebitis; or
   3. Diabetes mellitus; or
   4. Peripheral vascular disease; or
   5. Peripheral neuropathy; or
   6. Raynaud’s disease; and
2. The individual is at risk of impeded healing that could potentially jeopardize life of limb, for example, evidence of sensory loss or prior ulceration or amputation, Charcot foot, history of angioplasty or vascular surgery, retinopathy, renal disease, or current symptoms of neuropathy (pain, burning, numbness) and vascular disease (leg fatigue, claudication); and
3. Performance of foot care services by a nonprofessional person would put the individual at risk; and
4. Foot care services are not provided more frequently than once every 2 months (unless documentation demonstrates clinical appropriateness).

Debridement of mycotic nails, no more than once every 2 months (unless documentation demonstrates clinical appropriateness), in the absence of a systemic condition above, is considered medically necessary when the following criteria are met:

1. For ambulatory individuals, pain results in difficulty walking and/or abnormality of gait in conventional walking footwear; or
2. In non-ambulatory individuals, there is pain or secondary infection resulting from the thickening and dystrophy of the infected toenail plate.

Surgical removal or care rendered as treatment of ingrown toenail(s) is considered medically necessary.

Not Medically Necessary:

Foot care services, including cutting or removal of corns or calluses, or trimming, cutting, clipping or debriding of nails (including mycotic nails) are considered not medically necessary when the criteria above are not met and for all other indications.

Cleaning and soaking of the feet is considered not medically necessary for all indications.

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Medically Necessary:

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

When services are also Not Medically Necessary:

Foot care services are an integral part of care in individual with a systemic condition such as a metabolic, neurologic or peripheral vascular disease that may result in severe diminished circulatory sensation of the legs or feet. Foot care may include the cutting or removal of corns and calluses; the trimming, cutting, clipping or debriding of nails; other hygienic and preventive maintenance care may include cleaning and soaking the feet, the use of skin creams to maintain skin tone of either ambulatory or bedrest individuals, or any other services performed in the absence of localized illness, injury or symptoms involving the foot.

According to the American Diabetes Association (ADA), diabetes is one of the most common chronic diseases in the United States (U.S.), with approximately 30 million Americans with diagnosed disease. Another 8 million are believed to have undiagnosed disease. Diabetes mellitus is a leading cause of chronic disease and limb loss, marked by impaired metabolism of carbohydrate, protein and fat. The underlying problem in diabetes is in the production or utilization of insulin, the hormone secreted by the pancreas that controls the level of blood sugar by regulating the transfer of glucose from the blood into the cells. Diabetes mellitus, if poorly controlled, can cause cardiovascular disease, retinal damage that could lead to blindness, damage to the peripheral nerves, and injury to the kidneys.

Peripheral neuropathy is a common condition that occurs when nerves are damaged or destroyed, which interferes with the transmission of messages from the brain and spinal cord to other parts of the body. The condition can affect single or multiple nerves and involve different nerve types, including motor, sensory, and autonomic nerves. There are many different types of peripheral neuropathy, and each type has its own symptoms based on the nerves involved. Common symptoms include pain, tingling, numbness, stabbing sensations, electric-like sensations, burning sensations and weakness.

There are many causes of peripheral neuropathy. Diabetic peripheral neuropathy is a type of nerve damage that can occur in individuals with diabetes mellitus as a result of chronic high blood sugar levels that can injure nerve fibers throughout the body. While diabetes and post-herpetic neuralgia (due to herpes viral infection, shingles) are the most common causes of peripheral neuropathy, other causes include, but are not limited to, vitamin deficiency (particularly B12 and folate), alcohol abuse, autoimmune diseases (such as lupus, rheumatoid arthritis or Guillain-Barre syndrome), autoimmune deficiency syndrome (AIDS) (from the disease or its treatment), kidney failure, inherited disorders (such as amyloid polyneuropathy or Charcot-Marie-Tooth disease), exposure to toxins (such as heavy metals, gold compounds, lead, arsenic, mercury, and organophosphate pesticides), chemotherapy agents (such as vincristine) and other medications (such as antibiotics including isoniazid, metronidazole, and statins which have been linked to peripheral neuropathy), and rarely, diseases such as neurofibromatosis. Rare congenital conditions with neuropathies include Fabry disease, Tangier disease, hereditary sensory autonomic neuropathy, and hereditary amyloidosis. Often the etiology is unknown, and this condition is referred to as idiopathic peripheral neuropathy.

In 2023, the ADA published standards of care in diabetes, the committee provided the following recommendations for foot care:

• 12.21 Perform a comprehensive foot evaluation at least annually to identify risk factors for ulcers and amputations. A
• 12.22 The examination should include inspection of the skin, assessment of foot deformities, neurological assessment (10-g monofilament testing with at least one other assessment: pinprick, temperature, vibration), and vascular assessment, including pulses in the legs and feet. B
• 12.23 Individuals with evidence of sensory loss or prior ulceration or amputation should have their feet inspected at every visit. A
• 12.24 Obtain a prior history of ulceration, amputation, Charcot foot, angioplasty or vascular surgery, cigarette smoking, retinopathy, and renal disease and assess current symptoms of neuropathy (pain, burning, numbness) and vascular disease (leg fatigue, claudication). B
• 12.25 Initial screening for peripheral arterial disease should include assessment of lower-extremity pulses, capillary refill time, rubor on dependency, pallor on elevation, and venous filling time. Individuals with a history of leg fatigue, claudication, and rest pain relieved with dependency or decreased or absent pedal pulses should be referred for ankle–brachial index and for further vascular assessment as appropriate. B
• 12.26 A multidisciplinary approach is recommended for individuals with foot ulcers and high-risk feet (e.g., those on dialysis, those with Charcot foot, those with a history of prior ulcers or amputation, and those with peripheral artery disease). B
• 12.27 Refer individuals who smoke or have a history of prior lower-extremity complications, loss of protective sensation, structural abnormalities, or peripheral arterial disease to foot care specialists for ongoing preventive care and lifelong surveillance. B
• 12.28 Provide general preventive foot self-care education to all people with diabetes, including those with loss of protective sensation, on appropriate ways to examine their feet (palpation or visual inspection with an unbreakable mirror) for daily surveillance of early foot problems. B

Foot ulcers and amputation, which are consequences of diabetic neuropathy and/or peripheral arterial disease (PAD), are common and represent major causes of morbidity and mortality in people with diabetes. Early recognition and treatment of individuals with diabetes and feet at risk for ulcers and amputations can delay or prevent adverse outcomes.

The risk of ulcers or amputations is increased in people who have the following risk factors:

• Poor glycemic control
• Peripheral neuropathy with LOPS
• Cigarette smoking
• Foot deformities
• Pre-ulcerative callus or corn
• PAD
• History of foot ulcer
• Amputation
• Visual impairment
• Chronic kidney disease (especially patients on dialysis)

Foot care services include cutting or removal of corns or calluses, or trimming, cutting, clipping or debriding of nails may be clinically appropriate in individuals with a systemic condition resulting in circulatory insufficiency or desensitization of the lower extremity of sufficient severity that performance of foot care services by a nonprofessional person would put the individual at risk, and the individual is at risk of impeded healing that could potentially jeopardize life of limb. Foot care services should be clinically appropriate and in accordance with generally accepted standards of medical practice for the individual’s clinical condition. Unless documentation demonstrates appropriateness, clinical care of corns, calluses, or nails is not required more frequently than once every 2 months. In the absence of a systemic condition, debridement of mycotic nails may be clinically appropriate for ambulatory individuals when pain results in difficulty walking and/or abnormality of gait in conventional walking footwear, or in non-ambulatory individuals, when there is pain or secondary infection resulting from the thickening and dystrophy of the infected toenail plate. Unless documentation demonstrates clinical appropriateness, debridement of mycotic nails is not required more frequently than once every 2 months.

Ingrown toenails are common and occur either when the skin grows over the side of the toenail or when the toenail grows into the skin. They can cause pain, discomfort, and infection. Surgical treatment for ingrown toenails may include removal of part of the nail or the entire nail, removing part of the underlying nailbed, or removing part of the soft tissue adjacent to the toenail. Treatment may also include excision of the nail and nail matrix, resulting in permanent removal of the nail.

The document is based on peer-reviewed published literature, professional, and podiatric and medical organizational input regarding generally accepted standards of medical practice, and current American Diabetes Association standards.

Peer Reviewed Publications:

1. O'Connor JJ, Deroche CB, Wipke-Tevis DD, et al. Foot care self-management in non-diabetic older adults: A pilot controlled trial. West J Nurs Res. 2021; 43(8):751-761.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Diabetes Association. Standards of Care in Diabetes–2023. Diabetes Care 2023; 46(Suppl 1):S203-S215.
2. Bus SA, Armstrong DG, van Deursen RW, et al. International Working Group on the Diabetic Foot. IWGDF guidance on footwear and offloading interventions to prevent and heal foot ulcers in patients with diabetes. Diabetes Metab Res Rev. 2016a; 32 Suppl 1:25-36.
3. Bus SA, van Deursen RW, Armstrong DG, et al. International Working Group on the Diabetic Foot (IWGDF). Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review. Diabetes Metab Res Rev. 2016b; 32 Suppl 1:99-118.
4. Lewis J, Lipp A. Pressure-relieving interventions for treating diabetic foot ulcers. Cochrane Database Syst Rev. 2013; (1):CD002302.
5. van Netten JJ, Price PE, Lavery LA, et al. International Working Group on the Diabetic Foot (IWGDF). Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review. Diabetes Metab Res Rev. 2016; 32 Suppl 1:84-98.

1. American Academy of Orthopaedic Surgeons (AAOS). OrthoInfo. Ingrown toenail. Last reviewed September 2012. Available at: https://orthoinfo.aaos.org/en/diseases--conditions/ingrown-toenail/. Accessed on November 13, 2023.
2. American Diabetes Association. Standards of Care in Diabetes-2023. Available at: https://diabetesjournals.org/care/issue/46/Supplement_1. Accessed on November 13, 2023.
3. American Diabetes Association. Diabetes complications. Available at: https://diabetes.org/diabetes/foot-complications. Accessed on November 13, 2023.
4. American Diabetes Association. Peripheral neuropathy. Available at: https://diabetes.org/diabetes/neuropathy/peripheral-neuropathy. Accessed on November 13, 2023.
5. National Institutes of Health. Peripheral neuropathy. Available at: https://www.ninds.nih.gov/health-information/disorders/peripheral-neuropathy. Accessed on November 13, 2023.