Cosmetic and Reconstructive Surgery - Medicare Advantage Form


Dermal injections for the treatment of facial lipodystrophy syndrome (LDS)

Indications

(956443) Is the dermal filler approved by the US Food & Drug Administration (FDA) for the treatment of lipodystrophy? 
(956444) Is the use only for HIV-infected individuals with lipodystrophy caused by antiretroviral HIV treatment? 
(956445) Is the lipodystrophy a significant contributor to the individual's depression? 

Benign Skin Lesion Treatment or Removal

Indications

(956446) Is there destruction or removal of lesions by various methods for medical illness or improvement of functioning of a malformed body member? 

Botulinum Toxin (Botox) Injections

Notes: Coverage and indications may be found in the Botox (Botulinum Toxin) Pharmacy Coverage Policy.

Indications

(956447) Are Botox injections indicated as per the Botox (Botulinum Toxin) Pharmacy Coverage Policy? 

YesNoN/A
YesNoN/A
YesNoN/A

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Effective Date

NA

Last Reviewed

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Original Document

  Reference



Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals.
Type Title Dermal injections for the treatment of facial lipodystrophy syndrome (LDS)
Treatment of Actinic Keratosis
Chapter 16 General Exclusions from Coverage; Section 120 Cosmetic Surgery NCD NCD Internet- Only Manuals (IOMs) Cosmetic and Reconstructive Surgery Removal of Benign Skin Lesions ID Number 250.5 250.4 Medicare Benefit Policy Manual L39051 A58774 L35498 A57482 Billing and Coding: Removal of Benign Skin Lesions A54602 Removal of Benign Skin Lesions Cosmetic and Reconstructive Surgery Benign Skin Lesion Removal (Excludes Actinic Keratosis, and Mohs) Plastic Surgery Benign Skin Lesion Removal (Excludes Actinic Keratosis, and Mohs) Plastic Surgery L34200 A57044 L39506 A59299 L34233 A57161 L35163 A57221 L33979 A57162 L37020 A57222 LCD LCA LCD
LCA LCA LCD LCA LCD
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LCA Cosmetic and Reconstructive Surgery Page: 2 of 42 Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories J5, J8 - Wisconsin Physicians Service Insurance Corporation J5 - Wisconsin Physicians Service Insurance Corporation J6, JK - National Government Services, Inc. (Part A/B MAC) J15 - CGS Administrators, LLC (Part A/B MAC) J15 - CGS Administrators, LLC (Part A/B MAC) JE - Noridian Healthcare Solutions, LLC JE - Noridian Healthcare Solutions, LLC JF - Noridian Healthcare Solutions, LLC JF - Noridian Healthcare Solutions, LLC IA, KS, MO, NE
IN, MI IA, KS, MO, NE
IN, MI IL, MN, WI CT, NY, ME, MA, NH, RI, VT KY, OH KY, OH CA, HI, NV, American Samoa, Guam, Northern Mariana Islands CA, HI, NV, American Samoa, Guam, Northern Mariana Islands AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY















Cosmetic and Reconstructive Surgery Page: 3 of 42 LCD
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LCA Cosmetic and Reconstructive Surgery Cosmetic and Reconstructive Surgery Cosmetic and Reconstructive Surgery L35090 A56587 L33428 A56658 L38914 A58573 JH, JL - Novitas Solutions, Inc. (Part A/B MAC) JJ, JM - Palmetto GBA (Part A/B MAC) JN - First Coast Service Options, Inc. (Part A/B MAC) AR, CO, NM, OK, TX, LA, MS DE, D.C., MD, NJ, PA AL, GA, TN NC, SC, VA, WV FL, PR, U.S. VI

Cosmetic surgery is performed to reshape normal structures of the body in order to improve or change appearance or self-esteem.
Reconstructive surgery is performed on abnormal structures of the body, caused by congenital (occurring at birth) defects, developmental abnormalities, infection, injury/trauma, tumors, or disease. It is generally performed to improve or restore bodily function when an objective functional impairment present. Scar revision is performed to correct, remove or improve the tissue that forms as skin heals after an injury or surgery. The amount of scarring may be determined by the size, depth and location of the wound. Coverage Determination Humana follows the CMS requirement that only allows coverage and payment for services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.
In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria: Reconstructive Surgery Reconstructive surgery will be considered medically reasonable and necessary for bodily injury, congenital disease or anomaly, infection, trauma, tumor or other disease of the involved part to correct a functional impairment or to approximate normal appearance.
Functional impairment is defined as a direct and measurable reduction in physical performance of an organ or body part.
The following procedures will be considered medically necessary and reasonable in order to treat a medical illness or injury or to improve functioning of a malformed body member and/or when requirements specified below are met.















Cosmetic/Reconstructive Procedure Actinic Keratoses Treatment Benign Skin Lesion Treatment or Removal
Botulinum Toxin (Botox) Injections Breast Procedures • Areola Repigmentation (tattoo)
• Augmentation Mammoplasty (enlargement)
• Mastopexy
• Reduction Mammoplasty
Chemical Peel Collagen Implants Dermabrasion Facial Implants Fat Grafts/Autologous Fat Grafts Forehead Reduction/Reshaping Gender Affirmation Procedures (eg, clitoroplasty, phalloplasty, vaginoplasty) Genioplasty/Mentoplasty Gynecomastia Surgery
Hair Removal Hair Transplant Cosmetic and Reconstructive Surgery Page: 4 of 42 Indication(s)/Criteria
Destruction or removal of lesions by various methods (eg, chemical peels, cryosurgery, curettage, dermabrasion, excision, laser, photodynamic therapy) Destruction or removal of lesions by various methods (eg, cautery, cryosurgery, excision, injection, laser) Coverage and indications may be found in the Botox (Botulinum Toxin) Pharmacy Coverage Policy Coverage and indications may be found in the following Medical Coverage Policies: • Breast Reconstruction • Reduction Mammaplasty Application of chemical agents to remove the epidermal and/or dermal layers of skin
Injection of a natural protein which adds bulk to a body part or increases tissue surface area
Use of a powered instrument with a rotating wheel or brush tip that abrades and smooths outer skin layers Surgical placement of shaped implants to build up a receding chin, add prominence to cheekbones or reshape the jawline Harvesting and processing of fat to be used to augment soft tissue Surgery performed to reduce the size of or reshape the contour of the forehead Coverage and indications may be found in the Gender Affirmation Medical Coverage Policy Surgical reduction of a prominent chin or implant placement to enhance a receding chin Male Breast Reduction Laser hair removal MAY be considered medically reasonable and necessary ONLY in the presence of a recurrent pilonidal cyst previously treated with surgery
For gender affirming surgery hair removal coverage and indications please see the Gender Affirming Surgery Medical Coverage Policy Punch grafting procedure that fills in balding areas with an individual’s own hair and MAY be considered reconstructive when used for eyebrows or symmetric hairline replacement following a burn injury, trauma or tumor removal 23, 24




Cosmetic/Reconstructive Procedure Injectable Dermal Fillers
(Tissue Volume Replacement) May be considered medically reasonable and necessary when ALL of the following requirements are met31: Cosmetic and Reconstructive Surgery Page: 5 of 42 Indication(s)/Criteria
Keloid Removal
(Excess overgrowth of scar tissue) Labiaplasty, Labia Reduction, Labia Rejuvenation
• Dermal filler is approved by the US Food & Drug Administration (FDA) for the treatment of lipodystrophy; AND • Use is only for HIV-infected individuals with lipodystrophy caused by antiretroviral HIV treatment; AND • When the lipodystrophy (caused by antiretroviral HIV treatment is a significant contributor to the individual’s depression MAY be considered medically reasonable and necessary ONLY in the presence of a functional impairment Labiaplasty MAY be considered medically reasonable and necessary ONLY when ANY of the following requirements are met: • Chronic irritation not relieved or controlled by at least 3 months of dermatological therapy (eg, topical antibiotic, antifungal, corticosteroid cream) or other prescribed treatment if medically appropriate and not contraindicated AND supporting documentation details the presence of a functional impairment; OR • Correction of congenital atypicality or abnormality in genital appearance (eg, ambiguous genitalia congenital adrenal hyperplasia); OR • Injury; OR • Trauma Malar Augmentation, Mandible Augmentation Enhancement of the midface or jawline contour by See also Coverage Limitations Orthognathic Surgery
inserting a permanent silicone implant or injecting a temporary dermal filler (eg, Juvederm, Radiesse, Restylane) into the cheek or jaw area Surgery performed on abnormalities of the mandible (lower jaw), the maxilla (upper jaw) or both










Cosmetic/Reconstructive Procedure Otoplasty
(Ear Reconstruction) MAY be considered medically reasonable and necessary for correction of deformities/defects due to:
Cosmetic and Reconstructive Surgery Page: 6 of 42 Indication(s)/Criteria
• Congenital malformation (eg, aural atresia, aural stenosis, microtia); OR • Disease (eg, infection, auricular perichondritis, tumor); OR • Trauma Surgical procedure designed to remove a panniculus or pannus, (excess apron of redundant skin and fat) from the abdomen Procedures include, but may not be limited to, embolization, freezing or tattooing of the area, laser removal, sclerotherapy or surgical excision. Removal MAY be considered medically reasonable and necessary if the port wine stain, hemangioma or vascular lesion is on the head or neck and a functional impairment is present or the lesion is ulcerated Rhinoplasty reshape the noses while septoplasty corrects a deviated nasal septum Excision or surgical planing of rhinophyma MAY be considered medically reasonable and necessary when ALL of the following requirements are met: • Presence of an objective functional impairment (eg, obstructed nasal airway); AND • Bleeding or infection requiring repeated cauterizing or antibiotics
See also Coverage Limitations
MAY be considered medically reasonable and necessary if ANY of the following requirements are met: • Revision is required to correct an objective functional impairment* (eg, restricted movement, severe contracture);
• Scar resulted from an accidental injury or a medically necessary surgical procedure;
Panniculectomy Port Wine Stain, Hemangioma, Cutaneous Vascular Lesion Removal
Rhinoplasty/Septoplasty Rosacea, Phymatous (Rhinophyma) Scar Reduction, Release, Revision
Reduction technique examples include fractional ablative laser fenestration, fractional laser ablation (using carbon dioxide or erbium YAG lasers) Release technique examples include hydrodissection, ultrasound-guided hydrodissection













Cosmetic/Reconstructive Procedure Revision technique examples include scar excision (eg, elliptical, lazy S), scar irregularization (eg, Z-plasty, W-plasty, geometric broken line), skin flaps or skin grafts Skin Removal, Abdomen (including fat removal) Vaginoplasty Cosmetic and Reconstructive Surgery Page: 7 of 42 Indication(s)/Criteria
• Scar is hypertrophic Surgical removal of excess skin and subcutaneous tissue (usually associated with extreme weight loss or panniculectomy with underlying skin condition such as intertrigo)
Surgical construction or reconstruction of the vagina MAY be considered medically reasonable and necessary when either of the following requirements are met:
• Presence of a functional impairment*; OR
Correction of congenital atypicality or abnormality in genital appearance (eg, ambiguous genitalia, congenital discrepancy between external genitalia and chromosomal sex) The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage Cosmetic surgery or expenses incurred in connection with such surgery is not a covered Medicare benefit. Cosmetic surgery includes any surgical procedure directed at improving appearance, except when required for the prompt (ie, as soon as medically feasible) repair of accidental injury or for the improvement of the functioning of a malformed body member. These treatments and services fall within the Medicare program’s statutory exclusion that prohibits payment for items and services that have not been demonstrated to be reasonable and necessary for the diagnosis and treatment of illness or injury (§1862(a)(1) of the Act). Note: This exclusion does not apply to surgery for therapeutic purposes which coincidentally also serves some cosmetic purpose.30















The following procedures will not be considered medically reasonable and necessary for ANY indications: Cosmetic and Reconstructive Surgery Page: 8 of 42 Procedure Abdominoplasty (Tummy Tuck) Acne and Acne Scar Treatment Brachioplasty
(Upper Arm Lift)
Hair Growth/Hair Loss Reversal Hair Removal Injection Lipolysis/Lipo-dissolve/Mesotherapy Labiaplasty/Labia Rejuvenation
Lip Augmentation Liposuction/Suction-assisted Lipectomy/Ultrasonic Assisted Liposuction Onychomycosis Treatment
(Nail Fungus) Purported Use (Not covered for ANY indication) Cosmetic Surgery performed to remove excess abdominal skin and tighten the underlying muscles Treatments that attempt to reduce the amount of oil production, fight infection, reduce inflammation and lesson or eliminate scarring Surgical reduction or elimination of excess skin from the upper arms Application of topical medication to promote hair growth Application of low-level light therapy (iGrow) to reverse hair loss Use of depilatory, electrolysis, epilating, intense pulsed light, laser, threading, waxing to temporarily or permanently rid the body of unwanted hair For gender affirming surgery hair removal coverage and indications please see the Gender Affirming Surgery Medical Coverage Policy Series of injections to dissolve small unwanted localized areas of fat using alpha lipid acid, chemical agents, deoxycholic acid (Kybella), enzymes, multivitamins, phosphatidyl choline, plant extracts or medications (eg, antibiotics, hormones, nonsteroidal anti-inflammatory drugs) Surgery to reduce the size of the labia minora for appearance or to enhance sexual performance Injection of fat, collagen or filler to enlarge and/or enhance the lips Use of suction to remove fat from various body sites to contour and enhance appearance Nonpharmacological treatments, such as the delivery of laser or ultraviolet light or abrasive tools (eg, dremel, drill), to the fingernail or toenail For indications regarding medication for onychomycosis, please refer to Topical
Onychomycotic Agents Pharmacy Coverage Policy.














Procedure Piercing
Platysmaplasty
(Neck Lift)
Rhytidectomy, Meloplasty Rosacea Treatment
Skin Removal, Back, Hips (including fat removal) Skin Tightening, Nonsurgical Submental Lipectomy
(Neck Lift) Tattoo Removal Thighplasty
(Thigh/Buttock Lift)
Vitiligo Treatments Cosmetic and Reconstructive Surgery Page: 9 of 42 Purported Use (Not covered for ANY indication) Cosmetic Puncturing of the skin in order to attach a piece of jewelry Tightening of platysma muscle and removal of excess fat and skin from the neck Surgical removal and tightening of sagging skin, sometimes including repositioning of facial fat and tightening of muscles Nonpharmacological treatments (laser, dermabrasion and chemical peels) to eliminate erythema, telangiectasias and other cosmetic effects of rosacea For information regarding medication for rosacea, please refer to Oracea (doxycycline) and Topical Rosacea Products Pharmacy Coverage Policies Excision and/or liposuction removal of excess skin and subcutaneous tissue to improve the contour and appearance of the back and/or hips Use of targeted heat energy that purports to stimulate collagen and elastin production in order to improve skin tone (eg, Exilis, Morpheus8, Profound, Renuvion, Thermage, Ultherapy) Surgical elimination of a double chin by removal of fat and correction of skin and muscle laxity Removal of tattoo ink by dermabrasion, laser, salabrasion or surgical excision Surgery performed to improve the contour of the thigh/buttocks area Re-establishment of skin pigmentation by surgery, ultraviolet light or laser therapy (see summary of evidence below) For information regarding medication for vitiligo, please refer to Opzelura (ruxolitinib) Pharmacy Coverage Policy Summary of Evidence Vitiligo Treatment Vitiligo is a condition characterized by areas of skin with a loss of pigment (color). It is considered an autoimmune condition with both genetic and environmental factors and does not affect general health or physical functioning. According to the American Vitiligo Research Foundation (AVRF), the goal in treating vitiligo is to attempt to restore skin pigment and improve appearance. A clinical guideline found excimer





Cosmetic and Reconstructive Surgery Page: 10 of 42 laser skin therapy evidence insufficient, conflicting, or poor and demonstrates an incomplete assessment of net benefit vs harm for vitiligo.59 Although there is a small body of literature, it is lacking in peer-reviewed, human clinical data and is of insufficient quantity to evaluate the safety and effectiveness of home UVB therapy to treat vitiligo.47 There is no cure for vitiligo, and despite treatment, most patients experience alternating periods of pigment loss and stability, with some experiencing spontaneous repigmentation.77 The following procedures will not be considered medically reasonable and necessary for ANY indications: Procedure Adipose-Derived Regenerative Cell (ADRC) Therapy Vaginal Rejuvenation
using energy-based devices (eg, laser, radiofrequency) Purported Use (Not covered for ANY indication) Insufficient Evidence Liposuction harvest of stem cells from an individual’s own subcutaneous fat tissue followed by processing, concentrating and injection back into the individual, purportedly to improve healing, promote blood vessel growth and prevent cell death. Habeo Cell Therapy is a specific form of ADRC therapy being explored to treat the hands of individuals with scleroderma.
Procedures designed to treat genitourinary syndrome of menopause (vulvovaginal atrophy, atrophic vaginitis), a collection of symptoms caused by age- related changes to the urogenital tissue such as painful urination, pain during sexual intercourse, vaginal dryness or vaginal laxity. Proposed treatments may include laser therapy (MonaLisa Touch) or radiofrequency devices (Viveve). The safety and effectiveness of energy-based devices for treatment of these conditions has not been established.3, 80 A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management. Summary of Evidence Adipose-Derived Regenerative Cell (ADRC) Therapy
Systemic sclerosis (scleroderma) may cause loss of tissue beneath the skin and sores on the fingers, resulting in decreased hand function. Because there is no cure, symptom management and improving available treatment options is a goal. Research into methods to increase circulation to the fingers and replacing subcutaneous fat include methods for harvesting, processing and injecting tissue taken from one part of the body into the individual’s hands, usually fingers. A randomized clinical trial found that although efficacy trends were observed in some patients, ADRC therapy failed to meet the primary end point, a change in Cochin Hand Function Scale (CHFS) score.58 A systematic meta-analysis concluded that further






Cosmetic and Reconstructive Surgery Page: 11 of 42 studies with larger sample sizes and long-term follow-up are needed to address limitations such as the lack of control groups, reporting bias, and limited sample sizes.8 Vaginal Rejuvenation The US FDA issued a safety communication warning against use of energy-based devices to perform vaginal rejuvenation or vaginal cosmetic procedures, due to the possibility of serious adverse event, noting that the safety and effectiveness of such devices to treat symptoms related to menopause, urinary incontinence, or sexual function, has not been established. Although some devices were approved as surgical instruments,
the FDA has not cleared or approved for marketing any energy-based devices to treat symptoms related to menopause, urinary incontinence, or sexual function. The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.80 Substantial uncertainty exists due to a low-quality body of literature, a lack of a standardized treatment protocol, a lack of comparative studies and limited long-term results.51 A professional organization committee opinion noted that the size, shape, and color of the external genitalia vary considerably from woman to woman and that there is a lack of high- quality data that support the effectiveness of genital cosmetic surgical procedures.3