Medical Policy: 04.01.11 

Original Effective Date: May 2015 

Reviewed: April 2018 

Revised: April 2018 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Vaginal atrophy, also known as atrophic vaginitis, vulvovaginal atrophy and urogenital atrophy, is a condition that causes the vagina and tissue near the vagina to get dry, thin and inflamed. There is a reduction of blood flow, normal vaginal fluid, and an increase in the pH balance of the vagina, which leads to reduction of natural Lactobacilli (heathy bacteria in the vagina). Vaginal atrophy is often caused by lack of a geno typical woman’s ability to produce estrogen due to the following:

  • Menopause
  • Perimenopause
  • Surviving cancer/radiation (as a result of ovarian failure)
  • Medications – Tamoxifen (anti-estrogen to prevent cancer recurrence), hormonal contraception (prolonged use of birth control)
  • Contraindications to hormone replacement therapy
  • Vaginal dryness and atrophy stemming from prolonged breast feeding

 

Symptoms associated with vaginal atrophy include dyspareunia, vaginal burning, itching, dryness and laxity. Urge incontinence, frequency dysuria and stress incontinence have also been reported.

 

Treatment options for vaginal atrophy includes fractional CO2 laser therapy which delivers controlled energy to the vaginal tissue leaving the surrounding tissue intact, this allows faster healing as the mucosa of the vaginal wall is rejuvenated. This micro-ablative process contracts existing fibers and stimulates the formation of new collagen, rejuvenating the target tissue. This procedure can be performed in the office or in an outpatient setting, it does not require anesthesia or down time ensuring the geno typical women can return to their normal routine post procedure. This procedure may require 3 treatments over an 18 week period and will require annual maintenance treatment once completed.

 

Vaginal Relaxation Syndrome

Vaginal relaxation syndrome (loose vagina) is defined as the increase in the inner diameter of the vaginal wall. It can result in loss of friction and sexual satisfaction for both a geno typical woman and her partner.

 

The most common cause of vaginal relaxation is the overstretching of the vaginal wall during childbirth, which can increase with the number of births. Other causes are congenital connective tissue weakness and natural aging.

 

Until now, effective results could only be achieved through invasive surgical treatments such as anterior and posterior vaginal plastic surgery. There are many post-operative complications associated with these procedures and high degree of dissatisfaction with the results. With advances recently available with non-surgical lasers, vaginal canal tightening is becoming more mainstream and far more easily contemplated. Usually two sessions are recommended. There is no special pre-op preparation or post-op precautions necessary. Patients can immediately return to their normal everyday activities.

 

Radiofrequency laser technology also is utilized as a treatment option for vaginal tightening. The radiofrequency technology induces collagen contraction without damaging the epidermis. The result is skin tightening via soft tissue coagulation. The radiofrequency technology emits energy in the form of electromagnetic waves, which creates a heated treatment zone. Increased resistance causes heat buildup at the subdermal junction. The heat induces collagen denaturation and collagen contraction. Protein stimulation causes new collagen formation and production in the dermis which results in epidermal tightening. A series of 3 treatments done 7-10 days apart is recommended for optimal results. May also require maintenance on an annual basis.

Fractional CO2 laser therapy can also be utilized for vaginal tightening as well.

 

MonaLisa Touch

A new technology approved in the United States, the MonaLisa Touch is a CO2 laser that delivers controlled energy via side firing probe inserted into the vaginal canal. At the point of contact, the laser dot removes a tiny area of tissue. This creates a pinhole around the diameter of a human hair. As the body repairs itself, it stimulates cells to create healthy tissue at the site of the dot and the area immediately surrounding it. This device promotes and stimulates the regeneration of collagen fibers and restores hydration and elasticity within the vaginal mucosa i.e. vaginal rejuvenation.

 

The MonaLisa Touch is an in-office procedure typically performed by an obstetrician/gynecologist. The procedure requires 3 treatments over a 12 week period, treatments take less than 10 minutes. The patient should expect to come back annually for maintenance treatment.

 

Stretching of the vagina and introitus can occur from vaginal delivery or be a part of the natural aging process. MonaLisa Touch laser acts directly on the mucosa of the walls of the vagina to: tighten, reshape, tone, stimulate tissue and regenerate collagen.

 

Treatment with MonsaLisa Touch will:

  • Maintain the collagen content of the vaginal epithelium
  • Maintain its thickness and elasticity
  • Maintain optimal genital blood flow
  • Maintain mucopolysaccharides and hyaluronic acid, which keep vaginal mucosa moist and healthy

 

Based on the peer reviewed medical literature there has been a multisite study conducted at The Christ Hospital, Cincinnati, OH and Stanford University Medical Center, the trial assessed the use of CO2 fractional laser therapy on 30 women with vaginal health issues due to natural or induced menopause. All of the patients in the trial were treated with the MonaLisa Touch laser. Preliminary findings show positive results. However, the safety and effectiveness of vaginal rejuvenation and tightening procedures have not been documented. There is lack of data supporting the efficacy and that these procedures are medically indicated. Randomized controlled trials or comparative effectiveness trials with long term follow up, comparing MonaLisa Touch laser treatments to established procedures/treatments are necessary to evaluate the effectiveness of this technology.

 

Femi-Lift (Alma Lasers)

Alma FemiLift™ is a minimally invasive outpatient solution that incorporates CO2 laser technology to provide results for various female concerns. Life processes such as childbirth, weight fluctuations and hormonal changes may overstretch and damage vaginal tissue, damge the pelvic floor and alter the mucosal tone of the vaginal wall. These physiological changes can lead to conditions such as involuntary urine leakage, vaginal laxity, dryness and recurring infections which negatively affect a woman’s quality of life and self-confidence.

 

FemiLift™ is utilized to treat the following indications:

  • Vaginal tightening: FemiLift offers a simple and safe solution that restores the mucosal quality of the vaginal walls and enhances the sensitivity of vaginal tissue. Concentrated thermal heating and micro-ablation is applied to various layers of the vaginal tissue, stimulating collagen regeneration contracture of elastin fibers, neovascularization and improved vaginal lubrication. The female genital tissue is restored to a more youthful state, embedded with thick epithelim, long collagen fibers and decreased vaginal diameter.
  • Stress urinary incontinence (SUI): FemiLift stimulates collagen renewal as well as contraction of the elastin fibers, inducing rejuvenation and tissue remodeling. It treats the entire pre-urethral space, increasing the thickness of the vaginal walls and provides better support to the mid urethra underside. The result is significant reduction in SUI.
  • Vaginal dryness and recurrent infections: dryness and recurrent vaginal infections are treated through the rejuvenation of the vulvo-vaginal tissue, which improves vaginal lubrication and normalizes vaginal pH and flora. FemiLift utilizes laser treatment to enhance the local immune system response and help eliminate chronic vaginal infections.
  • Post-Menopause – GSM (genito-urinary syndrome): rejuvenates the vaginal lining, increasing the thickness of the vaginal walls and restoring natural lubrication. The treatment reduces uncomfortable symptoms such as itching, burning and friction.
  • Post – delivery rehabilitation: reinforcing and toning vaginal tissue, restoring strength and flexibility

 

FemiLift Probe

The FemiLift handpiece is a unique, single use hygienic probe, which is uniquely designed to fit varying vaginal sizes and ensure maximum patient comfort. During the treatment the physician rotates the probe in a 360 degree pattern to cover the entire vaginal wall, providing optimal coverage.

 

FemiLift Slim Probe

The new and hygienic, single use FemiLift Slim Probe was designed to fit women with inherently narrower anatomical structures, as well as those who have experienced anatomical or histological changes such as vaginal atrophy or tissue damage resulting from oncology treatments. Working with this slender probe follows the same protocol as with the standard probe.

 

FemiTight

FemiTight is a CO2 probe that was created for the treatment of labia majora tightening. Treatments conducted with this probe use a low power CO2 laser that gently heats the tissue, restoring and reviving collagen growth.

 

Pelleve RF System – Ellman International, Inc (A CynoSure Company)

Pellevé® S5 System uses radiofrequency technology that emits energy in the form of electromagnetic waves, which creates a heated treatment zone. Increased resistance causes heat buildup at the subdermal junction. Heat induces collagen denaturation and collagen contraction. Protein stimulation causes new collagen formation and production in the dermis which also results in epidermal tightening.

 

CO2 RE Intima – Syneron

CO2 RE Intima is a non-surgical CO2 laser procedure used to restore vaginal health.

 

CO2 RE Intima is used for the following:

  • Treatment of dryness, itching and pain
  • Restore vaginal tone, flexibility and shape
  • Relieve signs of childbirth and aging

 

Syneron Medical LTD announced on November 5, 2015 the US FDA granted numerous additional indications for CO2 RE device which included gynecology applications (including vaginal treatments).

 

Protégé Intima – BTL Aesthetics

Protégé Intima is a FDA-approved device utilizing radiofrequency (RF). RF thermally excites the fibroblast and subcutaneous structures of the skin, reaching temperatures of 40-42 Celsius. The body’s natural healing process will produce new collagen fibers. This procedure is done in the office, requires no needles, involves no downtime and patients can return to their regular activities as soon as they leave the office.

 

Protégé Intima remodels the external labia and internal vagina improving the appearance. This painless radiofrequency device also tightens the vagina and increases blood flow which may lead to an increase in sexual satisfaction. An additional reported benefit is improvement and often elimination of urinary stress incontinence.

 

A series of 3 Protégé Intima treatments are required, done 7-10 days apart for optimal results.

 

IntimaLase – Fotona

IntimaLase® is Er YAG laser therapy for incisionless, non-invasive photothermal tightening of the vaginal canal. The indication for IntimaLase is vaginal relaxation syndrome, which is the loss of the optimum structural form of the vagina. This condition is generally associated with overstretching of the vaginal canal during childbirth as well as with natural aging.

 

Fotona’s 2940 nm Er YAG non-ablative laser with proprietary “smooth mode” technology thermally affects the vaginal tissue, stimulating collagen remodeling and the synthesis of new collagen fibers in the vaginal mucosa tissue and collagen–rich endopelvic fascia. The final result of collagen neogenesis and remodeling is tightening of the vaginal canal.

 

Usually two sessions are recommended. There are no special pre-op preparation or post-op precautions necessary. Patients can immediately return to their normal everyday activities.

 

IntimaLase and other aesthetic gynecology treatments can be performed with the following Fotona laser systems:

  • FotonaSmooth SP – multi-application laser system from Fotona provides a single, uniquely capable gynecology solution that combines the power of the industrys’ highest performance Er YAG, Nd YAG and QCW Nd YAG lasers, ideal for treatment all gynecological applications plus a wide range of other treatments in aesthetic, dermatology and surgery.
  • FotonaSmooth XS Er YAG laser offers the power and precision to perform a range of non-contact, non-invasive gynecological procedures with greater patient comfort, reduced downtime and quicker healing. In addition to gynecological treatments, the FotonaSmooth XS is also a utilized for skin rejuvenation with functions ranging from superficial to deep peels, from non-ablative to fully ablative and from full-field to fractional resurfacing.

 

Summary

Based on review of the medical literature in all published trials to date, only several hundred geno typical women have been studied and most studies are only 12 weeks in duration. Another limitation of these short term studies is that the potential risk of long-term complications, such as scarring is not addressed. Patients were not monitored for concurrent use of intravaginal products or systemic medications that could affect vaginal and vulvar health. Over-the-counter moisturizers, lubricants, prescribed local estrogen products, or systemic hormones could have contributed to any observed improvements with these treatments.

 

Many of the laser companies claim on their websites that the CO2 fractional laser may be a treatment for a variety of post-partum/lactational incontinence, and dyspareunia in geno typical women with breast cancer, even though no data have been published on these unique patient populations, nor are there any high-quality clinical trials to support these claims.

 

The safety and effectiveness regarding vaginal rejuvenation and tightening have not been documented. There is lack of data supporting the efficacy and that these procedures are medically indicated. Randomized controlled trials with long term follow up, including comparative effectiveness trials to established procedures/treatments are necessary to evaluate the efficacy of these technologies. Therefore, vaginal rejuvenation and tightening for any indication regardless of the device utilized is considered investigational.

 

Practice Guidelines and Position Statements

American College of Obstetricians and Gynecologists (ACOG)

In 2007 (reaffirmed 2017), ACOG issued a Committee Opinion (number 378) regarding vaginal “rejuvenation” and cosmetic vaginal procedures that states: “So-called “vaginal rejuvenation,” “revirgination,” and “G-spot amplification” are vaginal surgical procedures being offered by some practitioners. These procedures are not medically indicated, and the safety and effectiveness of these procedures have not been documented. Clinicians who receive requests from patients for such procedures should discuss with the patient the reason for her request and perform an evaluation for any physical signs or symptoms that may indicate the need for surgical intervention. Women should be informed about the lack of data supporting the efficacy of these procedures and the potential complications, including infection, altered sensation, dyspareunia, adhesions, and scarring.” No adequate studies have been published assessing the long-term satisfaction, safety and complication rates of these procedures.

 

North American Menopause Society (NAMS)

In 2013, the North American Menopause Society (NAMS) issued a position statement on the management of symptomatic vulvovaginal atrophy which noted “that the choice of therapy for genitourinary syndrome of menopause (GSM) depends on the severity of symptoms, the efficacy and safety of therapy for the individual patient, and patient preference.

 

To date, estrogen therapy is the most effective treatment for moderate to severe GSM, although a direct comparison of estrogen and ospemifene is lacking. Non-hormonal therapies available without a prescription provide sufficient relief for most women with mild symptoms. When low dose estrogen is administered locally, a progestin is not indicated for women without a uterus - and generally is not indicated for women with an intact uterus. However, endometrial safety has not been studied in clinical trials beyond 1 year. Data are insufficient to confirm the safety of local estrogen in women with breast cancer.

 

Future research on the use of the fractional CO2 laser, which seems to be a promising emerging therapy, may provide clinician with another option to treat the common and distressing problem of GSM. The need for large, long term, randomized, sham controlled studies are needed to further evaluate the safety and efficacy of this procedure.”

 

Regulatory Status

MonaLisa Touch was developed in Milan, Italy and received marketing clearance from the U.S. Food and Drug Administration in September 2014.

 

Syneron Medical LTD announced on November 5, 2015 the US FDA granted numerous additional indications for CO2 RE device which included gynecology applications (including vaginal treatments).

 

Viveve Treatment - Viveve Medical – is not for sale in the U.S.

 

ThermaiVa – Thermi Aesthetics are FDA cleared for use in dermatological and general surgical procedures for electrocoagulation and hemostasis and to create lesions in nerve tissue. ThermaiVa is pending FDA approval for the vaginal tightening indication.

 

Lasers intended for medical purposes have been marketed in the United States for more than 20 years. Carbon dioxide and argon lasers were among the earliest laser technologies used in medicine. With the enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act in May 1976, all new devices, including new medical lasers, became subject to FDA premarket clearance. There are two forms of premarket clearance procedures. The premarket notification (510(k)) procedure is principally used for those devices that are documented to be substantially equivalent to legally marketed Class I and Class II devices. The 510(k) procedure can also apply to devices which are substantially equivalent to a Class III device for which the effective date of the requirements for premarket approval has not yet been established. The premarket approval (PMA) process applies to devices in Class III.

 

Prior Approval:

Not applicable

 

Policy:

Vaginal rejuvenation and vaginal tightening procedures including but not limited to the following are considered investigational for all indications:

  • MonaLisa Touch
  • FemiLift - FemiLift Probe/FemiLift Slim Probe/FemiTight
  • CO2 RE Intima
  • Pixel CO2 laser
  • Protégé Intima
  • Pelleve RF (radiofrequency)
  • IntimaLase Er YAG laser (FotonaSmoth SP, FotonaSmooth XS Er YAG)

 

Based on the available published peer reviewed medical literature the safety and effectiveness of these devices for the treatment of vaginal rejuvenation and vaginal tightening cannot be established. The evidence is insufficient as currently there are no published studies that assess the clinical utility, long-term outcomes, safety and complication rates of these procedures. Further randomized controlled trials with long term follow up and comparative effectiveness to established procedures and treatments are necessary to evaluate the efficacy of these technologies. The evidence is insufficient to determine the effects of the technology on net health outcomes.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 58999 Unlisted procedure female genital system (nonobstetrical)

 

Selected References:

  • Cheryl B. Iglesia, M.D., Sheryl Kingsberg, PhD, The Quest for the “Perfect” Vagina, The Female Patient Vol 34 February 2009.
  • Society of Obstetricians and Gynecologists of Canada (SOGC), Policy Statement Female Genital Cosmetic Surgery, J Obstet Gynaecol Can 2013;35(12):e1-e5
  • The American College of Obstetricians and Gynecologists (ACOG), Committee Opinion Number 378, September 2007 (Reaffirmed 2017), Vaginal “Rejuvenation” and Cosmetic Vaginal Procedures, Obstet Gynecol 2007;110:737-738
  • Medical Daily- FDA Approves MonaLisa Touch Laser for Vaginal Dryness Caused by Vaginal Atrophy.
  • Cynosure. Cynosure Signs Exclusive Agreement to Market MonaLisa TouchTM in North American for Gynecology Indications
  • MonaLisa Touch
  • UpToDate. Treatment of Vaginal Atrophy, Gloria Bachmann, M.D., Richard J. Santen, M.D.. Topic last updated April 4, 2014.
  • Salvatore S, Nappi RE, Zerbinati N, et. al. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric 2014 Aug;17(4):363-9. PMID 24605832
  • Salvatore S, Nappi RE, Parma M, et.al. Sexual function after fractional microablative CO2 laser in women with vulvovaginal atrophy. Climacteric 2015 Apr:1892):219-25. PMID 25333211
  • Krychman M, Shifren J, Liu J, et. al. Laser treatment safe for vulvovaginal atrophy? The North American Menopause Society (NAMS) 2015;11(3). Medscape
  • FemiLift
  • Viveve Treatment
  • ThermaiVa-Thermi Aesthetics
  • Pelleve System
  • CO2 RE Intima
  • IntimaLase
  • Protégé RF Intima
  • Vizintin Z, Rivera M, Fistonic I, et. al. Novel minimally invasive Er YAG laser treatments in gynecology. Journal of Laser and Health Academy, Vol 2012, No. 1 P 46-58
  • Jorge E, Gaviria P, Jose A, et. al. Laser vaginal tightening (LVT) – evaluation of a novel noninvasive laser treatment for vaginal relaxation syndrome. Journal of Laser and Health Academy Vol 2012, No. 1, P 59-66
  • Management of symptomatic vulvovaginal atrophy: 2013 position statement of the North American Menopause Society. Menopause. 2013;20(9):888–902.
  • Karram M, Sokol E and Salvatore S. Genitourinary Syndrome of Menopause: Current and Emerging Therapies. OBG Management Vol 27 No. 8 August 2015.
  • Salvatore S, Maggiore ULR, Origoni M, et. al. Microablative fractional CO2 laser improves dyspareunia related to valvovaginal atrophy: a pilot study. J Endometriosis Pelvic Pain Disorders 2014;6(3):121-162
  • Salvatore S, Maggiore ULR, Athanasiou S, et. al. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue; an ex vivo study. Menopause 2015;22(8):845-849. PMID 25608269
  • Zerbinati N, Serati M, Origoni M, et. al. Microscopic and ultrastructural modification of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment. Lasers Med Sci 2015 Jan;30(1):429-36. PMID 25410301
  • UpToDate. Treatment of Genitourinary Syndrome of Menopause (Vulvovaginal Atrophy). Gloria Bachmann M.D., Richard J Santen M.D. Topic last updated November 14, 2017.
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    Policy History:

    • April 2018 - Annual review, Policy revised
    • April 2017 - Annual Review, Policy Renewed
    • April 2016 - Annual review, Policy revised
    • May 2015 - New Policy

     

    Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

     

    *CPT® is a registered trademark of the American Medical Association.