| Coverage Policy Manual | |
| Policy #: | 2018019 |
| Category: | Medicine |
| Initiated: | July 2018 |
| Last Review: | July 2023 |
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| Use of Laser Therapy or Radiofrequency Therapy for the Treatment of Vaginal Atrophy or Vaginal Relaxation Syndrome | |
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| 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:
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 (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:
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:
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:
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:
Regulatory Status
Coding
There is not a specific code for these services. It is expected that these services would be billed using CPT 58999: Unlisted procedure female genital system (nonobstetrical)
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Policy/ Coverage: |
Effective July 2021
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Vaginal rejuvenation and vaginal tightening procedures including but not limited to the following do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
For members with contracts without primary coverage criteria, vaginal rejuvenation and vaginal tightening procedures including but not limited to the following are considered investigational:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to July 2021
Vaginal rejuvenation and vaginal tightening procedures including but not limited to the following do not meet member benefit certificate primary coverage criteria:
For members with contracts without primary coverage criteria, Vaginal rejuvenation and vaginal tightening procedures including but not limited to the following are considered investigational:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
This policy is developed based on a literature search of the MEDLINE database through June 2018. There were no randomized controlled trials identified that assessed the safety and effectiveness of these devices.
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 (ACOG, 2007). 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 (NAMS, 2013)
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.”
This statement was further supported in a 2015 statement that concluded large, long-term randomized, sham-controlled studies are needed to further evaluate the safety and efficacy of this procedure (NAMS, 2015).
Summary
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.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
A literature search was conducted through June 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement.
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| References: |
American College of Obstetricians and Gynecologists.(2007) Vaginal "rejuvenation" and cosmetic vaginal procedures. ACOG Committee Opinion No. 378. Obstet Gynecol 2007;110:737–8. Krychman ML., Shifren JL., Liu JH., et al.(2015) Laser Treatment Safe for Vulvovaginal Atrophy? The North American Menopause Society (NAMS). 2015;11(3). The North American Menopause Society (NAMS).(2013) Management of Symptomatic Vulvovaginal Atrophy: 2013 Position Statement of the North American Menopause Society. Menopause. 2013 Sep;20(9):888-902.. |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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