Highmark medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.
This policy provides information regarding the coverage of, as determined by applicable federal and/or state legislation.
This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.
The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the Delaware Department of Health and Social Services (DHSS) and all applicable state and federal regulations.
This medical policy outlines Highmark Health Options services for Treatment of Abnormal Uterine Bleeding and Fibroids.
Abnormal Uterine Bleeding- Abnormal uterine bleeding (AUB) is bleeding from the uterus between periods. It may also be prolonged bleeding during a period or an extremely heavy period (menorrhagia).
Highmark Health Options (HHO) – Managed care organization serving vulnerable populations that have complex needs and qualify for Medicaid. Highmark Health Options members include individuals and families with low income, expecting mothers, children, and people with disabilities. Members pay nothing to very little for their health coverage. Highmark Health Options currently services Delaware Medicaid: Diamond State Health Plan (DSHP), Delaware Healthy Children Program (DHCP), and Diamond State Health Plan Plus (DSHP) LTSS members.
Uterine Fibroids- Uterine fibroids are noncancerous growths of the uterus. Symptoms may include menorrhagia, pelvic pressure, or pain. Treatment options include hysterectomy, myomectomy, uterine artery embolization and fibroid ablation.
Prior Authorization
Prior Authorization may be required. Please validate codes on the Prior Authorization Lookup Tool https://www.highmarkhealthoptions.com/providers/prior-auth-lookup
Procedures
Transcatheter uterine artery embolization (UAE) of uterine arteries may be considered medically necessary for the treatment of uterine fibroids when any ONE of the following criteria is met:
· The individual is experiencing the following symptoms:
o Menorrhagia (excessive menstrual bleeding lasting more than eight (8) days) as a direct result of the fibroid (i.e., not resulting from hyperplasia, atypia, or cancer) that interferes with daily activities or causes anemia; or
o Pelvic pain or pressure as a direct result of the fibroid; or
o Lower back pain as a direct result of the fibroid; or
o Urinary symptoms (e.g., urinary frequency, urgency) related to compression of the bladder as a direct result of the fibroid; or
o Gastrointestinal symptoms related to compression of the bowel (e.g., constipation, bloating) as a direct result of the fibroid; or
o Dyspareunia (painful or difficult sexual relations) as a direct result of the fibroid; or
o An abdominally palpable fibroid; or
o Postpartum uterine hemorrage; or
o Placenta accreta, placenta increta or placenta percreta.
Or
· The individual is asymptomatic with an abdominally palpable fibroid or significantly enlarged fibroid on abdominal/vaginal examination and any ONE of the following:
o The use of anesthesia places the individual at high surgical risk; or
o The individual has medical contraindications to hysterectomy (e.g., morbid obesity); or
o The use of hormonal therapy is contraindicated, or the individual is intolerant to or has previously failed a course of hormone therapy; or
o The individual wishes to avoid hysterectomy; or
o The individual may want to become pregnant; or
o The individual has hydronephrosis.
One repeat transcatheter embolization of uterine arteries may be considered medically necessary to treat persistent symptoms of uterine fibroids after an initial uterine artery embolization when any ONE of the following criteria is met:
· Documentation of continued symptoms such as bleeding or pain; or
· Individual has persistent symptoms in combination with findings on imaging of an incomplete initial procedure, as evidenced by continued blood flow to the treated regions.
UAE may be considered medically necessary for the treatment of postpartum uterine hemorrhage.
Laparoscopic or transcervical ultrasound-guided radiofrequency ablation (e.g., Acessa™, Sonata) for the treatment of uterine fibroids may be considered medically necessary when the individual is experiencing any ONE of the following symptoms:
· Menorrhagia (excessive menstrual bleeding lasting more than eight (8) days) as a direct result of the fibroid (e.g., not resulting from hyperplasia, atypia, or cancer) that interferes with daily activities or causes anemia; or
· Pelvic pain or pressure as a direct result of the fibroid; or
· Lower back pain as a direct result of the fibroid; or
· Urinary symptoms (e.g., urinary frequency, urgency) related to compression of the bladder as a direct result of the fibroid; or
· Gastrointestinal symptoms related to compression of the bowel (e.g., constipation, bloating) as a direct result of the fibroid; or
· Dyspareunia (painful or difficult sexual relations) as a direct result of the fibroid; or
· An abdominally palpable fibroid.
Laparoscopic or transcervical ultrasound-guided radiofrequency ablation not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness have not been established by the available published peer-reviewed literature.
Endometrial ablation with or without hysteroscopic guidance, using an FDA-approved device, may be considered medically necessary in women who would otherwise be considered candidates for hysterectomy when any ONE of the following criteria is met:
· In women with menorrhagia who are not candidates for hormone therapy; or
· Decline hormone therapy; or
· Who are unresponsive to hormone therapy.
Endometrial ablation with or without hysteroscopic guidance for all other indications is considered not medically necessary.
Treatment of uterine fibroids is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature for any ONE of the following procedure/services.
Post Payment Audit Statement
The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Highmark Health Options at any time pursuant to the terms of your provider agreement.
Place of Service: Outpatient
Experimental/investigational (E/I) services are not covered regardless of place of service.
Treatment of Uterine Fibroids is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a comorbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
REIMBURSEMENT
Participating facilities will be reimbursed per their Highmark Health Options contract.
ACOG Practice Bulletin. Clinical Practice Guidelines for Obstetrician-Gynecologists. 2017(81). Reaffirmed 2018. Accessed July 25, 2018.
American College of Obstetricians and Gynecologists. ACOG practice bulletin. Alternatives to hysterectomy in the management of leiomyomas. Obstet Gynecol. Aug 2008;112(2 Pt 1):387-400. Reaffirmed in 2019.
Barnard EP, AbdElmagied AM, Vaughan LE, et al. Periprocedural outcomes comparing fibroid embolization and focused ultrasound: A randomized controlled trial and comprehensive cohort analysis. Am J Obstet Gynecol. 2017;216(5): 500.e1-500.e11.
Chudnoff S, Guido R, Roy K, Levine D, Mihalov L, Garza-Leal J. Ultrasound-Guided transcervical ablation of uterine leiomyomas. Obstet Gyn. 2019;133(1):13-22.
Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum hemorrhage. Obstet Gynecol. 2017;130(4): e168-e186.
Davis MR, Soliman AM, Castelli-Haley J, et al. Reintervention Rates After Myomectomy, Endometrial Ablation, and Uterine Artery Embolization for Patients with Uterine Fibroids. J Womens Health (Larchmt). Oct 2018; 27(10):1204-1214.
Gingold JA, Gueye NA, Falcone T. Minimally invasive approaches to myoma management. Journal of Minimally Invasive Gynecology. 2018;25(2):237-250.
Havryliu Y, Setton R, Carlow JJ, Shaktman BD. Symptomatic fibroid management: Systematic review of the literature. JSLS. 2017;21(3): e2017.00041.
Havryliuk Y, Setton R, Carlow JJ, Shaktman BD. Symptomatic fibroid management: systematic review of the literature. JSLS. 2017;21(3): e2017.00041.
Hayes Technology Assessment. Laparascopic radiofrequency volumetric thermal ablation (Acessa) for treatment of uterine fibroids. Lansdale, PA: Hayes, Inc. Nov. 17, 2020.
Hayes Technology Assessment. Transcervial raidiofrequency ablation with the Sonata System for symptomatic uterine fibroids. Lansdale, PA. Hayes, Inc. Nov. 17, 2020.
Hayes, Inc. Health Technology Breif. Laparoscopic Radiofrequency Volumetric Thermal Ablation (Acessa System; Halt Medical Inc.) for Treatment of Uterine Fibroids. November 3, 2017. Accessed February 5, 2018.
Keltz J, Levie M, Chudnoff S. Pregnancy outcomes after direct uterine myoma thermal ablation: Review of the literature. J Minim Invasive Gynecol. 2017;24(4):538-545.
Laughlin-Tommaso SK. Nonsurgical management of myomas. Journal of Minimally Invasive Gynecology. 2018;25(2):229-236.
McCausland V, McCausland A, Barbis S. Partial endometrial ablation: A 10-20-year follow-up of impact on bleeding, pain, and quality of life. J Gynecol Surg. 2016;32(4),230-235.
Sandberg EM, Tummers F, Cohen SL, van den Haak L, Dekkers OM, et al. Reintervention risk and quality of life outcomes after uterine-sparing interventions for fibroids: A systematic review and meta- analysis. Fertil Steril. 2018;109(4):698-707.
van den Brink MJ, Beelen P, Herman MC, Claassen NJJ, Bongers MY, et al. Women’s preferences for levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding, Eur J Obstet Gynecol. 2018. doi: 10.1016/j.ejogrb.2018.06.020.
Miller CE, Osman KM. Transcervical radiofrequency ablation of symptomatic uterine fibroids: 2-Year results of the SONATA pivotal trial. J Gynecol Surg. 2019;35(6):345-349.
Bradley LD, Pasic RP, Miller LE. Clinical performance of radiofrequency ablation for treatment of uterine fibroids: Systematic review and meta-analysis of prospective studies. J Laparoendosc Adv Surg Tech A. 2019;29(12):1507-1517.
Lin L, Ma H,m Wang J et al. Quality of life, adverse events and reintervention outcomes after laparoscopic radiofrequency ablation for sympotomatic uterine fibroids: A meta-analysis. J Minim Invasive Gynecol. 2019;26(3):409-416.