Medical policy: Noncontraceptive Use of Intrauterine Devices (IUDs)

Número de política: MP 7.026

Fecha de entrada en vigor: 6/1/2026

Política

NOTE: For the use of intrauterine devices for contraceptive purposes - refer to the Benefit Booklet and Preventive Benefits.

Intrauterine devices (IUDs) may be medically necessary for non-contraceptive uses for the following indications:

• As indicated by the Food and Drug (FDA) label information, use of levonorgestrel intrauterine systems (LNG IUS) devices containing 52 mg levonorgestrel (Mirena®, Liletta®) may be considered medically necessary to treat heavy menstrual bleeding in individuals who use intrauterine contraception as their method of pregnancy prevention.
• Off-label use of levonorgestrel intrauterine systems (LNG IUS) devices containing 52 mg levonorgestrel (Mirena®, Liletta®) for conditions other than specified in the FDA label information above may be considered medically necessary for the following:
  • As an alternative to other hormonal regimens (oral contraceptives, cyclic or continuous progestin’s, etc.) or as a treatment option to surgical interventions in an individual who has excessive or irregular bleeding defined as one of the following:
    • Idiopathic menorrhagia: Excessively heavy, regular menses in the absence of intracavitary pathology or coagulopathy; OR
    • Menometrorrhagia: Bleeding that is excessive in amount, is prolonged in duration, and may occur at regular or irregular intervals.
  • As an alternative delivery system to protect against endometrial hyperplasia in individuals who are currently receiving selective estrogen receptor modulators.
  • Management of recurrent pelvic pain secondary to multi-treated endometriosis.

Levonorgestrel intrauterine systems (LNG IUS) devices containing less than 52 mg levonorgestrel (Skyla™, Kyleena™) for off-label non-contraceptive use are considered investigational. There is insufficient evidence to support a conclusion concerning the general health outcomes or benefits associated with this procedure.

The non-contraceptive use of IUDs for indications other than those described in the policy criteria are considered investigational as there is insufficient evidence to support a conclusion concerning the general health outcomes or benefits associated with this procedure.

Removal of an IUD for medical conditions such as unexplained abnormal uterine bleeding or pregnancy may be considered medically necessary.

Cross-references:

MP 2.103 Off Label Use of Medications
MP 7.013 Endometrial Ablation

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas de FEP.

Descripción/antecedentes

Intrauterine devices (IUDs) are devices that are inserted in the uterus to prevent effective conception. IUDs can be classified as non-hormonal (e.g., ParaGard® copper IUD) or hormonal. Hormonal devices include levonorgestrel-releasing intrauterine systems (LNG-IUS) like Mirena®, Liletta®, Skyla® and Kyleena®.

The U.S. Food and Drug Administration (FDA) approved Mirena® (levonorgestrel-releasing intrauterine system) 52 mg, a hormone-releasing system to prevent pregnancy for up to 8 years and treatment of heavy menstrual bleeding for 5 years.

The U.S. Food and Drug Administration (FDA) approved Skyla™ (levonorgestrel-releasing intrauterine system) 13.5 mg, a hormone-releasing system that is placed in the uterus for the prevention of pregnancy for up to three years. No studies have been completed for the use of Skyla™ for the treatment of heavy menstrual bleeding.

The U.S. Food and Drug Administration (FDA) approved Liletta® (levonorgestrel-releasing intrauterine system) 52 mg, a hormone-releasing system to prevent pregnancy for up to 8 years and treatment of heavy menstrual bleeding for 5 years.

The U.S. Food and Drug Administration (FDA) approved Kyleena® (levonorgestrel-releasing intrauterine system) 19.5 mg, a hormone-releasing system to prevent pregnancy for up to 5 years. No studies have been completed for the use of Kyleena® for the treatment of heavy menstrual bleeding.

Fundamento

Employing an IUD for heavy menstruation can reduce symptoms of cramping and pain and reduce associated comorbidities, such as anemia.

The use of LNG IUS devices for dysfunctional uterine bleeding may also allow women to avoid more invasive procedures such as hysterectomy or endometrial ablation.

Definiciones

Dysfunctional Uterine Bleeding (DUB) is abnormal bleeding from the uterus not caused by tumor, inflammation, or pregnancy.

Menorrhagia is excessive uterine bleeding occurring at the regular intervals of menstruation, the period of flow being of greater than usual duration.

Off-label Use is the use of a prescription drug or medical device in the treatment of an illness or injury for which it has not been specifically approved by the FDA.

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo permita la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios del miembro, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: esta lista de códigos puede no ser exhaustiva y los códigos están sujetos a cambios en cualquier momento. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Investigational; therefore, not covered when used for any indication other than contraception:

Cubierto cuando sea médicamente necesario:

Referencias

1. Abou-Setta AM, Al-Inany HG, Farquhar CM. Levonorgestrel-releasing intrauterine device (LNG-IUD) for symptomatic endometriosis following surgery. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD005072. DOI: 10.1002/14651858.CD005072.pub2. Update in: Cochrane Database Syst Rev. 2013; 1:CD005072. PMID: 17054236
2. American College of Obstetricians and Gynecologists (ACOG). Dysmenorrhea and Endometriosis in the Adolescent. Committee Opinion 760. December 2018.
3. American College of Obstetricians and Gynecologists (ACOG). Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Practice Bulletin 186. November 2017 (Reaffirmed 2021).
4. Apgar BS, Kaufman AH, George-Nwogu U, Kittendorf A. Treatment of menorrhagia. Am Fam Physician. 2007 Jun 15; 75(12): 1813-9. PMID: 17619523
5. Bahamondes L, Petta CA, Fernandes A, Monteiro I. Use of the levonorgestrel-releasing intrauterine system in women with endometriosis, chronic pelvic pain, and dysmenorrhea. Contraception. 2007 Jun; 75(6 Suppl): S134-9. Epub 2007 Feb 16. PMID: 17531605
6. Beatty M, Blumenthal P. The levonorgestrel-releasing intrauterine system: Safety, efficacy, and patient acceptability. Ther Clin Risk Manag. 2009 Jun;5(3):561-574. PMID 19707273.
7. Behera M. Abnormal (Dysfunctional) Uterine Bleeding. Article 257007. eMedicine. Actualización: 29 de enero de 2026.
8. Johnson BA. Insertion and removal of intrauterine devices. Am Fam Physician 2005; 71(1): 95-102. PMID: 1566031
9. Kaunitz, Andrew M. Patient education: Heavy or prolonged menstrual bleeding (menorrhagia) (Beyond the Basics). In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated May 23, 2024. Literature review current through Jan 2026.
10. Lethaby AE, Cooke I, Rees M. Progesterone/progestogen releasing intrauterine systems versus either placebo or any other medication for heavy menstrual bleeding. Cochrane Database Syst Rev 2005; (4): CD002126. Cochrane Database Syst Rev. 2015 Apr 30 ;(4): CD002126. doi: 10.1002/14651858.CD002126.pub3. Update in: Cochrane Database Syst Rev. 2020 Jun 12; 6:CD002126. PMID: 25924648
11. Reed S, Urban R. Management of Endometrial Hyperplasia : Management and Prognosis. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated September 24, 2025. Literature review current through Jan 2026.
12. Reid, PC, Virtanen-Kari, S. Randomised comparative trial of the levonorgestrel intrauterine system and mefenamic acid for the treatment of idiopathic menorrhagia: a multiple analysis using total menstrual fluid loss, menstrual blood loss, and pictorial blood loss assessment charts. BJOG 2005; 112:1121. Aug; 112(8):1121-5. doi: 10.1111/j.1471-0528.2005.00642.x. PMID: 16045528
13. Schaedel ZE, Dolan G, Powell MC. The use of the levonorgestrel-releasing intrauterine system in the management of menorrhagia in women with hemostatic disorders. Am J Obstet Gynecol. 2005; 193(4):1361-1363. doi:10.1016/j.ajog.2005.05.002
14. Shaw RW, Symonds IM, Tamizian O, Chaplain J, Mukhopadhyay S. Randomised comparative trial of thermal balloon ablation and levonorgestrel intrauterine system in patients with idiopathic menorrhagia. Aust N Z J Obstet Gynaecol. 2007; 47(4):335-340. doi:10.1111/j.1479-828X.2007.00747.x
15. Kaunitz, Andrew M. Abnormal Uterine Bleeding in Nonpregnant Reproductive-Age Patients: Management. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated December 18, 2025. Literature review current through Jan 2026.