Latest Review Date: September 2024

Category:  OB/Gyn Reproductive                                         

POLICY:

Mirena (Levonorgestrel-releasing intrauterine system [LNG-IUS]) may be considered medically necessary for the following medical conditions:

• Idiopathic menorrhagia
• Dysfunctional uterine bleeding
• Premenopausal menorrhagia
• Adenomatous hyperplasia
• Metrorrhagia

Mirena is currently covered for groups which provide coverage for contraception.

The use of any other levonorgestrel intrauterine systems (LNG IUS) devices other than Mirena® for non-contraceptive use is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVCIE:

Levonorgestrel-releasing intrauterine system (LNG-IUS), (Mirena®), is a device that releases levonorgestrel into the uterine cavity at a rate of approximately 20mcg per day for five years.  It is indicated for intrauterine contraception for up to 8 years.  It may also cause significant reduction in menstrual blood loss, thus it has been used for the treatment of menorrhagia and dysfunctional uterine bleeding.  It has also been used to treat endometrial hyperplasia, as an effective method for suppression of the endometrium and as an alternative to hysterectomy.

KEY POINTS:

The most recent literature search was conducted through September 25, 2024.

Summary of Evidence

For women who are experiencing heavy menstrual bleeding and receive a levonorgestrel releasing IUS (i.e. Mirena), the evidence consists of meta-analyses and randomized controlled trials. The primary endpoints were quality of life, safety, and surgical reinterventions.  Overall, studies have shown more patient satisfaction with LNG-IUDs compared to medical treatment. In a systematic review and meta-analysis conducted, the LNG-IUS was superior to conventional medical treatment in reducing menstrual blood loss and more women were satisfied with the LNG-IUS than with the use of conventional medical treatment. In other trials, the LNG-IUS group was more satisfied compared to medical treatment.  The evidence is sufficient to determine that the device results in a meaningful improvement in the net health outcome.

Practice and Position Statements

American College of Obstetricians and Gynecologists

In February 2019, ACOG published Practice Bulletin 206: Use of Hormonal Contraception in Women with Coexisting Medical Conditions. It states that the “Use of a 52-mg LNG-IUD may be particularly effective for the management of perimenopausal bleeding.” It goes on to state that “Because the 52-mg LNG-IUD provides effective contraception and significantly reduces menstrual blood loss, it is an excellent contraceptive method for patients taking anticoagulants.”

In April 2013 (reaffirmed 2019) ACOG published Committee Opinion Number 557: Management of Acute Abnormal Uterine Bleeding in Nonpregnant Reproductive-Aged Women that states, “Once the acute episode of bleeding has been controlled, multiple treatment options are available for long-term treatment of AUB. Effective medical therapies include the levonorgestrel intrauterine system….”

KEY WORDS:

Mirena®, levonorgestrel-releasing intrauterine system, LNG-IUS, menorrhagia, premenopausal menorrhagia, endometrial hyperplasia, adenomatous hyperplasia, dysfunctional uterine bleeding, hysterectomy, IUS, menstrual bleeding, heavy menstrual bleeding

APPROVED BY GOVERNING BODIES:

The FDA approved Mirena® (levonorgestrel-releasing intrauterine device) in December 2000 as a hormone-releasing system for intrauterine contraception.

The FDA approved Mirena® (levonorgestrel-releasing intrauterine device) October 1, 2009 for the treatment of heavy menstrual bleeding in women who use intrauterine contraception as a method of pregnancy prevention.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.  The use of this device for contraceptive management is a group specific benefit.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT codes:

HCPCS codes:

REFERENCES:

1. American College of Obstetricians and Gynecologists. ACOG committee opinion no. 557: Management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women.  Obstet Gynecol. 2013 Apr;121 (4):891-896.
2. American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 206: Use of hormonal contraception in Women with coexisting medical conditions. Obstet Gynecol. 2019 Feb; 133(2):e128-e150.
3. Barrington JW, et al.  Comparison between the levonorgestrel intrauterine system (LNG-IUS) and thermal balloon ablation in the treatment of menorrhagia, European Journal of Obstetrics, Gynecology, and Reproductive Biology, May 2003; 108(1): 72-74.
4. Creinin, M. D., Barnhart, K. T., Gawron, L. M., Eisenberg, D., Mabey, R. G., Jr, & Jensen, J. T. (2023). Heavy Menstrual Bleeding Treatment With a Levonorgestrel 52-mg Intrauterine Device. Obstetrics and gynecology, 141(5), 971–978.
5. de Souza SS, Camargos AF, de Rezende CP, et al. A randomized prospective trial comparing the levonorgestrel-releasing intrauterine system with thermal balloon ablation for the treatment of heavy menstrual bleeding. Contraception. 2010 Mar;81(3):226-31.
6. Endrikat J, Shapiro H, Lukkari-Lax E, et al. A Canadian, multicentre study comparing the efficacy of a levonorgestrel-releasing intrauterine system to an oral contraceptive in women with idiopathic menorrhagia. J Obstet Gynaecol Can. 2009 Apr;31(4):340-7.
7. Gupta J, Kai J, Middleton L, et al. Levonorgestrel intrauterine system versus medical therapy for menorrhagia. N Engl J Med. 2013 Jan 10;368(2):128-37.
8. Heliövaara-Peippo S, Halmesmäki K, Hurskainen R, et al. The effect of hysterectomy or levonorgestrel-releasing intrauterine system on lower abdominal pain and back pain among women treated for menorrhagia: a five-year randomized controlled trial. Acta Obstet Gynecol Scand. 2009;88(12):1389-96.
9. Hurskainen R, et al.  Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia:  Randomized trial 5-year follow-up, The Journal of the American Medical Association, March 2004; 291(12): 1503-1504.
10. Hurskainen R, et al.  Levonorgestrel-releasing intrauterine system for menorrhagia improved quality of life but cost less than hysterectomy, Evidence-Based Obstetrics and Gynecology, March 2002, Vol. 4, No. 1.
11. Hurskainen R, et al.  Levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of essential menorrhagia:  Predicts of outcome, Acta Obstetricia at Gynecologica Scandinavica, April 2004; 83(4): 401-403.
12. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
13. Kai J, Middleton L, Daniels J, et al. Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term randomized pragmatic trial in primary care. Br J Gen Pract. 2016 Dec;66(653):e861-e870.
14. Kaunitz AM, Bissonnette F, Monteiro I, et al. Levonorgestrel-releasing intrauterine system or medroxyprogesterone for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):625-32.
15. Kaunitz AM, Meredith S, Inki P, et al. Levonorgestrel-releasing intrauterine system and endometrial ablation in heavy menstrual bleeding: a systematic review and meta-analysis. Obstet Gynecol. 2009 May; 113(5): 1104-16.
16. Marjoribanks J, Lethaby A, Farquhar C. Surgery versus medical therapy for heavy menstrual bleeding. Cochrane Datatbase Syst Rev. 2016 Jan 29;(1):CD003855.
17. Maybin JA, Critchley HO. Medical management of heavy menstrual bleeding. Women's Health (Long). 2016 Jan;12(1): 27-34.
18. Nagrani R, et al.  Can the levonorgestrel intrauterine system replace surgical treatment for the management of menorrhagia?, BJOG:  An International Journal of Obstetrics and Gynecology, March 2002; 109(3): 345-347.
19. Stewart A, et al.  The effectiveness of the levonorgestrel-releasing intrauterine system in menorrhagia:  A systematic review, British Journal of Obstetrics and Gynecology, January 2001, Vol. 108, pp. 74-86.
20. Vereide AB, et al.  Nuclear morphometric changes and therapy monitoring in patients with endometrial hyperplasia:  A study comparing effects of intrauterine levonorgestrel and systemic medroxyprogesterone, December 2003; 91(3): 526-533.
21. Wildemeersch D and Dhont M.  Treatment of nonatypical and atypical endometrial hyperplasia with a levonorgestrel-releasing intrauterine system, American Journal of Obstetrics and Gynecology, May 2003, Vol. 188, No. 5.
22. Wildemeersch D and Schacht E.  The effect on menstrual blood loss in women with uterine fibroids of a novel “frameless” intrauterine levonorgestrel-releasing drug delivery system:  A pilot study, European Journal of Obstetrics, Gynecology, and Reproductive Biology, April 2002; 102(1): 74-79.
23. Wildemeersch D and Schacht E.  Treatment of menorrhagia with a novel ‘frameless’ intrauterine levonorgestrel-releasing drug delivery system:  A pilot study, European Journal of Contraception and Reproductive Health Care, June 2001; 6(2): 93-101.
24. Wildemeersch D, et al.  Development of a miniature, low-dose, frameless intrauterine levonorgestrel-releasing system for contraception and treatment:  A review of initial clinical experience, Molecular Cancer Therapeutics, January 2002; 4(1): 71-82.
25. Xiao B, et al.  Therapeutic effects of the levonorgestrel-releasing intrauterine system in the treatment of idiopathic menorrhagia, Fertility and Sterility, April 2003; 79(4): 963-969.

POLICY HISTORY:

Medical Policy Group, October 2004 (3)

Medical Policy Administration Committee, October 2004

Available for comment November 24, 2004-January 7, 2005

Medical Policy Group, October 2007 (1)

Medical Policy Group, January 2009 (3)

Medical Policy Administration Committee, February 2009

Available for comment January 14-February 27, 2009

Medical Policy Group, October 2009 (3)

Medical Policy Administration Committee, October 2009

Medical Policy Group, January 2013 (1): Update to Key Points and References related to annual review process; no change in policy statement

Medical Policy Group, February 2016: 2016 Annual Coding Update.  Created Previous coding section and moved HCPCs code J7302 to this section.  Added HCPCs code J7298 to current coding.

Medical Policy Group, April 2016 (2): Update to Current coding; code J7298 updated to 5 year duration.

Medical Policy Group, September 2018 (4): Updates to Title, Key Points, Key Words, and References.  No policy statement change. Added Key Words IUS, menstrual bleeding, heavy menstrual bleeding. Added “for Heavy Menstrual Bleeding” to the title.

Medical Policy Group, April 2020 (4): Updates to Policy, Key Points, Coding, and References. Added clarification statement regarding other LNG-IUS devices are investigational. Removed Previous Coding Section- J7302 deleted 12/31/2015.

Medical Policy Group, August 2021 (4): Updates to References.  Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical policy Group, September 2022 (4): Reviewed by consensus.  Updates to Key Points and References.  No change to policy statements.

Medical Policy Group, September 2023 (4): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Key Points, Benefit Application, and References. No change to Policy Statement.

Medical Policy Group, September 2024 (4): Reviewed by consensus.  Updates to Description and Key Points.  No change to policy statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.