Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Noncontraceptive Use of the Levonorgestrel-Releasing Intrauterine System

Policy #:07.10.05k

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin 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 Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Insertion and use of the 52 mg levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena®) for noncontraceptive use is considered medically necessary and, therefore, covered for either of the following:
  • As an alternative to hysterectomy in an individual who has excessive or irregular bleeding that necessitates an alteration in lifestyle, defined as one of the following:
    • Idiopathic menorrhagia: excessively heavy, regular menses in the absence of intracavitary pathology or coagulopathy
    • 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 women who are under 65 years of age and currently receiving menopausal estrogen therapy

In addition, both of the following criteria must be met for all individuals in order to receive the LNG-IUS (Mirena®) for noncontraceptive use:
  • Attempted prior treatment with standard medical therapies (i.e., oral contraceptives, oral progesterone) has failed, was medically contraindicated, or was not tolerated by the individual.
  • All of the following have been ruled out:
    • Endometrial and cervical pathology
    • A coagulopathy problem
    • The use of medications or supplements that could promote bleeding
    • Any other pertinent medical conditions that could cause bleeding (e.g., thyroid disease)

Removal of the LNG-IUS (Mirena®) is considered medically necessary and, therefore, covered for any of the following indications:
  • Complications related to the LNG-IUS (Mirena®) such as, but not limited to:
    • Infection
    • Migration of the device
    • Inflammatory reaction
    • Bleeding of unknown etiology
  • Pregnancy
  • End of FDA-approved effectiveness period

All other uses for the LNG-IUS (Mirena®) are considered a benefit contract exclusion and, therefore, not covered or eligible for reimbursement, unless the individual has a contraceptive benefit.

EXPERIMENTAL/INVESTIGATIONAL

Insertion and use of the 13.5 mg LNG-IUS (Skyla®) for noncontraceptive use is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Insertion and use of the 19.5 mg LNG-IUS (Kyleena®) for noncontraceptive use is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Insertion and use of the 52 mg LNG-IUS (Liletta®) for noncontraceptive use is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

ABSOLUTE CONTRAINDICATIONS

LNG-IUS (Mirena®) for noncontraceptive use is considered not medically necessary and, therefore, not covered for individuals with any of the following absolute contraindications:
  • Pregnancy or suspicion of pregnancy
  • Congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity
  • Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy
  • Postpartum endometritis or infected abortion in the past three months
  • Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear
  • Genital bleeding of unknown etiology (which has been appropriately evaluated)
  • Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infection until infection is controlled
  • Acute liver disease or liver tumor (benign or malignant)
  • Conditions associated with increased susceptibility to pelvic infections
  • A previously inserted intrauterine device (IUD) that has not been removed
  • Hypersensitivity to any component of this product
  • Known or suspected carcinoma of the breast

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, the levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena®) for noncontraceptive use is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, when LNG-IUS (Mirena®) for noncontraceptive use is given to an individual who has any of the absolute contraindications listed in the policy, it is considered not medically necessary and, therefore, not covered.

Services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

MIRENA®
Mirena®, an LNG-IUS containing 52 mg of levonorgestrel, was approved by the FDA on December 6, 2000, for intrauterine contraception.

The FDA labeling supports the continued use of the system for up to five years. Thereafter, if continued use is desired, the system should be replaced.

In July 2008, the FDA approved safety labeling revisions for a long-acting LNG-IUS (Mirena®) (Bayer HealthCare Pharmaceuticals, Inc.; Leverkusen, Germany) to provide updated information regarding the risks for ectopic pregnancy, sepsis, perforation, ovarian cysts, and breast cancer. Women who become pregnant while using the device should be evaluated for ectopic pregnancy. According to the FDA, up to 50 percent of pregnancies that occur with the device in place are ectopic. Although ectopic pregnancy occurred in only 0.1 percent of women with no risk factors in clinical trials, the incidence rate may be increased in those with a previous history of its occurrence, tubal surgery, or pelvic infection.

On October 1, 2009, the FDA approved Mirena® (LNG-IUS) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention.

SKYLA®
Skyla®, an LNG-IUS containing 13.5 mg of levonorgestrel, was approved by the FDA on January 9, 2013 for the prevention of pregnancy for up to 3 years.

Skyla has not been approved by the FDA for non-contraceptive use.

LILETTA®
Liletta® an LNG-IUS containing 52 mg of levonorgestrel, was approved by the FDA on February 26, 2015 for the prevention of pregnancy for up to 3 years.

Liletta has not been approved by the FDA for non-contraceptive use.

KYLEENA®
KYLEENA®, an LNG-IUS containing 19.5 mg of levonorgestrel, was approved by the FDA on September 16, 2016 for the prevention of pregnancy for up to 5 years.

Kyleena has not been approved by the FDA for non-contraceptive use.
Description

LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM

CONTRACEPTIVE AND NONCONTRACEPTIVE USE: MIRENA®
An intrauterine device (IUD) is a birth control device that is inserted into the uterus. An intrauterine system (IUS) is an IUD that slowly releases a hormone. Mirena® is a levonorgestrel-releasing intrauterine system (LNG-IUS). The LNG-IUS consists of a "T"-shaped polyethylene frame with a steroid reservoir. The reservoir consists of a white cylinder, made of a mixture containing 52 mg of levonorgestrel (a progestogen) and silicone. Levonorgestrel is released into the uterine cavity through the intrauterine delivery system. Initially, levonorgestrel is released at a rate of approximately 20 mcg/day. Although the rate decreases progressively over the years, the hormone levels from the device remain high enough to make it an effective contraceptive. The insertion of the LNG-IUS is a simple office procedure.

Mirena®, an LNG-IUS containing 52 mg of levonorgestrel, was approved in 2000 by the US Food and Drug Administration (FDA) for the indication of intrauterine contraception for up to five years.

On October 1, 2009, the FDA approved Mirena® to treat heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of pregnancy prevention. Mirena® is the only IUD approved by the FDA for this additional indication.

CONTRACEPTIVE USE: SKYLA®, LILETTA® AND KYLEENA®
Skyla®, an LNG-IUS containing 13.5 mg of levonorgestrel, was approved by the FDA on January 9, 2013 for the prevention of pregnancy for up to 3 years.

Liletta®, an LNG-IUS containing 52 mg of levonorgestrel, was approved by the FDA on February 26, 2015 for the prevention of pregnancy for up to 3 years.

Kyleena , an LNG-IUS containing 19.5 mg of levonorgestrel, was approved by the FDA on September 16, 2016 for the prevention of pregnancy for up to 5 years.

ABNORMAL UTERINE BLEEDING
Abnormal uterine bleeding is defined as bleeding that occurs between menstrual periods or excessive menstrual bleeding. Any significant change in a female’s menstrual pattern or amount of bleeding should be investigated. Abnormal uterine bleeding can be developmental or endocrinologic in nature; it can also be caused by factors such as acquired anatomic lesions (e.g., fibroids or polyps), congenital or acquired coagulopathy, infections, pregnancy, or cancer.

Menorrhagia is defined as menstrual bleeding that is excessive in both amount and duration; it occurs at regular intervals. When excessive menstrual bleeding occurs at irregular intervals, it is referred to as menometrorrhagia. For some women, the only way to treat excessive menstrual bleeding is a hysterectomy.

Any female who has excessive menstrual bleeding should have a thorough evaluation (history and physical) after the possibility of a pregnancy has been eliminated. Based on the findings of the history and exam, the appropriate diagnostic tests should be ordered. These may include pelvic ultrasonography, endometrial biopsy, and serum lab tests (eg, thyroid-stimulating hormone [TSH], complete blood count [CBC]).

POST-MENOPAUSAL ENDOMETRIAL HYPERPLASIA
Endometrial hyperplasia occurs when the endometrium (the lining of the uterus) does not shed and becomes too thick. If the lining does not shed, the cells can become abnormal and lead to cancer. Endometrial hyperplasia is most often caused by excess estrogen without progesterone. Estrogen replacement therapy is prescribed to relieve symptoms of menopause and slow bone loss after menopause. Progestins keep the lining of the uterus from growing too thick. Progestins can be administered in many ways, including the LNG-IUS. The use of the LNG-IUS to prevent post-menopausal endometrial hyperplasia represents an off-label indication.

MECHANISM OF ACTION
The LNG-IUS is used to control heavy menstrual bleeding and prevent post-menopausal endometrial hyperplasia because of the local progestogenic effects in the uterine cavity. Specifically, the higher local levels of levonorgestrel lead to thinning of the uterine lining by altering the connective tissue of the lining, reducing the size of the glands, and decreasing cell division. These effects may cause vaginal bleeding in menopausal women like a menstrual period.

COMPLICATIONS
The most common side effects of the device include irregular bleeding and other hormonal side effects such as breast tenderness, mood changes, ovarian cysts, headaches/migraines, and acne. Other potential disadvantages can include abdominal pain, infection, and difficulty with insertion. Also, there have been reports to the FDA regarding device migration and potential for perforation of surrounding organs and tissue.

CLINICAL RESEARCH FINDINGS
Several randomized controlled trials were performed to address the noncontraceptive use of the 52 mg LNG-IUS (Mirena®) with other treatments. These studies included comparison with norethindrone (a progestogen found in some oral contraceptive pills and a mainstay of oral therapy for menorrhagia as norethindrone acetate, marketed as Aygestin) and transcervical resection of the endometrium (TCRE) for women with menorrhagia. Meta-analysis revealed that the LNG-IUS can be significantly more effective than oral cyclical norethindrone as a treatment for heavy menstrual bleeding. The LNG-IUS was also compared to TCRE or endometrial ablation. Although the use of the LNG-IUS resulted in a smaller mean reduction of menstrual blood loss at one year, the rates of patient satisfaction at one year were similar in both groups.

A randomized study, which took place between October 1, 1994, and October 6, 2002, involved 236 women with an average age of 43 years who had menorrhagia. Participants were randomly assigned to treatments of either the LNG-IUS (Mirena®) (n=119) or a hysterectomy (n=117). Health-related quality of life (HRQL) and other measures of psychosocial well-being (i.e., anxiety, depression, sexual function) and costs were monitored. After five years, outcomes for 232 women (99 percent) were analyzed. There were 50 women from the LNG-IUS group who eventually underwent a hysterectomy. There remained no substantial difference in quality of life and psychosocial well-being between the groups.

Another trial that compared endometrial ablation to the LNG-IUS (Mirena®) revealed a blood loss reduction of 79 percent in the group using the LNG-IUS, versus 89 percent in the group that underwent endometrial ablation.

Additional studies involving women with a diagnosis of idiopathic menorrhagia (defined as excessively heavy, regular menses in the absence of intracavitary pathology or coagulopathy) revealed that the LNG-IUS (Mirena®) appears to significantly reduce menstrual blood loss.

In addition to treating menorrhagia, the 52 mg LNG-IUS (20µg/day) has been found comparable to systemic progesterone use in the prevention of endometrial proliferation in perimenopausal and postmenopausal women receiving menopausal estrogen therapy.

The National Guideline Clearinghouse, as a Grade A (evidence based on randomized controlled trials) and the American College of Obstetricians and Gynecologists (ACOG) both support the use of LNG-IUS
(Mirena®) for treating menorrhagia and for women receiving menopausal estrogen therapy who may use the device to provide protection against hyperplasia and malignancy.

In summary, there is sufficient evidence supporting the use of a 52 mg LNG-IUS (Mirena®) as a treatment option for idiopathic menorrhagia, and as a protection against endometrial hyperplasia in women who are receiving menopausal estrogen therapy. Currently, there are no studies supporting off-label use of the 13.5 mg or the 52 mg LNG-IUS with three year approvals for contraception only.

Additional research is recommended for the use of the LNG-IUS for the indications of endometriosis-associated pelvic pain, adenomyosis, dysmenorrhea, endometrial hyperplasia, uterine fibroids, or endometrioid uterine adenocarcinoma, or as adjuvant therapy with tamoxifen to prevent endometrial carcinoma, a known side effect of tamoxifen therapy.
References

Abou-Setta AM, Houston B, Al-Inany HG, et al. Levonorgestrel-releasing intrauterine device (LNG-IUD) for symptomatic endometriosis following surgery. Cochrane Database Syst Rev. 2013;1:CD005072.


Adeyemi-Fowode OA, Santos XM, Dietrich JE, et al. Levonorgestrel-Releasing Intra-Uterine Device Use in Adolescent Females with Heavy Menstrual Bleeding and Bleeding Disorders: Single Institution Review. J Pediatr Adolesc Gynecol. 2016;pii: S1083-3188(16)30008-0.

American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin No. 186 Summary: Long-Acting Reversible Contraception Implants and Intrauterine Devices. Obstet Gynecol. 2017;130(5):e251-e269.

American College of Obstetricians and Gynecologists. Committee Opinion No. 631. Endometrial intraepithelial neoplasia. Obstet Gynecol. 2015;125:1272-8. (Reaffirmed 2017).

American College of Obstetricians and Gynecologists (ACOG). Intrauterine device. Practice Bulletin #59, ACOG, Washington DC. January: 2005. (Reaffirmed: 2007; replaced by Practice Bulletin 121).

American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin No. 121: Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Obstet Gynecol. 2011;118:184–95. (Reaffirmed 2015; replaced by Practice Bulletin 186).

American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin No. 110: noncontraceptive uses of hormonal contraceptives. Obstet Gynecol. 2010;115(1):206-18. (Reaffirmed: 2016).

Buttini MJ, Jordan SJ, Webb PM. The effect of the levonorgestrel releasing intrauterine system on endometrial hyperplasia: an Australian study and systematic review. Aust N Z J Obstet Gynaecol. 2009;49(3):316-22.

Chin J, Konje JC, Hickey M. Levonorgestrel intrauterine system for endometrial protection in women with breast cancer on adjuvant tamoxifen. Cochrane Database Syst Rev. 2009;(4):CD007245.

Dominick S, Hickey M, Chin J, et al. Levonorgestrel intrauterine system for endometrial protection in women with breast cancer on adjuvant tamoxifen. Cochrane Database Syst Rev.2015;12: CD007245.

El Behery MM, Saleh HS, Ibrahiem MA, et al. Levonorgestrel-releasing intrauterine device versus dydrogesterone for management of endometrial hyperplasia without atypia. Reprod Sci. 2015;22(3):329-34.

Furness S, Roberts H, Marjoribanks J, et al. Hormone therapy in postmenopausal women and risk of endometrial hyperplasia. Cochrane Database Syst Rev. 2012;8:CD000402.

Gupta J, Kai J, Middleton L, et al.; ECLIPSE Trial Collaborative Group. Levonorgestrel intrauterine system versus medical therapy for menorrhagia. N Engl J Med. 2013;368(2):128-37.

Hammond CB, Riddick DH. Menstruation and disorders of menstrual function. In: Scott JR, Di Saia PJ, Hammond CB, Spellacy WN, eds. Danforth's Obstetrics & Gynecology. 8th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 1999: 601-614.

Heliövaara-Peippo S, Hurskainen R, Teperi J, et al. Quality of life and costs of levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of menorrhagia: a 10-year randomized controlled trial. Am J Obstet Gynecol. 2013;209(6):535.e1-535.e14.

Hurskainen R, Teperi J, Rissanen P, et al. Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: randomized trial 5-year follow-up. JAMA. 2004;291(12):1456-1463.

Irvine GA, Campbell-Brown MB, Lumsden MA, et al. Randomised comparative trial of the levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia. Br J Obstet Gynaecol. 1998;105(6):592-598.

Lee KH, Kim JK, Lee MA, et al. Relationship between uterine volume and discontinuation of treatment with levonorgestrel-releasing intrauterine devices in patients with adenomyosis. Arch Gynecol Obstet. 2016;294(3):561-6.

Lethaby A, Hussain M, Rishworth JR, et al. Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding. Cochrane Database Syst Rev. 2015;4:CD002126.

Luo L, Luo B, Zheng Y, et al. Levonorgestrel-releasing intrauterine system for atypical endometrial hyperplasia. Cochrane Database Syst Rev. 2013;6:CD009458.

Macchia G, Deodato F, Cilla S, et al. Progestin-releasing intrauterine device insertion plus palliative radiotherapy in frail, elderly uterine cancer patients unfit for radical treatment. Oncol Lett. 2016;11(5):3446-3450.

Marjoribanks J, Lethaby A, Farquhar C. Surgery versus medical therapy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2016;1: CD003855.

Sangkomkamhang US, Lumbiganon P, Laopaiboon M, et al. Progestogens or progestogen-releasing intrauterine systems for uterine fibroids. Cochrane Database Syst Rev. 2013;2:CD008994.

Silva-Filho AL, Pereira Fde A, de Souza SS, et al. Five-year follow-up of levonorgestrel-releasing intrauterine system versus thermal balloon ablation for the treatment of heavy menstrual bleeding: a randomized controlled trial. Contraception. 2013;87(4):409-15.

Somboonporn W, Panna S, Temtanakitpaisan T, et al. Effects of the levonorgestrel-releasing intrauterine system plus estrogen therapy in perimenopausal and postmenopausal women: systematic review and meta-analysis. Menopause. 2011;18(10):1060-6.

Theodoridis TD, Zepiridis L, Zafrakas M, et al. Levonorgestrel-releasing intrauterine system vs. endometrial thermal ablation for menorrhagia. Hormones (Athens).2009;8(1):60-64.

US Food and Drug Administration (FDA). FDA news release. FDA approves additional use for IUD Mirena to treat heavy menstrual bleeding in IUD users - Archived Content. [FDA Web site]. 10/01/09. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm184747.htm. [The link to this reference is no longer active on the FDA Web site.]. Accessed October 4, 2016.

US Food and Drug Administration. (FDA). Labeling for Kyleena® (levonorgestrel-releasing intrauterine system). 09/19/2016 [FDA Web site]. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208224s000lbl.pdf. Accessed January 9, 2018.

US Food and Drug Adminstration. (FDA). Labeling for Liletta® (levonorgestrel-releasing intrauterine system). 02/2015. [FDA Web site]. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206229s000lbl.pdf. Accessed January 9, 2018.

US Food and Drug Administration. (FDA). Labeling for Mirena® (levonorgestrel-releasing intrauterine system). Revised 6/2017. [FDA Web site]. Available at:
http://labeling.bayerhealthcare.com/html/products/pi/Mirena_PI.pdf. Accessed January 9, 2018.

US Food and Drug Adminstration. (FDA). Labeling for Skyla® (levonorgestrel-releasing intrauterine system). Revised 12/2016 [FDA Web site]. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203159s008lbl.pdf. Accessed January 9, 2018.

US Food and Drug Administration (FDA). Safety information. Mirena® (levonorgestrel-releasing intrauterine system). Detailed view: Safety labeling changes approved by FDA Center for Drug Evaluation and Research (CDER) -- July 2008. [FDA Web site]. 06/19/2009. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm121936.htm. [The link to this reference is no longer active on the FDA Web site.]. Accessed October 4, 2016.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

58300, 58301


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY


THE FOLLOWING CODES ARE USED TO REPRESENT THE INSERTION (58300) OF THE LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM (MIRENA®) (J7298, S4981):

N92.0 Excessive and frequent menstruation with regular cycle

N92.1 Excessive and frequent menstruation with irregular cycle

N92.4 Excessive bleeding in the premenopausal period

Z79.890 Hormone replacement therapy

THE FOLLOWING CODES ARE USED TO REPRESENT THE REMOVAL (58301) OF THE LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM (MIRENA®):

T83.31xA Breakdown (mechanical) of intrauterine contraceptive device, initial encounter

T83.31xD Breakdown (mechanical) of intrauterine contraceptive device, subsequent encounter

T83.31xS Breakdown (mechanical) of intrauterine contraceptive device, sequela

T83.32xA Displacement of intrauterine contraceptive device, initial encounter

T83.32xD Displacement of intrauterine contraceptive device, subsequent encounter

T83.32xS Displacement of intrauterine contraceptive device, sequela

T83.39xA Other mechanical complication of intrauterine contraceptive device, initial encounter

T83.39xD Other mechanical complication of intrauterine contraceptive device, subsequent encounter

T83.39xS Other mechanical complication of intrauterine contraceptive device, sequela

T83.69XA Infection and inflammatory reaction due to other prosthetic device, implant and graft in genital tract, initial encounter

T83.69XD Infection and inflammatory reaction due to other prosthetic device, implant and graft in genital tract, subsequent encounter

T83.69XS Infection and inflammatory reaction due to other prosthetic device, implant and graft in genital tract, sequela

T83.81xA Embolism due to genitourinary prosthetic devices, implants and grafts, initial encounter

T83.81xD Embolism due to genitourinary prosthetic devices, implants and grafts, subsequent encounter

T83.81xS Embolism due to genitourinary prosthetic devices, implants and grafts, sequela

T83.82xA Fibrosis due to genitourinary prosthetic devices, implants and grafts, initial encounter

T83.82xD Fibrosis due to genitourinary prosthetic devices, implants and grafts, subsequent encounter

T83.82xS Fibrosis due to genitourinary prosthetic devices, implants and grafts, sequela

T83.83xA Hemorrhage due to genitourinary prosthetic devices, implants and grafts, initial encounter

T83.83xD Hemorrhage due to genitourinary prosthetic devices, implants and grafts, subsequent encounter

T83.83xS Hemorrhage due to genitourinary prosthetic devices, implants and grafts, sequela

T83.84xA Pain due to genitourinary prosthetic devices, implants and grafts, initial encounter

T83.84XD: Pain due to genitourinary prosthetic devices, implants and grafts, subsequent encounter

T83.84XS: Pain due to genitourinary prosthetic devices, implants and grafts, sequela

T83.86xA Thrombosis due togenitourinary prosthetic devices, implants and grafts, initial encounter

T83.86xD Thrombosis due to genitourinary prosthetic devices, implants and grafts, subsequent encounter

T83.86xS Thrombosis due to genitourinary prosthetic devices, implants and grafts, sequela

T83.89xA Other specified complication of genitourinary prosthetic devices, implants and grafts, initial encounter

T83.89xD Other specified complication of genitourinary prosthetic devices, implants and grafts, subsequent encounter

T83.89xS Other specified complication of genitourinary prosthetic devices, implants and grafts, sequela

T83.9xxA Unspecified complication of genitourinary prosthetic device, implant and graft, initial encounter

Z33.1 Pregnant state, incidental



HCPCS Level II Code Number(s)

MEDICALLY NECESSARY


J7298 Levonorgestrel-releasing intrauterine contraceptive system (Mirena), 52 mg

S4981 Insertion of levonorgestrel-releasing intrauterine system


EXPERIMENTAL/INVESTIGATIONAL FOR NON-CONTRACEPTIVE USE

J7296 Levonorgestrel-releasing intrauterine contraceptive system, (Kyleena), 19.5 mg

J7297 Levonorgestrel-releasing intrauterine contraceptive system (Liletta), 52 mg

J7301 Levonorgestrel-releasing intrauterine contraceptive system (Skyla), 13.5 mg



Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

Revisions from 07.10.05k
02/15/2018This policy has undergone a routine review, and no revisions have been made.
Version Effective Date: 01/01/2018
Version Issued Date: 12/29/2017
Version Reissued Date: 02/15/2018

Connect with Us        


© 2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.