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Medical Policy

Policy Num:       04.001.024
Policy Name:    SERVICES FOR INTRA-UTERINE DEVICE MANAGEMENT
Policy ID:          [04.001.024]     [Ac / L / M+ / P+ ]  [0.00.00]

Last Review:       November 9, 2022
                            ARCHIVED 
 

Related Policies:  4.02.03 Birth Control

SERVICES FOR INTRA-UTERINE DEVICE MANAGEMENT

Summary

The intrauterine device (IUD) is the most commonly used method of long-acting reversible contraception because of its high efficacy, safety, ease of use, and cost effectiveness. It provides a nonsurgical option for pregnancy prevention that is as effective as surgical sterilization without the risk of surgery. The most frequently used intrauterine devices have a plastic frame and release either copper or a progestin to enhance the contraceptive action of the device.

Several terms are used to describe IUDs, including IUD and intrauterine contraception; the hormonal IUD or progestin-containing device is also referred to as an intrauterine system. 

Types of IUDs — Two types of IUDs are available in the United States, copper containing and levonorgestrel releasing:

●Copper IUD – The copper IUD is a T-shaped device which contains 380 mm² copper (abbreviated TCu380A, commercial name ParaGard) . It is approved by the US Food and Drug Administration (FDA) for 10 years of use. There are other copper-containing IUDs, but none are currently FDA approved for use in the United States. 

●Levonorgestrel IUDs – The levonorgestrel IUDs are T-shaped devices that release levonorgestrel (LNg). There are four FDA-approved LNg IUDs available in the United States, which release a varying amount of LNg. The LNg-releasing IUDs are available in three different formulations in the United States. Four levonorgestrel IUD are FDA approved in the US: A 52 mg LNg IUD (Mierena IUD 52/5/Liletta IUD 52/5), a 19.5 mg LNg IUD (Kyleena IUD 19.5/5 ), and a 13.5 mg LNg IUD (Skyla IUD 13.5/3).

Objective

The objective is to evaluate the efficacy, safety and acceptability of Intrauterine devices as a long-acting reversible contraception.

Policy Statements

Intrauterine devices are considered medically necessary in the prevention of pregnancy.

Policy Guidelines

The TCu380A is approved by the US Food and Drug Administration (FDA) to remain in place for 10 years; this may vary elsewhere. However, some clinicians use the TCu380A for more than 10 years before exchanging it for a new IUD. The use of the TCu380A beyond 10 years is supported by several studies. In two studies of 314 women who used the TCu380A for an additional two years (10 to 12 years from insertion), no pregnancies were reported [59,60].  Additionally, no pregnancies were reported in the subgroup of eight women who used the device for up to 16 years.

Noncontraceptive benefits — Noncontraceptive benefits of the copper IUDs include continued menstrual cyclicity, reduced risk of cervical cancer, and possibly a reduction in endometrial cancer

The Liletta LNg 52/5 IUDs are approved for up to five years of use by the FDA,  the Mirena is also approved for up to five years. After five years of use, the LNg 52/5 releases approximately double the amount of levonorgestrel as the LNg 13.5/3 IUD releases after three years, which suggests that both the LNg 52/5 IUDs can be used beyond five years.

Evidence also supports extended use of the LNg 52/5 IUDs beyond five years. In a prospective cohort study of nearly 500 women with extended use of one of the LNg 52/5 IUDs, two pregnancies were reported during the two year extended observation, for six- and seven-year cumulative failure rates of 0.25 and 0.43 per 100 woman-years. A different chart review of 766 women who used the LNg 52/5 beyond five years reported no pregnancies after a mean of 73 months of use (range 61 to 184 months) .

Because the data on extended use of the LNg 52/5 IUD are limited, we offer extended use for one additional year up to 6 years of use. Based on current data, neither LNg 52/5 IUD should not be used for more than seven years. The LNg 19.5/5 and 13.5/3 have a lower LNg dose and there is no evidence supporting extended use of these IUDs .

Noncontraceptive benefits — Noncontraceptive benefits of 52 mg LNg IUDs include reduction in menorrhagia, anemia, dysmenorrhea, endometriosis-related pain, endometrial hyperplasia, pelvic inflammatory disease, and cervical cancer. The use of the LNg 52/5 IUD for treatment of heavy menstrual bleeding is FDA approved. Use of the LNg 52/5 is not currently approved for this indication, although, given the similarity of bleeding patterns between the two devices, it appears likely to have a similar effect. Use of 52 mg LNg IUDs for these other noncontraceptive indications is off-label but a common practice that is supported by strong medical evidence. There is also a reduction in the risk of endometrial cancer and ovarian cancer with LNg IUDs. One analysis of LNg IUD users found the standardized incidence ratio for endometrial adenocarcinoma was 0.50 (95% CI 0.35-0.70) after the first LNg IUD, and the standardized incidence ratio for ovarian cancer was 0.60 (95% CI 0.45-0.76) compared with the general population [88]. There is minimal information on the noncontraceptive benefits of the LNg 19.5/5 and 13.5/3 IUDs.

Benefit Application

BlueCard/National Account Issues

Contracts and certificates of coverage vary widely in relation to coverage for birth control. Birth control can be a separate benefit to include family planning, counseling, prescriptions, and devices, or the benefit may include the office visit for prescriptions and devices only. Some contracts exclude benefits for all methods of birth control as not related to an illness or injury. Some contracts may just provide coverage for family planning and counseling. Other contracts may provide benefits under the Prescription Drug benefit for oral contraceptives and diaphragms, but do not cover subcutaneous implants, which they consider to be devices. Any over-the-counter methods or supplies for birth control are not covered. The exam for methods of birth control or fittings for birth control devices may be covered, depending on contracts. Still other contracts provide benefits for sterilization but do not provide benefits for other methods of birth control. Contracts also vary in coverage for abortions and reversal of sterilization. Reversal of sterilization is a routine exclusion. Contracts vary in coverage for the insertion and/or removal of IUDs and the Norplant® system. Consideration may be given to cover the removal of either, if their use results in complications. When benefits are provided for the insertion of IUDs or cervical caps, these services are generally considered to be part of the office visit and not adjudicated separately. Complications related to the use of birth control may be eligible for coverage under the appropriate Medical/Surgical benefit. Plans may wish to review their contract language on methods of birth control to ensure that the contract language is consistent with the Plan’s medical policy on birth control.

Background

The IUD is the most commonly used method of reversible contraception worldwide and is used by an average of 23 percent of female contraceptive users, with

a range of <2 to >40 percent depending on the country. In 2014, IUDs were used by 27 percent of female contraceptive users in Asia and 17 percent of female

contraceptive users in Europe. Use of IUDs has increased in the United States (US): In the decade from 2002 to 2012, IUD use rose from 2 to 10 percent

among US women using contraception. Actively informing women about benefits, risks, and common side effects of IUDs appears to improve consideration

and acceptance of the method.

Types of IUDs — Two types of IUDs are available in the US, copper containing and levonorgestrel releasing:

●Copper IUD – The copper IUD is a T-shaped device which contains 380 mm² copper (abbreviated TCu380A, commercial name ParaGard). The US

Food and Drug Administration FDA) approve it for 10 years of use. There are other copper-containing IUDs, but none are currently FDA approved for

use in the US.

●Levonorgestrel IUDs – The levonorgestrel IUDs are T-shaped devices that release levonorgestrel (LNg). There are four FDA-approved LNg IUDs

available in the US, which release a varying amount of LNg 

Multiple other IUD types and shapes have been used globally.

Mechanism of action — Multiple mechanisms appear to contribute to the contraceptive action of IUDs. Pregnancy appears to be prevented by a foreign body

effect induced by the IUD frame and by local changes caused by the released medication. When the uterus is exposed to a foreign body, a sterile inflammatory

reaction occurs, which is toxic to sperm and ova and impairs implantation. The production of cytotoxic peptides and activation of enzymes lead to inhibition of

sperm motility, reduced sperm capacitation and survival, and sperm phagocytosis. These cytotoxic effects are supported by studies in which fallopian tubes of

IUD users were flushed but no sperm or fertilized ova were found. Additional studies of IUD users were unable to find embryos or detect human chorionic

gonadotropin, indicating that transient, or chemical, pregnancies were not occurring

●Copper IUD – The addition of copper provides further contraceptive benefits. Copper enhances the cytotoxic inflammatory response within the

endometrium; impairs sperm migration, viability, and acrosomal reaction; and impairs implantation.

●Levonorgestrel IUDs – The addition of LNg provides further contraceptive benefits. Progestins thicken cervical mucus, which acts as a barrier to the

upper genital tract, causing endometrial decidualization and glandular atrophy that impairs implantation and may inhibit the binding of the sperm and

egg by increasing glycodelin A production.

Interruption of ovulation is not a major mechanism of IUDs. Copper IUDs have no impact on ovulation. For LNg IUDs, ovulation rates vary based upon the initial

progestin dose and then increase as the progestin level falls over time. Most cycles are ovulatory. In clinical trials evaluating ovulation during the first year of

IUD use, 45 percent of cycles were ovulatory for women using 52 mg LNg IUDs while 88 to 97 percent of cycles were ovulatory for lower-dose IUDs.

There is no evidence that IUDs disrupt an implanted pregnancy [31].

Regulatory Status

N/A

Rationale

There are multiple benefits of IUD use for women:

●Highly effective pregnancy prevention (>99 percent)

●Does not require regular adherence from user to maintain high effectiveness.

●Long acting.

●Rapidly reversible.

●Few medical contraindications for most women, including teens and nulliparous women

●Few side effects.

●Private and does not interfere with the spontaneity of sex.

●Avoidance of exogenous estrogen (both IUD types) and hormones (copper IUD only).

●Reduced costs with long-term use.

●Reduced risk of cervical cancer – A meta-analysis of 16 studies assessing the incidence of cervical cancer in IUD users reported that women with any history

of IUD use were approximately 30 percent less likely to develop cervical cancer (summary odds ratio 0.64, 95% CI 0.53-0.77) [32]. The proposed mechanism is an altered immune response resulting from device insertion and presence [33,34]. This finding may be particularly relevant for women who have not received

the human papillomavirus vaccine or who have limited access to cervical cancer screening. It is not yet known if the type of device further influences the reduction in cervical cancer risk.

Population Reference No. 1 Policy Statement

Individuals in need of long term contraception. Interventions of interest are intrauterine device contraception. Comparators of interest are other contraceptive methods. Relevant outcomes are benefits, cost effectiveness.

Supplemental Information

N/A

Practice Guidelines and Position Statements

American College of Obstetricians and Gynecologists

American College of Obstetricians and Gynecologists recommends the following strategies to reduce barriers and increase access to implants and IUDs (ie,

long-acting reversible contraception [LARC] methods):

• For all women at risk of unintended pregnancy, obstetrician–gynecologists should provide counseling on all contraceptive options, including implants and IUDs. Encourage consideration of implants and IUDs for all appropriate candidates, including nulliparous women and adolescents.
• Adopt best practices for LARC insertion.
• Advocate for coverage and appropriate payment and reimbursement for every contraceptive method by all payers in all clinically appropriate circumstances.

Become familiar with and support local, state (including Medicaid), federal, and private programs that improve affordability of all contraceptive methods

Medicare National Coverage

N/A

References

1. ACOG LARC Practice-Bulletins Number 186, Nov 2017, updated 3/5/2019

2 Package insert FDA Mirena, Kyleena, skyla 2019

3. UpToDate  Intrauterine contraception: Background and device types Author: Tessa Madden, MD, MPH Section Editor: Courtney A Schreiber, MD, MPH Deputy Editor: Kristen Eckler, MD,FACOG

Codes

Applicable Modifiers

N/A

Policy History