Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Intrauterine Systems (IUSs) (e.g., Mirena®, Skyla®, Liletta®, Kyleena®)
Policy #:MA07.025e

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


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

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

Intrauterine systems (IUSs) (e.g., Mirena®, Skyla®, Liletta®, Kyleena®) for contraceptive or non-contraceptive use are not covered by the Company because these items are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, Intrauterine systems (IUSs) (e.g., Mirena®, Skyla®, Liletta®, Kyleena®) for contraceptive or non-contraceptive use are not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because these items are considered not covered by Medicare.

Description

An intrauterine device (IUD) is a birth control device that is inserted into the uterus. An intrauterine system (IUS) is an intrauterine device (IUD) that slowly releases a hormone. The IUSs that are currently approved by the US Food and Drug Administration (FDA) are: Mirena®, Skyla®, Liletta® and Kyleena®.

MIRENA®

Mirena®, a levonorgestrel-releasing intrauterine system (LNG-IUS), was approved in 2000 by the FDA for the indication of intrauterine contraception for up to five years.

Mirena® consists of a T-shaped polyethylene frame (T-body) with a steroid reservoir (hormone elastomer core) around the vertical stem. The reservoir consists of a white or almost white cylinder, made of a mixture of levonorgestrel and silicone (polydimethylsiloxane), containing a total of 52 mg levonorgestrel. 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.

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 IUS approved by the FDA for this additional indication.

SKYLA®

Skyla® is a progestin-containing intrauterine system (IUS) approved by the FDA on January 9, 2013, for prevention of pregnancy for up to three years.

Skyla® consists of a T-shaped polyethylene frame with a steroid reservoir containing 13.5 mg levonorgestrel, a type of progestin. The release rate of levonorgestrel (LNG) is 14 mcg/day after 24 days and declines to 5 mcg/day after three years; Skyla® must be removed or replaced after 3 years.

LILETTA®

Liletta®, a levonorgestrel-releasing intrauterine system, was approved in 2015 by the FDA for prevention of pregnancy for up to three years. In 2019, it received FDA approval for prevention of pregnancy for up to 6 years.

Liletta® contains 52 mg of LNG. Initially, LNG is released at a rate of approximately 20 mcg/day. This rate decreases progressively to approximately 8.6 mcg/day after 6 years. The average in vivo release rate of LNG is approximately 14.3 mcg/day over a period of 6 years. Liletta® must be removed or replaced after 6 years.

KYLEENA®

Kyleena was approved by the FDA on September 16, 2016 for the prevention of pregnancy for up to 5 years.

Kyleena® contains 19.5 mg of LNG. Initially, LNG is released at a rate of 17.5 mcg/day. This rate decreases progressively to approximately 9.8 mcg/day at 1 year, and 7.4 mcg/day after 5 years after insertion. Kyleena® must be removed or replaced after 5 years.
References

Medicare Learning Network® (MLN) July 1, 2013. Available at: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM8286.pdf. Accessed March 02, 2020.

Medicines 360. Press release: FDA approves Medicine360's Liletta® (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to six years, the longest approved duration of use of any hormonal IUDs. 10/28/2019. Available at: https://www.medicines360.org/2019/10/28/fda-approves-medicines360s-liletta/ . Accessed on February 20, 2020.

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 March 02, 2020.

US Food and Drug Adminstration. (FDA). Labeling for Liletta® (levonorgestrel-releasing intrauterine system). 10/2019. [FDA Web site]. Available at: https://media.allergan.com/actavis/actavis/media/allergan-pdf-documents/product-prescribing/liletta_shi_pi.pdf. Accessed February 20, 2020.

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 March 02, 2020.

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 March 02, 2020.

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 March 02, 2020.

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


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)

N/A


HCPCS Level II Code Number(s)

NOT COVERED

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

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

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

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

S4981 Insertion of levonorgestrel-releasing intrauterine system



Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA07.025e
04/20/2020This version of the policy will become effective 04/20/2020. The intent of this policy remains unchanged, but the policy has been updated to reflect updated duration of use for Liletta®.

MA07.025d
03/27/2019This policy has undergone a routine review, and no revisions have been made.
02/15/2018This policy has undergone a routine review, and no revisions have been made.
01/01/2018This policy has undergone a code update. The following changes were made:

The following HCPCS code has been deleted from this policy: Q9984
The following HCPCS code has been added to this policy: J7296

MA07.025c
07/01/2017The following NOC code has been removed from this policy and is replaced by the following ICD-10 CM:

REMOVED: S4989: Contraceptive intrauterine device (e.g., Progestacert IUD), including implants and supplies

REPLACED WITH: Q9984: Levonorgestrel-releasing intrauterine contraceptive system, (Kyleena), 19.5 mg

MA07.025b
03/08/2017The intent of this policy remains unchanged, but the policy has been updated to include Kyleena®.

Title changed:

FROM:
Intrauterine Systems (IUSs) (e.g. Mirena®, Skyla®, Liletta®)

TO:
Intrauterine Systems (IUSs) (e.g. Mirena®, Skyla®, Liletta®, Kyleena®)

The following HCPCS code has been added to this policy:
S4989

MA07.025a
01/20/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on noncontraceptive uses of the levonorgestrel-releasing intrauterine system.
01/01/2016This version of the policy will become effective 01/01/2016.

The following HCPCS code has been termed from this policy: J7302 Levonorgestrel-releasing intrauterine contraceptive system, 52 mg.

The following HCPCS codes have been added to this policy: J7297 Levonorgestrel-releasing intrauterine contraceptive system, 52mg, 3 year duration (Noncovered) and J7298 Levonorgestrel-releasing intrauterine contraceptive system, 52 mg, 5 year duration (Noncovered).

MA07.025
01/07/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Intrauterine Systems (IUSs) (e.g., Mirena®, Skyla®).
01/01/2015This is a new policy.





Version Effective Date: 04/20/2020
Version Issued Date: 04/21/2020
Version Reissued Date: N/A