Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Deoxycholic Acid (Kybella™)
Policy #:MA08.074

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.

COSMETIC SERVICES

Deoxycholic acid (Kybella) is not covered by the Company because cosmetic services are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.
Policy Guidelines

There is no Medicare coverage determination addressing deoxycholic acid (Kybella); therefore, the Company policy is applicable.

BENEFIT APPLICATION

Services that are cosmetic are excluded for the Company’s Medicare Advantage products because they are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Deoxycholic acid (Kybella) was approved by the FDA on April 29, 2015 for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. The safety and effectiveness of deoxycholic acid (Kybella™) in the pediatric population have not been established and is not intended for use in children or adolescents.

Description

Loss of definition in the submental region is commonly referred to as "double-chin." This condition may be associated with looking older or overweight; therefore an individual may be self-conscious and have low self-esteem and discomfort.

Surgical procedures to reduce neck fullness, including liposuction and neck lifts, are invasive techniques that require the use of anesthesia and a qualified staff, and incur significant operating room costs. Surgery may be associated with complications such as aesthetic deformity and long recovery times, and, thus, not all individuals are candidates for surgery.

Research has been done on deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat. A synthetic version, known as deoxycholic acid (Kybella), was developed and subsequently approved by the US Food and Drug Administration (FDA) on April 29, 2015 for use in improving the appearance of moderate to severe convexity or fullness associated with submental fat (double-chin) in adults. Deoxycholic acid (Kybella) works by destroying the cell membrane of fat cells in the area under the chin.

The safety and effectiveness of deoxycholic acid (Kybella) have only been established for use in the submental region and have NOT been established for use outside the submental region; use outside the submental region, therefore, is not recommended.

PEER-REVIEWED LITERATURE

SUMMARY
The safety and effectiveness of deoxycholic acid (Kybella) were evaluated in two randomized, multi-center, double-blind, placebo-controlled trials for use in improving the appearance of moderate or severe convexity or fullness associated with submental fat in adults. The severity of convexity was rated by the clinician and the participant on a 5-point grading scale, where 0 = no submental convexity and 4 = extreme submental convexity. Participants were administered up to 6 subcutaneous treatments with deoxycholic acid (Kybella) (N=514, combined trials) or placebo (N=508, combined trials) at no less than 1-month intervals; 59% of participants received all 6 treatments. For each treatment, a maximum of 100 mg (10 ml) was injected into the submental region.

Twelve weeks after the final treatment, reductions in submental fat volume were observed more frequently in the deoxycholic acid (Kybella) group compared to the placebo group, as measured by the composite clinician and participant ratings. Magnetic resonance imaging (MRI) showed a greater change in submental fat volume in deoxycholic acid (Kybella) group, as compared to placebo. A participant-reported survey showed a greater improvement in the deoxycholic acid (Kybella) group when compared to placebo in the visual and emotional impacts of submental fat (happy, bothered, self-conscious, embarrassed, looking older or overweight).

COSMETIC SERVICES

Cosmetic services are those provided to improve an individual's physical appearance, from which no significant improvement in physiologic function can be expected. Emotional and/or psychological improvement alone does not constitute improvement in physiologic function.
References

American Hospital Formulary Service (AHFS). Drug Information 2018. Deoxycholic acid (Kybella). [Lexicomp Online Web site]. 09/14/16. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed March 7, 2018.

Deoxycholic acid (Kybella). [prescribing information] Allergan USA, Inc., Irvine, CA; 01/2018. Available at: http://hcp.mykybella.com/ . Accessed March 7, 2018.

Elsevier’s Clinical Pharmacology Compendium. Deoxycholic acid (Kybella). 05/01/15. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/pharmacology/monograph/3994?sec=monindi&n=Kybella [via subscription only]. Accessed March 7, 2018.

Lexi-Drugs Compendium. Kybella. 02/13/18. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed March 7, 2018.

Truven Health Analytics. Micromedex® DrugDex® Compendium. Deoxycholic acid (Kybella). [Micromedex® 2.0 Web site]. 01/23/18. Available at: http://www.micromedexsolutions.com/micromedex2/librarian . Accessed March 7, 2018.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Deoxycholic acid (Kybella) approval letter [FDA Web site]. Original 04/2015. Available at:http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206333Orig1s000ltr.pdf . Accessed March 7, 2018.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Deoxycholic acid (Kybella) drug label [FDA Web site]. Original 04/2015; Updated 01/18/2018. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed March 7, 2018.



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)

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 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)



THE FOLLOWING CODE IS USED TO REPRESENT DEOXYCHOLIC ACID (KYBELLA)

J3490 Unclassified drugs



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References




Policy History

MA08.074
03/27/2019This policy has been reissued in accordance with the Company's annual review process.
04/25/2018This policy has undergone a routine review, and no revision have been made.
04/26/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on deoxycholic acid (Kybella™).
06/22/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on deoxycholic acid (Kybella™).
08/28/2015The following new policy has been developed to communicate the Company’s coverage criteria for deoxycholic acid (Kybella™).





Version Effective Date: 08/28/2015
Version Issued Date: 08/28/2015
Version Reissued Date: 03/28/2019