​Effective March 8, 2021, changes will apply to providers who bill for leuprolide acetate (Fensolvi^®​). Fensolvi was approved by the U.S. Food and Drug Administration (FDA) on May 1, 2020 for the treatment of children with central precocious puberty, and is represented by HCPCS J1950 (Injection, leuprolide acetate [for depot suspension], per 3.75 mg). Fensolvi will only be covered for non-oncologic diagnoses based on the medical necessity criteria outlined in our medical policies.

Billing guidelines

In alignment with other leuprolide acetate products, the following coding guidelines will still apply:

• Leuprolide acetate, 7.5 mg (HCPCS J9217) represents Eligard^® and Lupron Depot^® and will be covered for both oncologic and non-oncologic diagnoses based on the medical necessity criteria outlined in our medical policies.
• Leuprolide acetate, 3.75 mg (HCPCS J1950) represents Fensolvi and Lupron Depot and will only be covered for non-oncologic diagnoses based on the medical necessity criteria outlined in our medical policies.

Medical necessity criteria

According to Independence's definition of medical necessity, a service cannot be more costly than an alternative service that is at least as likely to produce equivalent therapeutic or diagnostic results for the treatment of an individual's illness.

Fensolvi has been FDA approved for the treatment of children with central precocious puberty and will only be covered for that indication.

The billing guidelines are also in alignment with Medicare's (Novitas Solutions, Inc.) local coverage determination on Luteinizing Hormone-Releasing (LHRH) Analogs. 

Learn more

The original article discussing Eligard and Lupron Depot was communicated on January 6, 2017. Notifications were posted on December 8, 2020, for the following updated medical policies that go into effect March 8, 2021:

• Commercial: #08.01.33c: Gonadotropin-Releasing Hormone Agonist (Eligard^®, Fensolvi^®, Lupron Depot^®)
• Medicare Advantage: #MA08.083c: Gonadotropin-Releasing Hormone (Eligard^®, Fensolvi^®, Lupron Depot^®)

To view the Notifications for these policies, visit our Medical and Claim Payment Policy Portal and select either Commercial or Medicare Advantage under Active Notifications.