Medical Policy

Effective Date:11/01/2016 Title:Hydroxyprogesterone Caproate
Revision Date:10/01/2020 Document:BI517:00
CPT Code(s):J1726
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    All dosage forms of Makena (hydroxyprogesterone) require prior authorization.

2)    Makena (hydroxyprogesterone caproate) is used to prevent pre-term delivery.

Medical Statement

Makena (hydroxyprogesterone caproate) injection is considered medically necessary for patients meeting the following criteria:

1)    Patient had a previous singleton (single offspring) spontaneous pre-term birth AND

2)    Patient is having a singleton pregnancy AND

3)    Therapy will be started between 16 weeks, 0 days and 20 weeks, 6 days of gestation AND

4)    Therapy will be continued until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Codes Used In This BI:

J1726   Injection, Hydroxyprogesterone Caproate, (Makena), 10 mg (new 1/1/18)


Hydroxyprogesterone caproate is limited to a maximum 30 day supply per fill.


1)    Makena Prescribing Information. Ther-Rx Corporation.  April 2016

2)    Clinical Pharmacology. Accessed online 8/12/2016


Effective 07/01/2017: Added new HCPCS code Q9986 – Injection, Hydroxyprogesterone Caproate, 10 mg, effective 7/1/17.

Application to Products

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.