Hydroxyprogesterone Caproate Injection as a Technique to Reduce Preterm Birth in High-Risk Pregnancies

Policy ID: I-56-030

Section: Injections

Effective Date: October 01, 2020

Revised Date: January 10, 2024

Revision Effective Date: March 01, 2024

Last Reviewed: January 16, 2024

Applies To: Commercial Only

Description

Preterm labor and delivery is a major cause of neonatal morbidity and mortality. Women who have had a spontaneous preterm delivery are at increased risk for preterm delivery in subsequent pregnancies.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Makena (hydroxyprogesterone caproate) is considered experimental/investigational and therefore non-covered as there is a lack of conclusive evidence confirming clinical efficacy.

Procedure Code

J1726

NOTE: J1729 may be considered medically necessary for FDA-approved or compendia supported indications.

NOTE: All products under J1729 became inactive as of November 29, 2023

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J1729

C54.0

C54.1

C54.2

C54.3

C54.8

C54.9

N20.1

N20.2

N20.9

N91.0

N91.1

N91.2

N93.8

Professional Statements and Societal Positions Guidelines

Not Applicable

Internal Medical Policy Committee 9-21-2022 - Effective October 1, 2020

Adopted policy

Internal Medical Policy Committee 9-21-2022 - Annual Review, no clinical content change

Internal Medical Policy Committee 3-23-2022 - Effective May 1, 2022

Updated E/I statement
Updated Professional Statements and Societal Positions Section

Internal Medical Policy Committee 3-23-2023 - Annual Review, no clinical content change

Internal Medical Policy Committee 5-23-2023 - Effective April 7, 2023

Updated policy to make Makena (hydroxyprogesterone caproate) always experimental/investigational due to the FDA withdrawal of approval of Makena which occurred on April 6, 2023.
Removed J1729 from the criteria
Added Note concerning J1729

Internal Medical Policy Committee 1-16-2024 - Effective March 01, 2024

Added note: All products under J1729 became inactive as of November 29, 2023
Added diagnosis codes for J1729 for any supply that is being depleted

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-56-029

Section: Injections

Effective Date: October 01, 2020

Revised Date: April 11, 2023

Revision Effective Date: April 07, 2023

Last Reviewed: May 23, 2023

Archived Date: February 29, 2024