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| Medical Policy: | I-56-025 |
| Topic: | Hydroxyprogesterone Caproate Injection as a Technique to Reduce Preterm Birth in High-Risk Pregnancies |
| Section: | Injections |
| Effective Date: | July 9, 2018 |
| Issue Date: | July 9, 2018 |
| Last Reviewed: | May 2018 |
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. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Any hydroxyprogesterone injection (e.g., Makena™) may be considered medically necessary in a pregnancy that meets All of the following conditions:
- Current singleton pregnancy; and
- Ultrasound confirmed pregnancy is between 16 weeks, 0 days and 20 weeks, 6 days; and
- History of singleton spontaneous preterm birth (less than 37 weeks, 0/7 days) but no preterm labor in the current pregnancy.
Hydroxyprogesterone injection is considered experimental/investigational and therefore not covered for all other indications not listed above. Scientific evidence does not support its use for other indications.
Dosage recommendations per the FDA label.
| Professional Statements and Societal Positions |
American College of Obstetricians and Gynecologists
Society for Maternal-Fetal Medicine
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| Place of Service: Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
Hydroxyprogesterone Caproate Injection as a Technique to Reduce Preterm Birth in High-Risk Pregnancies is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
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