Procedure code J1726 (Injection, hydroxyprogesterone caproate, Makena, 10 mg)
A. CDER approved Makena to reduce the risk of preterm birth in women pregnant with a single baby who previously had spontaneous (unexplained) preterm birth. Preterm birth refers to delivery before 37 weeks of pregnancy.
O09. 21 - Supervision of pregnancy with history of pre-term labor. ICD-10-CM.
Most pay no more than $35 per injection To be eligible, patients must meet the FDA-approved indication for Makena. In compliance with federal regulations, patients insured by a government-funded program (Medicaid, TRICARE, etc.) are not eligible.
Makena (hydroxyprogesterone caproate) is a prescription hormone medicine (progestin) used in women who are pregnant with only one baby and who have delivered a premature baby in the past. Makena is used in these women to help lower the risk of having a preterm baby again.
NDC: Makena 250 mg/mL auto-injector 1.1 mL pre-filled syringe: 64011-0301-xx.
Should the provider specify that the pregnancy is incidental to the encounter, ICD-10-CM code Z33. 1 (pregnancy state, incidental) should be used in place of ICD-10-CM codes O00-O9A. Include the condition being treated and document that it is not affecting the pregnancy.
ICD-10-CM Code for Encounter for supervision of normal pregnancy, unspecified, unspecified trimester Z34. 90.
O80 - Encounter for full-term uncomplicated delivery | ICD-10-CM.
Makena® (hydroxyprogesterone caproate injection) has a unique J code J1726 as of January 1, 2018. The code should be used in column 24D of the CMS 1500 claim form. A National Drug Code (NDC) and quantity should be used when billing Makena.
Do Medicare prescription drug plans cover Makena? No. In general, Medicare prescription drug plans (Part D) do not cover this drug.
Costs. The initial acquisition cost of Makena was set at $1,440 per injection; thus, for 18 to 20 injections, the total cost was about $30,000 per pregnancy.
In a clinical study, taking Makena significantly lowered the rate of preterm birth compared to moms who did not take Makena. If you answer “yes” to all of the questions below, talk with your healthcare provider to see if Makena could help you reduce your risk of another preterm birth.
But the drug doesn't work, according to the Food and Drug Administration. A recent large study “unequivocally failed to demonstrate” that Makena reduced the risk of preterm birth, agency scientists explained in a 2020 memo. They recommended it be taken off the market. The company has refused.
It is very important that you do not miss a dose of Makena and that you continue to receive the medicine once a week. If you miss a dose, talk to your healthcare provider for specific directions on how to get back on schedule.
Progesterone is a hormone that helps the uterus grow during pregnancy and keeps it from contracting. Treatment with progesterone during pregnancy may help some people reduce their risk for premature birth. If you have a short cervix, treatment with vaginal progesterone gel may help prevent premature birth.