Billing and coding Makena® (hydroxyprogesterone caproate injection)

When Makena is purchased from a specialty distributor, the healthcare provider is responsible for submitting a claim to the patient’s insurer for each weekly injection. Makena can be ordered through either of the specialty distributors listed below. Please call for specific ordering instructions.

Makena is also available via drop shipment through your preferred wholesaler. If you prefer to receive your order via drop shipment, please contact your wholesaler directly for more information.

A billing and coding process has been established for healthcare providers performing Makena-related services. However, code and claim requirements may vary by insurer and benefit plan.

The information below will be required when completing the CMS 1500 claim form.

*	National Drug Code (Payer requirements regarding 10-digit and 11-digit NDC may vary).
†	Current Procedural Terminology.
‡	International Classification of Diseases–9th Revision–Clinical Modification.
§	Healthcare Common Procedure Coding System.

Patient Information and Coding Worksheet—Make a copy of this form to keep track of your patients’ insurance information and codes needed for reimbursement.

Important HCPCS billing and coding information

Makena has been assigned the unique J code J1725, which should be used in column 24D of the CMS 1500 claim form. The J code must be billed in milligrams (mg). Each Makena vial contains a total of 1250 mg, which equals 5 (250-mg) weekly injections.

When using the J code, enter the number of mg used in Box 24G (ie, “250” for each weekly injection of Makena)

You can also download a Billing Guide that will help you with the CMS 1500 form.

Important information about reimbursement

When calculating reimbursement, it is important to record the appropriate billable unit. The reimbursement per billable unit may vary based on your contracted payer rate; check with the payer to ensure that your claim is recorded correctly.
There are 250 mg in one weekly dose (1 mL) of Makena therapy.

J code calculation: 250 mg x (reimbursement rate per Billable unit)

For additional questions, please contact the Makena Care Connection^®
at 1-800-847-3418

Disclaimer:
This resource and all supporting materials are supplied for information only and are not intended to be a thorough description or analysis of the subject matter herein, nor are they opinions of Ther-Rx Corporation. The information and opinions are based on the CPT 2010 and ICD-9-CM 2010 coding manuals and AMA HCPCS 2010. Because payer benefits change regularly, providers are responsible for confirming coverage, coding, and payment with respective payers. Providers are also responsible for ensuring accuracy of service claim forms and supportive documentation sent to payers. Ther-Rx Corporation does not make any representation or guarantees concerning the coverage or reimbursement of any service or item.

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Makena^® is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.

Important safety information for Makena (hydroxyprogesterone caproate injection)

Do not use Makena in women with any of the following conditions:

–	Current or history of thrombosis or thromboembolic disorders
–	Known or suspected breast cancer, other hormone-sensitive cancer or history of these conditions
–	Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
–	Cholestatic jaundice of pregnancy
–	Liver tumors, benign or malignant, or active liver disease
–	Uncontrolled hypertension

Makena should be discontinued if thrombosis or thromboembolism occurs
Allergic reactions, including urticaria, pruritus and angioedema, have been reported with use of Makena or with other products containing castor oil

Women receiving Makena should be monitored if they:

–	Are prediabetic or diabetic
–	Have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction
–	Have a history of clinical depression; Makena should be discontinued if depression recurs
–	Develop jaundice; consider whether benefit of use warrants continuation
–	Develop hypertension

Certain pregnancy-related fetal and maternal complications or events were numerically increased in Makena-treated subjects as compared to placebo subjects, including miscarriage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (3.6% vs. 1.3%)
The most common adverse reactions reported in ≥2% of subjects and at a higher rate in the Makena group than in the control group were injection site reactions (pain [35% vs. 33%], swelling [17% vs. 8%], pruritus [6% vs. 3%], and nodule [5% vs. 2%]), urticaria (12% vs. 11%), pruritus (8% vs. 6%), nausea (6% vs. 5%), and diarrhea (2% vs. 1%)

Please see full prescribing information for Makena.

Reference: 1. Abraham M, Beebe M, Dalton JA, et al. Current Procedural Terminology 2010: Standard Edition.Chicago, IL: American Medical Association; 2009. 2. Buck CJ. 2010 ICD-9-CM Volumes 1 & 2. St. Louis, MO: Saunders Elsevier; 2010. 3. American Medical Association. 2010 HCPCS: Level II. Maryland Heights, MO: American Medical Association; 2010.