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DESCRIPTIONPreterm birth is the leading cause of neonatal morbidity and mortality. Although secondary or tertiary interventions have led to reduced morbidity and mortality caused by preterm birth, effective primary preventive interventions have remained elusive. Use of progesterone is being studied to prevent preterm birth.
Preterm labor and delivery is a major determinant of neonatal morbidity and mortality; in the United States the rate of preterm birth is 12%. A variety of diagnostic and prophylactic measures have been investigated including home uterine activity monitoring, subcutaneous terbutaline tocolytic therapy and routine culture and antibiotic treatment of subclinical bacterial vaginosus. To date, none of the above had made a significant demonstrable impact on the incidence of preterm delivery. In the past intramuscular injections of 17 alpha hydroxyprogesterone (i.e., Delalutin) were used routinely to prevent premature labor. However, the drug was shown to have teratogenic properties and the FDA labeled the drug as Category D (i.e., studies have demonstrated fetal risk, but that the use of the drug may outweigh the potential risk). Delalutin is no longer marketed. Most recently there has been renewed research interest in intramuscular injection of 17 alpha-hydroxyprogesterone caproate (17P). 17P is weakly acting naturally occurring progesterone metabolite, which when coupled with caproate dextran works as a long acting progestin when administered intramuscularly. 17P is not commercially available, but can be manufactured locally by compounding pharmacies. Intravaginal progesterone suppositories have also been investigated.
On February 3, 2011, an injectable formulation containing 17-alpha-hydroxyprogesterone caproate was approved by the FDA through the premarket approval process. The product is called Makena and will be marketed by KV Pharmaceuticals. It is indicated to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. Makena is not intended for use in women with multiple gestations or in women with other risk factors for preterm birth. Injectable hydroxyprogesterone caproate had previously been approved by the FDA in 1956 under the brand name Delalutin®. This product was voluntarily withdrawn from the market in 1999. As of August 2013, McGuff Pharmaceuticals is pursuing the approval of an Abbreviated New Drug Application (ANDA) for injectable hydroxyprogesterone caproate; this is a generic version of Delalutin.
POLICYPrior authorization is required for Makena.
For women with a singleton pregnancy and prior history of spontaneous preterm birth before 37 weeks’ gestation, the following may be considered medically necessary:
For women with a singleton pregnancy and a short cervix (less than 20mm), daily vaginal progesterone initiated between 20 and 23 weeks 6 days of gestation and continued until 36 weeks 6 days may be considered medically necessary.
Progesterone therapy as a technique to prevent preterm delivery is considered investigational in pregnant women with other risk factors for preterm delivery, including but not limited to:
POLICY GUIDELINESAdministration of 17 alpha-hydroxyprogesterone caproate or vaginal suppositories in the home setting is considered not medically necessary.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY3/25/2004: Approved by Medical Policy Advisory Committee (MPAC)
5/3/2004: Code Reference section completed
5/18/2006: Policy reviewed, no changes
1/3/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
5/1/2008: Policy reviewed, no changes
05/13/2010: Policy description updated. Policy statement revised to clarify that the medically necessary use applies to women with a singleton pregnancy. Also, prior history of cervical cerclage, or uterine anomaly changed to investigational. Removed outdated references from the Sources section. Added CPT code 96372 to the covered table. Added a non-covered code table to include 99506 and S9208, which describe home management.
08/23/2011: Policy description updated regarding FDA approval of Makena. Use of vaginal progesterone to treat women with singleton pregnancies and short cervical length added as medically necessary. Start and stop dates of injectable progesterone changed to be consistent with label of FDA-approved product.
01/09/2013: Policy statement revised to add prior episode of preterm labor in current pregnancy (i.e. progesterone therapy in conjunction with tocolysis or following successful tocolysis) as an investigational indication. Also added "twin or multiple gestations" for clarity purposes.
10/22/2013: Policy description updated regarding injectable hydroxyprogesterone caproate. No changes to policy statement.
SOURCE(S)Blue Cross Blue Shield Association policy # 4.01.16
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.