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DESCRIPTIONPreterm birth is the leading cause of neonatal morbidity and mortality, and effective primary preventive interventions have remained elusive. In recent years, there has been renewed interest in the use of progesterone (injectable and intravaginal formulations) to prevent preterm birth.
Preterm labor and delivery are major determinants of neonatal morbidity and mortality. In the United States, the rate of preterm birth is 12%. A variety of diagnostic and prophylactic measures to prevent preterm labor and delivery have been investigated, including home uterine activity monitoring, subcutaneous terbutaline tocolytic therapy, and routine culture and antibiotic treatment of subclinical bacterial vaginosis. To date, none of these have made a significant demonstrable impact on the incidence of preterm delivery. In the past, intramuscular injections of hydroxyprogesterone caproate (i.e., Delalutin) were used routinely to prevent premature labor. However, the drug has teratogenic properties, and the FDA labeled the drug as Category D (i.e., studies have demonstrated fetal risk, but the use of the drug may outweigh the potential risk). Delalutin was voluntarily withdrawn from the market in 1999.
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 has been manufactured locally by compounding pharmacies. After an extended application process, Makena, another injectable form of 17P was approved by FDA in February 2011. Intravaginal progesterone gel and suppositories have also been used.
On February 3, 2011, Makena® (K-V Pharmaceuticals), an injectable formulation containing 17-alpha-hydroxyprogesterone caproate was approved by the FDA through the premarket approval process. 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 women with multiple gestations or in women with other risk factors for preterm birth.
POLICYPrior authorization is required for Makena®.
For women with a singleton pregnancy and prior history of spontaneous preterm birth before 37 weeks of 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:
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Administration of 17 alpha-hydroxyprogesterone caproate by a practitioner in the home setting is considered not medically necessary.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
12/02/2014: Policy reviewed; description updated. Policy statements unchanged.
08/12/2015: Policy description updated to update the rate of preterm birth in the United States. Policy guidelines updated to clarify that administration of 17 alpha-hydroxyprogesterone caproate by a practitioner in the home setting is considered not medically necessary. It previously stated that administration of 17 alpha-hydroxyprogesterone caproate or vaginal suppositories in the home setting is considered not medically necessary.
08/26/2015: Medical policy revised to add ICD-10 codes.
12/03/2015: Policy description updated regarding the rate of preterm birth in the U.S. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
05/27/2016: Policy number A.4.01.16 added.
08/09/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
08/11/2016: Code Reference section updated to add HCPCS code J1725.
09/22/2016: Policy description updated. Policy statements unchanged.
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.