This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions

Medical Policy Search
Printer Friendly Version Progesterone Therapy as a Technique to Reduce Preterm Delivery in High Risk Pregnancies

Progesterone Therapy as a Technique to Reduce Preterm Delivery in High Risk Pregnancies

 

DESCRIPTION

 Preterm 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.

Also, refer to the Home Uterine Activity Monitoring and Acute and Maintenance Tocolysis medical policies.

 

POLICY

 For women with a singleton pregnancy and prior history of spontaneous preterm birth before 37 weeks’ gestation, the following may be considered medically necessary:
  • Weekly injections of 17 alpha-hydroxyprogesterone caproate, performed in the office setting, initiated between 16 and 20 weeks of gestation and continued until 36 weeks 6 days
  • Daily vaginal progesterone between 24 and 34 weeks of gestation

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 multiple gestations, or positive tests for cervicovaginal fetal fibronectin, cervical cerclage, or a uterine anomaly.

 

POLICY EXCEPTIONS

None

 

POLICY GUIDELINES

 Administration 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 HISTORY

 3/25/2004: 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.

 

SOURCE(S)

 Blue Cross Blue Shield Association policy # 4.01.16

 

CODE REFERENCE

Covered Codes

This is not intended to be a comprehensive list of codes. Some covered procedure codes have multiple descriptions.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

Code Number

Description

CPT-4

 

96372

Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular  (Added 05-13-2010)

ICD-9 Procedure

 

 

ICD-9 Diagnosis

V23.41

Supervision of pregnancy with history of pre-term labor

HCPCS

J3490

Unclassified drugs

Q4082 

Drug or biological, not otherwise classified, Part B drug competitive acquisition program (CAP)

Non -Covered Codes

This is not an all-inclusive list of non-covered procedure codes.

The code(s) listed below and ANY code not listed in the previous section are considered non-covered for this procedure.

Code Number

Description

CPT-4

 

 99506

Home visit for intramuscular injections (Added 05-13-2010)

ICD-9 Procedure

 

 

ICD-9 Diagnosis

 

 

HCPCS

S9208

Home management of preterm labor, including administrative services, professional pharmacy services, care coordination, and all necessary supplies or equipment (drugs and nursing visits coded separately), per diem (do not use this code with any home infusion per diem code) (Added 05-13-2010)

 

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