Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Hydroxyprogesterone Caproate Injection as a Technique to Reduce the Risk of Preterm Birth in High-Risk Pregnancies

Policy #:08.01.00g

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Hydroxyprogesterone caproate (Makena® and preservative-free compound 17-alpha-hydroxyprogesterone caproate) is considered medically necessary and, therefore, covered for individuals at risk of preterm birth when all of the following criteria are met:
  • The singleton pregnancy is confirmed by ultrasound.
  • The individual is not currently in preterm labor, and there are no other risk factors for preterm birth (such as pregnancy-induced hypertension).
  • There is a documented history of singleton spontaneous preterm birth (occurring between 20 weeks and 37 weeks gestation).
  • The weekly injections of hydroxyprogesterone caproate are administered between 16 weeks 0 days and 36 weeks 6 days of gestation.

NOT MEDICALLY NECESSARY

Hydroxyprogesterone caproate (Makena® and preservative-free compound 17-alpha-hydroxyprogesterone caproate) is considered not medically necessary and, therefore, not covered for multiple gestations (twins, triplets, etc).

EXPERIMENTAL/INVESTIGATIONAL

All other uses for hydroxyprogesterone caproate (Makena® and preservative-free compound17-alpha-hydroxyprogesterone caproate) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

Due to the prevalence of utilization in the medical community regarding the use of compounded preservative-free 17-P (17-alpha-hydroxyprogesterone caproate), and the economical impact that follows, the Company will continue to provide coverage for both the preservative-free compound 17P (17-alpha-hydroxyprogesterone caproate) and the commercially available hydroxyprogesterone caproate (Makena®), pursuant to a valid prescriber's prescription, which should be in accordance with the US Food and Drug Administration (FDA)'s pronouncements:
  • On March 30, 2011, the FDA issued the following statement: "In order to support access to this important drug, at this time and under this unique situation, the FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate (Makena®) based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products."
  • On November 8, 2011, the FDA clarified their statement that "The FDA prioritizes enforcement actions related to compounded drugs using a risk-based approach, giving the highest enforcement priority to pharmacies that compound products that are causing harm or that amount to health fraud."
  • On June 15, 2012, the FDA issued the following statement after sampling and analyzing the purity and potency of the active ingredient and the final compounded product: "Although the analysis of this limited sample of compounded hydroxyprogesterone caproate products and active pharmaceutical ingredients did not identify any major safety problems, approved drug products, such as Makena®, provide a greater assurance of safety and effectiveness than do compounded products."

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, hydroxyprogesterone caproate
(Makena®) and the preservative-free compound 17P (17-alpha-hydroxyprogesterone caproate) are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Hydroxyprogesterone caproate (Makena®) was approved by the FDA on February 3, 2011, to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The safety and effectiveness in pediatric patients less than 16 years of age have not been established.
Description

The American College of Obstetricians and Gynecologists (ACOG) defines the time-frame of preterm births as births between 20 weeks and 37 weeks of gestation. They are the leading cause of infant mortality in the United States, where they occur in 12 percent of all births; of those births, 70-80 percent are spontaneous preterm births.

The synthetic progestin, hydroxyprogesterone caproate, was first marketed under the trade name Delalutin in 1956 to reduce the risk of recurrent preterm births. The mechanism of action is unknown but thought to relax uterine smooth muscle, inhibit T-lymphocyte activation, inhibit oxytocin effects on the myometrium, and other mechanisms. The manufacturer withdrew the drug from the market in 2000. Since then, pharmacies compounded the drug, which is known as 17P (17-alpha-hydroxyprogesterone caproate). During the compounding process, pharmacies must maintain the same standards of quality as other manufacturing plants governed by the US Food and Drug Administration (FDA). Such guidelines include compliance with the United States Pharmacopoeia (USP) Chapter <797> guidelines for sterile compounding and independent batch testing for potency and sterility.

On February 3, 2011, hydroxyprogesterone caproate (Makena®) received an Orphan Drug designation from the FDA after showing the drug's efficacy in decreasing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

The formulation of hydroxyprogesterone caproate (Makena®) contains castor oil and the preservative benzyl alcohol. In cases where individuals may be sensitive to these ingredients, the compounding pharmacy may be able to formulate the preservative-free compound 17P without these ingredients.

PEER-REVIEWED LITERATURE

SUMMARY
Hydroxyprogesterone caproate (Makena® and preservative-free compound 17-alpha-hydroxyprogesterone caproate) is not intended for use in women with multiple gestations (twins, triplets, etc) or other risk factors for preterm birth. Two systematic reviews and meta-analyses (Likis et al 2012, Sotiriadis et al 2012) have demonstrated that hydroxyprogesterone caproate use did not decrease the rate of preterm birth in twin or triplet gestations (measured as delivery before 28, 32, or 35 weeks), nor did its use reduce neonatal morbidity when compared to placebo. Furthermore, trials in twins have demonstrated an increase in adverse outcomes, including perinatal death or complications such as respiratory distress syndrome. Also, a 2008 Committee Opinion by the American College of Obstetricians and Gynecologists (ACOG) stated that "Current evidence does not support the routine use of progesterone in women with multiple gestation."

A multicenter, randomized, double-blind, placebo-controlled trial was performed in 463 pregnant women who had a current singleton pregnancy and had a history of singleton spontaneous preterm birth after 20 weeks gestation. Women were randomized to receive weekly intramuscular injections of either hydroxyprogesterone caproate (in the form of 17-P compound) or a placebo between 16 weeks, 0 days of gestation and 20 weeks, 6 days of gestation, and continue until week 37 of gestation or delivery. Hydroxyprogesterone caproate decreased the proportion of women who delivered at the time points of less than 32 weeks, less than 35 weeks, and less than 37 weeks, compared to the women who received the placebo. There were no overall differences in fetal loss or neonatal deaths between the two groups, and no statistically significant differences between the groups as far as adverse outcomes in live births. There were also no differences between the two groups in the developmental scores of the 79.9 percent of infants who were enrolled in an extension of this trial for evaluation by the Ages & Stages Questionnaire (ASQ), a tool that measures communication, gross motor, fine motor, problem solving, and personal/social parameters.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References

AMAG Pharmaceuticals. Hydroxyprogesterone caproate (Makena®). Package insert updated 04/2016. Available at: http://www.amagpharma.com/our-products/ or http://www.makena.com/ . Accessed August 25, 2017.


American College of Obstetricians and Gynecologists (ACOG). ACOG Committee Opinion. Use of progesterone to reduce preterm birth. Obstet Gynecol.2008;419:1-3.

American College of Obstetricians and Gynecologists (ACOG). Frequently Asked Questions (FAQ087): Preterm (Premature) Labor and Birth. [ACOG Web site]. 11/2016. Available at:
http://www.acog.org/~/media/For%20Patients/faq087.pdf?dmc=1&ts=20120723T1533448976. Accessed August 25, 2017.

American College of Obstetricians and Gynecologists (ACOG). Frequently Asked Questions (FAQ100): Repeated Miscarriage. [ACOG Web site]. May 2016. Available at:
http://www.acog.org/~/media/For%20Patients/faq100.pdf?dmc=1&ts=20120723T1532486320. Accessed August 25, 2017.

American College of Obstetricians and Gynecologists (ACOG). Management of Preterm Labor. Practice Bulletin 159, 01/2016. Interim Update.

American College of Obstetricians and Gynecologists (ACOG). ACOG practice bulletin no.130: prediction and prevention of preterm birth. Obstet Gynecol 2012;120(4):964-73.

American College of Obstetricians and Gynecologists (ACOG). Preterm (Premature) Labor and Birth: Resource Overview. 2017. Available at: https://www.acog.org/Womens-Health/Preterm-Premature-Labor-and-Birth . Accessed August 28, 2017.

American College of Obstetricians and Gynecologists (ACOG). Preventing Preterm Birth: The Role of 17α Hydroxyprogesterone Caproate. ACOG Resource Guide. 01/09.

American Hospital Formulary Service (AHFS). Drug Info 2017. Hydroxyprogesterone caproate (Makena®). [Lexicomp Online Web site]. 12/13/11. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed August 25, 2017.

American Pregnancy Association. Miscarriage. [American Pregnancy Association Web site]. 05/2017. Available at: http://www.americanpregnancy.org/pregnancycomplications/miscarriage.html. Accessed August 25, 2017.

Caritis SN, Rouse DJ, Peaceman AM, et al. Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial. Obstet Gynecol. 2009; 113(2 Pt 1):285-92.

Combs CA, Garite T, Maurel K, et al. Failure of 17-hydroxyprogesterone to reduce neonatal morbidity or prolong triplet pregnancy: a double-blind, randomized clinical trial. Am J Obstet Gynecol. 2010;203(3):248 e1-9.

Dodd JM, Jones L, Flenady V, Cincotta R, Crowther CA. Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth. Cochrane Database Syst Rev. 2013;(7):CD004947.

Edlow AG, Srinivas SK, and Elovitz MA. Second-trimester loss and subsequent pregnancy outcomes: What is the real risk? Am J Obstet Gynecol 2007;197:581.e1-581.e6.

Elsevier’s Clinical Pharmacology Compendium. Hydroxyprogesterone caproate (Makena®). 06/15/15. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed August 25, 2017.

González-Quintero VH, Istwan NB, Rhea DJ, Smarkusky L, Hoffman MC, Stanziano GJ. Gestational age at initiation of 17-hydroxyprogesterone caproate (17P) and recurrent preterm delivery. J Matern Fetal Neonatal Med. 2007;20(3):249-52.

Hall NR. What agent should be used to prevent recurrent preterm birth: 17-P or natural progesterone? Obstet Gynecol Clin N Am. 2011;38:235–246.

How HY, Barton JR, Istwan NB, Rhea DJ, Stanziano GJ. Prophylaxis with 17 alpha-hydroxyprogesterone caproate for prevention of recurrent preterm delivery: does gestational age at initiation of treatment matter? Am J Obstet Gynecol. 2007;197(3):260.e1-4.

Iams JD, Berghella V. Care for women with prior preterm birth. Am J Obstet Gynecol. 2010;203(2):89-100. Epub 2010 Apr 24.

Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, eds. Measurement of Fetal and Infant Maturity. In: Preterm Birth: Causes, Consequences, and Prevention. Washington, DC: National Academies Press; 2007. [National Center for Biotechnology Information (NCBI) Web site]. Available at: http://www.ncbi.nlm.nih.gov/books/NBK11382/. Accessed August 25, 2017.

Johnson JW, Austin KL, Jones GS, Davis GH, King TM. Efficacy of 17alpha-hydroxyprogesterone caproate in the prevention of premature labor. N Engl J Med. 1975 2;293(14):675-80.

Lexi-Drugs Compendium. Hydroxyprogesterone caproate (Makena®). 08/02/17. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed August 25, 2017.

Likis FE, Edwards DR, Andrews JC, et al. Progestogens for preterm birth prevention: a systematic review and meta-analysis. Obstet Gynecol. 2012 Oct;120(4):897-907.

Lockwood CJ. Diagnosis of preterm labor and overview of preterm birth. [UpToDate Web site]. 07/2016. Available at: http://www.uptodate.com/contents/overview-of-preterm-labor-and-birth?view=print [via subscription only]. Accessed August 25, 2017.

Manuck TA, Esplin MS, Biggio J, et al. Predictors of response to 17-alpha hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth. Am J Obstet Gynecol. 2016;214(3):376.e1-8. Epub 2015 Dec 12.

Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003;348(24):2379-2385.

Norwitz ER. Progesterone supplementation to reduce the risk of spontaneous preterm birth. [UpToDate Web site]. 07/2017. Available at: https://www.uptodate.com/contents/progesterone-supplementation-to-reduce-the-risk-of-spontaneous-preterm-birth?source=see_link&sectionName=Threatened+preterm+labor&anchor=H14419401#H14419401 [via subscription only]. Accessed August 25, 2017.

Rebarber A, Ferrara LA, Hanley ML, Istwan NB, Rhea DJ, Stanziano GJ, Saltzman DH. Increased recurrence of preterm delivery with early cessation of 17-alpha-hydroxyprogesterone caproate. Am J Obstet Gynecol. 2007;196(3):224.e1-4.

Rouse DJ, Caritis SN, Peaceman AM, et al. A trial of 17 alpha-hydroxyprogesterone caproate to prevent prematurity in twins. N Engl J Med. 2007;357(5):454-461.

Society for Maternal-Fetal Medicine Publications Committee; Berghella V. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol 2012;206(5):376-86.

Sotiriadis A, Papatheodorou S, Makrydimas G. Perinatal outcome in women treated with progesterone for the prevention of preterm birth: a meta-analysis. Ultrasound Obstet Gynecol. 2012;40(3):257-66.

Truven Health Analytics. Micromedex® DrugDex® Compendium. Hydroxyprogesterone caproate (Makena®). [Micromedex® Solutions Web site]. 08/18/17. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed August 25, 2017.

United States Pharmacopeia: 2008-2009 USP Pharmacists’ Pharmacopeia. 2nd ed. 5th
supplement. Chapter <797> Pharmaceutical Compounding-Sterile Preparations.
Rockville, MD: United States Pharmacopeia Convention. April 21-24, 2010. Washington, DC.

US Food and Drug Administration (FDA). Accelerated approval letter. [FDA Web site]. 02/03/11. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021945s000ltr.pdf. Accessed August 25, 2017.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Hydroxyprogesterone caproate (Makena®) drug label [FDA Web site]. updated 08/2017. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm . Accessed August 25, 2017.

US Food and Drug Administration (FDA). Citizen Petition: Hydroxyprogesterone caproate (Delalutin®). [FDA Web site]. 03/27/06. Available at: http://www.fda.gov/ohrms/dockets/dockets/06p0144/06p-0144-cp00001-Tab-01-vol1.pdf. Accessed August 25, 2017.

US Food and Drug Administration (FDA). Facts About Current Good Manufacturing Practices (cGMPs). [FDA Web site]. 01/06/2015. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105. Accessed August 25, 2017.

US Food and Drug Administration (FDA). FDA Statement on Makena®. FDA Press Announcement: FDA Statement on Makena. [FDA Web site]. 11/08/11. Available online at: https://wayback.archive-it.org/7993/20170113192839/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm279098.htm . Accessed August 28, 2017.

US Food and Drug Administration (FDA). Hydroxyprogesterone caproate (Makena®). FDA Press Announcement: FDA approves drug to reduce risk of preterm birth in at-risk pregnant women. [FDA Web site]. 02/04/11. Available online at: https://wayback.archive-it.org/7993/20170112232046/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm242234.htm . Accessed August 28, 2017.

US Food and Drug Administration (FDA). Hydroxyprogesterone caproate (Makena®). FDA Press Announcement: FDA Statement on Makena. [FDA Web site]. 03/30/11. Available online at: https://wayback.archive-it.org/7993/20170113192840/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249025.htm . Accessed August 28, 2017.

US Food and Drug Administration (FDA). Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena®). FDA Press Announcement. [FDA Web site]. 06/15/12. Available online at: https://wayback.archive-it.org/7993/20170112232040/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308546.htm . Accessed August 28, 2017.

World Health Organization (WHO), March of Dimes, Partnership for Maternal, Newborn & Child Health, Save the Children. Born too soon: the global action report on preterm birth. Published 2012. Available at: www.who.int/maternal_child_adolescent/documents/born_too_soon/en/. Accessed August 25, 2017.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

HYDROXYPROGESTRONE CAPROATE IS CONSIDERED MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODES:


O09.212 Supervision of pregnancy with history of pre-term labor, second trimester

O09.213 Supervision of pregnancy with history of pre-term labor, third trimester


HYDROXYPROGESTRONE CAPROATE IS CONSIDERED NOT MEDICALLY NECESSARY WHEN REPORTED WITH THE FOLLOWING DIAGNOSIS CODES:

O30.001 Twin pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, first trimester

O30.002 Twin pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, second trimester

O30.003 Twin pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, third trimester

O30.009 Twin pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, unspecified trimester

O30.011 Twin pregnancy, monochorionic/monoamniotic, first trimester

O30.012 Twin pregnancy, monochorionic/monoamniotic, second trimester

O30.013 Twin pregnancy, monochorionic/monoamniotic, third trimester

O30.019 Twin pregnancy, monochorionic/monoamniotic, unspecified trimester

O30.021 Conjoined twin pregnancy, first trimester

O30.022 Conjoined twin pregnancy, second trimester

O30.023 Conjoined twin pregnancy, third trimester

O30.029 Conjoined twin pregnancy, unspecified trimester

O30.031 Twin pregnancy, monochorionic/diamniotic, first trimester

O30.032 Twin pregnancy, monochorionic/diamniotic, second trimester

O30.033 Twin pregnancy, monochorionic/diamniotic, third trimester

O30.039 Twin pregnancy, monochorionic/diamniotic, unspecified trimester

O30.041 Twin pregnancy, dichorionic/diamniotic, first trimester

O30.042 Twin pregnancy, dichorionic/diamniotic, second trimester

O30.043 Twin pregnancy, dichorionic/diamniotic, third trimester

O30.049 Twin pregnancy, dichorionic/diamniotic, unspecified trimester

O30.091 Twin pregnancy, unable to determine number of placenta and number of amniotic sacs, first trimester

O30.092 Twin pregnancy, unable to determine number of placenta and number of amniotic sacs, second trimester

O30.093 Twin pregnancy, unable to determine number of placenta and number of amniotic sacs, third trimester

O30.099 Twin pregnancy, unable to determine number of placenta and number of amniotic sacs, unspecified trimester

O30.101 Triplet pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, first trimester

O30.102 Triplet pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, second trimester

O30.103 Triplet pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, third trimester

O30.109 Triplet pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, unspecified trimester

O30.111 Triplet pregnancy with two or more monochorionic fetuses, first trimester

O30.112 Triplet pregnancy with two or more monochorionic fetuses, second trimester

O30.113 Triplet pregnancy with two or more monochorionic fetuses, third trimester

O30.119 Triplet pregnancy with two or more monochorionic fetuses, unspecified trimester

O30.121 Triplet pregnancy with two or more monoamniotic fetuses, first trimester

O30.122 Triplet pregnancy with two or more monoamniotic fetuses, second trimester

O30.123 Triplet pregnancy with two or more monoamniotic fetuses, third trimester

O30.129 Triplet pregnancy with two or more monoamniotic fetuses, unspecified trimester

O30.131 Triplet pregnancy, trichorionic/triamniotic, first trimester

O30.132 Triplet pregnancy, trichorionic/triamniotic, second trimester

O30.133 Triplet pregnancy, trichorionic/triamniotic, third trimester

O30.139 Triplet pregnancy, trichorionic/triamniotic, unspecified trimester

O30.191 Triplet pregnancy, unable to determine number of placenta and number of amniotic sacs, first trimester

O30.192 Triplet pregnancy, unable to determine number of placenta and number of amniotic sacs, second trimester

O30.193 Triplet pregnancy, unable to determine number of placenta and number of amniotic sacs, third trimester

O30.199 Triplet pregnancy, unable to determine number of placenta and number of amniotic sacs, unspecified trimester

O30.201 Quadruplet pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, first trimester

O30.202 Quadruplet pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, second trimester

O30.203 Quadruplet pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, third trimester

O30.209 Quadruplet pregnancy, unspecified number of placenta and unspecified number of amniotic sacs, unspecified trimester

O30.211 Quadruplet pregnancy with two or more monochorionic fetuses, first trimester

O30.212 Quadruplet pregnancy with two or more monochorionic fetuses, second trimester

O30.213 Quadruplet pregnancy with two or more monochorionic fetuses, third trimester

O30.219 Quadruplet pregnancy with two or more monochorionic fetuses, unspecified trimester

O30.221 Quadruplet pregnancy with two or more monoamniotic fetuses, first trimester

O30.222 Quadruplet pregnancy with two or more monoamniotic fetuses, second trimester

O30.223 Quadruplet pregnancy with two or more monoamniotic fetuses, third trimester

O30.229 Quadruplet pregnancy with two or more monoamniotic fetuses, unspecified trimester

O30.231 Quadruplet pregnancy, quadrachorionic/quadra-amniotic, first trimester

O30.232 Quadruplet pregnancy, quadrachorionic/quadra-amniotic, second trimester

O30.233 Quadruplet pregnancy, quadrachorionic/quadra-amniotic, third trimester

O30.239 Quadruplet pregnancy, quadrachorionic/quadra-amniotic, unspecified trimester

O30.291 Quadruplet pregnancy, unable to determine number of placenta and number of amniotic sacs, first trimester

O30.292 Quadruplet pregnancy, unable to determine number of placenta and number of amniotic sacs, second trimester

O30.293 Quadruplet pregnancy, unable to determine number of placenta and number of amniotic sacs, third trimester

O30.299 Quadruplet pregnancy, unable to determine number of placenta and number of amniotic sacs, unspecified trimester

O30.801 Other specified multiple gestation, unspecified number of placenta and unspecified number of amniotic sacs, first trimester

O30.802 Other specified multiple gestation, unspecified number of placenta and unspecified number of amniotic sacs, second trimester

O30.803 Other specified multiple gestation, unspecified number of placenta and unspecified number of amniotic sacs, third trimester

O30.809 Other specified multiple gestation, unspecified number of placenta and unspecified number of amniotic sacs, unspecified trimester

O30.811 Other specified multiple gestation with two or more monochorionic fetuses, first trimester

O30.812 Other specified multiple gestation with two or more monochorionic fetuses, second trimester

O30.813 Other specified multiple gestation with two or more monochorionic fetuses, third trimester

O30.819 Other specified multiple gestation with two or more monochorionic fetuses, unspecified trimester

O30.821 Other specified multiple gestation with two or more monoamniotic fetuses, first trimester

O30.822 Other specified multiple gestation with two or more monoamniotic fetuses, second trimester

O30.823 Other specified multiple gestation with two or more monoamniotic fetuses, third trimester

O30.829 Other specified multiple gestation with two or more monoamniotic fetuses, unspecified trimester

O30.831 Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, first trimester

O30.832 Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, second trimester

O30.833 Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, third trimester

O30.839 Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, unspecified trimester

O30.891 Other specified multiple gestation, unable to determine number of placenta and number of amniotic sacs, first trimester

O30.892 Other specified multiple gestation, unable to determine number of placenta and number of amniotic sacs, second trimester

O30.893 Other specified multiple gestation, unable to determine number of placenta and number of amniotic sacs, third trimester

O30.899 Other specified multiple gestation, unable to determine number of placenta and number of amniotic sacs, unspecified trimester

O30.90 Multiple gestation, unspecified, unspecified trimester

O30.91 Multiple gestation, unspecified, first trimester

O30.92 Multiple gestation, unspecified, second trimester

O30.93 Multiple gestation, unspecified, third trimester



HCPCS Level II Code Number(s)

J1726 Injection, hydroxyprogesterone caproate, (makena), 10 mg


J1729 Injection, hydroxyprogesterone caproate, not otherwise specified, 10 mg



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

08.01.00g
10/01/2018This policy has been identified for the ICD-10 CM code update, effective 10/01/2018.

The following ICD-10 CM codes have been added to this policy:

O30.131 Triplet pregnancy, trichorionic/triamniotic, first trimester
O30.132 Triplet pregnancy, trichorionic/triamniotic, second trimester
O30.133 Triplet pregnancy, trichorionic/triamniotic, third trimester
O30.139 Triplet pregnancy, trichorionic/triamniotic, unspecified trimester
O30.231 Quadruplet pregnancy, quadrachorionic/quadra-amniotic, first trimester
O30.232 Quadruplet pregnancy, quadrachorionic/quadra-amniotic, second trimester
O30.233 Quadruplet pregnancy, quadrachorionic/quadra-amniotic, third trimester
O30.239 Quadruplet pregnancy, quadrachorionic/quadra-amniotic, unspecified trimester
O30.831 Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, first trimester
O30.832 Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, second trimester
O30.833 Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, third trimester
O30.839 Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, unspecified trimester


08.01.00f
01/01/2018This policy has been identified for the HCPCS code update, effective 01/01/2018.

The following HCPCS codes have been removed from this policy:
J1725 Injection, hydroxyprogesterone caproate, 1mg
Q9985 Injection, hydroxyprogesterone caproate, not otherwise specified, 10 mg
Q9986 Injection, hydroxyprogesterone caproate (Makena), 10 mg

The following HCPCS codes have been added to this policy:
J1726 Injection, hydroxyprogesterone caproate, (makena), 10 mg
J1729 Injection, hydroxyprogesterone caproate, not otherwise specified, 10 mg
08.01.00e
10/18/2017This policy has been updated to clarify the ultrasound criteria and the definition of preterm birth. The frequency and duration of dosing have also been added.
Effective 10/05/2017 this policy has been updated to the new policy template format.
Version Effective Date: 10/01/2018
Version Issued Date: 10/01/2018
Version Reissued Date: N/A

Connect with Us        


© 2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.