Clinical UM Guideline

This document addresses the use of standard electric breast pumps (non-hospital grade) or heavy-duty, hospital-grade breast pumps for initiating and maintaining expression of human breast milk in specified situations.

Medically Necessary:

A standard, non-hospital grade, electric breast pump is considered medically necessary when there is documentation of ongoing breastfeeding.

An electric, heavy-duty, hospital-grade breast pump is considered medically necessary for any of the following indications:

1. When a breastfeeding infant is confined to the hospital; or
2. When a breastfeeding infant has a medical (for example, respiratory, cardiac or genetic condition) or congenital condition (for example, cleft palate) that interferes with breastfeeding; or
3. When the lactating individual has been unsuccessful expressing sufficient breast milk after a trial using a manual, battery powered or standard electric pump.

Not Medically Necessary:

An electric breast pump (standard non-hospital grade or heavy-duty hospital grade) is considered not medically necessary in the absence of ongoing breastfeeding.

An electric, heavy-duty, hospital grade breast pump is considered not medically necessary when the criteria above are not met.

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

The Food and Drug Administration (FDA) regulates breast pumps as medical devices that extract or “express” breast milk. Breast pumps may be used to increase or maintain an individual’s milk supply, relieve engorged breasts and plugged milk ducts, or pull out flat or inverted nipples so a nursing baby can latch-on to its lactating parent’s breast more easily (FDA, 2018). There are three main types of breast pumps: manual, battery-powered and electric pumps. Standard manual and electric breast pumps are intended for single person use and are typically sold as a medical device. The standard models may be available from lactation and durable medical equipment (DME) providers as well as select retail stores. Expression of human milk from the breast with standard powered (electric) or non-powered (manual) breast pumps may facilitate ongoing nutritional requirements of infants.

An electric, heavy-duty breast pump is a pump approved by the FDA for safe use by multiple users, where each user utilizes their own collection kit (typically includes breast shields and tubing). These pumps are more durable and powerful to support more frequent pumping of breast milk. The pumps tend to be larger and heavier, and therefore, not as portable as the typical electric personal breast pump. These devices are typically available in the hospital setting for lactating individuals who have hospitalized infants. Lactation consultants, specialty medical supply stores, and DME supply sources may rent or sell hospital-grade breast pumps. The FDA (2018) website states “Please note that the term “hospital-grade pump” is not recognized by the FDA and there is no consistent definition for this term, so individual companies could mean different things when they label their breast pumps as hospital-grade.”

An electric, heavy-duty, hospital-grade breast pump is recommended for lactating individuals who are dependent on the expression of pumped breast milk (initiation or continuation of milk production) due to circumstances that do not allow for breastfeeding. Expressed breast milk is needed for times when the infant is unable to breastfeed due to medical (for example, confinement in an intensive care unit, prematurity, apnea, etc.) and/or congenital reasons (for example, a cleft lip). During these situations, the lactating individual needs to extract breast milk in order to provide nutrients necessary for healthy growth and development.

The National Association of Neonatal Nurses (NANN, 2016) issued a position statement on the use of human milk and breastfeeding in the neonatal intensive care unit (NICU). Recommendations include use of a hospital-grade electric pump with a double collection kit to initiate lactation and establish an adequate milk supply. NANN states it is critical to monitor early and frequent breast milk supply from pumping during the first 2 weeks to ensure that the lactating individual will have an adequate supply at the time of the infant‘s discharge.

Breastfeeding and human milk provide natural, normal nutrition for all infants. There are many short- and long-term benefits of breastfeeding for both infant and the lactating individual. Exclusive breastfeeding is recommended for the first 6 months of life by the American College of Obstetricians and Gynecologists (ACOG, 2016), American Academy of Pediatrics (AAP, 2012), and the World Health Organization (WHO, 2018). The AAP recommends breast feeding continue through the infant’s first year of life or longer.

Various groups continue to support promotion of breastfeeding interventions to improve the rate of breastfeeding in the United States. The U.S. Preventive Services Task Force (USPSTF, 2016) recommends interventions during pregnancy and after birth to promote and support the initiation and continuation of breastfeeding.

Benefits of breastfeeding include a lower risk of diarrhea, otitis media and lower respiratory tract diseases than bottle-fed infants during the first year of life (AAP, 2012; Ip, 2007). Additional short- and long-term effects of breastfeeding include additional health benefits.

While the benefits of breastfeeding are well documented and the majority of individuals in the United States initiate breastfeeding, the incidence of continued breastfeeding drops sharply by 3 months. According to a 2016 survey, 81.1% of individuals initiate breastfeeding following birth. At 6 months of age only 22.3% of infants have been fed breastmilk exclusively (Meeks, 2017). While individuals initially report intention to breastfeed exclusively for at least 3 months, only 32.4% report achieving this goal (Meeks, 2017).

In an update of the 2008 Cochrane study on the methods of breast milk expression for lactating individuals, data from a total of 1998 individuals in 34 studies were analyzed (Becker, 2014). The studies were conducted in the U.S. and at international sites which included preterm or ill neonates as well as term and older, healthy infants. Milk expression was achieved by a variety of methods which included hand-expression, manual pumps and electric pumps. The authors concluded the time of birth, and the purpose for expression of breast milk influence the most suitable method for expressing milk. Methods to promote optimal milk expression (such as early initiation of milk expression, relaxation music, hand expression, manual pumps and warming of the breasts) were “As effective or more effective, than large electric pumps for some outcomes.” The authors noted caution in interpretation of the results as the interventions and study methodologies varied across the studies.

In 2011, the Institute of Medicine (IOM) Committee on Preventive Services for Women provided the recommendations on preventive services to address health needs specific to women. Under provisions of the Patient Protection and Affordable Care Act, the U.S. Department of Health and Human Services (DHHS) released health plan coverage guidelines, which included recommendations from the IOM, which require health insurance plans cover breast pumps and certain other preventive services. Beginning on or after August 1, 2012, new health plans and non-grandfathered plans are required to provide coverage consistent with these guidelines in the first plan year (in the individual market, policy year), when delivered by a network provider. The guidelines recommend coverage of costs for renting breast feeding equipment for each birth.

In 2020 the Academy of Breastfeeding Medicine (ABM) published a clinical protocol: “Lactation Care for Lesbian, Gay, Bisexual, Transgender, Queer, Questioning, Plus Patients” which states:

Standard guidance on exclusive breastfeeding may need to be altered based on the expected production of a non-gestational parent and whether milk will be provided by a gestational parent. For instance, full production is not usually achievable in induced lactation, or after ‘‘top’’ surgery. Therefore, parents should be encouraged to provide as much human milk as possible, and be educated on the indications for supplementation, types and methods of supplementation, and need for close follow-up.

In 2022 the ABM revised their guidelines to include the following recommendations; when the lactating individual is medically ready for hospital discharge, but the newborn is not, or vice versa, the newborn and lactating individual should continue 24-hour rooming in to facilitate breastfeeding. The lactating individual should be encouraged to spend as much time as possible with the hospitalized newborn, regularly breastfeed, and be instructed in techniques to express breast milk so that expressed milk can be given to the hospitalized newborn if separation occurs. It should also be ensured the lactating individual has access to a breast pump or knows how to hand express if a breast pump is not available. High-quality education regarding breast pump use should be provided. Programs should be in place for the lactating individual to borrow a pump for use at home if the individual does not otherwise have access.

The AAP (2022) policy on breastfeeding and the use of human milk supports policies that protect breastfeeding including universal paid maternity leave, the right of an individual to breastfeed in public, insurance coverage for lactation support and breast pumps, universal workplace break time with a clean, private location for expressing milk, the right to feed expressed milk, and the right to breastfeed in childcare centers and lactation rooms in schools to sustain breastfeeding.

In 2023 ACOG published an update to the previous 2016 breastfeeding recommendation. The updated guidance supports continued breastfeeding while foods are introduced, if mutually desired by a lactating parent and child, for up to 2 years or beyond. The new recommendation is based on alignment with the AAP’s 2022 updated guidance that documented the benefits of breastfeeding for both the lactating parent and the child. These recommendations are also aligned with the 2023 World Health Organization (WHO) guidelines, which recommend initiating breastfeeding within the first hour of a child's birth and exclusively breastfeeding for the first six months. During this period, no other food or liquid, including water, should be given to the infant. Infants should be breastfed as often as they demand, at any time of the day or night. Introduction of nutritionally-adequate and safe solid foods at 6 months, together with continued breastfeeding up to 2 years of age is desired when possible.

In recent years there have been several advances in breastfeeding equipment which could encourage breastfeeding and continue for a longer period of time. Devices are available which are worn inside the bra which allow an individual to perform activities of daily living while pumping. Other devices support wireless connectivity and allow for tracking of pumping and infant activities. Standard non-hospital grade breast pumps can include these features and can be considered appropriate as a means of promoting infant health.

Electric breast pump: A powered breast pump, electrically powered suction device used to express milk from the breast.

Hospital-grade breast pump: Non-standard, electric, heavy-duty breast pump, which is FDA approved for reuse by multiple lactating individuals (not for single person/personal use).

Manual breast pump: Nonpowered device designed to express breast milk using suction created through a manual process.

Peer Reviewed Publications:

1. Larkin T, Kiehn T, Murphy PK, Uhryniak J. Examining the use and outcomes of a new hospital-grade breast pump in exclusively pumping NICU mothers. Adv Neonatal Care. 2013; 13(1):75-82.
2. Martino K, Wagner M, Froh EB, et al. Postdischarge breastfeeding outcomes of infants with complex anomalies that require surgery. J Obstet Gynecol Neonatal Nurs. 2015; 44(3):450-457.
3. Meier PP, Engstrom JL, Hurst NM, et al. A comparison of the efficiency, efficacy, comfort, and convenience of two hospital-grade electric breast pumps for mothers of very low birthweight infants. Breastfeed Med. 2008; 3(3):141-150.
4. Renfrew MJ, Craig D, Dyson L, et al. Breastfeeding promotion for infants in neonatal units: a systematic review and economic analysis. Health Technol Assess. 2009; 13(40):1-146, iii-iv.
5. Rollins NC, Bhandari N, Hajeebhoy N, et al; Lancet Breastfeeding Series Group. Why invest, and what it will take to improve breastfeeding practices? Lancet. 2016; 387(10017):491-504.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American College of Obstetricians and Gynecologists (ACOG). Committee Opinion No. 658: Optimizing Support for Breastfeeding as Part of Obstetric Practice. Obstet Gynecol. 2016; 127(2):e86-e92.
2. American College of Obstetricians and Gynecologists (ACOG). Practice Advisory to Update the Duration of Breastfeeding. February 2023. Available at: https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/02/duration-of-breastfeeding-update. Accessed on February 12, 2024.
3. Becker GE, Smith HA, Cooney F. Methods of milk expression for lactating women. Cochrane Database Syst Rev. 2015; (2):CD006170.
4. Chantry CJ, Eglash A, Labbok M. ABM Position on Breastfeeding-Revised 2015. Breastfeed Med. 2015; 10(9):407-411.
5. Chung M, Raman G, Trikalinos T, et al. Interventions in primary care to promote breastfeeding: an evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2008; 149(8):565-582.
6. Committee on Preventive Services for Women; Institute of Medicine. Clinical Preventive Services for Women: Closing the Gaps. July 19, 2011. Available at: https://cdn.cnsnews.com/documents/INSTITUTE%20OF%20MEDICINE-PREVENTIVE%20SERVICES%20REPORT.pdf. Accessed on February 12, 2024.
7. Ferri RL, Rosen-Carole CB, Jackson J, et al. Academy of Breastfeeding Medicine. ABM Clinical Protocol #33: Lactation Care for Lesbian, Gay, Bisexual, Transgender, Queer, Questioning, Plus Patients. Breastfeed Med. 2020;15(5):284-293. Available at: https://www.bfmed.org/assets/DOCUMENTS/PROTOCOLS/Protocol%20%2333%20-%20English%20Translation.pdf. Accessed on February 12, 2024.
8. Hoyt-Austin A, Kair L, Larson, I, et al. Guidelines for birth hospitalization discharge of breastfeeding dyads, Revised 2022. Academy of Breastfeeding Medicine Clinical Protocol No. 2. Breastfeeding Medicine, 2022; (17). Available at: https://www.bfmed.org/assets/DOCUMENTS/PROTOCOLS/ABM%20Protocol%20%232bfm.2022.29203.aeh.pdf. Accessed on February 12, 2024.
9. Ip S, Chung M, Raman G, et al. Breastfeeding and maternal and infant health outcomes in developed countries. Evid Rep Technol Assess (Full Rep). 2007; (153):1-186.
10. James DC, Lessen R. American Dietetic Association. Position of the American Dietetic Association: promoting and supporting breastfeeding. J Am Diet Assoc. 2009; 109(11):1926-1942.
11. Johnston M, Landers S, Noble L, et al. Breastfeeding and the use of human milk. Pediatrics. 2012; 129(3):e827-e841.
12. Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2012; (15):CD003517.
13. Meek JY, Hatcher AJ; Section on Breastfeeding. The breastfeeding-friendly pediatric office practice. Pediatrics. 2017; 139(5):e1-e9.
14. Meek JY, Nobel L. Breastfeeding and the use of human milk. American Academy of Pediatrics, Policy Statement. Pediatrics 2022; 150(1). Available at: https://publications.aap.org/pediatrics/article/150/1/e2022057988/188347/Policy-Statement-Breastfeeding-and-the-Use-of. Accessed on February 12, 2024.
15. Spatz DL, Edwards TM. The Use of Human Milk and Breastfeeding in the Neonatal Intensive Care Unit: Position Statement 3065. Adv Neonatal Care. 2016; 16(4):254.
16. U.S. Food and Drug Administration 510(k) Premarket Notification Database.
    • Ameda Platinum Breast Pump Symphony^®. No. K100435. Rockville, MD: FDA. May 28, 2010. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/K100435.pdf. Accessed on February 12, 2024.
    • Ardo Calypso Pro Powered Breast Pump. No. K150721. Rockville, MD: FDA. June 19, 2015. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf15/K150721.pdf . Accessed on February 12, 2024.
    • Elvie Pump^®. No. K181863. Rockville, MD: FDA. July 12, 2018. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181863.pdf. Accessed on February 12, 2024.
    • Limmerick PJ’s Serenity. No. K132220. Rockville, MD: FDA. February 20, 2015. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/K132220.pdf. Accessed on February 12, 2024.
    • Lucina-Melodi Advance Breast Pump. No. K112856. Rockville, MD: FDA. May 10, 2012. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K112856.pdf. Accessed on February 12, 2024.
    • Medela^® AG Powered Breast Pump Symphony^®. No. K151632. Rockville, MD: FDA. November 5, 2015. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf15/K151632.pdf. Accessed on February 12, 2024.
    • Nurture III Breast Pump. No. K020375. Rockville, MD: FDA. May 3, 2002. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K020375.pdf. Accessed on February 12, 2024.
    • The Pump by Babyation. No. K173699. Rockville, MD: FDA. April 4, 2018. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173699.pdf. Accessed on February 12, 2024.
17. US Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, ET AL. Primary Care Interventions to Support Breastfeeding: US Preventive Services Task Force Recommendation Statement. JAMA. 2016; 316(16):1688-1693.
18. World Health Organization. Long-term effects of breastfeeding: a systematic review. 2013. Available at:https://apps.who.int/iris/bitstream/handle/10665/79198/9789241505307_eng.pdf?sequence=1. Accessed on February 12, 2024.

1. Centers for Disease Control and Prevention. Strategies to prevent obesity and other chronic diseases: the CDC guide to strategies to support breastfeeding mothers and babies. Atlanta: U.S. Department of Health and Human Services; 2013. Available at: http://www.cdc.gov/breastfeeding/pdf/BF-Guide-508.PDF. Accessed on February 12, 2024.
2. U.S. Department of Health and Human Services National Institutes of Child Health and Human Development. How do I pump and store breast milk. Last reviewed Jan 31,2017. Available at: https://www.nichd.nih.gov/health/topics/breastfeeding/conditioninfo/pump. Accessed on February 12, 2024.
3. U.S. Department of Health and Human Services Office of Disease Prevention and Health Promotion. Breastfeed your baby. Last reviewed July,14 2022. Available at https://health.gov/myhealthfinder/pregnancy/doctor-and-midwife-visits/breastfeed-your-baby. Accessed on February 12, 2024.
4. U.S. Department of Health and Human Services Offices on Women’s Health. Breastfeeding. Last updated March 14, 2019. Available at: https://www.womenshealth.gov/Breastfeeding. Accessed on February 12, 2024.
5. U.S. Food & Drug Administration. Breast Pumps. March 26, 2018. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BreastPumps/default.htm. Accessed on February 12, 2024.
6. U.S. National Library of Medicine. MedlinePlus. Breastfeeding. Last reviewed on January 14, 2022. Available at: https://www.nlm.nih.gov/medlineplus/breastfeeding.html. Accessed on February 12, 2024.
7. World Health Organization. Infant and young child feeding. 2023. Available at: https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding. Accessed on February 12, 2024.
8. World Health Organization. 10 facts on breastfeeding. Updated February 2018. Available at: https://www.who.int/health-topics/breastfeeding#tab=tab_1 Accessed on February 12, 2024.

Ameda Elite Breast Pump^®
Ameda Finesse Double Breast Pump^®
Ameda Platinum Breast Pump^®
Ameda Purely Yours Breast Pump^®
Hygeia Enjoye
Hygeia EnRiche
Hygeia Q
Lansinoh SignaturePro
Lansinoh Smartpump
Medela^® Powered Breast Pump Symphony^®
Motif DUO
Nurture III Breast Pump^®
NUK Expressive Single Electric Breast Pump
Spectra Dew 350 Electric Breast Pump^®
Spectra S1 PLUS Electric Breast Pump^®
Spectra S2 PLUS Electric Breast Pump^®
Tomy Quiet Expressions
White River Automatic Breast Pump^®

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

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