Clinical UM Guideline

 

Subject: Electric Breast Pumps
Guideline #:  CG-DME-35 Publish Date:    08/29/2018
Status: Reviewed Last Review Date:    07/26/2018

Description

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.

Clinical Indications

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 mother 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.

Coding

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.

HCPCS

 

E0603

Breast pump, electric (AC and/or DC), any type

E0604

Breast pump, hospital grade, electric (AC and/or DC), any type

 

 

ICD-10 Diagnosis

 

 

All diagnoses

Discussion/General Information

The FDA regulates breast pumps as medical devices that extract or “express” breast milk.  Breast pumps may be used to increase or maintain a woman’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 mother’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 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. 

A type of pump which is approved by the FDA for safe use by multiple users, and each woman utilizes her own collection kit (typically includes breast shields and tubing) is the electric, heavy-duty breast pump.  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 mothers who have infants that are still hospitalized.  Lactation consultants, specialty medical supply stores, and durable medical equipment (DME) supply sources may rent or sell hospital-grade breast pumps.  The FDA (2018) states on their website “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 mothers 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 mother 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 mother 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 mother.  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, 2012).  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 women in the United States initiate breastfeeding, the incidence of continued breastfeeding drops sharply by three months.  According at a 2016 survey, 81.1% of women initiate breastfeeding following birth.  At six months of age only 22.3% of infants have been fed breastmilk exclusively (Meeks, 2017).  While women initially report intention to breastfeed exclusively for at least three months, only 32.4% of the women report achieving this goal (Meeks, 2017).

In an update of the 2008 Cochrane study on the methods of breast milk expression for lactating women, 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, that require health insurance plans cover breast pumps and certain other women's 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.

Definitions

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, that is FDA approved for reuse by multiple lactating women (not for single person/personal use).

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

References

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. Meek JY, Hatcher AJ; Section on Breastfeeding. The Breastfeeding-Friendly Pediatric Office Practice. Pediatrics. 2017; 139(5). Available at: http://pediatrics.aappublications.org/content/pediatrics/139/5/e20170647.full.pdf. Accessed on June 4, 2018.
  2. 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.
  3. Chantry CJ, Eglash A, Labbok M. ABM Position on Breastfeeding-Revised 2015. Breastfeed Med. 2015; 10(9):407-411.
  4. Becker GE, Smith HA, Cooney F. Methods of milk expression for lactating women. Cochrane Database Syst Rev. 2015; (2):CD006170.
  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: http://www.nationalacademies.org/hmd/Reports/2011/Clinical-Preventive-Services-for-Women-Closing-the-Gaps.aspx. Accessed on June 4, 2018.
  7. 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.
  8. 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.
  9. Johnston M, Landers S, Noble L, et al. Breastfeeding and the use of human milk. Pediatrics. 2012; 129(3):e827-e841.
  10. Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2012; (15):CD003517.
  11. 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.
  12. U.S. Food and Drug Administration 510(k) Premarket Notification Database.
  13. 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.
  14. World Health Organization. Long-term effects of breastfeeding: a systematic review. 2013. Available at: http://www.who.int/maternal_child_adolescent/documents/breastfeeding_long_term_effects/en/. Accessed on June 4, 2018.
Websites for Additional Information
  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 June 4, 2018.
  2. U.S. Department of Health and Human Services Offices on Women’s Health. Breastfeeding. Last updated April 25, 2018. Available at: https://www.womenshealth.gov/Breastfeeding. Accessed on June 4, 2018.
  3. U.S. Food and Drug Administration. Breast Pumps. March 26, 2018. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BreastPumps/default.htm. Accessed on June 4, 2018.
  4. U.S. National Library of Medicine. MedlinePlus. Breastfeeding. Last reviewed on September 25, 2017. Available at: https://www.nlm.nih.gov/medlineplus/breastfeeding.html. Accessed on June 4, 2018.
  5. World Health Organization. 10 facts on breastfeeding. Updated August 2017. Available at: http://www.who.int/features/factfiles/breastfeeding/en/index.html. Accessed on June 4, 2018.
Index

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 Smartpump
Lansinoh SignaturePro
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.

History

Status

Date

Action

Reviewed

07/26/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Discussion and References sections.

 

05/02/2018

The document header wording updated from “Current Effective Date” to “Publish Date.”

Revised

08/03/2017

MPTAC review. Revised to add medically necessary and not medically necessary indications for standard, non-hospital grade electric breast pumps. Revised title from Breastfeeding Pumps to Electric Breast Pumps. Updated Coding, Description, Discussion/General Information, References and Websites sections.

Reviewed

08/04/2016

MPTAC review. Updated Discussion/General Information, References and Websites sections. Updated formatting in Clinical Indications section. Removed ICD-9 codes from Coding section.

Reviewed

08/06/2015

MPTAC review. Updated Description/Scope, References and Websites sections.

Reviewed

08/14/2014

MPTAC review. Updated Discussion/General Information, References and Websites sections.

New

08/08/2013

MPTAC review. Initial document development.