Clinical UM Guideline


Subject:Breastfeeding Pumps
Guideline #:  CG-DME-35Current Effective Date:  10/08/2013
Status:NewLast Review Date:  08/08/2013

Description

Breastfeeding and human milk provide natural, normal nutrition for all infants.  Manual and standard electric breast pumps are available for mothers of healthy infants, who are not always home to breast-feed the baby due to work, travel, or other reasons.

This document addresses the non-standard, electric, heavy-duty, hospital-grade breast pump for initiating and maintaining expression of human breast milk in specified situations.  An electric, heavy-duty, hospital-grade breast pump is defined as durable medical equipment (DME) that is U.S. Food and Drug Administration (FDA) approved for reuse by multiple lactating women (not for single person/personal use) and billed with HCPCS code E0604.

Clinical Indications

Medically Necessary:

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, 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.  A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference. 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 
E0604Breast pump, hospital grade, electric (AC and/or DC), any type
  
ICD-9 Diagnosis 
 All diagnoses
  
ICD-10 DiagnosisICD-10-CM draft codes; effective 10/01/2014
 All diagnoses
  
Discussion/General Information

The U.S. 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 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, 2013).  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. 

The strongest type of pump is the electric, heavy-duty breast 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).  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 (2012) 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 completely 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 adequate, necessary nutrients for healthy growth and development.  

The National Association of Neonatal Nurses (NANN, 2011) 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, 2007), 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, 2008) 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.

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) and billed with the HCPCS code E0604.

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

References

Peer Reviewed Publications:

  1. Johnston M, Landers S, Noble L, et al. Breastfeeding and the use of human milk. Pediatrics. 2012; 129(3):e827-e841.
  2. 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.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Academy of Breastfeeding Medicine Board of Directors. Position on breastfeeding. Breastfeed Med. 2008; 3(4):267-270.
  2. Becker GE, Cooney F, Smith HA. Methods of milk expression for lactating women. Cochrane Database of Systematic Reviews 2011, Issue 12. Art. No.: CD006170.
  3. 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.
  4. Committee on Preventive Services for Women; Institute of Medicine. Clinical Preventive Services for Women: Closing the Gaps. July 19, 2011. Available at: http://www.iom.edu/~/media/Files/Report%20Files/2011/Clinical-Preventive-Services-for-Women-Closing-the-Gaps/preventiveservicesforwomenreportbrief_updated2.pdf. Accessed on June 13, 2013.
  5. 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.
  6. 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.
  7. Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2012, Issue 15. Art.8 No.:CD003517.
  8. National Association of Neonatal Nurses. The use of human milk and breastfeeding in the neonatal intensive care unit: NANN position statement #3052. Adv Neonatal Care. 2012; 12(1):56-60.
  9. 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 June 11, 2013.
  10. U.S. Food and Drug Administration 510(k) Premarket Notification Database. 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 June 11, 2013.
  11. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Medela® Powered Breast Pump Symphony®. No. K020518. Rockville, MD: FDA. May 3, 2002. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K020518.pdf. Accessed on June 11, 2013.
  12. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Nurture III Breast Pump. No. K020375. Rockville, MD: FDA. June 10, 1997. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K020375.pdf. Accessed on June 11, 2013.
  13. U.S. Preventive Services Task Force (USPSTF). Primary care interventions to promote breastfeeding: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2008; 149(8):560-564.
  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 15, 2013.
Web Sites for Additional Information
  1. Centers for Disease Control and Prevention. Breastfeeding. October 20, 2009. Available at: http://www.cdc.gov/breastfeeding/resources/guide.htm. Accessed on June 13, 2013.
  2. U.S. Department of Health and Human Services Offices on Women's Health. Breastfeeding. April 5, 2013. Available at: http://www.womenshealth.gov/breastfeeding/. Accessed on June 13, 2013.
  3. U.S. Food and Drug Administration. Breast Pumps. January 26, 2013. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BreastPumps/default.htm. Accessed on June 15, 2013.
  4. World Health Organization. 10 facts on breastfeeding. July 2012. Available at: http://www.who.int/features/factfiles/breastfeeding/en/index.html. Accessed on June 15, 2013.
Index

Medela® Powered Breast Pump Symphony®
Nurture III Breast Pump®
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

New

08/08/2013

 

Medical Policy & Technology Assessment Committee (MPTAC) review. Initial document development.