Commercial

Breast Pumps
05.00.76d

Policy

State mandates do not automatically apply to self-funded groups; therefore, individual group benefits must be verified.

BREAST PUMPS

MEDICALLY NECESSARY
Non-hospital grade electric, battery-powered, or manual breast pumps are considered medically necessary and, therefore, covered for all breastfeeding individuals for the duration of breastfeeding.

Hospital-grade breast pumps are considered medically necessary and, therefore, covered when any of the following criteria are met:
  • Separation of infant from mother due to a prolonged hospitalization (e.g., detained premature newborn)
  • Prematurity up to 36 6/7 weeks of gestation and the mother is pumping breast milk awaiting the baby's ability to nurse directly from the breast.
  • Infant has a medical condition that interferes with breastfeeding, including, but not limited to:
    • Cleft lip or palate
    • Excessive weight loss
    • Insufficient weight gain
    • Muscular hypotonicity
    • Other cranial/facial malformation that interferes with breastfeeding
    • Other neurological condition that interferes with breastfeeding
  • Mother has a medical condition that interferes with breastfeeding

SUPPLIES

COVERED
Only a breast pump supply that is an integral part of the breast pump function is covered and eligible for reimbursement consideration by the Company.

NOT COVERED
Breast pump supplies not integral to the function of a breast pump are not covered. Therefore, they are not eligible for reimbursement consideration.

Examples of breast pump supplies not integral to the function of the breast pump, include, but are not limited to, any of the following:
  • Breast milk storage bags
  • Breast pump cleaning supplies including soap, sprays, wipes, steam cleaning bags, and other similar products
  • Electrical power adapters for travel
  • Garments or other products that allow for positioning or hands-free pump operation
  • Ice-packs
  • Labels, labeling lids, and other similar products
  • Nursing bras, bra pads, and other similar products
  • Scales
  • Travel bags, and other similar travel or carrying accessories

BILLING REQUIREMENTS

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.
  • Manual, battery-powered, and electric breast pumps are only eligible as a purchase.
  • Hospital-grade breast pumps are only eligible as a rental.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services 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.

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES (WHEN APPLICABLE)
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.

Guidelines

Only one non-hospital grade electric, battery-powered, or manual breast pump is covered per pregnancy.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, breast pumps are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

NEW JERSEY STATE ​​MANDATE

 

This policy is consistent with applicable state mandates. The laws of the state where the group benefit contract is issued determine the mandated coverage: 

 

For individuals enrolled in New Jersey commercial products, the State of New Jersey mandates coverage of breast pumps and supplies and establishes deadlines by which breast pumps and supplies must be provided to an individual following a request.​ This mandate is effective for all newly issued contracts and contracts renewed on or after July 14, 2020.


The following breast pumps and supplies may be eligible​ for coverage: ​

  • Purchase of a single-user breast pump – may be manual or double electric. No letter of medical necessity, prior authorization or prescription is required. The pump will be repaired or replaced, if necessary. 
  • Rental of a multi-user (hospital-grade) breast pump on the recommendation of a professional provider. A physician's order is required. 
  • ​Purchase of two breast pump kits, which includes a collection of tubing, valves, collection bottles, appropriate size breast pump flanges, or other lactation accessories recommended by a professional provider per birth event. ​
US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved manual, battery-powered, and electric breast pumps and considers them Class I or II devices. Hospital-grade breast pumps are defined by the FDA as an electric breast pump approved for multiple users. These are considered Class II devices.

Description

BREASTFEEDING

Breastfeeding has been proven to provide many benefits to infants. Studies have shown that breastfeeding decreases the rate of infant mortality, gastrointestinal infections, ear infections, childhood leukemia, asthma, respiratory diseases, risk of obesity, urinary tract infections, and hospitalizations. Breastfeeding benefits the mother as well by significantly lowering the risk of breast and ovarian cancers. The national rate for breastfeeding has been increasing over the years due to initiatives to promote and support breastfeeding. The 2015 national rate for infants ever breast fed is 83.2% with 57.6% for 6 months and 35.9% for 12 months.

RECOMMENDATIONS FOR BREASTFEEDING
While there are some specific conditions where a mother should not breastfeed, the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommends that all babies, with rare exceptions, be exclusively breastfed for approximately six months and continue breastfeeding with appropriate complementary foods for at least one year. The World Health Organization (WHO) and the American College of Obstetricians and Gynecologists (ACOG) also recommends exclusively breastfeeding for approximately six months, but they recommend that breastfeeding with complementary foods can continue beyond one year.

BREAST PUMPS

Breast pumps are medical devices regulated by the US Food and Drug Administration (FDA) to assist women to extract their breast milk. Breast pumps can be used to maintain or increase a woman’s milk supply, relieve engorged breasts and plugged milk ducts, assist in relieving mastitis, or pull out flat or inverted nipples so a nursing baby can latch-on to its mother’s breast more easily. There are three basic types of breast pumps; manual, battery-powered, and electric. Most manual and battery-powered pumps extract milk one breast at a time. Unlike manual and battery-powered pumps, most electric breast pumps are able to extract milk from both breasts at the same time. Most standard manual, battery powered, and electric breast pumps are intended for a single user. Hospital-grade pumps are heavy-duty electric pumps FDA-approved for multiple users. Hospital-grade breast pumps can help to increase milk supply.

Per the FDA, all breast pumps consist of a few basic parts:
  • Breast Shield: a cone-shaped cup that fits over the nipple and the circular area surrounding the nipple (the areola).
  • Pump: creates the gentle vacuum that expresses milk. The pump may be attached to the breast-shield or have plastic tubing to connect the pump to the breast-shield.
  • Milk Container: a detachable container that fits below the breast-shield and collects milk as it is pumped. The container is typically a reusable bottle or disposable bag that can be used to store the milk or be attached to a nipple and used for feeding a baby.

The breast pump also has associated supplies required for the function of the pump, such as tubing, breast pump bottle and cap, breast shield and splash protector, locking ring for bottle cover, and tubing adapters that allow the breast milk to be pumped directly into the baby bottle, instead of the breast pump bottle.

Additional breast pump supplies may be offered with the pump (e.g. ice packs, travel bag, cleaning supplies) but, may not be integral to the functioning of the breast pump.

RECOMMENDATIONS FOR BREAST PUMPS
In accordance with the Affordable Care Act, the US Department of Health and Human Services recommends the costs of renting breastfeeding equipment is a preventive service and is, therefore, covered at no cost-share for an individual for the duration of breastfeeding. This recommendation was based on the Institute of Medicine’s Clinical Preventive Services for Women: Closing the Gaps report. This report stated it is important for mothers to have access to obtaining a breast pump to maintain their milk supply and improve overall breastfeeding rates.

Hospital-grade breast pumps are beneficial for infants who have difficulty breastfeeding for anatomic or mechanical reasons or who are hospitalized or otherwise separated from their mother for a prolonged period. The AAFP recommends that a mother use a hospital-grade pump to prevent reduction in milk supply during long periods of maternal-infant separation due to maternal or neonatal issues. The prolonged period of separation is usually due to the baby being in the neonatal intensive care unit (NICU).

Infants may have medical disorders that may interfere with breastfeeding, such as hypotonia or cleft lip and/or cleft palate. Infants with these types of disorders have difficulty creating suction during breastfeeding. This can lead to malnutrition. Due to this difficulty in creating suction, it is recommended that the baby's mother use a hospital-grade breast pump to produce adequate amounts of breast milk to provide to the baby.

References


Academy of Breastfeeding Medicine. ABM Clinical Protocol #10: Breastfeeding the late preterm infant (34-36 6/7 weeks of gestation) and early term infants (37-38 6/7 weeks of gestation). (Second Revision December 2016). Breastfeeding Medicine. 2016;11(10):494-500.

Academy of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #7: Model Breastfeeding Policy (Revision 2010). Breastfeeding Medicine. 2010;5(4):173-177.

Academy of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #9: Use of galactogogues in initiating or augmenting maternal milk production (Second Revision January 2018). Breastfeeding Medicine. 2018;13(5):307-314.

American Academy of Family Physicians. Breastfeeding, family physicians supporting (position paper). [AAFP Web site]. 10/01/2014. Available at: http://www.aafp.org/about/policies/all/breastfeeding-support.html. Accessed October 20, 2020.

American Academy of Family Physicians. Breastfeeding (Policy Statement). [AAFP Web site]. 2017. Available at: http://www.aafp.org/about/policies/all/breastfeeding.html. Accessed October 20, 2020.

American Academy of Family Physicians (AAFP) Releases Position Paper on Breastfeeding. Am Fam Physician. 2015;91(1):56-57.

American Academy of Pediatrics. Breastfeeding and the use of human milk. Pediatrics. 2012;129:e827-e841.

American College of Obstetricians and Gynecologists. ACOG committee opinion No. 756. Optimizing support for breastfeeding as part of obstetric practice. Obstet Gynecol.  2018; 132(4):e187-e196.

American College of Obstetricians and Gynecologists. Breastfeeding: maternal and infant aspects. Obstet Gynecol. 2007;109:479-480.

Becker GE, McCormick FM, Renfrew MJ. Methods of milk expression for lactating women. Cochrane Database Syst Rev. 2008;4:CD006170.

Institute of Medicine. Clinical Preventive Services for Women: Closing the Gaps. 2011. Women’s Preventive Services Recommended by IOM to be Covered Under Affordable Care Act. Available at:
http://www.nationalacademies.org/hmd/Reports/2011/Clinical-Preventive-Services-for-Women-Closing-the-Gaps/Action-Taken.aspx. Accessed October 20, 2020.

Meier P, Engstrom J et al. Improving the use of human milk during and after the NICU stay. Clin Perinatol. 2010;37(1):217-245.

NJ AN ACT concerning health benefits coverage for breastfeeding support and supplementing various parts of the statutory law. P.L.2019, c.343 (C.17:48-6ss et al.)​ [NJ.gov Web site]. Available at : https://www.nj.gov/treasury/pensions/documents/laws/ch343-2019.pdf. Accessed October 20, 2020.

Reilly S, Reid J. ABM Clinical Protocol #17:Guidelines for breastfeeding infants with cleft lip, cleft palate, or cleft lip and palate, revised 2013. Breastfeeding Medicine. 2013;8(4):349-353.

Thomas J, Marinelli K. ABM Clinical Protocol #16: Breastfeeding and the Hypotonic Infant. Breastfeeding Medicine. 2007;2(2): 112-118.

US Centers for Disease Control and Prevention. Breastfeeding Report Card. 2020. Available at: https://www.cdc.gov/breastfeeding/data/reportcard.htmAccessed October 20, 2020

US Department of Health and Human Services. Women's Preventive Services: Required Health Plan Coverage Guidelines Supported by the Health Resources and Services Administration. last reviewed October 2019. Available at: https://www.hrsa.gov/womens-guidelines-2016/index.html. Accessed October 20, 2020.

US Department of Health and Human Services. The Surgeon General's Call to Action to Support Breastfeeding. 01/05/2020. Available at: https://www.cdc.gov/breastfeeding/resources/calltoaction.htm.
 Accessed October 20, 2020.

US Food and Drug Administration. Buying and Renting a Breast Pump. [FDA Web site]. 01/15/2018. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BreastPumps/ucm061952.htm. Accessed October 20, 2020.

US Food and Drug Administration. Types of Breast Pumps. [FDA Web site]. 02/04/2018. Available at:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BreastPumps/ucm061584.htm. Accessed October 20, 2020.

World Health Organization (WHO). Infant and young child feeding.08/24/2020. Available at:
http://who.int/mediacentre/factsheets/fs342/en/. Accessed October 20, 2020.


Coding

CPT Procedure Code Number(s)
N/A

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)
N/A

HCPCS Level II Code Number(s)

THE FOLLOWING CODES ARE USED TO REPRESENT BREAST PUMPS:

E0602 Breast pump, manual, any type

E0603 Breast pump, electric (AC and/or DC), any type

E0604 Breast pump, hospital grade, electric (AC and/or DC), any type

THE FOLLOWING CODES ARE USED TO REPRESENT BREAST PUMP SUPPLIES:

A4281 Tubing for breast pump, replacement

A4282 Adapter for breast pump, replacement

A4283 Cap for breast pump bottle, replacement

A4284 Breast shield and splash protector for use with breast pump, replacement

A4285 Polycarbonate bottle for use with breast pump, replacement

A4286 Locking ring for breast pump, replacement

NOT COVERED

K1005 Disposable collection and storage bag for breast milk, any size, any type, each


Revenue Code Number(s)
N/A



Coding and Billing Requirements


Policy History

12/7/2020
12/7/2020
05.00.76
Medical Policy Bulletin
Commercial
No