Commercial

Medical Policy

Notification

Breast Pumps

Notification Issue Date:

This version of the policy will become effective 01/01/2023.

This policy has been updated to expand the medical necessity criteria for coverage of breast pumps and supplies in accordance with the Health Resources & Services Administration (HRSA), Women's Preventive Services Initiative (WSPI).

Title:

Breast Pumps

Policy #:

05.00.76h

Policy

BREAST PUMPS

MEDICALLY NECESSARY
Nonhospital 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 hospitalization and direct breastfeeding is not possible (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
Breast pump supplies that are an integral part of the breast pump function and breast milk storage supplies (e.g., breast milk storage bags, collection bottles) are 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 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 durable medical equipment (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 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 7 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 5 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 DME supplier may be required to reimburse the Company for overpayments.

Guidelines

Only one nonhospital-grade electric, battery-powered, or manual breast pump and breast milk storage supplies (e.g., breast milk storage bags, collection bottles) are 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.

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.

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 2019 national rate for infants receiving some breastmilk was 83.2%. At 6 months, 55.8% of infants receive any breast milk and 24.9% received breast milk exclusively.

RECOMMENDATIONS FOR BREASTFEEDING
Although there are some specific conditions in which a mother should not breastfeed, the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) recommend that all babies, with rare exceptions, be exclusively breastfed for approximately 6 months and continue breastfeeding with appropriate complementary foods for at least 1 year. The World Health Organization (WHO) and the American College of Obstetricians and Gynecologists (ACOG) also recommend exclusively breastfeeding for approximately 6 months, but they recommend that breastfeeding with complementary foods can continue beyond 1 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 that may 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 that 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 that 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.

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 2016. Breastfeed Med. 2016;11(10):494-500.

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

Academy of Breastfeeding Medicine. ABM Clinical Protocol #16: Breastfeeding and the Hypotonic Infant, Revision 2016. Breastfeed Med. 2016;11(6)271-276.

Academy of Breastfeeding Medicine. ABM Clinical Protocol #17: Guidelines for breastfeeding infants with cleft lip, cleft palate, or cleft lip and palate—Revised 2019. Breastfeed Med. 2019;14(7):437-444.

American Academy of Family Physicians (AAFP). Breastfeeding, family physicians supporting (position paper). [AAFP Web site]. 10/01/2014. Available at: https://www.aafp.org/about/policies/all/breastfeeding-position-paper.html. Accessed September 21, 2023.

American Academy of Family Physicians. Breastfeeding (Policy Statement). [AAFP Website]. 2017. Available at: https://www.aafp.org/about/policies/all/breastfeeding-policy-statement.html. Accessed September 21, 2023.

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. ACOG committee opinion No. 316: Breastfeeding: maternal and infant aspects. Obstet Gynecol. 2007;109:479-480.

Becker GE, Smith HA, Cooney F. Methods of milk expression for lactating women. Cochrane Database Syst Rev. 2016;9: Art. No.: CD006170.

Centers for Disease Control and Prevention (CDC). Breast feeding report card. [CDC Website]. 2022. Available at: https://www.cdc.gov/breastfeeding/data/reportcard.htm. Accessed September 21, 2023.

Health Resources & Services Administration (HRSA). Women's Preventive Services Guidelines: Affordable Care Act Expands Prevention Coverage for Women's Health and Well-Being. July 2022. [HRSA.gov Web site]. Available at: https://www.hrsa.gov/womens-guidelines/index.html. Accessed September 21, 2023.

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: https://nap.nationalacademies.org/catalog/13181/clinical-preventive-services-for-women-closing-the-gaps. Accessed September 21, 2023.

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

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 September 21, 2023.

US Centers for Disease Control and Prevention. The Surgeon General's Call to Action to Support Breastfeeding. 01/20/2011. Available at: https://www.cdc.gov/breastfeeding/resources/calltoaction.htm. Accessed September 21, 2023.

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 January 2022. Available at: https://www.hrsa.gov/womens-guidelines-2016/index.html. Accessed September 21, 2023.

US Food and Drug Administration. Buying and Renting a Breast Pump. [FDA Web site]. 09/14/2021. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BreastPumps/ucm061952.htm. Accessed September 21, 2023.

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 September 21, 2023.

World Health Organization (WHO). Infant and young child feeding. 06/09/2021. Available at: http://who.int/mediacentre/factsheets/fs342/en/. Accessed September 21, 2023.

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

A4287 Disposable collection and storage bag for breast milk, any size, any type, each

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 05.00.76h:

01/02/2024

This policy has been identified for the HCPCS code update and will become effective 01/02/2024.

The following HCPCS code has been deleted from this policy:

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

The following HCPCS code has been added to this policy:

A4287 Disposable collection and storage bag for breast milk, any size, any type, each

Revisions From 05.00.76g:

11/01/2023

This policy has been reviewed and reissued to communicate the Company's continuing position on Breast Pumps.

The following has been deleted from this policy:

New Jersey Mandate. Coverage of breast pumps and supplies has been nationally expanded in accordance with HRSA and WSPI, and no longer applies solely to New Jersey. The intent of the policy remains unchanged.

01/01/2023

This version of the policy will become effective 01/01/2023.

Revisions From 05.00.76f:

10/03/2022

This version of the policy will become effective 10/03/2022.

This policy has been updated to clarify the existing criteria language addressing the current State of New Jersey Breastfeeding mandate for coverage of breast pumps and supplies, specifically for breast milk storage bags.

The following HCPCS code has been revised to state it is not covered except for members enrolled in NJ products subject to the NJ mandate:

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

Revisions From 05.00.76e:

01/17/2022

This version of the policy will become effective 01/17/2022.

This policy has been updated to relocate the existing criteria language addressing the current State of New Jersey mandate for coverage of breast pumps and supplies for individuals enrolled in New Jersey commercial products to the Policy Section of this document.

Revisions From 05.00.76d:

12/07/2020

This version of the policy will become effective 12/07/2020.

This policy has been updated to address the State of New Jersey mandate for coverage of breast pumps and supplies for individuals enrolled in New Jersey commercial products.

Revisions From 05.00.76c:

01/01/2020

This policy has been identified for the HCPCS code update and will become effective 01/01/2020.

The following HCPCS code has been added to this policy as not covered:

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

Revisions From 05.00.76b:

02/25/2019

This version of the policy will become effective 02/25/2019.

The intent of this policy remains unchanged, but the policy has been updated to further clarify that a hospital-grade breast pump is eligible for rental when medical necessity criteria are met, and one non-hospital grade electric, battery-powered, or manual breast pump is covered per pregnancy.

Revisions From 05.00.76a:

02/15/2018

The policy has been reviewed and reissued to communicate the Company’s continuing position on Breast Pumps.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

1/2/2024

Version Issued Date:

1/2/2024

Version Reissued Date: