Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Breast Pumps

Policy #:05.00.76b

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

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 (E0602, E0603) are only eligible as a purchase.
  • Hospital-grade breast pumps (E0604) 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.

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete 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 order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
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
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.

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). Updated October 1, 2014. Available at: http://www.aafp.org/about/policies/all/breastfeeding-support.html. Accessed November 29, 2018.

American Academy of Family Physicians. Breastfeeding (Policy Statement). Available at: http://www.aafp.org/about/policies/all/breastfeeding.html. Accessed November 29, 2018.

American Academy of Family Physicians (AAFP) Releases Position Paper on Breastfeeding. Am Fam Physician. 2015;91(1):56-57. Available at:
http://www.aafp.org/afp/2015/0101/p56.html. Accessed November 29, 2018.

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 (2016). Optimizing support for breastfeeding as part of obstetric practice. 2018; 132(4):e187-e196. Available at: https://journals.lww.com/greenjournal/Fulltext/2018/10000/ACOG_Committee_Opinion_No__756___Optimizing.62.aspx. Accessed December 4, 2018.

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 November 29, 2018.

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.

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. 2018. Available at: https://www.cdc.gov/breastfeeding/pdf/2018breastfeedingreportcard.pdf. Accessed December 4, 2018.

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 10/2017. Available at: https://www.hrsa.gov/womens-guidelines-2016/index.html. Accessed November 29, 2018.

US Department of Health and Human Services. The Surgeon General's Call to Action to Support Breastfeeding. 2011. Available at: http://www.surgeongeneral.gov/library/calls/breastfeeding/calltoactiontosupportbreastfeeding.pdf. Accessed November 29, 2018.

US Food and Drug Administration. Buying and Renting a Breast Pump. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BreastPumps/ucm061952.htm. Accessed November 29, 2018.

US Food and Drug Administration. Types of Breast Pumps. Page Last Updated: 5/16/2016. Available at:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BreastPumps/ucm061584.htm. Accessed November 29, 2018.

World Health Organization (WHO). Infant and young child feeding. 2/2018. Available at:
http://who.int/mediacentre/factsheets/fs342/en/. Accessed December 4, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

05.00.76b
02/25/2019This 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.

05.00.76a
02/15/2018The 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: 02/25/2019
Version Issued Date: 02/25/2019
Version Reissued Date: N/A

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.