Rule 5160-10-25 | DMEPOS: lactation pumps.
(A) Definitions and explanations.
(1) "Multiple-user lactation pump" is a lactation pump that is safe for use by multiple individuals; it comes with a separate set of accessories (e.g., breast shields, tubing) for each individual, which reduces the risk of contamination. Such a pump is sometimes referred to as "hospital-grade," but this term is not recognized by the United States food and drug administration. A multiple-user lactation pump is characterized, but not defined, by the following capabilities:
(a) Adjustable suction pressure from one hundred to two hundred fifty millimeters of mercury (mm Hg);
(b) A mechanism to prevent suction greater than two hundred fifty mm Hg; and
(c) An adjustable pumping speed capable of reaching fifty-two cycles per minute.
(2) The prescriber of a lactation pump may be involved in the care of the individual woman, of the infant, or of both.
(1) Payment may be made for the purchase of a single-user manual or electric lactation pump as a medical supply item or for the rental of a multiple-user lactation pump for a period of ninety days.
(2) The default certificate of medical necessity (CMN) form is the ODM 01901, "Certificate of Medical Necessity: Lactation Pumps" (rev. 7/2018). The CMN must include an attestation to at least one of the following statements of need:
(a) The infant is unable to initiate breastfeeding because of a medical condition (e.g., prematurity, oral defect);
(b) Breastfeeding is not possible because the woman and the infant are separated;
(c) The woman is or will be taking a medication or undergoing a diagnostic test that contraindicates breastfeeding;
(d) The milk supply is inadequate for breastfeeding;
(e) The breasts are engorged; or
(f) Infection of the breast is present.
(3) After the initial rental period, payment may be made for additional rental of a multiple-user lactation pump. The additional rental period is limited to ninety days; overall rental cannot exceed one hundred eighty days. During the initial rental period, the provider must obtain a revised copy of the previously completed CMN, on which the prescriber includes the following information:
(a) A description, including approximate age and ownership, of any similar equipment currently in the individual's possession;
(b) An explanation of why additional rental of the multiple-user lactation pump is warranted; and
(c) The length of the additional rental period.
(C) Requirements, constraints, and limitations.
(1) The warranty period for a covered manual or electric lactation pump is one year from the date of delivery.
(2) When a manual lactation pump is supplied as part of a pump accessory kit, separate payment will not be made for the manual lactation pump, nor will separate payment be made for an additional manual lactation pump.
(3) Separate payment will not be made for more than one set of accessories nor for cleaning of a rental unit. Replacement of a lost or damaged accessory or payment of a reasonable charge for extensive cleaning (if a unit is returned in unusable condition) is the responsibility of the individual.
Last updated October 15, 2021 at 9:04 AM