Rule 5160-10-25 | DMEPOS: lactation pumps.
(A) Definitions and explanations.
(1) "Multiple-user lactation pump" is a lactation pump that is safe for sequential use by multiple individuals. (The term "hospital-grade," which is often applied to such a pump, is not recognized by the United States food and drug administration.) A multiple-user lactation pump comes with a separate set of accessories (e.g., breast shields, tubing) for each individual, which reduces the risk of contamination. It generally features adjustable suction pressure and adjustable pumping speed. It is intended only for temporary, short-term use.
(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 either or both of the following purposes:
(a) Purchase of a single-user manual or electric lactation pump as a medical supply item and purchase of any necessary replacement supplies; or
(b) Rental of a multiple-user lactation pump.
(2) For a single-user manual or electric lactation pump, a prescription is sufficient. No separate certificate of medical necessity (CMN) is needed.
(3) For a multiple-user lactation pump, the default CMN form is the ODM 01901, "Certificate of Medical Necessity: Multiple-User Lactation Pumps" (rev. 1/2022).
(a) On the CMN, the prescriber explains and attests to the medical necessity of the pump.
(b) On the CMN, the prescriber specifies the expected number of ninety-day rental periods. If additional rental periods are needed, the prescriber may either revise the existing CMN or complete a new CMN.
(C) Constraints and limitations.
(1) The warranty period for a covered single-user 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) Payment for the rental of a multiple-user lactation pump includes all accessories, supplies, and cleaning.
(4) ODM is not responsible for failure to return a multiple-user lactation pump in working order.
Last updated January 3, 2022 at 9:50 AM