Rule 5160-10-23 | DMEPOS: pulse oximeters.
(1) Any pulse oximeter for which payment is made must meet the following criteria:
(a) It is correctly calibrated, preset, and sealed such that its settings cannot be adjusted by the average user; and
(b) It is capable either of converting data (e.g., number of sampling hours, oxygen saturation level, aggregated results) directly to electronic or printed form or of recording and storing data for later conversion.
(2) Payment may be made for a pulse oximeter on a rental/purchase basis. The default certificate of medical necessity (CMN) form is the ODM 03401, "Certificate of Medical Necessity: Pulse Oximeters" (rev. 7/2018). The CMN must include an attestation by a prescriber that a need exists either for diagnostic monitoring or for continuous monitoring:
(a) For diagnostic monitoring undertaken in response to an acute clinical event or the exacerbation of an existing condition, the prescriber includes the following information:
(i) An attestation that at least one of the following two criteria has been met:
(a) The individual was currently being weaned or was about to be weaned from an oxygen supply; or
(b) The individual was oxygen-dependent and was in a clinically unstable condition; and
(ii) Any previously recorded oximeter data accompanied by an assessment of the resulting impact on the management of the individual's care.
(b) For continuous monitoring twenty-four hours per day, the prescriber attests to three statements:
(i) The individual exhibits clinical instability (evidenced by chronically compromised respiration and frequently varying oxygen requirements);
(ii) The individual is at risk for critical fluctuations in oxygen saturation (e.g., hyperoxia, hypoxia), and
(iii) At least one of the following conditions is present:
(a) Frequent bradycardia;
(b) Frequent oxygen desaturation;
(c) Chronic lung disease;
(e) Poor growth and development suggesting inadequate oxygenation; or
(f) Another specific risk factor that causes sudden, critical fluctuations in oxygen saturation.
(3) The rental or purchase of a pulse oximeter includes the following items and services:
(a) Service calls;
(b) Supplies and accessories (e.g., cable, printer, printer tape, carrying case); and
(c) Probe wraps or tape.
(4) Separate payment may be made for probes.
(B) Requirements, constraints, and limitations.
(1) It is understood that because of the nature of diagnostic monitoring, authorization for payment can generally be granted only after the service has been provided.
(2) No single rental period can be longer than three months.