CMS Pub. 100-08, ch. 5, § 5.2.6

to the Original Order

(Rev. 12512; Issued: 02-15-24; Effective: 01-01-24; Implementation: 02-19-24)

Per 42 CFR 410.38 related to DMEPOS products that are supplied as refills to the

original order/prescription, suppliers must contact the beneficiary prior to dispensing

the refill and not automatically ship on a pre-determined basis, even if authorized by

the beneficiary. This shall be done to ensure that the refilled item remains reasonable

and necessary and to confirm any changes/modifications to the SWO. The DMEPOS

supplier must document contact with the beneficiary or their representative to verify

the refill is needed. This documentation must include the following:

• Evidence of the beneficiary or their representative’s affirmative response of

the need for supplies, which should be obtained as close to the expected end

of the current supply as possible. However, such contact and affirmative

response must be within 30 calendar days from the expected end of the

current supply.

o For shipped items: the beneficiary’s name, date of contact, the item

requested, and an affirmative response from the beneficiary,

indicative of the need for refill, prior to dispensing the product is

required. Beneficiary’s need not count the remaining supply.

o For items obtained in-person from a retail store, the delivery slip

signed by the beneficiary or their representative or a copy of the

itemized sales receipt is sufficient documentation of a request for

refill.

Suppliers are permitted to use any mode of communication so long as the beneficiary

affirmation is received, and documentation of the contact is captured and can be

provided upon request.

• For example, automated text messaging or email may be used so long as the

captured information demonstrates the beneficiary’s name, item(s), date of

contact, and affirmative response.

For delivery of refills, the supplier must deliver the DMEPOS product no sooner than

10 calendar days prior to the end of usage for the current product. This is regardless of

which delivery method is utilized. DME MACs shall allow for the processing of

claims for refills delivered/shipped prior to the beneficiary exhausting his/her supply.