Items Provided on a Recurring Basis and Request for Refill Requirements - Annual Reminder - January 2024

Joint DME MAC Publication
Posted January 4, 2024

Requirements

For all DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary, and document an affirmative response, 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, existing supplies are expected to end, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to expected end of the current supply. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply. This is regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee and document an affirmative response, prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request and an affirmative response from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the ordering practitioners that any changed or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a one- or three-month quantity at a time. See below for billing frequencies.

Documentation Requirements

A routine refill prescription is not needed. A new order/prescription is required:

  • For all claims for purchases or initial rentals;
  • If there is a change in the DMEPOS order/prescription (e.g. quantity);
  • On a regular basis (even if there is no change in the order/prescription) only if it is so specified in the documentation section of a particular medical policy;
  • When an item is replaced; and
  • When there is a change in the supplier, and the new supplier is unable to obtain a copy of a valid order/prescription for the DMEPOS item from the transferring supplier.

For items that the beneficiary obtains in-person at a retail store, the signed delivery slip or copy of itemized sales receipt is sufficient documentation of a request for refill.

For items that are delivered to the beneficiary, documentation of a request for refill must be individualized to the beneficiary (i.e., the beneficiary or their caregiver/designee affirms the need for refill) and documented in the record. Medicare does not prescribe the mode of communication used to gather the information. For example, the refill request communication may be performed via automated text messaging or email as long as each required aspect of the refill request is captured. The refill request must occur and be documented before shipment. A retrospective attestation statement by the supplier or beneficiary is not sufficient. The refill record must include:

  • Beneficiary's name or authorized representative if different from the beneficiary
  • A description of each item that is being requested
  • Documentation of affirmative response indicating a need for refill
  • Date of refill request

This information must be kept on file and be available upon request.

Billing Frequencies

For refills of enteral and parenteral nutrients and supplies, immunosuppressive drugs, intravenous immune globulin, oral anti-cancer drugs, oral antiemetic drugs, and surgical dressings only a one-month quantity of supplies may be dispensed.

For all other refills that are provided on a recurring basis, suppliers may dispense no more than a three-month supply at any one time.

Miscellaneous

These requirements are not limited to DMEPOS refills for items addressed in LCDs only. All DMEPOS items that are refilled on a recurring basis are subject to these requirements.

For additional information, refer to the Standard Documentation Requirements for All Claims Submitted to DME MACs (A55426) article attached to each Local Coverage Determination and the DME MAC Supplier Manual.

Publication History

Date of Change Description
01/04/24 Annual Reminder as required by IOM 100-04, Ch. 20, Sec. 200
Last Updated Jan 04 , 2024