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Refill Documentation Updates Ask the Contractor Meeting (ACM) – December 20, 2023

The following questions and answers are from the CGS Jurisdiction B and Jurisdiction C ACM on December 20, 2023. During the meeting we reviewed the updates to refill documentation requirements published on December 14, 2023 and effective January 1, 2024 in the Standard Documentation Requirements for All Claims Submitted to DME MACs Policy Article (A55426)External Website.

We summarized and edited the questions and answers for clarity and conciseness. The answers were accurate at the time posted.

Questions and Answers

  1. When did the changes to the refill documentation take place?

    Answer: The DME MACs revised the Standard Documentation Requirements for All Claims Submitted to DME MACs Policy Article (A55426)External Website and applicable Local Coverage Determinations (LCDs) on December 14, 2023. We published the list of applicable LCDs and Policy Articles in the LCD and Policy Article Revisions Summary for December 14, 2023.

    The revisions were based on CMS Final Rule CMS-1780-F and were effective January 1, 2024.
  2. What changed in the refill documentation requirements about communication with the beneficiary?

    Answer: The policy article revisions clarify other modes of contact besides telephone calls are acceptable. “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 through automated text messaging or email if all required details of the refill request are captured.”

    We published the revised refill documentation requirements in the Standard Documentation Requirements for All Claims Submitted to DME MACs Policy Article (A55426)External Website. The Revision History Information dated 01/01/2024 details the changes to the policy article.
  3. Did anything change with the time frames to contact the beneficiary?

    Answer:  Yes. Contact with the beneficiary or caregiver about refills must take place no sooner than 30 calendar days prior to the expected end of the current supply. This replaces the fourteen calendar days contact requirement. We published the list of applicable LCDs and Policy Articles in the LCD and Policy Article Revisions Summary for December 14, 2023.
  4. When can the supplier ship the replacement supplies?

    Answer: The 10-day delivery rule was not changed. Suppliers must deliver refills of the product no sooner than 10 calendar days prior to the expected end of the current supply.
  5. Do suppliers still need to provide the exact number of supply items remaining or the current functional condition of those items?

    Answer: You no longer must keep track of the exact number of remaining supply items the beneficiary currently has on hand or document the condition or functional level of the current supply item.  Contact the beneficiary within 30 days of when you expect their supplies to run out, document an affirmative response to your request, then prepare the shipment within 10 days of the expected end of the current supply.  The DME MACs will not look for the exact number of remaining supply items or the current functional level of non-consumable supplies.
  6. What if the supplier needs a new standard written order at the same time a refill request comes in?

    Answer: You have 30 days from the expected end of their current supply to get the affirmation of need from the beneficiary.  In the example, you need a new standard written order from the treating practitioner to complete the refill request.  You may send the new order to the practitioner for their signature while you get affirmation of the need for refills from the beneficiary.  If the response from the practitioner falls outside of the 30-day time frame until the expected need ends, then you may follow up with the beneficiary to make sure they still need the supply items.
  7. Since you no longer require documentation of the quantity on hand, do you still require suppliers to ask for it?

    Answer: No. The refill record must include the following:
    • 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
  8. How do refill documentation requirements apply to a one-month refill supply versus a 90-day refill supply?

    Answer: You need to contact the beneficiary each month if it's an item you can only provide a one-month supply at a time.  For example, you may not supply more than a one-month quantity of immunosuppressive drugs, oral anti-cancer drugs, or enteral nutrition at a time.
  9. Do the refill documentation guidelines also apply for the local state Medicaid programs?

    Answer: Suppliers should contact their individual state Medicaid organizations for questions about their guidelines.
  10. For consumable supply items (for example surgical dressings, urological, and ostomy supplies), can we ask the beneficiary if they are almost out of supplies?   Then, based on the answer they give us, we'll either place the order or we will set up a follow up call.

    Answer:  Yes. Refer to Standard Documentation Requirements for All Claims Submitted to DME MACs Policy Article (A55426)External Website.
  11. For non-consumable items such as PAP or nebulizer supplies, we no longer need to state the reason for replacement, is that correct?

    Answer:  That is correct. You no longer need to verify the functionality or specific reason to replace that item.
  12. If the beneficiary contacts us instead of us calling them, is that an acceptable refill request?

    Answer: If the beneficiary reaches out to you, and it's in the time frame when they should be close to the end of their current supply, then note that conversation in your system.  Something as simple as “the beneficiary called and requested refills” will meet that requirement.
  13. Will Medicare follow the primary insurance refill guidelines when Medicare is the secondary payer?

    Answer: We will not. If you file a claim to the DME MAC, you must follow our guidelines.
  14. Do refill documentation requirements apply to the monthly billing allowance for continuous glucose monitor (CGM) supplies? 

    Answer:  This is a supply allowance and does not follow the standard refill guidelines.  Refer to the Glucose Monitor - Policy Article (A52464)External Website for updates to the provision and billing options effective January 1, 2024.
  15. Does the main drug need to be itemized in the documentation for the refill request?

    Answer:  Not for DME MAC purposes. There could be state laws that are more specific than Medicare. The refill record must include the following:
    • 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
  16. Are there any changes to refill requirements if the beneficiary comes into our location asking for supplies?

    Answer:  No. A signed delivery slip or a copy of the itemized sales receipt is sufficient documentation of a refill request.
  17. For non-consumable supplies, such as PAP accessories, do the items we dispense once every six months need to be listed differently in a refill request?

    Answer: The replacement guidelines in the LCDs are not changed. The only change for PAP accessories is the DME MACs will not look for the current condition or functional level in the refill documentation.
  18. The policy says you must document the beneficiary’s name or the authorized representative. Should we also document the authorized representative’s relationship to the patient?

    Answer:  The DME MACs strongly encourage suppliers to gather this information whenever possible.

Posted: 01.12.24

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