Medicare refill rules for wound dressings (2024 update)

What changed in 2024

The CY 2024 home health final rule wrote Medicare's refill rules into regulation at 42 CFR 410.38(d)(4), effective January 1, 2024. Before that, the Program Integrity Manual had said contact about refills “must take place no sooner than 14 calendar days prior to the delivery/shipping date,” a rule dating from 2011 (88 FR 77676).

What's different now:

• The window is tied to the supply, not the ship date. “Contact and affirmative response must be within 30 calendar days from the expected end of the current supply.”
• No counting. CMS's MLN Matters MM13480 says: “Patients don't have to count the remaining supply.” A55426 also dropped its old requirement that the supplier assess the quantity a patient has left.
• Any mode of contact. Suppliers may use “any mode of communication so long as the beneficiary affirmation is received,” provided the contact is documented. CMS gives automated text messages and email as examples.
• A documented, individual response. The rules now center on an affirmative response from the patient or caregiver, recorded before the refill ships.

The timing rules

LCD L33831 says the same in its own words: contact “no sooner than 30 calendar days prior to the expected end of the current supply,” and delivery “no sooner than 10 calendar days prior to the expected end of the current supply.” The regulation adds that the response “should be obtained as close to the expected end of the current supply as possible.”

Nothing ships on autopilot. 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” (Program Integrity Manual, Ch. 5 §5.2.6).

What a refill record needs

For shipped items, the regulation requires documentation of:

• the beneficiary name;
• the date of contact;
• the item requested; and
• an affirmative response from the beneficiary, indicative of the need for refill, prior to dispensing the product.

For items obtained in person from a retail store, a delivery slip signed by the patient or their representative, or a copy of the itemized sales receipt, “is sufficient documentation of a request for refill.”

A55426's refill record also lists a description of each item requested and the date of the refill request. The request “must be individualized to the beneficiary,” and it has to be documented before the refill ships; an after-the-fact attestation isn't enough.

Continued need and continued use

A55426 asks for two more things on an ongoing basis:

• Continued medical need. “Information used to justify continued medical need must be timely for the DOS under review.” Acceptable evidence includes a recent order by the treating practitioner for refills, a recent change in an order, or timely medical record documentation showing use. “Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in the policy.”
• Continued use. “Suppliers must discontinue billing Medicare when rental items or ongoing supply items are no longer being used by the beneficiary.” Refill records that meet A55426's refill documentation requirements also count as evidence of continued use.

For dressings, the policy specifies more: Policy Article A54563 requires the supporting clinical information to be updated monthly (wound evaluations weekly in some situations) and a new order every 3 months for each dressing. Our patient-direct guide covers both.

One month at a time

A55426 notes that most recurring supplies “can be dispensed with a three-month supply,” but points to each LCD's refill section, and the dressing LCD is stricter: “no more than a month's supply of dressings may be provided at one time,” unless the record supports more for an individual patient in the home setting.

Each refill should reflect current use. The LCD says “billing must be based on prospective, not retrospective use,” and quantities “must take into account the status of the wound(s), the likelihood of change, and the recent use of dressings.” Suppliers are “required to monitor the quantity of dressings that the beneficiary is actually using” and “must verify with the treating practitioner that any changed or atypical utilization is warranted.”

When a refill needs a new order

Refills follow the existing order until one of the Policy Article's triggers applies. A new order is needed:

• every 3 months, for each dressing being used;
• when a new dressing is added; or
• when the quantity of an existing dressing is increased.

So a refill can't raise a quantity on its own; an increase needs a new order signed by the treating practitioner. The standard written order builder lays one out.

Delivery and the date of service

For refills, the regulation sets the date of service as the date of delivery or, for items sent by a delivery or shipping service, the shipping date. It defines the shipping date as the date the delivery/shipping service label is created or the date the item is retrieved for delivery, and says “These dates must not demonstrate significant variation” (42 CFR 410.38(d)(4)(i)).

That date of service is what the 10-day limit applies to. If a delivery slip has both a supplier-entered date and a patient or designee signature date, “the beneficiary (or designee) entered date is the DOS” (A55426).

Proof of delivery works as it does for a first shipment. The supplier standards in 42 CFR 424.57(c)(12) say a supplier “Must be responsible for the delivery of Medicare covered items to beneficiaries and maintain proof of delivery.”

Keeping records for 7 years

“Proof of delivery documentation must be maintained in the supplier's files for seven years (starting from the date of service)” (Program Integrity Manual, Ch. 4 §4.7.3.1). Under 42 CFR 424.516(f), suppliers keep their documentation for 7 years from the date of service, and the ordering practitioner has the same 7-year duty for order documentation.

Who does what

Our summary of the sources above. It's general information, not CMS text.

For patient-direct orders, PCSS with its billing partners ships to the patient and bills the patient's coverage, up to one month's supply per shipment. Refills follow Medicare's timing rules, with no auto-shipping.

Questions

Sources

Checked on October 6, 2026. Medicare policy changes; confirm current versions before relying on them. This page is general information, not billing, coding or legal advice.