LEEDer Group Inc.
8508 North West 66th St.
Miami, Florida 33166 USA

Phone: 305.436.5030
Fax: 305.436.0086
E-mail Address: info {at] LEEDerGroup [dot] com

2012-06 Revised-Items on Recurring Basis & Refill Requirements

June 08, 2012

Items Provided on a Recurring Basis and Request for Refill Requirements – Revised – June 2012
  • For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. CMS has revised the requirements for refills effective for dates of service on or after August 2, 2011.
  • June 2012 Revision
    This revision updates the original article. Changes include;
    Revised refill documentation instructions regarding consumable and non-consumable supplies
    Addition of External Breast Prosthesis LCD to the list of included policies
    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 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 approaching exhaustion, and to confirm any changes/modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. 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.
  • For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request 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 physicians 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 prescription is needed when:
    There is a change of supplier
    There is a change in the item(s), frequency of use, or amount prescribed
    There is a change in the length of need or a previously established length of need expires
    State law requires a prescription renewal
    For items that the patient 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 either a written document received from the beneficiary or a contemporaneous written record of a phone conversation/contact between the supplier and beneficiary. 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 than the beneficiary
    A description of each item that is being requested
    Date of refill request
    For consumable supplies i.e., those that are used up (e.g., ostomy or urological supplies, surgical dressings, etc.) – The Supplier should assess the quantity of each item that the beneficiary still has remaining to document that the amount remaining will be nearly exhausted on or about the supply anniversary date.
    For non-consumable supplies i.e., those more durable items that are not used up but may need periodic replacement (e.g., Positive Airway Pressure and Respiratory Assist Device supplies) – The supplier should assess whether the supplies remain functional, providing replacement (a refill) only when the supply item(s) is no longer able to function. Document the functional condition of the item(s) being refilled in sufficient detail to demonstrate the cause of the dysfunction that necessitates replacement (refill).
    This information must be kept on file and be available upon request.
  • Billing Frequencies
    For refills of surgical dressings, enteral and parenteral nutrients and supplies, immunosuppressive drugs, oral anti-cancer drugs, intravenous immune globulin, external infusion pump drugs and supplies, and oral antiemetic drugs, only a one-month quantity of supplies may be dispensed.
  • For all other refills that are provided on a recurring basis, including but not limited to DME accessories or supplies, nebulizer drugs, urological and ostomy supplies, suppliers may dispense no more than a three-month supply at any one time.
  • Miscellaneous
    The Local Coverage Determinations affected by these requirements will be updated in a future revision. The following policies are subject to these requirements:
    Automatic External Defibrillators
    Enteral Nutrition
    External Breast Prosthesis
    External Infusion Pumps
    Glucose Monitors
    Immunosuppressive Drugs
    Intravenous Immune Globulin
    Negative Pressure Wound Therapy
    Oral Anticancer Drugs
    Oral Antiemetic Drugs
    Ostomy Supplies
    Oxygen (for billable contents)
    Parenteral Nutrition
    Positive Airway Pressure Devices
    Respiratory Assist Devices
    Suction Pumps
    Surgical Dressings
    Tracheostomy Supplies
    Transcutaneous Electrical Nerve Stimulator (TENS)
    Urologic Supplies
    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.

The original article, published August 2011, replaces the articles “Request for Refill – Documentation Requirements,” published in September 2010 and “Dispensing DMEPOS Items: Quantity Limits” published in June 2007.

The June 2012 revision replaces the version published in August 2011.

For additional information, refer to CMS’ Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-8, Chapter 5, Section 5.2.5 and 5.2.6, and the applicable Local Coverage Determination and the Supplier Manual.