RETIRED - Coverage Reminder - External Infusion Pumps (EIP), Supplies, and Drugs


Content Provided on this page contains outdated information and instruction and should not be considered current. Noridian is providing this archived information for research purposes only. This archived article contains previously issued instructions that have since been updated or are no longer applicable for Medicare billing purposes.

Article retired due to content incorporation into the applicable Local Coverage Determination or related Policy Article.

Joint DME MAC Publication

A recent examination of CERT reviews for EIP claims has identified common errors in the information submitted in support of claims payment. This article will review the findings and related policy requirements.


  • Prescriptions
    • Physician's detailed written order is missing, incomplete, or invalid – 29%
  • DME Information Form (DIF)
    • Missing DIF – 26%
  • Reasonable & Necessary (R&N)
    • LCD Coverage Criteria not met – 39%
  • Other
    • Continued Need Criteria not met – 3%
    • Unsigned Clinical Notes – 3%



All items billed to Medicare require a prescription. A detailed written order (DWO) is required before billing. Someone other than the ordering physician may produce the DWO. However, the ordering physician must review the content and sign and date the document. Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM

ACA 6407 requires a written order prior to delivery (WOPD) for the HCPCS code E0784, as specified in the table contained in the Policy Specific Documentation Requirements Section of the LCD for External Infusion Pumps (EIP) LCD L11570. The supplier must have received a complete WOPD that has been both signed and dated by the treating physician and meets the requirements for a DWO before dispensing the item.

DME Information Form:                                            

A DME Information Form (DIF), which has been completed, signed, and dated by the supplier, must be kept on file by the supplier and made available upon request. The DIF for External Infusion Pumps is CMS Form 10125. The initial claim must include an electronic copy of the DIF.

If a beneficiary begins using an infusion for one drug and subsequently the drug is changed, another drug is added, or if the code for a current drug changes, a Revised DIF must be submitted for use of the pump. The additional new or changed drug or the new HCPCS code for the existing drug must be listed along with all other drugs for which the pump is used should be included on the Revised DIF.

Reasonable and Necessary (R&N) Criteria:

This policy covers numerous drugs, and suppliers and providers are encouraged to review the specific coverage requirements for the relevant drug in question. In general, external infusion pumps and related drugs and supplies will be denied as not reasonable and necessary when the criteria described by indication (I), (II), (III), (IV) or (V) in LCD L11570 are not met. When an infusion pump is covered, the drug necessitating the use of the pump and necessary supplies are also covered.

When a pump has been purchased by the Medicare program, other insurer, the beneficiary, or the rental cap has been reached, the drug necessitating the use of the pump and supplies is covered as long as the coverage criteria for the pump are met.

Drugs are only covered as a supply to a covered DME infusion pump. Drugs billed alone (without a covered pump being used) will be denied as statutorily noncovered (no benefit).

Continued Medical Need:

For ongoing supplies and rental DME items, in addition to information described above that justifies the initial provision of the item(s) and/or supplies, there must be information in the beneficiary's medical record to support that the item continues to be used by the beneficiary and remains reasonable and necessary. Information used to justify continued medical need must be timely for the DOS under review. Any of the following may serve as documentation justifying continued medical need:

  • A recent order by the treating physician for refills
  • A recent change in prescription
  • A properly completed CMN or DIF with an appropriate length of need specified
  • Timely documentation in the beneficiary's medical record showing usage of the item

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in the policy.


In the event of a claim review:

  • Medicare requires that there is a prescription (order) for every separately billable item.
  • Medicare requires that there be sufficient detailed information contained in the beneficiary's medical record to demonstrate that the relevant policy requirements are met.

This article presents a summary of the policy requirements related to the errors identified in the CERT reviews. The majority of reasons for CERT errors (55%) are completely within the purview of suppliers. Thus, suppliers are encouraged to review their claim submission practices, in order to begin to reduce the high level of CERT errors. There are additional requirements necessary for coverage that are not discussed in this article. Please refer to the LCD L11570 and related Policy article for complete information. Further education regarding this policy is available on your DME MAC contractor website.

Last Updated Dec 11 , 2023