US · guidance
CMS Pub. 100-04, ch. 20, § 100.2.2.3
DME MAC Review of Initial PEN Certifications
B3-4450
In reviewing the claim and the supporting data on the CMN, the DME MAC compares
certain items, especially pertinent dates of treatment. For example, the start date of PEN
coverage cannot precede the date of physician certification. The estimated duration of
therapy must be contained on the CMN. This information is used to verify that the test of
permanence is met. Once coverage is established, the estimated length of need at the
start of PEN services will determine the recertification schedule.
The information shown on the certification must support the need for PEN supplies as
billed. A diagnosis must show a functional impairment that precludes the enteral patient
from swallowing and the parenteral patient from absorbing nutrients.
Initial assigned claims with the following conditions are denied without development:
• Inappropriate or missing diagnosis or functional impairment;
• Estimated duration of therapy is less than 90 consecutive days;
• Duration of therapy is not listed;
• Supplies have not been provided;
• Supplies were provided prior to onset date of therapy; and
• Stamped physician's signature.
Unassigned claims are developed for missing or incomplete information.
A. Revised Certifications/Change in Prescription
A revised certification is required when:
• There is a change in the attending physician's orders in the category of nutrients
and/or calories prescribed;
• There is a change by more than one liter in the daily volume of parenteral
solutions;
• There is a change from home-mix to pre-mix or pre-mix to home-mix parenteral
solutions;
• There is a change from enteral to parenteral or parenteral to enteral therapy; or
• There is a change in the method of infusion (e.g., from gravity-fed to pump-fed).
The PEN payments are not adjusted unless a revised or renewed certification documents
the necessity for the change. Payment levels for the most current certification or
recertification may not be changed unless a prescription change is documented by a new
recertification.
The DME MAC may adjust the recertification schedule as needed.
History
(Rev. 1, 10-01-03)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
5fbcb41ce0336b2990641f908d3d3002a99b627a153f186fca5d7147e98155d1
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