Medicare Program Integrity Manual (Pub. 100-08), Ch. 5 § 5.9
Documentation in the Patient’s Medical Record
5.9 – Documentation in the Patient’s Medical Record
(Rev. 10749; Issued: 05-11-21; Effective: 06-11-21; Implementation: 06-11-21)
For any DMEPOS item to be covered by Medicare, the patient’s medical record must
contain sufficient documentation of the patient’s medical condition to substantiate the
necessity for the type and quantity of items ordered and for the frequency of use or
replacement (if applicable). The information should include the patient’s diagnosis and
other pertinent information including, but not limited to, duration of the patient’s
condition, clinical course (worsening or improvement), prognosis, nature and extent of
functional limitations, other therapeutic interventions and results, past experience with
related items, etc. If an item requires a CMN or DIF, it is recommended that a copy of the
completed CMN or DIF be kept in the patient’s record. However, neither a physician’s
order nor a CMN nor a DIF nor a supplier prepared statement nor a physician attestation
by itself provides sufficient documentation of medical necessity, even though it is signed
by the treating physician or supplier. There must be information in the patient’s medical
record that supports the medical necessity for the item and substantiates the answers on
the CMN (if applicable) or DIF (if applicable) or information on a supplier prepared
statement or physician attestation (if applicable). When a CMN or DIF and a medical
record contain conflicting information due to a minor error or omission within the CMN
or DIF, but all coverage, coding and payment criteria are substantiated through the medical
record, the reviewer shall rely upon the content of the medical record (absent suspicion of
abuse or gaming) and shall not issue a denial.
See PIM, chapter 3, section 3.4.1.1, for additional instructions regarding review of
documentation during pre- and post-payment review.
The patient’s medical record is not limited to the physician’s office records. It may include
hospital, nursing home, or HHA records and records from other health care professionals.
The documentation in the patient’s medical record does not have to be routinely sent to
the supplier or to the DME MACs or UPICs. However, the DME MACs or UPICs may
request this information in selected cases. If the DME MACs or UPICs do not receive the
information when requested or if the information in the patient’s medical record does not
adequately support the medical necessity for the item, then on assigned claims the supplier
is liable for the dollar amount involved unless a properly executed advance beneficiary
notice (ABN) of possible denial has been obtained.