CMS Pub. 100-08, ch. 5, § 5.9

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 o f

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 atte station

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 om ission 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.