CMS Pub. 100-08, ch. 5, § 5.4.2

A supplier must maintain the SWO and the supporting documentation provided by the

treating practitioner and make them available to CMS and its contractors upon request. A

supplier must submit additional documentation to CMS or its contractors, upon request,

to support and/or substantiate the medical necessity for the DMEPOS.

The face-to-face encounter must support payment and be documented in the pertinent

portion of the medical record (for example, history, physical examination, diagnostic

tests, summary of findings, progress notes, treatment plans or other sources of

information that may be appropriate). The supporting documentation must include

subjective and objective beneficiary specific information used for diagnosing, treating, or

managing a clinical condition for which the DMEPOS is ordered.

Section 1834(h)(5) of the Act states that for purposes of determining the reasonableness

and medical necessity of orthotics and prosthetics, documentation created by orthotists

and prosthetists shall be considered part of the individual’s medical record to support

documentation created by eligible professionals as described in section 1848(k)(3)(B) of

the Social Security Act. Documentation from a face-to-face encounter conducted by a

treating practitioner, as well as documentation created by an orthotist or prosthetist,

becomes part of the medical records. If the orthotist or prosthetist notes support the

documentation created by eligible professionals described in section 1848(k)(3)(B), they

can be used together to support medical necessity of an ordered DMEPOS item. In the

event the orthotist or prosthetist documentation does not support the documentation

created by the eligible professional, payment may be denied.

If a supplier bills for an item listed on the Required Face-to-Face Encounter and Written

Order Prior to Delivery List and does not possess documentation of the face-to-face

encounter and/or the WOPD, the item will be denied.