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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or treatment of an illness or injury. Medically necessary services include services to improve the functioning of a malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 411.15(o). 
 
CMS has not issued specific coverage criteria in the form of an LCD (Local Coverage Determination) or NCD (National Coverage Determination) for this particular item or service. However, per Social Security Act, Section 1862 (a)1(A) and the 42 CFR 411.15(k), Medicare does not pay for any items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. The determination of medical necessity must be tailored to the individual patient and their unique clinical scenario. CMS considers services to be medically reasonable and necessary if they are:  - Safe and effective; - Not mainly for the convenience of the patient or the physician; - Not experimental or investigational; and - Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:    - Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member;    - Furnished in a setting appropriate to the patient's medical needs and condition;    - Ordered and furnished by qualified personnel;    - One that meets, but does not exceed, the patient's medical need; and    - At least as beneficial as an existing and available medically appropriate alternative. You can find this rule in the Medicare Program Integrity Manual, Chapter 13, Section 13.5.1. 
 
Before submitting a claim to the DME MAC the supplier must have on file a dispensing order, the detailed written order, the CMN (if applicable), the DIF (if applicable), information from the treating physician concerning the patient's diagnosis, and any information required for the use of specific modifiers or attestation statements as defined in certain DME MAC policies. The supplier should also obtain as much documentation from the patient's medical record as they determine they need to assure themselves that coverage criteria for an item have been met. If the information in the patient's medical record does not adequately support the medical necessity for the item, the supplier is liable for the dollar amount involved unless a properly executed ABN of possible denial has been obtained. You can find this information in Medicare Program Integrity Manual Chapter 5 - Items and Services Having Special DME Review Considerations, Supplier Documentation, 5.8.