‘Reasonable and necessary’ guidelines

In the absence of an LCD, NCD, or CMS manual instruction, reasonable and necessary guidelines still apply. 

Section 1862(a) (1) (A) of the Social Security Act directs the following:

“No payment may be made under Part A or Part B for any expenses incurred for items or services not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” 

Note: Malformed is defined as (of a person or part of the body) abnormally formed; misshapen.

The MAC will determine if an item or service is “reasonable and necessary” under §1862(a) (1) (A) of the Act if the service is:

• Safe and effective
• Not experimental or investigational, and 
• Appropriate, including the duration and frequency in terms of whether the service or item is:
  • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the beneficiary’s condition or to improve the function of a malformed body member
  • Furnished in a setting appropriate to the beneficiary’s medical needs and condition
  • Ordered and furnished by qualified personnel, and
  • One that meets, but does not exceed, the beneficiary’s medical need

For any service reported to Medicare, it is expected that the medical documentation clearly demonstrates that the service meets all of the above criteria. All documentation must be maintained in the patient’s medical record and be available to the contractor upon request.