Reasonable and Necessary describes services that are:

  • Safe and effective (Not experimental or investigational)
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it:
    • Is provided within 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
    • Is furnished in a setting appropriate to the patient’s medical needs and condition
    • Is ordered and provided by qualified personnel
    • Meets, but does not exceed, the patient’s medical need

There are several exceptions to the requirement that a service be reasonable and necessary for diagnosis or treatment of illness or injury. The exceptions appear in the full text of The Federal Register at Section 1862(a)(1)(A) and include but are not limited to:

  • Pneumococcal, influenza and hepatitis B vaccines are covered if they are reasonable and necessary for the prevention of illness
  • Hospice care is covered if it is reasonable and necessary for the palliation or management of terminal illness
  • Screen mammography is covered if it is within frequency limits and meets quality standards
  • Screening pap smears and screening pelvic exam are covered if they are within frequency limits
  • Prostate cancer screening tests are covered if within frequency limits
  • Colorectal cancer screening tests are covered if within frequency limits
  • One pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens

CMS Regulation Reference: Publication 100-08, Chapter 3, Section 3.6.2.2 (PDF, 598 KB).

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