CMS requires that for Specified Covered Items  payment  may  only  be  made  if  a  physician has provided the supplier with a  written order for the item before the delivery of the item.

    For many items of DME, a physician must  document that a physician, a physician assistant (PA), a nurse practitioner (NP), or a  clinical  nurse specialist (CNS)  has  had  a  face-to-face encounter with the beneficiary  pursuant to that order. The encounter must  occur  during  the six  months  prior to the  written order for each item.

    The  patient’s medical record must con  tain sufficient documentation of the patient’s medical condition to substantiate the
    necessity for the type and quantity of items ordered  and must be signed by the or dering physician.

    Documentation Requirements

    • Duration of patient’s condition
    • Clinical course
    • Prognosis
    • Nature and extent of functional limitations
    • Other Therapeutic interventionsand results


    Key Items to Address

    • Why does the patient require the item?
    • Do the physical examination findings support the need for the item?
    • Signs and symptoms that indicate the need for the item.
    • Diagnoses that are responsible for these signs and symptoms.
    • Other diagnoses that may relate to the need for the item.


    Documentation Tips

    •  The information must not be recorded in vague and subjective terms.
    • The information must provide objective measures, tests or observations.
    • Each medical record is expected to be individualized to the unique patient.


    Specific Documentation Requirements:

    The physician must document the faceto-face clinical evaluations and reevaluations in a detailed narrative note in their charts in the format that is used for other entries. For the initial evaluation, the report would commonly document pertinent information about the following elements, but may include other details:

    History –

    • Signs and symptoms of sleep disordered breathing including snoring, daytime sleepiness, observed apneas, choking or gasping during sleep, morning headaches.
    •  Duration of symptoms
    • Validated sleep hygiene in ventory such as the Epworth Sleepiness Scale

    Physical Exam –

    • Focused cardiopulmonary and upper airway system evaluation
    • Neck circumference
    • Body mass index


    Specific Coverage Criteria

        Continuous positive airway pressure device

        1. The patient has a face-to-face clinical evaluation by the treating physician prior to the sleep test to assess the patient for obstructive sleep apnea.The patient has a sleep test that meets

          • The apnea-hypopnea index or Respiratory Disturbance Index is greater than or equal to 15 events per hour with a minimum of 30 events; or
          • The AHI or RDI is greater than or equal to 5 and less than or• equal to 14 events per hour with a minimum of 10 events and documentation of a) exessive daytime sleepiness, impaired cognition, mood dis-orders, or insomnia; or
          • Hypertension, ischemic heart disease, or history of stroke
        2. The patient and/or their caregiver has received instruction from the supplier of the device in the proper use and care of the equipment.


    Bi-level respiratory assist device without backup rate

    – The patient meets the criteria for CPAP and the following additional criterion which must be documented in the patient’s medi-
    cal record:

      • A CPAP has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.