Respiratory Assist Devices CPAP-BiPAP - Health Plan of Nevada

A clinical study seeking Medicare payment for CPAP provided to the beneficiary pursuant to Coverage
with Evidence Development (CED) must address one or more of the following questions:
1. In Medicare aged subjects with clinically identified risk factors for OSA, how does the
diagnostic accuracy of a clinical trial of CPAP compare with PSG and Type II, III & IV HST in
identifying subjects with OSA who will respond to CPAP?
2. In Medicare aged subjects with clinically identified risk factors for OSA who have not
undergone confirmatory testing with PSG or Type II, III & IV HST, does CPAP cause
clinically meaningful harm?
Note: Studies must meet other Medicare Clinical Trial Study criteria.
There is a Local Coverage Determination for Nevada for Positive Airway Pressure (PAP) Devices for
the Treatment of Obstructive Sleep Apnea.
A bi-level respiratory assist device without back-up rate is covered as medically necessary for
those patients with OSA who meet the criteria for C-PAP, in addition to the following:
1. A C-PAP device has been tried and proven ineffective based on a therapeutic trial conducted in
either a facility or in a home setting.
Ineffective is defined as documented failure to meet therapeutic goals using an E0601 during the
titration portion of a facility-based study or during home use despite optimal therapy (i.e., proper mask
selection and fitting and appropriate pressure settings).
A bi-level positive airway pressure device with back-up rate (E0471) is not medically necessary if
the primary diagnosis is OSA;
For Medicare and Medicaid Determinations Related to States Outside of Nevada:
Please review Local Coverage Determinations that apply to other states outside of Nevada.
http://www.cms.hhs.gov/mcd/search
Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage
database on the Centers for Medicare and Medicaid Services’ Website.
BACKGROUND
A Continuous Positive Airway Pressure (CPAP) device delivers a constant level of positive air
pressure, within a single respiratory cycle (an inspiration followed by an expiration) by way of tubing
and a noninvasive interface (such as nasal or face mask, nasal cannula or oral interface) to assist
spontaneous respiratory efforts and supplement the volume of inspired air into the lungs. CPAP- Bipositive
Airway Pressure (BIPAP) devices are considered Durable Medical Equipment (DME) and as
such must meet the definition requirements. Consideration for approval will be based on the stated
indications and individual compliance with recommended conservative medical treatment plans. Refer
to plan benefits for DME coverage.
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