Changes

'''Respiratory Assist Device (RAD)<br />Order Template Guidance<br />Purpose'''<br /> This template is designed to assist a clinician in completing a Written Order Prior to Delivery (WOPD) nin order for a Respiratory Assist Device (RAD) and Detailed Written Order (DWO) for accessories to meetrequirements for Medicare eligibility and coverage. When completed appropriately, this template meetsrequirements for a WOPD or a DWO. The clinician can keep the completed template on file within thepatient’s medical record or it can be used to develop an order template for use with the systemcontaining the patient’s electronic medical record. '''Patient eligibility for coverage of RAD therapy under Medicare''' Eligibility for coverage of RAD therapy and accessories under Medicare requires a physician or qualifiedNon-Physician Practitioner (NPP, ''nurse practitioner, clinical nurse specialist, or physician assistant'')1 to establish that coverage criteria are met. This helps to ensure theRAD and accessories provided are consistent with the physician’s prescription and supported in thepatient’s medical record. 

*'''E0470 ''' - RESPIRATORY ASSIST DEVICE, BI-LEVEL PRESSURE CAPABILITY, WITHOUT BACKUP RATEFEATURE, USED WITH NONINVASIVE INTERFACE, E.G., NASAL OR FACIAL MASK (INTERMITTENTASSIST DEVICE WITH CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE)*'''E0471 ''' - RESPIRATORY ASSIST DEVICE, BI-LEVEL PRESSURE CAPABILITY, WITH BACK-UP RATEFEATURE, USED WITH NONINVASIVE INTERFACE, E.G., NASAL OR FACIAL MASK (INTERMITTENTASSIST DEVICE WITH CONTINUOUS POSITIVE AIRWAY AiRWAY PRESSURE DEVICE) 

 The F2F Encounter must be completed within a 6-month timeframe prior to completion of the WOPDthat starts RAD therapy for the treatment of a clinical condition supported by the patient’s diagnosis.(See Appendix A.) 1 *A Medicare allowed NPP is defined as a nurse practitioner, clinical nurse specialist, or physician assistant (asthose terms are defined in section 1861 (aa) (5) of the Social Security Act) who is working in accordance with Statelaw.DRAFTRespiratory Assist Device Order Template Draft R1.0b 4/12/2018 Page | 2Indications for use of a RAD is divided into four the following categories:• * Restrictive thoracic disorders, (i.e., progressive neuromuscular disorders or severe thoracic cageabnormalities);• * Severe chronic obstructive pulmonary disease (COPD); use of a RAD in COPD patients requires,o ** A facility-based polysomnogram to rule out obstructive sleep apnea in order to initiateMedicare coverage,o ** A prerequisite trial of noninvasive ventilation without a backup rate, ando ** Treatment with continuous positive airway pressure devices.• * Central sleep apnea, i.e., apnea not due to airway obstruction;• * Hypoventilation; and• * Obstructive sleep apnea (OSA). 

 '''Initial coverage -- first three (3) months of therapy'''

• * Daytime hypersomnolence;• * Excessive fatigue;• * Morning headache;• * Cognitive dysfunction;• * Dyspnea, etc.; and• * Beneficiary has one (1) of the disorders listed above and meets all coverage criteria for thatdisorder as listed below. '''Continued coverage (beyond the first three months of therapy) - E0470 or E0471'''Medical record documentation has a signed and dated statement that the beneficiary was re-evaluatedon/after the 61st day of therapy demonstrating:• * Progress of relevant symptoms; and• * Beneficiary usage of the device (average 4 hours per 24 hours) '''Beneficiaries entering Medicare'''

• * A qualifying test confirming that the beneficiary had testing prior to Fee-for-Service (FFS)

• * There must be an a F2F clinical evaluation following enrollment in FFS Medicare that confirms allof the following:o ** The beneficiary has the qualifying medical condition for the applicable scenario; ando ** Testing performed, date of the testing used for qualification and results; ando ** The beneficiary continues to use the device; ando ** The beneficiary is benefiting from the treatment.

DRAFTRespiratory Assist Device Order Template Draft R1.0b 4/12/2018 Page | 3'''Other guidance'''Completing the RAD order template does not guarantee eligibility and coverage but does provide anarea within the patient’s medical file that is readily identifiable and available in support of RAD therapyequipment and accessories ordered and billed to Medicare. This template may be used with theRespiratory Assist Device Laboratory Test Results Template and Respiratory Assist Device Face to FaceTemplate. '''Who can complete the Respiratory Assist Device Order Template?'''