OAR 410-122-0202: Positive Airway Pressure (PAP) Devices for Adult Obstructive Sleep Apnea

(1) Indications and limitations of coverage and medical appropriateness: (a) The Division may cover the initial three (3) month trial period of a positive airway pressure (PAP) device for treatment of obstructive sleep apnea (OSA) when the client meets the conditions of coverage in OAR 410-122-0080 and when all the following guidelines and criteria are met: (A) The client has a face-to-face clinical evaluation by the treating practitioner prior to a sleep test to assess the client for obstructive sleep apnea; (B) The client has a home sleep test or a polysomnogram performed in a facility-based laboratory to test for obstructive sleep apnea and the type of sleep test performed meets all CMS requirements for a valid sleep test and in accordance with Prioritized List of Health Services Diagnostic Testing for Obstructive Sleep Apnea (OSA) Guideline Note; (C) The client demonstrates a positive diagnosis of OSA, as defined in the Prioritized List of Health Services Treatment of Sleep Apnea Guideline Note; and (D) The client or their caregiver has received instruction from the supplier in the proper use and care of the PAP device equipment and accessories. (b) Prior Authorization (PA) is not required for PAP device (E0601) rental and the purchase of prescribed accessories during the initial three (3) month trial period. The DMEPOS provider is responsible to ensure all requirements in this rule are met. (c) A Bi-level Positive Airway Pressure (BiPAP) device without backup rate (E0470) may be covered for treatment of OSA when the following criteria are met: (A) Criteria in (1)(a)(A)–(D) of this rule; and (B) A Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP) device (E0601) has been tried and proven ineffective or there is documentation of medical contraindication to E0601 devices as determined by the treating practitioner. Ineffective use is defined as documented failure to meet therapeutic goals using a CPAP/APAP device during the titration period of a facility-based study or during home use despite optimal therapy (i.e., proper mask selection and fitting and appropriate pressure settings); (C) If a CPAP/APAP device is tried and found ineffective during the initial facility-based titration or three (3) month home trial, substitution of a BiPAP does not require a new face-to-face clinical evaluation or sleep test; (D) If a CPAP/APAP device has been used for more than three (3) months and the client is switched to a BiPAP, a clinical re-evaluation must occur, but a new sleep test is not required. A new three (3) month trial shall begin for use of the BIPAP. (d) PA is not required for BiPAP device (E0470) rental and purchase of prescribed accessories during the initial three (3) month trial period. The DMEPOS provider is responsible to ensure all requirements in this rule are met. (2) Continued Coverage of PAP device (PA Required): (a) Purchase or ongoing rental of a PAP device (E0601 or E0470) beyond the three-month trial period may be covered when the conditions of coverage have been met per the Prioritized List of Health Services Treatment of Sleep Apnea Guideline Note. The DMEPOS provider must submit the following documentation, with request for authorization, prior to the fourth (4th) date of service: (A) A face-to-face re-evaluation visit conducted by the treating practitioner no sooner than the thirty-first (31st) day but no later than the ninety-first (91st) day after initiating therapy that supports client’s clinical benefit, compliance, and demonstrates symptoms of OSA are improved; and (B) Objective evidence of adherence to use of the PAP device, including a summary of PAP compliance report through a direct download of usage. PAP compliance report data can be documented by the treating practitioner in the clinical re-evaluation. Adherence to therapy is defined as use of PAP four (4) hours or more per night on seventy percent (70%) of nights during a consecutive thirty (30) day period anytime during the first three months of initial usage; (C) If the clinical re-evaluation by the treating practitioner does not occur until after the ninety-first (91st) day but the re-evaluation demonstrates the client is compliant, as defined in this rule, and benefiting from PAP therapy at the time of their re-evaluation, the provider shall submit a PA request for continued coverage. The request for authorization shall include the following documentation: (i) The clinical re-evaluation with the treating practitioner that demonstrates the client is compliant, as defined in this rule, and benefiting from the PAP therapy at the time of the re-evaluation; and (ii) Objective evidence of adherence to use of the PAP device, including a summary of PAP compliance report through a direct download of usage, at the time of the client’s re-evaluation. PAP compliance report data can be documented by the treating practitioner in the clinical re-evaluation. Adherence to therapy is defined as use of PAP four (4) hours or more per night on seventy percent (70%) of nights during a consecutive thirty (30) day period prior to client’s re-evaluation. (D) If there is a break in billing of sixty (60) days or more between the end of the trial period and the request to purchase or continue renting the PAP device, the provider shall also supply current objective evidence of adherence to use of the PAP device from the date the prior authorization request to resume coverage is submitted; (i) Adherence to therapy is defined as use of PAP four (4) hours or more per night on seventy percent (70%) of nights during a consecutive thirty (30) day period; (ii) Capped rental period begins the date the equipment is dispensed and shall not extend beyond the thirteenth (13th) consecutive month; (b) If objective data does not support compliance and efficacy, extending the trial period beyond the third month may be approved on a case-by-case basis by the appropriate authorizing unit. To ask for an exception, the DMEPOS provider must submit the following documentation with the prior authorization request: (A) Documentation of a face-to-face visit with the treating practitioner clearly specifying a treatment plan with measurable goals to improve adherence to treatment; and (B) Objective evidence of PAP use, including a PAP summary report through direct download of usage; (C) The trial period may extend up to a maximum of two (2) months to allow the client to achieve compliance, as defined in this rule, and therapeutic benefit; (D) Purchase or ongoing rental of a PAP device (E0601 or E0470) beyond the two (2) month extended trial period may be covered when the conditions for continued coverage have been met. Submit the following documentation with request for prior authorization: (i) A face-to-face clinical re-evaluation conducted by the treating practitioner which documents the following: (I) Client is compliant and benefiting from PAP therapy; and (II) Objective evidence of adherence to use of the PAP device, including a summary of PAP compliance report through a direct download of usage; (ii) Adherence to therapy is defined as use of PAP four (4) hours or more per night on seventy percent (70%) of nights during a consecutive thirty (30) day period anytime during the two (2) month extended rental period. (E) If there is a break in billing of sixty (60) days or more between the end of the extended trial period and the request to purchase or continue renting the PAP device, the provider shall also supply current objective evidence of adherence to use of the PAP device from the date the prior authorization request to resume coverage is submitted; (i) Adherence to therapy is defined as use of PAP four (4) hours or more per night on seventy percent (70%) of nights during a consecutive thirty (30) day period; (ii) Capped rental period begins the date the equipment is dispensed and shall not extend beyond the thirteenth (13th) consecutive month. (c) Clients who fail their PAP trial, may be eligible to re-qualify for a PAP device trial but must have both: (A) Face-to-face clinical re-evaluation by the treating practitioner to determine etiology of the failure to respond to PAP therapy; and (B) Repeat sleep test in a facility-based setting if deemed necessary by the treating practitioner. This may be a repeat diagnostic titration or split night study in accordance with the Prioritized List of Health Services Diagnostic Testing for Obstructive Sleep Apnea (OSA) Guideline Note. (d) For a client using a PAP device prior to Oregon Health Plan (OHP) enrollment, continuing coverage for the device and related accessories may be authorized on a case-by-case basis upon submission and review of the following required documentation: (A) Record of initial delivery date when the PAP equipment was dispensed; and (B) Documentation from the client’s treating practitioner to support the diagnosis of OSA and that coverage criteria in this rule are met in accordance with the Prioritized List of Health Services Treatment of Sleep Apnea Guideline Note; and (C) A facility-based polysomnogram report or home sleep test that meets all CMS requirements for a valid sleep test in accordance with the Prioritized List of Health Services Diagnostic Testing for Obstructive Sleep Apnea (OSA) Guideline Note; and (D) Objective evidence of client’s ongoing adherence to PAP therapy at the time the prior authorization for continued coverage is requested. Adherence to therapy is defined as use of PAP four (4) hours or more per night on seventy percent (70%) of nights during a consecutive thirty (30) day period. (e) The continued rental of PAP equipment and the purchase of related accessories shall not be reimbursed, under any circumstance, when client is not using the equipment or non-compliant with its use; (A) It is the provider’s responsibility to monitor appropriate and effective use of the device as ordered by the treating practitioner; and (B) When the equipment is not being used as prescribed or member is non-compliant with its use, it is the provider’s responsibility to stop billing for the continued rental of the equipment and the purchase of related accessories and supplies. (3) Accessories: (a) Either a non-heated (E0561) or heated (E0562) humidifier is covered and reimbursed separately when ordered by the treating practitioner for use with a covered PAP device (E0470, E0601). No PA is required; (b) Accessories are separately reimbursable at the time of initial issue and when replaced. For replacement of accessories beyond initial issue: (A) Suppliers are required to verify the PAP or BiPAP device is still in use; (B) Regardless of utilization, a supplier must not dispense more than a three (3) month quantity of accessories; (C) Automatic shipments on a pre-determined basis, even if authorized by the client or designee, are not allowed. An order refill does not have to be approved by the ordering practitioner. However, a client or their caregiver must request specific ongoing PAP supplies and accessories, subject to rule limitations and requirements, before they are dispensed. The DMEPOS provider shall not automatically dispense a quantity of supplies and accessories on a predetermined regular basis, even if the client has "authorized" this in advance; (c) The following represents the usual maximum number of accessories expected to be medically appropriate: (A) A4604 — 1 per 3 months; (B) A7027 — 1 per 3 months; (C) A7028 — 2 per month; (D) A7029 — 2 per month; (E) A7030 — 1 per 3 months; (F) A7031 — 1 per month; (G) A7032 — 2 per month; (H) A7033 — 2 per month; (I) A7034 — 1 per 3 months; (J) A7035 — 1 per 6 months; (K) A7036 — 1 per 6 months; (L) A7037 — 1 per 3 months; (M) A7038 — 2 per month; (N) A7039 — 1 per 6 months; (O) A7046 — 1 per 6 months. (4) Replacement of PAP Device: (a) For PAP devices initially covered through the Oregon Health Plan, a replacement PAP may be covered on a case-by-case basis in accordance with OAR 410-122-0184. The DMEPOS provider must submit the following documentation with the PA request: (A) An order for the replacement PAP device from the treating practitioner; and (B) A face-to-face clinical evaluation by the treating practitioner that documents the present medical need for replacement and confirms the beneficiary continues to use and benefit from the PAP device. (b) For PAP devices not initially covered through the Oregon Health Plan, a replacement PAP may be covered on a case-by-case basis in accordance with OAR 410-122-0184. The DMEPOS provider must submit records to support the client meets criteria in (1)(a)(A)–(D) of this rule and the following documentation with the PA request: (A) An order for the replacement PAP device from the treating practitioner; (B) A face-to-face clinical evaluation by the treating practitioner that documents the present medical need for replacement and confirms the beneficiary continues to use and benefit from the PAP device; and (C) Name of prior DMEPOS provider and the date the PAP device was initially issued. (5) Prior authorization is obtained from the same authorizing authority as specified in OAR 410-122-0040. PA is required for the following: (a) All subsequent rentals or purchase of a PAP device starting with the fourth (4th) month date of service; (b) Quantities of PAP accessories that exceed their usual maximum number as defined in (3)(c)(A-O); (c) A replacement PAP device. (6) Mandibular advancement devices (oral appliances) may be covered for those for whom CPAP fails or is contraindicated. A face-to-face clinical evaluation with the treating practitioner is required to document the presence of either condition and the medical necessity for the device. If a custom fabricated device is prescribed, the practitioner’s evaluation must also include why a less costly prefabricated device will not meet the client’s needs. No PA is required. (7) Reimbursement: (a) Rental charges apply toward purchase; (b) Capped rental period begins the date the equipment is dispensed and shall not extend beyond the thirteenth (13th) consecutive month; (c) Equipment is considered purchased either upon completion of the capped rental period, after the Division fee schedule purchase price is met, or when the actual charge from the provider is met, whichever is less; (d) Accessories are separately reimbursable at the time of initial issue. (8) Documentation Requirements: (a) For services requiring PA, submit documentation that supports coverage criteria and guidelines in this rule are met; (b) Medical records and documentation to support the client meets criteria and conditions of coverage in this rule must be on file with the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) provider and made available to the Division on request. (9) For children and youth 18 years old or younger: the Division may cover a positive airway pressure (PAP) device for treatment of obstructive sleep apnea (OSA) when the criteria and conditions of coverage in the Prioritized List of Health Services Treatment of Sleep Apnea Guideline Note are met. (10) A Respiratory Assist Device (RAD) with backup rate (E0471) is not medically indicated for the treatment of obstructive sleep apnea. Coverage, coding, and documentation requirements are addressed in OAR 410-122-0205 Respiratory Assist Devices. (11) Table 122-0202 — PAP Devices. [ED. NOTE: To view attachments referenced in rule text, click here to view rule.]