Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea - Policy Article

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”). Positive airway pressure devices are covered under the Durable Medical Equipment benefit [Social Security Act §1861(s)(6)]. In order for a beneficiary’s DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met. Accessories are separately reimbursable at the time of initial issue and when replaced. No aspect of a home sleep test, including but not limited to delivery and/or pickup of the device, may be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests or to tests conducted in facility-based sleep laboratories. A liner used in conjunction with a PAP mask is considered comfort/convenience item. There is no additional payment for liners used with a PAP mask. These products should be coded A9270 (Noncovered item or service) in accordance with the Medicare Benefit Policy Manual (CMS Pub. 100-02) Chapter 15, Section 110.1. Claims for A9279 (MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE CLASSIFIED) are denied as statutorily non-covered (No Medicare benefit). REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217) Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here . Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary. If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage. POLICY SPECIFIC DOCUMENTATION REQUIREMENTS In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD. Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below. INITIAL EVALUATION: For the initial in-person evaluation, the report would commonly document pertinent information about the following elements, but may include other details. Each element would not have to be addressed in every evaluation. 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 inventory such as the Epworth Sleepiness Scale (see Appendices of related LCD) Physical Exam Focused cardiopulmonary and upper airway system evaluation Neck circumference Body mass index (BMI) Suppliers are reminded that all Medicare coverage and documentation requirements for DMEPOS also apply. There must be sufficient information included in the medical record to demonstrate that all of the applicable coverage criteria are met. This information must be available upon request. For beneficiaries changing from an E0601 to E0470 due to ineffective therapy while on E0601 (either during a facility-based titration or in the home setting), the treating practitioner must document that both of the following issues were addressed prior to changing to an E0470 device: Interface fit and comfort. An appropriate interface has been properly fit and the beneficiary is using it without difficulty. This properly fit interface will be used with the E0470 device; and, E0601 pressure settings. The current pressure setting of the E0601 prevents the beneficiary from tolerating the therapy and lower pressure settings of the E0601 were tried but failed to: Adequately control the symptoms of OSA; or, Improve sleep quality; or, Reduce the AHI/RDI to acceptable levels. The re-evaluation must take place within the first 3 months of treatment; however, formal assessment of improvement cannot be documented before the 31st day. The re-evaluation must document both improvement in subjective symptoms of OSA and objective data related to adherence to PAP therapy. Documentation of adherence to PAP therapy shall be accomplished through direct download or visual inspection of usage data with documentation provided in a written report format to be reviewed by the treating practitioner and included in the beneficiary’s medical record. This information does not have to be submitted with the claim but must be available upon request. Many suppliers have created forms which have not been approved by CMS which they send to practitioners and ask them to complete. Even if the practitioner completes this type of form and puts it in his/her chart, this supplier-generated form is not a substitute for the comprehensive medical record as noted above. Suppliers are encouraged to help educate practitioners on the type of information that is needed to document a beneficiary’s need for PAP therapy. Proper use of modifiers is discussed below. Specific modifiers must be used and differ depending on whether or not the requirements outlined in the documentation section have been met. INITIAL COVERAGE (FIRST THREE MONTHS): On claims for the first through third months, suppliers must add a KX modifier to codes for PAP equipment (E0470 or E0601) and accessories only if all of the criteria in the “Coverage Indications, Limitations, and/or Medical Necessity” section of the related LCD ("Initial Coverage") have been met. CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY: On the fourth month’s claim (and any month thereafter), the supplier must add a KX modifier to codes for PAP equipment (E0470 or E0601) and accessories only if both the "Initial Coverage" criteria and the "Continued Coverage" criteria in the “Coverage Indications, Limitations, and/or Medical Necessity” section of the related LCD have been met. If the supplier does not obtain information from the treating practitioner that the beneficiary has demonstrated improvement in their OSA symptoms and is adhering to PAP therapy in time for submission of the fourth or succeeding months’ claims, the supplier may still submit the claims, but a KX modifier must not be added. If the supplier chooses to hold claims for the fourth and succeeding months pending receipt of information from the treating practitioner that the beneficiary received a clinical re-evaluation between the 31st and 91st day, had documented improvement in OSA symptoms and is adhering to PAP therapy, those claims may then be submitted with the KX modifier. If the supplier chooses to hold claims for the fourth and succeeding month pending receipt of information from the treating practitioner but learns that the beneficiary did not receive a clinical re-evaluation between the 31st and 91st day but rather was re-evaluated at a later date and had documented improvement in OSA symptoms and is adhering to PAP therapy, those claims may then be submitted with the KX modifier but only for dates of service following the date of the clinical re-evaluation. For a PAP device dispensed prior to November 1, 2008, if the initial coverage criteria in effect at the time were met and the criteria for coverage after the first 3 months that were in effect at the time were met, the KX modifier may be added to claim with dates of service on or after November 1, 2008 as long as the beneficiary continues to use the device. REPLACEMENT OF ACCESSORIES FOR MEDICARE-PAID, BENEFICIARY-OWNED EQUIPMENT: For claims for replacement accessories (e.g., interfaces, tubing, filters, humidifier chambers), if Medicare paid for the base PAP device initially (i.e., for 13 months of continuous use), the medical necessity for the beneficiary-owned base PAP device is assumed to have been established. Therefore, to make a payment determination, there must only be documentation that the base DME item continues to meet medical need; and (2) The replacement of specific accessories or furnishing of new accessories remain medically necessary and are essential for the effective use of the base DME. Documentation of continued medical need for the base item must come from the treating practitioner’s records. The supplier's documentation records must support the need to replace the accessory to maintain the equipment's functionality and meet the beneficiary's medical need. This guidance does not apply to PAP devices when Medicare did not originally provide payment for the base item. In cases where Medicare did not originally pay for the DME item