Article - Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea - Policy Article (A52467)

CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor 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 beneficiarys 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 TOFINAL RULE1713 (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 availablehere.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 REQUIREMENTSIn 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-personevaluation, 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.HistorySigns and symptoms of sleep disordered breathing including snoring, daytime sleepiness, observed apneas, choking or gasping during sleep, morning headachesDuration of symptomsValidated sleep hygiene inventory such as the Epworth Sleepiness Scale (see Appendices of related LCD)Physical ExamFocused cardiopulmonary and upper airway system evaluationNeck circumferenceBody 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 beneficiarys 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 beneficiarys 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 months 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 practitioners 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, all coverage, coding and documentation requirements in effect for the date of service (DOS) on the claim under review must be met (see below for beneficiary-owned devices entering Medicare).BENEFICIARIES ENTERING MEDICARE:For beneficiaries who received a PAP device prior to enrollment in fee for service (FFS) Medicare and are seeking Medicare coverage of either rental of the device, a replacement device or accessories, the supplier may add the KX modifier only if both of the criteria listed in the Coverage Indications, Limitations, and/or Medical Necessity for Beneficiaries Entering Medicare section of the related LCD have been met.The supplier may hold claims, pending confirmation that the above requirements are met, and then submit claims with the KX modifier beginning with the date of FFS Medicare enrollment.CONCURRENT USE OF OXYGEN WITH PAP THERAPY:In the rare instance where beneficiaries require the simultaneous use of home oxygen therapy and a PAP device, documentation by the treating practitioner in the beneficiarys medical record must clearly demonstrate that the requirements for coverage outlined in the PAP LCD Coverage Indications, Limitations, and/or Medical Necessity have been met. In addition, the beneficiarys medical record must also clearly demonstrate that the requirements for coverage outlined in the Oxygen and Oxygen Equipment LCD Coverage Indications, Limitations, and/or Medical Necessity have been met. This information does not have to be submitted with the claim but must be available upon request.Suppliers should refer to the Oxygen and Oxygen Equipment LCD and related Policy Article for additional coverage, coding and documentation requirements.MODIFIERSGA, GZ, and KX MODIFIERS:In all of the situations above describing use of the KX modifier, if all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for the PAP equipment and accessories. When there is an expectation of a reasonable and necessary denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed without a GA, GZ or KX modifier will be rejected as missing information.MISCELLANEOUS:Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.The order must include the type(s) of supplies ordered and the approximate quantity to be used per unit of time. A new order is required if there is an increase in the quantity of the supply used per month and/or the type of supply used.The supplier must enter the diagnosis code for the PAP device on each claim submitted for PAP supplies.Refer to the Supplier Manual for additional information on documentation requirements.CODING GUIDELINES