Itamar Medical 2016 Reimbursement Coding Guide

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Itamar Medical 2016 Reimbursement Coding Guide Continuous positive airway pressure (CPAP) and associated devices for Obstructive Sleep Apnea (OSA) DISCLAIMER: The information contained in this guide is provided to assist you in understanding the reimbursement process. It is intended to assist providers in accurately obtaining reimbursement for health care services. It is not intended to increase or maximize reimbursement by any payer. We strongly suggest that you consult your payer organization with regard to local reimbursement policies. The information contained in this document is provided for information purposes only and represents no statement, promise or guarantee by Itamar Medical concerning levels of reimbursement, payment or charge. Similarly, all CPT and HCPCS codes are supplied for information purposes only and represent no statement, promise or guarantee by Itamar Medical that these codes will be appropriate or that reimbursement will be made.

Physician Services 3 CPAP and Bi-level Devices 4 Accessories 6 Integrated Devices 7 ICD-10-CM Diagnosis Codes 9 2

2016 Reimbursement Coding Guide Continuous positive airway pressure (CPAP) and associated devices for Obstructive Sleep Apnea (OSA) PHYSICIAN SERVICES Physicians may receive payment for patient visits related to the initial or subsequent management of PAP therapy. 2016 Medicare Physician Fee Schedule (MPFS) Payments 1 CPT Code 94660 CPT CODE DESCRIPTION Continuous positive airway pressure ventilation (CPAP), initiation and management 2016 NATIONAL AVERAGE PAYMENT (Non-Facility) $64.09 Noninvasive, continuous positive airway pressure (CPAP) therapy or bi-level positive airway pressure (BPAP) is commonly prescribed for the treatment of obstructive sleep apnea. CPT Code 94660 describes the initiation or the subsequent management of PAP therapy. The code includes reviewing medical history, performing a physical examination, and reviewing diagnostic test results, all focused on the management of PAP and the underlying disorder. Discussions with the patient may include various device options and masks available; prior experiences with PAP devices; desensitization therapy to manage side effects such as claustrophobia or facial lesions; ordering durable medical equipment (DME); and addressing any related health care needs. Frequently Asked Questions2 The following questions and answers are from the CPT Assistant Archives Q: May I report code 94660 for an inpatient? For a nursing home patient? A: Yes. Code 94660 has no site of service restrictions. Q: May I report both an evaluation and management code (99201-99499) and code 94660 on the same day? A: Typically, no. The services of code 94660 are included in National Correct Coding Initiative edits in every evaluation and management code (99201-99499). Q: May I report an evaluation and management code (99201-99499) instead of code 94660? A: Yes. If addressing other issues or diagnoses in addition to sleep apnea in the same patient encounter, an evaluation and management service may be a more appropriate code to select. However, even if only instructing a patient on CPAP initiation, an evaluation and management code at the proper code level, based upon the Documentation Guidelines can be appropriate to select. An evaluation and management code may be selected in this circumstance based on time spent counseling the patient and coordinating his or her care for sleep-disordered breathing. 3

CPAP AND BI-LEVEL DEVICES Continuous positive airway pressure (CPAP) and bi-level devices are indicated for patients with obstructive sleep apnea (OSA). Patients wear a face or nasal mask during sleep. The mask, connected to a pump, provides a positive flow of air into the nasal passages in order to keep the airway open. Medicare and commercial payers cover PAP devices based on the criteria outlined below. 2016 Durable Medical Equipment, Prosthetics/Orthotics, and Supplies (DMEPOS) Fee Schedule3 DEVICE DESCRIPTION HCPCS 2016 Medicare Reimbursement (Revised July 2016) CPAP Continuous positive airway pressure (CPAP) device E0601 $44.74 39.42 BI-LEVEL Respiratory assist device, bi-level pressure capability, without backup rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device) E0470 $117.42 102.10 Important Billing Criteria4 Medicare has specific criteria for coverage of CPAP and bi-level devices for treatment of OSA. Please refer to the local coverage policies for specific details. Coverage Criteria Required for All CPAP Claims A single-level CPAP device (E0601) is covered for the treatment of OSA if criteria are met: The patient has face-to-face clinical evaluation by treating physician prior to the sleep test to assess the patient for OSA. NOTE: - Physicians shall document the face-to-face evaluation and re-evaluation in a detailed narrative note in their charts. For the initial evaluation, the report would commonly document pertinent information (i.e., history and physical exam), but may include other details. The patient has a sleep test that meets either of the following criteria: The apnea hypopnea index (AHI) or respiratory disturbance index (RDI)* is 15 events per hour with minimum of 30 events; or The AHI or RDI is 5 and 14 events per hour with minimum of 10 events and documentation of: - Excessive daytime sleepiness, impaired cognition, mood disorders or insomnia; or - Hypertension, ischemic heart disease or history of stroke. The patient and/or their caregiver has received instruction from the supplier of the CPAP device and accessories in the proper use and care of the equipment. Coverage Criteria Required for All Bi-level Claims A bi-level without backup rate (E0470) is covered for those patients with OSA who meet criteria above, in addition to the following: An E0601 has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or a home setting. Treating physician must document both of the following issues were addressed prior to changing a patient from an E0601 to an E0470 device due to ineffective therapy: 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. 4

Coverage Criteria for Sleep Tests Covered sleep tests include Type I, II, III or IV devices. Some MAC LCDs define an other category which includes devices that utilize peripheral arterial tone Beneficiaries must receive face-to-face demonstration, or video or telephonic instruction on HST device prior to test Education on home apnea sleep testing (HSAT) device must be provided by entity performing the test (not by DME supplier) All sleep tests must be interpreted by a physician who holds either: 1. Current certification in sleep medicine by the American Board of Sleep Medicine (ABSM); or 2. Current subspecialty certification in sleep medicine by member board of American Board of Medical Specialists (ABMS); or 3. Completed training by ABMS member board and completed all requirements for subspecialty certification in sleep except exam itself; or 4. Active staff of a sleep center or lab accredited by the AASM, ACHC or The Joint Commission. Continued Coverage Beyond the First Three Months of Therapy Continued coverage documented between 31st and 91st day after initiation of therapy 1. Face-to-face clinical re-evaluation by treating physician and documentation of improved symptoms of OSA; and 2. Physician review of objective evidence of adherence (defined as use of PAP 4 hours per night on 70% of nights during a consecutive 30-day period) via AirView, direct download or visual inspection of usage data. Continued Coverage Documentation for Bi-level Devices: Switch to bi-level day 1 60 following CPAP setup - Obtain Rx for E0470 device (clinical re-evaluation must occur between 31st and 91st day following initiation of CPAP). Switch to bi-level day 61 90 following CPAP setup - Obtain Rx for E0470 device (clinical re-evaluation must occur before 120th day following initiation of CPAP). Switch to bi-level post day 90 following CPAP setup - Obtain Rx for E0470 device and new initial face-to-face clinical evaluation (clinical re-evaluation must occur between 31st and 91st day following initiation of bi-level). 5

ACCESSORIES Accessories for a positive airway pressure (PAP) device include items such as masks, cushions, tubing and filters. These items can be replaced regularly, according to Medicare replacement schedule guidelines shown in the chart below table. If members require additional supplies they will be asked to provide detailed reasoning for the request. 2016 Durable Medical Equipment, Prosthetics/Orthotics, and Supplies (DMEPOS) Fee Schedule3 HCPCS CODE HCPCS CODE DESCRIPTION 2016 Medicare Reimbursement (Revised July 2016) Replacement Schedule A4604 Tubing with integrated heating element for use with positive $43.72 39.19 airway pressure (PAP) device A7027 Combination oral/nasal mask, used with continuous positive $130.83 111.80 airway pressure (CPAP) device, each A7028 Oral cushion for combination oral/nasal mask, replacement only, $36.98 31.61 2 per month each A7029 Nasal pillows for combination oral/nasal mask, replacement only, $16.82 14.62 2 per month pair A7030 Full face mask used with PAP device, each $98.24 86.51 A7031 Face mask interface, replacement for full face mask, each $37.44 33.06 1 per month A7032 Replacement cushion for nasal application device, each $20.84 18.34 2 per month A7033 Replacement pillows for nasal application device, pair $16.90 15.10 2 pairs per month A7034 Nasal mask or cannula type application device, used with PAP $61.19 53.32 device A7035 Headgear used with PAP device $20.20 17.98 1 per 6 months A7036 Chin strap used with PAP device $11.52 10.15 1 per 6 months A7037 Tubing used with PAP device $13.39 11.89 A7038 Filter, disposable, used with PAP device $2.31 20.06 2 per month A7039 Filter, non-disposable, used with PAP device $6.66 5.94 1 per 6 months A7046 Replacement water chamber for humidifier, used with PAP device $14.44 12.40 1 per 6 months Accessory Refill Supply 4 A prescription is required for a continuous positive airway pressure (CPAP) or respiratory assist device (RAD) to authorize the coverage of related accessories. To authorize ongoing billing for supplies, providers should obtain and keep on file the original prescription for the patient s device. In order to deliver supplies, beneficiaries or their caregivers must specifically request refills of supplies before a supplier dispenses them. The supplier should obtain patient authorization before delivering DMEPOS to Medicare beneficiaries. In order for a Medicare beneficiary to receive replacement accessories, the patient should: 1) Be contacted by the DME supplier. 2) Acknowledge that the supplies are needed; and 3) Approve the quantity. The information should always be documented in the patient s medical file. 6

According to CMS, for DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products (A4604, A7027-A7046) that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized. For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/ designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary. Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the ordering physicians that any changed or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a three (3) month quantity at a time. INTEGRATED DEVICES An integrated device is a device that consists of multiple components such as flow generator, humidifier, and a remote monitor that can be billed separately. Separately billed items may be classified under different payment categories. The most common payment categories for positive airway pressure medical devices include inexpensive or other routinely purchased DME and capped rental items. 2016 Durable Medical Equipment, Prosthetics/Orthotics, and Supplies (DMEPOS) Fee Schedule3 HCPCS CODE HCPCS CODE DESCRIPTION 2016 Medicare Reimbursement (Revised July 2016) PAYMENT CATEGORY E0465 E0466 E0470 E0471 E0472 E0561 E0562 E0601 E1390 E1392 A9279 Home ventilator, any type, used with invasive interface (e.g. tracheostomy tube) Home ventilator, any type, used with non-invasive interface (e.g. mask, chest shell) Respiratory assist device (RAD), bi-level pressure capability, without backup rate feature, used with noninvasive interface RAD, bi-level pressure capability, with backup rate feature, used with noninvasive interface RAD, bi-level pressure capability, with backup rate feature, used with invasive interface Humidifier, non-heated, used with PAP device Humidifier, heated, used with PAP device CPAP device Oxygen concentrator, single delivery port, capable of delivering 85% or greater oxygen concentration at the prescribed flow rate Portable oxygen concentrator, rental Monitoring feature/device, stand-alone or integrated, any type, includes all accessories, components and electronics, not otherwise classified. $1754.45 896.95 $1754.45 896.95 $117.42 102.10 $291.56 256.38 $433.28 353.60 $77.66 68.32 $150.03 134.57 $44.74 39.42 $86.87 75.75 $42.15 38.81 N/A FSS FSS CR CR CR IRP IRP CR OX OX Non-Covered Item *IRP = Inexpensive and Routinely Purchased; CR = 13-month Capped Rental; FSS = Frequent and Substantial Servicing; OX = 36-month Oxygen Capped Rental 7

Capped Rental Payment Category 6 Payments for this category are made on a monthly rental basis not to exceed a continuous 13-month period. For the first three rental months, the monthly rental fee schedule is limited to 10% of the average allowed purchase price. For each of the remaining months, the monthly rental is limited to 7.5% of the average allowed purchase price. This means that months 1 3 are paid at the published fee schedule rental rate, and months 4 13 are paid at 75% of the published rate. At the end of the capped rental period (after 13 paid rental months), the title of ownership for capped rental devices transfers from the provider to the patient. Inexpensive and Routinely Purchased Payment Category Payment options for this category are made on either a rental or lump sum purchase basis. The cumulative rental payment amounts may not exceed the fee for a purchase, which would occur following 10 months of rental. The option to purchase or rent must be presented to the Medicare beneficiary. An Advance Beneficiary Notices of Non-Coverage (ABN) serves as a courtesy notice to the beneficiary advising him/her of possible financial obligation for an item or service. An ABN is not required for an item that is not covered by statute under Medicare, but may be issued voluntarily. If an ABN is used as a voluntary notice, the beneficiary should not be asked to choose an option box or sign the notice. To submit a non-covered line item where an ABN was issued voluntarily, providers should append the GX modifier. This modifier can only be used on statutorily non-covered services. Providers are encouraged to consult with local payers and Medicare for specific guidance as to whether to issue a mandatory or voluntary ABN. Non-covered Items 7,8 Medicare will not provide payment, for items that are statutorily non-covered. The financial liability that remains when Medicare does not pay belongs to either providers or beneficiaries. Medicare allows providers and beneficiaries to make their own agreements on payment without billing Medicare. Modifiers MODIFIER DESCRIPTION RR KH KI KJ NU UE KX GX Rental First rental month Second and third rental months Fourth to the thirteenth months Purchase of new equipment Purchase of used equipment Requirements specified in the medical policy have been met Notice of Liability Issued, Voluntary under payer policy 8

ICD-10-CM DIAGNOSIS CODES International Classification of Diseases, 10th Revision. ICD-10-CM replaced ICD-9-CM, Volumes 1 and 2 on October 1, 2015. ICD-9-CM is still used for claims for dates of service prior to October 1, 2015. Commonly Used ICD-10-CM Diagnosis Codes Symptoms and Signs of Sleep Apnea Confirmed Diagnosis of OSA ICD-10 DESCRIPTION ICD-10 DESCRIPTION 80.51 327.23 780.53 Insomnia with sleep apnea, unspecified Obstructive sleep apnea (adult)(pediatric) Hypersomnia with sleep apnea, unspecified G47.33 780.57 Obstructive sleep apnea (adult)(pediatric) Unspecified sleep apnea References 1. CMS-1631-FC Medicare Physician Fee Schedule (MPFS) Final Rule CY 2016 2. CPT Assistant Archives (4th Quarter 1990 - present) - Copyright American Medical Association. How to Code for the Provision of Positive Pressure Therapy (October 2014, Volume 24, Issue 10, page 8) 3. The rates listed are based on the Medicare 2016 DMEPOS National Fee Schedule. Competitive bidding rates may be applicable in certain CBAs; please reference the single payment amounts for these areas 4. Centers for Medicare & Medicaid Services LCDs: Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea V8 (Rev. Eff. 07/01/2016) L33718 Respiratory Assist Devices V9 (Rev. Eff. 07/01/2016) L33800 Local Coverage Article for Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea A52467 5. CMS Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-08, Chapter 5, Section 5.2.6. 6. https://med.noridianmedicare.com/web/jddme/topics/payment-categories/capped-rental 7. http://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/mm7821.pdf 8. http://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/mm6563.pdf Itamar Medical, Inc. Tel: 1-888-748-2627. FAX: 1-888-748-2628 http://www.itamar-medical.com/email-your-reimbursement-questions/ Itamar Medical provides this information only for your convenience. It is not intended as a recommendation of clinical practice or as legal advice. It is the responsibility of the provider to determine coverage and submit appropriate codes, modifiers, and charges for the services rendered. Contact your Medicare Administrative Contractor (MAC) or other commercial payer for interpretation of coverage, coding and payment policies. 9