Positive Airway Pressure Devices (PAP) New Policy Effective September 1, 2008

New Policy is Diagnosis Driven Only one diagnosis code will cover the items listed in this new policy – Obstructive Sleep Apnea (adult)(pediatric)

Initial Coverage for First 3 Months A CPAP (E0601) is covered for the treatment of Obstructive Sleep Apnea if the following conditions are met Patient has a face-to-face clinical evaluation Patient has a Medicare covered sleep test Patient/caregiver has received instructions on how to use the equipment

Clinical Face-to-Face Evaluation Clinical evaluation must be performed by the treating physician prior to the sleep test to assess the patient for OSA Clinical evaluation shall be documented in a detailed narrative note in the physician chart in the format used for other entries For dates of service on or after September 1, 2008 the clinical evaluation by the treating physician must include, at a minimum, the following the following items

Clinical Evaluation Minimum Requirements Sleep history and symptoms including, but not limited to, snoring, morning headaches, gasping or choking during sleep, observed apneas, excessive daytime sleepiness, and Epworth sleepiness scale, and Physical examination that documents body mass index, neck circumference, and a focused cardiopulmonary and upper airway system evaluation

How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? This refers to your usual way of life in recent times. Even if you have not done some of these things recently try to work out how they would have affected you. Use the following scale to choose the most appropriate number for each situation: 0 = would never doze or sleep. 1 = slight chance of dozing or sleeping 2 = moderate chance of dozing or sleeping 3 = high chance of dozing or sleeping Situation Chance of Dozing or Sleeping Sitting and reading ____ Watching TV ____ Sitting inactive in a public place ____ Being a passenger in a motor vehicle for an hour or more ____ Lying down in the afternoon ____ Sitting and talking to someone ____ Sitting quietly after lunch (no alcohol) ____ Stopped for a few minutes in traffic while driving ____ Total score (add the scores up) (This is your Epworth score) ____ 0-9 – Average score, normal population – Sleep specialist advice recommended Epworth Sleepiness Scale reprinted with permission of the Associated Professional Sleep Societies (Johns MW; A New Method for Measuring Daytime Sleepiness: The Epworth Sleepiness Scale. SLEEP 1991;14(6): ). Epworth Sleepiness Scale

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Medicare Covered Sleep Test An AHI or RDI ≥ 15 events per hour with a minimum of 30 events, or An AHI or RDI ≥ 5 or ≤ 14 events per hour with a minimum or 10 events and documentation of: –Excessive daytime sleepiness, mood disorders, insomnia or impaired cognition, or –Hypertension, ischemic heart disease or history of stroke

Sleep Test Must be ordered by the beneficiaries treating physician Must be conducted by an entity that qualifies as a Medicare provider of sleep tests and is in compliance with all applicable state regulatory requirements

Home Sleep Test For DOS on or after September 1, 2008, all beneficiaries who undergo a HST must, prior to having the test, receive a face to face demonstration of how to properly apply a portable sleep monitoring device. This education must be provided by the entity conducting the HST and may not be performed by the DME supplier No aspect of an HST, including but not limited to delivery and or pickup of the device, may be performed by a DME supplier

Sleep Test Requirements as of September 1, 2008 All sleep tests must be interpreted by a physician who is: –A diplomat of the American Board of Sleep Medicine (ABSM), or –Diplomat in Sleep Medicine by a member board of the American Board of Medical Specialties (ABMS), or –Active staff member of a sleep center or laboratory accredited by the American Academy of Sleep Medicine (AASM) or JCAHO

Supplier Instruction The supplier has instructed the patient and/or caregiver on the proper use and care of the CPAP device and accessories

Initial RAD E0470 Coverage Diagnosis of OSA Patient has a face-to-face clinical evaluation Patient has a Medicare covered sleep test Patient/caregiver has received instructions on how to use the equipment An E0601 has been tried and proven ineffective based on a therapeutic trial conducted in either facility or in a home setting (if this requirement is not met payment will be based on an E0601)

Initial Coverage E0471 An E0471 is not medically necessary for OSA (ICD ) If requirements for E0470 are met, the E0471 will be paid based on allowance for E0470 If requirement for E0601 are met, the E0471 will be paid based on the allowance for the E0601

RAD Substitution If CPAP is tried and found ineffective during initial 3 month in home trial, substitution of a RAD does not require a new initial face to face clinical evaluation or a new sleep test If a CPAP device is tried and found ineffective during the initial 3 month home trial, substitution of a RAD (E0470) does not change the length of the trial. The clinical re-evaluation would occur between the 61st and 91st day following the initiation of CPAP.

RAD Substitution If patient used CPAP > 3 months and is switched to a RAD, a new clinical face to face evaluation is required, but a new sleep test is not required. A new 3 month trial would begin for the RAD If a CPAP device was used for more that 3 months and the patient was switched to a RAD, then the clinical re- evaluation would occur between the 61st and 91st day following the initiation of the RAD. There would also need to be documentation of adherence to therapy during the 3 month trial with the RAD.

Continued Coverage Past First 3 Months The treating physician must conduct a clinical re-evaluation and document that the beneficiary is benefiting from the PAP therapy Clinical evaluation must be done no sooner than the 61 st day and no later than the 91 st day after initiating therapy

Clinical Re-Evaluation Documentation Face to Face clinical re-evaluation by the treating physician with documentation that symptoms of OSA are improved (this must be a detailed narrative note in the physician chart in the format that they use for other entries, and Evidence that the patient is using the PAP. Defined by PAP ≥ 4 hours per night on 70% of nights during a consecutive thirty day period anytime during the first 3 months of initial use

Delayed Re-Evaluation If the physician re-evaluation does not occur until after the 91 st day (and the evaluation demonstrates that the patient is benefitting from the PAP therapy as described in the previous slide) the coverage will continue on the date of the re-evaluation.

Humidifier A non-heated E0561 or a heated E0562 humidifier is covered when ordered by the treating physician for use with a covered PAP device (E0601, E0470)

Supplies A4604 – 1 per 3 monthsTubing used with a heated humidifier A7027 – 1 per 3 monthsCombination oral/nasal mask A7028 – 2 per 1 monthOral cushion for combination oral/nasal mask A7029 – 2 per 1 monthNasal pillows for combination oral/nasal mask A7030 – 1 per 3 monthsFull Face mask A7031 – 1 per 1 month Face mask interface, replacement for full face mask A per 1 monthCushion, each A7033 – 2 per 1 monthPillow, pair A per 3 months Nasal interface A per 6 months Headgear A per 6 months Chinstrap A per 3 months Tubing A per 1 month Filter, disposable A per 6 months Filter, non-disposable A7046 – 1 per 6 monthsWater chamber for humidifier