| Highmark Medicare Advantage Medical Policy in West Virginia |
| Section: | Durable Medical Equipment |
| Number: | E-20 |
| Topic: | Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea |
| Effective Date: | October 1, 2011 |
| Issued Date: | May 21, 2012 |
A single-level continuous positive airway pressure (CPAP) device (E0601) delivers a constant level of positive air pressure (within a single respiratory cycle) by way of tubing and a noninvasive interface (such as a nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.
Indications and Limitations of Coverage
For any item to be covered, it must:
For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage.
For an item to be covered, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.
DEFINITIONS:
Apnea is defined as the cessation of airflow for at least 10 seconds.
Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% decrease in oxygen saturation.
The apnea-hypopnea index (AHI) is defined as the average number of episodes of apnea and hypopnea per hour of sleep without the use of a positive airway pressure device. For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the AHI. Sleep time can only be measured in a Type I (facility based polysomnogram) or Type II sleep study (see descriptions below).
The respiratory disturbance index (RDI) is defined as the average number of apneas plus hypopneas per hour of recording without the use of a positive airway pressure device. For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the RDI. The RDI is reported in Type III, Type IV, and Other home sleep studies.
If the AHI or RDI is calculated based on less than 2 hours of sleep or recording time, the total number of recorded events used to calculate the AHI or RDI (respectively) must be at least the number of events that would have been required in a 2 hour period (i.e., must reach ≥30 events without symptoms or ≥10 events with symptoms).
INITIAL COVERAGE
In this policy, the term PAP (positive airway pressure) device will refer to both a single-level continuous positive airway pressure device (E0601) and a bi-level respiratory assist device without back-up rate (E0470) when it is used in the treatment of obstructive sleep apnea.
I. An E0601 device is covered for the treatment of obstructive sleep apnea (OSA) if criteria A - C are met:
If a claim for an E0601 is submitted and all of the criteria above have not been met, it will be denied as not medically necessary.
II. An E0470 device is covered for those patients with OSA who meet criteria A-C above, in addition to criterion D:
D. An E0601 has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.
Ineffective is defined as documented failure to meet therapeutic goals using an E0601 during the titration portion of a facility-based study or during home use despite optimal therapy (i.e., proper mask selection and fitting and appropriate pressure settings).
If E0470 is billed for a patient with OSA and criterion A-D are not met, it will be denied as not medically necessary.
A bi-level positive airway pressure device with back-up rate (E0471) is not medically necessary if the primary diagnosis is OSA. If an E0471 is billed with a diagnosis of OSA, it will be denied as not medically necessary.
If an E0601 device is tried and found ineffective during the initial facility-based titration or home trial, substitution of an E0470 does not require a new initial face-to-face clinical evaluation or a new sleep test.
If an E0601 device has been used for more than 3 months and the patient is switched to an E0470, a new initial face-to-face clinical evaluation is required, but a new sleep test is not required. A new 3 month trial would begin for use of the E0470.
Coverage, coding and documentation requirements for the use of E0470 and E0471 for diagnoses other than OSA are addressed in Respiratory Assist Devices, Medicare Advantage Medical Policy Bulletin E-34.
Sleep Tests
Coverage of a PAP device for the treatment of OSA is limited to claims where the diagnosis of OSA is based upon a sleep test (Type I, II, III, IV, Other) that meets the coverage criteria in effect for the date of service of the claim for the PAP device. The sleep test must be either a polysomnogram performed in a facility-based laboratory (Type I study) or a home sleep test (HST) (Types II, III, IV, Other). The test must be ordered by the member's treating physician and conducted by an entity that qualifies as a provider of sleep tests and is in compliance with all applicable state regulatory requirements.
A Type I sleep test is the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep with physician review, interpretation, and report. It is facility-based and must include sleep staging, which is defined to include a 1-4 lead electroencephalogram (EEG), electro-oculogram (EOG), submental electromyogram (EMG) and electrocardiogram (ECG). It must also include at least the following additional parameters of sleep: airflow, respiratory effort, and oxygen saturation by oximetry. It may be performed as either a whole night study for diagnosis only or as a split night study to diagnose and initially evaluate treatment.
An HST is performed unattended in the member's home using a portable monitoring device. A portable monitoring device for conducting an HST must meet one of the following criteria:
For all PAP devices, members who undergo an HST must, prior to having the test, receive instruction on how to properly apply a portable sleep monitoring device. This instruction must be provided by the entity conducting the HST and may not be performed by a DME supplier. Patient instruction may be accomplished by either:
For all PAP devices, the sleep test (Type I-IV, Other) must be interpreted by a physician who holds either:
CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:
Continued coverage of a PAP device (E0470 or E0601) beyond the first three months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating physician must conduct a clinical re-evaluation and document that the member is benefiting from PAP therapy.
For PAP devices with initial dates of service on or after November 1, 2008, documentation of clinical benefit is demonstrated by:
Adherence to therapy is defined as use of PAP ≥ 4 hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three (3) months of initial usage.
If the above criteria are not met, continued coverage of a PAP device and related accessories will be denied as not medically necessary.
If the physician re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the patient is benefiting from PAP therapy as defined in criteria 1 and 2 above, continued coverage of the PAP device will commence with the date of that re-evaluation.
Members who fail the initial 12 week trial are eligible to requalify for a PAP device but must have both:
If an E0601 device is tried and found ineffective during the initial facility-based titration or home trial, substitution of an E0470 does not change the length of the trial unless there is less than 30 days remaining in the trial period. If more than 30 days remain in the trial period, the clinical re-evaluation would still occur between the 31st and 91st day following the initiation of an E0601 and objective documentation of adherence on the E0470 would need to occur prior to the 91st day following initiation of the E0601. If less than 30 days remain in the trial period, the clinical re-evaluation and objective documentation of adherence must occur before the 120th day following the initiation of the E0601.
If an E0601 device was used for more than 3 months and the patient was then switched to an E0470, the clinical re-evaluation must occur between the 31st and 91st day following the initiation of the E0470. There would also need to be documentation of adherence to therapy during the 3 month trial with the E0470.
If there is discontinuation of usage of a PAP device at any time, the supplier is expected to ascertain this and stop billing for the equipment and related accessories and supplies.
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 device will continue to be covered for PAP devices with initial dates of service on or after November 1, 2008 as long as the patient continues to compliantly use the device.
REPLACEMENT:
This section applies to PAP devices initially provided and covered while the member was in Medicare Advantage.
If a PAP device is replaced during the 5 year reasonable useful lifetime (RUL) because of loss, theft, or irreparable damage due to a specific incident, there is no requirement for a new clinical evaluation, sleep test, or trial period.
If a PAP device is replaced following the 5 year RUL, there must be a face-to-face evaluation by their treating physician that documents that the member continues to use and benefit from the PAP device. There is no requirement for a new sleep test or trial period.
MEMBERS ENTERING MEDICARE ADVANTAGE:
For members who received a PAP device prior to enrollment in Medicare Advantage and are seeking Medicare Advantage coverage of either rental of the device, a replacement PAP device and/or accessories, both of the following coverage requirements must be met:
If either criteria 1 or 2 above are not met, the claim will be denied as not medically necessary.
In these situations, there is no requirement for a clinical re-evaluation or for objective documentation of adherence to use of the device.
ACCESSORIES:
Accessories used with a PAP device are covered when the coverage criteria for the device are met. If the coverage criteria are not met, the accessories will be denied as not medically necessary. The following table represents the usual maximum amount of accessories expected to be medically necessary:
A4604 - 1 per 3 months
A7027 - 1 per 3 months
A7028 - 2 per 1 month
A7029 - 2 per 1 month
A7030 - 1 per 3 months
A7031 - 1 per 1 month
A7032 - 2 per 1 month
A7033 - 2 per 1 month
A7034 - 1 per 3 months
A7035 - 1 per 6 months
A7036 - 1 per 6 months
A7037 - 1 per 3 months
A7038 - 2 per 1 month
A7039 - 1 per 6 months
A7046 - 1 per 6 months
Quantities of supplies greater than those described in the policy as the usual maximum amounts will be denied as not medically necessary.
Accessories are separately reimbursable at the time of initial issue and when replaced.
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 member prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the member. This shall be done to ensure that the refilled item remains medically necessary, existing supplies are approaching exhaustion, and to confirm any changes/modifications to the order. Contact with the member or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery or refills, the supplier must deliver 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 member or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a member. Items delivered without a valid, documented refill request will be denied as not medically necessary.
Suppliers must not dispense a quantity of supplies exceeding a member’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.
Either a non-heated (E0561) or heated (E0562) humidifier is covered when ordered by the treating physician for use with a covered PAP (E0470 or E0601) device.
If the criteria on this policy are not met, a provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.
Documentation Requirements
It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.
An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. 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. Items submitted with an EY modifier will be denied as not medically necessary.
The ICD-9 code that justifies the need for the item must be included on the claim.
REFILLS:
A routine refill prescription is not needed. A new prescription is needed when:
For items that the patient obtains in person at a retail store, the signed delivery slip or copy of itemized sales receipt is sufficient documentation of a request for refill.
For items that are delivered to the member, documentation of a request for refill must be either a written document received from the member or a contemporaneous written record of a phone conversation/contact between the supplier and member. The refill request must occur and be documented before shipment. A retrospective attestation statement by the supplier or beneficiary is not sufficient. The refill record must include:
This information must be kept on file and be available upon request.
Physicians shall document the face-to-face clinical evaluations and re-evaluations in a detailed narrative note in their charts in the format that they use for other entries. For the initial 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
Physical Exam
For members 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 physician must document that both of the following issues were addressed prior to changing to an E0470 device:
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 physician and included in the member'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 they send to physicians and ask them to complete. Even if the physician 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 physicians on the type of information that is needed to document a patient’s need for PAP therapy.
MODIFIERS:
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 “Indications and Limitations of Coverage” section of this policy ("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 “Indications and Limitations of Coverage” section of this policy have been met.
If the supplier does not obtain information from the physician that the member 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 physician that the member 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 physician but learns that the member 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 patient continues to use the device.
MEMBERS ENTERING MEDICARE ADVANTAGE
For members who received a PAP device prior to enrollment in Medicare Advantage and are seeking 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 "Indications and Limitations of Coverage" for "Members Entering Medicare Advantage" section 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 enrollment.
GA and GZ 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 medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a Pre-Service Denial Notice or the GZ modifier if they have not obtained a valid Pre-Service Denial Notice.
Claim lines billed without a GA, GZ or KX modifier will be rejected as missing information.
| A4604 | A7027 | A7028 | A7029 | A7030 | A7031 |
| A7032 | A7033 | A7034 | A7035 | A7036 | A7037 |
| A7038 | A7039 | A7044 | A7045 | A7046 | E0470 |
| E0471 | E0561 | E0562 | E0601 |
A respiratory cycle is defined as an inspiration, followed by an expiration.
A single-level continuous positive airway pressure (CPAP) device (E0601) delivers a constant level of positive air pressure (within a single respiratory cycle) by way of tubing and a noninvasive interface (such as a nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.
For auto-titrating single-level CPAP devices, use HCPCS code E0601.
A bi-level respiratory assist device without backup rate (E0470) allows independent setting of inspiratory and expiratory pressures to deliver positive airway pressure within a single respiratory cycle by way of tubing and a noninvasive interface (such as a nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.
A bi-level respiratory assist device with backup rate (E0471) allows independent setting of inspiratory and expiratory pressures to deliver positive airway pressure within a single respiratory cycle by way of tubing and a noninvasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs. In addition, E0471 devices have a timed backup feature to deliver this air pressure whenever sufficient spontaneous inspiratory efforts fail to occur.
Code A4604 describes tubing used with a heated humidifier and has a heated wire running the length of the tubing. It is designed for use with a positive airway pressure device and a non-invasive interface - i.e., nasal or face mask, nasal cannula, or oral interface.
Code A7032 is used for a replacement nasal mask interface that goes around the nose, but not into the nostrils. The unit of service for this code is “each.”
Code A7033 is used for a replacement nasal cannula-type interface. This interface extends a short distance into the nostrils. The unit of service for this code is “pair.” For some products, there are two physically separate cushions or “pillows” - one for each nostril. Two cushions/pillows equals one unit of service of A7033. For other products, the interface is a single piece with two protrusions that extend into the nostrils. One of these interfaces equals one unit of service of A7033.
Code A7027 (Combination oral/nasal mask, used with continuous positive airway pressure device, each) is a two piece system with separate elements for oral and nasal use. One unit of service for A7027 includes both the oral and the nasal components.
Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) contractor for guidance on the correct coding of these items.
Provider News
08/2010, Positive airway pressure devices for the treatment of obstructive sleep apnea policy guidelines revised for FreedomBlue
02/2011, Elimination of least costly alternative for Medicare Advantage
Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.
CMS Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 240.4
EPWORTH SLEEPINESS SCALE
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
| 327.23 |