LCD/NCD Portal

L11518 POSITIVE AIRWAY PRESSURE (PAP) DEVICES FOR THE TREATMENT

OF OBSTRUCTIVE SLEEP APNEA

 

Region IV

 

DME

Jurisdiction C

 

01/01/2013

 

 

• For any item to be covered by Medicare, it must

o Be eligible for a defined Medicare benefit category.

o be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and

o Meet all other applicable Medicare statutory and regulatory requirements.

• For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act §1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

• For an item to be covered by Medicare, a detailed written order (DWO) must be received by the supplier before a claim is submitted.

o If the supplier bills for an item addressed in this policy without first receiving the completed DWO, the item will be denied as not reasonable and necessary.

 

 

• DEFINITIONS:

o Apnea is defined as the cessation of airflow for at least 10 seconds.

o 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.

o 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).

o 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.

o 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:

o 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.

 An E0601 device is covered for the treatment of obstructive sleep apnea (OSA) if criteria A – C are met:

• The beneficiary has a face-to-face clinical evaluation by the treating physician prior to the sleep test to assess the beneficiary for obstructive sleep apnea.

• The beneficiary has a sleep test (as defined below) that meets either of the following criteria (1 or 2):

o The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour with a minimum of 30 events; or,

o The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a 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 beneficiary and/or their caregiver have received instruction from the supplier of the device in the proper use and care of the equipment.

 If a claim for an E0601 is submitted and all of the criteria above have not been met, it will be denied as not reasonable and necessary.

 An E0470 device is covered for those beneficiaries with OSA who meet criteria A-C above, in addition to criterion D:

 An E0601 has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.

o 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).

o If E0470 is billed for a beneficiary with OSA and criteria A-D are not met, it will be denied as not reasonable and necessary.

o A bi-level positive airway pressure device with back-up rate (E0471) is not reasonable and necessary if the primary diagnosis is OSA. If an E0471 is billed with a diagnosis of OSA, it will be denied as not reasonable and necessary.

o 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.

o If an E0601 device has been used for more than 3 months and the beneficiary 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.

o Coverage, coding and documentation requirements for the use of E0470 and E0471 for diagnoses other than OSA are addressed in the Respiratory Assist Devices (RAD) Local Coverage Determination (LCD) and related Policy Article (PA).

 

• Sleep Tests

o Coverage and Payment rules for sleep tests may be found in the LCDs for the applicable Medicare Part A or Part B contractor. There may be differences between those LCDs and the DME MAC LCD. For the purposes of coverage of PAP therapy, the DME MAC coverage, coding and payment rules take precedence.

o 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 Medicare 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 beneficiary’s treating physician and conducted by an entity that qualifies as a Medicare provider of sleep tests and is in compliance with all applicable state regulatory requirements.

o 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.

o An HST is performed unattended in the beneficiary’s home using a portable monitoring device. A portable monitoring device for conducting an HST must meet one of the following criteria:

 Type II device – Monitors and records a minimum of seven (7) channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory movement/effort and oxygen saturation

 Type III device – Monitors and records a minimum of four (4) channels: respiratory movement/effort, airflow, ECG/heart rate and oxygen saturation

 Type IV device – Monitors and records a minimum of three (3) channels, one of which is airflow

 Other

• Devices that monitor and record a minimum of three (3) channels that include actigraphy, oximetry and peripheral arterial tone and for which there is substantive clinical evidence in the published peer-reviewed medical literature that demonstrates that the results accurately and reliably correspond to an AHI or RDI as defined above.

• This determination will be made on a device by device basis (See Appendix B for list of approved devices in this category).

• For all PAP devices, beneficiaries 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. Beneficiary instruction may be accomplished by either:

o Face-to-face demonstration of the portable sleep monitoring device’s application and use

o Video or telephonic instruction, with 24 hour availability of qualified personnel to answer questions or troubleshoot issues with the device.

o For all PAP devices the sleep test (Type I - IV, Other) must be interpreted by a physician who holds either:

 Current certification in Sleep Medicine by the American Board of Sleep Medicine (ABSM)

 Current subspecialty certification in Sleep Medicine by a member board of the American Board of Medical Specialties (ABMS)

 Completed residency or fellowship training by an ABMS member board and has completed all the requirements for subspecialty certification in sleep medicine except the examination itself and only until the time of reporting of the first examination for which the physician is eligible

 Active staff membership of a sleep center or laboratory accredited by the

 American Academy of Sleep Medicine (AASM)

 Accreditation Commission for Health Care (ACHC)

 The Joint Commission

 (TJC, formerly the Joint Commission on Accreditation of Healthcare Organizations – JCAHO).

 

• CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

o 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 beneficiary is benefiting from PAP therapy.

o For PAP devices with initial dates of service on or after November 1, 2008, documentation of clinical benefit is demonstrated by:

 Face-to-face clinical re-evaluation by the treating physician with documentation that symptoms of obstructive sleep apnea are improved; and

 Objective evidence of adherence to use of the PAP device, reviewed by the treating physician.

o 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.

o If the above criteria are not met, continued coverage of a PAP device and related accessories will be denied as not reasonable and necessary.

o If the physician re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the beneficiary 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.

o Beneficiaries who fail the initial 12 week trial are eligible to re-qualify for a PAP device but must have both:

 Face-to-face clinical re-evaluation by the treating physician to determine the etiology of the failure to respond to PAP therapy; and

 Repeat sleep test in a facility-based setting (Type 1 study).This may be a repeat diagnostic, titration or split-night study.

o 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.

o If an E0601 device was used for more than 3 months and the beneficiary 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.

o 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.

o For a PAP device dispensed prior to November 1, 2008, if the initial Medicare 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 dates of service on or after November 1, 2008 as long as the beneficiary continues to use the device.

 

 

 

• CONCURRENT USE OF OXYGEN WITH PAP THERAPY

o Some beneficiaries may require the simultaneous use of home oxygen therapy with a PAP device.

 To be considered for simultaneous coverage, all requirements in the Indications and Limitations of Coverage and/or Medical Necessity for both Oxygen and Oxygen Equipment and Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea LCDs must be met. Consequently, in addition to this LCD, suppliers should refer to the Oxygen and Oxygen Equipment LCD and related Policy Article for additional coverage, coding and documentation requirements.

o Coverage of home oxygen therapy requires that the beneficiary be tested in the “chronic stable state.” Chronic stable state is a requirement of the National Coverage Determination (CMS Internet-only Manual, Pub. 100-3, Section 240.2) and is one of the key criteria when determining coverage of home oxygen therapy.

 The NCD defines chronic stable state as “…not during a period of an acute illness or an exacerbation of their underlying disease.”

 Based on this NCD definition, all co-existing diseases or conditions that can cause hypoxia must be treated and the beneficiary must be in a chronic stable state before oxygen therapy is considered eligible for payment.

 In addition, the beneficiary must have a severe lung disease, such as chronic obstructive pulmonary disease, diffuse interstitial lung disease, cystic fibrosis, bronchiectasis, widespread pulmonary neoplasm, or hypoxia-related symptoms or findings that might be expected to improve with oxygen therapy

 (see Oxygen LCD for additional information).

o For beneficiaries with OSA, this means that the OSA must be sufficiently treated such that the underlying severe lung disease is unmasked.

 This must be demonstrated before oxygen saturation results obtained during polysomnography are considered qualifying for oxygen therapy.

 A qualifying oxygen saturation test may only occur during a titration polysomnographic study (either split-night or stand-alone) if all of the following criteria are met:

 The titration is conducted over a minimum of two (2) hours; and,

 During titration:

 The AHI/RDI is reduced to less than or equal to an average of ten (10) events per hour; or,

 If the initial AHI/RDI was less than an average of ten (10) events per hour, the titration demonstrates further reduction in the AHI/RDI; and,

 Nocturnal oximetry conducted for the purpose for oxygen reimbursement qualification may only be performed after optimal PAP settings have been determined and the beneficiary is using the PAP device at those settings; and,

 The nocturnal oximetry conducted during the PSG demonstrates an oxygen saturation ≤ 88% for 5 minutes total (which need not be continuous).

o If all of the above criteria are met, for the purposes of a qualifying oxygen saturation test, the beneficiary is considered to be in the “chronic stable state.”

 To be eligible for Medicare coverage and payment for home oxygen therapy for concurrent use with PAP therapy, in addition to being in the chronic stable state, the beneficiary must meet all other coverage requirements for oxygen therapy.

o Suppliers should refer to the Oxygen and Oxygen Equipment LCD and related Policy Article for additional coverage, coding and documentation requirements.

 

 

• REPLACEMENT:

o This section applies to PAP devices initially provided and covered while the beneficiary was in Medicare fee-for-service (FFS).

o 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.

o 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 beneficiary continues to use and benefit from the PAP device.

 There is no requirement for a new sleep test or trial period.

 

 

• BENEFICIARIES ENTERING MEDICARE:

o 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 PAP device and/or accessories, both of the following coverage requirements must be met:

 Sleep test – There must be documentation that the beneficiary had a sleep test, prior to FFS Medicare enrollment, that meets the Medicare AHI/RDI coverage criteria in effect at the time that the beneficiary seeks Medicare coverage of a replacement PAP device and/or accessories; and,

 Clinical Evaluation – Following enrollment in FFS Medicare, the beneficiary must have a face-to-face evaluation by their treating physician who documents in the beneficiary’s medical record that:

 The beneficiary has a diagnosis of obstructive sleep apnea; and,

 The beneficiary continues to use the PAP device.

 

o If either criteria 1 or 2 above are not met, the claim will be denied as not reasonable and necessary.

o In these situations, there is no requirement for a clinical re-evaluation or for objective documentation of adherence to use of the device.

 

 

• ACCESSORIES:

o 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 reasonable and necessary.

o The following table represents the usual maximum amount of accessories expected to be reasonable and 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 reasonable and necessary.

 

 

• REFILLS REQUIREMENTS

o 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. (CMS’ Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-8, Chapter 5, Section 5.2.6).

o 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.

o 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.

o 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.

 

 

Bill Type Codes:

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

Revenue Codes:

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

 

CPT/HCPCS Codes

The appearance of a code in this section does not necessarily indicate coverage.

 

HCPCS MODIFIERS:

 

EY - No physician or other licensed health care provider order for this item or service

 

GA - Waiver of liability statement issued as required by payer policy, individual case

 

GZ - Item or service expected to be denied as not reasonable and necessary

 

KX - Requirements specified in the medical policy have been met

 

HCPCS CODES:

 

EQUIPMENT:

 

E0470 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)

E0471 RESPIRATORY ASSIST DEVICE, BI-LEVEL PRESSURE CAPABILITY, WITH BACK-UP RATE FEATURE, USED WITH NONINVASIVE INTERFACE, E.G., NASAL OR FACIAL MASK (INTERMITTENT ASSIST DEVICE WITH CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE)

E0601 CONTINUOUS AIRWAY PRESSURE (CPAP) DEVICE

 

 

ACCESSORIES

 

A4604 TUBING WITH INTEGRATED HEATING ELEMENT FOR USE WITH POSITIVE AIRWAY PRESSURE DEVICE

A7027 COMBINATION ORAL/NASAL MASK, USED WITH CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE, EACH

A7028 ORAL CUSHION FOR COMBINATION ORAL/NASAL MASK, REPLACEMENT ONLY, EACH

A7029 NASAL PILLOWS FOR COMBINATION ORAL/NASAL MASK, REPLACEMENT ONLY, PAIR

A7030 FULL FACE MASK USED WITH POSITIVE AIRWAY PRESSURE DEVICE, EACH

A7031 FACE MASK INTERFACE, REPLACEMENT FOR FULL FACE MASK, EACH

A7032 CUSHION FOR USE ON NASAL MASK INTERFACE, REPLACEMENT ONLY, EACH

A7033 PILLOW FOR USE ON NASAL CANNULA TYPE INTERFACE, REPLACEMENT ONLY, PAIR

A7034 NASAL INTERFACE (MASK OR CANNULA TYPE) USED WITH POSITIVE AIRWAY PRESSURE DEVICE, WITH OR WITHOUT HEAD STRAP

A7035 HEADGEAR USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7036 CHINSTRAP USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7037 TUBING USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7038 FILTER, DISPOSABLE, USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7039 FILTER, NON DISPOSABLE, USED WITH POSITIVE AIRWAY PRESSURE DEVICE

A7044 ORAL INTERFACE USED WITH POSITIVE AIRWAY PRESSURE DEVICE, EACH

A7045 EXHALATION PORT WITH OR WITHOUT SWIVEL USED WITH ACCESSORIES FOR POSITIVE AIRWAY DEVICES, REPLACEMENT ONLY

A7046 WATER CHAMBER FOR HUMIDIFIER, USED WITH POSITIVE AIRWAY PRESSURE DEVICE, REPLACEMENT, EACH

E0561 HUMIDIFIER, NON-HEATED, USED WITH POSITIVE AIRWAY PRESSURE DEVICE

E0562 HUMIDIFIER, HEATED, USED WITH POSITIVE AIRWAY PRESSURE DEVICE

 

ICD-9 Codes that Support Medical Necessity

 

 

• The presence of an ICD-9 code listed in this section is not sufficient by itself to assure coverage.

• Refer to the section on Indications and Limitation of Coverage and/or Medical Necessity for other coverage criteria and payment information.

327.23 OBSTRUCTIVE SLEEP APNEA (ADULT) (PEDIATRIC)

 

 

Documentations Requirements

• 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".

o It is expected that the beneficiary's medical records will reflect the need for the care provided.

o The beneficiary'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.

o This documentation must be available upon request.

 

• PRESCRIPTION (ORDER) REQUIREMENTS

 

• GENERAL (PIM 5.2.1)

o All items billed to Medicare require a prescription.

 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 dispensed and/or billed that do not meet these prescription requirements and those below must be submitted with an EY modifier added to each affected HCPCS code.

 

 

• DISPENSING ORDERS (PIM 5.2.2)

o Equipment and supplies may be delivered upon receipt of a dispensing order except for those items that require a written order prior to delivery. A dispensing order may be verbal or written. The supplier must keep a record of the dispensing order on file. It must contain:

 Description of the item

 Beneficiary's name

 Prescribing Physician's name

 Date of the order and the start date, if the start date is different from the date of the order

 Physician signature (if a written order) or supplier signature (if verbal order)

o For the “Date of the order” described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

o Signature and date stamps are not allowed.

 Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

o The dispensing order must be available upon request.

o For items that are provided based on a dispensing order, the supplier must obtain a detailed written order before submitting a claim.

 

 

• DETAILED WRITTEN ORDERS (PIM 5.2.3)

o A detailed written order (DWO) is required before billing.

 Someone other than the ordering physician may produce the DWO.

 However, the ordering physician must review the content and sign and date the document.

 It must contain:

 Beneficiary's name

 Physician's name

 Date of the order and the start date, if start date is different from the date of the order

 Detailed description of the item(s) (see below for specific requirements for selected items)

 Physician signature and signature date

o For items provided on a periodic basis, including drugs, the written order must include:

 Item(s) to be dispensed

 Dosage or concentration, if applicable

 Route of Administration

 Frequency of use

 Duration of infusion, if applicable

 Quantity to be dispensed

 Number of refills, if applicable

• For the “Date of the order” described above, use

o the date the supplier is contacted by the physician (for verbal orders) or

o The date entered by the physician (for written dispensing orders).

• Frequency of use information on orders must contain detailed instructions for use and specific amounts to be dispensed. Reimbursement shall be based on the specific utilization amount only.

o Orders that only state “PRN” or “as needed” utilization estimates for replacement frequency, use, or consumption are not acceptable. (PIM 5.9)

• The detailed description in the written order may be either a narrative description or a brand name/model number.

• Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

• The DWO must be available upon request.

• A prescription is not considered as part of the medical record.

o Medical information intended to demonstrate compliance with coverage criteria may be included on the prescription but must be corroborated by information contained in the medical record.

• 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.

o 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 ICD-9 diagnosis code for the PAP device on each claim submitted for PAP supplies.

 

 

• MEDICAL RECORD INFORMATION

 

• GENERAL (PIM 5.7 - 5.9)

o The Indications and Limitations of Coverage and/or Medical Necessity section of this LCD contains numerous reasonable and necessary (R&N) requirements. The Nonmedical Necessity Coverage and Payment Rules section of the related Policy Article contains numerous non-reasonable and necessary, benefit category and statutory requirements that must be met in order for payment to be justified. Suppliers are reminded that:

o Supplier-produced records, even if signed by the ordering physician, and attestation letters (e.g. letters of medical necessity) are deemed not to be part of a medical record for Medicare payment purposes.

o Templates and forms, including CMS Certificates of Medical Necessity, are subject to corroboration with information in the medical record.

o Information contained directly in the contemporaneous medical record is the source required to justify payment except as noted elsewhere for prescriptions and CMNs.

 The medical record is not limited to physician's office records but may include records from hospitals, nursing facilities, home health agencies, other healthcare professionals, etc. (not all-inclusive).

 Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for the purpose of determining that an item is reasonable and necessary.

 

• CONTINUED USE

o Continued use describes the ongoing utilization of supplies or a rental item by a beneficiary.

o Suppliers are responsible for monitoring utilization of DMEPOS rental items and supplies.

 No monitoring of purchased items or capped rental items that have converted to a purchase is required.

 Suppliers must discontinue billing Medicare when rental items or ongoing supply items are no longer being used by the beneficiary.

o Beneficiary medical records or supplier records may be used to confirm that a DMEPOS item continues to be used by the beneficiary.

 Any of the following may serve as documentation that an item submitted for reimbursement continues to be used by the beneficiary:

 Timely documentation in the beneficiary’s medical record showing usage of the item, related option/accessories and supplies

 Supplier records documenting the request for refill/replacement of supplies in compliance with the Refill Documentation Requirements

 (This is deemed to be sufficient to document continued use for the base item, as well)

 Supplier records documenting beneficiary confirmation of continued use of a rental item

 Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in this policy.

 

• CONTINUED MEDICAL NEED

o For all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered

 Therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription.

 For purchased items, initial months of a rental item or for initial months of ongoing supplies or drugs, information justifying reimbursement will come from this initial time period.

 Entries in the beneficiary's medical record must have been created prior to, or at the time of, the initial DOS to establish whether the initial reimbursement was justified based upon the applicable coverage policy.

o For ongoing supplies and rental DME items, in addition to information described above that justifies the initial provision of the item(s) and/or supplies, there must be information in the beneficiary's medical record to support that the item continues to be used by the beneficiary and remains reasonable and necessary.

 Information used to justify continued medical need must be timely for the DOS under review.

 Any of the following may serve as documentation justifying continued medical need:

 A recent order by the treating physician for refills

 A recent change in prescription

 A properly completed CMN or DIF with an appropriate length of need specified

 Timely documentation in the beneficiary's medical record showing usage of the item.

 Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in the policy.

 

• REFILL DOCUMENTATION (PIM 5.2.5-6)

o A routine refill prescription is not needed. A new prescription is needed when:

 There is a change of supplier

 There is a change in the item(s), frequency of use, or amount prescribed

 There is a change in the length of need or a previously established length of need expires

 State law requires a prescription renewal

o For items that the beneficiary obtains in-person at a retail store, the signed delivery slip or a copy of the itemized sales receipt is sufficient documentation of a request for refill.

o For items that are delivered to the beneficiary, documentation of a request for refill must be either a written document received from the beneficiary or a contemporaneous written record of a phone conversation/contact between the supplier and beneficiary.

 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:

 Beneficiary's name or authorized representative if different than the beneficiary

 A description of each item that is being requested

 Date of refill request

o For consumable supplies, i.e., those that are used up (e.g., ostomy or urological supplies, surgical dressings, etc.)

 The supplier should assess the quantity of each item that the beneficiary still has remaining, to document that the amount remaining will be nearly exhausted on or about the supply anniversary date.

o For non-consumable supplies, i.e., those more durable items that are not used up but may need periodic replacement (e.g., PAP and RAD supplies)

 The supplier should assess whether the supplies remain functional, providing replacement (a refill) only when the supply item(s) is no longer able to function.

 Document the functional condition of the item(s) being refilled in sufficient detail to demonstrate the cause of the dysfunction that necessitates replacement (refill).

o This information must be kept on file and be available upon request.

 

• PROOF OF DELIVERY (PIM 4.26, 5.8)

o Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files.

 For medical review purposes, POD serves to assist in determining correct coding and billing information for claims submitted for Medicare reimbursement.

 Regardless of the method of delivery, the contractor must be able to determine from delivery documentation that the supplier properly coded the item(s), that the item(s) delivered are the same item(s) submitted for Medicare reimbursement and that the item(s) are intended for, and received by, a specific Medicare beneficiary.

o Suppliers, their employees, or anyone else having a financial interest in the delivery of the item are prohibited from signing and accepting an item on behalf of a beneficiary (i.e., acting as a designee on behalf of the beneficiary).

 The signature and date the beneficiary or designee accepted delivery must be legible.

o For the purpose of the delivery methods noted below, designee is defined as any person who can sign and accept the delivery of DMEPOS items on behalf of the beneficiary.

o Proof of delivery documentation must be available to the Medicare contractor on request.

 All services that do not have appropriate proof of delivery from the supplier will be denied and overpayments will be requested.

 Suppliers who consistently fail to provide documentation to support their services may be referred to the OIG for imposition of Civil Monetary Penalties or other administrative sanctions.

o Suppliers are required to maintain POD documentation in their files. There are three methods of delivery:

 Delivery directly to the beneficiary or authorized representative

 Delivery via shipping or delivery service

 Delivery of items to a nursing facility on behalf of the beneficiary

 

• Method 1—Direct Delivery to the Beneficiary by the Supplier

o Suppliers may deliver directly to the beneficiary or the designee.

o In this case, POD to a beneficiary must be a signed and dated delivery slip.

o The POD record must include:

 Beneficiary's name

 Delivery address

 Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

 Quantity delivered

 Date delivered

 Beneficiary (or designee) signature and date of signature

o The date of signature on the delivery slip must be the date that the DMEPOS item was received by the beneficiary or designee. In instances where the supplies are delivered directly by the supplier, the date the beneficiary received the DMEPOS supply item must be the date of service on the claim.

 

• Method 2—Delivery via Shipping or Delivery Service Directly to a Beneficiary

o If the supplier utilizes a shipping service or mail order, the POD documentation must be a complete record tracking the item(s) from the DMEPOS supplier to the beneficiary. An example of acceptable proof of delivery would include both the supplier's own detailed shipping invoice and the delivery service's tracking information. The supplier's record must be linked to the delivery service record by some clear method like the delivery service's package identification number or supplier's invoice number for the package sent to the beneficiary. The POD record must include:

 Beneficiary's name

 Delivery address

 Delivery service's package identification number, supplier invoice number or alternative method that links the supplier's delivery documents with the delivery service's records.

 Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

 Quantity delivered

 Date delivered

 Evidence of delivery

o If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of service on the claim.

o Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a POD. This type of POD record must contain the information specified above.

 

• Method 3—Delivery to Nursing Facility on Behalf of a Beneficiary

o When a supplier delivers items directly to a nursing facility, the documentation described for Method 1 (see above) is required.

o When a delivery service or mail order is used to deliver the item to a nursing facility, the documentation described for Method 2 (see above) is required.

o Regardless the method of delivery, for those beneficiaries that are residents of a nursing facility, information from the nursing facility showing that the item(s) delivered for the beneficiary's use were actually provided to and used by the beneficiary must be available upon request.

 

• POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

o 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.

o 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)

o Physical Exam

 Focused cardiopulmonary and upper airway system evaluation

 Neck circumference

 Body mass index (BMI)

o 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 physician 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.

o 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.

o 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 beneficiary’s medical record.

o This information does not have to be submitted with the claim but must be available upon request.

o Many suppliers have created forms which have not been approved by CMS 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 beneficiary’s need for PAP therapy.

o 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):

o 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 and/or Medical Necessity” section of this policy ("Initial Coverage") have been met.

 

• CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

o 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 and/or Medical Necessity” section of this policy have been met.

o If the supplier does not obtain information from the physician 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.

o If the supplier chooses to hold claims for the fourth and succeeding months pending receipt of information from the treating physician 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.

o 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 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.

o 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.

 

• BENEFICIARIES ENTERING MEDICARE:

o 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 Indications and Limitations of Coverage and/or Medical Necessity for Beneficiaries Entering Medicare section have been met.

o 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

o In the rare instance where beneficiaries require the simultaneous use of home oxygen therapy and a PAP device, documentation by the treating physician in the beneficiary’s medical record must clearly demonstrate that the requirements for coverage outlined in the PAP LCD Indications and Limitations of Coverage and/or Medical Necessity above have been met.

 In addition, the beneficiary’s medical record must also clearly demonstrate that the requirements for coverage outlined in the Oxygen and Oxygen Equipment LCD Indications and Limitations of Coverage and/or Medical Necessity have been met.

 This information does not have to be submitted with the claim but must be available upon request.

o Suppliers should refer to the Oxygen and Oxygen Equipment LCD and related Policy Article for additional coverage, coding and documentation requirements.

 

• GA and GZ MODIFIERS:

o 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.

o Claim lines billed without a GA, GZ or KX modifier will be rejected as missing information.

o Refer to the Supplier Manual for more information on documentation requirements.

 

• REPAIR/REPLACEMENT (BPM Ch 15, §110.2)

o A new Certificate of Medical Necessity (CMN) and/or physician’s order is not needed for repairs.

o The supplier must maintain detailed records describing the need for and nature of all repairs including a detailed explanation of the justification for any component or part replaced as well as the labor time.

o A physician’s order and/or new Certificate of Medical Necessity (CMN), when required, are needed to reaffirm the medical necessity of the item for replacement of an item.

 

• Appendices

• PIM citations above denote references to CMS Program Integrity Manual, Internet Only Manual 100-8.

 

 

• APPENDIX A: 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.

o 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:

o 0 = would never doze or sleep.

o 1 = slight chance of dozing or sleeping

o 2 = moderate chance of dozing or sleeping

o 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

• 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):540-545).

 

APPENDIX B: List of Approved Other Devices that Indirectly Measure AHI/RDI

• Watch-PAT devices (Itamar Medical)

 

Sources of Information and Basis for Decision

 

A20195 - Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea - Policy Article - Effective February 2011

 

Local Coverage Determination (LCD) for Positive Airway Pressure (PAP) Devices for the Treatment of  Obstructive Sleep Apnea (L11518)