|
A single level continuous positive airway pressure (CPAP) device (E0601) is covered
for the treatment of obstructive sleep apnea (OSA) if criteria A - C are met:
- The patient has a face-to-face clinical evaluation by the treating physician prior
to the sleep test to assess the patient for obstructive sleep apnea.
- The patient has a Medicare-covered sleep test that meets either of the following
criteria (1 or 2):
- 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,
- 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 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.
If a claim for a CPAP (E0601) is submitted and all of the criteria above have not
been met, it will be denied as not medically necessary.
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.
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.
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).
Respiratory Assist Devices (RAD)
A RAD without backup rate (E0470) is covered for those patients with OSA who meet
criteria A-C above, in addition to criterion D:
- A single level (E0601) positive airway pressure device has been tried and proven
ineffective based on a therapeutic trial conducted in either a facility or in a
home setting.
If E0470 is billed and criterion D is not met, payment will be based on the allowance
for the least costly medically appropriate alternative, E0601.
A RAD with backup rate (E0471) is not medically necessary if the primary diagnosis
is OSA; therefore, if E0471 is billed with a diagnosis of OSA, the following payment
rules apply:
- If criteria A - D above are met, payment will be based on the allowance for the
least costly medically appropriate alternative, E0470; or,
- If criteria A-C above are met but not criterion D, payment will be based on the
allowance for the least costly medically appropriate alternative, E0601.
If a CPAP device is tried and found ineffective during the initial 3 month 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 has been used for more that 3 months and the patient is switched
to a RAD, 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 RAD.
Coverage, coding and documentation requirements for the use of RADs for diagnoses
other than OSA are addressed in the RAD policy.
Sleep Tests
Coverage and Payment rules for sleep tests may be found in the local coverage determinations
(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.
Coverage of a PAP device for the treatment of OSA is limited to claims where the
diagnosis of OSA is based upon a Medicare-covered sleep test (Type I, II, III, IV).
A Medicare-covered 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, or IV). 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.
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 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;
or,
- Type III device – Monitors and records a minimum of four (4) channels: respiratory
movement/effort, airflow, ECG/heart rate and oxygen saturation; or,
- Type IV device – Monitors and records a minimum of three (3) channels that allow
direct calculation of an AHI or RDI as the result of measuring airflow or thoracoabdominal
movement. Devices that record information other than airflow or thoracoabdominal
movement that allow calculation of an AHI or RDI may be considered as acceptable
alternatives if 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 Type IV devices that do not report
AHI/RDI based on direct measurement of airflow or thoracoabdominal movement).
For PAP devices with initial dates of service on or after November 1, 2008, all
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.
Patient instruction may be accomplished by either:
- Face-to-face demonstration of the portable sleep monitoring device’s application
and use; or,
- Video or telephonic instruction, with 24 hour availability of qualified personnel
to answer questions or troubleshoot issues with the device.
For PAP devices with initial dates of service on or after November 1, 2008, all
HSTs (Type II, III, or IV) must be interpreted by a physician who holds either:
- Current certification in Sleep Medicine by the American Board of Sleep Medicine
(ABSM); or,
- Current subspecialty certification in Sleep Medicine by a member board of the American
Board of Medical Specialties (ABMS); or,
- 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; or,
- Active staff membership of a sleep center or laboratory accredited by the American
Academy of Sleep Medicine (AASM) or The Joint Commission (formerly the Joint Commission
on Accreditation of Healthcare Organizations – JCAHO).
For PAP devices with initial dates of service on or after January 1, 2010, physicians
interpreting facility-based polysomnograms (Type I) must meet one of the requirements
listed above (1-4) for credentialing.
No aspect of an HST, including but not limited to delivery and/or pickup of the
device, may be performed by a DME supplier. This prohibition does not extend to
the results of studies conducted by hospitals certified to do such tests.
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 beneficiary 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:
- 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.
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.
Beneficiaries who fail the initial 12 week trial are eligible to requalify 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).
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.
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 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 CPAP. If less than 30 days remain in the
trial period, the clinical re-evaluation must occur before the 120th day following
the initiation of CPAP.
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 31st 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.
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 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 patient
continues to use the device.
|
Documentation Requirements
|
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. ncluded on the claim.
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
- 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)
Physical Exam
- Focused cardiopulmonary and upper airway system evaluation
- Neck circumference
- Body mass index (BMI)
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 beneficiary’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 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 patient’s need for PAP therapy.
|
|