Supplier self-audit checklist

Medicare PAP documentation requirements

Initial coverage Sleep test interpretation supplier must verify

n Face-to-face clinical evaluation by the treating physician has been n The sleep test must be interpreted by a physician who holds either:
performed prior to the patient undergoing a sleep test. n Current certification in Sleep Medicine by the American Board
n Clinical notes obtained clearly document the need for a sleep test of Sleep Medicine (ABSM); or,
and may include the following: n Current subspecialty certification in Sleep Medicine by a
n Signs/symptoms of OSA, including duration board member of the American Board of Medical Specialties
n Epworth or other validated sleep hygiene inventory results (ABMS); or,
n Physical exam BMI, neck circumference, cardiopulmonary and n Completed residency or fellowship training by an ABSM board
upper airway system evaluation member, completed all requirements for subspecialty certification
n Specific reason(s) for referral for sleep test must be in sleep medicine except the examination itself, and only until
documented in patient medical record the time of reporting of the first examination for which the
n Patient had a qualifying sleep test, either an in-lab PSG or a Type II, physician is eligible; or,
III, or IV home sleep test (HST) and meets the following criteria n Active staff membership of a sleep center or laboratory
for an E0601 device: accredited by the American Academy of Sleep Medicine (AASM),
n Diagnosis of OSA (327.23) Accreditation Commission for Health Care (ACHC), or The
n Apnea-hypopnea index (AHI) or Respiratory Disturbance Index Joint Commission (TJC, formerly the Joint Commission on
(RDI) is 15 events/hour with a minimum of 30 events Accreditation of Healthcare Organizations JCAHO)
n The AHI or RDI is 5 and 14 events/hour with a minimum
of 10 events and documentation of:
n Excessive daytime sleepiness, impaired cognition, mood Dont forget:
disorders, or insomnia; or, n Proof of delivery documentation should be kept on file
n Hypertension, ischemic heart disease, or history of stroke n ABN can be obtained between days 60-91, if compliance may
n Patient and/or caregiver received instruction from the supplier not be met (cannot obtain at set up)
in the proper use and care of the PAP equipment
n For an HST: Face-to-face, telephone, or video instruction on
proper test set up by entity conducting test, not DME supplier
n For an E0470 device only: In addition to the above, an E0601
has been tried and proven ineffective based on a therapeutic trial
in a facility or a home setting, supported by documentation that:
n 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,
n 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:
n Adequately control the symptoms of OSA; or,
n Improve sleep quality; or,
n Reduce the AHI/RDI to acceptable levels

Note: An E0471 device is non-covered for a diagnosis of OSA.

 Coverage beyond the first three months (E0601 or E0470)
n Between the 31st and 91st days of therapy:
n Face-to-face clinical re-evaluation by the treating physician
documenting that symptoms of sleep apnea have improved;
and,
n Adherent use of the PAP device for 4 hours per night on 70%
of the nights within a consecutive 30-day period, within the
first 90 days of therapy, documented by direct download
or visual inspection of usage data in a written report
n Trial extends to 120 days only when an E0470 device has
been initiated with less than 30 days remaining in the initial
90-day trial period
n If face-to-face does not occur by the 91st day, but subsequent
evaluation documents criteria have been met, therapy coverage
commences on date of the re-evaluation.
Failure of the initial 90-day trial requires:
n Face-to-face re-evaluation by the treating physician
documenting reason for failure
n Repeat sleep test (diagnostic, titration, or split-night) in a
facility Type I sleep test
Supplies and accessories
n A signed, dated order from the treating physician documenting
each item to be provided, the quantity, and the frequency of
replacement
n For refills: Documentation of the request by the patient for
refill of the supplies and accessories to be provided and initial
physician prescription that supports patient request
Device replacement
n Replacement after the five-year reasonable useful life (RUL):
n Face-to-face clinical re-evaluation by treating physician
documenting patient using device and continuing to benefit
from therapy; no sleep test or trial period required
n New prescription
n Replacement due to loss, theft, or irreparable damage does not
require evaluation, sleep test, or trial period.
PAP therapy patients entering Medicare
n PAP device received prior to enrollment in fee for service (FFS)
Medicare and coverage of either rental of the device, a
replacement PAP device, and/or accessories, requirements:
n Sleep test Patient had a sleep test, prior to FFS Medicare
enrollment, that meets the Medicare AHI/RDI coverage criteria
in effect at the time the beneficiary seeks coverage of a
replacement PAP device and/or accessories; and,
n Clinical evaluation Following enrollment in FFS Medicare, the
patient must have a face-to-face evaluation by treating physician
documenting in the medical record that:
n Patient has a diagnosis of obstructive sleep apnea (327.23);
and,
n Patient continues to use the PAP device
Concurrent use of PAP with oxygen
n All coverage criteria for both the PAP device and oxygen must
be met as outlined in each LCD
n For those with OSA, OSA must be sufficiently treated so that
lung disease is evident before O saturation levels during PSG
2

are qualifying for O therapy 2

n Qualifying O level can only be obtained during titration study

2

n Split night or full night titration

n AHI/RDI reduced to 10 events/hour
n Initial AHI/RDI < average 10 events/hour and is further
reduced
n Nocturnal oximetry for O qualification only after optimal
2

PAP settings determined and PAP device being used at settings

n Nocturnal oximetry during PSG has O saturation 88% 2

for 5 minutes total, can be non-continuous

Please visit www.philips.com/respironics

2013 Koninklijke Philips N.V. All rights are reserved. Philips Healthcare is part of Royal Philips

Philips Healthcare reserves the right to make changes in specifications and/or to Respironics Asia Pacific Philips Respironics
discontinue any product at any time without notice or obligation and will not be liable +65 6298 1088 1010 Murry Ridge Lane
for any consequences resulting from the use of this publication. Respironics Australia Murrysville, PA 15668
+61 (2) 9666 4444
CAUTION: US federal law restricts these devices to sale by or on the order of a Respironics Europe, Middle East, Africa Customer Service
physician. +33 1 47 52 30 00 +1 724 387 4000
Respironics United Kingdom +1 800 345 6443 (toll free, US only)
e-doc SB 6/28/13 MCI 4105718 +44 800 1300 845 www.philips.com/respironics