Medicare Requires Data Capable Machines

[OldLincoln]

The tech in my sleep doc's office told me the Medicare revisions that went into effect 11/1 require a data capable machine and they must collect data that verifies improvement from the sleep study. He said it is a treatment effectiveness requirement so they substantiate what they pay for.

So, I'm thinking those getting new machines will get the card versions. If a DME pushes a "dumb" machine at you, push back and make them check the rules.

[Snoredog]

it's about time the regular people won one.

[Slinky]

Be still my heart!!!

Before we get too excited about this ... I believe, and I hope that I am wrong ... that the only data Medicare is requiring is compliance data. There are still xPAPs available that don't actually provide downloadable, printable compliance data. Currently DME suppliers have been able to establish compliance only by providing a form to the patient asking the patient to sign a statement that they are using their xPAP regularly which is then provided to Medicare.

[chrisd]

Be still my heart!!!

Before we get too excited about this ... I believe, and I hope that I am wrong ... that the only data Medicare is requiring is compliance data. There are still xPAPs available that don't actually provide downloadable, printable compliance data. Currently DME suppliers have been able to establish compliance only by providing a form to the patient asking the patient to sign a statement that they are using their xPAP regularly which is then provided to Medicare.

DING, DING! We have a winner!

Medicare basically want's proof that people are actually using their machine. This doesn't mean they have to be downloadable. Just have to have a compliance meter.

Something else that's being left out here is the fact that Medicare also now requires that the patient follows-up with the treating physician, no earlier than 30 days after initiating CPAP therapy and no later than 90 days. If you don't, or your doctor does not document that you are benefiting from the therapy, Medicare will no longer pay for the equipment and the DME company will come to your home an pick it up.

So, before everyone starts jumping up and down thinking the government has made some new rule to benefit the Medicare recipient, they haven't. They've just made it that much harder for you to be able to get a higher end machine. They have decreased reimbursement and increased the qualifications. The burden is on the DME's to prove that you are doing what you are supposed to be doing. So you think DME's are going to put out upgraded machines when the reimbursement is down and their risk of getting paid is up?

[rested gal]

I agree with Slinky and chrisd's assessment of what the new Medicare requirement means.

I'd say that compliance data (hours of use) is still the only "machine data" that matters to Medicare.

The new requirement about benefiting from treatment could probably be as simple as a written comment -- "patient shows improvement with CPAP treatment" -- put into the person's medical record by the doctor after the follow-up visit at the thirty day mark.

If some DMEs think they must now give out machines that provide more data than just "compliance", great. But I don't think that's what Medicare's new requirement means. I think the DMEs can still give out machines that record only "hours of use" and let the doctor assess whether CPAP is helping the person or not.

People on Medicare who want to keep using cpap had better be careful what they say to the doctor/DME at the 30 day mark. The machine may get yanked if the person says "I don't feel any better." or "I feel worse!" which can certainly be the case for people who are still struggling with mask or comfort issues. Especially people who haven't found their way to this message board where they can get better tips than most DMEs know about, for making the treatment comfortable enough to be effective.

[Snoredog]

I agree with Slinky and chrisd's assessment of what the new Medicare requirement means.

I'd say that compliance data (hours of use) is still the only "machine data" that matters to Medicare.

The new requirement about benefiting from treatment could probably be as simple as a written comment -- "patient shows improvement with CPAP treatment" -- put into the person's medical record by the doctor after the follow-up visit at the thirty day mark.

If some DMEs think they must now give out machines that provide more data than just "compliance", great. But I don't think that's what Medicare's new requirement means. I think the DMEs can still give out machines that record only "hours of use" and let the doctor assess whether CPAP is helping the person or not.

People on Medicare who want to keep using cpap had better be careful what they say to the doctor/DME at the 30 day mark. The machine may get yanked if the person says "I don't feel any better." or "I feel worse!" which can certainly be the case for people who are still struggling with mask or comfort issues. Especially people who haven't found their way to this message board where they can get better tips than most DMEs know about, for making the treatment comfortable enough to be effective.

This probably just the Compliance "number" the new machines generate which extrapolated indicates compliance/non-compliance.

[OldLincoln]

Alas, per the Medicare publications, tis true than I'm in error and the requirement is only for compliance.
The tech did say they would require smart card machines for the data. That may be only them and I took it as all DME's would.

[Guest]

The original wording on this policy was "Compliance obtained thru direct download", however Medicare has changed that to read. "Direct observation and verification OR direct download" The original effective date of this policy was 1 Oct, 2008, but that was pushed back to 1 Nov, 2008 and many changes were made to the wording of the policy.

[OldLincoln]

The original wording on this policy was "Compliance obtained thru direct download", however Medicare has changed that to read. "Direct observation and verification OR direct download" The original effective date of this policy was 1 Oct, 2008, but that was pushed back to 1 Nov, 2008 and many changes were made to the wording of the policy.

I spent a lot of time, without success, looking for the exact requirements for "patient shows improvement with CPAP treatment". I keep asking how does compliance demonstrate improvement, and I don't believe it does. To be diagnosed you must exceed a threshold of sleep events, to show improvement, it seems to me you should be required to show improvement in the same categories. Of course this is Medicare we're talking about.

Can you direct me to the policy document for the "Direct observation and verification OR direct download"?

[papdad]

Something else that's being left out here is the fact that Medicare also now requires that the patient follows-up with the treating physician, no earlier than 30 days after initiating CPAP therapy and no later than 90 days. If you don't, or your doctor does not document that you are benefiting from the therapy, Medicare will no longer pay for the equipment and the DME company will come to your home an pick it up.


Am new to this whole thing -- have had my machine about a week now -- and do have Medicare and a supplement. Have an appointment to go back to Dr. mid Dec. Do I take my card with me to the Dr. -- or will he just ask me if I am doing better ? How does this work ?

[Guest]

OL, the only link I have is to a password proctected area of the Medicare site. I'm sure this policy is somewhere on their open site. I have however pasted the complete policy here for you. If everything worked correctly I have underlined and bolded the info you were looking for it's towards the bottom of the policy. The policy number if you want to search the Medicare site is L171.


Contractor Information
Contractor Name
Noridian Administrative Services
Contractor Number
19003
Contractor Type
DME MAC
LCD Information
LCD ID Number
L171
LCD Title
Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea
Contractor's Determination Number
PAP
AMA CPT / ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other
date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental
Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein)
is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights
reserved. Applicable FARS/DFARS apply.
CMS National Coverage Policy
CMS Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 240.4
Primary Geographic Jurisdiction
Alaska
American Samoa
Arizona
California - Entire State
Guam
Hawaii
Iowa
Idaho
Kansas
Missouri - Entire State
Montana
North Dakota
LCD for Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea
(L171)
LCD Information
LCD ID Number
Nebraska
Nevada
Oregon
South Dakota
Utah
Washington
Wyoming
Northern Mariana Islands
Oversight Region
Region X
DME Region LCD Covers
Jurisdiction D
Original Determination Effective Date
For services performed on or after 10/01/1993
Original Determination Ending Date
Revision Effective Date
For services performed on or after 03/13/2008
Revision Ending Date
Indications and Limitations of Coverage and/or Medical Necessity
For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be
reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a
malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.
For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the
following indications and limitations of coverage and/or medical necessity.
For an item to be covered by Medicare, 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.
INITIAL COVERAGE:
LCD Information
LCD ID Number
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:
A. 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.
B. The patient has a Medicare-covered sleep test that meets either of the following criteria (1 or 2):
1. 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,
2. 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:
a. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
b. Hypertension, ischemic heart disease, or history of stroke.
C. 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 recorded 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
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.
LCD Information
LCD ID Number
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:
1. If criteria A - D above are met, payment will be based on the allowance for the least costly medically
appropriate alternative, E0470; or,
2. 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 than 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, or 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), electrooculogram
(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:
LCD Information
LCD ID Number
A. 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,
B. Type III device – Monitors and records a minimum of four (4) channels: respiratory movement/effort,
airflow, ECG/heart rate and oxygen saturation; or,
C. Type IV device – Monitors and records a minimum of three (3) channels that allow direct calculation
of an AHI or RDI as defined above. Devices that record channels that do not allow direct 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. This determination will be made on a device by
device basis. Currently there is no device that indirectly measures AHI or RDI that meets this
criterion.
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:
1. Face-to-face demonstration of the portable sleep monitoring device’s application and use; or,
2. 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:
1. Current certification in Sleep Medicine by the American Board of Sleep Medicine (ABSM); or,
2. Current subspecialty certification in Sleep Medicine by a member board of the American Board of
Medical Specialties (ABMS); or,
3. 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,
4. 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 facilitybased
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.
LCD Information
LCD ID Number
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:
1. Face-to-face clinical re-evaluation by the treating physician with documentation that symptoms of
obstructive sleep apnea are improved; and,
2. 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:
1. Face-to-face clinical re-evaluation by the treating physician to determine the etiology of the failure to
respond to PAP therapy; and,
2. 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 reevaluation
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.
LCD Information
LCD ID Number
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.
ACCESSORIES:
Accessories used with a PAP device are covered when the Medicare coverage criteria for the device are met.
If the Medicare 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.
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.
Coverage Topic
Continuous Positive Airway Pressure (CPAP) Device
Coding Information
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.
0 TBD
Coding Information
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.
KX - Specific required documentation on file.
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
Coding Information
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.
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
Coding Information
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.
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)
Diagnoses that Support Medical Necessity
All diagnoses that are specified in the preceding section.
ICD-9 Codes that DO NOT Support Medical Necessity
All ICD-9 codes that are not specified in the preceding section.
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
All diagnoses that are not specified in the preceding section.
General Information
Documentation Requirements
General Information
Documentation 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".
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.
The ICD-9 code that justifies the need for the item must be included 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.
General Information
Documentation Requirements
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.
Proper use of the KX modifier is discussed below. The KX modifier must not be used on claims submitted
until 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
and/or Medical Necessity” 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 and/or Medical Necessity”
section of this policy have been met.
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.
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.
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.
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.
Refer to the Supplier Manual for more information on documentation requirements.
Appendices
EPWORTH SLEEPINESS SCALE
General Information
Documentation Requirements
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)
____
____
General Information
Documentation Requirements
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).
Utilization Guidelines
Refer to Indications and Limitations of Coverage and/or Medical Necessity.
Sources of Information and Basis for Decision
http://www.abim.org/certification/polic ... sleep.aspx
1. The Centers for Medicare & Medicaid Services (CMS). Coverage Decision Memorandum for
Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-
00093R2) (Acessed on June 22, 2008 at
http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=204)
2. Collop NA, Anderson WM, Boehlecke B, et. al. Clinical guidelines for the use of unattended portable
monitors in the diagnosis of obstructive sleep apnea in adult patients. J Clin Sleep Med 2007;3(7):737
-747.
3. Standards of Accreditation of Sleep Disorders Centers. American Academy of Sleep Medicine. 2007.
(Accessed May 22, 2008 at http://aasmnet.org/resources/PDF/CenterStandards.pdf)
4. Kushida CA, Littner MR, Morgenthaler T, et. al. Practice parameters for the indications for
Polysomnography and related procedures: an update for 2005. Sleep 2005;28:499-521.
5. Kribbs NB, Pack AI, Kiln LR, et. al. Objective measurement of patters of nasal CPAP use by patients
with obstructive sleep apnea. Am Rev Respir Dis. 1993;147:887-895.
General Information
Documentation Requirements
6. Hui DS, Choy DK, Li TS, et. al. Determinants of continuous positive airway pressure compliance in a
group of Chinese patients with obstructive sleep apnea. Chest 2001;120:170-176.
7. Massie CA, Hart RW, Perzlez K, Richards GN. Effects of humidification on nasal symptoms and
compliance in sleep apnea patients using continuous positive airway pressure. Chest 1999;116:403-
408.
8. McArdle N, Devereux G, heidarnejad H, et. al. Long-term use of CPAP therapy for sleep
apnea/hypopnea syndrome. Am J Respir Crit Care Med. 1999;159:1108-1114.
9. Nieto FJ, Young TB, Lind BK, et. al. Association of sleep disordered breathing, sleep apnea and
hypertension in a large community-based study. JAMA 2000;283:1829-1836.
10. Agency for Healthcare Research and Quality. Home diagnosis of obstructive sleep apnea-hypopnea
syndrome. 2007. Accessed June 12, 2008 at
http://www.cms.hhs.gov/determinationpro ... id48TA.pdf
11. Waldhorn RE, Herrick TW, Nguyen MC, et. al. Long-term compliance with nasal continuous positive
airway pressure therapy of obstructive sleep apnea. Chest 1990;97:33-38.
12. Popescu G, Latham M, Allgar V, et. al. Continuous positive airway pressure for sleep
apnoea/hypopnea syndrome: usefulness of a 2-week trial to identify factors associated with long term
use. Thorax 2001;56:727-733.
13. Campos-Rodriquez F, Peña-Griñan N, Reyes-Nuñez N, et. al. Mortality in obstructive sleep apneahypopnea
patients treated with positive airway pressure. Chest 2005;128:624-633.
14. American Board of Internal Medicine board certification information may be found at
http://www.abim.org/certification/polic ... sleep.aspx
Advisory Committee Meeting Notes
Start Date of Comment Period
04/30/1993
End Date of Comment Period
06/14/1993
Start Date of Notice Period
08/01/1993
Revision History Number
CPAP010
General Information
Documentation Requirements
Revision History Explanation
Revision Effective Date (September Revision): 3/13/2008 except where noted otherwise in the LCD.
INDICATIONS AND LIMITATIONS OF COVERAGE:
Revised: Coverage criteria for documentation of initial evaluation and moved to Documentation section
Revised: Clarified extrapolation of AHI and RDI results
Revised: Definition of Type IV device
Revised: Extended implementation dates for credentialing of physicians interpreting home sleep tests and
facility-based polysomnograms.
Revised: Requirement for beneficiary education by entity conducting home sleep test
Revised: Expanded dates during which patients must be re-evaluated for documenting benefit from PAP
therapy.
Revised: Expanded dates for patients switched from CPAP to RAD with less than 30 days remaining in initial
trial period
Added: Requalifying after failed initial 12 week trial of PAP therapy
DOCUMENTATION:
Revised: Expanded dates for documentation of benefit from PAP therapy.
Revised: Documentation of adherence to PAP therapy to allow visual inspection of usage data.
Revision Effective Date (July Revision): 3/13/2008 except where noted otherwise in the LCD.
Changed title from CPAP Device to Positive Airway Pressure Devices for the Treatment of OSA to reflect
addition of coverage for bilevel devices.
INDICATIONS AND LIMITATIONS OF COVERAGE:
Added: Revised coverage criteria for CPAP to include home sleep testing and face-to-face clinical evaluation
and re-evaluation.
Moved: Use of bilevel devices (E0470 and E0471) for OSA from the Respiratory Assist Devices LCD to this
LCD.
Added: Coverage criteria for changing from a CPAP to RADs both before and after the first three months of
PAP therapy.
Added: Definition of adherence
Added: Criteria for portable sleep monitoring devices
Added: Requirements for administering and interpreting home sleep studies
Moved: Information previously contained in Appendices.
DOCUMENTATION:
Added: Information about documenting adherence and clinical re-evaluation
Added: Grandfathered patients and the use of the KX modifier.
Revised: Use of KX modifier for claims in fourth and subsequent months
APPENDICES
Added: Epworth Sleepiness Scale
3/1/2008- In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to
DME MAC Noridian Administrative Services (19003) LCD L171 from DME PSC Electronic Data Systems
Corp. (77006) LCD L171.
Revision Effective Date: 01/01/2008
INDICATIONS AND LIMITATIONS OF COVERAGE:
Added: Usual maximum quantity parameters for new HCPCS codes - A7027, A7028, A7029
HCPCS CODES:
Added: A7027, A7028, A7029
Removed: K0553, K0554, K0555
Revision Effective Date: 07/01/2007
General Information
Documentation Requirements
INDICATIONS AND LIMITATIONS OF COVERAGE:
Removed: DMERC references.
Revised: Usual maximum quantity parameter for A7037.
Added: Usual maximum quantity parameters for new HCPCS codes – K0553, K0554 and K0555.
HCPCS CODES AND MODIFIERS:
Added: K0553, K0554 and K0555
DOCUMENTATION REQUIREMENTS:
Removed: DMERC references.
Revision Effective Date: 03/01/2006
In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to
DME PSC Electronic Data Systems Corp. (77006) from DMERC CIGNA Government Services (05655).
Revision Effective Date: 01/01/2006
HCPCS CODES:
Added: A4604
Revised: A7032, A7033
INDICATIONS AND LIMIITATIONS OF COVERAGE:
Accessories:
Added frequency guideline for A4604, A7030 and A7046.
Added clarification regarding Full Face Mask Seals (A7031)
DOCUMENTATION REQUIREMENTS:
Revised requirements for documenting excess quantities of supplies.
APPENDICES:
Revised definition of apnea-hypopnea index (AHI) to reflect NCD.
Revision Effective Date: 01/01/2005
HCPCS CODES AND MODIFIERS:
Added: A7045
APPENDICES:
Clerical correction to move definitions from Policy Article to LCD.
Clarified calculation of AHI.
Revision Effective Date: 07/01/2004
LMRP converted to LCD and Policy Article.
INDICATIONS AND LIMITATIONS OF COVERAGE:
Clarified how accessories are denied when medical necessity is not met.
Revision Effective Date: 01/01/2004
HCPCS CODES AND MODIFIERS:
Crosswalked codes E0561 and E0562 to K0268 and K0531, respectively.
Added new code A7046
OTHER COMMENTS:
Revised the definition of AHI to require a minimum of two hours of recording time without the use of the
device rather than two hours of recorded sleep.
Revision Effective Date: 04/01/2003
HCPCS CODES AND MODIFIERS:
Added: A7030 – A7039, A7044, EY
Discontinued: K0183 – K0189
INDICATIONS AND LIMITATIONS OF COVERAGE:
Added standard language concerning coverage of items without an order.
Updated utilization table to incorporate new A codes which were crosswalked from K codes.
General Information
Documentation Requirements
Removed reference to RDI in definitions section.
DOCUMENTATION REQUIREMENTS:
Added standard language concerning use of EY modifier for items without an order.
The revision dates listed below are the dates the revisions were published and not necessarily the effective
dates for the revisions.
07/01/2002 – Revised language regarding who is a qualified provider of polysomnographic studies.
04/01/2002 – Updated Coverage and Payment Rules section to reflect National Coverage Decision to cover
CPAP based on apnea-hypopnea index. Eliminated Certificate of Medical Necessity requirement. Added KX
modifier to indicate coverage criteria met. Revised verbiage of HCPCS code K0184. Allowed coverage of
either heated or non-heated humidifier with a covered CPAP device.
10/01/1995 – Added HCPCS codes for accessories.
12/01/1993 – Corrected typo from HAO to HA0 in the Documentation section.
Reason for Change
CMS Requirement
Last Reviewed On Date
09/10/2008
Related Documents
Article(s)
A19827 - Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (September
2008 Revision) - Policy Article - Effective March 2008
LCD Attachments
There are no attachments for this LCD.
Other Versions
Updated on 09/14/2008 with effective dates 03/13/2008 - N/A
Updated on 07/11/2008 with effective dates 03/13/2008 - N/A
Updated on 07/11/2008 with effective dates 03/13/2008 - N/A
Updated on 07/10/2008 with effective dates 03/13/2008 - N/A
Updated on 03/13/2008 with effective dates 01/01/2008 - 03/12/2008
Updated on 03/05/2008 with effective dates 07/01/2007 - 12/31/2007
Other Versions

[Slinky]

THANK YOU, akcpapguy!!!

I've got a question about the following (bold highlight is mine):

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:
1. If criteria A - D above are met, payment will be based on the allowance for the least costly medically
appropriate alternative, E0470; or,
2. 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.

Is this "least costly medically appropriate alternative ..." a new addition or change to previous wording? Am I correct in reading it to mean "the cheapest, bare-bones CPAP (E0601) or bi-level (E0471) the local DME supplier can scrounge up?? It sounds like this wording has taken away our bargaining/negotiating "chip" to try to get a fully data capable xPAP.

[OldLincoln]

Yes thanks!

I guess nothing has changed as far as the data requirements go. They still accept the Epworth and usage as proof of treatment efficacy.

[OldLincoln]

Have an appointment to go back to Dr. mid Dec. Do I take my card with me to the Dr. -- or will he just ask me if I am doing better ? How does this work ?

The experiences I've read here is that cards get erased by the doctors so either take printouts or at the minimum save a copy of your card to the PC with the Card Reader Utility. You can get it from http://www.mycpap.org. It allows making a copy of card data to the PC and copying it back when you return from the doctor.

[yenjen]

If your machine was entirely a purchase, you may find it difficult to get the brick replaced with a data-capable machine. It’s worth a try, but expect it to be difficult and there is no guarantee of success (nothing on this blog constitutes any guarantee, anyway).