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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.
Home oxygen therapy is covered only if all of the following conditions are
met:
- The treating physician has
determined that the patient has a severe lung disease or
hypoxia-related symptoms that might be expected to improve with oxygen
therapy, and
- The patient's blood gas study
meets the criteria stated below, and
- The qualifying blood gas study
was performed by a physician or by a qualified provider or supplier of
laboratory services, and
- The qualifying blood gas study
was obtained under the following conditions:
- If the
qualifying blood gas study is performed during an inpatient hospital
stay, the reported test must be the one obtained closest to, but no
earlier than 2 days prior to the hospital discharge date, or
- If the
qualifying blood gas study is not performed during an inpatient hospital
stay, the reported test must be performed while the patient is in a
chronic stable state – i.e., not during a period of acute illness or
an exacerbation of their underlying disease, and
- Alternative
treatment measures have been tried or considered and deemed clinically
ineffective.
Group I criteria include any of the following:
- An arterial PO
2 at or below 55 mm Hg or an arterial oxygen saturation at or
below 88 percent taken at rest (awake), or
- An arterial PO 2 at or
below 55 mm Hg, or an arterial oxygen saturation at or below 88
percent, for at least 5 minutes taken during sleep for a patient who
demonstrates an arterial PO 2 at or above 56 mm Hg or an
arterial oxygen saturation at or above 89% while awake, or
- A decrease in arterial PO 2
more than 10 mm Hg, or a decrease in arterial oxygen saturation more
than 5 percent, for at least 5 minutes taken during sleep associated
with symptoms or signs reasonably attributable to hypoxemia (e.g., cor
pulmonale, "P" pulmonale on EKG, documented pulmonary
hypertension and erythrocytosis), or
- An arterial PO
2 at or below 55 mm Hg or an arterial oxygen saturation at or
below 88 percent, taken during exercise for a patient who demonstrates
an arterial PO 2 at or above 56 mm Hg or an arterial oxygen
saturation at or above 89 percent during the day while at rest. In
this case, oxygen is provided for during exercise if it is documented
that the use of oxygen improves the hypoxemia that was demonstrated
during exercise when the patient was breathing room air.
Initial coverage for patients meeting Group I criteria is limited to 12
months or the physician-specified length of need, whichever is shorter.
(Refer to the Documentation section for information on recertification.)
Group II criteria include the presence of (a) an arterial PO 2
of 56-59 mm Hg or an arterial blood oxygen saturation of 89 percent at rest
(awake), during sleep for at least 5 minutes, or during exercise (as
described under Group I criteria) and (b) any of the following:
- Dependent edema suggesting
congestive heart failure, or
- Pulmonary hypertension or cor
pulmonale, determined by measurement of pulmonary artery pressure,
gated blood pool scan, echocardiogram, or "P" pulmonale on
EKG (P wave greater than 3 mm in standard leads II, III, or AVF), or
- Erythrocythemia
with a hematocrit greater than 56 percent.
Initial coverage for patients meeting Group II criteria is limited to 3
months or the physician specified length of need, whichever is shorter. (Refer
to the Documentation section for information on recertification.)
Group III includes patients with arterial PO
2 levels at or above 60 mm Hg or arterial blood oxygen saturations at
or above 90 percent. For these patients there is a rebuttable presumption
of noncoverage.
For all the sleep oximetry criteria described above, the 5 minutes does not
have to be continuous.
When both arterial blood gas (ABG) and oximetry tests have been performed
on the same day under the same conditions (i.e., at rest/awake, during
exercise, or during sleep), the ABG result will be used to determine if the
coverage criteria were met. If an ABG test at rest/awake is nonqualifying,
but an exercise or sleep oximetry test on the same day is qualifying, the
oximetry test result will determine coverage.
If all of the coverage conditions specified above are not met, the oxygen
therapy will be denied as not medically necessary. Oxygen therapy will also
be denied as not medically necessary if any of the following conditions are
present:
- Angina pectoris in the absence of
hypoxemia. This condition is generally not the result of a low oxygen
level in the blood and there are other preferred treatments.
- Dyspnea without cor pulmonale or
evidence of hypoxemia.
- Severe peripheral vascular
disease resulting in clinically evident desaturation in one or more
extremities but in the absence of systemic hypoxemia. There is no
evidence that increased PO 2
will improve the oxygenation of tissues with impaired circulation.
- Terminal
illnesses that do not affect the respiratory system.
Oxygen is covered for patients who are enrolled subjects in clinical trials
approved by CMS and sponsored by the National Heart, Lung, and Blood
Institute (NHLBI) and who have an arterial PO
2 from 56 to 65 mmHg or an oxygen saturation
at or above 89%. The additional Group 2 coverage criteria do not apply to
these patients.
TESTING SPECIFICATIONS:
The qualifying blood gas study must be one that complies with the Fiscal
Intermediary or Local Carrier policy on the standards for conducting the
test and is covered under Medicare Part A or Part B. This includes a
requirement that the test be performed by a provider who is qualified to
bill Medicare for the test – i.e., a Part A provider, a laboratory, an
Independent Diagnostic Testing Facility (IDTF), or a physician. A supplier
is not considered a qualified provider or a qualified laboratory for
purposes of this policy. Blood gas studies performed by a supplier are not
acceptable. In addition, the qualifying blood gas study may not be paid for
by any supplier. This prohibition does not extend to blood gas studies
performed by a hospital certified to do such tests.
For sleep oximetry studies, the oximeter provided to the patient must be
tamper-proof and must have the capability to download data that allows
documentation of the duration of oxygen desaturation below a specified
value.
When oxygen is covered based on an oxygen study obtained during exercise,
there must be documentation of three (3) oxygen studies in the patient’s
medical record – i.e., testing at rest without oxygen, testing during
exercise without oxygen, and testing during exercise with oxygen applied
(to demonstrate the improvement of the hypoxemia). Only the qualifying test
value (i.e., testing during exercise without oxygen) is reported on the
CMN. The other results do not have to be routinely submitted but must be
available on request.
The qualifying blood gas study may be performed while the patient is on
oxygen as long as the reported blood gas values meet the Group I or Group
II criteria.
Home Sleep Oximetry Studies:
Beneficiaries may self-administer home based overnight oximetry tests under
the direction of a Medicare-enrolled Independent Diagnostic Testing
Facility (IDTF). A DME supplier or another shipping entity may deliver a
pulse oximetry test unit and related technology to a beneficiary’s home
under the following circumstances:
- The beneficiary’s treating
physician has contacted the IDTF to order an overnight pulse oximetry
test before the test is performed.
- The test is performed under the
direction and/or instruction of a Medicare-approved IDTF. Because it
is the beneficiary who self-administers this test, the IDTF must
provide clear written instructions to the beneficiary on proper operation
of the test equipment and must include access to the IDTF in order to
address other concerns that may arise. The DME supplier may not create
this written instruction, provide verbal instructions, answer
questions from the beneficiary, apply or demonstrate the application
of the testing equipment to the beneficiary, or otherwise participate
in the conduct of the test.
- The test unit
is sealed and tamper-proof such that test results cannot be accessed
by anyone other than the IDTF who is responsible for transmitting a
test report to the treating physician. The DME supplier may use
related technology to download test results from the testing unit and
transmit those results to the IDTF. In no cases may the DME supplier
access or manipulate the test results in any form.
The IDTF must send the test results to the physician. The IDTF may send the
test results to the supplier if the supplier is currently providing or has
an order to provide oxygen or other respiratory services to the beneficiary
or if the beneficiary has signed a release permitting the supplier to
receive the report.
Oximetry test results obtained through a similar process while the
beneficiary is awake, either at rest or with exercise, may not be
used for purposes of qualifying the beneficiary for home oxygen therapy.
CERTIFICATION:
For Initial Certifications, the blood gas study reported on the Certificate
of Medical Necessity (CMN) must be the most recent study obtained prior to
the Initial Date indicated in Section A of the CMN and this study must be
obtained within 30 days prior to that Initial Date. There is an exception
for patients who were on oxygen in a Medicare HMO and who transition to
fee-for-service Medicare. For those patients, the blood gas study does not
have to be obtained 30 days prior to the Initial Date, but must be the most
recent test obtained while in the HMO.
For patients initially meeting Group I criteria, the most recent blood gas
study prior to the thirteenth month of therapy must be reported on the
Recertification CMN.
For patients initially meeting Group I criteria, if the estimated length of
need on the Initial CMN is less than lifetime and the physician wants to
extend coverage, a repeat blood gas study must be performed within 30 days
prior to the date of the Revised Certification.
For patients initially meeting Group II criteria, the most recent blood gas
study which was performed between the 61st and 90th day following Initial
Certification must be reported on the Recertification CMN. If a qualifying
test is not obtained between the 61st and 90th day of home oxygen therapy,
but the patient continues to use oxygen and a test is obtained at a later
date, if that test meets Group I or II criteria, coverage would resume
beginning with the date of that test. For patients initially meeting Group
II criteria, if the estimated length of need on the Initial CMN is less
than lifetime and the physician wants to extend coverage, a repeat blood
gas study must be performed within 30 days prior to the date of the Revised
Certification.
For any Revised CMN, the blood gas study reported on the CMN must be the
most recent test performed prior to the Revised date.
A repeat blood gas study may be requested at any time.
The patient must be seen and evaluated by the treating physician within 30
days prior to the date of Initial Certification. The patient must be seen
and re-evaluated by the treating physician within 90 days prior to the date
of any Recertification. If the patient is not seen and re-evaluated within
90 days prior to Recertification but is subsequently seen, payment can be
made for dates of service between the scheduled Recertification date and
the physician visit date if the blood gas study criteria are met.
PORTABLE OXYGEN SYSTEMS:
A portable oxygen system is covered if the patient is mobile within the
home and the qualifying blood gas study was performed while at rest (awake)
or during exercise. If the only qualifying blood gas study was performed
during sleep, portable oxygen will be denied as not medically necessary.
If coverage criteria are met, a portable oxygen system is usually
separately payable in addition to the stationary system. (See exception in
Liter Flow Greater Than 4 LPM.)
If a portable oxygen system is covered, the supplier must provide whatever
quantity of oxygen the patient uses; Medicare’s reimbursement is the same,
regardless of the quantity of oxygen dispensed.
LITER FLOW GREATER THAN 4 LPM:
If basic oxygen coverage criteria have been met, a higher allowance for a
stationary system for a flow rate of greater than 4 liters per minute (LPM)
will be paid only if a blood gas study performed while the patient is on 4
LPM meets Group I or II criteria. If a flow rate greater than 4 LPM is
billed and the coverage criterion for the higher allowance is not met,
payment will be limited to the standard fee schedule allowance.
If a patient qualifies for additional payment for greater than 4 LPM of
oxygen and also meets the requirements for portable oxygen, payment will be
made for either the stationary system (at the higher allowance) or the
portable system (at the standard fee schedule allowance for a portable
system), but not both. In this situation, if both a stationary system and a
portable system are billed for the same rental month, the portable oxygen
system will be denied as not separately payable.
MISCELLANEOUS:
Emergency or stand-by oxygen systems will be denied as not medically
necessary since they are precautionary and not therapeutic in nature.
Topical hyperbaric oxygen chambers (A4575) will be denied as not medically
necessary.
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