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Prescribing Physician’s Respiratory Therapy Orders

Q&A’s - Oxygen Therapy Prescriptions:

Q. What are the Medicare requirements before oxygen therapy is prescribed to a patient?
A. Before supplemental oxygen therapy can be initiated, the patient must meet one of the following criteria:

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 PO2 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 purpose 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 ordered 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.

Continuous Positive Airway Pressure (CPAP)

Q. What are the Medicare requirements before a CPAP device can be prescribed to a patient?
A. Before a CPAP device can be initiated, the patient must meet one of the following criteria:

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.

INITIAL COVERAGE:

A single level continuous positive airway pressure (CPAP) device (E0601) is covered if the patient has a diagnosis of obstructive sleep apnea (OSA) documented by an attended, facility-based polysomnogram and meets either of the following criteria (1 or 2):

The apnea-hypopnea index (AHI) is greater than or equal to 15 events per hour; or,
The AHI is from 5 to 14 events per hour with documented symptoms of:
- Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
- Hypertension, ischemic heart disease, or history of stroke.

If a claim for a CPAP device (E0601) is submitted and the criteria above have not been met, it will be denied as not medically necessary.

For the purpose of this policy, polysomnographic studies must be performed in a facility based sleep study laboratory, and not in the home or in a mobile facility. These labs must be qualified providers of Medicare services and comply with all applicable state regulatory requirements.

For the purpose of this policy, polysomnographic studies must not be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

If there is discontinuation of usage of an E0601 device at any time, the supplier is expected to ascertain this, and stop billing for the equipment and related accessories and supplies.

CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

Continued coverage of an E0601 device beyond the first three months of therapy requires that, no sooner than the 61st day after initiating therapy, the supplier ascertain from either the beneficiary or the treating physician that the beneficiary is continuing to use the CPAP device.

If the above criterion is not met, continued coverage of an E0601 device and related accessories will be denied as not medically necessary.

BiLevel Positive Airway Pressure (BIPAP) /Respiratory Assist Devices

Q. What are the Medicare requirements before a BIPAP device can be prescribed to a patient?
A. Before a BIPAP device can be initiated, the patient must meet one of the following criteria:

GENERAL:

The "treating physician" must be one who is qualified by virtue of experience and training in non-invasive respiratory assistance, to order and monitor the use of respiratory assist devices (RAD). Physicians who treat patients for other medical conditions may or may not be so qualified, and if not, though they may be the treating physician of the beneficiary for other conditions, they are not considered the "treating physician" for the administration of non-invasive positive pressure respiratory assistance (NPPRA) therapy.

For the purpose of this policy, polysomnographic studies must be performed in a sleep study laboratory, and not in the home or in a mobile facility. It must comply with all applicable state regulatory requirements.

For the purpose of this policy, arterial blood gas, sleep oximetry and polysomnographic studies may not be performed by a DME supplier. A DME supplier is not considered a qualified provider or supplier of these tests for purposes of this policy’s coverage and payment guidelines. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

If there is discontinuation of usage of an E0470 or E0471 device at any time, the supplier is expected to ascertain this, and stop billing for the equipment and related accessories and supplies.

INITIAL COVERAGE CRITERIA FOR E0470 And E0471 DEVICES FOR THE FIRST THREE MONTHS OF THERAPY:

For an E0470 or an E0471 RAD to be covered, the treating physician must fully document in the patient’s medical record symptoms characteristic of sleep-associated hypoventilation, such as daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, dyspnea, etc.

A RAD (E0470, E0471) used to administer NPPRA therapy is covered for those patients with clinical disorder groups characterized as (I) restrictive thoracic disorders (i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities), (II) severe chronic obstructive pulmonary disease (COPD), (III) central sleep apnea (CSA), or (IV) obstructive sleep apnea (OSA) (E0470 only) and who also meet the following criteria:

I. Restrictive Thoracic Disorders:

There is documentation in the patient’s medical record of a progressive neuromuscular disease (for example, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (for example, post-thoracoplasty for TB), and
B.
1) An arterial blood gas PaCO2 , done while awake and breathing the patient’s usual FIO2 is greater than or equal to 45 mm Hg, or

2) Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing the patient’s usual FIO2, or,

3) For a progressive neuromuscular disease (only), maximal inspiratory pressure is less than 60 cm H20 or forced vital capacity is less than 50% predicted, and
C. Chronic obstructive pulmonary disease does not contribute significantly to the patient’s pulmonary limitation.

If all of the above criteria are met, either an E0470 or an E0471 device (based upon the judgment of the treating physician) will be covered for patients within this group of conditions for the first three months of NPPRA therapy. (See below for continued coverage after the initial three months.)

If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not medically necessary.

II. Severe COPD:

A. 1) An arterial blood gas PaCO2, done while awake and breathing the patient’s usual FIO2, is greater than or equal to 52 mm Hg, and

2) Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing oxygen at 2 LPM or the patient’s usual FIO2 (whichever is higher), and

B. Prior to initiating therapy, OSA (and treatment with CPAP) has been considered and ruled out.

If all of the above criteria for patients with COPD are met, an E0470 device will be covered for the first three months of NPPRA therapy. (See below for continued coverage after the initial three months.)

If all of the above criteria are not met, E0470 and related accessories will be denied as not medically necessary.

An E0471 device will not be covered for a patient with COPD during the first two months, because therapy with an E0470 device with proper adjustments of the device’s settings and patient accommodation to its use will usually result in sufficient improvement without the need of a back-up rate. (See below for coverage of an E0471 device for COPD after 2 month’s use of an E0470 device.) If E0471 is billed and the criteria for an E0470 device are met, it will be paid as the least costly medically appropriate alternative, E0470. If E0471 is billed and the criteria for an E0470 device are not met, it will be denied as not medically necessary.

III. Central Sleep Apnea or Complex Sleep Apnea:

Prior to initiating therapy, a complete facility-based, attended PSG must be performed documenting the following:

The diagnosis of central sleep apnea (CSA) or complex sleep apnea (CompSA) (see definitions in Appendices section) and
The ruling out of CPAP as effective therapy if either CSA or OSA is a component of the initially observed sleep-associated hypoventilation, and
Significant improvement of the sleep-associated hypoventilation with the use of an E0470 or E0471 device on the settings that will be prescribed for initial use at home, while breathing the patient’s usual FIO2.

If all of the above criteria are met, either an E0470 or an E0471 device (based upon the judgment of the treating physician) will be covered for patients with documented CSA or CompSA for the first three months of NPPRA therapy. (See below for continued coverage after the initial three months.)

If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not medically necessary.

IV. Obstructive Sleep Apnea (OSA):

Criteria (A) and (B) are both met:

A. A complete facility-based, attended polysomnogram, has established the diagnosis of obstructive sleep apnea according to the following criteria:
1. The apnea-hypopnea index (AHI) is greater than or equal to 15 events per hour, or
2. The AHI is from 5 to 14 events per hour with documented symptoms of:
a. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia, or
b. Hypertension, ischemic heart disease, or history of stroke, and

B. A single level device (E0601, Continuous Positive Airway Pressure (CPAP) Device) has been tried and proven ineffective.

If the above criteria are met, an E0470 device will be covered for the first three months of NPPRA therapy (see below for continued coverage after the initial three months). If E0470 is billed and these criteria are not met but the coverage criteria in the Continuous Positive Airway Pressure System (CPAP) LCD are met, payment will be based on the allowance for the least costly medically appropriate alternative, E0601.

An E0471 device is not medically necessary if the primary diagnosis is OSA. If E0471 is billed and the criteria for an E0470 device are met, it will be paid as the least costly medically appropriate alternative, E0470. If E0471 is billed and the criteria for an E0470 device are not met, but the coverage criteria in the Continuous Positive Airway Pressure System (CPAP) LCD are met, payment will be based on the allowance for the least costly medically appropriate alternative, E0601.

CONTINUED COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES BEYOND THE FIRST THREE MONTHS OF THERAPY:

Patients covered for the first 3 months of an E0470 or an E0471 device must be re-evaluated to establish the medical necessity of continued coverage by Medicare beyond the first three months. While the patient may certainly need to be evaluated at earlier intervals after this therapy is initiated, the re-evaluation upon which Medicare will base a decision to continue coverage beyond this time must occur no sooner than 61 days after initiating therapy by the treating physician. Medicare will not continue coverage for the 4th and succeeding months of NPPRA therapy until this re-evaluation has been completed.

There must be documentation in the patient’s medical record about the progress of relevant symptoms and patient usage of the device up to that time. Failure of the patient to be consistently using the E0470 or E0471 device for an average of 4 hours per 24 hour period by the time of the re-evaluation (on or after 61 days after initiation of therapy) would represent non-compliant utilization for the intended purposes and expectations of benefit of this therapy. This would constitute reason for Medicare to deny continued coverage as not medically necessary.

The following items of documentation must be obtained by the supplier of the device for continued coverage beyond three months:

A signed and dated statement completed by the treating physician no sooner than 61 days after initiating use of the device, declaring that the patient is compliantly using the device (an average of 4 hours per 24 hour period) and that the patient is benefiting from its use, and
A Medicare beneficiary statement completed by the patient no sooner than 61 days after initiating use of the device (see below).

If the above criteria are not met, continued coverage of an E0470 or an E0471 device and related accessories will be denied as not medically necessary.

For Group II patients (COPD) who qualified for an E0470 device, if at a time no sooner than 61 days after initial issue and compliant use of an E0470 device, the treating physician believes the patient requires an E0471 device, the E0471 device will be covered if the following criteria are met:

An arterial blood gas PaCO2, repeated no sooner than 61 days after initiation of compliant use of the E0470, done while awake and breathing the patient’s usual FIO2, still remains greater than or equal to 52 mm Hg, and
A sleep oximetry, repeated no sooner than 61 days after initiation of compliant use of a E0470 device, and while breathing with the E0470 device, demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing oxygen at 2 LPM or the patient’s usual FIO2 [whichever is higher], and
A signed and dated statement from the treating physician, completed no sooner than 61 days after initiation of the E0470 device, declaring that the patient has been compliantly using the E0470 device (an average of 4 hours per 24 hour period) but that the patient is NOT benefiting from its use, and
A Medicare beneficiary statement completed by the patient, no sooner than 61 days after initiation of the E0470 device.

If the above criteria for an E0471 are not met, but the criteria for an E0470 are met, the device will be paid as the least costly medical alternative, E0470. If E0471 is billed and the criteria for an E0470 device are not met, it will be denied as not medically necessary.