Oxygen and oxygen equipment as durable medical equipment (DME) involves the system for furnishing it, the vessels that store it, the tubing and administration sets that allow the safe delivery of oxygen in the home, and the oxygen contents. 

The term blood gas study in this policy refers to either an arterial blood gas (ABG) test or an oximetry test. An ABG is the direct measurement of the partial pressure of oxygen (PO₂ ) on a sample of arterial blood. The PO₂ is reported as mm Hg. An oximetry test is the indirect measurement of arterial oxygen saturation using a sensor on the ear or finger. The saturation is reported as a percent.

NOTE:

Effective March 20, 2006, claims for Medicare Advantage members who are participating in an approved clinical trial should be submitted to the appropriate DMERC/RHHI. See www.cms.hhs.gov/clinicaltrialpolicies for the appropriate billing guidelines.

See Medicare Advantage Medical Policy Bulletin G-27 for additional information on clinical trials.

For any item to be covered, 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 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.

For an item to be covered, 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.

For home oxygen therapy, only rented oxygen equipment is eligible for coverage. Home oxygen therapy is covered only if all of the following conditions are met:

1. 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
2. The patient’s blood gas study meets the criteria stated below; and
3. The qualifying blood gas study was performed by a physician or by a qualified provider or supplier of laboratory services, and
4. 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
     
     
5. Alternative treatment measures have been tried or considered and deemed clinically ineffective.

In this policy, the term blood gas study includes both an oximetry test and an arterial blood gas test.

Group I criteria includes any of the following:

• An arterial PO₂  at or below 55 mm Hg, or an arterial oxygen saturation at or below 88%, taken at rest (awake), or
• An arterial PO₂  at or below 55 mm Hg, or an arterial oxygen saturation at or below 88%, for at least 5 minutes taken during sleep for a patient who demonstrates an arterial PO₂  at or above 56 mm Hg or an arterial oxygen saturation at or above 89% while awake, or
• A decrease in arterial PO₂  more than 10 mm Hg, or a decrease in arterial oxygen saturation more than 5%, for at least 5 minutes taken during sleep associated with symptoms (e.g., impairment of cognitive processes and [nocturnal restlessness or insomnia]) or signs (e.g., cor pulmonale, “P” pulmonale on EKG, documented pulmonary hypertension and erythrocytosis) reasonably attributable to hypoxemia  or
• An arterial PO₂  at or below 55 mm Hg or an arterial oxygen saturation at or below 88%,  taken during exercise for a patient who demonstrates an arterial PO₂ at or above 56 mm Hg or an arterial oxygen saturation at or above 89% 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 Certification section for information on recertification.)

Group II criteria includes the presence of (a) an arterial PO₂  of 56-59 mm Hg or an arterial blood oxygen saturation of 89% 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 Certification section for information on recertification.)

Group III criteria includes patients with arterial PO₂  levels at or above 60 mm Hg or arterial blood oxygen saturations at or above 90%. 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:

1. 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.
2. Dyspnea without cor pulmonale or evidence of hypoxemia.
3. 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 PO₂  will improve the oxygenation of tissues with impaired circulation.
4. Terminal illnesses that do not affect the respiratory system.

TESTING SPECIFICATIONS

The qualifying blood gas study must be performed by a provider who is qualified to bill for the test - i.e., a Part A provider, a laboratory, 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). All 3 tests must be performed within the same testing session. 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. 

CERTIFICATION 

An Initial, Recertification, or Revised CMN must be obtained and submitted in the situations described below. The Initial Date, Recertification Date, and Revised Date specified below refer to the dates reported on the CMN.

Initial CMN is Required:

1. With the first claim for home oxygen, (even if the patient was on oxygen prior to Medicare eligibility or oxygen was initially covered by Medicare).

2. During the first 36 months of the rental period, when there has been a change in the patient’s condition that has caused a break in medical necessity of at least 60 days plus whatever days remain in the rental month during which the need for oxygen ended. Refer to the Reasons for Noncoverage section of this policy for additional information.

3. When the equipment is replaced because the reasonable useful lifetime of prior equipment has been reached.

4. When the equipment is replaced because of irreparable damage, theft, or loss of the originally dispensed equipment.

1. Irreparable damage refers to a specific accident or to a natural disaster [e.g., fire, flood].
2. Irreparable damage does not refer to wear and tear over time.

Testing and Visit Requirements:

Initial CMN for situations 1 and 2

• The blood gas study must be the most recent study obtained within 30 days prior to the Initial Date.
  • For situation 1, there is an exception to the 30-day test requirement for patients who were started on oxygen while enrolled in a fee-for-service Medicare and transitioned to Medicare Advantage. 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 qualifying test obtained while in the Medicare fee-for-service.
• The patient must be seen and evaluated by the treating physician within 30 days prior to the date of Initial Certification.

Initial CMN for scenarios 3 and 4 (replacement equipment)

• Repeat blood gas testing is not required. Enter the most recent qualifying value and test date. This test does not have to be within 30 days prior to the Initial Date. It could be the test result reported on the most recent prior CMN.
• There is no requirement for a physician visit that is specifically related to the completion of the CMN for replacement equipment.

Recertification CMN is Required:

5. 12 months after Initial Certification (i.e., with the thirteenth month’s claim) for Group I.

6. 3 months after Initial Certification (i.e., with the fourth month’s claim) for Group II.

Testing and Visit Requirements:

Recertification following initial certification situations 1 and 2

• For patients initially meeting Group I criteria, the most recent qualifying blood gas study prior to the thirteenth month of therapy must be reported on the Recertification CMN.
• For patients initially meeting Group II criteria, the most recent blood gas study that 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 I or II criteria, the patient must be seen and re-evaluated by the treating physician within 90 days prior to the date of any Recertification. If the physician visit is not obtained within the 90-day window but the patient continues to use oxygen and the visit is obtained at a later date, coverage would resume beginning with the date of that visit.

Recertification following initial situations 3 and 4 (replacement equipment)

• Repeat testing is not required. Enter the most recent qualifying value and test date. This test does not have to be within 30 days prior to the Initial Date. It could be the test result reported on the most recent prior CMN.
• There is no requirement for a physician visit that is specifically related to the completion of the CMN for replacement equipment.

Revised CMN is Required:

7. When the prescribed maximum flow rate changes from one of the following categories to another:

1. less than 1 LPM,
2. 1-4 LPM,
3. greater than 4 LPM.

If the change is from category (a) or (b) to category (c), a repeat blood gas study with the patient on 4 LPM must be performed.

8. When the length of need expires – if the physician specified less than lifetime length of need on the most recent CMN.

9. When a portable oxygen system is added subsequent to Initial Certification of a stationary system.

10. When a stationary system is added subsequent to Initial Certification of a portable system.

11. When there is a new treating physician but the oxygen order is the same.

12. If there is a new supplier and that supplier does not have the prior CMN.

Submission of a Revised CMN does not change the Recertification schedule specified above.

If the indications for a Revised CMN are met at the same time that a Recertification CMN is due, file the CMN as a Recertification CMN.

Testing and Visit Requirements:

None of the Revised Certification situations (7-12) require a physician visit.

Revised Certification situations 7 and 8

• The blood gas study must be the most recent study obtained within 30 days prior to the Initial Date.

Revised Certification situation 9

• There is no requirement for a repeat blood gas study unless the initial qualifying study was performed during sleep, in which case a repeat blood gas study must be performed while the patient is at rest (awake) or during exercise within 30 days prior to the Revised Date.

Revised Certifications situations 10-12

• No blood gas study is required.
• For situations 11 and 12, the revised certification does NOT have to be submitted with the claim.

A completed and signed Certificate of Medical Necessity (CMN) is required to receive payment for oxygen. Claims submitted without a valid CMN will be denied as not medically necessary.

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; reimbursement is the same, regardless of the quantity of oxygen dispensed.

MISCELLANEOUS

Emergency or stand-by oxygen systems for patients who are not regularly using oxygen 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.

Liter Flow Greater than 4 LPM

If the 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 Group 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 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 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.

Reasons for Noncoverage

REASONABLE USEFUL LIFETIME (RUL)

The reasonable useful lifetime for oxygen equipment is 5 years. The RUL is not based on the chronological age of the equipment. It starts on the initial date of service and runs for 5 years from that date.

RUL also does not take into account exchanges of equipment, new suppliers, or changes of modality (concentrator, gaseous, liquid).

OXYGEN EQUIPMENT

Initial 36 months

Reimbursement for oxygen equipment is limited to 36 monthly rental payments. Payment for accessories (e.g., cannula, tubing, etc.), delivery, back-up equipment, maintenance, and repairs is included in the rental allowance. Payment for oxygen contents (stationary and/or portable) is included in the allowance for stationary equipment (E0424, E0439, E1390, E1391).

Payment for stationary equipment is increased for patients requiring greater than 4 liters per minute (LPM) of oxygen flow and decreased for patients requiring less than 1 LPM. 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 the stationary system at the higher allowance, but not for the portable system. 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.

The supplier who provides oxygen equipment for the first month must continue to provide any necessary oxygen equipment and all related items and services through the 36-month rental period, unless one of the following exceptions is met:

• Member relocates temporarily or permanently outside of the supplier’s service area
• Member elects to obtain oxygen from a different supplier
• Individual case exceptions made by the Medicare Advantage Plan

Providing different oxygen equipment/modalities (e.g., concentrator [stationary or portable], gaseous, liquid, transfilling equipment) is not permitted unless one of the following requirements is met:

• Supplier replaces the equipment with the same or equivalent item
• Physician orders different equipment
• Member chooses to receive an upgrade and signs a Pre-Service Denial Notice
• The Medicare Advantage Plan determines that a change in equipment is warranted

A new 36-month rental period can begin only in the following situations:

• Specific incident of damage beyond repair (e.g., dropped and broken, fire, flood, etc.) or the item is stolen or lost
• Break-in-need for at least 60 days plus the days remaining in the month of discontinuation and new medical necessity is established (see “BREAK-IN-SERVICE” below)

A new 36-month rental period does not start in the following situations:

• Replacing equipment due to malfunction, wear and tear, routine maintenance, repair
• Providing different equipment based on a physician order or member request for an upgrade
• Break-in-need less than 60 days plus the days remaining in the month of discontinuation (see “BREAK-IN-SERVICE” below)
• Break-in-billing (see “BREAK-IN-SERVICE” below)
• Changing suppliers

Months 37-60

There is no further payment for oxygen equipment during the 5-year reasonable useful lifetime (RUL) of the equipment after 36 rental payments have been made. If use of portable equipment (E0431, E0433, E0434, E1392, K0738) begins after the use of stationary equipment begins, payment for the portable equipment can continue after payment for the stationary equipment ends until 36 rental payments have been made for the portable equipment.

For information on payment for contents and maintenance, see separate sections below.
 
The supplier who provided the equipment during the 36th rental month is required to continue to provide the equipment, accessories, contents (if applicable), maintenance, and repair of the oxygen equipment during the 5 year reasonable useful lifetime of the equipment.

Rules for providing different equipment/modalities are the same in months 37-60 as they are in the initial 36 months (see above).

A new 36-month rental period can begin only in the following situation:

• There is a specific incident of damage beyond repair (e.g., dropped and broken, fire, flood, etc.) or the item is stolen or lost

A new 36-month rental period does not start in the following situations:

• Replacing equipment due to malfunction, wear and tear, routine maintenance, repair
• Providing different equipment based on a physician order or member request for an upgrade
• Break-in-need (see “BREAK-IN-SERVICE” below)
• Break-in-billing (see “BREAK-IN-SERVICE” below)
• Changing suppliers

Months 61 and after

At any time after the end of the 5-year reasonable useful lifetime for oxygen equipment, the member may elect to receive new equipment, thus beginning a new 36-month rental period.

If the member elects not to receive new equipment after the end of the 5-year reasonable useful lifetime and if the supplier retains title to the equipment, all elements of the payment policy for months 37-60 remain in effect. There is no separate payment for accessories or repairs. If the patient was using gaseous or liquid oxygen equipment during the 36th rental month, payment can continue to be made for oxygen contents.

If the member elects not to receive new equipment after the end of the 5-year reasonable useful lifetime and if the supplier transfers title of the equipment to the member, accessories, maintenance, and repairs are statutorily noncovered. Contents are separately payable for patient-owned gaseous or liquid systems.

If a member enters Medicare Advantage with patient-owned equipment, accessories, maintenance, and repairs are statutorily noncovered. Contents are separately payable for patient-owned gaseous or liquid systems.

OXYGEN CONTENTS

Payment for stationary and portable contents is included in the allowance for stationary equipment. No payment can be made for oxygen contents in a month in which payment is made for stationary equipment.

If the patient was using stationary gaseous or liquid oxygen equipment during the 36th rental month, payment for stationary contents (E0441 or E0442) begins when the rental period for the stationary equipment ends.

If the patient was using portable gaseous or liquid equipment during the 36th rental month of stationary equipment (gaseous, liquid, or concentrator), payment for portable contents (E0443 or E0444) begins when the rental period for the stationary equipment ends. If the patient began using portable gaseous or liquid equipment after starting on stationary equipment, payment for the portable equipment would continue until the end of the 36-month rental period for that equipment even though payment was also being made for the portable contents.

If the patient is using only portable gaseous or liquid equipment and not stationary equipment during months 1 through 36 of the portable equipment rental, payment for portable contents begins when the rental period for the portable equipment begins. If stationary equipment is subsequently added, separate payment for portable contents ends because payment for contents is included in the payment for stationary equipment.

If the patient was not using gaseous or liquid equipment (stationary or portable) in the 36th month, but was subsequently switched to gaseous or liquid oxygen based on a physician order, contents may be paid.

If the patient has a stationary concentrator, portable liquid equipment, and a stationary liquid tank to fill the portable cylinders, when payment for contents begins, payment will only be made for portable liquid contents.

Suppliers must provide whatever quantity of oxygen contents are needed for a patient’s activities both inside and outside the home.

A maximum of 3 months of oxygen contents may be delivered at any one time. (Refer to Billing Information section [below] for additional information concerning billing oxygen contents.)

There is no difference in payment for oxygen contents for members receiving more than 4 LPM or less than 1 LPM.

MAINTENANCE OF EQUIPMENT

Initial 36 months

There is no separate payment for maintenance and servicing (M&S).

Months 37 through 60

If a patient was using a stationary concentrator, portable concentrator, or transfilling equipment during the 36th rental month, payment will be made for a maintenance and servicing visit no more often than every 6 months, beginning 6 months following the end of the rental period. A supplier must actually make a visit to bill the service.

There is no M&S payment for gaseous or liquid equipment.

Month 61 and after

If the member elects not to replace a concentrator or transfilling equipment and if the supplier retains title to the equipment, coverage for M&S is the same as in months 37-60.

If the member elects not to replace a concentrator or transfilling equipment and if the supplier transfers title to the member, M&S is statutorily non-covered.

OXYGEN ACCESSORIES

Accessories, including but not limited to, transtracheal catheters (A4608), cannulas (A4615), tubing (A4616), mouthpieces (A4617), face tent (A4619), masks (A4620, A7525), oxygen conserving devices (A9900), oxygen tent (E0455), humidifiers (E0555), nebulizer for humidification (E0580), regulators (E1353), and stand/rack (E1355) are included in the allowance for rented oxygen equipment. The supplier must provide any accessory ordered by the physician. Accessories used with patient-owned oxygen equipment will be denied as non-covered.

RELOCATION and TRAVEL

Months 1 through 36

If the member relocates outside the supplier’s service area (either short-term travel, extended temporary relocation, or permanent relocation), then for the remainder of the rental month for which it billed, the home supplier is required to provide the equipment and related items/service itself or make arrangements with a different supplier to provide the equipment, items, and services. For subsequent rental months that the member is outside the service area, the home supplier is encouraged to either provide the equipment and related items/services itself or assist the member in finding another supplier in the new location. The home supplier may not bill for or be reimbursed if it is not providing oxygen equipment or has not made arrangements with a different supplier to provide the equipment on the anniversary billing date. Payment will be made to only one supplier to provide oxygen during any one-rental month.

Months 37 through 60

If the member relocates outside the supplier’s service area (either short-term travel, extended temporary relocation, or permanent relocation), the home supplier is required to either provide the equipment and related items/services itself or make arrangements with a different supplier to provide the equipment and related items/services.

Miscellaneous

Oxygen services furnished by an airline to a member are noncovered. Payment for oxygen furnished by an airline is the responsibility of the member and not the responsibility of the supplier.

Items or services provided/used outside the United States and its territories are not covered. The supplier is not required to provide or arrange for oxygen use in those situations.

BREAK-IN-SERVICE

• Break-in-billing/Medicare Advantage payment without break-in-medical necessity
  • If patient enters hospital or SNF or joins Medicare fee-for-service and continues to need/use oxygen, when patient returns home or rejoins Medicare Advantage, payment resumes where it left off
    
    
• Break-in-medical necessity (break-in-need)
  • If need/use of oxygen ends for less than 60 days plus the remainder of the rental month of discontinuation and then resumes, payment resumes where it left off
  • During the 36-month rental period, if need/use of oxygen ends for more than 60 days plus the remainder of the rental month of discontinuation and new medical necessity is established, a new 36 month rental period would begin
  • During months 37-60, if need/use of oxygen ends for more than 60 days plus the remainder of the rental month of discontinuation and new medical necessity is established, a new rental period does not begin. The supplier who provided the oxygen equipment during the 36th rental month must provide all necessary items and services for the duration of the reasonable useful lifetime.

MISCELLANEOUS

Only rented oxygen equipment is eligible for coverage. Purchased oxygen equipment is statutorily non-covered. As such, it is billable to the member.

Oximeters (E0445) and replacement probes (A4606) will be denied as non-covered because they are monitoring devices that provide information to physicians to assist in managing the patient’s treatment. The provider can bill the member for the non-covered device.

Respiratory therapist services are non-covered under the DME benefit.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and be 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 procedure code. Items submitted with an EY modifier will be denied as not medically necessary.

A Certificate of Medical Necessity (CMN) which has been completed, signed, and dated by the treating physician must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for a written order if it is sufficiently detailed. In addition to the order information that the physician enters, the supplier can use the CMN for a written confirmation of other details of the oxygen order or the physician can enter the other details directly - e.g., the means of oxygen delivery (cannula, mask, etc.) and the specifics of varying oxygen flow rates and/or noncontinuous use of oxygen.

For patients who qualify for oxygen coverage based only on a sleep oximetry study, the oxygen saturation value reported must be the lowest value (not related to artifact) during the 5 minute qualifying period reported on the sleep oximetry study. A report of the sleep study documenting the qualifying desaturation must be available upon request.

If both an arterial blood gas and oximetry test have been performed on the same day under the condition reported on the CMN (i.e., at rest/awake, during exercise, or during sleep), the ABG PO2 must be reported on the CMN.

REPLACEMENT EQUIPMENT

For situations 3 and 4 described in the CERTIFICATION section of the “Indications and Limitations of Coverage,” the following special instructions apply:

• Initial Date should be the date that the replacement equipment is initially needed. This is generally understood to be the date of delivery of the oxygen equipment.
• The Recertification Date should be 12 months following the Initial Date when the value on the Initial CMN (for the replacement equipment) meets Group I criteria or 3 months following the Initial Date when the qualifying blood gas value on the Initial CMN meets the Group II criteria. (Note: The Initial Date [for the replacement equipment] should also be entered on the Recertification CMN.)
• Claims for the initial rental month (and only the initial rental month) must have the RA modifier (Replacement of DME item) added to the procedure code for the equipment when there is replacement due to reasonable useful lifetime or replacement due to damage, theft, or loss.
• Claims for the initial rental month must include a narrative explanation of the reason why the equipment was replaced and supporting documentation must be maintained in the supplier’s files.

MISCELLANEOUS

In the following situations, a new order must be obtained and kept on file by the supplier, but neither a new CMN nor a repeat blood gas study are required:

• Prescribed maximum flow rate changes but remains within one of the following categories: (a) less than 1 LPM, (b) 1-4 LPM, (c) greater than 4 LPM.
• Change from one type of stationary system to another (i.e., concentrator, liquid, gaseous).
• Change from one type of portable system to another (i.e., gaseous or liquid tanks, portable concentrator, transfilling system).

A new CMN is not required just because the supplier changes assignment status on the submitted claim.

Suppliers are reminded that in an audit they may be asked to provide a copy of the actual test report and/or information from the medical record to verify that coverage criteria have been met.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

The appropriate modifier must be used if the prescribed flow rate is less than 1 LPM (QE) or greater than 4 LPM (QF or QG). These modifiers may only be used with stationary gaseous (E0424) or liquid (E0439) systems or with an oxygen concentrator (E1390, E1391). They must not be used with codes for portable systems or oxygen contents.

Code E1391 (Oxygen concentrator, dual delivery port) is used in situations in which two members are both using the same concentrator. In this situation, this code should only be billed for one of the members.

Codes E1405 and E1406 (oxygen and water vapor enriching systems) may only be used for products for which a written coding verification has been received from the PDAC.

Code E1392 describes an oxygen concentrator which is designed to be portable, is capable of delivering 85% or greater oxygen concentration, and is capable of operating on either AC or DC (e.g., auto accessory outlet) power. Code E1392 includes the device itself, an integrated battery or patient-replaceable batteries that are capable of providing at least 2 hours of remote portability at a minimum of 2 LPM equivalency, a battery charger, an AC power adapter, a DC power adapter, and a carry bag and/or cart. The combined weight of the concentrator and the battery/batteries capable of 2 hours of portability must be 20 pounds or less. If a concentrator meets all of these criteria and is also capable of functioning as a stationary concentrator, operating 24 hours per day, 7 days per week, the stationary concentrator code (E1390) is billed in addition to code E1392.

Code K0738 describes a feature of an oxygen concentrator that allows the member to fill portable gaseous oxygen cylinders from a stationary concentrator. This feature may be integrated into the stationary concentrator or be a separate component. When code K0738 is billed, code E0431 (portable gaseous oxygen system, rental) must not be used.

Code E0433 describes a feature of an oxygen concentrator that allows the member to fill portable liquid oxygen cylinders from a stationary concentrator. This feature may be integrated into the stationary concentrator or be a separate component. When code E0433 is billed, code E0434 (portable liquid oxygen system, rental) must not be used.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items. https://www.dmepdac.com/.

BILLING INFORMATION 

When billing oxygen contents (refer to Reasons for Noncoverage section of this policy), suppliers should use a date of service (DOS) that is the anniversary date of the equipment whose rental period has ended. The billed DOS will usually not be the actual delivery date. The supplier must have a delivery slip for the actual delivery date.

A supplier does not have to deliver contents every month in order to bill every month. In order to bill for contents, the supplier must have previously delivered quantities of oxygen that are expected to be sufficient to last for one month following the DOS on the claim.

Suppliers may bill a flat rate for contents each month. The submitted charges do not have to vary with the quantity of tanks delivered.

Claims for oxygen contents and/or oxygen accessories should not be submitted in situations in which they are not separately payable.

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.

CMS Pub. 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Section 240.2, 240.2.1

Equipment

Accessories