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" based on Social Security Act §1862(a)(1)(A) provisions are defined by the following indications and limitations of coverage.

For an item to be covered, a detailed written 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 is covered only when both the reasonable and necessary criteria discussed below and the statutory criteria discussed in the Policy Article are met. Refer to the Policy Article for additional information on statutory payment policy requirements.

Home oxygen therapy is reasonable and necessary 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%, from baseline saturations, 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. 

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.

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 mm Hg or an oxygen saturation at or above 89 percent. The additional Group 2 coverage criteria do not apply to these patients.

CLUSTER HEADACHES:
Oxygen is covered for the treatment of cluster headaches for patients enrolled in a clinical trial approved by CMS and are in compliance with the requirements at IOM 100-3 240.2.2 for dates of service on or after 01/04/2011. Refer to the CODING GUIDELINES section of this policy for information on the coding to be used for these claims.

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, 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. These prohibitions do 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.

For all the sleep oximetry criteria described above, the 5 minutes does not have to be continuous. Baseline saturation is defined as the mean saturation level during the duration of the test. For purposes of meeting criterion 3 described in Group I above there must be a minimum of 2 hours test time recorded for sleep oximetry. The result must reach a qualifying test value otherwise the Group III presumption of noncoverage applies.

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 . Testing at rest without oxygen, testing during exercise without oxygen, and testing during exercise with oxygen applied (to demonstrate the improvement of the hypoxemia) are required. All 3 tests must be performed within the same testing session. Only the testing during exercise without oxygen is used for qualification and 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. 

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 done at rest and awake is nonqualifying, but either an exercise or sleep oximetry test on the same day is qualifying, the exercise or oximetry test result will determine coverage.

Home Sleep Oximetry Studies:
The member may self-administer home based overnight oximetry tests under the direction of an enrolled Independent Diagnostic Testing Facility (IDTF). A DME supplier or another shipping entity may deliver a pulse oximetry test unit and related technology to the member’s home under the following circumstances:

1. The member’s treating physician has contacted the IDTF to order an overnight pulse oximetry test before the test is performed.
2. The test is performed under the direction and/or instruction of an approved IDTF. Because it is the member who self-administers this test, the IDTF must provide clear written instructions to the member 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 member, apply or demonstrate the application of the testing equipment to the member, or otherwise participate in the conduct of the test.
3. The test unit is sealed and tamper-proof such that test results cannot be accessed by anyone other than the IDTF which 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 case 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 member or if the member has signed a release permitting the supplier to receive the report.

Oximetry test results obtained through a similar process while the member is awake, either at rest or with exercise, may not be used for purposes of qualifying the member for home oxygen therapy.

Polysomnography and Home Sleep Tests:

Coverage of home oxygen therapy requires that the patient be tested in the “chronic stable state.” Chronic stable state is a requirement of the National Coverage Determination (CMS Internet-only Manual, Pub. 100-3, Section 240.2) and is one of the key criteria when determining coverage of home oxygen therapy.

The NCD defines chronic stable state as “…not during a period of an acute illness or an exacerbation of their underlying disease.” Based on this NCD definition, all co-existing diseases or conditions that can cause hypoxia must be treated and the patient be in a chronic stable state before oxygen therapy is considered eligible for payment. In the case of OSA, it is required that the OSA be appropriately and sufficiently treated such that the patient is in the chronic stable state before oxygen saturation results obtained during sleep testing are considered qualifying for oxygen therapy.

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.

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

Testing and Visit Requirements:

Initial CMN for situations 1 and 2

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 reasonable and medically necessary since they are precautionary and not therapeutic in nature.

Topical hyperbaric oxygen chambers (A4575) will be denied as not reasonable and medically necessary. (IOM 100-3 20.29 (B) & (C)).

Topical oxygen delivery systems (E0446) will be denied as not reasonable and necessary. (IOM 100-3 20.29(C))

REFILLS OF OXYGEN CONTENTS INSERT

REFILLS OF OXYGEN CONTENTS:
For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the member prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the member. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes/modifications to the order. Contact with the member or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized. (CMS’ Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-8, Chapter 5, Section 5.2.6).

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the member or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a member. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a member's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the ordering physicians that any changed or atypical utilization is warranted. Refer to the Policy Article for additional information about the billing of contents.

Under REASONABLE USEFUL LIFETIME (RUL):

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. 

Refills of Oxygen Contents

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).

Stationary and portable oxygen equipment is often provided at the same time therefore the RUL for both items runs concurrently. When the RUL of a member’s portable oxygen equipment differs from the RUL of the member’s stationary oxygen equipment, the RUL of the stationary oxygen equipment shall govern the application of RUL-based rules and processes for both types, stationary and portable, of oxygen equipment.

Until such time as the end date of the RUL of the stationary oxygen equipment is reached, the supplier must continue to furnish both the portable and stationary oxygen equipment.

1. If the end date of the RUL of the portable oxygen equipment precedes the end date of the RUL of the stationary oxygen equipment, the end date of the RUL of the portable oxygen equipment is adjusted (extended) to coincide with the end date of the RUL of the stationary oxygen equipment.
2. If the end date of the RUL of the portable oxygen equipment follows the end date of the RUL of the stationary oxygen equipment, the end date of the RUL of the portable oxygen equipment is adjusted (shortened) to coincide with the end date of the RUL of the stationary oxygen equipment.

When the end date of the RUL of the stationary oxygen equipment occurs, the member may elect to obtain replacement of both the stationary and the portable oxygen equipment.

If the member elects to obtain replacement of the stationary and the portable oxygen equipment, both types of oxygen equipment must be replaced at the same time.

When the stationary and the portable oxygen equipment are replaced, a new 36-month rental period and new RUL is started for both the replacement stationary oxygen equipment and the replacement portable oxygen equipment.

Beginning January 1, 2011, a member who resides in a DMEPOS competitive bidding area (CBA) may obtain replacement of both the stationary and portable oxygen systems only from a contract supplier having a competitive bidding contract for the CBA in which the member permanently resides.

A grandfathered supplier for oxygen and other grandfathered equipment as of January 1, 2011, who has continued to furnish such equipment that has not yet reached the 36-month rental cap, does not qualify to furnish replacement equipment once the end date of the RUL of the stationary equipment is reached, if the member resides in the CBA when the end of the RUL has been reached, unless the status of the grandfathered supplier has changed to a contract supplier for the current round of the competitive bidding program.

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
• Item becomes subject to competitive bidding

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 non-covered. 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 non-covered. 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 no sooner than 6 months following the end of the rental period. If the equipment is covered under a warranty that covers labor related to routine/general maintenance and servicing (e.g., inspection, changing filters, cleaning, and calibration), payment for the first M&S visit can be no sooner than 6 months following the end of that warranty.

A supplier must actually make a visit to bill the service. If multiple M&S visits are made during a 6 month period, only one will be paid.

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 non-covered. 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

Prescription (order) Requirements (PIM 5.1)

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 dispensed and/or billed that do not meet these prescription requirements and those below must be submitted with an EY modifier added to each affected procedure code.

Dispensing Orders (PIM 5.2.2)

Equipment and supplies may be delivered upon receipt of a dispensing order. A dispensing order may be verbal or written. It must contain,

• Description of the item
• Member name
• Physician name
• Start date of the order (if different than the order date)

The supplier must keep a record of the dispensing order on file which must be available upon request.

For items that are dispensed based on a dispensing order, the supplier must obtain a detailed written order (DWO) before submitting the claim.

Detailed Written Orders (PIM 5.2.3)

A DWO is required before billing. Someone other than the ordering physician may produce the DWO. But the ordering physician must review the content and sign and date the document.

A prescription is not considered as part of the medical record. Medical information intended to demonstrate compliance with coverage criteria may be included on the prescription but must be corroborated by information contained in the medical record.

Medical Record Information (PIM 5.7-5.9)

The Indications and Limitations of Coverage section of this policy contain numerous reasonable and necessary (R&N) and statutory requirements, that must be met in order for payment to be justified. Suppliers are reminded that,

• Supplier produced records, even if signed by the ordering physician, and attestation letters (e.g. letters of medical necessity) are deemed to not be part of a medical record for payment purposes.
• Templates and forms, including Certificates of Medical Necessity are subject to corroboration with information in the medical record.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS (NCD 240.2)

Initial claims for oxygen must be supported by medical information that specifies:

• A diagnosis of the disease requiring home use of oxygen,
• The oxygen flow rate,
• An estimate of the frequency or duration of use, and
• Duration of need.

"Oxygen PRN" or "Oxygen as needed" does not meet the frequency/duration of use requirement. Neither provides any basis for determining if the amount of oxygen is reasonable and necessary for the patient.

If no frequency or duration of use is specified "continuous use" is assumed. Duration of need may be specified on the CMN in the "Length of Need" field

Documentation for initial coverage requires:

• Evidence of qualifying test results done within 30 days before the initial date of service
• Evidence of an in-person visit with a treating physician done within 30 days before the initial date of service

Information contained directly in the medical record is the source required to justify payment except as noted elsewhere for prescriptions and CMNs. The medical record is not limited to physician's office records but may include records from hospitals, nursing facilities, home health agencies, other healthcare professionals, etc. (not all-inclusive).

CONTINUED USE:

Continued use describes the ongoing utilization of an item or service by a member.

Suppliers are responsible for monitoring utilization of DMEPOS items and must discontinue billing when an item is no longer being used by the member. Ongoing use must be periodically documented. Either member medical records or supplier records are sufficient to confirm that a DMEPOS item continues to be used by the member.

CONTINUED MEDICAL NEED:

For all DMEPOS items, the initial medical need or justification is established at the time the item(s) is first ordered; therefore, member medical records demonstrating that the item is reasonable and necessary are formed prior to the creation of the initial order. For a purchased item, the initial months of
a rental item or for ongoing supplies or drugs, information justifying reimbursement will come from this initial time period. Information from the member's medical record must have been created prior to the initial DOS to establish whether reimbursement was justified based upon the applicable coverage policy.

For DMEPOS items (for which there is on-going use in addition to information described above that justifies the initial provision of the item(s) and/or supplies, there must be information in the member's medical record to support that the item continues to remain reasonable and necessary. Information used to justify this continued need must be timely for the DOS under review.

REFILL DOCUMENTATION:

A routine refill prescription is not needed. A new prescription is needed when:

• There is a change of supplier
• There is a change in treating physician
• There is a change in the item(s), frequency of use, or amount prescribed
• There is a change in the length of need or a previously established length of need expires
• State law requires periodic prescription renewal

For items that the patient obtains in person at a retail store, the signed delivery slip or copy of itemized sales receipt is sufficient documentation of a request for refill. For items that are delivered to the member, documentation of a request for refill must be either a written document received from the member or a contemporaneous written record of a phone conversation/contact between the supplier and member. The refill request must occur and be documented before shipment. A retrospective attestation statement by the supplier or member is not sufficient. The refill record must include:

• Member's name or authorized representative if different than the member
• A description of each item that is being requested
• Date of refill request
• Quantity of each item that the member still has remaining

This information must be kept on file and be available upon request.

CERTIFICATE OF MEDICAL NECESSITY:

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 the detailed written order if it contains the same information as required in a detailed written order. The CMN for home oxygen is CMS Form 484(DME form 484.03). In addition to the order information that the physician enters in Section B, the supplier can use the space in Section C 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 in question 1b of the Oxygen CMN 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 a patient changes from Medicare Secondary to Medicare primary.

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

CLUSTER HEADACHES:
A CMN is not required for claims for cluster headaches.

Claims for oxygen used for the treatment of cluster headaches that meet the approved clinical trial and diagnosis requirements described in the Indications and Limitations of Coverage and/or Medical Necessity section of this policy must be submitted with the Q0 (Q-zero) modifier. Claims for oxygen used for cluster headaches that do not meet these criteria must not use this modifier.

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.

Appendices 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:

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.

When oxygen is supplied as part of a CMS approved clinical trial for cluster headaches, equipment must be coded using E1399 (durable medical equipment, miscellaneous). Refill contents used with equipment to treat cluster headaches must be coded using E1399. One (1) unit of service equals one (1) month’s supply.

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 should monitor usage of contents. Billing may continue on a monthly basis as long as sufficient supplies remain to last for one month as previously described. If there are insufficient contents to be able to last for a month additional contents should be provided.

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