LCD/NCD Portal

L11446

 

OXYGEN AND OXYGEN EQUIPMENT

 

Region IV

DME

Jurisdiction C

 

01/01/2013

 

 

• For any item to be covered by Medicare, it must

o be eligible for a defined Medicare benefit category

o be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

o Meet all other applicable Medicare statutory and regulatory requirements.

o For the items addressed in this local coverage determination, 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 and/or medical necessity.

• For an item to be covered by Medicare, a detailed written order must be received by the supplier before a claim is submitted.

o If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not reasonable and 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.

o 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:

o The treating physician has determined that the beneficiary has a severe lung disease or hypoxia-related symptoms that might be expected to improve with oxygen therapy

o The beneficiary's blood gas study meets the criteria stated below

o The qualifying blood gas study was performed by a physician or by a qualified provider or supplier of laboratory services

o 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

 If the qualifying blood gas study is not performed during an inpatient hospital stay, the reported test must be performed while the beneficiary is in a chronic stable state – i.e., not during a period of acute illness or an exacerbation of their underlying disease

 Alternative treatment measures have been tried or considered and deemed clinically ineffective.

• In this policy, the term blood gas study refers to either an oximetry test or an arterial blood gas test.

 

• Group I criteria include any of the following:

o An arterial PO 2 at or below 55 mm Hg or an arterial oxygen saturation at or below 88 percent taken at rest (awake)

o 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 beneficiary who demonstrates an arterial PO 2 at or above 56 mm Hg or an arterial oxygen saturation at or above 89 percent while awake

o A decrease in arterial PO 2 more than 10 mm Hg, or a decrease in arterial oxygen saturation more than 5 percent from baseline saturation, 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

o 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 beneficiary 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 beneficiary was breathing room air.

• Initial coverage for beneficiaries 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 include the presence of

o 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)

o Any of the following:

 Dependent edema suggesting congestive heart failure

 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)

 Erythrocythemia with a hematocrit greater than 56 percent.

• Initial coverage for beneficiaries meeting Group II criteria is limited to 3 months or the physician specified length of need, whichever is shorter.

o (Refer to the Certification section for information on recertification.)

• Group III includes beneficiaries with arterial PO 2 levels at or above 60 mm Hg or arterial blood oxygen saturations at or above 90 percent.

o For these beneficiaries 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 reasonable and necessary.

o Oxygen therapy will also be denied as not reasonable and 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

 

 

• LONG TERM OXYGEN THERAPY CLINICAL (LTOT) TRIALS

o Oxygen and oxygen equipment is covered for beneficiaries 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 beneficiaries.

o Refer to the APPENDICES section of this policy for additional information about approved clinical trials.

 

• CLUSTER HEADACHES (CH):

o Only a stationary gaseous oxygen system (E0424) and related contents (E0441) are covered for the treatment of cluster headaches (ICD-9 339.00, 339.01, 339.02) for beneficiaries enrolled in a clinical trial approved by CMS which are in compliance with the requirements described in the CMS National Coverage Determination Manual (Internet Only Manual 100-3) §240.2.2 for dates of service on or after 01/04/2011.

 This section states, in part:

• Only those beneficiaries diagnosed with the condition of cluster headache are eligible for participation in a clinical study.

• CMS adopts the diagnostic criteria used by the International Headache Society to form a definitive diagnosis of CH.

• Therefore, the home use of oxygen to treat CH is covered by Medicare only when furnished to Medicare beneficiaries who have had at least five severe to very severe unilateral headache attacks lasting 15-180 minutes when untreated.

o Intensity of pain:

 Degree of pain usually expressed in terms of its functional consequence and scored on a verbal 5-point scale:

• 0=no pain;

• 1=mild pain, does not interfere with usual activities;

• 2=moderate pain, inhibits but does not wholly prevent usual activities;

• 3=severe pain, prevents all activities;

• 4=very severe pain.

• It may also be expressed on a visual analogue scale.

o The headaches must be accompanied by at least one of the following findings:

 Ipsilateral conjunctival injection and/or lacrimation

 Ipsilateral nasal congestion and/or rhinorrhea

 Ipsilateral eyelid edema

 Ipsilateral forehead and facial sweating

 Ipsilateral miosis and/or ptosis

 A sense of restlessness or agitation

o Claims for oxygen equipment not meeting the criteria above will be denied as not reasonable and necessary.

o Claims for stationary oxygen equipment other than E0424 and all portable oxygen equipment used for cluster headaches will be denied as not reasonable and necessary.

o Claims for E0424 and E0441 used to treat cluster headaches follow the same payment rules for all other covered oxygen equipment. Refer to the related Policy Article for information on statutory payment rules and coding guidelines to be used for these claims.

o Refer to the APPENDICES section of this policy for additional information about approved clinical trials.

 

 

• TESTING SPECIFICATIONS:

• General

o For purposes of this policy:

 “Blood gas study” shall refer to both arterial blood gas (ABG) studies and pulse oximetry

 “Oximetry” shall refer to routine or “spot” pulse oximetry

 “Overnight oximetry” shall refer to stand-alone pulse oximetry continuously recorded overnight. It does not include oximetry results done as part of other overnight testing such as polysomnography or home sleep testing.

o Refer to the Positive Airway Pressure Devises used for the Treatment of Obstructive Sleep Apnea policy for information on sleep tests used for the diagnosis of sleep apnea.

o The qualifying blood gas study must be one that complies with the Fiscal Intermediary, Local Carrier, or A/B Medicare Administrative Contractor (MAC) policy on the standards for conducting the test and is covered under Medicare Part A or Part B.

 This includes a requirement that the test be performed by a provider who is qualified to bill Medicare for the test

• i.e., a Part A provider, a laboratory, an Independent Diagnostic Testing Facility (IDTF), or a physician.

 A supplier is not considered a qualified provider or a qualified laboratory for purposes of this policy.

 Blood gas studies performed by a supplier are not acceptable.

 In addition, the qualifying blood gas study may not be paid for by any supplier.

 These prohibitions do not extend to blood gas studies performed by a hospital certified to do such tests.

o The qualifying blood gas study may be performed while the beneficiary is on oxygen as long as the reported blood gas values meet the Group I or Group II criteria.

o 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.

o All oxygen qualification testing must be performed in-person by a physician or other medical professional qualified to conduct oximetry testing.

 With the exception of overnight oximetry (see below), unsupervised or remotely supervised home testing does not qualify as a valid test for purposes of Medicare reimbursement of home oxygen and oxygen equipment.

• Exercise testing

o When oxygen is covered based on an oximetry study obtained during exercise, there must be documentation of three (3) oximetry studies in the beneficiary’s medical record.

• Testing at rest without oxygen.

• Testing during exercise without oxygen.

• Testing during exercise with oxygen applied (to demonstrate the improvement of the hypoxemia) is required.

• All 3 tests must be performed within the same testing session.

• Exercise testing must be performed in-person by a physician or other medical professional qualified to conduct exercise oximetry testing.

• Unsupervised or remotely supervised home exercise testing does not qualify as a valid test for purposes of Medicare reimbursement of home oxygen and oxygen equipment.

• Only the testing during exercise without oxygen is used for qualification and reported on the CMN.

• The other two results do not have to be routinely submitted but must be available on request.

o Oximetry obtained after exercise while resting, sometimes referred to as “recovery” testing, is not part of the three required test elements and is not valid for determining eligibility for oxygen coverage.

• Overnight Oximetry Studies:

o Overnight sleep oximetry may be performed in a facility or at home.

 For home overnight oximetry studies, the oximeter provided to the beneficiary 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.

o For all the overnight 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.

o Home overnight oximetry is limited solely to stand-alone overnight pulse oximetry performed in the beneficiary’s home under the conditions specified below.

 Overnight oximetry performed as part of home sleep testing or as part of any other home testing is not considered to be eligible under this provision to be used for qualification for reimbursement of home oxygen and oxygen equipment even if the testing was performed in compliance with the requirements of this section.

o Beneficiaries may self-administer home based overnight oximetry tests under the direction of a Medicare-enrolled Independent Diagnostic Testing Facility (IDTF).

 A DME supplier or another shipping entity may deliver a pulse oximetry test unit and related technology to a beneficiary’s home under the following circumstances:

• The beneficiary’s treating physician has contacted the IDTF to order an overnight pulse oximetry test before the test is performed.

• The test is performed under the direction and/or instruction of a Medicare-approved IDTF.

o 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.

o 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 which is responsible for transmitting a test report to the treating physician.

o The DME supplier may use related technology to download test results from the testing unit and transmit those results to the IDTF.

o In no case may the DME supplier access or manipulate the test results in any form.

o 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.

o Oximetry test results obtained through a similar process as described for home overnight oximetry (see above) 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.

o Overnight oximetry does not include oximetry obtained during polysomnography or other sleep testing for sleep apnea, regardless of the location the testing was performed.

 See below for information on sleep testing that may be used to qualify for oxygen coverage.

• Obstructive Sleep Apnea (OSA), Polysomnography and Home Sleep Tests:

o Some beneficiaries may require the simultaneous use of home oxygen therapy with a PAP device.

 To be considered for simultaneous coverage, all requirements in the Indications and Limitations of Coverage and/or Medical Necessity for both the Oxygen and Oxygen Equipment and Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea LCDs must be met.

 Consequently, in addition to this LCD, suppliers should refer to the Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea LCD and related Policy Article for additional coverage, coding and documentation requirements.

o Coverage of home oxygen therapy requires that the beneficiary 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 beneficiary must be in a chronic stable state before oxygen therapy is considered eligible for payment.

 In addition, the beneficiary must have a severe lung disease, such as chronic obstructive pulmonary disease, diffuse interstitial lung disease, cystic fibrosis, bronchiectasis, widespread pulmonary neoplasm, or hypoxia-related symptoms or findings that might be expected to improve with oxygen therapy.

 In the case of OSA, it is required that the OSA be appropriately and sufficiently treated such that the beneficiary is in the chronic stable state before oxygen saturation results obtained during sleep testing are considered qualifying for oxygen therapy (see PAP LCD for additional information).

o For beneficiaries with OSA, this means that the OSA must be sufficiently treated such that the underlying severe lung disease is unmasked.

 This must be demonstrated before oxygen saturation results obtained during polysomnography are considered qualifying for oxygen therapy.

 A qualifying oxygen saturation test may only occur during a titration polysomnographic study (either split night or stand-alone) if all of the following criteria are met:

• The titration is conducted over a minimum of two (2) hours

• During titration:

o The AHI/RDI is reduced to less than or equal to an average of ten (10) events per hour

o If the initial AHI/RDI was less than an average of ten (10) events per hour, the titration demonstrates further reduction in the AHI/RDI

• Nocturnal oximetry conducted for the purpose for oxygen reimbursement qualification may only be performed after optimal PAP settings have been determined and the beneficiary is using the PAP device at those settings

• The nocturnal oximetry conducted during the PSG demonstrates an oxygen saturation ≤ 88% for 5 minutes total (which need not be continuous)

 If all of the above criteria are met, for the purposes of a qualifying oxygen saturation test, the beneficiary is considered to be in the “chronic stable state.”

• To be eligible for Medicare coverage and payment for home oxygen therapy for concurrent use with PAP therapy, in addition to being in the chronic stable state, the beneficiary must meet all other coverage requirements for oxygen therapy.

• Beneficiaries that qualify for oxygen therapy based on testing conducted only during the course of a sleep test are eligible only for reimbursement of stationary equipment.

o Overnight oximetry performed as part of home sleep testing or as part of any other home testing is not considered to be eligible to be used for qualification for reimbursement of home oxygen and oxygen equipment (see overnight oximetry section above for additional information).

o Claims for oxygen equipment and supplies for beneficiaries who do not meet the coverage requirements for home oxygen therapy will be denied as not reasonable and necessary.

 

• CERTIFICATION:

o 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 in Section A of the CMN.

o Initial CMN is Required:

 With the first claim for home oxygen, (even if the beneficiary was on oxygen prior to Medicare eligibility or oxygen was initially covered by a Medicare HMO).

 During the first 36 months of the rental period, when there has been a change in the beneficiary’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 Policy Article NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES for additional information

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

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

o Irreparable damage refers to a specific accident or to a natural disaster [e.g., fire, flood].

o Irreparable damage does not refer to wear and tear over time.

o 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 beneficiaries who were started on oxygen while enrolled in a Medicare HMO and transition to fee-for-service Medicare.

• For those beneficiaries, 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 HMO.

 The beneficiary must be seen and evaluated by the treating physician within 30 days prior to the date of Initial Certification.

o Initial CMN for scenarios 3 and 4 (replacement equipment)

o 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.

o There is no requirement for a physician visit that is specifically related to the completion of the CMN for replacement equipment.

o Recertification CMN is Required:

 12 months after Initial Certification,

• (i.e., with the thirteenth month’s claim) for Group I.

 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

o For beneficiaries 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.

o For beneficiaries 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 beneficiary 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.

o For beneficiaries initially meeting group I or II criteria, the beneficiary 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 beneficiary continues to use oxygen and the visit is obtained at a later date, coverage would resume beginning with the date of that visit.

o Recertification following initial situations 3 and 4 (replacement equipment)

o 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.

o There is no requirement for a physician visit that is specifically related to the completion of the CMN for replacement equipment.

o Revised CMN is Required:

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

• Less than 1 LPM

• 1-4 LPM

• Greater than 4 LPM

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

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

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

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

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

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

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

o 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:

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

o Revised Certification situations 7 and 8

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

 

o Revised Certification situation 9

o 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 beneficiary is at rest (awake) or during exercise within 30 days prior to the Revised Date.

 

o Revised Certifications situations 10-12

o No blood gas study is required

o For situations 11 and 12, the revised certification does NOT have to be submitted with the claim.

o 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 reasonable and necessary.

 

• PORTABLE OXYGEN SYSTEMS:

o A portable oxygen system is covered if the beneficiary 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 reasonable and necessary.

o If coverage criteria are met, a portable oxygen system is usually separately payable in addition to the stationary system.

 See exception in the related Policy Article Nonmedical Necessity Coverage and Payment Rules, OXYGEN EQUIPMENT, Initial 36-Months section.

o If a portable oxygen system is covered, the supplier must provide whatever quantity of oxygen the beneficiary uses

 Medicare’s reimbursement is the same, regardless of the quantity of oxygen dispensed.

 

• LITER FLOW GREATER THAN 4 LPM:

o 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 beneficiary is on 4 or more 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.

• (Refer to related Policy Article for additional information on payment for greater than 4 LPM oxygen.)

 

• MISCELLANEOUS:

o Emergency or stand-by oxygen systems for beneficiaries who are not regularly using oxygen will be denied as not reasonable and necessary since they are precautionary and not therapeutic in nature.

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

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

 

• REFILLS OF OXYGEN CONTENTS:

o For Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (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 beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary.

 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 beneficiary 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).

o For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items.

 Suppliers must not deliver refills without a refill request from a beneficiary.

 Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

o Suppliers must not dispense a quantity of supplies exceeding a beneficiary'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.

o See the Nonmedical Coverage and Payment Rules section of the related Policy Article for additional information about coverage of oxygen contents.

 

Bill Type Codes:

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

Revenue Codes:

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

 

CPT/HCPCS Codes

The appearance of a code in this section does not necessarily indicate coverage.

 

HCPCS MODIFIERS:

 

EY – No physician or other licensed health care provider order for this item or service

 

Q0 – (Q-zero) - Investigational clinical service provided in a clinical research study that is in an approved clinical research study

 

QE – Prescribed amount of oxygen is less than 1 liter per minute (LPM)

 

QF – Prescribed amount of oxygen is greater than 4 liter per minute (LPM) and portable oxygen is also prescribed

 

QG – Prescribed amount of oxygen is greater than 4 liters per minute (LPM) and portable oxygen is not prescribed

 

QH – Oxygen conserving device is being used with an oxygen delivery system

 

RA – Replacement of a DME item

 

 

HCPCS CODES:

 

EQUIPMENT:

E0424 STATIONARY COMPRESSED GASEOUS OXYGEN SYSTEM, RENTAL; INCLUDES CONTAINER, CONTENTS, REGULATOR, FLOWMETER, HUMIDIFIER, NEBULIZER, CANNULA OR MASK, AND TUBING

E0425 STATIONARY COMPRESSED GAS SYSTEM, PURCHASE; INCLUDES REGULATOR, FLOWMETER, HUMIDIFIER, NEBULIZER, CANNULA OR MASK, AND TUBING

E0430 PORTABLE GASEOUS OXYGEN SYSTEM, PURCHASE; INCLUDES REGULATOR, FLOWMETER, HUMIDIFIER, CANNULA OR MASK, AND TUBING

E0431 PORTABLE GASEOUS OXYGEN SYSTEM, RENTAL; INCLUDES PORTABLE CONTAINER, REGULATOR, FLOWMETER, HUMIDIFIER, CANNULA OR MASK, AND TUBING

E0433 PORTABLE LIQUID OXYGEN SYSTEM, RENTAL; HOME LIQUEFIER USED TO FILL PORTABLE LIQUID OXYGEN CONTAINERS, INCLUDES PORTABLE CONTAINERS, REGULATOR, FLOWMETER, HUMIDIFIER, CANNULA OR MASK AND TUBING, WITH OR WITHOUT SUPPLY RESERVOIR AND CONTENTS GAUGE

E0434 PORTABLE LIQUID OXYGEN SYSTEM, RENTAL; INCLUDES PORTABLE CONTAINER, SUPPLY RESERVOIR, HUMIDIFIER, FLOWMETER, REFILL ADAPTOR, CONTENTS GAUGE, CANNULA OR MASK, AND TUBING

E0435 PORTABLE LIQUID OXYGEN SYSTEM, PURCHASE; INCLUDES PORTABLE CONTAINER, SUPPLY RESERVOIR, FLOWMETER, HUMIDIFIER, CONTENTS GAUGE, CANNULA OR MASK, TUBING AND REFILL ADAPTOR

E0439 STATIONARY LIQUID OXYGEN SYSTEM, RENTAL; INCLUDES CONTAINER, CONTENTS, REGULATOR, FLOWMETER, HUMIDIFIER, NEBULIZER, CANNULA OR MASK, & TUBING

E0440 STATIONARY LIQUID OXYGEN SYSTEM, PURCHASE; INCLUDES USE OF RESERVOIR, CONTENTS INDICATOR, REGULATOR, FLOWMETER, HUMIDIFIER, NEBULIZER, CANNULA OR MASK, AND TUBING

E0441 STATIONARY OXYGEN CONTENTS, GASEOUS, 1 MONTH’S SUPPLY = 1 UNIT

E0442 STATIONARY OXYGEN CONTENTS, LIQUID, 1 MONTH’S SUPPLY = 1 UNIT

E0443 PORTABLE OXYGEN CONTENTS, GASEOUS, 1 MONTH’S SUPPLY = 1 UNIT

E0444 PORTABLE OXYGEN CONTENTS, LIQUID, 1 MONTH’S SUPPLY = 1 UNIT

E0445 OXIMETER DEVICE FOR MEASURING BLOOD OXYGEN LEVELS NON-INVASIVELY

E0446 TOPICAL OXYGEN DELIVERY SYSTEM, NOT OTHERWISE SPECIFIED, INCLUDES ALL SUPPLIES AND ACCESSORIES

E1390 OXYGEN CONCENTRATOR, SINGLE DELIVERY PORT, CAPABLE OF DELIVERING 85 PERCENT OR GREATER OXYGEN CONCENTRATION AT THE PRESCRIBED FLOW RATE

E1391 OXYGEN CONCENTRATOR, DUAL DELIVERY PORT, CAPABLE OF DELIVERING 85 PERCENT OR GREATER OXYGEN CONCENTRATION AT THE PRESCRIBED FLOW RATE, EACH

E1392 PORTABLE OXYGEN CONCENTRATOR, RENTAL

E1405 OXYGEN AND WATER VAPOR ENRICHING SYSTEM WITH HEATED DELIVERY

E1406 OXYGEN AND WATER VAPOR ENRICHING SYSTEM WITHOUT HEATED DELIVERY

K0738 PORTABLE GASEOUS OXYGEN SYSTEM, RENTAL; HOME COMPRESSOR USED TO FILL PORTABLE OXYGEN CYLINDERS; INCLUDES PORTABLE CONTAINERS, REGULATOR, FLOWMETER, HUMIDIFIER, CANNULA OR MASK, AND TUBING

ACCESSORIES:

A4575 TOPICAL HYPERBARIC OXYGEN CHAMBER, DISPOSABLE

A4606 OXYGEN PROBE FOR USE WITH OXIMETER DEVICE, REPLACEMENT

A4608 TRANSTRACHEAL OXYGEN CATHETER, EACH

A4615 CANNULA, NASAL

A4616 TUBING (OXYGEN), PER FOOT

A4617 MOUTH PIECE

A4619 FACE TENT

A4620 VARIABLE CONCENTRATION MASK

A7525 TRACHEOSTOMY MASK, EACH

A9900 MISCELLANEOUS DME SUPPLY, ACCESSORY, AND/OR SERVICE COMPONENT OF ANOTHER HCPCS CODE

E0455 OXYGEN TENT, EXCLUDING CROUP OR PEDIATRIC TENTS

E0555 HUMIDIFIER, DURABLE, GLASS OR AUTOCLAVABLE PLASTIC BOTTLE TYPE, FOR USE WITH REGULATOR OR FLOWMETER

E0580 NEBULIZER, DURABLE, GLASS OR AUTOCLAVABLE PLASTIC, BOTTLE TYPE, FOR USE WITH REGULATOR OR FLOWMETER

E1353 REGULATOR

E1354 OXYGEN ACCESSORY, WHEELED CART FOR PORTABLE CYLINDER OR PORTABLE CONCENTRATOR, ANY TYPE, REPLACEMENT ONLY, EACH

E1355 STAND/RACK

E1356 OXYGEN ACCESSORY, BATTERY PACK/CARTRIDGE FOR PORTABLE CONCENTRATOR, ANY TYPE, REPLACEMENT ONLY, EACH

E1357 OXYGEN ACCESSORY, BATTERY CHARGER FOR PORTABLE CONCENTRATOR, ANY TYPE, REPLACEMENT ONLY, EACH

E1358 OXYGEN ACCESSORY, DC POWER ADAPTER FOR PORTABLE CONCENTRATOR, ANY TYPE, REPLACEMENT ONLY, EACH

 

ICD-9 Codes that Support Medical Necessity

 

 

E0424 used for cluster headaches

339.00 CLUSTER HEADACHE SYNDROME, UNSPECIFIED

339.01 EPISODIC CLUSTER HEADACHE

339.02 CHRONIC CLUSTER HEADACHE

V70.7 (must be used concurrently with one of the above diagnosis codes)

V70.7 EXAMINATION OF PARTICIPANT IN CLINICAL TRIAL

For all codes used for long term oxygen therapy - not specified

 

 

 

Documentations Requirements

• Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider."

o It is expected that the beneficiary's medical records will reflect the need for the care provided.

o The beneficiary'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.

o This documentation must be available upon request.

 

• PRESCRIPTION (ORDER) REQUIREMENTS

• GENERAL (PIM 5.2.1)

o All items billed to Medicare require a prescription.

o An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request.

o 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 HCPCS code.

 

• DISPENSING ORDERS (PIM 5.2.2)

o Equipment and supplies may be delivered upon receipt of a dispensing order except for those items that require a written order prior to delivery.

o A dispensing order may be verbal or written.

o The supplier must keep a record of the dispensing order on file. It must contain:

 Description of the item

 Beneficiary's name

 Prescribing Physician's name

 Date of the order and the start date, if the start date is different from the date of the order

 Physician signature (if a written order) or supplier signature (if verbal order)

o For the "Date of the order" described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

o Signature and date stamps are not allowed.

 Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

o The dispensing order must be available upon request.

o For items that are provided based on a dispensing order, the supplier must obtain a detailed written order before submitting a claim.

 

• DETAILED WRITTEN ORDERS (PIM 5.2.3)

o A detailed written order (DWO) is required before billing.

 Someone other than the ordering physician may produce the DWO.

 However, the ordering physician must review the content and sign and date the document. It must contain:

 Beneficiary's name

 Physician's name

 Date of the order and the start date, if start date is different from the date of the order

 Detailed description of the item(s) (see below for specific requirements for selected items)

 Physician signature and signature date

o For items provided on a periodic basis, including drugs, the written order must include:

 Item(s) to be dispensed

 Dosage or concentration, if applicable

 Route of Administration

 Frequency of use

 Duration of infusion, if applicable

 Quantity to be dispensed

 Number of refills, if applicable

• For the "Date of the order" described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

o Frequency of use information on orders must contain detailed instructions for use and specific amounts to be dispensed.

 Reimbursement shall be based on the specific utilization amount only.

 Orders that only state "PRN" or "as needed" utilization estimates for replacement frequency, use, or consumption are not acceptable. (PIM 5.9)

o The detailed description in the written order may be either a narrative description or a brand name/model number.

o Signature and date stamps are not allowed.

 Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

o The DWO must be available upon request.

o 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

 

• GENERAL (PIM 5.7 - 5.9)

o The Indications and Limitations of Coverage and/or Medical Necessity section of this LCD contain numerous reasonable and necessary (R&N) requirements.

 The Nonmedical Necessity Coverage and Payment Rules section of the related Policy Article contains numerous non-reasonable and necessary, benefit category 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 not to be part of a medical record for Medicare payment purposes.

 Templates and forms, including CMS Certificates of Medical Necessity, are subject to corroboration with information in the medical record.

o Information contained directly in the contemporaneous 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).

 Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for the purpose of determining that an item is reasonable and necessary.

 

• CONTINUED USE

o Continued use describes the ongoing utilization of supplies or a rental item by a beneficiary.

o Suppliers are responsible for monitoring utilization of DMEPOS rental items and supplies.

 No monitoring of purchased items or capped rental items that have converted to a purchase is required.

 Suppliers must discontinue billing Medicare when rental items or ongoing supply items are no longer being used by the beneficiary.

o Beneficiary medical records or supplier records may be used to confirm that a DMEPOS item continues to be used by the beneficiary.

 Any of the following may serve as documentation that an item submitted for reimbursement continues to be used by the beneficiary:

o Timely documentation in the beneficiary's medical record showing usage of the item, related option/accessories and supplies

 Supplier records documenting the request for refill/replacement of supplies in compliance with the Refill Documentation Requirements (This is deemed to be sufficient to document continued use for the base item, as well)

 Supplier records documenting beneficiary confirmation of continued use of a rental item

o Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in this policy.

 

• CONTINUED MEDICAL NEED

o For all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered

 Therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription.

 For purchased items, initial months of a rental item or for initial months of ongoing supplies or drugs, information justifying reimbursement will come from this initial time period.

 Entries in the beneficiary's medical record must have been created prior to, or at the time of, the initial DOS to establish whether the initial reimbursement was justified based upon the applicable coverage policy.

o For ongoing supplies and rental DME items, in addition to information described above that justifies the initial provision of the item(s) and/or supplies, there must be information in the beneficiary's medical record to support that the item continues to be used by the beneficiary and remains reasonable and necessary.

 Information used to justify continued medical need must be timely for the DOS under review.

 Any of the following may serve as documentation justifying continued medical need:

 A recent order by the treating physician for refills

 A recent change in prescription

 A properly completed CMN or DIF with an appropriate length of need specified

 Timely documentation in the beneficiary's medical record showing usage of the item.

o Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in the policy.

 

• REFILL DOCUMENTATION (PIM 5.2.5-6)

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

 There is a change of supplier

 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 a prescription renewal

• For items that the beneficiary obtains in-person at a retail store, the signed delivery slip or a copy of the itemized sales receipt is sufficient documentation of a request for refill.

• For items that are delivered to the beneficiary, documentation of a request for refill must be either a written document received from the beneficiary or a contemporaneous written record of a phone conversation/contact between the supplier and beneficiary.

o The refill request must occur and be documented before shipment.

o A retrospective attestation statement by the supplier or beneficiary is not sufficient.

o The refill record must include:

 Beneficiary's name or authorized representative if different than the beneficiary

 A description of each item that is being requested

 Date of refill request

• For consumable supplies i.e., those that are used up

 (e.g., ostomy or urological supplies, surgical dressings, etc.)

o The Supplier should assess the quantity of each item that the beneficiary still has remaining, to document that the amount remaining will be nearly exhausted on or about the supply anniversary date.

• For non-consumable supplies i.e., those more durable items that are not used up but may need periodic replacement (e.g., PAP and RAD supplies)

o The supplier should assess whether the supplies remain functional, providing replacement (a refill) only when the supply item(s) is no longer able to function.

o Document the functional condition of the item(s) being refilled in sufficient detail to demonstrate the cause of the dysfunction that necessitates replacement (refill).

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

 

• PROOF OF DELIVERY (PIM 4.26, 5.8)

o Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files.

 For medical review purposes, POD serves to assist in determining correct coding and billing information for claims submitted for Medicare reimbursement.

 Regardless of the method of delivery, the contractor must be able to determine from delivery documentation that the supplier properly coded the item(s), that the item(s) delivered are the same item(s) submitted for Medicare reimbursement and that the item(s) are intended for, and received by, a specific Medicare beneficiary.

o Suppliers, their employees, or anyone else having a financial interest in the delivery of the item are prohibited from signing and accepting an item on behalf of a beneficiary (i.e., acting as a designee on behalf of the beneficiary).

 The signature and date the beneficiary or designee accepted delivery must be legible.

o For the purpose of the delivery methods noted below, designee is defined as any person who can sign and accept the delivery of DMEPOS on behalf of the beneficiary.

o Proof of delivery documentation must be available to the Medicare contractor on request.

 All services that do not have appropriate proof of delivery from the supplier will be denied and overpayments will be requested.

 Suppliers who consistently fail to provide documentation to support their services may be referred to the OIG for imposition of Civil Monetary Penalties or other administrative sanctions.

o Suppliers are required to maintain POD documentation in their files. There are three methods of delivery:

 Delivery directly to the beneficiary or authorized representative

 Delivery via shipping or delivery service

 Delivery of items to a nursing facility on behalf of the beneficiary

 

• Method 1—Direct Delivery to the Beneficiary by the Supplier

• Suppliers may deliver directly to the beneficiary or the designee. In this case, POD to a beneficiary must be a signed and dated delivery slip. The POD record must include:

o Beneficiary's name

o Delivery address

o Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

o Quantity delivered

o Date delivered

o Beneficiary (or designee) signature and date of signature

• The date of signature on the delivery slip must be the date that the DMEPOS item was received by the beneficiary or designee.

o In instances where the supplies are delivered directly by the supplier, the date the beneficiary received the DMEPOS supply must be the date of service on the claim.

 

• Method 2—Delivery via Shipping or Delivery Service Directly to a Beneficiary

• If the supplier utilizes a shipping service or mail order, the POD documentation must be a complete record tracking the item(s) from the DMEPOS supplier to the beneficiary. An example of acceptable proof of delivery would include both the supplier's own detailed shipping invoice and the delivery service's tracking information. The supplier's record must be linked to the delivery service record by some clear method like the delivery service's package identification number or supplier's invoice number for the package sent to the beneficiary. The POD record must include:

o Beneficiary's name

o Delivery address

o Delivery service's package identification number, supplier invoice number or alternative method that links the supplier's delivery documents with the delivery service's records.

o Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

o Quantity delivered

o Date delivered

o Evidence of delivery

• If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of service on the claim.

• Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a POD. This type of POD record must contain the information specified above.

 

• Method 3—Delivery to Nursing Facility on Behalf of a Beneficiary

• When a supplier delivers items directly to a nursing facility, the documentation described for Method 1 (see above) is required.

• When a delivery service or mail order is used to deliver the item to a nursing facility, the documentation described for Method 2 (see above) is required.

• Regardless the method of delivery, for those beneficiaries that are residents of a nursing facility, information from the nursing facility showing that the item(s) delivered for the beneficiary's use were actually provided to and used by the beneficiary must be available upon request.

 

• POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

• (NCD 240.2)

o Documentation for initial coverage requires information in the medical record showing:

 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

o As required by the NCD Home Use of Oxygen (240.2), coverage of home oxygen therapy requires that the beneficiary be tested in the “chronic stable state” and that all co-existing diseases or conditions that can cause hypoxia must be treated sufficiently.

 Moreover, the beneficiary must have a severe lung disease, such as chronic obstructive pulmonary disease, diffuse interstitial lung disease, cystic fibrosis, bronchiectasis, widespread pulmonary neoplasm, or hypoxia-related symptoms or findings that might be expected to improve with oxygen therapy.

o In order to provide coverage for these beneficiaries, there must be evidence in the medical record documenting:

 A severe underlying lung disease, such as chronic obstructive pulmonary disease, diffuse interstitial lung disease, cystic fibrosis, bronchiectasis, widespread pulmonary neoplasm or hypoxia-related symptoms or findings that might be expected to improve with oxygen therapy

 The beneficiary is not experiencing an exacerbation of their underlying lung disease described in (A) or other acute condition(s) impacting the beneficiary’s oxygen saturation

 For beneficiaries with concurrent PAP therapy, the qualifying oxygen saturation test is performed following optimal treatment of the OSA as described in the Indications and Limitations of Coverage and/or Medical Necessity.

o Information contained directly in the medical record is the source required to justify payment except as noted elsewhere for prescriptions and CMNs.

o 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).

 

• CERTIFICATE OF MEDICAL NECESSITY:

o 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.

o For beneficiaries who qualify for oxygen coverage based only on an overnight 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 home overnight study documenting the qualifying desaturation must be available upon request.

o 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 PO 2 must be reported on the CMN.

 

• REPLACEMENT EQUIPMENT:

o 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 HCPCS 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.

 

• LONG TERM OXYGEN THERAPY TRIALS:

o For LTOT Trial claims, the “clinicaltrials.gov” identifier number of the CMS approved clinical trial must be included in the narrative field on each claim.

o Claims for LTOT Trial participants that meet the approved clinical trial and testing 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 that do not meet these criteria must not use this modifier.

 

• CLUSTER HEADACHES:

o A CMN is not required for claims for cluster headaches.

o The ICD-9 for the qualifying cluster headache condition must be included on the claim.

o ICD-9 V70.7 must be included on the claim for cluster headache if the beneficiary is enrolled in an approved study.

o For cluster headache claims there must be information in the medical record justifying:

 Participation in an approved study

 The qualifying ICD-9 diagnosis

o For cluster headache claims, the “clinicaltrials.gov” identifier number of the CMS approved clinical trial must be included in the narrative field on each claim.

o 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.

o Claims for oxygen used for cluster headaches that do not meet these criteria must not use this modifier.

 

• 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 beneficiary changes from Medicare secondary to Medicare primary.

• 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.

• Refer to the Supplier Manual for more information on documentation requirements.

 

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.

• PIM citations above denote references to CMS Program Integrity Manual, Internet Only Manual 100-08.

• Oxygen used to treat cluster headaches and for participants in an LTOT Trial is provided under special coverage rules.

• Reimbursement is only available for beneficiaries who are enrolled in an approved clinical trial.

• CMS maintains a list of policies that require study participation as a condition of coverage on the CMS web site.

• For each policy the approved studies are listed and a link provided to the study on the clinicaltrials.gov web site.

• The clinicaltrials.gov identifier number required on each claim is listed on this site.

 

Sources of Information and Basis for Decision

 

CR7235 for cluster headache trial

 

A33750 - Oxygen and Oxygen Equipment - Policy Article - Effective October 2012

 

Local Coverage Determination (LCD) for Oxygen and Oxygen Equipment (L11446)