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Oxygen Therapy and Respiratory Equipment (POC 9) Issuing Authority: Director General, Policy Effective Date: May 18, 2012 This policy replaces the following VPPM 2 policy: 2.2.18 Oxygen Therapy- Respiratory Equipment General. Purpose This policy outlines the Long Term Home Oxygen Therapy Program and provides direction on the requirements for the provision of oxygen (O2) supplies and respiratory equipment. It must be recognized that oxygen is a drug. Policy General 1. The Long Term Home Oxygen Therapy (Respiratory Equipment) Program provides Long Term Home Oxygen Therapy and equipment and supplies in response to clients' respiratory conditions. 2. In the overwhelming majority of cases the opinion of a respirologist, a cardiologist, or even a general internist will not be seen to be necessary to recommend this therapy. 3. The equipment and supplies that may be approved for eligible clients are listed in the Oxygen Therapy (Respiratory Equipment) Benefit Grids. For items not listed on the grids, refer to the Federal Health Claims Processing System (FHCPS) and FHCPS Benefit Grids policy. 4. Short Term Home Oxygen Therapy (less than three months) is not covered by Veterans Affairs Canada as it is considered part of the current acute treatment phase. Veterans Affairs will provide short term oxygen only in palliative cases as outlined in paragraph 27. Eligibility 5. Client eligibility for treatment benefits, including Long Term Home Oxygen Therapy is outlined in Eligibility for Health Care Programs – Eligible Client Groups. 6. Long Term Home Oxygen Therapy is available only to those eligible clients for whom it is medically necessary and who meet the criteria as indicated below. Approval Criteria 7. Long Term Home Oxygen Therapy may be approved for clients if they meet the following departmental physiological criteria: a. the client is in a stable condition on optimal non-oxygen therapy; and b. the client has chronic hypoxemia, with an arterial blood gas PaO2 reading of 55 or less at rest; or c. the client has 1. cor-pulmonale, 2. secondary polycythemia, or 3. pulmonary hypertension with an arterial blood gas PaO2 reading of 60 or less: i. Cor pulmonale - P-pulmonale ECG pattern, increase in P-wave amplitude (>2mm) in leads II,III, and AVF; jugular venous distension; hepatomegaly or tender liver; peripheral edema. ii. Secondary polycythemia - erythrocytosis with a hematocrit > 55 (Hard copy must be provided) iii. Pulmonary hypertension - documentation of pulmonary hypertension with evidence of pulmonary artery pressure or ultrasound indicating elevated pulmonary artery pressure. 8. To approve Long Term Home Oxygen Therapy there must be: a. demonstrable evidence that the treatment is needed and essential; b. a resultant benefit demonstrable by various clinical criteria; and c. no resultant harm, or a certainty that the potential for benefit outweighs the potential for harm. Exceptional cases should be sent to Head Office for review Arterial Blood Gases 9. In order to be considered for Long Term Home Oxygen Therapy, two independent Arterial Blood Gases are required. The client is expected to be stabilized and to have these readings taken in a hospital or ABG lab setting. If a client is bedridden and within a thirty minute radius of such a facility, an ABG may be done at home by a registered health professional who has been accredited in the performance of this procedure. The first ABG should be obtained when the client’s condition has stabilized, i.e. no longer in acute distress. The second ABG should be obtained three months later. The timing of the ABGs permits a determination of the therapeutic benefit to the client whose condition has been stabilized. Exceptions from ABG requirement 10. The Arterial Blood Gas requirement is necessary. Exceptions should be considered only in exceptional circumstances. When a client lives more than thirty minutes from an ABG lab setting or hospital where an ABG can be done, and travel to this centre is not feasible, an oximetry reading may be substituted using room air. For the client to be considered for Long Term Home Oxygen Therapy, the oximetry must indicate a level of saturation of 88% or less while awake and at rest for at least five minutes before oximetry is performed (the client should not be in the recovery stage following exertion). Copies of the reports should be forwarded to District Nursing Officer (DNO) for review and discussion with the Senior District Medical Officer (SDMO). Oximetry 11. Oximetry could be used: a. for those who have been on oxygen therapy for over a year, b. for bedridden clients who are more than thirty minutes from a collection site, or c. for nocturnal and exertional studies (see paragraphs 13-26). In all cases, the rationale for oximetry must be provided. Cardiac Patients 12. Long Term Home Oxygen Therapy is not indicatedin the treatment of patients with primary heart disease. The recommendation for the use of Long Term Home Oxygen Therapy for cardiac patients who present with other complicating pulmonary factors, should be made only by a cardiologist or, when no cardiologist is available, an internist. A report from the family physician is acceptable only when there is no internist available. Nocturnal O2 Desaturation 13. Nocturnal desaturations can occur for different reasons Nocturnal O2 desaturation will not be recognized for Long Term Home Oxygen therapy except in exceptional circumstances. Where it is requested, evidence would include a significant, repetitively-measured decrease in Oxygen saturation well below minimal acceptable levels in the circumstances described. All of these cases would have to be individually medically judged by the SDMO with appropriate preauthorization. These cases should seldom occur. 14. To qualify for Long Term Home Oxygen Therapy nocturnal desaturations must be confirmed by a full sleep study (polysonography) or oximetry completed in a sleep laboratory, or by a sleep screening study. If a sleep screening study is used it must include, at a minimum, a continuous recording of oxygen saturation, heart rate, and a direct measurement of air flow. 15. The most frequently used measurement from a polysonogram (a formal sleep study) is an apnea- hypopnea index (AHI) which is the number of respiratory events (apnoeic episodes and hypopneic episodes per hour. 16. For nocturnal oximetry an oxygen desaturation index (ODI) can be generated, which is the number of desaturations greater than 3%, per hour of study. There is no one cut-off of ODI that can be used on its own to decide treatment. The ODI alone should not be used to decide treatment. When the ODI parameter is satisfied it can be taken into the clinical context to decide whether therapy is appropriate. Although an AHI of greater than or equal to 10 is commonly associated with symptoms, again no one cut-off of AHI should be used exclusively to decide therapy. There is an increasing likelihood ratio for the development of hypertension with AHI’s greater than or equal to 5. 17. For those who desaturate for another reason, e.g., COPD, then often the percentage of time below a certain saturation is used to decide if oxygen is prescribed, e.g. at least 5% of sleep time with an oxygen saturation at or below 85% without nocturnal oxygen therapy. Respiratory vendors may administer the testing in an individual’s home, if absolutely necessary. Apnea 18. Apnea is transient cessation of breathing with absence of air flow through the nose for eight to ten seconds. 19. The two most common types of sleep apnea are obstructive (upper airway blockage despite airflow drive), and central (decreased respiratory center output). The most common cause of sleep apnea is airway obstruction. 20. Obstructive sleep apnea occurs most often in moderately or severely obese persons and varies in severity from mild to potentially lethal. Upper airway narrowing leads to obstruction during sleep. In severely obese persons, a combination of hypoxemia and hypercapnia may induce central apnea as well. Apneic periods last at least 10 sec (some for 2 min). A repeating cycle of sleep, obstructive choking, and arousal with gasping may result from repeated nocturnal obstruction followed by daytime drowsiness. Similar but less pronounced cycles occur in non obese persons, presumably due to developmental or congenital abnormalities of the upper airway. 21. With obesity-related sleep apnea, weight reduction may reduce obstructive episodes, improve blood gases, and reduce resultant daytime drowsiness. Nasal continuous positive airway pressure (CPAP) may be used to lessen apnea during weight loss. Continuous Positive Airways Pressure (CPAPs) and Bi level Positive Airways Pressure (BiPAPs) 22. A CPAP is a device which normally delivers room air under pressure set specifically to a client’s needs to prevent episodes of obstructive sleep apnea. The pressure must be adjusted to eliminate the obstructive apneas through all positions and stages of sleep. 23. A BiPAP unit delivers two different positive pressure levels, one in inspiration and one in expiration. It may be used to treat central sleep apnea. A BiPAP will ordinarily deliver room air. 24. Oxygen may be used with CPAP or BiPAP when the units cannot maintain on room air the oxygen saturations greater or equal to 85%. There may also be situations (cor pulmonale, erythrocytosis, pulmonary hypertension) where the goal may be to maintain the oxygen saturation greater or equal to 90%. The need for oxygen should be written as a prescription by a specialist - taking into account the criteria for the use of oxygen as described in this policy. Exertional Oxygen Desaturation 25. Exercise-induced O2 desaturation will not be recognized for Long Term Home Oxygen Therapy except in exceptional circumstances. Where oxygen therapy related to exertion is requested, evidence from a blinded exercise testing is required. This would include a repetitively-measured significant decrease in oxygen saturation well below minimal acceptable levels in the circumstances described. All of these cases would have to be individually medically judged by the SDMO with appropriate pre-authorization. These cases should seldom occur. 26. The evaluation should be done at a time of stability when the patient is considered optimized. a. To qualify for oxygen therapy: i. the patient must be pre-screened and show a SPO2 < 90% persistently for at least one minute during exercise, i.e. activities of daily living - getting dressed, brushing teeth etc. ii. the testing must be done within one month prior to the walk test being done. A walk test is walking at a reasonable pace (for the patient) for at least five minutes. Failure to complete the time, or a drop in SPO2 during that time would be significant. A blinded air versus oxygen test with oximetery is performed. b. Clients are judged to benefit from low oxygen therapy if they have i. objective measured improvement in walking performance on oxygen compared to air so that the distance walked increases by 25% (at least 30 metres); or ii. desaturation to < 80%, regardless of dyspnea or distance walked. c. Differences between air and oxygen walking which are less than these amounts do not qualify for oxygen during exertion. d. If the patient is unable to walk for reasons unrelated to dyspnea or arterial desaturation, then the patient does not qualify for oxygen for exercise. There cannot be a significant improvement in walking performance with oxygen if the patient is physically incapable of walking because of some other medical problem or infirmity. Palliative Care 27. The District Nursing Officer (DNO) in consultation with the SDMO may approve Long Term Home Oxygen Therapy as a palliative support measure in exceptional cases for terminally ill clients who do not otherwise meet the approval criteria. In such cases the approval of Long Term Home Oxygen should be reconsidered after three months Approval Authority 28. All Long Term Home Oxygen Therapy including equipment must be approved by the DNO and must follow the prescriber and recommender requirements outlined in the Oxygen Therapy Benefit Grids. This should include approval of monthly frequency limits of minor respiratory supplies such as tubing, masks, filters and cannula. The Treatment Authorization Centre or the District Office must check the client’s file to ensure that the limits on refills or replacement of supplies established by the DNO upon initial approval are not exceeded. 29. A request for approval of Long Term Home Oxygen Therapy must include reports from a physician and an RRT. The physician’s report must include a diagnosis and a prescription form which indicates the flow rate of oxygen, the expected hours of usage per day, and whether the client is likely to need a portable oxygen system. The RRT report must include a description of the equipment necessary to fulfill the prescription and ABG data (see paragraph 46). 30. The departmental approver, i.e. the DNO, will determine if the approval criteria are met by verifying that the prescription provided by the treating physician reflects the conditions outlined in the departmental physiological criteria. If these criteria are not met, and in exceptional cases only, the DNO will refer the case to the SDMO to confirm that Long Term Home Oxygen should be approved on an exceptional basis. The rationale for exceptional approval must be recorded on the clients electronic file CSDN Client Notes. Approval Process 31. First-time approval of Long Term Home Oxygen Therapy must be based on a physician’s diagnosis, prescription, and an RRT report as described in paragraph 29. The approval is for an initial four-month period only, in order to permit a review of the three-month follow-up ABG to determine if the client continues to meet the approval criteria. 32. In approving the initial four-month treatment, the DNO should ensure that: a. the Long Term Home Oxygen Therapy is prescribed by a physician; b. clients are advised of the provisional approval by letter and that the Department will be requesting reconfirmation of their blood gas levels after three months to determine if Long Term Home Oxygen Therapy is still appropriate to their health needs; and, c. the equipment recommender is an RRT. 33. In approving oxygen at the three month follow-up the DNO should ensure that suppliers provide an RRT assessment of the client's oxygen usage including a blood gas reading from an independent laboratory/hospital, three months after installing the Long Term Home Oxygen equipment. 34. If the three-month follow-up indicates that the client continues to meet the approval criteria, Long Term Home Oxygen Therapy may be approved for up to the maximum frequency period (usually 12 months) indicated on the Oxygen Therapy Benefit Grids. 35. If the three-month follow-up indicates that the client does not meet the approval criteria noted in paragraph 7, the DNO will consult with the SDMO in determining how to proceed. The SDMO should consult with the appropriate private physician prior to making a decision on the continuation/cancellation of benefits. 36. The rational for approval as per paragraph 35 should be exceptional and documented on CSDN. Approval Authority for CPAPs and BiPAPs 37. Use of a CPAP may be approved by an SDMO when supported by the following documentation: a. polysonography diagnostic of obstructive sleep apnea or UARS (Upper Airways Resistance Syndrome) interpreted by a specialist (as per paragraph 38). b. home study diagnostic of obstructive sleep apnea interpreted by a specialist. This home study preferably should be a Level III type study, however, when not available, oximetry could be an acceptable substitute. 38. Specialists who would generally be knowledgeable of sleep disordered breathing include: a. respirologists, b. ear, nose and throat specialists, c. neurologists, d. psychiatrists with special interest training or a fellowship in sleep medicine (approximately 6 in Canada - refer to HO list), or e. in certain circumstances, general internists with specialized knowledge in sleep medicine would be acceptable where no one else is available. 39. BiPAP: A specialist, i.e. respirologist, sleep specialist or general internist with specialized knowledge in sleep should be involved and make the recommendation for the use of BiPAP. The requirement for BiPAP would indicate increased disease severity or in particular a type of problem that requires specialized investigations and therapy. Clients Currently Receiving Long Term Home Oxygen Therapy 40. It is not intended that implementation of the above-noted approval criteria result in an immediate reassessment of all clients currently receiving Long Term Home Oxygen Therapy. Safe Use of Oxygen 41. Smoking a. The Department will not be held responsible for any injury or damages resulting from the use of Long Term Home Oxygen and smoking. For clients who smoke, the DNO should ensure that the prescriber and recommender are aware of the client's smoking status, and that the client has been advised of the health and safety hazards associated with smoking and Long Term Home Oxygen use. 42. Wood Stoves or Open Flames a. Clients on oxygen must stay at least five feet away from a wood stove or open flames and for longer periods of time should remain ten feet away from a wood stove or open flame. These numbers are the absolute minimum for safety. Optimally, clients with oxygen wouldn’t be in the same room as a wood stove or open flame. i. Clients should be off their oxygen for at least 30 minutes before stoking the wood stove or being near an open flame. ii. Concentrators must be at least 10 feet away from a wood stove or open flame. iii. Oxygen tanks must be kept in another room away from a wood stove or open flame. Equipment 43. The types of Long Term Home Oxygen equipment that may be approved are identified on the Oxygen Therapy Benefit Grids and a brief explanation of each is provided in paragraphs 56-61. In determining which system should be approved, the intent of the Oxygen Therapy Program should be kept in mind, that being to cover the cost of the delivery system including a backup system that most reasonably responds to the client's oxygen needs. 44. In many cases the type of oxygen systems available within the client's geographic location will dictate the one to be approved for the client. 45. If a choice of systems exists, approval of the most appropriate, cost-effective one, and the backup that may be required, should be based primarily on the prescribed flow rate and hours of usage per day. In addition, each system's features (briefly outlined in paragraphs 56-61) in terms of safety, ease of use, and mobility should also be considered. In making the final decision as to the appropriate type of system , the DNO will take into consideration the RRT's recommendation. Portable Units 46. Portable oxygen units consist of small cylinders of compressed oxygen or liquid oxygen. The small cylinders are mounted on a stroller or cart or contained in a pouch suspended by a shoulder strap. 47. Portable oxygen units approved by the Department may be approved, as outlined on the Oxygen Therapy Benefit Grids, for those clients who meet the criteria for long term oxygen therapy: a. who have led an active lifestyle prior and up to their need for oxygen; b. who require continuous oxygen and for whom a D or E cylinder will satisfy their oxygen needs to remain ambulatory outside the home or to maintain regular routines. c. who are determined in exceptional circumstances to need oxygen therapy for exertional dyspnea. Portable oxygen units are available in shoulder or stroller models. Oxygen Conserving Devices (OCDs) 48. An OCD is a device that delivers fixed pulses of oxygen at varying breath intervals to provide continuous flow oxygen at varying flow rates. OCDs extend the life of the oxygen supply by reducing the amount of oxygen wasted during exhalation and the latter portion of inhalation; they are most often used with portable units, especially the D or E cylinders. 49. OCDs may be approved, as outlined on the Oxygen Therapy Benefit Grids, for clients: a. who meet the requirements for the supply of Oxygen; b. who meet the requirements for portable Oxygen as outlined in paragraph 47; c. whose flow rate for the Oxygen, and the equipment supplying the Oxygen (e.g. mask or nasal cannula) are consistent with the use of an OCD. Purchase or Rental 50. Since first-time oxygen approvals are on a provisional basis only, oxygen equipment should initially be rented with the option to cancel should a decision be made not to approve long term oxygen usage. 51. The policy on Purchase, Rental or Lease to Buy, and Maintenance and Training Requirements provides general criteria on determining the most appropriate, cost-effective method of obtaining treatment benefits items. With respect to Long Term Home Oxygen equipment, the following factors need to be considered in making this determination: a. client's age and prognosis, e.g. it would generally be more cost effective to purchase rather than to rent an oxygen concentrator if the client is expected to require it for at least one year, especially if the concentrator were recycled by the Department (concentrators cost approximately $3,500 and rent for approximately $250 per month); b. ability and willingness of the client or caregiver to assume responsibility for the operation and routine maintenance of the purchased equipment (responsibilities that would normally be covered under the terms of a rental agreement); c. inclusion of, or requirement to buy, service contracts to cover costs such as equipment delivery and set up; refilling/replacing tanks; replacing expendable items and supplies; conducting regular maintenance checks and assessments; providing an emergency back-up system, emergency service and warranty; d. variations that may exist in the coverage provided by a service contract that is included as part of a rental agreement versus one that is purchased; e. penalties associated with breaking a service contract or rental agreement should the equipment no longer be needed; f. availability of a supplier to overhaul the purchased equipment for recycling, and the cost of doing so; g. the logic of renting low-cost items with minimum maintenance requirements and a high recycle potential (e.g. oxygen strollers or cart that rent for approximately $7 per month but cost only approximately $125 to purchase). Responsibility of Suppliers 52. Suppliers are expected to be responsible for the following (these requirements must be included as a condition of the purchase, rental or lease-to-buy agreement): a. obtaining approval from Veterans Affairs for the provision of Long Term Home Oxygen therapy; b. installing the oxygen equipment by a person duly certified to do so; c. instructing the client or caregiver on equipment operation, safety and maintenance requirements; d. maintaining the equipment in good working order; e. providing emergency service when needed; and f. providing a follow-up RRT assessment to the DNO at three months following installation and every 12 months thereafter. 53. As a minimum the RRT assessments must: a. describe the system(s) in place; b. identify whether actual usage complies with the prescription; c. provide an assessment of client's respiratory condition, including smoking status, education and safety aspects; d. indicate if the oxygen system is still appropriate to the client's needs; and e. provide an oximetry reading; f. provide initial assessment as previously described for subsequent request. DNO Responsibilities 54. The DNO reviews the RRT reports, which must be submitted on a yearly basis, and renews approval in accordance with the information provided in the reports. Rates Payable 55. Payment may be made up to the rates outlined in the Rates Payable For Treatment Benefits policy. Long Term Home Oxygen Equipment 56. Oxygen Concentrator a. Description - An electrically-powered machine (approximately the size of a dehumidifier), which takes in room air, filters out the carbon dioxide and nitrogen, and delivers a relatively pure oxygen flow. b. Features - When placed centrally in the home with up to 50-feet of oxygen supply lines, access to supplemental oxygen via the concentrator is available throughout the house. This type is convenient, safe, reliable and inexpensive to run. It is used mainly for continuous oxygen supply at low or medium flow rates, e.g. L/min 6, can be moved from room to room, and is small enough to be transported to other locations for holidays or travel. It is not suited to high or very low flow rate requirements unless specially fitted with a flow meter designed to control low flow-rate usage. c. Backup System - Compressed oxygen cylinder. 57. Compressed Oxygen Cylinder a. Description - An upright metal cylinder, secured by a cylinder stand or a chain connected to a wall. In usage the flow rate is controlled by an oxygen regulator. b. Features - Good for any flow rates. Smaller cylinders can be used for short trips outside the home, b. Features - Good for any flow rates. Smaller cylinders can be used for short trips outside the home, Due to the inconvenience of replacing and storing the tanks, the system is most suited to intermittent usage. Expensive to use as cylinders are depleted very quickly and require replacement. c. Backup System - An extra compressed oxygen cylinder. 58. Liquid Oxygen a. Description of Liquid Oxygen - Oxygen stored in an insulated, metal canister (approximately three feet high and one to two feet wide, mounted on wheels) in liquid form that is converted to a gas and delivered at the desired flow rate through the use of a flow gauge. When the canister becomes empty, it is refilled or a new one is supplied. Frequency of replacement depends on the rapidity with which the tank is emptied (the canister has a slow rate of continuous evaporation whether in use or not). b. Features - May be used with an oxygen conserver. Oxygen may be transferred to a portable unit for outdoor use. c. Backup System - Compressed oxygen cylinder. 59. Oxygen Conserver (OCD) a. Description - An oxygen conserver is a device that delivers fixed pulses of oxygen during a portion of inspiration only, thereby extending the duration of the oxygen supply. 60. Continuous Positive Airways Pressure (CPAP) Unit a. Description - A CPAP is a device which normally delivers room air under pressure set specifically to a client’s needs to prevent episodes of obstructive sleep apnea. A CPAP may be used with a full-face mask, a nasal mask or nasal pillows. With the latter two a chin strap is usually required. Tubing goes from the mask to the CPAP unit which is plugged into an electrical outlet to provide a constant flow of air to the mask. The pressure delivered varies according to the unit setting. Room air is normally used and heated humidification enhancements are available to keep the client’s airways from becoming dry. 61. Bi level Positive Airways Pressure (BiPAP) Unit a. Description - A BiPAP unit delivers two different positive pressure levels, one in inspiration and one in expiration. It may be used to treat central sleep apnea, in contra distinction to obstructive sleep apnea. References Veterans Health Care Regulations, paragraph 4(b) Eligibility for Health Care Programs – Eligible Client Groups Rates Payable for Treatment Benefits Oxygen Therapy (Respiratory Equipment) (POC 9) - Benefits Grids