National Medical Policy

Transcription

1 National Medical Policy Subject: Pulse Oximetry for Home Use in Adults and Children Policy Number: NMP260 Effective Date*: April 2006 Updated: August 2017 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Home Use of Oxygen (240.2) National Coverage Manual Citation X Local Coverage Determination (LCD)* Oxygen and Oxygen Equipment: Article (Local)* x Other Medicare Claims Processing Manual Chapter 20 - Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Oxygen and Oxygen Equipment 4c20.pdf MLN Matters Number: MM5993. July 9, Critical Care Visits and Neonatal Intensive Care (Codes ): Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/mm5993.pdf Pulse Oximetry for Home Use in Adults and Children Aug 17 1

2 MLN Matters Number: MM5438. December 22, January Updated October 31, Update of the Hospital Outpatient Prospective Payment System (OPPS): Summary of Payment Policy Changes and OPPS PRICER Logic Changes and Instructions for Updating the Outpatient Provider Specific File (OPSF): Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/mm5438.pdf None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Important Note Pulse oximetry testing is considered incidental to office visits or procedures. When pulse oximetry for oxygen saturation is utilized to monitor a patient s respiratory status/oxygen saturation during a surgical procedure, endoscopy, or cardiac or pulmonary rehabilitation, oximetry is considered included in the primary service and is not separately reimbursable. Coverage of home oximeters is subject to the terms, conditions and limitations of the Durable Medical Equipment (DME) benefit. Current Policy Statement Health Net, Inc. considers usage of a rented or purchased pulse oximeter as durable medical equipment (DME) for measurement of oxygen saturation in the home medically appropriate for adults and children when the absence of readily available saturation measurements represents an immediate and demonstrated health risk, such as in any of the following: 1. Patients requiring continuous/long-term monitoring (> 3 months) who have a trained caregiver available to respond to changes in the oxygen saturation level ordered by the physician, and who meet either of the following: Patients who are ventilator-dependent in the home; or Pulse Oximetry for Home Use in Adults and Children Aug 17 2

3 Patients with neuromuscular disease involving the muscles of respiration causing impairment of ventilatory capacity 2. Patients who require short-term monitoring (3 months or less) who meet the following: Patients without a history of hypoxemia who are hospitalized for acute respiratory illnesses and who, within the last 2 days before discharge to home, have severe oxygen desaturation defined as having, on room air, a resting po2 of 55 or less on ABG determination or a resting oxygen saturation of 88% or less on pulse oximetry and oximetric measurements are integral for management of the patient (until 2 weeks after oxygen saturation has been stable or has begun to improve). Note: Pulse oximetry use in neonates/infants is the subject of a separate National Medical Policy. Health Net, Inc. does not consider pulse oximetry medically necessary for any of the following because there is inadequate scientific data in the medical literature to substantiate its effectiveness: 1. Routine testing in the absence of signs or symptoms suggestive of oxygen desaturation 2. Repetitive or continuous oximeter use for routine monitoring of an individual with oxygen with a stable respiratory condition while receiving oxygen therapy; or 3. The use of pulse oximetry in the home, as part of an individual's asthma management; or 4. When used alone for screening or diagnostic testing for suspected obstructive sleep apnea in lieu of polysomnography Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes (List may not be all inclusive) Cystic fibrosis Symptoms involving respiratory system and other chest symptoms Hypoxemia V46.11-V46.9 Dependence on respirator [Ventilator] V46.2 Dependence on supplemental oxygen Pulse Oximetry for Home Use in Adults and Children Aug 17 3

4 ICD-10 Codes E84.0-E84.9 Cystic fibrosis R Abnormalities 0f breathing R06.4 R09.02 Hypoxemia Z99.11 Dependence on respirator [ventilator] status Z99.81 Dependence on supplemental oxygen CPT Codes Non-invasive ear or pulse oximetry for oxygen saturation; single determination Non-invasive ear or pulse oximetry for oxygen saturation; multiple determinations (e.g., during exercise) Non-invasive ear or pulse oximetry for oxygen saturation; by continuous over night monitoring (separate procedure) HCPCS Codes A4606 E0445 Oxygen probe for use with oximeter device, replacement Oximeter device for measuring blood oxygen levels noninvasively Scientific Rationale Update August 2015 Ross et al. (2014) For children with cyanotic congenital heart disease or acute hypoxemic respiratory failure, providers frequently make decisions based on pulse oximetry, in the absence of an arterial blood gas. The study objective was to measure the accuracy of pulse oximetry in the saturations from pulse oximetry (SpO2) range of 65% to 97%. This institutional review board-approved prospective, multicenter observational study in 5 PICUs included 225 mechanically ventilated children with an arterial catheter. With each arterial blood gas sample, SpO2 from pulse oximetry and arterial oxygen saturations from CO-oximetry (SaO2) were simultaneously obtained if the SpO2 was 97%. The lowest SpO2 obtained in the study was 65%. In the range of SpO2 65% to 97%, 1980 simultaneous values for SpO2 and SaO2 were obtained. The bias (SpO2 - SaO2) varied through the range of SpO2 values. The bias was greatest in the SpO2 range 81% to 85% (336 samples, median 6%, mean 6.6%, accuracy root mean squared 9.1%). SpO2 measurements were close to SaO2 in the SpO2 range 91% to 97% (901 samples, median 1%, mean 1.5%, accuracy root mean squared 4.2%). Previous studies on pulse oximeter accuracy in children present a single number for bias. This study identified that the accuracy of pulse oximetry varies significantly as a function of the SpO2 range. Saturations measured by pulse oximetry on average overestimate SaO2 from COoximetry in the SpO2 range of 76% to 90%. Better pulse oximetry algorithms are needed for accurate assessment of children with saturations in the hypoxemic range. Scientific Rationale Update November 2010 There is a Medicare NCD for the Home Use of Oxygen (240.2), which contains the following minimal information about pulse oximetry: New medical documentation written by the patient's attending physician must be submitted to the carrier in support of revised oxygen requirements when there has been a change in the patient's condition and need for oxygen therapy. Pulse Oximetry for Home Use in Adults and Children Aug 17 4

5 Carriers are required to conduct periodic, continuing medical necessity reviews on patients whose conditions warrant these reviews and on patients with indefinite or extended periods of necessity as described in the Medicare Program Integrity Manual, Chapter 5, "Items and Services Having Special DMERC Review Considerations." When indicated, carriers may also request documentation of the results of a repeat arterial blood gas or oximetry study. NOTE: Section 4152 of OBRA 1990 requires earlier recertification and retesting of oxygen patients who begin coverage with an arterial blood gas result at or above a partial pressure of 55 or an arterial oxygen saturation percentage at or above 89. (See the Medicare Claims Processing Manual, Chapter 20, "Durable Medical Equipment, Prosthetics and Orthotics, and Supplies (DMEPOS)," for certification and retesting schedules.) Laboratory Evidence Initial claims for oxygen therapy must also include the results of a blood gas study that has been ordered and evaluated by the attending physician. This is usually in the form of a measurement of the partial pressure of oxygen (PO 2) in arterial blood. (See Medicare Carriers Manual, Part 3, for instructions on clinical laboratory tests.) A measurement of arterial oxygen saturation obtained by ear or pulse oximetry, however, is also acceptable when ordered and evaluated by the attending physician and performed under his or her supervision or when performed by a qualified provider or supplier of laboratory services. When the arterial blood gas and the oximetry studies are both used to document the need for home oxygen therapy and the results are conflicting, the arterial blood gas study is the preferred source of documenting medical need. There is also a LCD for specific areas on PULSE OXIMETRY (L28296). However, there is very little information on the use of home therapy as noted below: In outpatient or HOME management for patients with chronic cardiopulmonary problems, PULSE OXIMETRY determinations once or twice a year are considered reasonable. In all instances, there must be a documented request by a physician/nonphysician provider in the medical record for these services. Regular or routine testing will not be allowed for reimbursement. In all circumstances, testing would be expected to be useful in the continued management of a patient particularly in acute exacerbations or unstable conditions (e.g., acute bronchitis in a patient with COPD) where increased frequency of testing would be considered for coverage purposes. Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review. Scientific Rationale Initial Hypoxemia is defined as insufficient oxygenation of the blood. Pulse oximetry is a simple, transcutaneous, non-invasive method of measuring and monitoring the percentage of hemoglobin (Hb) which is saturated with oxygen, that is, the amount of oxygen dissolved in the arterial blood. The pulse oximeter is a small lightweight device that has to be in contact with the skin to detect the oxygen saturation. The device is usually placed on the patient's finger, earlobe, toe or nose and is linked to a computerized unit having a digital screen where the arterial saturation is constantly displayed graphically. Pulse oximetry provides estimates of arterial oxyhemoglobin Pulse Oximetry for Home Use in Adults and Children Aug 17 5

6 saturation (SaO2) by utilizing selected wavelengths of light (light-absorbance) directed through the body tissue to determine the saturation of oxyhemoglobin (SpO2). The pulsating arterial blood in the tissue absorbs some of the light, causing small variation in detected light. A detector then measures the absorption and provides a measurement of arterial oxygen saturation. In addition, the unit has an audible signal for each pulse beat, a calculated heart rate and in some models, a graphical display of the blood flow past the probe. The alarms usually respond to a slow or fast pulse rate or an oxygen saturation below 90%. At this level there is a marked fall in PaO2 representing serious hypoxia. A pulse oximeter has wide applications. Pulse oximetry is used in a variety of settings, including hospitals, clinics, physician offices and homes to monitor patients with compromised respiratory status. For patients who are homebound, trained home health personnel can use oximeters to measure the oxygen saturation in patients with certain unstable illnesses who have compromised or potentially compromised, respiratory status and report to the physician, who then can make adjustments in the oxygen therapy prescription. Continuous pulse oximetry is used routinely in operating rooms, recovery rooms and is also widely used in certain facility settings such as intensive care units and other settings where detection of hypoxemia is important. In many settings it has replaced the use of arterial blood gas analysis to diagnose hypoxemia. Indications include: (1) the need to monitor and manage the adequacy of arterial oxyhemoglobin saturation (e.g., patients on ventilator support); (2) the need to quantitate the response of arterial oxyhemoglobin saturation to therapeutic intervention; and (3) its use by various health care personnel as an assessment tool. No matter for what it is used for, it is important to note that an oximeter reading alone cannot rule out disease or dictate intervention, and must be interpreted in association with the patient's existing pulmonary function. Because it does not assess ventilation, over-reliance on pulse oximetry may delay detection of clinically significant hypoxemia. After agreement has been initially established between SaO2 and SpO2, the frequency of SpO2 monitoring (i.e., continuous vs intermittent) depends on the clinical status of the patient and the indications for performing the procedure. A discrepancy between the SpO2 level and the patient's clinical course should always prompt a direct measurement of SaO2 by arterial blood gas samples to properly assess the clinical state. It also should be recognized that in individuals receiving supplemental oxygen at high FiO2 and showing a high SpO2 (99%-100%), there can be a dramatic decrease in PaO2 before a corresponding decrease in oxygen saturation is manifested due to the shape of the oxygen-hb dissociation curve. In other words, an individual can show high oxygen saturation but really be hypoxic by real oxygen levels in relation to other components of the arterial blood gas evaluation. PaO2 can fall to 60 mm Hg with hemoglobin still over 90% saturated. But with a drop from 60 to 40 mm Hg, saturation falls steeply to below 75%. Clinically this relationship explains a fundamental goal in treating hypoxemia, that is, get the PaO2 above 60 mm Hg (the flat portion of the curve). A value of greater than 60 mm Hg usually indicates mild hypoxemia, mm Hg is moderate, and below 45 mm Hg is severe. Pulse oximetry is considered a safe procedure, but because of device limitations, false-negative results for hypoxemia and/or false-positive results for normoxemia or hyperoxemia may lead to inappropriate treatment of the patient. There are many factors, which may limit the true value of this device and hamper the accuracy of its Pulse Oximetry for Home Use in Adults and Children Aug 17 6

7 results. Oximeters are not able to accurately measure levels of oxygen saturation below 80 percent. The oximeter may give inaccurate and erroneous results because of low perfusion rate or low signal strength, excessive motion, intravascular dyes, skin pigmentation, nail polish or nail coverings, elevated dyshemoglobin levels, electromagnetic interference, and exposure to ambient light. In addition, tissue injury may occur at the measuring site as a result of probe misuse (e.g., pressure sores from prolonged application or electrical shock and burns from the substitution of incompatible probes between instruments). Home overnight pulse oximetry has been used to evaluate nocturnal desaturation in patients with chronic obstructive pulmonary diseases (COPD). However, Lewis et al (2003) found that nocturnal desaturation in patients with COPD exhibited marked night-to-night variability when measured by home oximetry. Intermittent or shortterm pulse oximetry readings are also routinely used in the home for patients on long-term oxygen therapy. Fussell et al (2003) performed a prospective cohort study with 20 patients with COPD for purpose of comparing the standard method with ambulatory oximetry monitoring. The authors noted that the study supports the hypothesis that there is a poor relationship between results of conventional methods and results from continuous ambulatory oximetry, but that additional studies are needed to determine if the prescription of oxygen based on continuous ambulatory oximetry can result in the desired oxygen saturation range in a higher percent of time. Gay (2004) reviewed COPD and sleep and noted that: that there is no universal agreement as to how and when COPD patients should be evaluated for nocturnal hypoxemia, because it is controversial what level of nocturnal hypoxemia merits treatment, who should be treated, and how aggressively to follow it. The American College of Physicians Chronic Obstructive Pulmonary Disease Guideline Algorithm states that there is no evidence for using pulse oximetry to diagnose or gauge the severity of acute exacerbations of COPD. After all, chronic obstructive pulmonary disease, by definition, involves pulmonary damage that usually includes impaired gas exchange. We can, therefore, expect lower baseline readings in many individuals who have chronic cardiopulmonary disease. Also, pulse oximetry doesn't measure acid-base balance or carbon dioxide retention. If a hypoxic individual also retains CO2, administering too much oxygen can worsen the situation by reducing the respiratory drive and increasing CO2 retention; therefore, excessive reliance on pulse oximetry results can be problematic. The guideline recommends to always use pulse oximetry judiciously. Don't draw conclusions about a patient's condition or the urgency of a situation based pulse oximetry alone. Instead, combine oxygen saturation results with a patient exam and thorough patient history, and an arterial blood gas, if necessary. A 1995 National Heart, Lung and Blood Institute/World Health Organization Global Asthma Initiative Report concluded that pulse oximetry is not an appropriate method of monitoring patients with asthma. The report explained that, during asthma exacerbations, the degree of hypoxemia may not accurately reflect the underlying degree of ventilation-perfusion mismatch. The available studies in the peer-reviewed literature have demonstrated that portable monitoring based on oximetry alone is not an efficient method of screening or diagnosing patients with suspected obstructive sleep apnea. The sensitivity and negative predictive value of pulse oximetry is not adequate to rule out obstructive sleep apnea in patients with mild to moderate symptoms. Therefore, a follow up sleep study would be required to confirm Pulse Oximetry for Home Use in Adults and Children Aug 17 7

8 or exclude the diagnosis of obstructive sleep apnea, regardless of the results of pulse oximetry screening. As a screening tool for the diagnosis of sleep apnea, oximetry sensitivity and specificity remain controversial and deserve further clarification through controlled studies. Netzer et al. (2001) performed a review of the literature for use of overnight pulse oximetry for sleep-disordered breathing in adults. The authors note that limitations of pulse oximetry for this use include the inability of the technology to detect other forms of sleep-disordered breathing where oxygen desaturation does not occur such as upper airway resistance syndrome or pure central sleep apnea. The authors conclude that the sensitivity and specificity of pulse oximetry for this use are controversial and need further clarification through controlled studies. Wiltshire et al (2001) performed a case study of 100 patients with suspected sleep apnea hypopnea syndrome (SAHS) for the purpose of comparing pulse oximeters used in the home with laboratory on-line recording. It was concluded by the authors that home studies using memory shortage pulse oximeters may underestimate the number of hypoxic dips and therefore clinically significant hypoxic SAHS may be missed. Technical limitations, limited user knowledge, and the lack of consensus on interpretation of data all play a role in diminishing the value of pulse oximetry as a diagnostic tool. Pulse oximetry will also not identify patients suffering from Upper Airway Resistance Syndrome. A 2003 review by the American Academy of Sleep Medicine, the American College of Chest Physicians and the American Thoracic Society states that the utility of oximetry alone is not well established in the attended or unattended setting. Gay (2004) stated that for COPD patients who exhibit more profound daytime hypercapnia, polysomnography is preferred over nocturnal pulse oximetry to rule out other co-existing sleep-related breathing disorders such as obstructive sleep apnea (overlap syndrome) and obesity hypoventilation syndrome. Review History April 2006 November 2006 November 2010 September 2011 August 2012 August 2013 August 2014 August 2015 August 2016 August 2017 Medical Advisory Council initial approval Revised added as also applies to children Added Medicare Table with link to NCD and LCD which contains minimal information regarding Home Pulse Oximetry. Information from NCD and LCD noted in Scientific Rationale. No revisions. Update. Added Revised Medicare Table with links to NCD, LCD, articles, etc. No Revisions. Update no revisions Update - no revisions. Codes updated. Update no revisions. Codes updated. Update no revisions. Codes updated. Update no revisions Update no revisions This policy is based on the following evidence-based guidelines: 1. American Association for Respiratory Care (AARC) Clinical Practice Guideline. Pulse Oximetry. Respir Care 1991;36: No authors listed. AARC clinical practice guideline. Oxygen therapy in the home or extended care facility. American Association for Respiratory Care. Respir Care. 1992;37(8): Pulse Oximetry for Home Use in Adults and Children Aug 17 8

9 3. Netzer N, et al. Overnight Pulse Oximetry for Sleep-Disordered Breathing in Adults. Chest. 2001;120: References Update August Welsh EJ, Carr R. Pulse oximeters to self monitor oxygen saturation levels as part of a personalized asthma action plan for people with asthma. Cochrane Database Syst Rev Sep 27;(9):CD References Update August Ross PA, Newth CJ, Khemani RG. Accuracy of pulse oximetry in children. Pediatrics Jan;133(1):22-9. Epub 2013 Dec 16. References Update August Collop N. Out-of-center sleep testing in obstructive sleep apnea in adults. UpToDate. May 21, Mechem CC. Pulse Oximetry. UpToDate. January 5, Pedersen T, Dyrlund Pedersen B, Møller AM. Pulse oximetry for perioperative monitoring. Cochrane Database Syst Rev Updated August 4, References Update August Bach JR. Continuous noninvasive ventilatory support for patients with neuromuscular or chest wall disease. UpToDate. February Bauman KA, Kurili A, Schmidt SL, et al. Home-based overnight transcutaneous capnography/pulse oximetry for diagnosing nocturnal hypoventilation associated with neuromuscular disorders. Arch Phys Med Rehabil. 2013;94 (1): Epstein SK. Respiratory muscle weakness due to neuromuscular disease: Clinical manifestations and evaluation and Management. UpToDate. February Hill NS, Kramer NR. Types of noninvasive nocturnal ventilatory support in neuromuscular and chest wall disease. UpToDate. February References Update August Chung F, Liao P, Elsaid H, et al. Oxygen desaturation index from nocturnal oximetry: a sensitive and specific tool to detect sleep-disordered breathing in surgical patients. Anesth Analg May;114(5): Epub 2012 Feb Nardi J, Prigent H, Adala A, et al. Nocturnal Oximetry and Transcutaneous Carbon Dioxide in Home-Ventilated Neuromuscular Patients. Respir Care Feb 17. References - Update September Fernández R, Rubinos G, Cabrera C, et al. Nocturnal Home Pulse Oximetry: Variability and Clinical Implications in Home Mechanical Ventilation. Respiration Jan 6. [Epub ahead of print] 2. Hardisty A, Primhak R. The interpretation of overnight oximetry tracings. Arch Dis Child Mar;96(3):322. Epub 2010 Nov Mason DG, Iyer K, Terrill PI, et al. Pediatric obstructive sleep apnea assessment using pulse oximetry and dual RIP bands. Conf Proc IEEE Eng Med Biol Soc. 2010;2010: References - Update November Gélinas JF, Davis GM, Arlegui C, et al. Prolonged, documented home-monitoring of oxygenation in infants and children. Pediatr Pulmonol. 2008;43(3): Pulse Oximetry for Home Use in Adults and Children Aug 17 9

10 2. Nassi N, Piumelli R, Lombardi E, et al. Comparison between pulse oximetry and transthoracic impedance alarm traces during home monitoring. Arch Dis Child. 2008;93(2): CMS Centers for Medicare & Medicaid. Local Coverage Determination (NCD) for Home Use of Oxygen (240.2). 4. CMS Centers for Medicare & Medicaid. Local Coverage Determination (LCD) for Pulse Oximetry (L28296). Palmetto GBA. (Northern California). 5. CMS Centers for Medicare & Medicaid. Local Coverage Determination (LCD) for Pulse Oximetry (L28296). Palmetto GBA. (Southern California). 6. CMS Centers for Medicare & Medicaid. Article for PULSE OXIMETRY Supplemental Instructions Article (A49272). (Southern California). 7. CMS Centers for Medicare & Medicaid. Article for PULSE OXIMETRY Supplemental Instructions Article (A49272). (Northern California). References Initial 1. Karnani NG, Reisfield GM, Wilson GR. Evaluation of chronic dyspnea. Am Fam Physician Apr 15;71(8): Welch J. Pulse oximeters. Biomed Instrum Technol Mar-Apr;39(2): Whitelaw WA, Brant RF, Flemons WW. Clinical usefulness of home oximetry compared with polysomnography for assessment of sleep apnea. Am J Respir Crit Care Med. 2005;171(2): Allen K. Principles and limitations of pulse oximetry in patient monitoring. Nurs Times Oct 12-18;100(41): Gay PC. Chronic obstructive pulmonary disease and sleep. Respir Care. 2004;49(1):39-51; discussion Lewis CA, Eaton TE, Fergusson W, et al. Home overnight pulse oximetry in patients with COPD: More than one recording may be needed. Chest. 2003;123(4): Valentine VG, Taylor DE, Dhillon GS, et al. Success of lung transplantation without surveillance bronchoscopy. J Heart Lung Transplant. 2002;21(3): Wiltshire N, Kendrick AH, Catterall JR. Home oximetry studies for diagnosis of sleep apnea/hypopnea syndrome: limitation of memory storage capabilities. Chest Aug;120(2): Snow V, et al. Evidence base for management of acute exacerbations of chronic obstructive pulmonary disease. Ann Intern Med 2001 Apr;134(7): Golpe R, Jimenez A, Carpizo R, et al. Utility of home oximetry as a screening test for patients with moderate to severe symptoms of obstructive sleep apnea. Sleep. 1999;22(7): Carone M, Patessio A, Appendini L, et al. Comparison of invasive and noninvasive saturation monitoring in prescribing oxygen during exercise in COPD patients. Eur Respir J. 1997; 10(2): National Heart, Lung and Blood Institute (NHLBI) and World Health Organization (WHO). Global Strategy for Asthma Management and Prevention NHLBI/WHO Workshop (based on a March 1993 meeting). Publication Number Bethesda, MD: National Institutes of Health; January Ferber R, Millman R, Coppola M, et al. Portable recording in the assessment of obstructive sleep apnea. ASDA Standards of Practice. Sleep. 1994;17: Series F, Marc I, Cormier Y, et al. Utility of nocturnal home oximetry for case finding in patients with suspected sleep apnea hypopnea syndrome. Ann Int Med. 1993;119: Schnapp LM, Cohen NH. Pulse oximetry-uses and abuses. Chest 1990;98: Pulse Oximetry for Home Use in Adults and Children Aug 17 10

11 16. Welch JP, DeCesare MS, Hess D. Pulse oximetry: instrumentation and clinical applications. Respir Care 1990;35: Jubran, A Tobin MJ. Reliability of pulse oximetry in titrating supplemental oxygen therapy in ventilator-dependent patients. Chest 1990;97: Cahan C, Decker MJ, Hoekle PL, Strohl KP. Agreement between noninvasive oximetric values for oxygen saturation. Chest 1990;97: Severinghaus JW, Naifeh KH, Koh SO. Errors in 14 pulse oximeters during profound hypoxia. J Clin Monit 1989;5: Huch A, Huch R, Konig V, Neuman MR, Parker D, Yount J, Lubbers D. Limitations of pulse oximetry. Lancet 1988;1: King T, Simon RH. Pulse oximetry for tapering supplemental oxygen in hospitalized patients: evaluation of a protocol. Chest 1987;92: Farney RJ, Walker LE, Jensen RL, et al. Ear oximetry to detect apnea and differentiate rapid eye movement (REM) and non-rem sleep. Screening for the sleep apnea syndrome. Chest. 1986;89: Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. Pulse Oximetry for Home Use in Adults and Children Aug 17 11

12 The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Pulse Oximetry for Home Use in Adults and Children Aug 17 12