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Medical Policy

Policy Num:       02.005.003
Policy Name:     OXIMETRY
Policy ID:          [02.005.003]    [Ar / L / M+/ P ]          [0.00.00]

Last Review:      January 31, 2020
Next Review:      Archive
Issue:                   1:2020

Related Policies: NONE

ARCHIVE

OXIMETRY

Summary

Pulse oximetry is a non-invasive way to measure oxygen levels in the blood. It may be used in a home, office or medical facility setting to monitor the health of people with certain medical conditions that can affect their blood oxygen levels. A pulse oximeter is a device that attaches to the fingertip or earlobe and uses wavelengths of light to measure blood oxygen levels and heart rate. Continuous pulse oximetry measures oxygen levels for longer periods of time (1 hour or more).

Pulse oximetry provides estimates of arterial oxyhemoglobin saturation (SaO2) by utilizing selected wavelengths of light to noninvasively determine the saturation of oxyhemoglobin (SpO₂). An oximeter can be used to monitor and manage patients who require ventilator support, and patients with chronic lung disease (e.g. bronchopulmonary dysplasia, chronic obstructive pulmonary disease). An oximeter is also used by various health care personnel as an assessment tool.

Objective

The objective of this evidence review is to evaluate the medical use of pulse oximetry in diferent dettings.

Policy Statements

Oximetry is considered for payment when:

It is performed at the physician’s office or at the patient’s home for the following conditions:

-    Failure to Thrive
-    Cardiac Congestive Failure
-    Lung Fibroquistic Disease
-    Asthmatic state
-    Bronchiectasia
-    Alveolitis
-    Chronic Obstructive Asthma
-    Patients using oxygen at home

Oximetry is not considered for payment when:

1.    It is performed at an ambulatory surgery facility or in a hospital because they are included in their per diem.

2.    It is used under supervision for intravenous sedation at the office.

3.    Used with surgical procedures classified as Type 2 and is performed in the office, for it is considered a necessary element or factor to perform the procedure.

The values obtained must be documented in the clinical file. Other obstructive condition will be evaluated on its merit for payment.
 

Policy Guidelines

• Home pulse oximetry may be considered medically appropriate for ANY ONE of the following:

• • Long term (years) oxygenation monitoring using home pulse oximetry for ANY ONE of the following:

  • • Diagnosis of a chronic condition that may impair ventilation (e.g. neuromuscular disease such as Duchenne muscular dystrophy or spinal muscular atrophy, airway anomalies such as congenital subglottic stenosis, tracheal malformations, or Pierre Robin, lung disease/disorders of infancy such as bronchopulmonary dysplasia or barotrauma from mechanical ventilation)

    • Ventilator dependent individual

  • Short term (months) oxygenation monitoring using home pulse oximetry may be indicated for ANY ONE of the following:

  • • Diagnosis of acute respiratory condition with documented oxygen desaturation when the use of home pulse  oximetry will guide home oxygen management (e.g., Apnea of Prematurity, polycythemia, failure to thrive, exacerbations of COPD)

    • Changes in individual’s condition that requires adjustment of home oxygen therapy (e.g. hypoplastic left heart, post-operative heart surgery such as the Norwood procedure, COPD with resting hypoxemia)

    • Home supplemental oxygen therapy assessments are needed during ambulation, exercise and/or sleep (e.g. Cystic Fibrosis, spinal muscular atrophy, use of nighttime home noninvasive ventilation)

    • Weaning individual from home oxygen therapy

Benefit Application

BlueCard/National Account Issues

Background

Pulse Oximetry provides estimates of arterial oxyhemoglobin saturation (SaO2) by utilizing selected wavelengths of light to noninvasively determine the saturation of oxyhemoglobin. It is used to both measure and monitor blood oxygen saturation.

For patients with chronic stable cardiopulmonary problems oximetric determinations are usually not necessary more frequently than once or twice a year unless it is needed to document an acute exacerbation of chronic pulmonary disease or unstable conditions, or acute illnesses with signs indicating or suggesting increased hypoxemia.

A provider requesting long term use of pulse oximetry for a patient must provide the patient’s clinical history which will be reviewed on a case by case basis. There must be, either in the clinical notes or in a separate letter, the medical reason(s) for requesting the long term use.

In a retrospective case‐series study, Bauman et al (2013) determined the utility of home‐based, unsupervised transcutaneous partial pressure of carbon dioxide (tc‐Pco(2)) monitoring/oxygen saturation by pulse oximetry (Spo(2)) for detecting nocturnal hypoventilation (NH) in individuals with neuromuscular disorders. Subjects (n = 35, 68.6 % men; mean age of 46.9 yrs) with spinal cord injury (45.7 %) or other neuromuscular disorders underwent overnight tests with tc‐Pco(2)/Spo(2) monitoring. Fifteen (42.9 %) were using nocturnal ventilatory support, either bilevel positive airway pressure (BiPAP) or tracheostomy ventilation (TV). A respiratory therapist brought a calibrated tc‐Pco(2)/Spo(2) monitor to the patient's home and provided instructions for data collection during the subject's normal sleep period. Forced vital capacity (FVC), body mass index (BMI), and exhaled end‐tidal Pco(2) (ET‐Pco(2)) were recorded at a clinic visit before monitoring. Main outcome measure was detection of NH (tc‐Pco(2) greater than or equal to 50 mmHg for greater than or equal to 5 % of monitoring time). Data were also analyzed to determine whether nocturnal oxygen desaturation (Spo(2) less than or equal to 88 % for greater than or equal to 5 % of monitoring time), FVC, BMI, or daytime ET‐Pco(2) could predict the presence of NH. Nocturnal hypoventilation was detected in 18 subjects (51.4 %), including 53.3 % of those using BiPAP or TV. Nocturnal hypoventilation was detected in 43.8 % of ventilator‐independent subjects with normal daytime ET‐Pco(2) (present for 49.4 % +/‐ 31.5 % [mean +/‐ SD] of the study period), and in 75 % of subjects with an elevated daytime ET‐Pco(2) (present for 92.3 % +/‐ 8.7 % of the study period). Oxygen desaturation, BMI, and FVC were poor predictors of NH. Only 3 attempted monitoring studies failed to produce acceptable results. The authors concluded that home‐based, unsupervised monitoring with tc‐Pco(2)/Spo(2) is a useful method for diagnosing NH in neuromuscular respiratory failure (NMRF). The findings of this small retrospective case‐series study need to be validated by well‐designed studies.

Nardi et al (2012) noted that pulse oximetry alone has been suggested to determine which patients on home mechanical ventilation (MV) require further investigation of nocturnal gas exchange. In patients with neuromuscular diseases, alveolar hypoventilation (AH) is rarely accompanied with ventilation‐ perfusion ratio heterogeneity, and, therefore, oximetry may be less sensitive for detecting AH than in patients with lung disease. These investigators examined if Spo(2) and tc‐Pco(2) during the same night were interchangeable or complementary for assessing home MV efficiency in patients with neuromuscular diseases. Data were collected retrospectively from the charts of 58 patients with chronic NMRF receiving follow‐up at a home MV unit. Spo(2) and tc‐Pco(2) were recorded during a 1‐night hospital stay as part of standard patient care. These researchers compared AH detection rates by tc‐Pco(2), Spo(2), and both. Alveolar hypoventilation was detected based on tc‐Pco(2) alone in 24 (41 %) patients, and based on Spo(2) alone with 3 different cut‐offs in 3 (5 %), 8 (14 %), and 13 (22 %) patients, respectively. Using both tc‐Pco(2) and Spo(2) showed AH in 25 (43 %) patients. The authors concluded that pulse oximetry alone is not sufficient to exclude AH when assessing home MV efficiency in patients with neuromuscular diseases. Both tc‐Pco(2) and Spo(2) should be recorded overnight as the first‐line investigation in this population.

Also, UpToDate reviews on "Respiratory muscle weakness due to neuromuscular disease: Clinical manifestations and evaluation" (Epstein, 2013a); "Respiratory muscle weakness due to neuromuscular disease: Management" (Epstein, 2013b); "Continuous noninvasive ventilatory support for patients with neuromuscular or chest wall disease" (Bach, 2013), and "Types of noninvasive nocturnal ventilatory support in neuromuscular and chest wall disease" (Hill and Kramer, 2013) do not mention the use of home pulse oximetry. Studies have demonstrated improvements in survival of infants undergoing the Norwood procedure for hypoplastic left heart syndrome with interstage monitoring with home pulse oximetry (Ghanayem et al, 2003; Dobrolet et al, 2011; Hansen et al, 2012). In a feasibility study, Cross et al (2012) noted that strategies to reduce inter‐stage morbidity and mortality for patients with single ventricle following stage I palliation included standardized care protocols, focused high‐risk outpatient clinics, dedicated teams that focus on the unique needs of these fragile patients and use of home surveillance monitoring. Use of telemedicine  devices for home monitoring has been shown to improve outcomes in adults. These devices allow for a more automated approach to home monitoring that have many advantages. These researchers described their program that utilizes a web‐based telemedicine device to capture and transmit data from the homes of their patients during the inter‐stage period. The authors stated that their early data suggested that home telemedicine is feasible, provides a more systematic data review and analysis and supports the assertion that patients using home surveillance have significantly better nutritional status than those not using home monitoring.

Ohman et al (2013) stated that shunt occlusion is a major cause of death in children with single ventricle. These investigators evaluated whether one daily measurement of oxygen saturation at home could detect life‐threatening shunt dysfunction. A total of 28 infants were included in this study. Parents were instructed to measure saturation once‐daily and if less than or equal to 70 % repeat the measurement. Home monitoring was defined as positive when a patient was admitted to Queen Silvia Children's Hospital because of saturation less than or equal to 70 % on repeated measurement at home. A shunt complication was defined as arterial desaturation and a narrowing of the shunt that resulted in an intervention to relieve the obstruction or in death. Parents' attitude towards the method was investigated using a questionnaire. A shunt complication occurred out of hospital 8 times in 8 patients. Home monitoring was positive in 5 out of 8 patients. In 2 patients, home monitoring was probably life‐saving; in 1 of them, the shunt was replaced the same day and the other had an emergency balloon dilatation of the shunt. In 3 out of 8 patients, home monitoring was negative; 1 had an earlier stage II and survived, but 2 died suddenly at home from thrombotic shunt occlusion. On 7 occasions in 3 patients, home monitoring was positive but there was no shunt complication. The method was well accepted by the parents according to the results of the questionnaire. The authors concluded that home monitoring of oxygen saturation has the potential to detect some of the life‐threatening shunt obstructions between stages I and II in infants with single‐ventricle physiology.

Also, an UpToDate review on “Management and outcome of heterotaxy (isomerism of the atrial appendages)” (Lowental et al, 2014) states that “Single ventricle physiology is predominant in RAI [right atrial isomerism], as patients usually have a hypoplastic left ventricle. These patients also typically have asplenia, as the spleen is a left side abdominal organ. In general, patients with RAI most often present during the neonatal period with cyanosis due to right‐to‐left shunting as a result of pulmonary outflow obstruction and septal defects between the atria and ventricles. In severely affected neonates, survival is dependent on maintaining a patent ductus arteriosus. In other cases, respiratory distress may develop because of pulmonary congestion due to pulmonary venous obstruction …. Single ventricle palliation ‐‐ Similar to other univentricular conditions, palliative management beginning in the neonate generally consists of a series of staged procedures, which vary with the underlying lesions …. Initial neonatal shunting ‐‐ Follow‐up visits are frequent for neonates who undergo palliative shunting to secure either pulmonary blood flow or systemic blood flow. At each visit, the clinical status is evaluated with a focus on the adequacy of oxygen saturation and somatic growth. As many of these single ventricle patients have ventricular overload and abnormal atrioventricular valves, surveillance echocardiograms are performed on a monthly basis to monitor for the development of atrioventricular insufficiency”. Moreover, this review does not mention the use of home pulse oximetry as a management tool.

In a Cochrane review, Welsh et al (2015) examined if pulse oximeters used as part of a personalized asthma action plan for people with asthma are safer and more effective than a personalized asthma action plan alone. These investigators searched the Cochrane Airways Group Specialised Register (CAGR), which includes reports identified through systematic searches of bibliographic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED) and PsycINFO, and by hand‐searching. They also searched ClinicalTrials.gov and the World Health   Organization (WHO) trials portal. These researchers planned to include randomized controlled trials (RCTs). Participants would have included adults, children or both with a diagnosis of asthma. They planned to include trials in which investigators compared participants who used pulse oximeters to monitor oxygen levels at home during an asthma exacerbation as part of a personalized asthma action plan (PAAP) versus those who used a PAAP without a pulse oximeter. They planned to include studies involving people receiving any treatment regimen provided that no medicine was included as part of the randomization schedule. The authors planned to use standard methods as recommended by The Cochrane Collaboration. They found no studies and no evidence to support or refute the use of home pulse oximetry in self‐management of asthma; thus, they could not make any recommendations about use of a pulse oximeter as part of a PAAP. The authors concluded that they found no reliable data to support or refute patient use of pulse oximeters to monitor oxygen saturation levels when experiencing an asthma attack. They stated that individuals should not use a pulse oximeter without seeking advice from a qualified healthcare professional. They identified no compelling rationale for home monitoring of oxygen levels in isolation for most people with asthma. Some people have a reduced perception of the severity of their own breathlessness when exposed to hypoxia. If trials on self‐monitoring of oxygen levels in the blood by pulse oximeter at home by people with asthma are conducted, the pulse oximeter must be given as part of a personalized asthma action plan.

Predicting the Need of Adenotonsillectomy in Children: Pavone and colleagues (20170 stated that nocturnal pulse oximetry has a high positive predictive value for polysomnographically diagnosed OSA in children. When significant adenotonsillar hypertrophy is diagnosed, adenotonsillectomy (T&A) represents a common treatment for OSA in children. These investigators examined the role of pulse oximetry in predicting those patients, referred for suspected OSA, who subsequently needed T&A. At‐home nocturnal pulse oximetry was performed on 380 children (65.7 % males), median age of 4.1 (IRQ 3.0 to 5.6) years, referred for suspected OSA, and data were retrospectively analyzed. For each recording McGill Oximetry Score (MOS) was categorized. Mean pulse rate (PR) z‐score and pulse rate variability (PRV)‐corrected (PRSD/mean PR) were significantly higher in children with abnormal MOS. Both parameters were significantly higher in subjects who underwent T&A compared with those not surgically treated. Both DI4 and PRV corrected showed a negative correlation with the elapsed time between pulse oximetry recordings and T&A. The logistic regression model showed a strong effect of an abnormal MOS as a predicting factor for T&A (adjusted odds ratio [OR] of 19.7). The authors concluded that children with OSA who subsequently needed T&A showed higher PRV compared to those without surgical indication. Children with abnormal MOS were nearly 20 times more likely to undergo T&A. They stated that nocturnal pulse oximetry had a high positive predictive value for polysomnographically diagnosed OSA in children. When significant adenotonsillar hypertrophy is diagnosed, adenotonsillectomy represents a common treatment for OSA in children. Moreover, they noted that an abnormal pulse oximetry highly predicted the indication for adenotonsillectomy. They suggested that the use of at‐home pulse oximetry as a method to predict prescription of adenotonsillectomy, and this may be useful in contexts where polysomnography is not readily available.

Regulatory Status

Peripheral pulse oximeters are one of the most widely used medical monitoring technologies. Although the Food and Drug Administration (FDA) considers all pulse oximeters to be prescription medical devices, most sold in drugstores or on the Internet are specifically labeled “not for medical use” and were not reviewed by FDA for accuracy.^1,2 Their package inserts indicate the intended use is for “sports and aviation”³ or “wellness.”⁴ In contrast, “medical use” (MU) pulse oximeters are only labeled as such after rigorous testing on human volunteers and review by FDA.¹ Laboratory-based research has found nonmedical use (NMU) pulse oximeters to be inaccurate when oxygen saturation is low.⁵ Unfortunately, most consumers, even physicians, do not read the package insert and assume all pulse oximeters are intended for medical use and have been reviewed for accuracy.

Rationale

Pulse oximetry is indicated in any clinical setting where hypoxemia may occur. These settings include patient monitoring in emergency departments, operating rooms, emergency medical services (EMS) systems, postoperative recovery areas, endoscopy suites, sleep and exercise laboratories, oral surgery suites, cardiac catheterization suites, facilities that perform conscious sedation, labor and delivery wards, inter-facility patient transfer units, altitude facilities, aerospace medicine facilities, and patients' homes.

Despite its widespread use, the value of oximetry has been poorly studied with no trials showing a convincing benefit on clinically meaningful outcome (eg, mortality, myocardial infarction, resource allocation [29]). Nonetheless, examples where routine use of pulse oximetry has some value include the following:

●In a pediatric intensive care unit (ICU), using pulse oximetry decreases the number of blood gases obtained and limits the duration of oxygen therapy, without jeopardizing patient outcome.

●In emergency departments, initial pulse oximetry readings in children with asthma exacerbations are predictive of the need for hospitalization. Several studies have shown that use of pulse oximetry also reduces the number of arterial blood gases obtained in the intensive care unit and emergency department [.

●In postoperative patients, routine pulse oximetry has been shown to decrease the need for rapid response team activation and transfer to the ICU [48]. In a randomized trial of 20,000 perioperative patients pulse oximetry use was associated with lower rates of hypoxemia when compared with patients in whom oximetry was not used (0.4 versus 8 percent).

●In newborns, pulse oximetry has value as a routine outpatient screen for congenital heart disease.

Home overnight pulse oximetry (OPO) 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 OPO. A single home OPO recording may be insufficient for accurate assessment of nocturnal desaturation. 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 OSA (overlap syndrome) and obesity hypoventilation syndrome.

Population Reference No. 1 Policy Statement

Home pulse oximetry, is considered medically necessary if the medical appropriateness criteria are met as stated in policy statement.

Supplemental Information

The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices.

In the guidance, published March 4, 2-13 the FDA specified new rules for identifying, testing and assuring safety for the systems. The new document overrides the 1992 guidance on the same category. The FDA’s goal is to help device companies prepare their premarket notifications, or 510(k)s, for any pulse oximeter.

A pulse oximeter is any device that uses radiation wavelengths through skin and blood to determine pulse and blood oxygen levels, sometimes with a fiberoptic catheter.

The federal watchdog agency recommended that companies identify their devices with a regulation number and product code. The company should also include the specific intended use for the device and the basic device design, including drawings and a thorough comparison to other similar devices on the market.

In regards to testing, the FDA document says that companies must test for accuracy, must conduct equivalent performance in group testing and must report wether the test incorporates original equipment manufacturer cleared technology. If the company modifies the device significantly, it will have to submit a new 510(k). "Significant" modifications include electrical sensor modifications or changes to the algorithms in the software.

Additionally, the document includes rules for biocompatibility (testing the toxicity of materials in the device that will be exposed to the skin) and sterilization procedures.

Practice Guidelines and Position Statements

A National Heart, Lung and Blood Institute/World Health Organization Global Asthma Initiative Report concluded that pulse oximetry was 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 (V‐Q) mismatch. Pulse oximetry alone is not an efficient method of screening or diagnosing patients with suspected obstructive sleep apnea (OSA). The sensitivity and negative predictive value of pulse oximetry is not adequate to rule out OSA in patients with mild to moderate symptoms. Therefore, a follow‐up sleep study would be required to confirm or exclude the diagnosis of OSA, regardless of the results of pulse oximetry screening.

Medicare National Coverage

Medicare coverage of home oxygen and oxygen equipment under the durable medical equipment (DME) benefit (see §1861(s)(6) of the Social Security Act) is considered reasonable and necessary only for patients with significant hypoxemia who meet the medical documentation, laboratory evidence, and health conditions specified below. The information below also includes special coverage criteria for portable oxygen systems. Finally, a statement on the absence of coverage of the professional services of a respiratory therapist under the DME benefit is included below.

References

1. Jubran A. Pulse oximetry. Intensive Care Med 2004; 30:2017.

2. Grace RF. Pulse oximetry. Gold standard or false sense of security? Med J Aust 1994; 160:638.

3. Van de Louw A, Cracco C, Cerf C, et al. Accuracy of pulse oximetry in the intensive care unit. Intensive Care Med 2001; 27:1606.

4. Le Bourdellès G, Estagnasié P, Lenoir F, et al. Use of a pulse oximeter in an adult emergency department: impact on the number of arterial blood gas analyses ordered. Chest 1998; 113:1042. Mardirossian G, Schneider RE. Limitations of pulse oximetry. Anesth Prog 1992; 39:194.

5. Centers for Medicare & Medicaid (CMS), National Coverage Determination (NCD) 240.2, Home Use of Oxygen, DME. Retrieved: http://www.cms.gov

6. Lewis, C.A., Eaton, T.E., Fergusson, W., et al. (2003). Home Overnight Pulse Oximetry in Patients with COPD: More Than One Recording May Be Needed. Chest,Vol. 123(4), p.1127-1133

7. Kirk, V.G., Bohn, S.G., Flemons, W.W., et al. (2003). Comparison of Home Oximetry Monitoring with Laboratory Polysomnography in Children. Chest, Vol. 124 (95), p. 1702-1708.

8. American Association for Respiratory Care (AARC). AARC clinical practice guideline. Oxygen therapy in the home or extended care facility. Respir Care. 1992;37(8):918‐922.

9. Nardi J, Prigent H, Adala A, et al. Nocturnal oximetry and transcutaneous carbon dioxide in home‐ventilated neuromuscular patients. Respir Care. 2012;57(9):1425‐1430.

Codes

Appplicable Modifiers

Policy History