Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Pulse Oximetry Devices in the Home Setting

Policy #:05.00.31e

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

A pulse oximetry device, for use in the home setting is considered medically necessary and, therefore, covered for individuals who are on oxygen or being evaluated for oxygen therapy when all of the following criteria are met:
  • The individual has one of the following indications:
    • A chronic respiratory, cardiovascular, or neuromuscular disease affecting the muscles of respiration requiring adjustments in oxygen concentration due to desaturations
    • Individual is being actively weaned from home oxygen therapy
    • Individual has a tracheostomy and/or requires mechanical ventilation requiring adjustments in oxygen concentration due to desaturations
    • Pediatric individuals requiring the monitoring of continuous oxygen saturation and heart rate, with or without oxygen, due to conditions such as, but not limited to congenital heart disease (e.g., transposition of the great arteries, hypoplastic left heart syndrome, pulmonary atresia [with intact septum]), pulmonary hypertension, chronic lung disease (e.g., Broncho-Pulmonary dysplasia), or Respiratory Distress of Newborn.
  • The individual has the physical and cognitive capacity to adjust the oxygen levels according to established guidelines set forth by the prescribing professional provider or a trained caregiver who can adjust the prescribed oxygen concentration.
  • The pulse oximeter requires a prescription by a professional provider

NOT MEDICALLY NECESSARY

All other uses for home pulse oximetry are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury, including the following:
  • Diagnosing sleep apnea
  • Management of obstructive sleep apnea without significant cardiopulmonary co-morbidities including chronic obstructive pulmonary disease (COPD), obesity hypoventilation, and heart failure
  • Asthma management
  • Continuous pulse oximetry use for routine monitoring of an individual whose condition is considered stable

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, pulse oximetry devices in the home setting are covered under the medical benefits of products when the medical necessity criteria listed in the medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for pulse oximetry.

Description

A pulse oximetry device indirectly measures and displays the arterial oxygen saturation levels in the blood through a noninvasive sensor probe that attaches to the ear, finger, toe, or nose. The device determines the relative amount of oxygenated and deoxygenated hemoglobin by measuring light absorbance changes resulting from arterial blood flow pulsations. When arterial oxyhemoglobin saturation (SaO2) is measured noninvasively by pulse oximetry, it is referred to as SpO2. The pulse rate is also measured and recorded in beats per minute, averaged over 5 to 20 seconds.

The American Association of Respiratory Care (AARC) suggests that pulse oximetry may be an adequate assessment of oxygen saturation when the acid-base status and/or partial oxygen tension in arterial blood (PaO2) are not required. The AARC recommends pulse oximetry for individuals who require continuous and prolonged monitoring for signs of hypoxia.

In the home setting a pulse oximetry device is used for individuals who require frequent adjustments in oxygen concentration. It can also be used for individuals that have progressive conditions with frequent fluctuating SpO2 levels (e.g., known or suspected heart disease or other circulatory or lung disorders). To achieve adequate arterial oxygen saturation, oxygen is typically administered by nasal cannula, by mask, or rarely by head box in some infants. Some individuals also require continuous mechanical ventilation. Oxygen therapy is titrated against pulse oximetry to maintain a satisfactory oxygen saturation.

Pulse oximetry is useful in the monitoring and treatment of a wide range of conditions that can affect blood oxygen levels such as chronic obstructive pulmonary disease (COPD), asthma, lung cancer, heart failure, and congenital heart defects. The pulse oximetry device can detect low blood oxygen levels which can assist in the titration of oxygen therapy in both adult and pediatric individuals.

Pulse oximetry may be beneficial for a number of other indications as well. According to The Centers for Disease Control (CDC) and Prevention and the American Heart Association (AHA), there are seven critical congenital heart defects (CCHDs) that can potentially be detected using pulse oximetry screening. Critical congenital heart disease occurs when a infant’s heart does not develop correctly. These defects are pulmonary atresia (with intact septum), tetralogy of Fallot, total anomalous pulmonary venous return, transposition of the great arteries, tricuspid atresia, truncus arteriosus, and hypoplastic left heart syndrome. Infants with one of these CCHDs are at significant risk for disability or death if their heart defect is not diagnosed soon after birth. Since not all newborns will have these symptoms early on, low blood oxygen levels detected by pulse oximetry monitoring can help identify a defect and prevent morbidity and mortality.

Children born with hypoplastic left heart syndrome, a defect which affects the normal blood flow through the heart, undergo a series of surgeries within the first weeks to years of life in order to increase blood flow to the body and bypass the poorly functioning left side of the heart. These children are at risk for serious morbidity, growth failure, and mortality during the high risk time period termed interstage, the time from discharge home after the first-stage hypoplastic left heart syndrome procedure until the second-stage surgical intervention. Studies have demonstrated improvements in survival of infants undergoing the Norwood procedure for hypoplastic left heart syndrome with interstage monitoring with home pulse oximetry.

In 2012, the National Institutes of Health summarized guidelines developed by the National Asthma Education and Prevention Program's expert panel after conducting a systematic review of the scientific literature on asthma care. Pulse oximetry for the management of asthma exacerbation was a recommended measure in the emergency department, however no recommendation about the use of pulse oximetry for self management was made. Education for self management included self-monitoring to assess level of asthma control and recognize signs of worsening asthma (either symptom or peak flow monitoring), taking medications correctly (inhaler technique, use of devices, understanding the difference between long-term control and quick-relief medications), avoiding environmental factors that worsen asthma, and the development of a written asthma action plan.

Cochrane (2015) sought to determine whether pulse oximeters used as part of a personalized asthma action plan (PAAP) for people with asthma are safer and more effective than a personalized asthma action plan alone. The authors found no studies and no evidence to support or refute the use of home pulse oximetry in self-management of asthma, and therefore made no recommendations about use of pulse oximetry as part of a PAAP.

A review by Netzer et al. concluded that overnight pulse oximetry is a very useful tool for the diagnosis of sleep-disordered breathing. However, it was noted that sensitivity and specificity remain controversial and deserve further clarification through controlled studies. 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. In addition, limitations that result from problems with blood flow, hemoglobin, or a lack of change in oxygen saturation were highlighted as they become of major importance in the application of pulse oximetry alone as a screening tool for breathing-disordered sleep.
References


American Association of Respiratory Care (AARC). AARC Clinical Practice Guideline.Pulse Oximetry. Respir Care. 1992;37(8):891-7. Also available on the AARC Web site at:
http://www.rcjournal.com/cpgs/pulsecpg.html. Accessed March 6, 2018.

American Association of Respiratory Care (AARC). AARC Clinical Practice Guideline Oxygen Therapy in the Home or Alternate Site Health Care Facility. 2007 Revision & Update. Available at: http://www.rcjournal.com/cpgs/pdf/08.07.1063.pdf. Accessed March 6, 2018.

Bauman KA, Kurili A, Schmidt SL, Rodriguez GM, Chiodo AE, Sitrin RG. Home-based overnight transcutaneous capnography/pulse oximetry for diagnosing nocturnal hypoventilation associated with neuromuscular disorders. Arch Phys Med Rehabil. 2013;94(1):46-52.

Centers for Disease Control and Prevention (CDC). Facts about critical congential heart defects. [CDC Web site]. 12/22/2015. Available at: https://www.cdc.gov/ncbddd/heartdefects/cchd-facts.html. Accessed March 6, 2018.

Golpe R, Jiménez A, Carpizo R, Cifrian JM. Utility of home oximetry as a screening test for patients with moderate to severe symptoms of obstructive sleep apnea. Sleep. 1999;22(7):932-7.

Hansen JH, Furck AK, Petko C, et al. Use of surveillance criteria reduces interstage mortality after the Norwood operation for hypoplastic left heart syndrome. Eur J Cardiothoracic Surg. 2012;41(5):1013-1018.

McNicholas WT. Diagnosis of obstructive sleep apnea in adults. Proc Am Thorac Soc. 2008;5 (2):154-60. http://www.atsjournals.org/doi/pdf/10.1513/pats.200708-118MG.
Accessed March 6, 2018.

National Heart, Lung, and Blood Institute (NHLBI). Expert panel report 3: Guidelines for the diagnosis and management of asthma (EPR-3). August 2007. [NHLBI Web site].https://www.nhlbi.nih.gov/files/docs/guidelines/asthsumm.pdf. Accessed March 6, 2018.

National Institutes of Health (NIH). Asthma care quick reference. Diagnosing and Managing Asthma. [NIH Web site]. June 2002. Revised September 2012. https://www.nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf. Accessed March 6, 2018.

Netzer N, Eliasson AH, Netzer C, et al. Overnight pulse oximetry for sleep-disordered breathing in adults: A Review. Chest. 2001; 120 (2): 623-33. http://journal.chestnet.org/article/S0012-3692(15)51478-5/fulltext.Accessed March 6, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Dolphin Medical Stand-Alone Pulse Oximeter (model 2100) and accessories. 510(k) summary. [FDA Web site]. 07/11/02. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K021959.pdf. Accessed March 6, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff. Document issued on: March 4, 2013. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm341718.htm. March 6, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Nellcor N-200 Pulse Oximeter. 510(k) summary. [FDA Web site]. 09/24/02. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/k022819.pdf. March 6, 2018.

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.2015; 27(9):CD011584. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011584.pub2/full. Accessed March 6, 2018.

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):188-93.

World Health Organization (WHO) Pulse Oximetry Training Manual. 2011. Available at: http://www.who.int/patientsafety/safesurgery/pulse_oximetry/who_ps_pulse_oxymetry_training_manual_en.pdf. Accessed March 6, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code to support medical necessity as listed in the policy.


HCPCS Level II Code Number(s)



A4606 Oxygen probe for use with oximeter device, replacement

E0445 Oximeter device for measuring blood oxygen levels noninvasively


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

05.00.31e
05/07/2018This policy was updated to clarify criteria for pediatric individuals and the not medically necessary criteria for routine monitoring for home pulse oximetry.

05.00.31d
12/29/2017This version of the policy will become effective 12/29/2017.

This policy has undergone a routine review and the medical necessity criteria have been revised to include indications for coverage and indications considered not medically necessary.
Version Effective Date: 05/07/2018
Version Issued Date: 05/07/2018
Version Reissued Date: N/A

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