Clinical UM Guideline

This document addresses the medically necessary indications for the use of back-up (or second additional) ventilators in the home setting, for use as a “back-up” machine, if needed.

Mechanical ventilation may be defined as a life support system designed to replace or support normal ventilatory lung function (AARC 2007).

Medically Necessary:

The use of a back-up (second) ventilator in the home setting is considered medically necessary when all of the following criteria are met:

1. The individual cannot maintain spontaneous ventilations for 4 or more consecutive hours; and
2. The individual lives in an area where a replacement ventilator cannot be provided within 2 hours.

The use of a back-up (second) ventilator in the home setting is considered medically necessary for the following additional indication, when applicable:

1. For individuals who require mechanical ventilation during mobility, as prescribed in their plan of care.

Not Medically Necessary:

The use of a back-up (second) ventilator in the home setting is considered not medically necessary when the above criteria are not met.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria for a back-up (second) device are not met.

Mechanical ventilation may be defined as a life support system designed to replace or support normal ventilatory lung function (AARC, 2007). There are a myriad of medical conditions that may cause an individual to require the use of mechanical ventilation for either a short-term or long-term basis. Ventilators can be categorized as either invasive or noninvasive. Invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal or tracheostomy tube. It is most often used to fully or partially replace the function of spontaneous breathing and gas exchange. Noninvasive ventilation (NIV) may be required part of the time and is delivered through an alternative interface such as a face mask (Hyzy, 2021).

According to the American Association for Respiratory Care (AARC), individuals eligible for invasive long-term mechanical ventilation in the home setting require a tracheostomy tube for ventilatory support, but no longer require intensive medical and monitoring services (AARC, 2007).

The medical necessity criteria in this document for use of back-up ventilators in the home setting are consistent with the recommendations of the AARC Clinical Practice Guidelines for Long-term Invasive Mechanical Ventilation in the Home Setting (AARC, 2007). This document has not been updated since 2007.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Association for Respiratory Care (AARC) Clinical Practice Guideline: Long-term invasive mechanical ventilation in the home. Original publication: Respir Care. 1995; 40(12):1313-1320. 2007 Update with Revisions. Resp Care. 2007; 52(1):1056-1062. Available at: https://www.aarc.org/wp-content/uploads/2014/08/08.07.1056.pdf. Accessed on July 2, 2024.
2. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Durable Medical Equipment. Reference List NCD #280.1. Effective September 1986; most recent update: May 5, 2005. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=190&ncdver=
   2&NCAId=3&ver=5&NcaName=Air-Fluidized+Beds+for+Pressure+Ulcers&bc=ACAAAAAAIAAA&. Accessed on July 2, 2024.
3. Centers For Medicare & Medicaid Services. Noninvasive positive pressure ventilation in the home. Available at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id108TA.pdf. Accessed on July 2, 2024.
4. Hyzy RC, McSparron JI. UpToDate. Overview of initiating invasive mechanical ventilation in adults in the intensive care unit. Available at: https://www.uptodate.com/contents/overview-of-initiating-invasive-mechanical-ventilation-in-adults-in-the-intensive-care-unit?search=invasive%20ventilation&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1#H4167959455. Accessed on July 2, 2024.
5. King AC. Respiratory Care. Long-term home mechanical ventilation in the united states. June 2012. Available at: https://rc.rcjournal.com/content/57/6/921. Accessed on July 2, 2024.  
6. MacIntyre NR, Epstein SK, Carson S, et al.; National Association for Medical Direction of Respiratory Care (NAMDRC). Management of patients requiring prolonged mechanical ventilation: report of a NAMDRC consensus conference. Chest. 2005; 128(6):3937-3954.
7. Make BJ, Hill NS, Goldberg AI, et al. Mechanical ventilation beyond the intensive care unit: report of a consensus conference of the American College of Chest Physicians (ACCP). Chest. 1998; 113(5Suppl):289S-344S.
8. McKim DA, Road J, Avendano M, et al. A Canadian Thoracic Society (CTS) Clinical Practice Guideline: Home Mechanical Ventilation. Can Respir J. 2011; 18(4):197-215. Available at: http://downloads.hindawi.com/journals/crj/2011/139769.pdf. Accessed on July 2, 2024.
9. Stuart M, Weinrich M. Protecting the most vulnerable: home mechanical ventilation as a case study in disability and medical care: report from a National Institutes of Health (NIH) conference. Neurorehabil Neural Repair. 2001; 15(3):159-166.

Ventilators, Back-up in the Home Setting

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.