Moving the HME Industry Forward


Non-Invasive Ventilators – Establishing Medical Necessity

October 29, 2017

by Jeffrey S. Baird, JD

AMARILLO, TX – Over the past five years, an increasing number of DME suppliers have been providing non-invasive ventilators (NIVs) to Medicare beneficiaries. While this has resulted in (i) beneficiaries receiving valuable treatment and (ii) additional revenue to suppliers, there has also been a downside. NIV suppliers have been subjected to aggressive audits and investigations by the Office of Inspector General (OIG). With the spotlight on NIVs, and the suppliers that provide them, it is important for suppliers to understand what they must do to establish medical necessity This is the purpose of this article … to lay out Medicare rules regarding the establishment of medical necessity.

Ventilators will only be covered by Medicare if they satisfy the applicable reasonable and necessary criteria for the diagnosis or treatment of illness. The Medicare National Coverage Determinations Manual states that ventilators are covered for the treatment of “neuromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to chronic obstructive pulmonary disease.” This language has been consistent since the National Coverage Determination (NCD) for Durable Medical Equipment (DME) Reference List was initially issued in April 1, 2003. The information in the NCD is not the only guidance provided by CMS for ventilators even though a local coverage determination (LCD) has not been issued for non-invasive ventilators. The LCD applicable to lower-level Respiratory Assist Devices (RAD) also provides guidance regarding when NIV or a RAD is more appropriate for a patient.

The first LCD for RADs was originally issued on October 1, 1999; however, the discussion on ventilators did not appear in the LCD until the revisions that became effective December 1, 2014. The two LCDs applicable during the time period of 12/1/14 through 12/31/15 explain that the ventilator-related disease groups that appear in the NCD “may appear to overlap” with the conditions described in the RAD LCD used to determine coverage for bi-level PAP devices, “but they are not overlapping.” The determination of whether NIV or a bi-level PAP device is more appropriate for a patient is based on the severity of the patient’s medical condition. These LCDs further state:

The conditions described in the Respiratory Assistance Devices (RAD) local coverage determination are not life-threatening conditions where interruption of respiratory support would quickly lead to serious harm or death. These policies describe clinical conditions that require intermittent and relatively short durations of respiratory support. Thus, any type ventilator would not be eligible for reimbursement for any of the conditions described in the RAD LCD even though the ventilator equipment may have the capability of operating in a bi-level PAP (E0470, E0471) mode. Bi-level PAP devices (E0470, E0471) are considered as reasonable and necessary in those clinical scenarios.

Notably, the LCDs effective for dates of service between 12/1/14 – 12/31/15 state, “Claims for ventilators (E0450, E0460-E0464) used for the treatment of conditions described in the RAD LCD will be denied as not reasonable and necessary.”

The language in the RAD LCDs is based on the aforementioned NCD for DME Reference List (280.1) and the original April 3, 2014 version of the DME MACs’ article entitled, “Correct Coding and Coverage of Ventilators” (Article). However, in May 2016, the Article was updated to acknowledge that ventilator-disease groups and clinical disorders for which RADs are generally prescribed do overlap. Seven months later, CMS revised its discussion on ventilators in the RAD LCD effective 1/1/17 reiterating “ventilator-related disease groups overlap conditions described in this Respiratory Assist Devices LCD used to determine coverage for bi-level PAP devices.” Further, CMS stated:

Each of these disease categories are conditions where the specific presentation of the disease can vary from patient to patient. For conditions such as these, the specific treatment plan for any individual patient will vary as well. Choice of an appropriate treatment plan, including the determination to use a ventilator vs. a bi-level PAP device, is made based upon the specifics of each individual beneficiary’s medical condition. In the event of a claim review, there must be sufficient detailed information in the medical record to justify the treatment selected.

Additionally, the Article, explains that claims submitted for ventilator accessories such as masks or tubing will be denied because ventilators fall under the “Frequent and Substantial Servicing” (FSS) payment category. As such, the monthly rental payment for items in the FSS category must include any options, accessories or supplies used with the ventilator, as well as all service, repairs, and replacements. Therefore, any claims submitted to Medicare for payment of options, accessories, supplies, service, repairs, or replacements related to ventilators will be denied.

The Article also provides guidance regarding when Medicare will cover a second device for a beneficiary. Medicare will not pay for backup equipment unless it will serve a different medical need or purpose for the beneficiary. For example, Medicare will pay for two ventilators if “[a] beneficiary requires one type of ventilator (e.g. a negative pressure ventilator with a chest shell) for part of the day and needs a different type of ventilator (e.g. positive pressure ventilator with a nasal mask) during the rest of the day.” CMS’s position regarding the coverage of a second device has been consistent throughout the Article’s revisions, and it remains its policy today.

Thus, in order to establish medical necessity for NIV, the patient’s medical records must demonstrate the patient suffers from a neuromuscular disease, a thoracic restrictive disease, or chronic respiratory failure consequent to COPD. Further, Medicare will not pay separately for accessories related to a patient’s use of NIV, and in general, Medicare will not pay for a patient to rent two similar devices.


Jeff Baird and Wayne van Halem will be presenting the following webinar:


Compliance Program: Your Most Important “Profit Center”

Presented by: Jeffrey S. Baird, Esq., Brown & Fortunato, P.C. & Wayne van Halem, President, The van Halem Group

Wednesday, November 15, 2017

2:30-4:00 p.m. EASTERN TIME

The OIG has stressed the importance of compliance programs for DME suppliers by issuing guidance on how the programs should be structured and implemented. Congress has also weighed in through the Affordable Care Act, which makes compliance programs mandatory for DME suppliers at a date to be set in the future. This program will discuss how an effective compliance program helps create financial success, customer loyalty, community support and employee satisfaction. Topics covered will include primary compliance program objectives, the role of management in overcoming implementation obstacles, and identifying and addressing risk areas. Topics will further include changing behaviors, balancing multiple roles, integration with other parts of the organization, education and training, and finding qualified staff. The program will review the elements of an effective compliance program, and the need to regularly review and update the program. Specific risk areas arising from marketing of DME will be discussed, as well as how to identify and address risk areas particular to DME suppliers.

Register for Compliance Program: Your Most Important “Profit Center” on Wednesday, November 15, 2017, 2:30-4:00 pm ET, with Jeffrey S. Baird, Esq., of Brown & Fortunato, P.C. and Wayne van Halem, of The van Halem Group.

Please contact Ika Sukh at if you experience any difficulties registering.

FEES:              Member: $99.00  Non-Member: $129.00

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, PC, a law firm based in Amarillo, Tex. He represents pharmacies, infusion companies, HME companies and other health care providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization, and can be reached at (806) 345-6320 or