Proposed Decision Memo For Non-Invasive Ventilators

Published in Government Relations on March 14, 2025

The Centers for Medicare & Medicaid Services (CMS) released a decision memo on Tuesday, March 11, for a proposal NCD for noninvasive ventilation (NIV) for the treatment of chronic respiratory failure secondary to chronic obstructive pulmonary disease (COPD).

VGM is working with the industry to review the details and provide comments due on April 10.

At an initial review, here are a few highlights from the proposal:

• In the proposal related to the RAD policy for COPD diagnosis, the requirement of qualifying with a sleep oximetry has been removed. This has been the most challenging to meet in the past. The proposal has removed it from the policy.
• The initial coverage criteria have specific qualifications listed for a RAD that are in bold below.

Initial Coverage Criteria - RAD with Backup Rate Feature

CMS proposes to cover a RAD with backup rate feature in the home to deliver high intensity NIV as treatment for an individual with chronic respiratory failure (CRF) consequent to COPD. A RAD with backup rate feature must be utilized in the high intensity mode (IPAP > 20 cm H2O and backup respiratory rate of at least 14 breaths per minute). A RAD with backup rate feature is covered in the home for an initial 180-day period for individuals with COPD when all the following criteria are met:

• The individual exhibits persistent hypercapnia as demonstrated by PaCO2 ≥ 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2;
• Sleep apnea is not the predominant cause of the hypercapnia;
• The individual exhibits the physical and cognitive ability to support home ventilation or has a caregiver who can assist, and;

The individual demonstrates one of the following characteristics:

• Stable COPD, defined as no increase in or new onset of more than one respiratory symptom (cough, sputum production, sputum purulence, wheezing, or dyspnea) lasting 2 or more days and no change of pharmacological treatment during the 4-week period before initiation of NIV, or
• Persistent hypercapnia for at least 2 weeks post hospitalization after resolution of an exacerbation of COPD requiring acute NIV.

There have been questions about adherence to the NIV and what the requirements consist of in the past this did not exist.

• In the proposal the compliance to the NIV is using a minimum of 5 hours/24 period. In addition to a re-evaluation with the treating practitioner every 6 months before payment can be made.

Home Ventilation Continued Coverage

CMS proposes that individuals receiving coverage for an HMV as described in (i) and (ii) above must be re-evaluated by day 180 after receiving an HMV, and at least every 6 months thereafter, to establish that continued coverage by Medicare beyond the first 180-days is medical necessity. Medicare will not continue coverage into the 7th and succeeding months of therapy until the required re-evaluation is performed and establishes that continued coverage is medically necessary.

During a re-evaluation to establish that continued coverage is medically necessary, the practitioner must evaluate and verify that the HMV has been used for an average of at least 5 hours per 24-hour period in order to continue coverage of the device.

VGM will be commenting to the proposal that is due April 10. Once we have comments formulated and aligned with the industry, we will share with our members to assist with responding. To review the proposal in detail and to submit comments, please use this link.

Ronda Buhrmester

ronda.buhrmeter@vgm.com 

Boone Lockard

boone.lockard@vgm.com