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

From Our Experts

You Got the Contract! …NOW WHAT?! A Short Series thumbnail You Got the Contract! …NOW WHAT?! A Short Series Congratulations! You FINALLY got the contract you've been working so hard on all these months. Now that you have it, what are the critical next steps you need to take to maintain and implement the contract and generate ROI? Welcome to the first of a short series of articles to help you accomplish just that. NAAOP Hosts First Ever In-Person Legislative Fly-In thumbnail NAAOP Hosts First Ever In-Person Legislative Fly-In Last week, 33 stakeholders, advocates, and leaders from around the O&P industry convened at the offices of Powers Pyles Sutter & Verville PC in Washington, D.C., as part of The National Association for the Advancement of Orthotics and Prosthetics's (NAAOP) first ever in-person legislative fly-in. Co-sponsored by OPGA, the fly-in kicked off with an in-depth discussion and strategy session surrounding several legislative priorities affecting O&P providers and patients. VGM Government Relations Unveils Grassroots Advocacy Toolkit to Empower DME Champions of Change thumbnail VGM Government Relations Unveils Grassroots Advocacy Toolkit to Empower DME Champions of Change The VGM Government Relations team is proud to announce the launch of its Grassroots Advocacy Toolkit, thoughtfully crafted to support durable medical equipment (DME) professionals, caregivers, industry partners, and patient advocates in advancing legislative initiatives that impact home medical equipment and services. Featuring Two Champions Of Change: Robert Beard of YD Home Medical & Rob Minicucci Jr. of Health System Services thumbnail Featuring Two Champions Of Change: Robert Beard of YD Home Medical & Rob Minicucci Jr. of Health System Services Today, we're proud to spotlight two outstanding durable medical equipment (DME) champions whose advocacy efforts are making a meaningful difference: Robert Beard of YD Home Medical of Alabama and Rob Minicucci Jr. of Health System Services of New York. These individuals took time out of their busy schedules to personally connect with elected officials, demonstrating how local action can spark national change. Survey: Share Your Thoughts on Proposed Accreditation Rule Changes thumbnail Survey: Share Your Thoughts on Proposed Accreditation Rule Changes CQRC, VGM, and AAHomecare are requesting your feedback on a new proposed rule that could significantly impact accreditation procedures. Under the proposal, accreditation organizations would be required to conduct site visits every year—a major shift from the current once-every-three-years schedule. WEBINAR: Navigating New CMS Guidelines: Unlocking Opportunities in NIPPV and RAD Coverage for COPD Care thumbnail WEBINAR: Navigating New CMS Guidelines: Unlocking Opportunities in NIPPV and RAD Coverage for COPD Care The Centers for Medicare & Medicaid Services (CMS) has revised the NCD for Noninvasive Positive Pressure Ventilation (NIPPV) in the home setting for treating Chronic Respiratory Failure (CRF) due to Chronic Obstructive Pulmonary Disease (COPD). The changes aim to establish clear coverage policies for devices such as Respiratory Assist Devices (RADs) and home mechanical ventilators (HMVs), potentially expanding access to these critical therapies for eligible patients. Adapting to new CMS guidelin Bipartisan Medicare O&P Bill Introduced thumbnail Bipartisan Medicare O&P Bill Introduced In a timely move ahead of next week's NAAOP Legislative Fly-In, a bipartisan group of lawmakers introduced the Medicare Orthotics and Prosthetics Patient-Centered Care Act, a bill aimed at improving access to high-quality orthotic and prosthetic care for Medicare beneficiaries. The Patient-Centered Care Act seeks to address critical gaps in Medicare coverage for orthotic and prosthetic (O&P) services. Under current rules, beneficiaries may receive devices without the necessary clinical services Proposed Rule Suggests Significant Change To Accreditation Process thumbnail Proposed Rule Suggests Significant Change To Accreditation Process The recently released proposed rule CMS-1828-P contains a significant change that could reshape how suppliers navigate accreditation. The rule proposes a major change that would require suppliers to be surveyed and reaccredited annually instead of the current three (3) year cadence. This proposal raises substantial questions about both operational feasibility and cost implications.