WASHINGTON, D.C. – Respiratory suppliers are encouraged to share comments with CMS on how major elements of the proposed National Coverage Determination (NCD) on noninvasive positive pressure ventilation (NIPPV) will negatively impact patients with significant respiratory challenges who depend on this life-sustaining care. Comments due by Thursday, April 10 (11:59pm ET).

AAHomecare, CQRC, and VGM are actively engaged with CMS and Members of Congress raising concerns about the potential access barriers, negative health care outcomes, and mortality that could result from the draft NCD if it is not altered. Our groups will be submitting official comments as well.  But your comments, with an emphasis on first-hand perspectives on the potential impacts to patient care, are critical to making sure that CMS takes into account the real-world practical impact the proposals will have on patients.

If significant issues in the proposal are not addressed, the policy is likely to compromise beneficiary access to home-based therapies that reduce patient morbidity and mortality and improve their quality of life. These therapies also reduce federal spending through reducing health care costs, including fewer hospital admissions, emergency department visits, and other expensive procedures and services. Your direct experience supporting patients with significant respiratory challenges who depend on NIPPV is needed to reinforce this message.

Key Messages For Your Comments
Key messages on how overly restrictive coverage criteria for this chronically ill patient population and burdensome administrative processes in the NCD that you can make in your comments are noted below. Please reframe in your own words and draw on your own experiences with NIPPV patients to have the strongest impact:

• Concern that there is no grandfathering of patients already receiving RAD or HMV therapies – Patients already relying on these devices are unlikely to have the documentation required by the draft NCD in their medical records. Moreover, if a physician/prescriber believes that the patient continues to benefit from the device, it would be inappropriate to remove the device from their home and risk hospitalization or death.
• Concern with the 6-month re-evaluation and its impact on continued therapy–The proposed six-month requirement will make it even harder for chronically ill patients, especially those in rural areas, to access essential ventilation therapy. Many patients already struggle to see their doctors annually, and more frequent visits will create additional barriers to care. Many patients may not have the financial ability to cover the cost-sharing required by these additional visits. This could lead to delays or disruptions in critical treatment, worsening health outcomes.
• Concern with the requirement that a repeat Arterial Blood Gas (ABG) is obtained every 6 months as part of the re-evaluation– Strict qualifying criteria, such as requiring a painful and invasive ABG draw is unnecessary and burdensome for this chronically ill patient population. Excluding the use of other reliable and less invasive tests like VBG or ETCO₂ will further limit access to care, particularly in rural areas lacking specialty facilities.
• Concern with the requirement for a patient to utilize the therapy on average 5 hours per day– The requirement is not consistent with current industry standards and policies which define adherence to therapy as using PAP for ≥4 hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three (3) months of initial usage. The implementation of a new measure has the potential to disrupt patient care, especially considering the complexities of adoption that will be faced by suppliers and device manufacturers.

Do not feel obligated to comment on every one of these points; focus on the ones you know best.  More tips on submitting effective comments can be found here.

Submitting Your Comments
To submit your comments, you will need to click the ‘Submit Public Comment’ blue button towards the top of the NIPPV Proposed Decision Memo posting page. From there, you will be led to a comment submission page where you will need to copy and paste your comments into the online form.

Comments are due Thursday, April 10 (11:59pm ET). AAHomecare’s Regulatory and HME/RT Councils are working to finalize our extensive comments this week. We will share our comments with membership as soon as they are complete.