NIV NCD: Stakeholders share concerns, push for comments

WASHINGTON – AAHomecare, the Council for Quality Respiratory Care and VGM are raising concerns with CMS and lawmakers about the access issues and the negative health outcomes that could result from a recent draft proposal for noninvasive positive pressure ventilation. 

CMS on March 11 released a proposed decision in response to the request to reconsider NCD 280.1 to establish coverage policies for the use of noninvasive home mechanical ventilators and respiratory assist devices for Medicare beneficiaries with COPD.   

Stakeholders are encouraging providers, in particular, to submit comments on the proposal by April 10. 

“Our groups will be submitting official comments, as well,” said AAHomecare in a bulletin. “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.” 
 
AAHomecare is providing key concerns for providers to use in their messaging. They include:  

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 six-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 six 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 five hours per day 

The requirement is not consistent with current industry standards and policies, which define adherence to therapy as using PAP for more than four hours per night on 70% of nights during a consecutive 30-day period anytime during the first three 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.  

More tips on submitting effective comments can be found here. 
 
To submit comments, 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. 

• Related: Stakeholders see hurdles, burdens in proposed decision on vents.