CQRC urges caution on implementation of NIV NCD

WASHINGTON – While it commends the Trump Administration for finalizing a National Coverage Determination (NCD) for “Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD,” the Council for Quality Respiratory Care (CQRC) is concerned about its quick implementation and potential access issues. 

The effective date of the final NCD is the date of publication, but the CQRC continues to urge CMS to provide an implementation glidepath of at least 12 months. This timing would allow the agency, professional societies and other stakeholders to educate the community about the changes in the coverage policy without risking patient access to these devices.  

The final NCD was published June 9.  

Removing barriers 

The CQRC notes that in the final memo outlining the NCD policy, CMS adopts several modifications to remove barriers to patients in need of respiratory assist devices (RADs) and home mechanical ventilators (HMV), including: 

• Clarifying that the new policies will not apply to patients who already rely on RADs or HMVs to ensure continuity of care. 

• Aligning the final NCD coverage adherence goal for NIV devices to be at least four hours per 24-hour period on at least 70% of days within the specified time periods in the NCD, consistent with clinical practice. 

• Clarifying the reassessment period to reduce burden on patients, physicians, and suppliers. 

• Expressly stating that the NCD policy should not be used as a justification for step-therapy that could force patients onto a device that a physician knows is not appropriate for that patient. 

• Allowing patients when discharged to continue using the same type of device that they were prescribed during their hospitalization.  

• Expanding the clinical criteria to support continued use of a RAD or HMV to include stabilization of their condition and improvements in sleep quality. 

Clarification to arterial blood gas requirement 

While CQRC is disappointed that CMS maintained that an invasive and painful arterial blood gas (ABG) is the only test permitted to initiate therapy (which is at odds with the recommendations of the American Thoracic Society guidelines), it is pleased that the final memo clarifies that an ABG is not required for re-certification of patient’s medical necessity. The NCD notes that Medicare contractors may also accept other test results at their discretion. Allowing for other testing options will be especially important for patients in rural and medically underserved areas who may not have access to the specialized facilities where ABGs must be performed. 

Gap in treatment 

Unfortunately, the final memo does not provide criteria to support access for patients diagnosed with hypercapnia with test results that aligned with the ATS guidelines for diagnosis of the disease, but that are lower than the thresholds outlined in the NCD. The CQRC looks forward to working with CMS to find ways to address this gap in treatment so that these patients are not left behind. 

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