CQRC Commends CMS for Modifying the Final Coverage Decision for Noninvasive Ventilation for Chronic Respiratory Failure

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Policy released by CMS reflects many of the recommendations submitted by CQRC to support effective management of chronic respiratory disease, prevent ER visits and hospitalizations, and enhance patient quality of life

WASHINGTON – The Council for Quality Respiratory Care (CQRC) – a coalition of the nation’s six leading home oxygen therapy provider and manufacturing companies – today commended 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” with several modifications recommended by the respiratory care community. 

However, CQRC members and other stakeholders remain concerned that the immediate implementation of the policy without time to update equipment to support the usage documentation and to educate physicians prescribing this therapy could create barriers for patients to access these life-sustaining devices. In addition, the CQRC is concerned that patients with earlier stages of the disease will not have access to effective treatment options.

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.

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 (ATS) guidelines), CQRC 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.

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.

According to CQRC, “when compared with those diagnosed with CRF consequent to COPD who do not receive a home mechanical ventilator (HMV), beneficiaries who have the therapy experience fewer emergency department visits, fewer hospitalizations, and lower mortality… studies find that the earlier the treatment begins, the better the outcomes for the patients.”

While CQRC understands that the effective date of the NCD is the date of publication, the coalition continues to urge CMS to provide an implementation glidepath of at least 12 months. This timing would allow for CMS, professional societies, and other stakeholders to educate the community about the changes in the coverage policy without risking patient access to these devices. It would also provide time to make sure manufacturers can update the equipment to include the tracking of usage software and modem connectivity. Suppliers will then need to work with the manufacturers to integrate these reporting systems into suppliers’ systems. The CQRC urges CMS to instruct the Medicare contractors to support these efforts as well through their education initiative, but most importantly by exercising the discretion not to deny claims during the first 12 months that the policy is effective. 

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The Council for Quality Respiratory Care (CQRC) is a coalition of the nation’s leading home oxygen therapy providers and manufacturing companies providing in-home patient services and respiratory equipment including liquid oxygen, oxygen concentrators, and sleep therapy devices to Medicare beneficiaries who rely upon home oxygen therapy to maintain their independence and enhance their quality of life. Learn more at cqrc.org.

Media Contact:

Ellen Almond

202-271-0234

ealmond@schmidtpa.com