The Centers for Medicare & Medicaid Services (CMS) has released the final national coverage determination (NCD) for noninvasive positive pressure ventilation (NIPPV) used in the home to treat chronic respiratory failure (CRF) stemming from chronic obstructive pulmonary disease (COPD).
“This final NCD provides coverage of RADs [respiratory assist devices] for the treatment of chronic respiratory failure that often accompanies COPD,” CMS said in the June 9 announcement. “In addition, for the first time, Medicare establishes coverage criteria for HMV [home mechanical ventilators] for patients with COPD. For all other patient indications not included within the NCD, the MACs have authority to decide coverage.”
Included in the NCD are the following:
— CMS will cover a RAD with a backup rate feature to provide high-intensity noninvasive ventilation (NIV) for patients with CRF as a result of COPD. The initial coverage is for a six-month period when patients meet a list of criteria, including hypercapnia “as demonstrated by PaCO2 ≥ 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2”; hypercapnia not caused by sleep apnea; and either stable COPD lasting at least two days with no change of pharmacological treatment in the two weeks before the start of NIV, or hypercapnia that’s been present for at least two weeks “post hospitalization after resolution of an exacerbation of COPD requiring acute NIV.”
— CMS will cover a RAD without backup rate feature for COPD patients with related CRF if the patients “cannot tolerate high-intensity NiV or for whom the backup fate feature is otherwise medically inappropriate.” The RAD without backup rate will be covered for an initial six-month period for COPD patients who demonstrate hypercapnia as demonstrated by PaCO2 ≥ 52 mmHg by arterial blood gas during waking hours while breathing his/her prescribed FiO2; and who do not have hypercapnia predominantly caused by sleep apnea.
— CMS will cover a RAD with or without backup feature for an initial six-month period for patients with acute or chronic respiratory failure from COPD who are discharged from the hospital and who required a RAD or ventilator within the 24 hours before hospital discharge. The clinician treating the patient must also determine that the patient is at risk of rapid symptom exacerbation or rise in PaCO2 after discharge.
To continue to qualify for the RAD, patients “must be evaluated within the first year after initially receiving a RAD,” the NCD said. “Evaluations must occur by the end of the six-month initial coverage period and again during months seven through 12.”
Criteria for continuing RAD coverage
In addition to requiring patients to be evaluated “at least twice within the first year” after first receiving the RAD, CMS listed criteria for patients to continue to qualify for a RAD:
— Clinician must confirm that patient is using the RAD at least four hours per 24-hour period on at least 70% of the days in a 30-day period.
— Using the RAD as required above, the patient must also achieve at least one of the following: normalization (< 46 mmHg of PaCO2); stabilization of a rising PaCo2; 20% reduction in PaCO2 from baseline value; or improvement in at least one of chronic hypercapnia symptoms specified (headache, fatigue, shortness of breath, sleep quality, confusion).
For the second evaluation, which must take place between seven and 12 months after the patient receives the RAD, the treating clinician must confirm that the patient uses the RAD at least four hours in a 24-hour period on at least 70% of the days in each rental month.
For evaluations subsequent to the second one, patients “must be using the device at least four hours per 24-hour period on at least 70% of days in each remaining paid rental month and any month in which accessories/supplies are dispensed,” the NCD said.
Criteria for coverage of HMV
The NCD said CMS will cover HMV “used in a volume targeted mode” for patients with CRF from COPD if the patients present with certain characteristics.
For the initial six-month period, patients must present with hypercapnia “as demonstrated by PaCO2 ≥ 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2.” Sleep apnea cannot be the predominant cause of the hypercapnia. Patients must also require oxygen at FiO2 ≥36% or ≥4L nasally or require ventilatory support for more than eight hours in a 24-hour period; or require the alarms and internal battery of an HMV to prevent life-threatening vent interruptions; or the clinician determines that outcomes such as a normal PaCO2, stabilization of a rising PaCO2, or improvement in symptoms such as shortness of breath or fatigue cannot be achieved with a RAD.
CMS will cover an HMV for the home after a hospital discharge if the patient’s needs can’t be met by a RAD, and if the clinician determines that the patient “is at risk of rapid symptom exacerbation or rise in PaCO2 after discharge.”
Patients will need to be evaluated at least twice in the first year after receiving the HMV, with clinicians being required to establish that usage criteria are being met and that the patient is using the HMV at least four hours in a 24-hour period and on at least 70% of days in a 30-day period or, after the first evaluation, for four hours per 24-hour period on at least 70% of days in each paid rental month.
HMV masks will also be covered for patients using HMV in a volume targeted mode for more than eight hours in a 24-hour period and who use an oronasal mask at night. “A different interface (e.g., mouthpiece ventilation or nasal mask) is covered for daytime hours,” the NCD said.
In alerting the industry to the release of the NCD, the American Association for Homecare (AAHomecare) said its regulatory team is reviewing the document “and will share analysis of the final NCD as soon as possible.”
