Noninvasive ventilation (NIV) supports patient’s breathing without the immediate need for tracheotomy or intubation. The Center for Medicare and Medicaid Services (CMS) defines respiratory assist devices (RAD) as bi-level devices with back-up respiratory rate capability, which provide noninvasive modes of ventilation for respiratory insufficiency or sleep-related respiratory disorders in a home or hospital setting (21 CFR 868.5895). These devices are smaller in size with provision of the external battery (if needed) but limited by inability to offer daytime ventilatory mode (ie, mouthpiece ventilation). Currently, respiratory assist devices have been in DMEPOS Competitive Bidding Program since 2011, (similar to PAP devices for sleep apnea syndromes), which puts a 13-month capped rental in which the patient gets the device, supplies, and services for 13 months subsequent to which patient owns the device and supplies are paid separately by CMS (https://www.dmecompetitivebid.com/cbic/cbic.nsf/DocsCat/Home).
On the other hand, CMS defines home mechanical ventilators (HMV) as life supporting/sustaining devices for patients of all age groups used in various settings, included but not limited to home, hospital, institutional setting, transportation, or wherever portability is needed. The ventilators have increased portability due to external and internal battery, provision of mouthpiece ventilation, and at least six pressure modes and three volumes modes. Currently, the ventilators are under the frequently and substantially serviced act [42 U.S.C. § 1395m(a)(3)]. Under this act, the patient never owns the device but the device, ancillary supplies, clinical support (trained respiratory therapists), and servicing of the device are included in the monthly payments, which can last indefinitely. Thus, ventilators have both higher reimbursement rates and uncapped rental periods; beneficiaries not only pay higher monthly co-payments for these devices but also pay over a longer rental period. Nonetheless, these services are vital in keeping a certain subset of patients comfortable at home and out of higher cost settings. The current populations that directly benefit from this service are patients with polio, amyotrophic lateral sclerosis, muscular dystrophies, spinal muscle atrophy, thoracic restrictive disorder, and chronic hypercapnic respiratory failure due to COPD, to name a few. Thus, HMV has been vital in “freeing” these frail and vulnerable patient populations from their hospital beds, improving the quality of life, as well as mortality.
With the advent of technologic advancements, HMV, especially the noninvasive pressure support ventilator, is now capable of doing multiple modes, including CPAP, RAD modes, and ventilator modes. This could create a potential of abuse when the durable medical equipment supplier bills CMS for the ventilator but clinically, a lower cost CPAP, auto bi-level PAP, or RAD is indicated. The 2016 report from the Office of Inspector General (OIG) noted that CMS paid 85 times more claims for noninvasive pressure support ventilators in 2015 than in 2009 (from $3.8 million to $340 million). [https://tinyurl.com/y3ckskrb]. Expenditure increased from 2014 to 2015 alone accounted for 47% of the entire $337 million increase from 2009 to 2015. But, the report could not implicate reduced prices for CPAP devices and RADs under the Competitive Bidding Program to be driving increased billing for ventilators. They did find that the diagnoses used for these claims have shifted dramatically from neuromuscular diseases to other chronic respiratory conditions.
Since then, in January 2016, CMS consolidated billing codes for ventilators, and also reduced the reimbursement amount for noninvasive pressure support ventilators. After this change, between 2015 and 2016, median monthly rental rate of products decreased from $1,561 to $1,055; a reduction of 32% [https://tinyurl.com/y3ckskrb]. CMS presently is proposing to include HMV in the competitive bidding program to help with misuse and cost reduction. But proposed addition of the home ventilators in competitive bidding risks elimination of the vital services that are so important to keep a very “vulnerable and frail” population out of higher cost facilities. Because of this, CMS would see increased costs due to frequent emergency rooms visits, frequent intubations, intensive care unit stays, and admissions to long-term care at skilled nursing on one hand, but negatively impacting the quality of life of these patients on the other hand. This addition would have serious unintended consequences on Medicaid recipients, especially the pediatric population.
As a clinical guide, RADs are used for similar clinical conditions as HMV, but are meant for less severe respiratory conditions. Ideally, getting a RAD device for a patient should be governed by the physician’s clinical judgment rather than rigorous qualification criteria, nonetheless current RAD coverage policy in not only difficult but includes unnecessary qualification criteria, and as a result pushing the patient towards more costly ventilators. Unfortunately, CMS policies have not kept up with the technological advances of noninvasive ventilation. This has led to increased costs and utilization of noninvasive ventilators. In our opinion, including noninvasive ventilators in competitive bidding to reduce cost utilization is not the solution.
CMS needs to work with medical providers, beneficiaries, and various stakeholders to revise the current respiratory assist device and home mechanical ventilator guidelines in order to ensure that the appropriate patient is eligible for the correct device, without putting a very vulnerable patient population at risk.
Dr. Sahni is Clinical Assistant Professor, Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Illinois at Chicago; Dr. Wolfe is Associate Professor of Medicine (Pulmonary & Critical Care) and Neurology (Sleep Medicine), Northwestern University, Chicago, Illinois.