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* From the Mayo Clinic College of Medicine, Rochester, MN.
Correspondence to: Joseph S. Lewarski, BS, RRT, Vice President of Clinical & Governmental Affairs, Inogen, Inc, 6120 Parkland Blvd, Suite 304, Mayfield Heights, OH 44124; e-mail: jlewarski{at}inogen.net
Abstract
As modern health care continues to evolve, we expect and are seeing that more sophisticated medical care will be provided outside the traditional acute care environments. Advances in home medical technology, economic pressures, health-care consumerism, and societal changes are all factors playing a role in this evolution. Medically fragile and technology-dependent individuals who were once limited to care in acute and subacute institutional settings are now frequently cared for at home, most often by their immediate family members. Mechanical ventilation has found its way into the patient’s home such that physicians and other providers must be prepared for the challenges associated with managing the conditions of complex, ventilator-dependent individuals outside of the walls, controls, and safety of the institutional setting. With little published science and recognized standards of practice, there are fewer rules to guide clinicians through this process. Experience has shown, however, that successful home management of ventilator-dependent individuals can be traced to a smooth and collaborative discharge from the hospital to home. Reimbursement and coverage issues must also be well understood to avoid the aggravation of denials and challenges for necessary equipment and assistance. Once home, a streamlined, patient-centered process supported by effective communication between all care providers can result in a safe and appropriate long-term home ventilation success story.
Key Words: home mechanical ventilation • management • reimbursement
Editor’s Note: The complex management of patients receiving home mechanical ventilation represents an undervalued, often unfunded responsibility for pulmonary providers. Lewarski and Gay nicely review both the optimal management and reimbursement opportunities for providing this care.—Scott Manaker, MD, PhD, FCCP, Section Editor, Topics in Practice Management There are ever-increasing incentives and financial pressures to transition medically complex patients from the acute care setting to less costly environments of care.12 In the United States, there is a recognized absence of objective evidence to help guide long-term care such that Medicare and other third-party policies and payment rules often become the de facto standard of practice. However, health-care economic forces alone are not enough to establish new levels of medical care outside of the institutional setting. Additional factors supporting the growth of technology dependency in the home include a growing social acceptance of persons with disabilities and significant medical technology advances, which can help to empower both the professional and nonprofessional caregivers to manage medically complex patients in the home.3 Modern health-care practice now routinely includes the management of medically fragile and technology/ventilator-dependent patients in a variety of nonacute settings, including a private home of nonprofessional and often elderly people.
The modern era of mechanical ventilation developed most prominently in response to the poliomyelitis epidemics that erupted during the mid-20th century.4 The process by which home mechanical ventilation (HMV) evolved has been much more gradual but was likely a result of the improved acute care survival rates of mechanically ventilated patients with chronic respiratory failure. This started as far back as the 1950s with the postpolio population and the use of the "iron lung." Economic pressures also played a major role, as rising health-care costs forced providers to look to lower cost environments of care. The myriad changes to third-party payment methods focusing on cost reductions, including the implementation of the diagnosis-related groups payment methodology, the growth of managed care, and the implementation of other health-care payment models, have also been catalysts promoting the transition of patients from acute care facilities to home. HMV as we think of it today can be traced to the early to mid-1980s, when the combination of technology and third-party payment systems created more tools to better manage the care of stable yet medically complex patients outside of the hospital. These tools include, but are not limited to, the following: third-party payment for the home ventilator and other home medical equipment (HME) and accessories; home nursing and skilled therapies (ie, physical or speech therapy); home infusion and enteral therapies; and, in some cases, home physician visits. More recently, advances in noninvasive positive-pressure ventilation (NPPV) and its applications have provided additional ventilatory options and cost savings to compliment the more traditional invasive systems.5
NPPV
The rapidly expanding home use of NPPV using a nasal or orofacial mask provides an even larger opportunity to allow patients to transition to the home environment without the need of a tracheostomy tube. Portable, lightweight, single-circuit flow generators that are capable of delivering bilevel pressure support with mask leak compensation can actually provide high levels of pressure support near 30 cm H2O. This treatment initially emerged and quickly proliferated with the successful application of nocturnal NPPV in the population of patients with neuromuscular disease (NMD) that has been described mostly in the European literature6 but also in the United States.7 Although one randomized trial89 suggested that patients with Duchenne muscular dystrophy who were introduced to NPPV as preventive therapy did not do as well as those patients receiving conservative treatment, the study was thought to be flawed, and NPPV has now become the standard of care for patients with NMD and hypoventilation.
As the advantages of NPPV were seen in NMD patients with hypercapnia, its use soon became popular for the treatment of patients with severe COPD and hypercapnia.10 Some randomized controlled trials validated the use of NPPV in COPD patients with hypercapnia and mild sleep-disordered breathing, but other trials showed conflicting results.111213
Home Noninvasive Mechanical Ventilation Policies and Practice Standards
The practice guidelines were presented in a publication14 that was based on an expert consensus conference panel precipitated in part by the alarming increase in NPPV use for COPD patients requesting very expensive reimbursement from Medicare. These recommendations included provisions for patients with restrictive thoracic cage disorders and NMD, as well as for patients with severe COPD and hypercapnia/nocturnal desaturation despite oxygen use, and finally those with other primarily nocturnal hypoventilation syndromes.
The reimbursement policies for NPPV, however, are very complex and most commonly have been directed by the Medicare local coverage decision policies (http://www.adminastar.com/Providers/DMERC/MedicalPolicy/Files/RespiratoryAssistDevicesRev42.pdf). The details are beyond the scope of this article, but the criteria consist of four categories including those for "restrictive lung disease," which is primarily for patients with NMD and COPD with hypercapnia who receive oxygen therapy at night. The other two categories are for central sleep apnea patients and, finally, obstructive sleep apnea patients who have confirmed obstructive sleep apnea based on a facility-based polysomnogram study and evidence as stated in the coverage decision policy above, that "continuous positive airway pressure has been tried and proven ineffective." A major reimbursement dilemma arises with the coverage criteria when a backup rate support is desired, which is essentially only available for patients with restrictive lung disease and central apnea, and, under very special circumstances, for those patients with COPD.
Home Invasive Mechanical Ventilation Policies and Practice Standards
One of the biggest obstacles that providers face in the provision of invasive HMV is simply a lack of strong, evidenced-based standards of care. As a result, local practice beliefs and reimbursement restrictions have produced marked regional variations. Unlike other home respiratory technologies (ie, home oxygen therapy and sleep disorder therapy), there is no standardized Medicare national coverage determination governing HMV, or even any local medical review policies or local coverage decisions among the durable medical equipment regional carriers. Despite the lack of a published medical necessity and payment policy, Medicare, Medicaid, and most private insurance companies do routinely provide for the coverage of home mechanical ventilators and related equipment with documented evidence of appropriate medical necessity (eg, diagnosis of respiratory failure).
Under Medicare, mechanical ventilators are in a class of medical devices known as "frequent and substantial service," which simply means that Medicare will rent the ventilator for the patients as long as the appropriate medical necessity exists. Among most payors, the key accessories, such as the ventilator circuits, humidifiers, sterile water, and respiratory therapist professional time, are all included in a "global" monthly ventilator rental payment. It is important to note that the "backup" or reserve ventilator, a commonly prescribed practice of many physicians and hospitals, which is also a recommendation contained within the American Association for Respiratory Care clinical practice guidelines for long-term mechanical ventilation in the home,15 is most often a noncovered item. This means that the HME provider often provides these backup devices at their expense as part of the overall "ventilator program." Again, the large regional variation in ventilator coverage policies is often a source of great frustration for patients, their families, physicians, hospital discharge planning personnel, and the HME providers.
Population of Ventilator-Assisted Individuals
Ventilator-assisted individuals (VAIs) are composed of a mix of adult and pediatric patients with a variety of underlying medical conditions contributing to chronic respiratory insufficiency and/or failure. Common disorders may include but are not limited to the following: spinal cord injury; NMD; chronic lung disease (obstructive and restrictive); bronchopulmonary dysplasia; and other birth-related anomalies contributing to respiratory insufficiency and/or failure.
There is very little accurate information regarding the numbers and types of VAIs living at home in the United States. There is no centralized database or standardized reporting method for both invasive and noninvasive HMV claims data, and, as a result, most estimates are extrapolations from insurance claims data or surveys with hospitals. Medicare has the most comprehensive national data set within the part B claims records, but extracting very specific data can be challenging. The HMV data for each state Medicaid program is a matter of public record but is not readily accessible. The data from the private insurance industry is even more difficult to acquire given the confidentiality provisions of the Health Insurance Portability and Accountability Act and the fact that many private organizations view their data sets as proprietary.
The 1998 American College of Chest Physicians consensus report on mechanical ventilation beyond the ICU estimated there to be 10,000 to 20,000 VAIs receiving treatment in their home.16 Medicare claims data from 2005 reveal $35.2 million in total payments for the health care common procedure coding system (HCPCS) code E0450, which is the most common code used for invasive HMV. The Medicare HMV claims data represent an estimated 3,100 patients.17 Based on the number of Medicare HMV patients, the actual number of invasive VAIs living at home is likely to be closer to the 10,000 number cited in the American College of Chest Physicians 1998 estimate.16 Medicare claims data for 2005 for NPPV suggest there to be approximately 7,600 patients using NPPV devices with a backup rate feature (HCPCS code E0471).
Coding and Reimbursement
Although the home has been noted to be one of the lowest cost points of care for VAIs,17 the lack of published information and recognized standards of care leaves notable gaps in the coding and coverage methodologies. An addition to the current procedure terminology (or CPT) coding may provide some relief in tracking VAI patient services. The new current procedure terminology code 94005 ("Home Ventilator Management Care Plan Oversight") can be used by physicians who are managing HMV patients.
The majority of coding and payments fall into the area of HME. HME is identified and billed using level II HCPCS codes and is reimbursed under the Medicare part B benefit (for Medicare beneficiaries) or the durable medical equipment benefit under Medicaid and/or private health plans. Home mechanical ventilators are identified by a series of four unique codes with a maximum payment allowable for each code. Medicare currently pays an average of approximately $950 per month as a global fee for invasive HMV. The maximum payment allowable for each state Medicaid and private insurance payor varies greatly, with an estimated range of $600 to $1,500 per month. Under Medicare part B, Medicare pays 80% of the allowed amount, leaving the 20% copay balance as the responsibility of the beneficiary. Most Medicaid programs do not have any copay or deductible for medical equipment; however, the copay and deductibles for medical equipment within the private insurance plans vary greatly, with the most extreme being no HME coverage. Table 1 outlines the most current HCPCS codes and descriptions.
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In the 1980s, we saw the introduction of what most clinicians consider to be the modern portable or home mechanical ventilators. Most portable ventilators were relatively small and lightweight (compared to hospital equipment) and typically were housed in cast aluminum frames. Nearly all of the first-generation portable home ventilators used some type of simple bellows or piston design to generate the needed flow, pressure, and volume. Although considered somewhat basic and low technology by critical care standards, the first-generation portable ventilation devices were clinically effective and very reliable; opening the doors to home for many ventilator-dependent individuals and their families.
The expanding use of invasive HMV in infants and pediatric patients has changed the home-care clinical landscape for both HME providers and the ventilator manufacturers.18 In contrast to the more basic provisioning of adult patients with long-term basic ventilation (ie, assist-control and no positive end-expiratory pressure), infants and pediatric patients often have more demanding and complex ventilation and airway management needs, with more critical care processes, such as weaning and tracheostomy tube decannulation, frequently incorporated into the care plan. As a result, the portable home ventilator technical capabilities have expanded to accommodate the complex clinical and lifestyle needs of this new and growing population of home VAIs. Modern portable ventilators now include advanced modes of ventilation with a variety of unique features and benefits.19
More Than a Ventilator
The management of VAI in the home incorporates more than just a ventilator. Medically complex VAIs often depend on a myriad of medical devices and services to duplicate the care provided in the institutional setting. Commodities such as oxygen, air, and suction, which are available at nearly every bedside in the hospital, must be produced from various devices in the home. For many VAIs, their homes often take on the appearance of a hospital room. The extensive list of adjunctive medical devices may include the following: oxygen systems; hospital bed; along with all of the supplies and accessories required to operate and manage and support these devices and treatments.
Critical Care to Home Care
Invasive HMV is arguably one of the most complex respiratory services delivered in the home. In contrast to many other home-care services, invasive HMV requires much more advanced decision making, planning, training, and oversight. Highly effective hospital discharge planning that includes well-choreographed interdisciplinary support is essential for long-term success.20 Physicians, nurses, professional therapies, home respiratory therapists, insurance case manager and, most importantly, family/caregiver acceptance, and buy-in are key components of any VAI home transition and management plan. For many families, especially new parents and elderly spouses dealing with a medically fragile loved one, this training and transition process can be very traumatic and frightening.2122 Despite the frequent administrative pressures to expedite the process, there must be adequate time for effective caregiver training, the preparation of the home environment, and the coordination of care among the various agencies. For many Medicare-aged adult patients, the primary caregivers are often the spouse and immediate family, with very limited professional support from home health agencies or other medical professionals. In the pediatric VAI population, the ability to provide more technically complex care in the home is often supplemented through professional, private-duty caregivers who are funded by third-party payors, including programs such as the Medicaid medically fragile waiver programs. In all cases, it is extremely important to respect and appreciate the needs of the patient, the caregivers, and the team members responsible for the care of the patient once they leave the safety and comfort of the institutional setting.
The Hidden Costs of HMV
Assuming the responsibility for the care and management of a VAI or other technology-dependent individual is a life-altering event for most families and caregivers. There are few available data that capture the myriad indirect costs associated with the care of VAIs in the home. These hidden costs include, but are not limited to, the following: lost wages for a spouse, parent, or child who stays home to care for the VAI; out-of-pocket costs of noncovered medical items and supplies; and the cost of custodial caregivers (ie, nurse aides) used to supplement the care and support and to provide respite for family members. Less well defined and more difficult to accurately measure are the emotional strains placed on both patients and families.2324 Carnevale and colleagues21 studied the stress occurring in the families of ventilator-assisted children living at home and noted that the parental responsibility was highly stressful and sometimes overwhelming. Health-care providers must be ever cognizant of the many unplanned emotional and financial costs associated with the provision of HMV.
Steps To Promote an Effective HMV Management Program
Although there remains an absence of recognized standards and objective science in this area, years of successful hospital discharge experiences with medically complex patients have produced a series of common-sense techniques that can help produce a smooth transition to home, as follows:
Summary
HMV is an important yet somewhat complex area of medicine that requires appropriate attention and support from all stakeholders. A well-executed HMV program produces a safe and appropriate environment of care for VAIs while concurrently delivering to the health-care system a cost-effective and patient-centric system for servicing the clinical and lifestyle needs of technology-dependent individuals. Even Medicare and Medicaid services are now beginning to recognize this value, and pilot programs to provide cost-saving home-based care vs institutionalized alternatives are underway.
Footnotes
Abbreviations: HCPCS = health care common procedure coding system; HME = home medical equipment; HMV = home mechanical ventilation; NMD = neuromuscular disease; NPPV = noninvasive positive-pressure ventilation; VAI = ventilator-assisted individual
The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.
Received for publication March 2, 2007. Accepted for publication May 9, 2007.
References
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