It has been quipped that technology doubles every 5 years and medical technology doubles every 2 years. While it is unclear whether that is truly accurate, it is clear that home mechanical ventilation (HMV) has certainly evolved by leaps and bounds over the past decades.

Accurate data relating to the total population of HMV patients are difficult to obtain, as there are no central databases tracking this information.

Estimates are based on extrapolations from regional populations and/or Medicare claims data. Using the 2010 US Census population, estimates for the home mechanical ventilation population in the United States range from just under 11,000 to 20,300. This includes invasive and noninvasive ventilators but excludes patients using noninvasive therapies for sleep-disordered breathing.1-3 Home mechanical ventilation was born out of a necessity to provide support for patients whose condition would ordinarily require lifelong care in a hospital, skilled nursing facility, or other institution-based program. Early ventilators, at least in hindsight, did not seem terribly sophisticated. The old PVV, rocking bed, iron lung, and others were somewhat basic in their design, but to those who used and depended on these devices, they were priceless. They were durable, dependable, and easy to operate in the home setting. There were no complex settings, calculations, or hidden menus to learn. You set the dials and used the equipment—period. When it was officially announced that service to the iron lung would be discontinued in 2004, certain patient groups and advocates were vocal about the change and moved unwillingly to the more traditional volume ventilators available at the time.

The advent of pressure-support ventilators for home use revolutionized the therapy. It meant that patients could benefit from previously “hospital-only” therapy, and home care companies no longer had to build intermittent mandatory ventilation into the circuit setups via H-valves. That type of setup was effective for certain patients, but it also made inadvertent disconnect more of a problem than it might have been in a traditional setup.

Additionally, more features became available to HMV patients, including various waveform options, bias flow, rise time, and even pressure control.

Contraindications to Home
Mechanical Invasive Ventilation

  • The presence of a physiologically unstable medical condition requiring higher level of care or resources than available in the home
  • Patient’s choice not to receive home mechanical ventilation
  • Lack of an appropriate discharge plan
  • Unsafe physical environment
    • Presence of fire, health, or safety hazards
    • Inadequate basic utilities
  • Inadequate resources for care in the home
    • Financial
    • Personnel
      • Inadequate medical follow-up
      • Inability of ventilator assisted individuals to care for self, if no caregiver is available1-6

NEW TECHNOLOGY IS COSTLY

New features and gadgets do not come without a price, however. in this case, the Centers for Medicare and Medicaid Services (cms) established additional Healthcare Common Procedure Codes to define pressure support versus volume ventilation, and whether it would be used invasively via tracheotomy, or noninvasively via mask or mouthpiece.4 supplies to support the new pressure-support ventilators, like ventilator circuits, pressure lines, etc, all bring incremental expense to the care of a ventilator-dependent patient in the home.

As technology continues to improve, the reality is that older technology is being replaced. With the announcement of end of life for the Puritan Bennett LP-10, CareFusion T-Bird ventilator series, and the Philips Respironics PLV 100 and PLV 102 volume-controlled ventilators, both patients and providers are faced with new management challenges. Similar to the required transition created by the obsolescence of negative pressure ventilators, patients must be converted from volume- to pressure-support ventilators with different features, flow patterns, and buttonology. This can be a very emotional and stressful time for transitioning patients, who have relied on and been comfortable with the breathing pattern of their life support system over many years. Home care providers face significant resistance from patients and physicians, who do not want to relinquish their dependable products. The truth is, however, that once manufacturers discontinue production of repair parts, it is impossible for providers to safely maintain these obsolete ventilators. The process of educating the patients, caregivers, and physicians requires strong communication and clinical collaboration with other health care managers and—most important—the physicians. Although these patients are medically stable, introduction of a new support device requires reeducation of all caregivers on ventilator operation. Additionally, the home care environment does not allow for patient monitoring, clinical evaluation of patient adjustment to the ventilator, or access to emergency medical services, should patients fail the trial on the new device. For this reason, physicians, respiratory therapists, and insurers must collaborate to identify a monitored environment to allow for a safe transition.

GOING HOME

High-quality providers have policies and procedures for accepting ventilator patients onto service, with safety and good clinical practice in mind. Generally speaking, the many components of a discharge to the home environment necessitate several days to a few weeks for planning and preparation. Significant time and support are necessary to prepare the patient and caregivers for the responsibility of total support for HMV patients. But before any of the training can begin, a number of important tasks must be completed. There has to be strong communication with the patient’s insurer, to determine coverage of the ordered equipment and supplies. The home should be assessed for proper space, electrical outlets, phone service, and other criteria necessary to ensure a safe environment. A care conference is an ideal way to bring home care and hospital personnel together to discuss the patients’ specific needs, and also begin identifying the primary caregiver.

While home health agencies are typically engaged for help after the initial ventilator discharge, it is not customary for this nursing support to continue long-term. Additionally, nursing shifts are staggered, leaving caregivers with full responsibility for large blocks of time. Therefore, it is imperative that home care providers invest in thorough planning and detailed training of at least two caregivers who will become “pseudo-ICU nurses” to safely provide 24-hour care. This could mean upwards of 10 to 15 clinical labor hours invested before the ventilator provider begins collecting any reimbursement for the equipment. Due to multiple factors, eg, caregiver competency, changed patient medical status, lack of nursing resources, or safety of the home environment, some patients never make it home. This investment by the home medical equipment provider is never recouped as there is no mechanism to obtain funding for services if the patient does not make the final transition home.

Iron lungs were pretty basic in their design, but to those who used and depended on them, they were priceless.

When patients do successfully move into the home setting, ventilator providers should be prepared to retrain new caregivers and home health nurses multiple times regarding ventilator function, features, and troubleshooting, since consistency in nursing staff assigned to patients can be difficult to maintain. Group in-services with agencies can help, but often, the time delay between these in-services and the actual provision of care necessitates a reteach.

REIMBURSEMENT CONCERNS

While technology has evolved quite dramatically, the support systems and reimbursement environment for home ventilator management have remained relatively stagnant over the past decade. Even with new coding, payment is not guaranteed. This not only contributes to burdens on caregivers, but places increasing pressures on providers of home ventilation.

Fee schedules for mechanical ventilation are set by the government insurers and/or commercial payors. It is expected that all respiratory therapy support required to educate caregivers, collaborate with discharge planning teams and physicians, provide clinical oversight for the aftercare in the home, make available 24-hour access to licensed professionals, and facilitate transfer to new technology will be included in the monthly equipment rental fee. Disposable ventilator accessories, such as ventilator circuits and pressure tubing, are typically deemed included in the rental fee as well.

A frequent area of concern is with the secondary ventilator. The term “backup ventilator” really does not do justice to the frequent scenario of a portable system mounted to a wheelchair and a stationary setup at the bedside. The logistics of switching one ventilator from bedside to wheelchair is almost impossible on a daily basis, and therefore, two ventilators make most sense for such patients.

While manufacturers’ failure rates for ventilators are low, ventilator malfunction or failures do occur, necessitating placement of backup equipment for ventilators, suction equipment, and other critical medical devices in the home. Although the American Association for Respiratory Care Clinical Practice Guidelines for Long-Term Invasive Mechanical Ventilation in the Home recommend backup ventilators for those who cannot sustain spontaneous ventilation for at least 4 consecutive hours and for those living in remote areas not easily accessible by the home care provider,5 backup ventilators are not routinely covered by insurers. There is a perception that “backup” ventilation is unnecessary and costly, so in some arrangements that second ventilator is not paid for by the insurer. This poses a reimbursement disconnect since many patients truly need the additional equipment to foster mobility, independence, and safety.

Of increasing concern are trends whereby insurers seek to convert ventilators to purchase after an initial rental period. Mechanically ventilated patients generally require lifetime support, and once the monthly rental ends, patients are left without resources for ventilator maintenance, clinical follow-up, and 24-hour availability for mechanical failure. While home care providers are attempting to bridge these challenges with equipment maintenance agreements, these are difficult to negotiate, often require customization based on payor restrictions, sometimes must be funded by the patient, and are difficult for home care providers to administer.

Keeping up with respiratory care practitioner (RCP) training requirements can often be difficult, especially with an ever-widening variety of makes, models, and options for physicians to prescribe. It is not uncommon for home care therapists to support six or more completely different ventilator models. With each model having different features, hidden menus, trouble-shooting guides, and testing procedures, therapists have to be very savvy. This is especially true when a call for help from a caregiver can come unexpectedly in the middle of the night. If therapists are not 100% solid in their knowledge, it will be very apparent at times like this. Fortunately, technology also provides newer and better options for training on complex ventilators and other equipment. Many current manufacturers offer DVDs and Web-based training in addition to the old stand-by: the clinical manual.

Managing the inventory of devices, disposables, and staff to support home ventilation patients adds a layer of complexity and cost that many home medical providers are not willing to approach. As old devices become obsolete, providers must dispose of depreciated equipment and replace these assets with higher-cost alternatives. As the majority of ventilators are rented, there is no reimbursement offset for the additional capital expense of obtaining the replacement technology. Additionally, for every ventilator in a patient’s home, there must be backup inventory maintained at a warehouse for immediate dispatch in situations of mechanical failure. The minimum staff level of licensed RCPs must be considered. Even medical equipment branches that manage a limited number of ventilator patients must have a minimum level of RCPs to effectively provide for 24-hour coverage and availability of a licensed professional when patients call for service or clinical support. State RCP practice acts dictate the tasks that nonclinical staff are allowed to conduct, so substituting a nonlicensed professional is generally not an option.

CONCLUSION

Given the complexity of ventilator management and trouble-shooting in the home, the skills of a trained RCP are vital.

While providers continue to contemplate the challenges and rewards of serving this patient base, new technology is sure to emerge and change the landscape even further. New ventilators will be smaller, lighter, quieter, and, in some cases, even “wearable.” As technology continues to evolve, the home environment remains an appropriate site of care for the medically stable ventilator patient. High quality home ventilator providers will continue to pay close attention to patients’ clinical and safety requirements with a hopeful eye on evolving reimbursement considerations.


Kelly Garber is National Director, Clinical and Respiratory Services, and Michelle Guertin is National Manager of Respiratory and Sleep Services, Apria Healthcare, Littleton, Colo. For further information, contact [email protected]

REFERENCES

  1. Divo MJ, Murray S, Cortopassi F, Celli BR. Prolonged mechanical ventilation in Massachusetts: the 2006 prevalence survey. Respir Care. 2010;55:1693-8.
  2. Lloyd-Owen SJ, Donaldson C, Ambrosino N, et al. Patterns of home mechanical ventilation use in Europe: results from the Eurovent survery. Eur Respir J. 2005;25:1025-31.
  3. King AC. Long-term mechanical ventilation in the United States. Respir Care. 2012;55:921-30.
  4. Alpha-Numeric HCPS. Available at: www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html. Accessed May 29, 2012.
  5. AARC Clinical Practice Guidelines. Long-term invasive mechanical ventilation in the home. Respir Care. 2007;52:1056-62.