Telehealth for Chronic Obstructive Pulmonary Disease (COPD): Opportunities for Respiratory Therapists (RTs)

Vernon R Pertelle

The New Healthcare Normal under the Patient Protection and Affordable Care Act (PPACA) contains several provisions that create new and emerging opportunities for RTs to leverage technologies to improve health outcomes and reduce costs associated with the care of patients COPD. 

The Centers for Medicare and Medicaid Services’ (CMS’), Centers for Medicare and Medicaid Innovation (CMI) is charged with identifying innovative health care delivery models that utilize electronic monitoring or Telehealth to coordinate patient care throughout the healthcare continuum.  Telehealth creates the capacity for allied health personnel and physician extenders to provide health services for patients with chronic conditions such as COPD. 

Accountable Care Organizations (ACOs) are required to promote evidence-based medicine and increase patient engagement, coordinate care of patients and report on quality and cost measures (meaningful use), to demonstrate their value in improving outcomes of patients with COPD.  Telehealth and other unobtrusive enabling technologies along with the expertise of RTs are essential for ACOs to succeed.  The face to face requirement, in which physicians certify the medical necessity for skilled home health care services under Medicare Part A or Durable Medical Equipment (DME) under Part B; can be accomplished through Telehealth in coordination with the RT in the home for Medicare beneficiaries with COPD.  

The PPACA also allows for a "Health Home" for patients covered under Medicaid (Section 2703; State Option to Provide Health Homes for Chronic Conditions) as an alternative for patients with COPD in which wireless health technology [or Telehealth] is used to coordinate care, improve the management of complex respiratory conditions and ensure full patient engagement with their treatment plan. The provision supports the use of a team of professionals including RTs to develop the framework for a comprehensive Health Home through the use of Telehealth.

The scope and impact of many of the provisions within the PPACA will be revealed as the rules and regulations are implemented. The opportunities for new and innovative programs involving the use of RTs are great; however requires us as a profession to collaborate, put aside differences and create services and programs to care for patients with COPD.  However, we must eliminate silos and I dare say – competition – in order to establish lasting solutions for RTs to thrive in the New Healthcare Normal. 

We Must Determine the Clinical Efficacy of Medical Devices

Vernon Pertelle

The demand for Home Medical Equipment (HME) will increase according to an independent study conducted by a Texas based company (See Medtrade Monday Article).  The firm recently conducted market research on the HME industry and forecasts an 8.2% increase, resulting in an industry that will tout well over $12.6 billion by 2018.  Industry leaders lauded the report as evidence on the value of the medical device focused meetings to support education and training on new and emerging medical devices. Additionally, noted the importance regarding the role of medical devices in meeting the needs of patients in low cost environments - the home.

While this is in part true based on the acute care shift; what is lacking currently with regards to medical device education is the evidence on the clinical utility to determine the effect on health outcomes and cost reduction.  This is the crux of the issue with the HME industry and the reason for the challenges that exists today under the competitive bidding program. Value Based Health Care (VBHC) is where the industry must focus its efforts to establish the role of HME providers as essential in the continuum of care.  The equipment is integral to patient care but the focus must be the patient; not the equipment (See Article on Value Based Health Care).

The fact is that not all medical devices are created equal when it comes to performance and frankly not all medical devices meet the therapeutic needs of patients with complex respiratory disease such as Chronic Obstructive Pulmonary Disease (COPD).  While one device may oxygenate a patient to ensure saturations are above 90%; an equivalent device may not - - for the same patient.  The problem is that the process that the Food and Drug Administration (FDA) utilizes to grant Pre Market Approval (PMA) for a manufacturer to sell a device to the general public is fundamentally flawed. Most devices in the category of 510(k) product approvals do not require clinical data for regulatory review in order to be approved by the FDA.

Many of the devices used for patients in the post acute environments are considered Class III (high-risk devices that may cause significant risk of illness or injury); although they do not require the level of rigor in the form of clinical trials to establish the efficacy of the device.  Oftentimes medical devices are approved based on substantial equivalence of a predicate device that has historical evidence of safety and efficacy; but the question is, what was the predicate device approved under? Another device? Rhetorical questions of course, and highlights the vicious cycle of no evidence on the clinical utility (efficacy) of a particular device for patients. The dilemma with the lack of evidence has created the perception of medical devices used in home care as commodities.

In my humble opinion the industry must focus the education and training regarding medical devices on the unique application of a particular device when used on patients; based on objective evidence on the efficacy to ensure positive health outcomes.  This is what the healthcare continuum demands and is a basic requirement under VBHC.  Until the conferences centered on medical devices begins to focus on the patient, improving health outcomes while reducing costs versus generating revenue; the industry will continue to face challenges with price compression and perceptions that it does not contribute directly to solving the problems associated with caring for patients with complex medical needs.  

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