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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The New Healthcare Normal

Filling the Disease Management Gaps in COPD

Vernon Pertelle

Reflect for a moment about the changes in healthcare over the past five years.  Now think about the transition from filling the inpatient beds and increasing overall volumes for surgical cases to reducing the length of stays and performing more procedures in same day centers or through robotics and minimally invasive methods. 

Then consider the methods and madness surrounding reimbursement for services and products under the Medicare Part B benefit; and the increased level of scrutiny and vigilance with utilization of resources relative to medical necessity.  No matter how you are affected, it is plain to see that things have definitely changed. Some may argue for the better because we are now charged with demonstrating value by improving health outcomes while reducing costs; while others may say things have changed too drastically and the patient will suffer as a result of the shift to value based healthcare.  

We have embarked on a new horizon in which health policy in our country is now focused on the patient. This is a very good thing because the system just might move away from a capitalistic and business centric model in which coverage has been the determining factor about using an effective resource; to one that will help improve healthcare in our country because using a resource that is effective - - is the right thing to do.  

The reality is that Centers for Medicare and Medicaid Services (CMS) has effectively gotten our attention to truly focus on establishing value for our patients; and will reward us for demonstrating better outcomes while reducing costs. 

We now must quantify data that clearly shows the use of resources results in better outcomes while reducing costs.¹ So, in the words of Michael Porter, management guru from Harvard Business School (HBS): "Since value depends on results, not inputs, value in health care is measured by the outcomes achieved, not the volume of services delivered, and shifting focus from volume to value is a central challenge."² So, the question then is how do we deal with the new normal in which we must demonstrate our value? 

Well, it begins with evaluating all of the resources in our armamentarium and critically assessing each intervention in terms of the value it adds to improving outcomes while reducing costs.  Take for instance patients that are diagnosed with Chronic Obstructive Pulmonary Disease (COPD); and the typical historic interventions and resources used to improve outcomes while reducing costs.  

Based on the evidence, we have done a poor job of effectively improving the outcomes of patients to the extent CMS has now included the diagnosis of COPD in the Hospital Readmission Reduction Program (HRRP) for FY 2015. We now must address the need to improve outcomes by considering tangible and effective alternatives that will help improve the overall care and outcomes.  The resource is a respiratory therapist (RT); specially trained, with laser sharp focus on the management of patients with COPD. The key is of course in developing programs and services that are centered on the patient with interventions that improve their engagement with self-management as well as adherence to their treatment plan.  

There are countless examples in regional and even some national managed care organizations on the effectiveness of this resource, yet - - by-and-large - - RT's have not been considered as essential in filling the disease management gaps. That said more must be done to demonstrate value and in essence establish RTs through validated clinical studies to once and for all get a better handle on the management of patients with COPD to improve health outcomes while reducing costs.

1 Michael E. Porter and Elizabeth Olmsted Teisberg, Redefining Health Care: Creating Value-Based Competition on Results (Boston: Harvard Business School Press, 2006), 86-87.

2 Michael E. Porter, “What Is Value in Health Care?” New England Journal of Medicine (2010) 363:2477-2481.

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The future of big data

Vernon Pertelle

Healthcare organizations and providers are charged with having the ability to quantify the data obtained from patients in the electronic health record (EHR) to show that the resources utilized in the care and treatment of patients results in better health outcomes while reducing costs.  

The expectations under the new healthcare laws and regulatory requirements; call for each entity whether hospitals and health systems or physicians to demonstrate meaningful use three (3) in which the data shows that the entity effectively cared for their patients.  So what does this mean for data analytics and dedicated resources with clinical and financial expertise to compile the information in a manner that is useful for the organization, relevant to Centers for Medicare and Medicaid Services (CMS) and allows for performance improvement?  

The future, current trends and direction of the New Healthcare Normal of pay for performance creates opportunities for information technology (IT) professionals that have expertise in clinical informatics and financial systems, budgeting and resource allocation. 

In order to effectively quantify your organization's performance in demonstrating meaningful use, establishing successful practices that lead to better health outcomes and cost reductions; as well as creating consistency with regards to connecting financial expenditures with clinical activities, each organization must create a new role that is focused solely on meaningful use demonstration.  

The individual is potentially a clinician with a passion for IT and formal education & training; and most important, understands the link between financial and clinical data.  This new role is one that may have existed in some organizations well in advance of the changes under the New Healthcare Normal; however will be essential for hospitals, health systems and physician practices to ensure the entity receives the rewards for performing better.  In addition, the role becomes a major component of the budgeting team to ensure resources are planned for and implemented at the right places, doing the right jobs, and for the right purposes.  The person is potentially a mid-level manager or director that reports in a matrix to the CFO, CNO; with regular interface with the CEO to ensure adequate authority and influence over the various teams and individuals accountable for performance.  

We have a plethora of data due to the systems and significant amount of information compiled via the EHR, financial systems, human resources and purchasing that can be leveraged to transform organizations into well run, efficient and quality driven entities. However there must be a dedicated resource that is accountable for quantifying the data in a manner that shows cost effective healthcare to demonstrate meaningful use.  The individual will help to shift the data paradigm to identify successful practices that can be shared throughout the organization and ultimately the healthcare industry.