Cover Story

Prevention rather than cure: an introduction to HDL, Inc.

Health Diagnostic Laboratory, Inc. derived its name from a conversation while crossing the Golden Gate Bridge. “Wouldn’t it be awesome to have a laboratory that actually worked to diagnose health, rather than disease?” The rest is history.

By Tonya Mallory, President & CEO, co-founder, Health Diagnostic Laboratory, Inc.

The laboratory has been an integral part of the continuum of medical care for centuries. It has been said that 60%–70% of critical decisions in diagnosis and treatment derive from laboratory data. Disease management outcomes can be influenced through effective use of this information. Today’s laboratories support disease management in the following ways: screening for early identification of disease; predictive tests to identify those at risk; diagnostic tests to identify and confirm disease; treatment selection or modification based upon lab test results; and compliance/monitoring to establish treatment efficacy or appropriate level of medication. Most modern clinical laboratories achieve these functions with an approach majorly influenced by the payer, existing reimbursements and a general emphasis on treating disease, rather than prevention.

The philosophy behind HDL, Inc.

At HDL, Inc. we concentrate on breaking all barriers to the traditional laboratory model. Despite the clinical utility of laboratory testing, the incidence of chronic disease has continued to climb. We interpret this to mean that the tests being used are inadequate. 75% of all health care dollars are spent on patients’ chronic conditions, many of which could be prevented, including diabetes, obesity, heart disease, lung disease, high blood pressure and cancer. If appropriate and thorough testing is conducted it is reasonable to expect a decline in chronic disease and a decrease in healthcare expenditures. The goals of HDL, Inc. are to provide tools to treat and reverse existing disease, and prevent major adverse events. This involves the understanding that cardiac disease, diabetes, metabolic syndrome and fatty liver disease, exist on a continuum: by identifying where the patient is on the continuum we can better understand the cause of their disease. It is possible to aggressively treat and reverse disease. Thus, it should be possible to diagnose health.

In recent years there has been renewed attention to coordination of medical care services across the continuum of care, particularly in the areas of prevention, monitoring, diagnosis, treatment ‘optimization’, ‘personalized’ medicine and disease management. HDL, Inc. is a full-service clinical laboratory that has integrated its laboratory functions with the disease management model as a means of providing tools for practitioners (e.g., clinical managers, physicians, nurse practitioners, physician assistants) to design and implement personalized plans of care for their patients. The HDL approach emphasizes prevention of exacerbations and complications utilizing evidence based practice guidelines and patient empowerment strategies. Services include: blood and urine laboratory analysis; chronic DM programs consistent with nationally accepted protocols for diabetes, hypertension, high cholesterol, stress, obesity, and smoking cessation; advisory services including the interpretation/integration of test results into the patient’s health management plan; health education tailored to the specific risks of each patient to ensure health literacy in those areas; HIPAA compliant population-based reporting to enable physicians to monitor patient progress, and a web-based personal health record and portals for patients and their health providers.

The cost of chronic disease

The American Heart Association (AHA) recently stated that costs in the U.S. from cardiovascular disease (CVD)–the leading cause of death here and in much of the rest of the world–will triple by 2030, to more than $800 billion annually¹. Adding to this ~$276 billion of “real indirect costs,” like productivity, brings this to over a trillion. Similarly, Type 2 diabetes is projected to cost $500 billion a year by 2020, when half of all Americans will have diabetes or pre-diabetes. The NIH has estimated obesity-related costs at about $150 billion. Layer on the prevalence and the current situation is even more alarming. CVD (including hypertension, heart failure and stroke) has grown at an annual average rate of 6% and accounted for ~15% of increased medical spending. The AHA estimates 37% of US adults have CVD. By 2030, under status-quo CVD prevention and treatment trends, the AHA estimates >116 million people will have CVD. This figure does not account for the increase in CVD from diabetes and obesity, which could add 5-15% more cases, resulting in 122-133 million people with CVD.

Reversing the trend

One point of emphasis is the term ‘status-quo’. The AHA states that CVD, diabetes and obesity will continue to climb if we continue to do what we have been doing. A study in the Journal of the American Medical Association reported that 62% of all cardiac events happen to people that have only 0 or 1 of the traditional risk factors and are not considered to be high risk using current assessment methods². In a 2009 study published in the American Heart Journal, 137,000 CVD hospitalizations were evaluated, of which 50% had normal traditional lipid results³. Additionally, we at HDL, Inc. evaluated 50,000 patients in our database, of which 15,000 had a normal lipid profile by NCEP Guidelines (ATPIII). While their traditional lipids were optimal, 62% (9,300) of these patients had elevated or abnormal advanced risk markers. Cumulatively, this data clearly demonstrates that we cannot continue to follow patients with the traditional lipid assessment and expect to reverse disease incidence or put a dent in the chronic disease epidemic.

At HDL, Inc. we work diligently to provide an understanding of the individual’s disease, the contributing factors that can be treated and the overall and cumulative risk of impending events for each patient. These tools enable physicians to devise an effective and non-arbitrary treatment plan. The result of the HDL, Inc. and physician partnership is improved clinical knowledge and improved quality in patient care, with appropriate combination of medications and lifestyle changes. Ultimately, the HDL, Inc. approach creates a huge cost savings in total healthcare expenditures. If we can annually affect change in patient care for only 1% (1.16 million) of the CVD patients, preventing the need for more invasive procedures, the savings amount to $137.6 billion to the healthcare system per year. Laboratory tests compared to these procedural costs are insignificant.

1. Heidenreich PA et al (2011) Circulation. 123:933-944.
2. Khol UN et al (2003) JAMA. 290(7):898-904.
3. Sachdeva A et al (2009) Am Heart J. 157(1):111-117.