When it comes to fixing the U.S. healthcare system, it's easy to envision the public plan option and emergency health records being at the forefront of the discussion. In fact a conversation about healthcare reform without these two elements mentioned probably wouldn't be much of one at all.

There are, however, two areas that often get little or no mention in the current healthcare reform debate that could be key in helping to develop a stronger more effective healthcare system in U.S. – diagnostics and laboratory screening tests.

A recent report conducted by the Lewin Group (Falls Church, Virginia) shows that with the right attention and focus diagnostics and screening could be crucial elements in healthcare reform.

According to the report, tests for such conditions as diabetes, cervical cancer, drug-resistant infections, and metastatic colon cancer are enabling important strides in early detection and diagnosis, as well as helping physicians select treatments that will work most effectively for patients. The end result is often better health outcomes for patients and greater savings and economic efficiencies for the health system—all key goals of health reform.

The report was sponsored by the American Clinical Laboratory Association Results for Life (Washington) and Advanced Medical Technology Association (Advamed; Washington).

"I think one of the reasons we commissioned this report was because we felt as if diagnostics had been overlooked in the current healthcare reform debate," Teresa Lee, VP of Payment and Healthcare Delivery at Advamed told Medical Device Daily. "We feel as if diagnostics and screening are the Rodney Dangerfields of healthcare reform, when in fact they are integral to healthcare."

The report specifically points out how the lack of mention of screening procedures should be included in talks and how a stronger emphasis on the topics could lead to greater outcomes in the healthcare industry.

It says that screening and diagnostic tests contribute to healthcare value across the spectrum of care and it addresses the cost and clinical implications of lab testing by focusing on four areas:

Rapid diagnostic tests for hospital acquired MRSA infections: Hospital-acquired infections (HAIs) cause 99,000 deaths and $20-$45 billion in healthcare costs annually. Antibiotic-resistant staph infections, called MRSA, cause half of HAIs. Rapid MRSA lab tests allow hospitals to identify the infection quickly and take action to limit its spread.

KRAS genetic testing: In metastatic colorectal cancer, the genetic test for the KRAS gene mutation can now determine which patients will benefit from specific drugs, and which will not. This allows many patients to avoid serious side-effects and enables physicians to select the most effective treatment from the start. The test could save $740 million per year, according to one estimate.

HbA1c blood glucose testing: Substantial evidence supports the value of HbA1c testing as a screening and diagnostic tool for diabetes and prediabetes. Delaying the onset of diabetes and improved management of the disease can reduce complications, the risk of death, and costs for treatment. The total cost of diabetes is $174 billion a year, about $58 billion of that comes from lost worker productivity.

HPV DNA testing for cervical cancer: Genetic tests for the HPV viruses that cause cervical cancer are improving diagnostic accuracy in identifying the disease at its earliest stages. The tests are leading to improved disease-free survival and quality of life, along with reductions in disease occurrence, death, and progression to advanced cancers.

The report says that many of the benefits of laboratory testing are not being realized in the current system. The main body of the report reviews the current processes for assessing the value of laboratory screening and diagnostic tests and key policy issues that limit the realization of the tests value.

The report also goes on to say that the hurdles to appropriate use of these services are: insufficient provider awareness regarding when to use tests, challenges in generating evidence regarding the clinical utility of tests for particular patient subgroups and indications, inconsistencies among clinical practice guidelines regarding appropriate use of tests, inconsistent or inadequate coverage and payment policies, and the need to provide additional evidence of the favorable economic impact of laboratory testing.

Lee said that the study was in a position to help correct some of the mistakes and bring diagnostics into the forefront.

"We think this is a good starting point," she told MDD. "Its studies like these that get the word out and stress the importance of these tests and the impact they can have on our healthcare system."

Omar Ford, 404-262-5546;

omar.ford@ahcmedia.com