• by bcarlson@marketresearch.com
  • November 11 2013


Proof Not Always Easy To Provide for IVD Tests

Proof Not Always Easy To Provide for IVD Tests

The key to a successful test product, one that will line up payors, is to establish the product’s effectiveness with clinical studies.  But testing is not the same as treatment, it’s an area that’s a lot harder to prove with clinical data, according to our report on Reimubrsement for IVD Tests.

"Clinical trials pose unique challenges for diagnostic products. This is because there are typically several steps between the performance of a diagnostic test and a clinical outcome, and the ability of the test to influence outcomes (such as patient cures) is subject to factors that are unrelated to the technical attributes of the test itself."

For example, while the information that tests provide has an impact on therapeutic choices which, in turn, influence patient outcomes, clinicians may interpret and act on lab test information differently, and this can complicate the evaluation of a test’s utility. Because of this, most studies of diagnostic tests focus on intermediate outcomes, like diagnostic accuracy or impact on diagnostic thinking, not absolute patient outcomes. These studies tend to work best when the therapeutic decision based on accurate test information is well established.

In the United States, the Centers for Medicare and Medicaid Services (CMS) determines and implements payment methodologies for specific types of healthcare services covered by Medicare and Medicaid.  These federal plans, which combined cover almost 100 million persons, represent the largest health care plans in the nation by a wide margin and thus most other public and private health plans defer to CMS regarding coverage decisions.   Decision-makers focus on cost-savings, according to Kalorama’s analysis, and reward products that save the healthcare system money and prove results.  This is not easy for IVD products, but some form of trial is the preferred way. 

Kalorama says that while randomized controlled trials remain the preferred study design for establishing the causal effects of medical interventions on patient outcomes, other study designs can sometimes substitute for them, particularly in the evaluation of diagnostic products. Well-designed, non-randomized observational studies like patient cohort studies, case control studies, registries, and surveillance studies may all provide evidence that is sufficiently strong to inform payers making coverage and payment determinations.

Kalorama’s report, Reimbursement for IVD Tests contains detailed case studies of successful products, a complete explanation of the reimbursement process, statistics and relevant codes.  The report can be found at http://www.kaloramainformation.com/Reimbursement-IVD-Tests-7852349/