In Part I of this two-part article, an important distinction was highlighted between diagnostic and prognostic tests. The latter typically are not a benefit category in insurance programs or are not a covered category of tests. That is, most health plans treat prognostic tests (e.g. some genetic tests) as experimental or investigational. This distinction is important in genomics and personalized medicine, the tailoring of medical treatment to the individual characteristics of each patient. In this arena, genetic testing and molecular diagnostic testing can help us attain a deep understanding of the mechanism of the disease and apply “actionable therapies” for treatment.
In the 2015 State of the Union address, President Obama launched the Precision Medicine Initiative (PMI). He lauded this initiative as helping to “give all of us access to personalized information we need to keep ourselves and our families healthier,” (cite: 2015 Presidential State of the Union Address, January 20, 2015). With this announcement, the President looked to Vice President Biden to lead a national “Moonshot” initiative to eliminate cancer. These developments reflect the importance that society places on advances in genomic knowledge and its application.
Next generation sequencing (NGS) comprises a collection of new technologies that allow rapid sequencing of large segments of an individual’s DNA and even an individual’s entire genome. Reliable and accurate NGS technologies have the potential to accelerate personalized or precision medicine. They may be able to discover rare variants for which it may be impractical for test developers to provide conclusive evidence supporting clinical significance.
Until the relatively recent acceptance of precision medicine most medical treatments have been designed for the “average” patient.
Precision medicine, on the other hand, is an innovative approach that takes into account potentially highly relevant differences in the genetic material present within an individual’s own germline or, in the case of cancer, the malignancy itself.
The National Institutes of Health (NIH) received funding for a national research cohort of at least one million Americans. They will be asked to volunteer to share their information – including genetic, clinical and other data – to improve research. This work will focus on expanding current cancer genomics research, and initiating new studies on how tumor DNA can inform prognosis and treatment choices.
The availability of precision medicine in the United States has been limited, in part, by federal regulatory agencies. For example, the Medicare program publishes coverage and payment policies based on medical policies developed by its medical directors. In many cases, those policies deem many diagnostic tests as experimental or investigational, thus, not eligible for reimbursement. This is a larger problem because commercial health plans tend to follow many Medicare practices.
A policy solution is being pursued by several representative organizations, including the American Bar Association whose Health Law Committee is considering amending the Medicare statute Section 1862 (42 USC 1395y). This policy effort is supported by a detailed advocacy paper, which is intended to be presented to government representatives in the near future.
