Gail H. Javitt and Robert E. Wanerman, Members of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, co-authored an article in Health Affairs, titled “CMS Coverage Decision May Raise Barriers to Precision Cancer Medicine and Reduce Incentives for Evidence Development.”

Following is an excerpt:

A national coverage decision (NCD) published on March 16, 2018 by the Center for Medicare and Medicaid Services (CMS) focuses attention on foundational challenges to integrating genomics into clinical medicine; in particular, who should decide whether a technology is ready for clinical integration, what criteria should be used, and whether the vision of a “learning healthcare system” is compatible with the current fragmented regulatory environment for laboratory testing. 

Next generation sequencing is a laboratory method that enables rapid sequencing of large sections of DNA derived from a patient’s specimen (blood or saliva). The increased efficiency of NGS cancer tests, combined with reductions in cost, has made it feasible for laboratories to deliver a substantial amount of patient genetic data to physicians. In the case of cancer, NGS cancer tests has been used to sequence both tumor DNA and the patient’s own (germline) DNA, in order to help physicians develop more precise treatments plans for their patients.

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