CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
The diversity of the organizations that have signed the letter to CMS demonstrates widespread concern over this policy.
CMS's move to restrict coverage could limit test access for early-stage cancer patients and negatively impact lab revenues.
At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.
Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.
The agency asked Reps. Bucshon and DeGette to consider the precertification program idea as they work on refining the draft of the Diagnostic Accuracy and Innovation Act.
These lobbying efforts aim to shore up willingness among legislators to step in and halt implementation of the NCD if certain provisions remain in the final version.
New Medicare rates established under PAMA will cause labs to scale back services, and in some cases shut down, the motion states.
The year brought more FDA approvals for molecularly targeted drugs and NGS tests for personalizing cancer treatment, but reimbursement remained a stress point for industry.
The suit filed against the acting HHS secretary alleges that a flawed data collection process failed to establish market-based rates.
Bloomberg reports that the DNA-for-cash deal reported in Kentucky might be a more widespread scam.
St. Jude Children's Research Hospital scientists have treated infants with X-linked severe combined immunodeficiency using gene therapy in an early phase study.
St. Louis Public Radio reports that some African Americans are turning to DNA ancestry testing to help guide genealogical searches.
In Nature this week: a genomic analysis of the snailfish Pseudoliparis swirei, ancient DNA analysis gives insight into the introduction of farming to England, and more.