Industry players, faced with vague communications from the agency, scramble to decipher regulatory expectations and criticize the agency for trying to control PGx knowledge.
The Centers for Medicare & Medicaid Services announced it would cover approved CAR-T therapies for Medicare patients, according to the Associated Press.
As NGS testing becomes more widespread, labs, payors, and professional groups confront questions about which genes should be required as part of clinical assays.
H.R. 3235, a long time priority for the National Society of Genetic Counselors, would allow CMS to reimburse genetic counselors for counseling Medicare beneficiaries.
Two senators have asked a government watchdog to see if CMS made payments to US providers who have partnered with firms including WuXi NextCode and BGI.
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.
In a point-counterpoint in the Boston Globe, researchers discuss the potential of gene editing to prevent Lyme disease, but also the pitfalls of doing so.
