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 CMS ruling follows the release of data showing strong performance of the test, including its ability to detect bloodstream pathogens missed by blood culture.
As NGS testing becomes more widespread, labs, payors, and professional groups confront questions about which genes should be required as part of clinical assays.
The ruling overturned a lower court decision that blocked ACLA's suit challenging the data collection process used by CMS to set test prices under PAMA.
The company said that the Centers for Medicare and Medicaid Services wrongly suspended its Medicare reimbursement payments, causing financial distress.
The bipartisan legislation would delay the reporting of lab payment data by a year and collect recommendations on improving PAMA payment reporting requirements.
