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In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
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 company attributed the revenue decline to a 96 percent drop in licensing revenues, which more than offset a 36 percent increase in product sales.
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.
Though the designation has seen slow uptake thus far, three tests received ADLT status in May, bringing the total number of approved ADLTs to five.
The bipartisan legislation would delay the reporting of lab payment data by a year and collect recommendations on improving PAMA payment reporting requirements.
The company's cofounders will pay $500,000 each to settle allegations by the US Department of Justice that they submitted false claims to Medicare.