AdvaMed
FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests
The rule, which would make explicit FDA's authority to regulate LDTs, is certain to face pushback from many in the laboratory and diagnostics industries.
AdvaMed Partners With Dx Companies to Create National COVID-19 Supply Registry
According to the registry's first dataset, more than 65 million tests have been manufactured and shipped across the US.
Senators Introduce Bill to Make Medicare Local Coverage Decision Process More Transparent
S.794 would require Medicare contractors to hold public meetings and disclose the rationale and evidence underlying an LCD at the start of the process.
The law contains provisions that proponents say will advance precision medicine and speed new tests to market, but critics worry if this will come at a cost to public health.
Industry-Backed Bill Introduced in House as Frustration Grows over CMS Payment Process for MDx
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Originally published Oct. 1.
A new bill strongly supported within the diagnostics industry could put pressure on the Centers for Medicare & Medicaid Services to alter its procedures for setting reimbursement rates for molecular diagnostics.