TAG:
Federal Register
FDA Issues Proposed Rule to Further Regulate LDTs
CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…
Draft Rule Standardizes Electronic Signatures
CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in…
Clinical Laboratories Face 20% Increase in CLIA Fees
CHANGES HAVE BEEN PROPOSED to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that would raise fees by 20% for clinical laboratories and amend certain testing personnel qualifications. The American Hospital Association (AHA) has obj…
Federal Rule to Revise Out-of-Network Billing
CEO SUMMARY: Remaining out of network with health insurance companies may boost revenue for providers, including anatomic pathologists and emergency room physicians. But the good times may soon end. Last month four federal agencies issued rules that implement new requirements under …
Comment Period Closing on Federal Surprise Billing Rule
PATHOLOGY GROUPS AND CLINICAL LABS HAD UNTIL SEPTEMBER 7 to comment on an interim final rule that provides federal protections against surprise billing and limits out-of-network (OON) cost sharing under many of the circumstances in which surprise bills arise most frequently….
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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