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US Department of Health and Human Services
Labs Directly Attack Upcoming PAMA Cuts
By Scott Wallask | From the Volume XXXII, No. 13 – September 15, 2025 Issue
CEO SUMMARY: The clinical laboratory industry once again finds itself advocating on Capitol Hill for proposed legislation to deal with an old problem: test reimbursement rate cuts under PAMA. While Congress has delayed scheduled rate cuts for the last several years, PAMA c…
Lab Stakeholders Discuss PAMA Reform
By Stephen Beale | From the Volume XXXII, No. 10 – July 14, 2025 Issue
CEO SUMMARY: Medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Although labs have received PAMA reprieves from Congress over the last few years, laboratory associations argue that Congress needs to vote on long-term reforms rather than …
Lab Industry Fallout from CLIAC Termination
By Stephen Beale | From the Volume XXXII, No. 9 – June 23, 2025 Issue
CEO SUMMARY: Some diagnostic lab leaders and anatomic pathology practice owners may not immediately think that the elimination of a federal advisory panel should be on their radar. But the demise of the Clinical Laboratory Improvement Advisory Committee may cost labs by de…
Draft Rule Standardizes Electronic Signatures
By Robert Michel | From the Volume XXX, No. 6 – April 17, 2023 Issue
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…
OIG’s Issues New Opinion on Use of Gift Cards for Lab Specimens
By Scott Wallask | From the Volume XXX, No. 6 – April 17, 2023 Issue
CEO SUMMARY: This new Advisory Opinion from the Office of Inspector General (OIG) outlines a narrow situation in which it may be allowable for clinical laboratories to use gift cards to encourage pa…
January 10, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 1 – January 10, 2022 Issue
Imagine a medical lab temporarily closing because of the demand for too many tests! That’s just what happened at one of Australia’s largest medical lab companies. Australian Clinical Labs had to temporarily discontinue offering COVID-19 testing because test volumes had gotten too large. Au…
CURRENT ISSUE
Volume XXXIII, No. 1 – January 19, 2026
The Dark Report looks at the FDA’s move to reclassify Oncology companion diagnostics as Class II medical devices and considers how labs can benefit. Also, observers are concerned about the effect of PAMA cuts on rural clinical laboratories.
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