TAG:
Centers for Medicare and Medicaid Services
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 …
Using Sophisticated Schemes, Fraudsters Hit the Next Level
By Jillia Schlingman | From the Volume XXXII, No. 10 – July 14, 2025 Issue
Investigators and fraudsters appear to be upping their game as the government seeks to punish those filing unscrupulous Medicare claims. These aspects were clear in the US Department of Justice’s (DOJ) announcement last month of the largest healthcare fraud takedown reportedly in US history. Cli…
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…
LDT Oversight May Fall to Congress, CLIA
By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
May 12, 2025, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue
Yet another clinical laboratory has sold off part of its services to a national commercial lab. Labcorp announced on April 21 that it had finalized its acquisition of North Mississippi Health Services’ (NMHS) ambulatory outreach laboratory business. A…
Enjoy the LDT Court Victory, Yet Remain Vigilant
By R. Lewis Dark | From the Volume XXXII, No. 6 – April 21, 2025 Issue
VICTORY IN COURT! FOR AN INDU…
In the Past, Labs Used Courts to Thwart Feds
By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue
CEO SUMMARY: A federal judge’s recent decision to vacate the FDA’s final rule on laboratory developed tests harkens back to a 2008 case where clinical labs stopped a CMS competitive bidding project. In the earlier case, legal risks led the government to back down. The …
Trump Signs Executive Order on Price Transparency
By Robert Michel | From the Volume XXXII, No. 5 – March 31, 2025 Issue
ON FEBRUARY 25, PRESIDENT DONALD TRUMP SIGNED AN EXECUTIVE ORDER targeted at driving price transparency requirements for hospitals and insurers. The order aims to strictly enforce a previous rule, signed during his first term, intended to provide patients with cl…
Proposed Clinical Laboratory Price Transparency Bill
By Robert Michel | From the Volume XXXII, No. 3 – February 17, 2025 Issue
IN DECEMBER, THE CLINICAL LABORATORY PRICE TRANSPARENCY ACT OF 2023 was referred to the U.S. House Ways and Means Subcommittee on Health for final approval. The bill requires labs to disclose information regarding pricing before administering services. The goal is to ensure patients better understand…
Federal Lawsuit Favors Lab Accused of AKS Violations
By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue
CEO SUMMARY: This whistleblower lawsuit initially charged a clinical lab with, among other things, violating the Anti-Kickback Statute and EKRA. After the judge ruled to exclude the AKS and EKRA claims, the whistleblower refiled the case and included claims the lab paid commissions for th…
CURRENT ISSUE
Volume XXXIII, No. 9 – July, 2026
Newsmaker Interview with Revvity’s Yves Dubaquie > How Specialty Diagnostic Tests Connect with Lab Customers: In this exclusive Q&A, Revvity’s Yves Dubaquie provides details about the in vitro diagnostics company’s priorities, including developing specialty tests and reviewing its business in China. Dubaquie also explains why clinical laboratories may need to consider hiring more technology-savvy workers in the future as the complexity of instruments grows.
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