Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

Subscriber?
Search

TDR Insider

FDA May Reclassify Oncology Companion Diagnostics to Class II Devices

TDR Insider /

Regulatory attorneys indicate that the FDA’s move to reclassify oncology companion diagnostics to Class II medical devices could speed approvals and reduce costs for submissions. From a business perspective, the proposal could allow clinical laboratories to expand their testing options, bring more tests in house, and attract new investment. The public comment period for the […]

To access this post, you must purchase The Dark Report.

FDA May Reclassify Oncology Companion Diagnostics to Class II Devices Read More »

Top Stories in 2025 Played Out in Courts and on Capitol Hill

TDR Insider /

For clinical laboratory and pathology leaders, 2025 presented a year of profound transformation. Regulatory rulings, legislative efforts, technological innovation, and market consolidation reshaped the landscape for clinical labs. Here, members of The Dark Report can read our top 10 stories of the year. In a repeat from last year, regulation of laboratory developed tests (LDTs)

To access this post, you must purchase The Dark Report.

Top Stories in 2025 Played Out in Courts and on Capitol Hill Read More »

Labs Enter a Critical PAMA Reform Window

TDR Insider /

CEO SUMMARY: A reprieve of upcoming PAMA cuts to lab test reimbursement rates is official with an extension through Jan. 30, 2026. This, however, is not a lot of time and pressure is on the clinical laboratory industry to get the RESULTS Act passed to permanently reform PAMA. Lab industry advocates are urging individual diagnostic

To access this post, you must purchase The Dark Report.

Labs Enter a Critical PAMA Reform Window Read More »

NYU Langone Rolls Out Digital Pathology in One Year

TDR Insider /

During an ambitious one-year project, NYU Langone Health implemented full-scale digital pathology. Although the initiative was large, a key organizer insists that smaller diagnostic labs can use some of the same approaches. Two big lessons to convey: Document the gritty details of pathology workflows with the IT team and push technology vendors to help a

To access this post, you must purchase The Dark Report.

NYU Langone Rolls Out Digital Pathology in One Year Read More »

CAP Regains Veterans’ Affairs Lab Accreditation Contract

TDR Insider /

In a blow to The Joint Commission, the US Department of Veterans Affairs has awarded a new clinical laboratory accreditation contract to the College of American Pathologists (CAP). The decision highlights the competition between the two accrediting organizations and sheds light on how CAP’s inspection process holds value to the federal agency. The deal could

To access this post, you must purchase The Dark Report.

CAP Regains Veterans’ Affairs Lab Accreditation Contract Read More »

After Regaining its Outreach Service, Lab Grows It by $10M

TDR Insider /

In this case study, Kootenai Health in Idaho explains how taking back lab outreach services from a commercial lab company can improve physician satisfaction, enhance patient care, and increase revenue. Although the transition was bumpy, within two years of bringing outreach in house, those services contributed $10 million to the health system’s bottom line. This

To access this post, you must purchase The Dark Report.

After Regaining its Outreach Service, Lab Grows It by $10M Read More »

RESULTS Act Directly Attacks Upcoming PAMA Cuts

TDR Insider /

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 critics feel a more permanent solution is needed. A new act offers hope that action

To access this post, you must purchase The Dark Report.

RESULTS Act Directly Attacks Upcoming PAMA Cuts Read More »

What’s Behind the Surge in Laboratory Outreach Sales?

TDR Insider /

The recent CHS-Labcorp deal is one of many that highlights a market shift. Clinical lab outreach services, once viewed as strategic assets, are being sold off rapidly as hospitals recenter around core services and offload logistical burdens. This year, 30% of lab mergers and acquisitions involve outreach agreements, with national lab companies seeing opportunities to

To access this post, you must purchase The Dark Report.

What’s Behind the Surge in Laboratory Outreach Sales? Read More »

Clinical Laboratories Battle Complex Claims Denials

TDR Insider /

While the number of denials is not going up, the reasons that private payers deny claims are becoming more complex and time-consuming to appeal. After reviewing noteworthy trends among payers, learn a three-level approach to appeals that may lead to greater success and speed up the process. “The good news is that the volume of

To access this post, you must purchase The Dark Report.

Clinical Laboratories Battle Complex Claims Denials Read More »

Lab Stakeholders Discuss PAMA Reforms

TDR Insider /

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 stop-gap measures. Labs scored one victory when the Trump administration declined to

To access this post, you must purchase The Dark Report.

Lab Stakeholders Discuss PAMA Reforms Read More »

;