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Centers for Medicare and Medicaid Services
Joint Commission Will Not Accept COLA Accreditation
By Robert Michel | From the Volume XXX No. 2 – January 23, 2023 Issue
CEO SUMMARY: This may be a first in the 40-year history of CLIA accreditation of clinical laboratories. The Joint Commission (TJC) announced it will no longer recognize COLA’s laboratory accreditation program within “TJC-accredited facilities,” effective Jan 1, 2023. COLA-accredited labs …
New CPT Codes Debut for Digital Pathology Services
By Scott Wallask | From the Volume XXX No. 2 – January 23, 2023 Issue
CEO SUMMARY: New digital pathology CPT codes took effect Jan. 1. Because the new codes are designated as Category III, they are not subject to Medicare and private payer reimbursement yet. Instead, federal health officials will monitor the use of the new codes in 2023 to determine h…
CLIA on Path to Recognize Lab Data As a Specimen
By Scott Wallask | From the Volume XXX No. 2 – January 23, 2023 Issue
CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to …
PAMA Cuts Have Simply Been Kicked Down the Road
By R. Lewis Dark | From the Volume XXX, No. 1 – January 3, 2023 Issue
PAYMENT RATE CUTS FOR CLINICAL LABORATORY TESTS, called for under the Protecting Access to Medicare Act of 2014 (PAMA), have been avoided temporarily—again. A down-to-the-wire bill in Congress to keep the federal government funded into the new year in…
Eight Macro Trends for Clinical Labs in 2023
By Robert Michel | From the Volume XXX, No. 1 – January 3, 2023 Issue
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
Congress Averts PAMA Cuts to Lab Test Rates for 2023
By Scott Wallask | From the Volume XXX, No. 1 – January 3, 2023 Issue
CONGRESS ENACTED LEGISLATION LAST MONTH that suspends implementation of the next round of price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) that was scheduled to take effect on Jan. 1. This is a welcome development for the medical laboratory industry….
How Genomic Testing Labs Can Improve Their Relationships with Payers
By Robert Michel | From the Volume XXIX, No. 14 – October 10, 2022 Issue
CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially curtails speedy reimbursement of new and novel genomic test claims. A panel …
Feds Target Genetic Test and Telemedicine Fraud
By Robert Michel | From the Volume XXIX, No. 13 – September 19, 2022 Issue
MEDICARE FRAUD TOTALING $562 MILLION in genetic and cardiovascular tests is at the heart of recent federal criminal cases involving telemedicine that names clinical laboratory owners, physicians, and healthcare marketers as defendants. A host of indictm…
On Appeal, ACLA Gains PAMA Victory in Court
By Robert Michel | From the Volume XXIX, No. 12 – August 29, 2022 Issue
CEO SUMMARY: Last month, a U.S. Court of Appeals issued a ruling that criticized how the Department of Health and Human Services originally implemented the Protecting Access to Medicare Act of 2014 (PAMA). This ruling was a win for the American Clinical Laboratory Association in its…
Clinical Laboratories Face 20% Increase in CLIA Fees
By Robert Michel | From the Volume XXIX, No. 12 – August 29, 2022 Issue
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…
CURRENT ISSUE

Volume XXX No. 2 – January 23, 2023
The Dark Report explores the decision by The Joint Commission to no longer accept COLA-accredited facilities at its own accredited organizations, and reprints the letters sent by both TJC and COLA relative to the move. In other news, CLIA changes are coming and The Dark Report has an exclusive interview with a member of the committee studying those potential changes.
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