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Federal Register
HHS Revises HIPAA Privacy, Security Rule
By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue
CEO SUMMARY: Officials at the Department of Health and Human Services (HHS) are proposing significant changes in what observers are calling a major revision to HIPAA’s requirements for protected health information (PHI) and cybersecurity. HHS issued a statement that the objective of the…
January 6, 2025, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXXII, No. 1 – January 6, 2025 Issue
In response to the 2021 federal law requiring all medical test results to be released to a patient’s electronic medical record upon availability, a team of researchers at Michigan Medicine recently conducted a study to learn whether patients could understand the standard pathology …
ACLA Files Court Challenge to FDA’s Final LDT Rule
By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue
CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.†ACLA and HealthTrackRx are challenging the FDA’s  
Significant Developments Are Shaping Lab Market
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
CEO SUMMARY: With 140 speakers and 1,000+ attendees, this year’s Executive War College again provided a comprehensive picture of the specific forces reshaping the U.S. market for lab testing services. Presented here is a smorgasbord of information and innovation shared by different spea…
FDA Issues Proposed Rule to Further Regulate LDTs
By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue
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
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…
Clinical Laboratories Face 20% Increase in CLIA Fees
By Scott Wallask | 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…
Federal Rule to Revise Out-of-Network Billing
By Robert Michel | From the Volume XXVIII, No. 14 – October 18, 2021 Issue
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
By Robert Michel | From the Volume XXVIII, No. 12 – September 7, 2021 Issue
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….
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