TAG:
laboratory association
Patient Privacy Laws Create Legal Risk for Labs
CEO SUMMARY: Before the nation’s healthcare system can achieve the integrated universal EHR, it must fix the crazy contradictions in state and federal laws governing patient privacy. There is discordance between federal law and state law that defines the role and responsibility…
Two Years Later, CMS Still Holds Labs’ Competitive Bid Documents
IF ACTIONS SPEAK LOUDER THAN WORDS, then the federal government sends a clear message by its repeated refusal to return bidding documents to laboratories involved with the now-defunct Medicare Clinical Laboratory Services Competitive Bidding Demonstration project. That’s because, more than two yea…
Serious Problems Plague Newfoundland Laboratory
CEO SUMMARY: Newfoundland’s St. John laboratory was rocked by revelations in February that its cyclosporine testing was flawed, exposing patients to the harmful affects from inappropriately high doses of the immunosuppressant drug. Within weeks of this news, the Chief of Laboratory Medi…
New Clinical Lab Trends To Shape Events in 2010
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…
2009’s Top Ten Lab Stories Reflect Some Good, Bad
CEO SUMMARY: As the closing year of the first decade of the new century and the new millennium, 2009 brought neither disruption nor upheaval to the majority of laboratories in the United States. Rather, it was marked by at least two themes. One was how public disclosure of problems with l…
October 12, 2009 “Intelligence: Late Breaking Lab News”
In the continuing saga of health reform efforts in Washington, DC, the clinical laboratory industry got a bit of good news, at least for the moment. In recent weeks, the Senate Finance Committee removed a provision to raise $750 million annually by enacting a tax on clinical lab revenue. The proposed…
$750 Million Lab Test Tax Proposed in Senate Bill
CEO SUMMARY: A bill that may be the U.S. Senate’s framework for reforming the U.S. healthcare system calls for a tax of $750 million per year to be paid by lab testing companies. The proposed bill also calls for a reduction in Medicare reimbursement for lab testing. One positiv…
Textbook Marketing Fuels Demand for BRCA Test
CEO SUMMARY: In today’s lab testing marketplace, the hot ticket is to introduce a proprietary or patent-protected molecular test for cancer. The sales and marketing model inspiring many of these new lab testing companies is that used by Myriad Genetics, Inc. since it introduced…
CMS Refuses to Return Competitive Bid Docs
CEO SUMMARY: The Acting Secretary of Health and Human Services (HHS) has refused the request of three San Diego-area labs for the return of their bid documents—even though the competitive bidding demonstration project was repealed by Congress last July. The HHS Acting Secretary…
Medically Unlikely Edits Are Back–and a Problem!
CEO SUMMARY: On January 1, 2009, CMS implemented Phase VIII of its policy on medically unlikely edits (MUEs) involving about 100 laboratory CPT Codes. It also began to deny whole claims, not just the “medically unlikely” parts of claims. After hearing of the problem in early …
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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