TAG:
american clinical laboratory
Congress Likely to Pass Deep Cuts in Lab Test Fees
By Robert Michel | From the Volume XVIII No. 14 – October 17, 2011 Issue
CEO SUMMARY: All signs point to a potentially dismal financial outcome for the clinical lab testing industry as Congress tries to trim spending by $1.2 trillion over the next 10 years. At least three proposals to significantly cut lab test reimbursement are in active debate by fe…
September 6, 2011 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XVIII No. 12 – September 6, 2011 Issue
Cleveland Heart Lab closed on a Series B financing round that totals $18.4 million. The money was provided by Excel Venture Management, Healthcare Ventures, and existing investors. Executives at Cleve- land Heart Lab said the new funds will be used t…
Congress Again Considers Co-Insurance for Lab Tests
By Robert Michel | From the Volume XXVIII No. 11 – August 15, 2011 Issue
CEO SUMMARY: Congressional cost-cutters are putting the 20% patient co-pay/coinsurance requirement for lab testing back on the table. The added complication this year is that the new Joint Select Committee on Deficit Reduction is mandated to produce its own list of cuts to the Me…
Many Questions About FDA Regulation of LDTs
By Robert Michel | From the Volume XVII No. 14 – October 4, 2010 Issue
CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprie…
Labs Hope to Renegotiate 1.75% Medicare Fee Cuts
By Robert Michel | From the Volume XVII No. 12 – August 23, 2010 Issue
CEO SUMMARY: As Congress crafted its reform of the nation’s healthcare system last year, it asked healthcare providers to contribute substantially to the cost of the Patient Protection and Affordable Care Act. The lab industry will see a 1.75% cut in reimbursement for Medicare …
Patient Privacy Laws Create Legal Risk for Labs
By Robert Michel | From the Volume XVII No. 10 – July 12, 2010 Issue
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
By Robert Michel | From the Volume XVII No. 6 – April 19, 2010 Issue
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…
New Clinical Lab Trends To Shape Events in 2010
By Robert Michel | From the Volume XVII No. 1 – January 4, 2010 Issue
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
By Robert Michel | From the Volume XVI No. 17 – December 14, 2009 Issue
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”
By Robert Michel | From the Volume XVI No. 14 – October 12, 2009 Issue
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…
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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