TAG:
clinical lab tests
Coming Next Year for Labs: PAMA, FDA, LDTs, and More
CEO SUMMARY: As 2016 approaches, nearly every lab organization is watching and waiting to learn how federal regulators at CMS and the FDA will move forward with plans to implement PAMA market reporting and regulation of laboratory-developed tests, respectively. Most knowledgeable observer…
Protecting Access to Medicare Act of 2014: Will price reporting rule drive small labs out of business?
This first assessment of the PAMA (Protecting Access to Medicare Act of 2014) proposed rule on market reporting of lab prices gives pathologists and lab executives insights about the good, the bad, and the…
CMS Releases Draft of PAMA Market Price Rule
CEO SUMMARY: CMS’ proposed rule details how it will collect private market data, then use that data to establish prices for the Medicare Part B Clinical Laboratory Fee Schedule beginning in 2017. The proposed rule will limit data reporting to les…
RFID Lab Inventory System Saves $465K in First Year
CEO SUMMARY: Seeking ways to automate every aspect of work flow, the clinical laboratory at St. Francis Health System in Tulsa, Oklahoma, implemented a unique automated laboratory inventory management system that utilizes RFID. In the first four months, the system helped the hosp…
Lab Test Utilization Delivers Big Gains at Cleveland Clinic
CEO SUMMARY: Since the launch of a laboratory test utilization program in 2011 at the Cleveland Clinic, more than 35,000 duplicate or inappropriate test orders have been stopped. The test utilization team introduced five initiatives that are not designed to cut spending but to in…
Fewer Blood Draws at UCSF Boost Patient Satisfaction
CEO SUMMARY: Physician residents at the UCSF School of Medicine set a target of reducing unnecessary blood draws. By eliminating needless needle sticks, the residents are focusing on patient experience while also encouraging physicians to pay more attention to the need to decreas…
What Labs Need to Do as Payers Audit More Claims
CEO SUMMARY: Attorneys who advise pathologists and clinical laboratories on compliance issues say the number of audits from the government and third-party payers has increased sharply in recent years. In those audits, payers are looking for recoupment of overpayments. A lab’s fai…
LabCorp Prepares to Expand Direct-to-Consumer Test Program
RECENT DEVELOPMENTS MAKE IT SEEM as if lab test orders signed by physicians might soon go out of style. Last month in Arizona, Theranos played a role in changing a state law that now lets consumers order their own clinical laboratory tests without a physician’s order. Then, before the end of …
April 20, 2015 Intelligence: Late Breaking Lab News
It’s a lawsuit that Quest Diagnostics Incorporated can’t seem to make go away. Last week in California, a federal judge ruled Hunter Laboratories and Surgical Pathology Associates (SPA) can continue to pursue their antitrust lawsuit against Quest Diagnostics. …
What’s New at Theranos? Lab Firm Expands in AZ
CEO SUMMARY: Over the past 18 months, Theranos has taken steps to enter the clinical lab marketplace. Across Greater Phoenix, Theranos now has specimen collection centers in about 40 Walgreens pharmacies. It is opening a CLIA lab facility in Scottsdale. Now that it is delivering…
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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