TAG:
laboratory association
ACLA Lawyer Says Judge’s PAMA Ruling Is Narrow
CEO SUMMARY: Many lab professionals were disappointed at the news that a federal judge dismissed the American Clinical Laboratory Association’s arguments in its lawsuit against the federal Department of Health and Human Services (HHS). In an interview, the ACLA’s lead lawyer on the ca…
No relief in sight for 2018 Clinical Laboratory Fee Schedule, but critical issues remain
This is an excerpt from a 2,400-word article in the October 1, 2018 issue of THE DARK REPORT. The complete article is available at all times to paid members of the Dark Intelligence Group, and non-members may access one premium article per month. CEO SUMMARY: Many lab professionals a…
FDA Issues Response to Draft Legislation to Regulate LDTs
DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA…
CMS physician fee schedule: Will hospital labs be excluded again from PAMA price reporting?
CEO SUMMARY: Publication of the draft CMS Physician Fee Schedule on July 12 brought unwelcome news for the clinical lab industry, at least as it pertains to that perennial question: Should hospital lab outreach data be included in a PAMA market study? The federal Centers for Medicare and …
CMS Shows Its Hand in New Draft Rules for 2019
CEO SUMMARY: Publication of the draft Medicare Physician Fee Schedule on July 12 brought unwelcome news for the clinical lab industry, at least as it pertains to whether hospital lab outreach data should be included in the PAMA market study that the federal Centers for Medicare and Medica…
In Lawsuit Against HHS, ACLA Has Strong Positions
CEO SUMMARY: Rulings from Judge Amy Berman Jackson of the U.S. District Court in Washington, D.C., are expected soon in the ACLA’s lawsuit against HHS concerning the PAMA final rule that set the course for the new Medicare CLFS rates implemented in January 2018. One lawyer following the…
Legal Briefs Explain Problems with PAMA Implementation
CEO SUMMARY: Several developments have moved the case forward since December when the American Clinical Laboratory Association filed suit in federal court against the Department of Health and Human Services. Inrecent weeks, ACLA filed for summary judgment; HHS responded with its own reque…
Response to FDA’s Gottlieb on Reducing Regulatory Burden
IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He …
FDA’s Gottlieb Favors Flexibility with LDTs, NGS
CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To d…
ACLA Sues HHS, Claims Flaws In How CMS Set 2018 Rates
CEO SUMMARY: When the American Clinical Laboratory Association filed its lawsuit Dec. 11 against the Secretary of Health and Human Services, one of its main claims is that HHS collected payment data on the clinical laboratory testing business in a manner that was deeply flawed. HHS then u…
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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