TAG:
acla
NILA, ACLA Respond to CMS 2019 Final Lab Rule
CEO SUMMARY: On Nov. 2, the federal Centers for Medicare and Medicaid Services released its Physician Fee Schedule for 2019. It says it will expand the number of labs from which it collects data about the lab test prices paid by private health insurers. While some labs may welcome these c…
ACLA Files Appeal in Federal PAMA Lawsuit
There is an important new development in the lawsuit in federal court that challenges how the Department of Health and Human Services (HHS) is implementing the Protecting Access to Medicare Act of 2014 (PAMA). An appeal was filed by attorneys representing the American Cli…
Two Federal Court Decisions Are Bad News for Labs
Every pathologist and clinical lab administrator should pay attention to two federal court decisions made recently in two different legal cases. One decision is bad news for the entire clinical lab industry. The other is bad news for lab companies that push compliance with federal anti-kickback laws….
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…
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…
Court Dismisses ACLA Claims in PAMA Case
CEO SUMMARY: While acknowledging that the American Clinical Laboratory Association raises important questions in its case against the federal Department of Health and Human Services, a district court judge ruled that the court cannot resolve the dispute and dismissed the ACLA’s claims f…
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 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…
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 …
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…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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