TAG:
clinical lab tests
ACLA Gets Procedural Win in Its Appeal of PAMA Case
IN A SIGNIFICANT WIN for the American Clinical Laboratory Association (ACLA) and other groups suing federal Department of Health and Human Services (HHS), the U.S. Court of Appeals for the District of Columbia ruled in the ACLA’s favor on July 30. Ruling on the ap…
Aetna Ends Payment for Professional Component
CEO SUMMARY: As of Aug. 1, Aetna will stop paying out-of-network pathologists for the professional component review of certain clinical pathology tests. Until now, the health insurer has paid for the professional component when out-of-network labs billed for clinical lab tests using the m…
What Labs Can Expect from PAMA in 2019
CEO SUMMARY: Attendees at the Executive War College learned that CMS has taken steps to expand the number of hospital labs required to report their private payer lab test price data under the Protecting Access to Medicare Act, but the unbundling of certain test panels could be problematic…
Senator Asks: Are Lab Test Payments Too High?
CEO SUMMARY: It is ironic that, after the federal Centers for Medicare and Medicaid Services (CMS) enacted the deepest price cuts to the Part B Clinical Laboratory Fee Schedule in more than 50 years, a U.S. Senator now asks CMS why it will pay billions more for lab testing. The question f…
CMS Adjustments for Medicare Fee Schedule Might Be Too Late
This is a summary of two articles in the Nov. 13, 2018 issue of THE DARK REPORT. The complete articles are available only to paid members of the Dark Intelligence Group. CEO SUMMARY: On Nov. 2, the federal Centers for Medicare and Medicaid Services released its Physician Fee S…
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…
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…
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…
Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry
“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.” …
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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