TAG:
Centers for Medicare and Medicaid Services
CLIA Accreditation Market: More Competitive Now?
CEO SUMMARY: It’s been three decades since compliance with the Clinical Laboratory Improvement Amendments (CLIA) became mandatory. During that time, there has been little competition among the major organizations with deeming status by the Medicare Program to accredit labs to CLIA…
Interesting New Surprises for Lab Leaders
Unexpected and surprising things continue to happen in the clinical laboratory industry. You might consider that to be one unifying theme to the intelligence briefings we present in this issue of The Dark Report. For example, a…
Genesis Lab Lawsuit Pursues UnitedHealth Over Unpaid Test Claims
This is an excerpt of a 1,946-word article in the July 6, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: New case law in how health insurers should reimburse for COVID-19 lab test claims might be one outc…
NJ Lab Sues UnitedHealth Over Unpaid Test Claims
CEO SUMMARY: New case law in how health insurers should reimburse for COVID-19 lab test claims might be one outcome if a New Jersey lab company were to prevail in a federal lawsuit it filed against UnitedHealthcare alleging non-payment of COVID-19 test claims. An interesting fact me…
CMS Shuts Missouri Lab Due to ‘Immediate Jeopardy’
CEO SUMMARY: CMS ordered Gamma Healthcare to close its two labs, revoked the owners’ CLIA licenses, prohibited them from operating a lab for two years, and ordered payment of more than $55,000 in civil penalties. The two lab facilities had been running COVID-19 and other tests for…
Understanding Key Parts of New AKS, Stark Law Rules
CEO SUMMARY: Both the federal Stark Law and Anti-Kickback Statute have been revised and the final rules became effective on Jan. 19. The good news for clinical laboratories and anatomic pathology groups is that federal regulators from the Centers for Medicare and Medicaid Services a…
New Federal Rule: Non-Physician Providers Can Supervise Testing
SUMMARY: It’s the latest example of how interim rules issued earlier this year in response to the pandemic are being made permanent by the federal Centers for Medicare and Medicaid Services. Issued on Dec. 2, this new final rule allows certain non-physician practitioners—includi…
FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says
This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implic…
HHS ‘Stands Down’ FDA on Its Oversight of LDTs
CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…
Proposed Medicare 2021 PFS Cuts Pathology Fees by 9%
IF THE PROPOSED MEDICARE 2012 PHYSICIAN FEE SCHEDULE (PFS) RULE—published by the Centers for Medicare and Medicaid Services (CMS) on Aug. 4—takes effect as currently written, pathology professional fees will be cut by 9%, effective Jan. 1, 2021. This was not…
CURRENT ISSUE
Volume XXVIII, No. 10 – July 26, 2021
In the past 24 to 36 months, some labs have quietly begun using AI-powered applications that are being used to improve operational work processes, to streamline coding/billing/collections, and for analyzing digital pathology images. Also, genetic tests are growing in number and complexity, making it ever harder for labs to get paid.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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