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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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