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Volume XXVII, No. 12 - August 24, 2020

FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says

TDR Insider / By Robert Michel

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 implications for the federal Food and Drug Administration’s efforts …

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Labs Adjust to COVID-19 as a Regular Part of Care

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

ONE INTERESTING NEW DEVELOPMENT NOT REPORTED MUCH BY THE NATIONAL MEDIA is that the daily number of new COVID-19 cases in the United States has declined steadily in the past month. It is too early to understand the implications of this development, but clinical lab administrators and pathologists may want to follow a basic statistic. Here at The Dark …

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HHS ‘Stands Down’ FDA on Its Oversight of LDTs

Laboratory Compliance / By Robert Michel

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 that labs “are not required” to obtain an FDA emergency use authorization or FDA clearance of LDTs. Clinical labs welcomed …

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DOJ Indicts Ten Individuals for Pass-Through Lab Test Billing Fraud

Laboratory Billing / By Robert Michel

PASS-THROUGH LAB TEST BILLING SCHEMES involving rural hospitals and $1.4 billion in fraudulent lab test claims are at the core of multiple indictments announced recently by the federal Department of Justice (DOJ). Ten individuals—including laboratory owners, billing company executives, and hospital administrators—were charged in an elaborate pass-through billing scheme using four rural hospitals in three states to submit fraudulent bills for laboratory testing, federal officials …

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Specimen Volume Returns at Dallas-based ProPath

Anatomic Pathology / By Robert Michel

CEO SUMMARY: Like other physician specialties, anatomic pathology saw a dramatic collapse in the number of daily procedures with a corresponding decline in cash flow as the COVID-19 pandemic hit with full force in March, April, and May. The good news is that the daily volume of tissue referrals is increasing steadily as patients decide it will be safe to …

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Quest Reports 46% Decline in New Cancer Diagnoses in March

Anatomic Pathology / By Robert Michel

ONCE SHELTER-IN-PLACE ORDERS WERE ENACTED IN MARCH because of the COVID-19 pandemic, the number of new diagnoses of cancer declined sharply in the United States. Newly-published data confirms this fact. The data also support the warnings of anatomic pathologists that—because of the pandemic and shelter-in-place directives—fewer patients visited physicians’ offices, meaning many cases of cancer and other conditions could go undiagnosed. In new …

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Wisconsin Lab Network Feeds Valuable Data to State Health Lab

Clinical Laboratory / By Robert Michel

CEO SUMMARY: From the earliest days of the COVID-19 pandemic, the 138-member Wisconsin Clinical Laboratory Network has reported to the state health lab the number of COVID-19 tests, the number of positive results, as well as other data that includes data on lab testing supplies and capacity. Founded 20 years ago, the network is a public-private partnership that allows participating …

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Thermo–Qaigen Merger Stopped, More IVDs Report Q2 Earnings

In Vitro Diagnostics / By Robert Michel

EACH TIME A MAJOR IN VITRO DIAGNOSTICS (IVD) COMPANY reports its quarterly earnings, clinical lab executives and pathologists gain useful new perspectives as to how the COVID-19 pandemic is fueling demand for IVD instruments, tests, and lab consumables. In this round-up of the most recent quarterly earnings reports, we provide details about Thermo Fisher Scientific, Agilent Technologies, bioMerieux, Bio-Rad, and Sysmex Corporation. IVD …

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CMS Publishes Proposed 2021 Medicare Physician Fee Schedule

Clinical Laboratory Trends / By Robert Michel

MEDICARE’S PROPOSED PHYSICIAN FEE SCHEDULE (PFS) rule was announced on Aug. 4, 2020. The rule had one positive development for clinical laboratories and hospital laboratory outreach programs and a negative development for anatomic pathologists. Clinical laboratories and hospital outreach labs will welcome the news that the proposed 2021 rule would delay the next Clinical Laboratory Fee Schedule (CLFS) reporting period by an additional year This …

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Proposed Medicare 2021 PFS Cuts Pathology Fees by 9%

Anatomic Pathology / By Robert Michel

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 welcome news for the anatomic pathology profession. The proposed 9% cut to Medicare payment for pathology services is the result of CMS deciding …

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