CMS Proposes a New Rule That Would Shift Many Procedures from High-Cost Inpatient Healthcare Settings to Lower-Cost Outpatient Ambulatory Surgical Centers

If the proposed rule becomes final, it may shift some inpatient medical laboratory testing away from hospital labs and to independent clinical laboratories Medical laboratories in hospitals and health systems already feel the pinch of less test orders originating from their own emergency departments (ED). Now, more tests associated with inpatient care might also shift away from hospital labs due to a new proposed rule from the federal Centers for Medicaid and Medicare Services (CMS) that would...

Kissinger, Mattis, and Murdoch Possible Government Witnesses for the Prosecution against Elizabeth Holmes in Theranos Clinical Laboratory Testing Fraud Case

The federal trial, now set to begin in March 2021, could become a media spectacle given the marquee names on the witness list Clinical laboratories following the federal criminal proceedings against Theranos founder and former CEO Elizabeth Holmes will have to wait until next year for the case to go to trial. When it does, it could become a media spectacle given the list of prominent witnesses who may be called as government witnesses. The names, according to a letter that prosecutors sent...

Delays in Reporting Results of COVID-19 Clinical Laboratory Tests Prompt Florida Governor to End SARS-CoV-2 Testing Contract with Quest Diagnostics

Quest said a ‘technical issue’ had delayed reporting of test data to the state and claimed that patients and providers still received the results in a timely manner Florida Governor Ron DeSantis has ordered state agencies to cut ties with Quest Diagnostics due to delays in reporting nearly 75,000 COVID-19 clinical laboratory test results going back as far as April. The medical laboratory giant provided the backlogged data in what the state described as an “unacceptable dump” that inflated the...

Despite the Coronavirus Pandemic, Medicare Officials Continue Push for Price Transparency by Pressuring Hospitals to Disclose Rates Negotiated with Private Payers

Clinical laboratories are advised to continue developing methods for making prices for procedures available to the general public Even as an effective treatment for COVID-19 continues to elude federal healthcare agencies, Medicare officials are pressing ahead with efforts to bring about transparency in hospital healthcare pricing, including clinical laboratory procedures and prescription drugs costs. In FY 2021 Proposed Rule CMS-1735-P, titled, “Medicare Program; Hospital Inpatient Prospective...

Abbott Lab’s ID NOW COVID-19 Rapid Molecular Test Continues to Face Scrutiny over ‘False Negatives’

Though the test initially drew ‘raves’ from Trump administration, the FDA now suggests negative results should be confirmed with an additional ‘high-sensitivity authorized SARS-CoV-2 molecular test’ This spring, as the United States attempted to jump-start a national response to the SARS-CoV-2 coronavirus pandemic, the Trump administration heralded Abbott Laboratories’ five-minute test for COVID-19 as a major breakthrough. But even as the federal Food and Drug Administration (FDA) issued...

Coronavirus Fraud Takes Many Forms as Federal and Local Officials Continue to Pursue Widespread Cases of Clinical Laboratory Testing Scams

Since the pandemic began, federal investigators are specifically looking for patterns of fraud in Medicare claims data for COVID-19 clinical laboratory testing Last month, the federal Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced it had been investigating trends in Medicare claims data that could indicate patterns of fraud in the billing for COVID-19 clinical laboratory tests, Modern Healthcare reported. Stretching back to at least March, fraudulent...