News & Analysis as of

Diagnostic Tests Department of Health and Human Services (HHS) Coronavirus/COVID-19

Knobbe Martens

FDA Issues Final Guidance on Transitioning from COVID-19 EUAs

Knobbe Martens on

The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more

Venable LLP

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

Venable LLP on

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

Holland & Hart - The Benefits Dial

It May Not Be Urgent…But It’s Still an Emergency

Although businesses, schools, and the general population seem to be moving COVID-19 to the background, it’s still very much on the forefront of employer health plan administration. Health and Human Services (HHS)...more

MoFo Life Sciences

New Opportunities For Test Developers: Monkeypox Diagnostics

MoFo Life Sciences on

For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more

ArentFox Schiff

Long COVID – Just the Facts

ArentFox Schiff on

The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an...more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Fox Rothschild LLP

Health Care Professionals Are Key Targets in COVID Aid-Related Fraud Prosecutions

Fox Rothschild LLP on

The U.S. Justice Department’s COVID-related health care fraud crackdown continues to intensify. On a single day in September 2021, the Justice Department announced criminal charges against 138 defendants in 31 federal...more

Akin Gump Strauss Hauer & Feld LLP

Diagnostics Reform Heats Back Up with Introduction of the Verifying Accurate Leading-edge IVCT Development Act of 2021

In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more

Wilson Sonsini Goodrich & Rosati

FDA Reaches Another Milestone in COVID-19 Diagnostic Testing: First Over-the-Counter COVID-19 Home Test

On December 15, 2020, the U.S. Food and Drug Administration (FDA) finally issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home...more

Seyfarth Shaw LLP

More Than a Game Changer: Fourth Amendment to PREP Act Declaration Establishes Federal Jurisdiction, Bolsters Immunities, and...

Seyfarth Shaw LLP on

On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued another groundbreaking amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). ...more

Proskauer - Minding Your Business

A Test Costs What? Pricing and Reimbursing COVID-19 Tests

Out-of-network providers appear to be inflating the price of COVID-19 diagnostic and antibody tests, according to a recent America’s Health Insurance Plans (AHIP) survey. The October 2020 survey reports that out-of-network...more

Stotler Hayes Group, LLC

Provider Requirement to post Cash Price of COVID-19 Diagnostic Testing pursuant to CARES Act & Potential to Incur Civil Monetary...

Stotler Hayes Group, LLC on

All providers should take note of an under the radar provision of the CARES Act, 3202(a) & 3202(b), that requires all providers of diagnostic testing for COVID-19 to publicly post the cash price for such a test on the...more

Mintz - Health Care Viewpoints

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Oversight of Laboratory-Developed Tests Continues To Evolve

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more

Holland & Hart - Health Law Blog

COVID-19 Testing: Who Pays?

As COVID-19 testing continues to increase throughout the nation, providers and patients alike are faced with the issue of who is responsible for covering the cost of testing. Whether a payor will reimburse for a COVID-19 test...more

Seyfarth Shaw LLP

HHS Advisory Opinion Concludes that the PREP Act Preempts Any State or Local Law that Prohibits Pharmacists from Administering...

Seyfarth Shaw LLP on

On May 19, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) issued an advisory opinion (Advisory Opinion) finding that the Public Readiness and Emergency Preparedness Act1(PREP Act)...more

Perkins Coie

Congress and HHS Make Additional $170 Billion Available to Healthcare Providers to Address COVID-19 Testing, Treatment, and Losses

Perkins Coie on

In recent days, the federal government has taken two significant steps to increase healthcare funding to assist providers in responding to the medical and economic consequences of the novel coronavirus pandemic. $100 Billion...more

Robinson+Cole Health Law Diagnosis

HHS Waives HIPAA Penalties for Operation of a Community-Based COVID-19 Testing Site

On April 9, 2020 the Department of Health & Human Services Office for Civil Rights (OCR) issued another Notification that it will exercise its enforcement discretion and not impose penalties for HIPAA violations in connection...more

McDermott Will & Emery

CMS Releases Fact Sheets on COVID-19 Medicare Coverage, Billing Guidelines

McDermott Will & Emery on

The Centers for Medicare and Medicaid Services (CMS) released several fact sheets on COVID-19 coverage and benefits, and announced a second Healthcare Common Procedure Coding System (HCPCS) code, U0002, for billing COVID-19...more

Holland & Knight LLP

FDA Issues Guidance for Diagnostic Testing Applicable to Coronavirus Disease

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed...more

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