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Clinical Laboratories

Goodwin

Envisioning the New Normal: Real Estate + Technology, Part 8: Series Wrap-Up

Goodwin on

This article is the final piece in a multi-part series examining the impact of the COVID-19 pandemic on select real estate sectors and the considerations around how technologies will shape future operations and accelerate...more

Jackson Walker

CMS Implements Stricter COVID-19 Testing Regulations on Nursing Homes

Jackson Walker on

As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...more

Bass, Berry & Sims PLC

Reimbursement and Liability Implications of Not Pursuing an Emergency Use Authorization for COVID-19 Laboratory-Developed Tests

In an unprecedented move touted as necessary to address the COVID-19 testing shortage, the U.S. Department of Health and Human Services (HHS) made a brief statement on August 19 that effectively rescinded the federal Food and...more

Butler Snow LLP

Tennessee Governor Lee Releases Executive Order No. 59 with Focus on Health Care

Butler Snow LLP on

On August 28, 2020, Governor Bill Lee issued Executive Order 59 which extends the state of emergency related to the COVID-19 crisis until September 30, 2020. To help facilitate ongoing targeted regulatory flexibility to...more

Bass, Berry & Sims PLC

Penalties for COVID-19 Reporting Failures and Other New CMS Rules on Mandatory Testing and Ordering Limits

Anyone conducting COVID-19 testing – whether using point of care or high complexity tests – should take note. On August 25, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with comment period...more

Verrill

News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including...

Verrill on

What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket...more

Wilson Sonsini Goodrich & Rosati

Administrative Notice Limits the FDA's Ability to Regulate Laboratory Developed Tests, Including COVID-19 Tests

Laboratory Developed Tests and Their Regulation - Laboratory developed tests (LDTs) are in vitro diagnostic tests (IVDs) that are designed, developed, manufactured, and performed within a single laboratory. Although the...more

Bass, Berry & Sims PLC

How the FDA's EUA for Convalescent Plasma Will Impact Healthcare Providers and Researchers

Bass, Berry & Sims PLC on

On Sunday, August 23, the Food & Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for investigational COVID-19 convalescent plasma (CCP) for the treatment of COVID-19 in hospitalized patients. This EUA...more

King & Spalding

HHS OIG Permits Labs to Offer Free COVID-19 Antibody Tests and Oncology Practices to Offer Free Lodging in Certain Circumstances

King & Spalding on

OIG has updated its FAQs regarding the application of its administrative enforcement authorities to arrangements directly connected with COVID-19 with the addition of two new FAQs. On August 4, 2020, the OIG issued an FAQ...more

Rivkin Radler LLP

Eleventh Circuit Affirms “Exceptional Case” Ruling: Insurer Had No Duty to Defend Construction Debris Claim Where Amended...

Rivkin Radler LLP on

Eleventh Circuit Affirms “Exceptional Case” Ruling: Insurer Had No Duty to Defend Construction Debris Claim Where Amended Complaint Omitted Crucial Fact Implicating Pollution Exclusion The Eleventh Circuit, affirming the...more

Womble Bond Dickinson

Liquid Biopsy and Next-Generation Sequencing Combined: Legal Implications?

Womble Bond Dickinson on

The Food and Drug Administration’s approval of Guardant Health’s Guardant360 CDx assay marks a new era for genetic mutation testing in cancer treatment. On August 7, 2020, the FDA approved the first diagnostic test that...more

Foley Hoag LLP

New Massachusetts Bulletin Makes COVID Testing Reimbursement Easier

Foley Hoag LLP on

In an effort to make it easier for laboratories to be reimbursed by insurers for COVID-19 testing, the Massachusetts Division of Insurance has issued a bulletin stating that it expects “carriers to relax” restrictions on...more

Hogan Lovells

FDA updates FAQ on COVID-19 tests and validation

Hogan Lovells on

Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions related to laboratories and...more

Epstein Becker & Green

New Jersey Governor Allows Certain In-Person Higher Education to Resume on July 1

Epstein Becker & Green on

On June 18, 2020, New Jersey Governor Phil Murphy issued Executive Order 155 (“EO 155”), which as of July 1, 2020, allows degree-granting public and private institutions of higher education (“IHE”) to resume instruction that...more

Nossaman LLP

DOJ Broadly Applies New Kickback Law Beyond Its Original Opioid-Related Purpose

Nossaman LLP on

On October 24, 2018, Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT Act”), two sections of which constitute the Eliminating...more

Womble Bond Dickinson

The Marriage of Digital Pathology and Artificial Intelligence Will Give Birth to Slideless Laboratories

Womble Bond Dickinson on

The process of creating traditional pathology slides for review is quite cumbersome, and the manual workflow requires many steps. A new and more efficient process using digital pathology (and artificial intelligence...more

Miller Canfield

Michigan Governor Relaxes Stay-Home Order in Northern Michigan, Addresses Workplace Safeguards

Miller Canfield on

On May 18, 2020, Michigan Governor Gretchen Whitmer signed executive orders 2020-91 and 2020-92, revising the state's Stay Home, Stay Safe Order and advancing the process to resume in-person work and activities that were...more

Mintz - Health Care Viewpoints

CMS Allows Pharmacies and Other Suppliers to Bill Medicare for COVID-19 Testing

In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they...more

Mintz - Health Care Viewpoints

OIG Updates Its COVID-19-Related FAQ Guidance to Okay Certain Specimen Processing Payments by Laboratories

A few weeks ago, we posted about a publication by the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) of responses to certain frequently asked questions (FAQs) received from the health...more

Snell & Wilmer

EKRA Guidance for Clinical Laboratories in the Wake of COVID-19 Testing Surge

Snell & Wilmer on

The U.S. Department of Justice (“DOJ”), the Federal Trade Commission (“FTC”) and various other federal, state and local government agencies have focused enforcement efforts on the COVID-19 pandemic and are aggressively...more

Health Care Compliance Association (HCCA)

CMS reveals new HCPCS code for coronavirus lab tests

Compliance Today (May 2020) - The Centers for Medicare & Medicaid Services (CMS) announced on March 6, 2020, in a special edition of MLN Connects[1] that the agency has taken “additional actions to ensure America’s...more

K&L Gates LLP

COVID-19: Labs Beware! – EKRA Expands DOJ’s Enforcement Arsenal in the COVID-19 Fraud Battle

K&L Gates LLP on

I. INTRODUCTION - As discussed in recent alerts, federal and state authorities have focused their enforcement efforts on combatting fraud related to the COVID-19 pandemic....more

Seyfarth Shaw LLP

FDA Authorizes Synthetic Nasal Swab to Increase COVID-19 Testing

Seyfarth Shaw LLP on

Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more

Seyfarth Shaw LLP

Guide For General Public: FDA Explains How Everyone Can “Make a Difference” During COVID-19 With Simple Infographic, Update

Seyfarth Shaw LLP on

The Food and Drug Administration has taken many steps to assist in the response to the COVID-19 health crisis, including easing regulations, expediting the availability of necessary medical equipment, and creating streamlined...more

Seyfarth Shaw LLP

FDA and NCI to Review COVID-19 Antibody Tests Marketed Under FDA Guidance Permitting Sale Without FDA Authorization

Seyfarth Shaw LLP on

In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more

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JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

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Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

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You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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California Privacy Rights

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You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Access/Correct/Update/Delete Personal Information

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Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

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How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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