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Clinical Laboratories

Mintz

Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs

Mintz on

In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 181: South Carolina’s Life Sciences Economy with Ashely...

Maynard Nexsen on

Recorded at SCbio’s 2024 annual conference, hosts Heather and Matthew welcome Ashely Teasdel, Deputy Secretary for the South Carolina Department of Commerce. Ashely is a key player in South Carolina’s economic development and...more

Holland & Knight LLP

No Sunset on the Horizon for EKRA

Holland & Knight LLP on

Recently, Holland & Knight healthcare attorneys have received questions as to whether the Eliminating Kickback in Recovery Act (EKRA) is still in effect, given the recent expiration of many provisions of the Substance...more

McGuireWoods Consulting

CMS Issues Final CLIA Rule Related to Fees and Personnel Qualifications

On Dec. 28, 2023, the Centers for Medicare and Medicaid Services (CMS) released a final rule that updates Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies CLIA regulations. CLIA regulates...more

ArentFox Schiff

Investigations Newsletter: Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations

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Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations - A New Jersey-based laboratory, RDx Bioscience Inc. (RDX), and its owner and CEO, Eric Leykin, agreed to pay $10,315,023 to the US...more

Akin Gump Strauss Hauer & Feld LLP

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more

Goodwin

FDA Targets April 2024 for Laboratory Developed Test (LDT) Final Rule

Goodwin on

On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding...more

Morgan Lewis

Proposal to Phase Out FDA Enforcement Discretion for Lab Developed Tests: More Than 6,500 Weigh in

Morgan Lewis on

The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development,...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Matthew welcome Shirley Paddock, Senior Vice President of Clinical Development for Syneos Health. She shares exciting insights on the...more

King & Spalding

OIG Releases Compliance Program Guidance Applicable to All Providers and Suppliers

King & Spalding on

On November 6, 2023, OIG released new General Compliance Program Guidance (General CPG). The General CPG applies to all individuals and entities involved in the healthcare industry. The release of the General CPG was not...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 166 — Christine Vannais, COO of Fujifilm Diosynth...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, hosts Heather and Lauren welcome Christine Vannais, COO of Fujifilm Diosynth Biotechnologies at the RTP location in North Carolina. Tune in for a fascinating...more

McDermott Will & Emery

OIG Pathology Lab: Don't Pay for Services You Don't Need

McDermott Will & Emery on

In September, the US Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion to a pathology laboratory concerning a proposed services arrangement with referring...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren are joined by Doug Edgeton, President and CEO of the North Carolina Biotechnology Center. Tune in to hear Doug discuss emerging life...more

Paul Hastings LLP

From General Discretion to Agency Authority? FDA’s Bold Bid to Regulate Laboratory Developed Tests

Paul Hastings LLP on

After years of FDA discussion and failed congressional efforts to assert greater oversight of laboratory developed tests (LDTs), FDA has proposed a rule that would require many LDTs to comply with FDA’s requirements for in...more

Goodwin

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA’s Proposed Phaseout Policy - Key Considerations &...

Goodwin on

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would implement a new...more

Goodwin

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part I: Underpinnings of FDA’s Proposed Rule

Goodwin on

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). The proposed rule and policy are the latest in an over...more

Bass, Berry & Sims PLC

Labs Take Note: In a New Opinion, OIG Reminds Us that Fair Market Value Payments Can Still Violate the Anti-Kickback Statute

Bass, Berry & Sims PLC on

On September 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, in which it declined to approve an anatomic pathology laboratory’s proposal to purchase...more

Wilson Sonsini Goodrich & Rosati

FDA's Threat of Lab-Developed Test Oversight Is Back on the Table with Proposed Rule

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published a proposed rule to regulate laboratory-developed tests (LDTs). The rule, if finalized, would amend FDA regulations to broaden the definition of “in...more

McDermott Will & Emery

Laboratory-Developed Tests: FDA Publishes Highly Anticipated Proposed Rule

McDermott Will & Emery on

On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more

McDermott+Consulting

The Ongoing Poker Game Between Congress and FDA: Who Will Win?

McDermott+Consulting on

Congress and federal agencies often engage in a game, each trying to see what the other is willing to do to achieve a particular policy or outcome. While Congress and federal agencies have unique authorities (legislative...more

Bass, Berry & Sims PLC

FDA Takes Definitive Step Toward the Regulation of LDTs

Bass, Berry & Sims PLC on

On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more

Mintz - Health Care Viewpoints

OIG Issues Advisory Opinion Nixing Purchased Services Arrangement Between Certain Anatomic Pathology Laboratories

Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase...more

Epstein Becker & Green

Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care

Epstein Becker & Green on

Throughout this series, we've talked about the growth of the direct access testing industry and the types of models developed to support the businesses that are using that type of testing. We've covered reimbursement...more

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 9th, 8:00 am - 5:00 pm CT

Get the latest strategies and insights for healthcare research compliance - Whether you missed this year’s in-person Research Compliance Conference or are looking for additional insights from research colleagues and...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

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JD Supra Privacy Policy

Updated: Dec 28, 2021:

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Information for EU and Swiss Residents

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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Changes in Our Privacy Policy

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Contacting JD Supra

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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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