Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
Changes in FDA, Cannabis Policies and AI Developments
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 181: South Carolina’s Life Sciences Economy with Ashely Teasdel, Deputy Secretary of SC Department of Commerce
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 166 — Christine Vannais, COO of Fujifilm Diosynth Biotechnologies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Jones Day Talks Health Care: The Eliminating Kickbacks in Recovery Act
A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure...more
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
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
Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory...more
With the enactment of the Eliminating Kickbacks in Recovery Act (“EKRA”) in 2018, the permissibility of commission-based compensation to laboratory sales representatives based on volume, revenue, or profit has come under...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
The U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) is tasked with combating fraud under Medicare, Medicaid, and other federally funded healthcare programs. ...more
Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more
Most health care providers have at least a basic understanding of the Anti-Kickback Statute. This federal law prohibits providers from offering, paying, soliciting, or accepting any form of “remuneration” for patient...more
The Centers for Medicare & Medicaid Services (CMS) has published the Calendar Year (CY) 2021 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule. Note that the...more
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
In October 2018, the President signed the SUPPORT for Patients and Communities Act, a portion of which is known as the “Eliminating Kickbacks in Recovery Act of 2018” or “EKRA.” EKRA, aimed at the ongoing opioid crisis, is...more
On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) is charged with ensuring the integrity of more than 100 programs administered by DHHS, including...more
Market Based Payment for Clinical Diagnostic Laboratory Tests - Summary - On June 17, 2016 the Centers of Medicare & Medicaid Services (CMS) issued the long awaited Medicare Clinical Diagnostic Laboratory Tests...more
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more
First Data Collection Period for Clinical Laboratories Is July 1, 2015 to December 31, 2015 - In the October 1, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule...more
CMS recently published a proposed rule that would substantially revise the methodology used to pay for clinical laboratory tests that continue to be compensated separately by Medicare. Medicare Program; Medicare Clinical...more
As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more
On September 25, 2015, CMS released proposed rulemaking that would extensively revise payment and reporting requirements for clinical diagnostic laboratory tests (CDLTs), as paid on the Clinical Laboratory Fee Schedule...more
On September 25, 2015, the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule...more
On Friday, the Centers for Medicare & Medicaid Services (“CMS”) issued a long-awaited proposed rule that would drastically change the payment rates for clinical laboratory services beginning January 1, 2017 (the “Proposed...more
CMS Announces New SNF Payment – On August 27, 2015, CMS announced “a new funding opportunity” for SNFs that is intended “to reduce avoidable hospitalizations by funding higher-intensity interventions in nursing...more