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CMS releases roadmap for states to accelerate adoption of value-based care

By Andrew Lu & Kelly Kearney

September 18, 2020

On September 15, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance to state Medicaid directors on how to advance value-based care (VBC) across their health care systems, with an emphasis on Medicaid populations, and how to share pathways for adoption of such approaches. Within the 33-page letter, CMS highlights the merits of VBC; provides an assessment of key lessons learned from early state and federal experiences in implementing VBC reforms, as well…

Technology Law Dispatch

New DIFC Data Protection Law on the way…Are you ready?

By Adela Mues, Tufayel Hussain & Howard Womersley Smith

September 18, 2020

The Dubai International Financial Centre (DIFC) enacted the DIFC Data Protection Law No. 5 of 2020 (the DP Law) July 1, 2020. The DP Law has been designed primarily to bring DIFC’s data protection legal regime in line with international best practices in data privacy laws, in particular the General Data Protection Regulation (GDPR), which has ignited privacy and data law reform worldwide. DIFC entities have until October 1, 2020 to put in place structures,…

EHS Law Insights

Up, Up, and a (New) Way to Facilitate Compliance: Drones and Their Capabilities as HSE Compliance Tools

By Andrew J. Wissinger & Ben H. Patton

September 18, 2020

Drones, a generic term for unmanned aircraft, have been utilized in military applications for decades. More recently, however, advances in drone technology and construction have made the devices more accessible. These advances and increased accessibility have allowed more commercial and industrial applications to take off. For example, certain retailers are considering ways to efficiently use drones to make residential deliveries, and drones can help developers plan and manage construction projects and monitor progress. Drones as…

Drug & Device Law

Another Supplement Class Action Runs Into Primary Jurisdiction

By Eric Alexander

September 18, 2020

Stop us if you have heard this before. A group of plaintiffs bring a purported class action under a range of California consumer protection laws seeking damages related to the purchase of a medical product (or collection of somewhat related medical products) that they claimed failed to comply with FDA requirements. The defendants raise preemption and/or primary jurisdiction in a motion to dismiss. We blog about the resulting decision. While the problem may be with…

Antitrust and Competition Report

DOJ’s Antitrust Division makes significant updates to Merger Remedies Manual

By Michelle A. Mantine, Christopher Brennan & Keely Dulaney

September 17, 2020

The Department of Justice’s Antitrust Division updated its Merger Remedies Manual for the first time in more than a decade. The updates improve upon the 2004 Manual by providing a significantly more detailed account of the Division’s approach to preserving competition pre- and post-merger. Our team highlights the various revisions and additions to the Manual in our recent alert.…

Ship Law Log

More transparency needed in shipping industry to tackle the impact of COVID-19

By Sally-Ann Underhill

September 17, 2020

Early results from our 2020 shipping survey – Navigating a post-COVID world indicate that industry participants believe more transparency is needed to tackle the impact and challenges caused by the pandemic. 66% of respondents so far indicate that transparency and sharing of information might be key to the shipping industry emerging stronger from the crisis. There has been much conversation in recent years about advancements in technology allowing for more information sharing across the industry.…

Drug & Device Law

Another Vaccine-Related Blogpost

By Bexis

September 17, 2020

Not quite two months ago, the Dept. of HHS published a notice of proposed rulemaking that would make a significant change in the National Vaccine Injury Compensation program. See 85 Fed. Reg. 43,791 (HHS July 20, 2020). If this becomes a final rule, it could affect the prevalence of civil litigation involving vaccines. HHS seeks to undo an Obama-era change that added two conditions to the table of compensable vaccine-related injuries: On January 19, 2017,…

Health Industry Washington Watch

FDA issues draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation

By John D. Kendzior & Ryan Pate

September 16, 2020

On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1] Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial. FDA recognizes this information as important because by integrating patients’ voices throughout the total product lifecycle, concepts important to patients can be considered in the…

Drug & Device Law

Pleasing Pennsylvania PMA Preemption Proceeding

By Bexis

September 16, 2020

Defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions, as our PMA Preemption Score Card (now with well over 500 decisions) demonstrates. Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020), is one of these, but some aspects of Conley make it more interesting than most PMA preemption decisions – presumably why West chose it for publication in F. Supp.…

Employment Law Watch

California requires new COVID-19 supplemental paid sick leave

By Michele Haydel Gehrke, Mark Phillips, Marianne Rittenburg & Ronnie Shou

September 15, 2020

On September 9, 2020, Governor Newsom signed Assembly Bill (AB) 1867 into law, adding section 248.1 to the Labor Code. Under this new section, “hiring entities” are required to provide supplemental COVID-19 paid sick leave (CPSL) to “covered workers.” This is in addition to any paid sick leave that may be available to the covered workers under California’s Healthy Workplace Healthy Family Act of 2014 (HWHFA)[1]. “Hiring entities” include private businesses with 500…

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CMS releases roadmap for states to accelerate adoption of value-based care

New DIFC Data Protection Law on the way…Are you ready?

Up, Up, and a (New) Way to Facilitate Compliance: Drones and Their Capabilities as HSE Compliance Tools

Another Supplement Class Action Runs Into Primary Jurisdiction

DOJ’s Antitrust Division makes significant updates to Merger Remedies Manual

More transparency needed in shipping industry to tackle the impact of COVID-19

Another Vaccine-Related Blogpost

FDA issues draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation

Pleasing Pennsylvania PMA Preemption Proceeding

California requires new COVID-19 supplemental paid sick leave

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