Dorsey Health Law Blog

Settlement Reached in the First Federal Opioids Trial

Alissa Smith

This post is an update from our earlier blog post, available here, on the bellwether federal opioids trial in the Northern District of Ohio.  Just hours prior to the start of the trial in a consolidated case involving two plaintiff counties in Ohio, all of the remaining defendants in the case, except Walgreens, reached a...

California Attorney General Issues Draft Regulations for CCPA

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The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Joseph Lynyak, Robert...

Drug Companies Preview Trial Defenses for Bellwether Opioid Trial

Andrew Brantingham

In the last several years, thousands of cities and counties, as well as most states, have sued various combinations of pharmaceutical manufacturers, retailers, and distributors for damages allegedly caused by the opioid epidemic.  Nearly 2,000 of those cases have been consolidated into a multi-district litigation (“MDL”) in the Northern District of Ohio. Until very recently,...

A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes to the Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP, Privacy Laws Governing Substance Use Disorder Records, and the Stark Law Advisory Opinion Process

Laura B. Morgan

Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and the civil monetary penalty law (CMP)...

CCPA Compliance Screening and Assessment Tools–Now Available

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From Robert Cattachach, a Dorsey Partner with our Regulatory Affairs Group: I am pleased to announce that Dorsey has launched web-based CCPA Screening and Assessment Tools to help organizations in preparing for the California Consumer Privacy Act (CCPA), which goes into effect on January 1, 2020. Companies can determine whether the CCPA will apply to...

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

Laura B. Morgan

As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug discount and rebate arrangements that are commonplace between pharmaceutical manufacturers and Medicare Part D Plans and Medicaid Managed Care Organizations (and...

The Eliminating Kickbacks in Recovery Act of 2018 (EKRA): A New Federal Kickback Law Applicable to All Payors

Laura B. Morgan

The Eliminating Kickbacks in Recovery Act of 2018 (EKRA) became law on October 24, 2018, and is codified at 18 U.S.C. § 220.  As part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, EKRA was enacted in response to a concern that the federal Anti-Kickback Statute...