News & Analysis as of

Department of Health and Human Services (HHS) Administrative Proceedings

Foley & Lardner LLP

CMS Finalizes Rule Change Applying Preponderance of the Evidence Standard to Agent, Broker, and Web-Broker Exchange Agreement...

Foley & Lardner LLP on

In its recently issued Final Rule (CMS-9884-F; 90 FR 27074-01; the Final Rule), the Centers for Medicare and Medicaid Services (CMS) finalized revisions to 45 C.F.R. § 155.220(g)(2) to specify a standard of proof for...more

Arnall Golden Gregory LLP

Healthcare Providers Could Finally Have Their Day in Court: Supreme Court Holds That Defendants Are Entitled to Jury Trials When...

On June 27, 2024, the Supreme Court of the United States released its opinion in SEC v. Jarkesy, a case involving a Securities and Exchange Commission (“SEC”) enforcement action for civil penalties against an investment...more

Morgan Lewis

HHS Last-Minute Final Rule Restricts Use of Guidance Standards in Civil Enforcement Actions

Morgan Lewis on

The US Department of Health and Human Services (HHS) issued a Final Rule on January 12, 2021 on Transparency and Fairness in Civil Administrative Enforcement Actions that amends 45 CFR Part I to set forth rules for...more

Hinshaw & Culbertson - Health Care

Change is on the Horizon for 340B Pharmacy Program's Administrative Dispute Resolution Process

The U.S. Health Resources and Services Administration (HRSA) published a final rule (the Rule) on December 14, 2020, which outlined the requirements and procedures for the 340B pharmacy program's administrative dispute...more

Harris Beach Murtha PLLC

Doe v. Merck: Vaccine Autism Lawsuit Dismissed as Baseless

The claim that the MMR vaccine caused autism was meritless on its face, held the U.S.D.C., Eastern District of New York (Doe v. Merck & Co, Inc.). The action filed on behalf of “Baby Doe” stemmed from Merck-manufactured...more

Baker Donelson

Court Rules in Favor of Hospitals in Bad Debt Collection Effort

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On July 25, 2016, the United States District Court for the District of Columbia issued an opinion favoring provider flexibility in the reasonable collection of Medicare bad debt. Winder HMA, LLC, et al. v. Sylvia Burwell. The...more

King & Spalding

D.C. District Court Invalidates CMS’s “Protest” Requirement

King & Spalding on

On August 19, 2016, the United States District Court for the District of Columbia granted a group of hospitals’ motion for summary judgment against HHS in a challenge of the Provider Reimbursement Review Board’s (PRRB) denial...more

McDermott Will & Schulte

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

King & Spalding

HHS Proposes Significant Changes to ALJ Hearing Procedures

King & Spalding on

HHS announced a Proposed Rule on July 5, 2016 aimed at reducing the backlog of appeals at the Office of Medicare Hearings and Appeals (OMHA) and Departmental Appeals Board (DAB) for Medicare payment and coverage...more

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