News & Analysis as of

Extrapolation

Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more

The Latest On Statistical Sampling In FCA Cases

by Morrison & Foerster LLP on

After waiting over a year to hear what the Fourth Circuit would say about statistical sampling in False Claims Act cases, the court of appeals recently chose to keep us in suspense. Despite initially granting the relators’...more

Fourth Circuit Declines to Address Use of Statistical Sampling in False Claims Act Cases

by Latham & Watkins LLP on

Court of Appeals panel rules use of statistical sampling is inappropriate for interlocutory appeal, leaving FCA litigants without any direct appellate court guidance. In the closely watched case United States ex rel....more

False Claims Act Alert: Fourth Circuit Punts on Sampling and Extrapolation

by Hogan Lovells on

Tuesday, the Fourth Circuit Court of Appeals ruled in the interlocutory appeal in United States ex rel. Michaels v. Agape Senior Community, Inc.. In an opinion considering two significant questions arising under the qui tam...more

[Webinar] Biologics and Biosimilars: Development with an Eye Towards FDA Approval - February 17th, 10:00am PST/1:00pm EST

In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final...more

Breaking News: Federal Court Finds Delaware’s Unclaimed Property Enforcement “Shocks the Conscience”

by McDermott Will & Emery on

On June 28, 2016, the much-anticipated memorandum opinion of the US District Court for the District of Delaware in Temple-Inland, Inc. v. Cook et al., No. 14-654-GMS was released on the parties’ cross-motions for summary...more

3 Takeaways from the Recent Ruling on Statistical Extrapolations in CMS Audits

by Polsinelli on

On Jan. 20, 2016, a federal district court in the Western District of Texas affirmed a decision of the Medical Appeals Council (Appeals Council) affirming a CMS contractor’s extrapolation methodology used to assess an...more

Fourth Circuit May Address Use of Statistical Sampling in False Claims Act Actions

by Latham & Watkins LLP on

Court has the opportunity to assess the use of statistical sampling/extrapolation as a method to prove FCA liability or damages. Courts require that plaintiffs prove each element of a legal claim with evidence — mere...more

Life Care Centers Seeks Sixth Circuit Review of Decision Allowing Statistical Sampling/Extrapolation in FCA Case

Last week, we posted about U.S. District Court Judge Harry Mattice’s September 29th ruling that government attorneys could extrapolate from a small sample of patient admissions to over 50,000 patient admissions (and over...more

No Judicial Review of Contractor’s Finding of a High Payment Error Rate, a Condition for Extrapolation

by Baker Donelson on

Before a Medicare contractor can use extrapolation to determine an overpayment amount, the Medicare statute requires that it must make a finding that there is a sustained or high level of payment error or that documented...more

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