David v. Goliath: Taking on Payment Suspension and Extrapolation
On August 12, 2024, OIG announced the results of an audit of payments made to hospitals for inpatient claims with the Medicare Severity Diagnosis-Related Groups (MS-DRGs) that require ninety-six hours of consecutive...more
BACKGROUND- A sugar distributor sought to acquire a sugar producer. The district court determined that the relevant product market included distributors as sources of refined sugar, in addition to sugar producers. The...more
Three appellate courts recently reversed sentences because the government did not adequately present evidence to support the alleged loss calculation underlying the court’s determination of the sentencing guidelines range. In...more
Payment suspension and overpayment extrapolation are among the most extreme and effective enforcement tools available to the Centers for Medicare and Medicaid Services (CMS) and its auditors. However, even these measures can...more
More than four years after it was proposed, on February 1, 2023 the Centers for Medicare & Medicaid Services (CMS) published the long-awaited risk adjustment data validation (RADV) Final Rule (Final Rule) that will affect...more
Statistical sampling and extrapolation have become accepted tools for establishing damages in health care administrative proceedings and False Claims Act (FCA) litigation over the past 30 years. Key Takeaways - 1....more
Sampling and extrapolation is a common approach for presenting evidence in complex construction and commercial disputes. The exercise involves identifying and examining a properly representative set of sample allegations, and...more
The financial stakes are often very high for providers when statistical sampling and extrapolation is used to calculate an alleged Medicare overpayment. In post-payment audits involving extrapolation, an actual claims denial...more
Research by Lucian A. Bebchuk, Harvard Law School, and Scott Hirst, Boston University School of Law, indicates three key index fund advisors could cast 34% of votes in the next decade at S&P 500 companies, and about 41% of...more
A recent report issued by OIG finding an Indiana community hospital owed over $22 million in extrapolated overpayments carries some important lessons for hospitals audited under OIG’s hospital compliance program. As described...more
The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for paediatric use. ...more
On Thursday, July 13, 2017, FDA’s Oncological Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilars of two blockbuster cancer drugs. The first, Amgen and Allergan’s ABP-215, is a proposed biosimilar...more
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
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
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
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
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
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
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
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
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