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Fourth Circuit Declines to Address Use of Stat Sampling in FCA Cases

Client Alert | 1 min read | 02.16.17

On February 14, the Fourth Circuit issued an opinion in U.S. ex rel. Michaels v. Agape Senior Cmty. Inc. on one of the two key issues that the district court had certified for interlocutory appeal under 28 U.S.C. § 1292(b): (1) whether the government possesses an unreviewable veto authority over proposed settlements and (2) whether statistical sampling is an appropriate methodology for establishing liability and damages in False Claims Act cases. On the first issue, the Fourth Circuit joined the Fifth and Sixth Circuits and held that the government has an unreviewable right to veto FCA settlements even after electing not to intervene. On statistical sampling, the district court had ruled that statistical sampling was not permissible because of the facts and available evidence in the case, but upon review, the Fourth Circuit determined that the appeal of that issue had been “improvidently granted” because the use of sampling is an evidentiary issue, not a pure question of law as required for interlocutory review. Accordingly, companies and FCA practitioners hoping for appellate-level guidance on the controversial issue of sampling will have to wait for another day.

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Client Alert | 7 min read | 06.26.26

Federal Roundup: Updates for PBMs and Medicare Advantage Organizations

In June 2026, federal regulators and lawmakers continued their efforts to improve drug affordability through targeted reforms. These recent developments will primarily impact pharmaceutical manufacturers, managed care organizations, and pharmacy benefit managers (PBM) serving Medicare Part D program members. PBMs, Medicare Advantage organizations, and Part D sponsors should monitor these changes in the interest of maintaining compliance and providing input on regulatory proposals that may influence their business operations or compensation structures in the future....