Tag Archives: Determinations

Are All ‘Medical Necessity’ Determinations Subject to False Claims Act Liability? Opinions May Differ.

Two federal appellate-court decisions handed down in the past few weeks have generated much speculation about whether “medical necessity” determinations underlying Medicare or Medicaid claims can now be considered “objectively false” — despite conflicting medical-expert opinions — and actionable under … Continue reading

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Appeal Court Says Judges Cannot Avoid Determinations of Grave Risk of Harm in Hague Convention Cases

The Ontario Court of Appeal recently reversed a Hague Convention order that a mother from England must return to England with her two children, failing which her British husband would have custody of their children. (Zafar v. Saiyid (2018) ONCA … Continue reading

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FDA Issues Guidance Regarding Obtaining Risk Determinations for Investigational IVDs in Oncology Trials

By Kurt R. Karst — On April 12, 2018, the three FDA Centers jointly issued the draft guidance, “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination” (draft available here). The draft guidance outlines a … Continue reading

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Supreme Court correctly applied the Doctrine of Collateral Estoppel to the hearing officer's determinations as to the reasons for the employee's termination

Supreme Court correctly applied the Doctrine of Collateral Estoppel to the hearing officer's determinations as to the reasons for the employee's terminationThe Appellate Division ruled that the New York State Department of Education's hearing officer's determination established that the reasons … Continue reading

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EPA Approvals of TMDLs Are Not “Drive-by Permitting Determinations”

Last week, the First Circuit Court of Appeals rejected the Conservation Law Foundation’s argument that EPA’s acceptance of TMDLs in Rhode Island and Massachusetts carried with it a concomitant obligation to require permits of landowners contributing to violations of the … Continue reading

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