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Court of Federal Claims Grants Summary Judgment on $214 Million ACA "Risk Corridors" Claim

Client Alert | 1 min read | 02.10.17

In Moda Health Plan, Inc. v. U.S. (Feb. 9, 2017), the Court of Federal Claims granted summary judgment in favor of a health insurer in a lawsuit seeking to recover "risk corridors" payments pursuant to §1342 of the Affordable Care Act, deciding on the merits that (i) the plaintiff was entitled to full payments owed to it under the statutory formula set forth in the ACA, (ii) Congress did not intend the risk corridors program to be budget-neutral, and (iii) later appropriations bills restricting HHS' access to the CMS Program Management Account for risk corridors payments did not repeal or amend this obligation to make full annual payments. In an important decision likely to reverberate throughout the individual insurance market, the Court stated that "the Government made a promise in the risk corridors program that it has yet to fill … [and] the Court directs the Government to fulfill that promise."

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Client Alert | 3 min read | 06.26.25

FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”

In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and “immediate review” of new clinical trials where American patients’ cells are sent to China or other “hostile countries” for genetic engineering with the expectation that the cells will be infused back into U.S. patients.[1] A subsequent podcast published by the agency also said that therapies that involved cells that were sent to China for genetic engineering and intended for subsequent infusion into U.S. patients would not be approved going forward. The announcement said that there is “mounting evidence” that some clinical researchers failed to obtain informed consent from trial participants about the international transfer and manipulation of biological material....