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Federal Circuit Confirms Qualification as a "U.S.-Made End Product" under the TAA, Does Not Require Substantial Transformation in the U.S.

Client Alert | 1 min read | 02.10.20

Today, in Acetris Health, LLC v. United States, the Federal Circuit held that a pharmaceutical manufactured in the United States qualified for sale, under the TAA, to the Department of Veterans Affairs even though the active pharmaceutical ingredient (API) came from a non-designated country, India. In reaching this decision, the court questioned, without deciding, the longstanding Customs and Border Enforcement position that the country where the API was manufactured defined the location of “substantial transformation” for any resulting pharmaceutical. In any event, the court held that under the Federal Acquisition Regulation definition, to qualify as a “U.S.-made end product” under the TAA, the product need be either “manufactured” in the U.S. or “substantially transformed” in the U.S. – it need not be both.

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Client Alert | 8 min read | 04.17.26

CMS Finalizes CY 2027 Medicare Advantage and Part D Rule: Key Implications for Plan Sponsors

On April 6, 2026, the Centers for Medicare & Medicaid Services (CMS) published its final rule governing the Medicare Advantage (Part C) and Prescription Drug Benefit (Part D) programs for Contract Year (CY) 2027. The final rule is effective June 1, 2026, with most provisions applicable to coverage beginning January 1, 2027, and marketing and communications changes taking effect October 1, 2026. Beyond payment, the rule pursues a broad deregulatory agenda aligned with Executive Order 14192, reversing marketing and enrollment safeguards introduced in 2023 and easing documentation and reporting obligations, while introducing new program integrity requirements....

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