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Customs Proposes To Substantially Transform The Substantial Transformation Test

Client Alert | less than 1 min read | 08.08.08

By Notice of Proposed Rulemaking, 73 Fed. Reg. 43385 (July 25, 2008), Customs & Border Enforcement has proposed substituting, for many purposes including rulings under the Trade Agreements Act (TAA), a "tariff shift" approach for determining country of origin in lieu of the longstanding and subjective "case-by-case" approach to determining the place where "substantial transformation" occurred. Under the proposed rule, contractors selling products under the contracts subject to the TAA would have to reevaluate their products under the rigid, pre-established formulaic tariff shift analysis to ensure products with significant non-designated country content qualify for sale to the federal government.

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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....