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Fraud, Wast and Abuse Guidance for Medicare Part D

Client Alert | 1 min read | 02.24.06

The Medicare Prescription Drug Benefit – Part D – imposes a legal requirement on Part D contractors to adopt a fraud, waste, and abuse (“FWA”) plan. On February 8, 2006, CMS issued a sixty-three page draft of FWA guidance to be contained in Chapter 9 of CMS’ Prescription Drug Benefit Manual, significantly enhancing the agency’s initial eight-page draft issued in June 2005. On February 23, 2006, the Health Care practice group at Crowell & Moring LLP conducted an online webinar in response to the new draft requirements. Crowell & Moring's webcast, aimed to quickly arm Plan Sponsors as well as downstream participants in the Part D benefit with what they need to know about the new requirements, discussed how to augment compliance and internal audit resources, develop new employee and subcontractor training programs, adopt scores of new "required" written policies and procedures, draft new contract clauses for Part D subcontractors, and enhance internal procedures for handling internal and external reports of potential Sponsor, provider, and beneficiary misconduct. To view a copy of the presentation, please click here.

Insights

Client Alert | 8 min read | 10.01.25

BIS Issues “Affiliates Rule” to Dramatically Expand Applicability of Entity and Military End-User Lists

On September 29, 2025, the U.S. Department of Commerce Bureau of Industry and Security (BIS) announced a sweeping Interim Final Rule (IFR), (the “Affiliates Rule”) expanding which entities qualify as Entity List or Military End-User entities, thereby subjecting those entities to elevated export control restrictions under the Export Administration Regulations (EAR). U.S. export restrictions applicable to entities on the Entity List, Military End-User (MEU) List, and Specially Designated Nationals and Blocked Persons (SDN List) now apply to foreign affiliates that are, in the aggregate, owned 50% or more by one or more of the aforementioned entities. An entity that becomes subject to these restrictions because of its ownership structure will be subject to the most restrictive controls that attach to any of its parent entities, regardless of ownership stakes....