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 | 9 min read | 10.21.26
The life sciences sector is uniquely vulnerable to the inherent risks of AI-generated evidence in drug development and discovery. This client alert focuses on five core challenges: hallucinations, skewed predictions from unrepresentative training data, the opacity of AI reasoning, input sensitivity that undermines reproducibility, and adversarial manipulation of training data. To address these risks, companies should use experimental validation and human oversight as the common legal and regulatory safety net. This entails among other measures auditing AI outputs, characterizing training data, and structural oversight. Companies also should prepare for evolving frameworks and guidance from the U.S. Food and Drug Administration (FDA) and the European Union (EU) that address use of AI in drug discovery and development .
Client Alert | 2 min read | 10.21.26
Client Alert | 3 min read | 10.21.26
Private Investigations Act Series: Temporal, material and territorial scope
Client Alert | 7 min read | 10.21.26
