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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 | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...