Capabilities
Life Sciences and Healthcare Regulatory

Pharmaceutical Pricing and Contracting

Our team is a leader providing a full range of counseling, litigation, and advocacy services on pharmaceutical pricing issues. We regularly provide advice, in-depth analyses, and internal training on calculating the various pricing metrics that are reported to federal agencies or that set price ceilings (e.g., AMP, Best Price, Section 340B, ASP, non-FAMP and federal ceiling price), and on related reporting and administrative requirements. We also represent clients in negotiating Federal Supply Schedule (FSS) contracts and advise on the price disclosure and reporting requirements associated with FSS contracts.

We routinely represent companies in connection with litigation, internal investigations, and government audits concerning pharmaceutical pricing issues and have frequently assisted manufacturers in conducting reviews to evaluate the adequacy of existing compliance policies and procedures in the pricing area. Our representation of an industry trade association on pricing and related legislative matters, combined with our work for a diverse range of individual companies, has given us a distinct, industry-wide perspective of the pharmaceutical pricing landscape.

Major manufacturers and a leading industry trade association rely on us for advice on the intersection of state and federal fraud and abuse laws with developing government pricing and reimbursement issues. Our activities in this area include analyzing state and federal regulations, developing offensive and defensive pricing, coverage and reimbursement strategies, and government advocacy.

Clinical Laboratories and Diagnostic Products

Our practice in clinical laboratories and diagnostics spans regulatory counseling, coverage and reimbursement strategy, and compliance matters. We have extensive experience in genomics and personalized medicine, and we can help you navigate the dynamic landscape for next-generation sequencing, companion diagnostics and regulation of laboratory-developed tests. We have advocated with CMS on PAMA implementation, developed offensive and defensive coding and pricing strategies, and advised on the development of compelling clinical and health economic evidence to achieve optimal coverage and reimbursement.

We routinely assist clients in complying with CLIA rules, and navigating the accreditation and inspection process. We help laboratories understand how their tests will be regulated in the future, and advise on strategies and evidence required to achieve FDA approval or clearance. We have conducted extensive reviews to evaluate the adequacy of existing compliance policies and procedures governing the marketing and billing of tests, and assisted clients in responding to CLIA and FDA inspections and government investigations. We routinely counsel our laboratory and diagnostic manufacturer on contracts and other matters implicating Stark, anti-kickback, and other compliance concerns.

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