Drug Pricing Policy & Reporting

Overview

The legal landscape surrounding drug pricing policy and reporting is constantly changing. Pharmaceutical and biologics companies have to navigate ever-evolving rules and regulations, ensuring compliance on both the federal and state levels. One misstep could cause a company to face a potentially costly investigation or enforcement action.

That is why working with experienced counsel who stay up to date with the latest legal changes is so important. Epstein Becker Green’s drug pricing policy and reporting team has deep knowledge of drug price reporting requirements and compliance obligations under Medicaid, Medicare, 340B Drug Discount, and other programs and keeps clients informed of critical legal developments. We leverage years of experience to provide comprehensive counsel tailored to our clients’ specific needs and goals.

Providing Strategic Advice and Solutions

Our drug pricing policy and reporting team works closely with pharmaceutical and biologics manufacturers, advising them on compliance, strategy, and outlook in this high-stakes area. Clients turn to us for advice on pricing-related matters, reporting requirements, and their rights and obligations relating to:

Medicare Average Sales Price
Medicaid Drug Rebate Statute
Medicare Part B, C, and D Program
340B Drug Discount Program
Medicare Advantage Program
TRICARE Program
Veterans Health Care Act/Federal Supply Schedule Program
State Drug Pricing Initiatives

We help pharmaceutical and biologics manufacturers develop methodologies and reasonable assumptions to support their drug pricing submissions, assist with responses to regulatory inquiries, and represent clients in drug pricing-related investigations, enforcement proceedings, and civil litigation. Physicians, hospitals, and insurers also look to us for guidance on drug pricing policy and reporting matters.

Keeping Our Clients Compliant

Our team drafts policies to help ensure that clients remain compliant with current federal legal standards and state drug pricing policy and transparency obligations. Clients also rely on us to keep them informed about legislative changes to drug pricing and reimbursement policies that may be on the horizon. In addition, we provide thorough compliance reviews that assess and update, if necessary, our clients’ existing compliance policies. At Epstein Becker Green, our drug pricing policy and reporting team provides diligent and effective counsel designed to help protect our clients from future legal exposure.

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Focus Areas

Experience

Assisted an emerging pharmaceutical manufacturer in developing a full suite of government program compliance and price reporting policies before the commercial launch of its first product.
Drafted and negotiated commercial supply, distribution, and pricing agreements for pharmaceuticals and other therapeutics for manufacturers and other industry stakeholders.
Assisted a large biotechnology and pharmaceutical company with various product launch activities and provided a comprehensive range of services that included legal and pricing training.
Represented the subsidiary of a global pharmaceutical company in a multimillion-dollar settlement in connection with a legacy government program pricing matter. We served as health care defense counsel in the negotiation of the amended Corporate Integrity Agreement with the Department of Health and Human Services’ Office of the Inspector General.