Simplifying Global Compliance
Drug Pricing and Reimbursement – Webinar Recording/Transcript
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Drug Pricing and Reimbursement: Navigating the Changes, Anticipating the Future
“With today’s historic action, we are fundamentally changing the nature of the healthcare marketplace.”
– HHS Secretary Alex Azar, on President Trump’s June 2019 executive order requiring healthcare providers to tell patients their out-of-pocket costs prior to receiving services
The drug pricing and reimbursement landscape is changing dramatically. The June 24, 2019 executive order… the May 2019 final rule requiring drug pricing in television ads… recent DOJ enforcement actions… CMS rules for Medicare Part D and drug pricing bills working through Congressional committees.
Healthcare providers are now required to:
- Tell patients their out-of-pocket costs prior to receiving services
- Disclose to patients the prices they and insurers will pay in an easy-to-read, accessible format
Understanding the current policies — and proposed changes — and how to apply them to product development and commercialization plans will greatly impact the success of your products.
Fortunately, nationally recognized FDA regulatory and life sciences attorney Bethany Hills-Grois, a partner with Morrison & Foerster, is here to help with this presentation.
Presentation Takeaways:
- How drug pricing policies may impact labeling and promotional activity, such as TV ads
- Practical tips on product data development to align with drug pricing policies
- The drug pricing and reimbursement framework, including the roles FDA, CMS and private parties play
- Drug pricing proposals being considered in Congress… and which ones are likely to pass before the November elections
Understand the new drug pricing/reimbursement changes, the issues you need to watch and the practical applications within your organization.
- Regulatory affairs professionals
- Legal counsel/FDA attorneys
- Compliance professionals
- Quality assurance professionals
- Sales and marketing managers
- Reimbursement professionals
Bethany Hills-Grois, Esq., a partner with Morrison & Foerster in their FDA regulatory and life sciences practice groups. She helps companies manage the full range of FDA regulation issues, from inspections and investigations through complex regulatory challenges, affecting everything from product approvals and labeling to collaborative research, supply, and distribution agreements. Ms. Hills-Grois’ work for clients regularly spans the full scope of pre-market and post-market issues, from devising unique regulatory strategies that are then implemented through FDA submissions, including post-approval compliance and enforcement.
