Federal government affairs
The work starts with knowing which office owns an issue, what it has already heard, and what it needs from a client in order to act.
Typical work
- Legislative strategy and bill-specific advocacy in the House and Senate
- Member and committee office outreach, meeting requests, and follow-up
- Hill days and fly-ins, from scheduling to briefing materials to readouts
- Hearing preparation, including witness briefing materials and questions for the record
Health policy analysis
The analysis is written for the people who have to make a decision, and it goes out the day the document does.
Typical work
- Same-day alerts on CMS payment rules, FDA actions, and executive orders
- Analysis of drug pricing programs, including Medicare negotiation cycles
- Tracking and plain-language summaries of introduced and moving legislation
- Comment letters and responses to agency and Congressional requests for information
- Weekly written updates on Congress and the agencies
Regulatory and market access strategy
This is where a product's clinical evidence has to hold up as a Medicare and FDA argument.
Typical work
- Coverage and payment strategy for novel drugs, devices, and diagnostics
- Medicare payment policy across hospital, laboratory, and other fee-for-service systems
- Translating clinical data into policy arguments for the Hill and technical comments for agencies
- Regulatory strategy and FDA engagement across review pathways
- Coding and payment classification for new technologies
Association and coalition management
We run associations and coalitions so their members can stay focused on their own companies. Alanna serves as President of the Midsized Biotech Alliance of America.
Typical work
- Association operations, governance, and member communications
- Member recruitment and retention
- Coalition letters, sign-ons, and joint comments to OMB and the agencies
- Fly-in planning and execution
- Policy agenda development and messaging frameworks
Bring us the issue and we will come back with where it sits on the Hill or at the agency, who decides it, and how we would partner with you on a strategic plan.