Engagements & Experience

Genomics Industry

• With the explosive growth in the genomics industries, about half of our current work is related to advanced diagnostics.
• Dr. Quinn has been tracking the cutting edge of U.S. genomics policy since 20006. From 2010-2014 Dr. Quinn has authored a series of well-known white papers on evolving CMS payment and coverage policies for genomics.
• Since 2014, most of his commentary runs on a blog (Discoveries in Health Policy), that currently logs over 100,000 hits per year and with an archive of some 400 articles. Dr. Quinn has also written a number of peer-reviewed articles on diagnostics policy.

Medicare National Policy

• We have helped many companies and stakeholders meet with meet with agency leaders, petition for new coverage decisions, and comment effectively on federal rulemaking.
• Key team member for a National Coverage Determination (NCD) on beta amyloid imaging; participated in strategy and negotiations throughout two year process.
• Key team member for national trade organization developing a strategy and then changing national PET scan policy in cancer.
• Help companies understand the dynamics and policy of new preventive screening benefits.

Health Policy: Applied Strategic Thinking and White Papers

• For a major trade organization, deep-dive review and strategic options for changing CMS outpatient imaging payment policy
• For a mid-cap cardiovascular technology company, assist in understanding rapidly evolving CMS payment modes of payment and laying out the company’s strategic market-facing options
• For a nonprofit, wrote an impactful overview of how payers will address next-generation Alzheimer drugs and key issues that pharma will face for patient access, contrasting regulatory and payer review processes.

Health Policy Peer Reviewed Publications (examples)

• Policy article for a peer reviewed journal on defining the foundations of clinical utility for diagnostic tests – here.
• Policy article on quantitative pharmacoeconomics paper on genetic testing for a major journal – here.
• Policy article on new trends in payers and coverage with evidence development (in prep)

Medicare Local Coverage Issues

• Helped a European biopharma in dealing with unusually complex coding, payment, and coverage policy for a device/drug project
• Key member of teams assisting major pharmas with local self administered drug issues and complex DME drug delivery issues
• For an advanced cardiac technology company, led team on strategy and implementation to reverse a highly negative local coverage decision
• For numerous genomics companies, assisted in strategy and execution for local coverage decisions with CMS MolDX program and with other regional MACs

Digital Health

• For a leading preventive behavioral medicine provider, assisted with federal policy change strategies critical to market expansion via virtual delivery to patients.
• For a leading remote cardiac monitoring provider, assisted in negotiating challenging Medicare payment and coding issues.
• For a leading remote disease management company, providing federal strategy roadmap and planned CMS policy comments and face to face meetings with agency leadership.
• For a leading developer of advanced wireless diabetes products, assisted in understanding and improving strategic national payer issues and also tactical implementation such as applying for new product coding.
• For the emerging “digital genomics” industry, have tracked trends for clients, produced white papers and national conference panel sessions, and assisted companies with strategic decisions for both commercialization and new product investments.