McDermott+Consulting Diagnostics Industry Survey

McDermott+Consulting, based in Washington, D.C., serves many clients in the diagnostics industry, as well as the larger healthcare industry. This survey is meant to elicit industry leaders’ insights into the most pressing regulatory and payment policy issues facing the industry. In addition, McDermott+Consulting is interested in learning how the diagnostics industry is handling recent payment policy changes and regulatory changes. We plan to share preliminary results with attendees at our +DX conference. The responses are made anonymously and results will be presented in an aggregated fashion only.

Please note that this survey allows you to edit your answers before sending.

* 1. What is your role in your organization? (Check all that apply)

* 2. How long have you served in this role at your current or former company(ies)?

* 3. What is the focus of your company or organization and the services it provides? (Check all that apply)

* 4. What aspect of the diagnostics market does your firm and its product(s) cover? (select all that apply)

* 5. In your role, how much of your time do you devote to regulatory issues (i.e., U.S. Food and Drug Administration (FDA)) that are most relevant to your company and industry?

* 6. In your role, how much of your time do you devote to payment, coding, coverage and policy issues that are most relevant to your company and industry? (We define payment and payment policy issues to include fee schedules, reimbursement rates and other payment policies that may be promulgated by the Centers for Medicare and Medicaid Services (CMS).)

* 7. If you do not cover regulatory issues, is there a dedicated, senior-level official in your company who focuses on regulatory issues that affect the company and the product offerings?

* 8. If you do not cover payment issues, is there a dedicated, senior-level official in your company who focuses on payment, coding, and coverage issues that affect the company and the product offerings?

* 9. In the past three years, has your company participated in drafting, providing feedback on comment letters or other direct engagement in writing or in person with FDA, CMS or the Office of Management and Budget (OMB) on regulatory or payment policies that affect your firm and your services/products?

* 10. In your opinion, how exposed is the diagnostics industry to regulatory policy changes that could have significant impact on decisions around product development, pricing, and strategy in the near term (e.g., 2 to 3 years?)

* 11. In your opinion, how exposed is the diagnostics industry to payment policy changes that could have significant impact on decisions around product development, pricing, and strategy in the near term (e.g., 2 to 3 years?)

* 12. In your opinion, which regulatory or payment policy concerns have had the largest impact on the diagnostics industry in the last year? (select all that apply)

* 13. In your experience, over the past three years, which regulatory or policy issue has been most important to the diagnostics industry?

* 14. Given your experience, what area(s) are likely to experience significant regulatory (i.e., FDA) reform over the next three years? (select all that apply)

* 15. Given your experience, what area(s) are likely to experience significant payment policy reforms over the next three years? (Check all that apply)

* 16. In your experience, what are the most effective tools available to industry to help shape regulations, policies, guidance documents, and laws affecting the diagnostics industry? (Rank order with 1 being the most effective tool.)

* 17. In your current capacity, which regulatory and policy issues would benefit most from timely, data driven engagement of industry stakeholders? (Select the top 2)

* 18. Recent reports suggest there may be a flattening of venture investments in diagnostics services. In your opinion, what are the likely drivers for changes in investing in the diagnostics industry? (Select the top 2)

* 19. What is your biggest worry in the next year with regard to the diagnostics industry?

* 20. What is your biggest worry in the next four years with regard to the diagnostics industry?

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