Pre Market Reimbursement Strategies for New Technologies

Transcription

1 Pre Market Reimbursement Strategies for New Technologies Marilyn Denegre-Rumbin, JD MBA Director Payer-Reimbursement Strategy Strategy & Business Development December 1, 2015

2 Early Strategy Integration is CRITICAL to any Product s Success

3 Reimbursement Must Start with the Initial Development of Product Product Design Diagnostic vs. therapeutic R&D must understand the need to show clinical value Setting of Care Different reimbursement based on site of care Provider type Surgical vs. Medical Physician vs. Non-physician Clinical Indications Define subset of patients. Include target patients in clinical trials 3

4 Pre Market Assessment s Market Analysis *Market Size * Target Pricing * Current trends and disease treatments on populations Competitive Landscape * Competition Mix ( companies, products, substitutes) * Points of Service ( trends, reimbursement) * Product mix and penetration, market share Intellectual Property * Licensing, * Patent application, * Trademark, Copyright

5 Additional Puzzle Pieces Regulatory Path * Review of FDA Application, product classification * Identify the pathway for FDA review, process, approval * SWAT Analysis * Data requirements * Clinical Evidence and trials * Status technologies in the pathway Reimbursement Path *Define products, services, technology currently covered. * Coding analysis ( CPT/DRG/APC codes) * Coding application and strategy

6 Reimbursement Assessment is Critical Reimbursement is one of the most critical elements in the life cycle of your product. Must understand current reimbursement landscape for a product/ procedure. Coverage Coding Payment Competitive landscape Legislative impact Impact of ACA Market Access Partnering Payers Payment Initiatives Domestic and International markets and strategy **Investors will ask about your reimbursement strategy!

7 Reimbursement Building Blocks

8 Understanding How the Key Elements

9 What is Coding? Coding represents the reimbursement language that payers and providers use to communicate. Its explains Who? What? Where?» CPT» DRG» HCPCS» RVU S» ICD-9» ICD-10 Resources listed in slide notes

10 Key Elements for Success! Reimbursement Terminology! Reimbursement Methodologies! Payment Systems! Health Policy! Contract strategies

11 Incorporating Reimbursement Into Your Strategy Pre Commercialization Clinical Study Review Cost, Coverage, Coding, Payment Assessment, Payer Mix Analysis, Payer Insights, Reimbursement Strategy Commercialization Coverage, Coding, Payment Assessment, Publication Strategy, Cost Effectiveness; Health Care Policy Analysis, Code Applications** Advocacy, Payer Communication; Sales Force Training, Tools, Reimbursement Guides Post Commercial: Targeted Payer Activities, Payor Experience Tracking, Health Policy Updates, Advocacy, Market Updates, Reimbursement Landscape;

12 Data Criteria and Collection

13 Development of the Payment Strategy

14 Collecting the Highpoints to Leverage the Payment Strategy

15 Why are Studies and Data Important?

16 Bring the Team Together

17 Incorporating the Economic Value Proposition

18 Filling in the Gaps Prioritize studies based on their costs and likelihood of influencing reimbursement decision makers. Develop a preliminary Economic Model and use it to identify gaps in available data. Share the model to verify strengths and weaknesses. Develop Payer Advisory Board Technology Assessment Reports- Coverage Policies for Proxy Devices ( supports reimbursement and direction of coding, bundling.

19 Evaluate and Start the Coding Process Review Coding requirements, background and categories, including CMS and with AMA for requirements. Requirements for Pass through Payments. Application for DRG add-on can be submitted. CMS s Application for New Medical Services and Technologies Seeking Quality for Add-On Payments under the Hospital Inpatient Prospective Payment System.

20 Four Key Strategies There are four key strategies hospitals and physicians should use to prepare for upcoming reimbursement changes: 1. Develop medical staff-hospital collaborations that include both private and employed physicians. 2. Develop integrated and comprehensive continuums of specialty care. 3. Deliberately invest in and implement clinical and functional outcomes collection and reporting. 4. Proactively define quality with payors and pilot alternative reimbursement models.

21 Plans for Project Funding Funding Requirements Identify and quantify the needed funding Pre FDA Project for *3-5 years Post FDA Early Market entry *3-5 years Constraints, potential leakages Budget and plan for a Rainy Day Assess resources, grants, investors, partners Develop your Value Proposition Messaging

22 Moving Forward

23 Project Plan Develop your project plan, Track and assess, Work your Plan.

24 Marilyn Denegre-Rumbin, JD MBA Director, Payor - Reimbursement Strategy Strategy & Business Development 7000 Cardinal Place Dublin, OH dir mobile marilyn.denegrerumbin@cardinalhealth.com

25 Thank you! 25 Copyright 2014 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and