Update on Coverage Reform. Business Development Working Group. September 13, 2017

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1 Update on Coverage Reform Business Development Working Group September 13, 2017

2 Coverage Reform Key Action Steps Created new coverage reform workgroup Fielded member survey on key coverage problems Develop alternatives and proposals to improve coverage process and assess risks/benefits Develop approaches to provide CMS resources and assess risks/benefits 2

3 Survey of Medtech Executives 19% Diagnostics companies (10 respondents) Therapeutic companies (42 respondents) 81% 44% 23 respondents are Accel members 3

4 Key Survey Findings No Single Problem But Instead a Set of Distinct and Interrelated Problems NCDs Evidence Needs Transparency LCDs Complexity Benefit Design Coding 4

5 Coverage and Access Challenges LCDs 55% of Medtech executives reported had preliminary discussions with one or more MACs prior to requesting local coverage or an LCD. But only 50% of them found preliminary discussions helpful. 48% More than 45% of Medtech companies have at least one technology that has varying levels of coverage across different MAC jurisdictions. Medtech companies have received an LCD restricting coverage for at least one technology. 5

6 Coverage and Access Challenges 55% NCDs of Medtech executives who had applied NCDs consider negative NCD as a significant or moderate challenge to their business. 46% of Medtech Executives discussed parallel review opportunities with CMS 33% of Medtech executives reported had preliminary discussions with CMS prior to requesting an NCD. 88% of them found preliminary discussions with CMS helpful. 60% of them pursued the NCD request after preliminary discussions with CMS. But only 19% of them reported an NCD initiated by CMS as a result of the request and only 25% of Medtech executives reported receiving the notification from the CMS that it would not open an NCD 6

7 Coverage and Access Challenges Technology did not meet Medicare benefit category Coverage Survey Preliminary Results Local coverage or LCD was not positive NCD with CED restricted coverage/access NCD resulted in non-coverage 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Significant or Moderate Challenge Minor or Not a Challenge Does not Apply 7

8 Coding & Payment Challenges Coverage/payment denied for Category III code Applied for HCPCS Level II code but code request denied Existing coding did not adequately describe the new technology/procedure Payment existed but payment amount was insufficient to support the new technology on the market 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Significant or Moderate Challenge Minor or Not a Challenge Does not Apply 8

9 Existing AdvaMed Proposals on Coverage 1. Breakthrough 2. LCD Transparency Process 3. Coverage for Category III Code Proposal 4. Automatic IDE Trial Coverage 5. PACER (Provisional Accelerated Coverage to Encourage Research would allow local coverage requirements for data development 9

10 Benefit Both Local National Range of Options Considered Additional Options to Improve Coverage Process 1. Expand Parallel Review to include 510(k) products and create a better link of CMS-guided evidence development with Medicare coverage 2. Allow CED or CDD without finding that something is not reasonable & necessary 3. Re-define reasonable & necessary standard using value framework 4. Create an automatic NCD approval based on positive decisions of multiple LCDs 5. Terminate local coverage process and make all coverage national 6. Reform local coverage process for more transparency and better processes 7. Use only one standard for both FDA approval and Medicare coverage 8. Allow coverage for any technologies selected by ACOs or bundle programs 9. Expand coverage through CMMI testing of new technologies that don t meet benefit category 10

11 Key Areas of Focus Based on Member Survey Expand Parallel Review to include 510(k) products and create a better link of CMS-guided evidence development with Medicare coverage (IMPACT Program) (slide 13) LCD Reforms (slide 14) Expand coverage through CMMI testing of new technologies that don t meet benefit category (for example, disposable DME, digital/telehealth tech) Breakthrough Pathway Proposal Best Practices Guide/Education for Coverage and Coding 11

12 Key Components of IMPACT Program Alternative to CMS/FDA Parallel Review Program Voluntary for company Evidence guidance from CMS with a link to coverage if technology meets requested outcomes Coverage through NCD, NCD with CED, LCD, or other PMA, de novo, and 510(k) products CMS entry point on coverage, coding and payment support/guidance from CMS IDE trials and other studies covered 12

13 Key Components of LCD Reforms LCD Transparency and Process Improvements Coverage for Category III Code Proposal Required coverage of IP NTAP and OP pass-through services PACER (Provisional Accelerated Coverage to Encourage Research) Allow Data Development at local level Appeals options Other Proposals 13