National Forum on Biomedical Imaging in Oncology CMS UPDATE

1. National Forum on Biomedical Imaging in Oncology CMS UPDATE Steve Phurrough MD, MPA Director, Coverage and Analysis Group

2. Recent Activities • PET scanning • NCI trials • Coverage with evidence development

3. PET for Alzheimer’s Disease • Limited coverage as differential in FTD • Clinical trials

4. PET for Cancer Indications • Added cervical cancer • All current & future noncoverage based on lack of evidence will be covered with data collection

5. National Decisions • National Coverage • National Noncoverage • National Coverage with restrictions • Specific populations • Specific providers/facilities • Evidence development

6. Percutaneous Coronary Interventions CP1027346-1

7. SCD-HeFT

8. Contributors to Variation • Inconsistent use of good evidence • Lack of high quality evidence from studies selected and designed to inform clinical decisions • Evidence gaps are systematic and widespread • Existing clinical research enterprise will not correct the problem • CMS aim is to help establish more robust research enterprise serving decision makers • pts, clinicians, payers, policymakers • One mechanism is through coverage authority

9. Unanswered Questions • Novel vs conventional imaging • Comparative effectiveness of drugs • Surgical procedures • Off-label uses of approved drugs • 510(k) devices • Risks and benefits of treatments in subgroups of pts studied • Patients with multiple co-morbidities

10. Developing EvidenceCore concept • Links coverage with prospective data collection • Extends concept of medical necessity • Adequate evidence of benefit • Adequate evidence of potential value and provided in appropriately designed study • i.e. “promising, important, potentially high value, and under careful investigation” • Retains EBM as conceptual framework for coverage and payment

11. Problems with EB coverage • Viewed as interference with pt/doc decisions • Payers appear to impede innovation in order to control spending / protect profits • Insensitive to real barriers to doing adequate trials, and different challenges by technology • When evidence limited, may still be strong demand for technology • Does not promote promising but unproven high value technologies

12. Benefits of approach • Addresses economic barriers to good trials, especially for promising technologies • Payers can promote innovation and access, while supporting better evidence • One strategy to establish clinical research agenda oriented to decision makers • Strong public/professional demand can be channeled to improve evidence • Focus discussion around improving evidence with key stakeholders • product developers, pt advocates, payers, clinicians

13. Key conceptual issues • How to evolve from ad hoc to systematic policy approach • Priority setting: criteria, participants, process • Roles and governance: what organizations oversee and implement various functions of the initiative • Funding • How much can be accomplished by PCE • What are other sustainable sources and mechanisms of funding • What is the business case for each potential funder?

14. Implementation Issues • Methods: When to use registries, practical trials, registries, outcomes studies, etc • Infrastructure: what exists, what needs to be created, how can this be done most efficiently • Legal and ethical: private payer contractual issues, HIPAA, human subjects, conflicts of interest

15. Next Steps • Guidance on coverage plus data • Open door forum 2/14 • Initial draft guidance soon • ICD registry workgroup and CMS-NCI collaboration moving forward • FDA discussions on Post Approval Studies • IOM/AHRQ/CMS discussions • Larger stakeholder mtg 3/1 • Initial focus on registries to “break trail” • Priorities, governance, funding, implementation

16. Contact Information Steve Phurrough SPhurrough@cms.hhs.gov 410-786-2281