----------------------------------------------------Monday, February 26-------------------------

Reception................................................................6:30 p.m. - 7:00 p.m.

Location: Ambassador Ballroom, Center Room
Hosted by the Fuqua School of Business, Duke University - Rex D. Adams, Dean

Dinner Meeting....................................................7:00 p.m. - 8:30 p.m.

Location: Ambassador Ballroom, Center Room
Keynote Address:
William L. Roper, MD, MPH
Dean of the School of Public Health
University of North Carolina at Chapel Hill
Former Administrator of the Health Care Financing Administration

--------------------------------------------------Tuesday, February 27------------------------

Location: All sessions will be held in the Ambassador Ballroom, Allen Room

Welcome/Introductions.........................................8:00 - 8:15 a.m.

• Kenneth Keller, Ph.D.
  Charles M. Denny, Jr., Professor of Science and Technology
  Hubert H. Humphrey Institute of Public Affairs, University of Minnesota
  

• Kevin Schulman, M.D.
  Director of the Health Sector Management Program
  Fuqua School of Business, Duke University

Meeting Purpose/Background Materials.........8:15 - 8:50 a.m.

• Dan Mendelson
  Managing Director, The Health Strategies Consultancy LLC
  Adjunct Professor, Fuqua School of Business, Duke University

The development of the Internet has enabled the development of many information-focused health-monitoring devices and systems; however, there is uncertainty over coverage and reimbursement of these products. The purpose of this conference is to discuss possible coverage options and to identify key issues from several perspectives, including the technology industry, government payers, patient groups, providers, and commercial payers.

The Introduction will cover the following issues:

• What types of technologies are likely to emerge?
• What are the coverage / payment precedents for CIT?
• What terminology best describes the new technology?
• What barriers or impediments hinder development and coverage?
• Is there an imperative for better coverage?

Background materials distributed included a summary of the structure of the industry, a review of the published literature and/or legislation relevant to the CIT industry (e.g., coding and payment policies, restrictions on the marketing of CIT devices, privacy).

Technology Perspective................................ 8:50 a.m. - 9:50 a.m.

Many new technologies that collect, analyze, and transmit information are approaching the market for both professional and consumer use. These include pure monitoring technologies as well as others that offer a treatment component. There is considerable uncertainty regarding the coverage and payment environment for these technologies, particularly related to valuing non-traditional service components (e.g., e-mail, telephonic, data interpretation, store/forward technology, etc.), which complicates key clinical development and commercialization decisions.

This panel discussion features representatives from three diverse types of companies, and will be facilitated by Dan Mendelson. Speakers include:

• Bob Thompson
  Medtronic, Inc.

• Steve Brown
  CEO, Health Hero Network, Inc.

Points of discussion:

• What kinds of challenges have CIT companies met in gaining reimbursement for their products?

• What initiatives have been undertaken to optimize or minimize?

• What additional new concerns emerge for CIT that is marketed directly to the consumer with no medical provider oversight?

• What are the reimbursement advantages and disadvantages seen in packaging CIT services within a disease management program approach?

• How should the value of the service be viewed, through a package approach or be valued separately?

• What evidence is there that consumers value clinical information technologies, and that they would want them covered or be willing to pay for the technologies themselves?

• What future capabilities might increase demand for these types of technologies such as:
  • Managing multiple diseases?
  • Downloadable software?

Break.......................................................9:50 a.m. - 10:00 p.m.

Government Payer Perspective......... 10:00 a.m. - 11:30 a.m.

• Sean Tunis, M.D., M.Sc.
  Director of the Coverage and Analysis Group
  Health Care Financing Administration

• Parashar Patel
  Center for Health Plans and Providers
  Health Care Financing Administration

Points of discussion:

• What kind of opportunities do you see for beneficiaries? What types of concerns do you have?

• How is the political environment likely to affect HCFA's decisions regarding coverage and payment for CIT?

• How does the existing coverage language or payment mechanisms assist or preclude payment for the many aspects of CIT such as data transmission, physician reading, frequency of patient download vs. physician read? (e.g., How will HCFA assign each component to a benefit category? How does CIT relate to current policies on telemedicine?)

• What types of clinical and economic studies will be required to support specific payment decisions in this area, and should the study requirements differ from other assessments? What specific study outcomes requirements are required?

• If different components of a given technology fall into distinct coverage categories, how can payment rates be made rational and consistent?

• How will HCFA value components of the technology (e.g., e-mail) within existing resource-based payment systems?

• If HCFA begins to cover these new CIT technologies, are there existing technologies that could also be affected (e.g., reimbursing physicians when diabetic patients fax/phone in/e-mail their blood glucose values)?

• What are HCFA's views on the need for "Quality Standards" for CIT?

• What are your impressions of CIT facilitating the management of a patient's multiple diseases or using software to upgrade a current implantable to accommodate a patient's newly diagnosed co-morbidities?

• Is inappropriate billing or over-utilization a concern, and if so, how can it be addressed?

Patient/Provider Perspective........................ 11:30 a.m. - 12:30 p.m.

Technologies that monitor, analyze, and report information on disease states can be expected to profoundly change the nature of the physician / patient relationship. Physicians are already spending an increasing amount of time working with patients to sort through new publicly available information (e.g., internet resources) on disease. Some technologies that give patient-specific information should be more useful, but will require more time and effort to help patients understand the information. Further, the different business models for bringing CITs to market raise important questions about role of the physician in interpreting and delivering information to the patient.

• Yank Coble, M.D.
  Secretary-Treasurer
  AMA Board of Trustees

• Robert Levine, M.D.
  Chairman, Clinical Affairs
  Juvenile Diabetes Foundation

• Eric D. Peterson, M.D., M.P.H.
  Director, Cardiovascular Outcomes and Research
  Duke Clinical Research Institute

Points of discussion:

• Should patients have direct access to clinical information - including data analyses of their vital statistics? Are there some observations that should be available only to the physician?

• How may the payment for the technology affect patient access to CIT?

• What evidence is there that consumers value clinical information technologies, and that they would want them covered or be willing to pay for the technologies themselves?

• What effect will chronic information of CIT data and vital statistics have on patient compliance?

• What effect will payment approaches have on the frequency of office visits (e.g., physician concerns that patients relying on remote devices may not return to the office)?

• How will CIT affect the amount of time physician spend with the patient? How will physician time and other resources be recognized (e.g., Relative Value Units)?

• How might future capabilities increase demand, by patients or physician, for these types of technologies such as:
  • Managing multiple diseases?
  • Downloadable software?

Lunch.............................................................12:30 p.m. - 1:30 p.m.

• Hon. Richard Burr
  United States House of Representatives, North Carolina

Commercial Payer Perspective.............. 1:30 p.m. - 2:30 p.m.

Payers have been, and will continue to critically evaluate these technologies to determine whether they should be covered, and if so, how they should be reimbursed. They often work with the assistance of benefit managers (e.g., Mercer, Hay Group), and are increasingly requesting more sophisticated data on health outcomes.

• Mitchell Sugarman
  Director, Medical Technology Assessment
  The Kaiser Permanente Federation

• Linda Bergthold, Ph.D.
  Research Associate
  Center for Health Policy, Stanford University

• Kathy King
  Vice President
  Washington Business Group on Health - Insurance Industry Representative

Points of discussion:

• What kind of opportunities do you see for subscribers? What types of concerns do you have?

• How does the existing coverage language or payment mechanisms assist or preclude payment for the many aspects of CIT such as data transmission, physician reading, frequency of patient download vs. physician read? (e.g., How will HCFA assign each component to a benefit category? How does CIT relate to current policies on telemedicine?)

• What are options for payment (e.g., monthly monitoring fees, capitated disease management fees)?

• What types of clinical and economic studies will be required to support specific payment decisions in this area, and should the study requirements differ from other assessments? What specific study outcomes requirements are required?

• When there are competing perspectives within a plan, how do you resolve the conflicts that arise between realizing short-term and long-term goals?

• How should patient preferences be balanced against costs and other considerations in making coverage and payment decisions?

• What are your impressions of CIT facilitating the management of a patient's multiple diseases or using software to upgrade a current implantable to accommodate a patient's newly diagnosed co-morbidities?

Wrap-Up/Next Steps......................2:30 - 3:00 p.m.

• Dan Mendelson / Kevin Schulman