Medical device and diagnostic manufacturers complete the FDA Regulatory process, win FDA-approval, and then find out that the more grueling insurance coverage and reimbursement process of approval has just begun. At the onset of product introduction, it difficult to ascertain what the result will be. Read More

Health Technology Assessment

Hospital HTA is a major strategic and tactical factor in creating a positive picture of the value a Community Hospital brings to the population it serves. Hospitals are the main entry points for new technologies in health care. Medical and surgical technologies such as devices are introduced on an ongoing basis. At this time in health care and healthcare reform, the pressure on hospitals to contain costs is mounting, conversely healthcare delivery systems often lack organizational resources and sometimes the know-how to evaluate these products, especially game changing technologies and services. Read More

Provider and Reimbursement Planning

The Life Tech industry is facing unprecedented challenges due to economics, insurers and providers evaluating not only cost, but cost-effectiveness and patient outcomes in the near and long term. This process will become increasingly important in the current and future marketplace due to complex components involved in the transition to Accountable Care Organizations and Federal/State Health Exchanges lead by public and private payers and providers Read More

Reimbursement Support Services

Reimbursement Strategies: A rock-solid market and reimbursement access strategy is crucial to attaining commercial success. Challenges and barriers surrounding a new or established technology can be multi-faceted Read More

Clinical Endpoint Strategies and Deliverables

Step II Comparative Effective Endpoints: It is imperative that the manufacturer initiate clinical, market and reimbursement assessments with a strategic plan of action regarding positive coverage, coding, and reimbursement early in the product development cycle. I.e. Phase II or Phase III. Read More