As the understanding of the molecular basis of disease grows, so will the availability of novel tests that will offer disease screening, guide therapy selection, and characterize the variability of therapy response in individual patients.

Boston Healthcare broadly supports both diagnostics/IVD and laboratory innovators in the development of comprehensive regulatory and commercialization strategies for novel technologies that drive the real value proposition for diagnostics— patients get optimal treatment while ineffective care and related expenses can be reduced.

A diagnostic company needs a reimbursement strategy and assessment for a novel breast cancer test. Boston Healthcare is engaged to implement a strategy to achieve appropriate coding, coverage, and payment. Boston Healthcare performs primary research with key stakeholders including physicians, payers, and laboratory directors. Boston Healthcare also performs research with key coding decision-makers to understand the appropriate coding and how the codes may change over time. A strategy is developed which aligns the clinical message with the best coverage and payment opportunity.

An IVD company with a novel cardiac risk marker needs to identify the critical path to achieve maximum value based on optimal business partnering and reimbursement pathways. Boston Healthcare is engaged to identify benchmarks that are critical for maximum success and to identify risks and rewards for different partnering models. Boston Healthcare uses primary and secondary research with blinded technology profile and discussion guides to assist in testing various business models with key stakeholders. Boston Healthcare constructs laboratory payer mix model which estimates the average reimbursement and profit expectations for various laboratory markets. Boston Healthcare analyzes the difference in implementation support needs based on various partnering options and finds coding application, cost impact modeling, lab partner support, and payer engagement to drive necessary coverage.

Boston Healthcare has worked with a company focused on novel diagnostics in the women’s health. Boston Healthcare has assisted the company in many areas to support reimbursement and commercialization, including development of a reimbursement strategy, preparation and submission of CPT coding applications, development of payer strategies and profiling, and health economic modeling and white paper development. Boston Healthcare has also worked closely with the client’s laboratory partners to support their effort in maximizing reimbursement and developing payer pull-through programs.

Boston Healthcare has worked extensively with this novel in vitro cardiovascular risk assessment technology to develop a reimbursement and coding strategy, as well as pricing and forecast models. Work has continued on implementation of these strategies, with Boston Healthcare providing support on alignment of reimbursement and market strategies, engaging laboratory partners to drive adoption, and preparation of a novel CPT coding application.

Boston Healthcare examined the reimbursement and coding environment for a novel amplification and hybridization technology. Issues addressed included the complex and changing environment for reimbursement and coding for genetic testing, likely reimbursement and payment outcomes for the technology, and strategies for engaging in and influencing the ongoing debate regarding coding and payment for molecular diagnostic technologies.

Boston Healthcare has worked with many companies, both test developers and service providers in clinical diagnostics, to assess the market opportunity and develop strategies for market entry of new tests or services. These engagements typically examine everything from test or service market potential, to likely reimbursement milestones, adoption curve modeling, and product/service forecasts and financial plans.