Shaping Health Policy Solutions

Building consensus on coverage, reimbursement, and the use of evidence

The FDA generally requires a demonstration of safety and efficacy before new pharmaceuticals and medical devices can be marketed.  However, products undergoing FDA review need not undergo rigorous comparisons to other products and approaches used to treat the same condition, and may not have been tested on all the different types of patients who will use the product after approval.   At the same time, new diagnostic technologies such as next generation sequencing are challenging existing models of disease and care delivery, but evidence of the patient benefit may not yet be clear. Consequently, even when a product is on the market and in broad use, clinicians and patients may not have the evidence they need to decide on the best course of care.  Payers may also need more broad-based, comparative data to determine if coverage for a new innovation is warranted.  

CMTP is collaborating with a variety of partners to address these limits.  We are evaluating the policies that create barriers to adoption of innovative new technologies.   We are assessing approaches like adaptive licensing and Coverage with Evidence Development (CED), which can promote innovation by allowing potentially important products to come to market more quickly, while supporting the development of evidence needed, and still safeguarding patients.

More specifically, CMTP collaborates with partners by:

  • Assessing and guiding new developments in the regulatory, coverage and reimbursement policy landscape to ensure better alignment with technology advancements.
  • Developing innovative strategies to improve adoption and diffusion of novel emerging technologies, focused on the information needs of the end user.
  • Providing thought leadership on innovative policy approaches, such as CED, Managed Entry Schemes, and Adaptive Licensing.
  • Leading the design of policy frameworks that enhance the efficiency of clinical research to make healthcare more affordable and patient-centered.

Current policy-related work includes:

  • Strategic Opportunities for Building a Patient-Centered Outcomes Research Data Infrastructure:  Under the Affordable Care Act, the Department of Health and Human Services (HHS) has been given about $200 million in funding to build a data capacity to support Patient-Centered Outcomes Research (PCOR).  Ultimately, a PCOR data infrastructure is expected to facilitate research that will generate knowledge for evidence-based decision making for health care and empower patients to make informed decisions related to the specific health outcomes they seek.  In partnership with NORC and AcademyHealth, CMTP is working with the Office of the Assistant Secretary for Planning and Evaluation and the Office of the National Coordinating Center for Health Information Technology to help shape a strategy for building this data capacity.  CMTP helped develop a conceptual framework that identified the components, characteristics, and functionalities needed in a data infrastructure that would support PCOR.  CMTP also completed more focused work to develop specific recommendations about how to leverage the wealth of existing federal data to be more useful for and more accessible to researchers for conducting PCOR.  Key findings from this work will help guide HHS investment priorities in this infrastructure over the next six years.
  • Next Generation Genome Sequencing: Next Generation Sequencing (NGS) has the potential to usher in an era of personalized medicine because of its ability to yield highly detailed, molecular pictures of diseases and the targeted therapies that might be designed to treat them.  However, the complexity of the information NGS produces creates challenges for the institutional systems of regulation, intellectual property, and coverage and reimbursement that were designed for genetic testing technologies of an earlier era.  The incompatibility of NGS with these systems of oversight could lead to barriers in the both clinical uptake and effective use of NGS.

    Working with Johns Hopkins University and Baylor College of Medicine, CMTP performed a landscape analysis of the NGS testing industry, focusing on the generation, delivery, and interpretation of genomic data.  Our white paper on the topic explores the legal, intellectual property, and regulatory boundaries, the challenges to payers, and outlines considerations for policymakers.   CMTP is now implementing a multi-stage, deliberative process of policy brainstorming with a panel of expert stakeholders and thought leaders (a “policy Delphi”) to assess the most pressing issues posed by NGS and identify solutions to those issues. These findings will be shared via public briefings and meetings with select federal officials, Congressional members and staff, and others in the field.

You can learn more about major CMTP policy projects in the Health Policy section of our Resource Center.