- Explicitly align policy with innovation: If existing regulatory or reimbursement policy is a barrier to either the development of improvements in the science or patient access to these advances, then those barriers should be re-evaluated and removed;
- Provide a meaningful voice to patients: In all appropriate venues where policy around the value of innovation is being measured, the patient voice should be included and ultimately reflected in the decision-making process;
- Protect against policies that impose blunt access restrictions to medical options that are best suited to individual patients: Medical management tools should be patient-centered and not based on one-size fits all evidence standards;
- Foster informed choices from the range of clinical/care options: Patients and providers can both advance innovation and benefit from it when reliable, accurate information is more readily available through modern information sharing tools;
- Incorporate constructs that were designed with the help and expertise of the patient community: PCORI created a new way to develop and design patient-centered outcomes research but the statute also includes protections around the misuse of innovative research;
- Ensure transparency and accountability as payment and delivery models evolve (i.e. ACOs and alternative payment models);
- Make the conversation about innovation as broad as possible to maximize the value to patients: It should be holistic and view the needs of patients across the care continuum.
The full comment letter is available below.