We’ve highlighted how the proposed Part B model lacks safeguards to protect patients from barriers and reduced quality of care.
Some stakeholders have suggested that the Part B proposal looks a lot like an “experiment on Medicare patients.” Here’s a look at how the proposal stacks up against a clinical trial.
Researchers sponsoring clinical trials (including biopharmaceutical companies) follow strict guidelines for review and approval to make sure patients are informed, risk is minimized and ongoing monitoring and evaluation are included.
The Administration’s Part B proposal does not include similar, essential patient protections. The model was developed without stakeholder input, analyses of unintended effects have not been made available, the proposal effects a large population (approximately 3 in 4 Medicare providers), beneficiaries will not be notified and do not have the opportunity to opt out, and there is a no clear plan for real time monitoring and evaluation to ensure patient access and health is not negatively impacted.