BIO's Principles for Payment System Reform (PSR) Policies

7. TRANSPARENCY:  Ensure sufficient stakeholder input through a transparent and inclusive process.   Payment system reforms must be adopted using transparent, predictable procedures that provide for adequate stakeholder input, and appeals processes.  Patients, physicians, manufacturers and other stakeholders must have a mechanism to conduct a comprehensive review and provide feedback through a formal comment-making process prior to implementation of reforms.  Cost and outcomes data generated through the implementation of reforms should be shared with stakeholders.  When pilot programs and demonstration projects are attempted, patient participation should be fully transparent and voluntary.

8. ADEQUATE REIMBURSEMENT:  Proceed cautiously before implementing payment bundles or reforms that eliminate separate reimbursement for drugs and biologicals.  Discontinuing separate reimbursement, particularly for costly therapies, should not be undertaken without comprehensive evidence that such changes will improve outcomes while lowering overall costs.  Any such policy must be undertaken with significant procedural protections to ensure that appropriate patient access is the primary goal.  In particular, it is critical that consideration be given to adjusting bundled payments for differences in patients’ risk profiles (to avoid adverse patient selection).  The burden should be on the sponsors of such policies to ensure that access to quality patient care and outcomes remain the cornerstone of any payment system reform