Advance Notice of Proposed Rulemaking: International Pricing Index Model for Medicare Part B Drugs

BIO strongly opposes the potential proposal detailed in the ANPRM and calls for withdrawal of the IPI model in its entirety, as:

1. The IPI model is inconsistent with the charge of CMS’ Innovation Center, and does not appropriately consider benefit to the patient;
2. The IPI model imports foreign price controls on American innovation, jeopardizing access to new medicines for Medicare’s vulnerable beneficiaries;
3. The IPI model introduces new middlemen and complexity into providers’ delivery of critical medicines, potentially jeopardizing care to patients without reducing beneficiary costs; and
4. The IPI model is part of broader Agency efforts that are eroding the value of the Medicare benefit for seniors and putting patient access to care at risk.

These concerns are described further in the balance of this comment letter.