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Recap: BIO Stakeholder Briefing on the Medicare Part B Drug Payment Model

May 3, 2016
On March 8, 2016, the Centers for Medicare and Medicaid Services’ (CMS) Center for Medicare and Medicaid Innovation (CMMI) published a Proposed Rule to test alternative payment models for the reimbursement of drugs covered under Medicare Part B. In the Proposed Rule, CMS has proposed a five-year demonstration program with two phases that will be established sequentially, and intends to require almost all Part B prescribers to participate.

Phase I is proposed to begin as early as summer 2016. This phase aims to change the formula by which providers receive reimbursement for drugs provided under Medicare Part B. Many worry that this proposed change could make it difficult for providers to acquire medicines under the Part B program, which in turn would negatively affect patient access to life saving therapies. Many patients and providers worry that this change could force patients who are currently on stable therapies to switch to different products or force patients who are currently receiving care in a physician office to instead travel to a hospital outpatient department, which can require longer travel times and higher out-of-pocket costs. In Phase II, proposed to begin as early as January 1, 2017, CMS proposes to test various value-based pricing strategies. There are few details available with regard to Phase II, but concerns have been raised that these strategies may be implemented in a manner that delays, not facilitates, patient access to needed medicines.

Earlier this month, BIO hosted a briefing to provide a forum for the stakeholder community to discuss CMMI’s Proposed Rule and how it would impact patients receiving needed treatments under the Medicare Part B program. The briefing was attended by nearly 40 patient and provider groups, representing numerous disease areas. Many attendees used the briefing as a forum to share their views on the substance of the proposal, and many highlighted the lack the transparency and engagement from CMMI as it developed the Proposed Rule. You can view the slides presented by the briefing panelists here.

Additional information about the proposed rule is available here. CMS is holding an open comment period through Monday, May 9, 2016, so that interested stakeholders have the opportunity to provide their input. If you have any questions about the rule or how to engage in the comment process, please contact Gautami Inamdar at

BIO is committed to working with the patient and provider communities to ensure they are able to receive access to the treatments that work best for them and their patients.