The Robert J. Margolis Center for Health Policy at Duke University is forming a consortium to address key issues in advancing value-based payment for drugs, medical devices and gene technologies. Composed of patient advocates, payers, manufacturers, providers, and experts on regulatory affairs, law and policy, the consortium will identify solutions to competing demands of complex health care systems with the aim of better health outcomes and lower cost of care. It also will seek to overcome barriers to value-based payment, develop conceptual frameworks for structuring the payment arrangements, facilitate stakeholder input and support, and explore other innovative approaches leading to greater value. Individual working groups will focus on payment models specific to devices, gene technologies and drugs used for chronic conditions.

U.S. lawmakers are asking the Centers for Medicare & Medicaid Services (CMS) to follow the law in how it reimburses for biosimilars by reversing a policy, adopted under the Obama administration, that lumps biosimilars under one Part B payment code while giving the reference biologic a unique code. Citing the statutory provisions establishing the U.S. biosimilar path, a bipartisan group of 52 House members pointed out that the law specifies reimbursement for biosimilars to be calculated separately. Thus, each biosimilar must have its own Healthcare Common Procedure Coding System (HCPCS) code, the group said.

The FDA released 37 draft product-specific guidances – 21 new and 16 revised – on how to develop generics that are therapeutically equivalent to specific drugs. The guidances provide recommendations on the design of bioequivalence studies to support generic applications.