The National Renal Administrators Association has expressed concern over the Centers for Medicare & Medicaid Services’ proposal to group multiple biosimilars for the same reference product under the same J-code for Medicare reimbursement purposes. The NRAA sent a letter to CMS Aug. 10, asking the agency to drop the provision in the proposed 2016 Medicare Physician Fee Schedule, and assign biosimilars a unique and permanent J-Code.

“NRAA is concerned the proposal from CMS could place an administrative burden on providers, which would ultimately lead to less treatment options for dialysis patients,” NRAA President Debbie Cote wrote. “Stable and accurate payment policies lead to the increased use of innovative therapies that benefit our patients.”

Congressional support for separate biosimilar reimbursement codes

A bipartisan delegation of 33 House of Representatives members also sent a letter, on Aug. 4, requesting that CMS drop the biosimilar provision.

“In this proposal, CMS treats biosimilars as if they are generic drugs,” the Representatives wrote. “As a primary matter, it is important to recognize that traditional small-molecule pharmaceuticals and biologics are fundamentally different in their development, manufacture and chemical makeup. A biologic is a large, complex molecule, which is grown in living systems such as a microorganism, a plant or animal cell.”

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The House letter also notes that the Social Security Act states that “the calculation for reimbursing biosimilars shall be made separately, such that each biosimilar will have its own unique payment rate and unique HCPCS code. This language reflects congressional intent to encourage a vibrant biosimilars market and we urge you to enact a final payment rule that provides each biosimilar with a unique code.”

According to the Biosimilars Forum, a nonprofit organization whose mission is to advance biosimilars in the United States, issuing unique Healthcare Common Procedure Coding System codes to each individual biosimilar is essential in order to:

  • Facilitate accurate attribution of adverse events.
  • Provide clarity where some but not all biosimilars of a biological product achieve interchangeability.
  • Provide clarity where different biosimilars of a biological product do not share the same indications.