Changes to HCPCS codes for immune globulin products would create “significant administrative, operational, reimbursement and patient care challenges without providing meaningful clinical or financial benefit,” the National Home Infusion Association (NHIA) said in draft comments intended for the Centers for Medicare & Medicaid Services (CMS).
In a May 26 announcement, NHIA said, “The comments emphasize that the proposal could disrupt patient access to life-sustaining therapies, increase claim denials and compliance risks, and require extensive system updates across providers, payors, manufacturers, and pharmacies. NHIA recommends that CMS withdraw the proposal entirely or, if changes proceed, standardize billing units across products, delay implementation by at least 18 months, provide transparent rationale for the changes, and allow overlap periods and automatic prior authorization crosswalks to minimize disruption.”
In the letter, to be sent to CMS Administrator Mehmet Oz, M.D., NHIA addressed changes due to take effect Jan. 1, 2027.
“The proposed changes primarily involve revisions to existing immune globulin HCPCS codes and significant changes to billing units and descriptors for intravenous immune globulin (IVIG) products,” NHIA said. “Specifically, many immune globulin products, which are currently billed in 500 mg increments, would transition to smaller 100 mg or 200 mg billing units, accompanied by entirely new HCPCS codes.”
NHIA recommends that CMS “abandon the proposal entirely, because it would create widespread disruption without meaningful patient benefit or cost savings.”
Instead, one of NHIA’s suggestions is to modify “the units for Yimmugo to be consistent — 500 mg — with other IV products.” Yimmugo is an immune globulin liquid to treat primary humoral immunodeficiency — a genetic condition in which the body does not naturally produce adequate functional antibodies — in patients 2 years and older.
“If CMS proceeds with modifying HCPCS billing units, NHIA recommends standardizing all immune globulin products to a consistent 100 mg billing unit across all products to reduce confusion and administrative complexity,” NHIA added.
NHIA also suggested that certain HCPCS codes — J0850, J7504 and J7511 — “be excluded from the broader immune globulin proposal and evaluated independently because they are not therapeutically used in the same manner as other Ig [immune globulin] products.”
“While standardization and modernization efforts are important, the proposed HCPCS coding and billing unit changes for immune globulin products would create substantial operational disruption and financial risk across the healthcare system, with little to no benefit to patients or CMS,” said Connie Sullivan, B.S. Pharm, the NHIA’s president and CEO. “CMS should abandon this proposal and work with affected stakeholders on any potential new coding changes.”
