|Articles|September 8, 2015

Biosimilars Forum Presents More Reasons to Reject Common J-Codes

The Biosimilars Forum argues that the assignment of a unique Healthcare Common Procedure Coding System (HCPCS) for each biosimilar product is in alignment with the intent of Congress.

The Biosimilars Forum is still advocating for unique Healthcare Common Procedure Coding System (HCPCS) codes, or J-Codes, for every single biosimilar product. The organization released a letter on Sept. 8, 2015 to Andrew Slavitt, acting administrator for the Centers for Medicare & Medicaid Services (CMS), explicating that it is Congress’ intent for biosimilars to have unique billing codes. The forum says that text in the Social Security Act and in the Affordable Care Act legislation directly refers to each biosimilar as a separate entity. Thus, the forum argues, repeated references of a biosimilar in its singular form in official documents imply that each biosimilar was meant to have a separate J-code.

The organization attests that unique codes will be required for “accurate calculation of Medicare Part B OPPS payments,” and for the calculation of Ambulatory Payment Classifications (APCs). It says that because biosimilars may differ from one another in terms of approved indications and interchangeability status, and because they may have different base prices, “CMS must have unique HCPCS codes for each biosimilar product in order to appropriately package biosimilars into existing APCs by appropriate therapeutic use, or to determine that the per-day cost of the product requires its own APC.”

The letter continues by further criticizing CMS’ proposed policy on J-codes, saying that the policy “inappropriately treats biosimilar products if they were multisource or generic drugs” and that the policy will likely lead to a reduction in the availability of biosimilar products.

Source: Biosimilars Forum

 

 


Related to this article

The BioPharm Brief: A Bispecific Approval in Head and Neck Cancer, TCR Bispecifics Head to the Clinic, and a New Antibody Target in Essential Thrombocythemia
FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.
The BioPharm Brief: Ivonescimab Priority Review in China, Stargardt Gene Therapy Moves Toward Phase 3, and Longer Dosing Intervals for an IBD Bispecific
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.