Physicians urge CMS to adopt unique billing codes for biosimilars Posted 10/11/2017

On 11 September 2017, groups representing physicians in the US commented on the biosimilar reimbursement policy of the Centers for Medicare & Medicaid Services (CMS). The six groups, which represent a broad spectrum of physicians who prescribe biologicals, have urged the CMS to revise its policy of assigning a single code to all biosimilars. Instead they urge the CMS to adopt unique Healthcare Common Procedure Coding System (HCPCS) billing codes, otherwise known as J‑Codes.

In July 2015 the CMS, which provides health insurance for the elderly and children in the US, released a proposed rule for the reimbursement of biosimilars [1]. However, despite various groups raising concerns about the proposal the policy was finalized in 2015 and took effect on 1 January 2016 [2].

The rule (CMS-1631-P) assigns a single code (HCPCS) to all biosimilars of a particular reference product and reimburses them based on the weighted average of their average sales price under Medicare Part B. However, concerns have been raised that this could ‘unfairly disadvantages non-interchangeable biosimilars’ [2], as well as discourage innovation, erect barriers to developing biosimilars and create safety issues due to the inability to differentiate between biosimilars and reference (brand-name) products [3].

The latest comments on the biosimilars policy come after the CMS issued a request for comments on the proposed revision of its payment policies in the Federal Register publication of 21 July 2017.

The six groups include the Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, American Gastroenterological Association, Biologics Prescribers Collaborative (BPC) and the Coalition of State Rheumatology Organizations.

The groups’ comments urge the CMS to consider the following points:

  • Biosimilars are not generics and CMS should not treat them as generics
  • A single J-Code policy does not properly recognize interchangeability
  • Grouping biosimilars of the same reference product into one J-Code creates barriers for physicians
  • Blended reimbursement may encourage inappropriate non-medical switching
  • Single J-Codes may reduce investment in the biosimilars market and limit therapeutic choices

For these reasons they believe that ‘unless a biosimilar is deemed by the US Food and Drug Administration to be “interchangeable” with the reference biologic, each biosimilar should have a unique J-code’.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Concerns raised over CMS biosimilars reimbursement policy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Policies-Legislation/Concerns-raised-over-CMS-biosimilars-reimbursement-policy
2. GaBI Online - Generics and Biosimilars Initiative. GPhA raises concerns over CMS biosimilars reimbursement policy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Policies-Legislation/GPhA-raises-concerns-over-CMS-biosimilars-reimbursement-policy
3. GaBI Online - Generics and Biosimilars Initiative. Lawmakers urge CMS to reverse its biosimilars policy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Policies-Legislation/Lawmakers-urge-CMS-to-reverse-its-biosimilars-policy 

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Source: BPC, CMS, Federal Register

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