Biosimilars Forum Statement Regarding the Need for Appropriate Coding for Biosimilars

Washington, DC, May 7, 2015 – Today, Michael Werner, Policy Advisor with the Biosimilars Forum, the first nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States, submitted a public statement about the need for appropriate coding for biosimilars to the Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Public Meeting.

The full statement is as follows:

“The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines and improving healthcare. The Biosimilars Forum will provide evidence-based information to inform and support public policies that encourage access, awareness, and adoption of biosimilars.

The introduction of biosimilars in the United States can help expand access to high-quality treatment options for clinicians and patients as well as reduce costs to families, caregivers, payers, and the healthcare system. Using state?of?the?art technology and techniques, biosimilars are manufactured with the same excellence in standards as reference biologics.

The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolio. The Forum works on a consensus basis to develop policy positions to ensure the United States has a competitive, safe, and sustainable biosimilars market, providing more options to patients and physicians. The goal of the forum is to promote a successful and sustainable biosimilar market in the United States that will provide options for patients and providers.

The Forum offers these comments today as a continuation of our dialogue with CMS aimed at productive cooperation to develop appropriate biosimilar policy options for Medicare.

Biosimilar Medicare Part B Payment and Coding Policy Suggestions:

We believe the Social Security Act (SSA) provides clear guidance for the Average Sales Price (ASP) payment formula and associated coding for biosimilars:

  • A reference product has a unique ASP and J-code
  • A biosimilar should receive Average Sales Price plus 6% of the reference product’s ASP (per the Medicare statute)
  • A unique payment rate for the biosimilar requires a unique and permanent Level II HCPCS “J”-code for the biosimilar.

We believe the statute supports each biosimilar, including subsequent biosimilars of the same reference product, be reimbursed based on their own ASP and receive a unique J-code.

We strongly believe that a scenario for payment that blends biosimilars into the same payment group/ASP would be very detrimental to the adoption of these products. Such a decision would not foster a sustainable and vibrant biosimilar market.

The statute grants CMS authority to create separate J-codes and ASPs for each biosimilar when a reference product has multiple biosimilars.

The ACA created a clear methodology for the payment amount for the first biosimilar with respect to a given reference product—CMS is to pay the sum of the ASP of the biosimilar and 6 percent of the ASP of the reference product. SSA § 1847A(b)(8).

The statute does not require CMS to combine ASPs for multiple biosimilars of the same reference product.

Section 1847A(b)(8)(A) cross-references the methodology for calculating ASP under section 1847A(b)(6), which is the ASP methodology for both single source and multiple source drugs. As with single source drugs, a methodology for creating a weighted average will be necessary for individual biosimilars because there may be several NDCs for individual biosimilar products.

Note that section 1847A(b)(6)(A) refers to “drug products within the same multiple source drug billing and payment code.” However, section 1847A(b)(4), which establishes payment rates for single source drugs, also cross-references 1847A(b)(6) using language similar to that in 1847A(b)(8)(A). Therefore, the cross-reference to 1847A(b)(6) does not limit CMS’s ability to create separate ASPs for each biosimilar when a reference product has multiple biosimilars.

In addition, if multiple biosimilars to the same reference product shared the same HCPCS code, MACs would not be able to write coverage policies that limit use of each particular biosimilar to certain indications. MACs and other payers would find it extremely difficult to write coverage policies describing when use of a particular biosimilar is clinically appropriate.

If multiple biosimilars to the same reference product share the same HCPCS codes providers may be confused as to what appropriate code to use and may not be confident that they will receive appropriate payment for the product (Biosimilar or Reference) they prescribe and administer.

In conclusion, I would like to reiterate, the Biosimilars Forum strongly believes that a scenario for payment that blends biosimilars into the same payment group/ASP would be very detrimental to the adoption of biosimilars. Such a decision would not foster a sustainable or vibrant biosimilar market. We are happy to follow up with the agency to answer any questions.”

To learn more about biosimilars, the Forum, and how to get involved, visit or go to @USbiosimilars to follow related conversations and join the dialogue.

Michael Werner

Aimee Steel

Lynn Blenkhorn