The ACR to the CMS: What You Need to Know About Biosimilars and G2211

On May 23, Chris Phillips, MD, and Rebecca Shepherd, MD, MBA, FACR, FACP, chairs of the ACR’s Committee on Rheumatologic Care and Insurance Subcommittee, respectively, and members of the ACR’s advocacy staff team met with officials from the Centers for Medicare & Medicaid Services (CMS) to discuss concerns on underwater biosimilars and restrictions on billing G2211.

Underwater Biosimilars

ACR members have expressed ongoing concerns regarding underwater reimbursement for infusing patients with biosimilar versions of certain drugs, particularly infliximab and rituximab. Evidence has strongly backed the cost-effectiveness of these biosimilars and their clinical results. However, the average sales price (ASP) of some biosimilars has fallen faster than the acquisition cost. Thus, infusing these drugs risks putting many independent clinics at a financial loss, threatening patient access to vital treatments.  

Dr. Phillips led the discussion on this issue. In addition to the above, he mentioned that a major contributing factor for certain biosimilars being under water is the fact that rebates, which are offered to pharmacy benefit managers (PBMs) in exchange for favorable placement in formularies, are factored into the drug’s average sales price (ASP), which leads to the ASP declining faster than the acquisition cost. 

The ACR will plan to work with a coalition of specialty societies that have similar concerns with underwater biosimilars and hold additional meetings with a larger audience at the CMS to find amenable ways to modify the ASP+6 equation to ensure it leads to adequate reimbursement for physicians. ACR’s concerns and plan-of-action can be found here.

Restrictions on Billing Medicare for G2211

The ACR supported the creation and successfully advocated for implementation of G2211, which pays more accurately for the complex, high value visits that rheumatologists provide as part of a continuous relationship with a patient. However, after CMS lifted the moratorium on billing for G2211 in January of this year, the ACR started hearing from members who are frustrated by a wrinkle in the new policy, namely its exclusion from evaluation and management visits for which rheumatologists are used to coding modifier 25. CMS has teased additional guidance on G2211, which is still forthcoming at an indeterminate time in the future.

Dr. Shepherd led this discussion, during which she strongly urged CMS to eliminate restrictions on the payment of G2211 when modifier 25 is attached to the E/M code. She also urged CMS to provide guidance on how G2211 can be billed by specialists. Namely, this guidance should provide examples of scenarios for which G2211 can be billed. It should also include how G2211 applies to new patients, and succinct definitions of “ongoing care” and “complex condition.”

CMS reiterated that guidance is forthcoming and that they will try to be more specific. They also encouraged her and other providers to review patient medical records to determine if the encounter satisfies the requirements for billing G2211. As with underwater biosimilars, the ACR is considering building an ad hoc coalition of like-minded societies to put more pressure on CMS to remove these harmful restrictions. ACR guidance on billing for G2211 can be found here.

Call to Action

The ACR encourages members to email the CMS and utilize the ACR’s Legislative Action Center to voice any concerns they have about these issues. It also encourages members to peruse our Q/A on billing for G2211 and our plan of action on underwater biosimilars for further guidance.