Every day, providers see firsthand how coverage and access decisions shape whether patients with rheumatoid arthritis can continue treatments that control their disease or spiral into avoidable pain and disease progression.
Earlier this year, I shared these perspectives with policymakers during a CMS session on the Medicare Drug Price Negotiation Program under the Inflation Reduction Act, an important step toward aligning policy with patient care.
In my practice, some patients are deeply engaged, while others feel overwhelmed by a complex system. That complexity was echoed in the session, where physicians stressed that treatment decisions are rarely straightforward and cannot be reduced to assumptions about “interchangeable” therapies. Patients and caregivers reinforced this, describing how access to treatment shapes their ability to stay stable, trust care plans, and manage disease over time. Their message was clear: access directly determines outcomes.
Rheumatoid arthritis is not one size fits all, and neither are its treatments. While biologic and targeted therapies are often grouped as “therapeutic alternatives,” they are not interchangeable in practice. Physicians select therapies based on clinical evidence and individual patient needs, not broad categorizations that overlook meaningful differences in how these drugs work and who they benefit.
Some therapies offer more targeted immune modulation and may better suit patients with certain comorbidities. During the CMS session on Orencia, I noted that many Medicare patients rely exclusively on this medicine, especially those with complex conditions. It is also the only FDA approved therapy to prevent moderate to severe acute graft-versus-host disease, underscoring how one treatment may be the right choice when others are not. Preserving treatment options is critical, since no single therapy works for every patient.
For patients, effective treatment means more than symptom control. It supports consistency, independence, connection to family, and overall quality of life. Even small differences between therapies can lead to loss of disease control, adverse events, and disruptions that are difficult to reverse.
At the same time, there are growing concerns about the sustainability of current payment systems for physician administered therapies. Many patients rely on provider administered biologics delivered in physician offices, which are often more convenient and lower risk than hospital settings. Under the “buy-and-bill model,” already thin margins may shrink further under current CMS policies, making it difficult for community practices like mine to continue offering these treatments.
If that happens, providers may stop administering these medications in office and refer patients to hospitals that can absorb the financial loss. For patients, this means less convenience, higher costs, and greater exposure to hospital acquired infections, disrupting care and outcomes. For taxpayers, it shifts patients away from physician offices, the lowest cost Medicare setting, to more expensive hospital outpatient departments or home infusion.
Even more concerning, some patients may lose access to their CMS negotiated Part B therapy altogether if alternative sites are unwilling to accept them under unfavorable reimbursement. We have seen this with other Part B biologics that are “underwater,” where payment falls below acquisition and administration costs, leaving patients without access to their preferred treatment. The warning signs are already clear.
Policymakers must also consider long-term market effects. Pricing decisions that are too aggressive for therapies nearing biosimilar entry risk discouraging investment and slowing development of lower cost alternatives, ultimately limiting access rather than expanding it.
As CMS moves forward with decisions on the 2028 Part B drugs selected for negotiation, it is critical that these real-world perspectives are reflected in final policy. Failing to do so risks undermining access and destabilizing care for vulnerable patients.
We are encouraged that Reps. Murphy and Gray are working toward a permanent fix through the Protecting Patient Access to Cancer and Complex Therapies Act, and we urge continued progress on policies that strengthen, rather than restrict, the physician patient relationship.
There is a clear opportunity for a more balanced approach that supports clinical judgment, preserves access to effective therapies, and fosters a competitive, innovative marketplace by grounding policy in the realities of patient care and ensuring patients can access and remain on the treatments that work for them to improve outcomes and sustain Medicare.
Robert Levin, MD, is Vice President at the Coalition of State Rheumatology Organizations.
