As Medicare physicians specializing in life-threatening autoimmune diseases, we excel at prescribing diagnostic tests and medications that dramatically improve our patients’ health and quality of life. We’re trained problem solvers who navigate complex medical challenges daily. However, the most significant obstacle facing our patients isn’t medical—it’s financial.
High medication costs create insurmountable barriers for countless Americans living with chronic autoimmune conditions. Diseases like rheumatoid arthritis, psoriatic arthritis, and scleroderma require ongoing pharmaceutical treatment, yet many patients cannot afford the very medications that could transform their lives. This affordability crisis forces impossible choices between essential treatments and basic living expenses.
The financial burden extends beyond individual hardship. When patients skip doses or abandon treatments due to cost, the healthcare system ultimately pays more through preventable hospitalizations, emergency interventions, and disability accommodations. This cycle of delayed care and worsening health outcomes serves no one—not patients, not providers, and not our healthcare infrastructure.
Medicare’s Drug Negotiation Program
The Centers for Medicare & Medicaid Services (CMS) holds a unique position to address pharmaceutical pricing challenges. Their policy decisions influence not only Medicare beneficiaries but also private insurance coverage, which typically follows CMS guidelines. This multiplier effect means CMS negotiations can reshape the entire American healthcare landscape.
The Inflation Reduction Act (IRA) of 2022 established groundbreaking authority for Medicare to negotiate drug prices directly with manufacturers. The initial framework targets 70 medications, with plans to extend negotiations to an additional 70+ drugs in coming years. This represents the most significant shift in pharmaceutical pricing policy in decades.
Representing the Rheumatology Community
When CMS hosted a town hall meeting this spring on the Medicare Drug Price Negotiation Program, we proudly represented the American College of Rheumatology (ACR) and our broader medical community. The event brought together clinicians, researchers, patients, and advocacy groups to discuss medications under consideration and their profound impact on human health.
Our testimony focused on explaining the unique therapeutic value of two drugs selected in the second negotiation round: Otezla (apremilast) and Ofev (nintedanib). Contributing to this historic process allowed us to advocate directly for our patients and provide critical clinical perspectives on these essential medications.
Critical Medications Under Review
Both Otezla and Ofev serve irreplaceable roles in rheumatology care, with tens of thousands of Medicare beneficiaries depending on them for disease management. Unfortunately, like numerous specialty medications, their prohibitive costs create access barriers that lead to devastating consequences.
When patients cannot afford their prescribed treatments, they make dangerous compromises—skipping doses, splitting pills, or abandoning therapy entirely. These decisions result in preventable hospitalizations, permanent disability, and other dire outcomes that proper medication access would avoid.
Ofev: Preventing Lung Disease Progression
For patients requiring Ofev, medication access directly correlates with life expectancy. This drug treats conditions like idiopathic pulmonary fibrosis and autoimmune-associated lung diseases, particularly scleroderma-related lung involvement. These diseases cause progressive lung scarring and permanent tissue damage.
Without consistent Ofev treatment, patients experience accelerating shortness of breath and declining respiratory function. The medication slows disease progression, preserving lung capacity and extending survival. Medication adherence literally determines whether patients can maintain independence and quality of life or face rapid deterioration.
Otezla: Oral Alternative for Better Compliance
Otezla addresses multiple rheumatic manifestations through a convenient oral formulation. It effectively treats painful oral ulcers in Behçet’s disease, disfiguring skin rashes in psoriasis, and both joint pain and structural joint damage in psoriatic arthritis.
Many rheumatic disease patients traditionally required intravenous infusions administered at medical facilities. While infusion therapies can be highly effective—often giving patients their lives back by alleviating debilitating pain—the logistics create significant obstacles. Patients must arrange transportation, take time from work, and navigate scheduling challenges.
Missing or delaying infusion appointments frequently triggers severe disease flares. Otezla offers these patients equivalent therapeutic benefits in pill form, eliminating logistical barriers and improving treatment consistency. The convenient dosing dramatically enhances medication adherence—provided the cost doesn’t create a different barrier to access.
Projected Savings and Patient Impact
The Medicare Drug Price Negotiation Program represents monumental progress toward reducing prescription costs for older Americans managing chronic conditions like rheumatoid arthritis, lupus, diabetes, and related diseases.
According to CMS projections, Medicare beneficiaries will see approximately $1.5 billion in combined out-of-pocket savings starting in 2026. These aren’t abstract numbers—they represent real families avoiding financial ruin, real patients accessing life-changing treatments, and real improvement in population health outcomes.
We enthusiastically support including Otezla and Ofev in this program. The recent Executive Order affirming this initiative’s continuation signals commitment to making highly effective, potentially life-changing therapies affordable and accessible for our most vulnerable patients.
Addressing Implementation Challenges
Despite overwhelming benefits, the IRA’s current structure may unintentionally create new access problems, particularly regarding Part B drugs administered in clinical settings.
The “Underwater” Reimbursement Problem
Medicare Part B traditionally reimburses physician-administered drugs at Average Sales Price (ASP) plus 6%. Under new IRA provisions, negotiated Part B drugs will be reimbursed at Maximum Fair Price (MFP) plus 6%.
This seemingly technical change creates a critical payment gap. If negotiated prices fall below acquisition costs, providers receive reimbursements insufficient to cover expenses—becoming “underwater” financially. Infusion centers cannot sustainably operate at a loss, forcing facility closures and service discontinuation.
The Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 4299) addresses this concern by reverting physician reimbursement to ASP standards for Part B drugs under Medicare, maintaining the pre-IRA methodology. This legislation protects both provider viability and patient access to essential infusion therapies.
The Role of Pharmacy Benefit Managers
No comprehensive discussion about drug pricing reform can ignore pharmacy benefit managers (PBMs) and their opaque middleman pricing schemes. These entities significantly inflate overall healthcare costs while extracting substantial profits.
We must enact legislation requiring PBMs to provide complete pricing transparency and eliminate perverse incentives like rebate structures that benefit large conglomerates while harming everyday Americans. True affordability requires addressing every link in the pharmaceutical supply chain.
Moving Forward Together
Rapidly escalating drug costs represent an urgent, universal crisis affecting millions of Americans. The Medicare Drug Price Negotiation Program marks significant advancement toward expanding care access and improving chronic disease management. We strongly support continued implementation and expansion of these negotiations.
Participating in the CMS town hall proved powerfully moving. Hearing personal stories of suffering and hope reminded us that while budgets and balance sheets require attention, human life remains priceless. Every policy decision affects real people facing real struggles.
We call for sustained action benefiting patients nationwide—through continued price negotiations, addressing reimbursement gaps, and reforming PBM practices. Together, we can build a healthcare system where life-saving medications remain accessible to everyone who needs them.
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