President Biden’s proposed $7.3 trillion budget emphasizes efforts to rein in healthcare costs. However, there is a concerning lack of understanding evident in the healthcare budget regarding the daily challenges and needs of patients.

Implementing quick fixes to address the escalating crisis of inaccessible and unaffordable medications without this understanding may make the situation worse, particularly for patients with rare or chronic diseases. While the expansion of Medicare drug price negotiations under the Inflation Reduction Act seems promising, the devil lies in the details. Rushing to broaden this initiative without assessing the ramifications of the first rollout is a recipe for disaster.

The push for rapid expansion in drug price negotiations under IRA demands careful, thorough investigation and analysis to circumvent potential adverse effects on medication development, availability, and the broader affordability of healthcare. A recent study warns that the IRA’s pricing provisions could severely affect 40 percent of the top 200 Part B and D drugs. Another estimate found that nearly 50 percent of new medicines would have never come to market under the proposed mandates, especially treatments for Americans and in areas of unmet need — cancer, brain and spinal cord conditions, and rare and infectious diseases.

Before expanding the drug pricing negotiations, the administration must undertake a comprehensive examination of how this program will influence health outcomes, with a particular focus on those living with chronic and rare diseases. These are not just policies on paper. They hold the potential to profoundly shape and damage the lives of those who depend on consistent and affordable access to their medications.

If the federal government is serious about reducing out-of-pocket costs, it’s crucial to reform the underlying structures driving costs. This includes the role of Pharmacy Benefit Managers (PBMs) and practices like copay accumulator adjustment programs. Unfortunately, Congress and the administration continue to delay reforming the PBM industry, thus allowing their opaque business practices to continue exploiting patients. Despite the evident need for reform, the budget seems to turn a blind eye to the pressing situation of PBM accountability.

Equally disconcerting is the lack of attention given to copay accumulator programs, which prevent financial assistance provided by manufacturers from counting toward patients’ deductibles. Copay accumulator programs further exacerbate financial burdens, particularly for those with chronic conditions. 

The programs cause so much harm that patient advocacy groups were forced to file a lawsuit, successfully blocking a rule that allowed insurers not to count drug manufacturer copay assistance toward a beneficiary’s deductible and out-of-pocket maximum. Addressing these issues could significantly enhance the effectiveness of broader healthcare reforms, ensuring that policies directly benefit the patients most in need.

President Biden, please recognize the frustrations of those you serve and invite patients to be part of the conversation. Genuine reform must prioritize patient involvement, thoroughly evaluate the real-world effects of policies, and consider the intricate interplay of factors that influence medication pricing and access.

Patients nationwide are anxiously watching and waiting, hopeful for a budget that reflects a genuine commitment to our health and well-being. Take the time needed to ensure patients are getting what they need to be active and healthy, and let them participate in planning that will dramatically affect their futures.