In more than two decades of healthcare policy work, I have never witnessed a period of change as rapid or consequential as what we see today. The regulatory environment is shifting almost daily, with new proposals and reforms that touch every aspect of cancer care, from reimbursement and drug pricing to provider autonomy and clinical trial access.
At McKesson, and through The US Oncology Network (The Network), our commitment is clear: we stand with community oncologists, patients and partners to champion policies that protect and advance high-quality, local cancer care. Our approach is rooted in collaboration - engaging with lawmakers, patient coalitions and provider organizations to ensure that the voice of community oncology is heard.
The Pressures and Possibilities of the Current Landscape
The evolving federal landscape presents both obstacles and opportunities for community practices. Reimbursement remains a central concern, as new laws and regulations around drug pricing impact the financial stability of independent providers. When reimbursement fails to reflect the true costs of care, the sustainability of community oncology is at risk. That’s why we are amplifying the voice of physicians across the country who are actively educating policymakers about the unique value of community-based care to deliver better patient outcomes, but also in driving cost savings for the healthcare system.
Providers are also facing pressure from a growing prevalence of utilization management protocols that increasingly dictate, delay or redirect treatment decisions and patient care. These interventions can fundamentally disrupt the patient-physician relationship and can often delay care, restrict access, and undermine adherence, potentially jeopardizing patient outcomes. Our message to policymakers and payers is simple: if we are to realize the importance of community practice and the promise of value-based care, providers must have the authority, autonomy and resources to deliver the right treatment, at the right time, for every patient.
While we must continue to navigate these dynamics that threaten the community setting, there are other policy proposals that provide an opportunity to showcase the unique role of community-based cancer care. Innovation in oncology depends on robust clinical trial participation, yet too many patients - especially those in rural areas, older adults and underrepresented groups - face barriers to enrollment. We advocate for policy solutions that expand trial access to more participants by eliminating barriers for enrollment and participation.
Regulatory Momentum and the Role of Community Sites
Currently, U.S. participation in many clinical trials is still below 10%1. The recent decision by the Food and Drug Administration (FDA) to publicly share complete response letters (CDLs) and thus, publicize why a trial was not approved, indicate the Trump Administration’s focus on bolstering U.S. patient enrollment in clinical trials. It’s now essential for clinical trial sponsors to partner with community-based sites of care in the U.S., which can play a critical role in driving overall success and compliance.
At McKesson, we are investing in operational support, education and outreach to empower community practices and research sites. By partnering with sponsors and leveraging direct-to-patient strategies, we are working to ensure that every patient has the opportunity to participate in cutting-edge trials close to home.
The Sarah Cannon Research Institute (SCRI) exemplifies this commitment, with more than 700 actively enrolling trials, with 3,400 patients. Over the past 24 months, we’ve seen a more than 20 percent increase in the number of trials opened per site, bringing more cutting-edge therapies closer to patients in their own communities.