Author: Janet Serluco, MS, SVP, Access Experience Team
The oncology market access playbook is evolving beyond traditional priorities of securing coverage, reducing utilization management barriers, ensuring reimbursement, and preserving gross-to-net value. While those fundamentals remain critical, a new dynamic is emerging: organized providers are increasingly evaluating clinical therapies through the added lens of operational and economic burdens.
The Centers for Medicare and Medicaid Services (CMS) proposed CY2027 Medicare Hospital Outpatient Prospective Payment System (OPPS) and proposed CY2027 Medicare Physician Fee Schedule (MPFS) both signal continued pressure on provider reimbursement and oncology practice sustainability. At the same time, health plans and employers continue pursuing strategies to shift care into lower-cost settings. Together, these forces reshape how oncology providers evaluate treatment adoption and where patients receive care.
For oncology manufacturers, the implication is clear: a therapy may achieve coverage yet still encounter adoption barriers if providers face growing economic or operational challenges in delivering the product.
CMS proposes to reduce Medicare reimbursement for 340B-acquired drugs paid separately under OPPS from Average Sales Price (ASP) plus 6% to ASP minus 33.4%. CMS based the proposed rate on its 2026 hospital acquisition cost survey to better align reimbursement with acquisition costs. Drugs with transitional pass-through status would be exempt, creating a potential advantage relative to established therapies acquired under 340B.
The proposal represents CMS’ return to acquisition cost-based 340B reimbursement following the Supreme Court’s 2022 decision invalidating the 2018 prior policy because CMS had not conducted the required survey. CMS estimates this proposal would reduce Medicare drug payments by approximately $4.55 billion and lower beneficiary cost sharing by approximately $1.15 billion in the first year. Under budget neutrality requirements, those dollars would be redistributed through increased payments for non-drug outpatient services.
This proposal arrives amid broader concerns from the oncology community regarding policy-related reimbursement pressures. Community Oncology Alliance (COA) leaders have publicly highlighted the cumulative impact of Inflation Reduction Act implementation, changes affecting 340B economics, and other reimbursement pressures on oncology care delivery. Their concern extends beyond provider margins to the impact on long-term sustainability of delivering cancer care at the local level.
For manufacturers launching new oncology products, this distinction could materially influence provider evaluations, formulary discussions, and adoption decisions. As providers become increasingly focused on financial sustainability, reimbursement economics may become a more visible component of product assessment alongside clinical evidence and payer coverage.
Some commercial payers are actively redirecting oncology care away from higher-cost settings, such as hospital outpatient clinics, to lower-cost settings like community oncology practices, stand-alone infusion centers, or home environments. These site-of-care (SOC) policies may be voluntary or mandated by national or regional payers for their commercial book of business.
While the CY2027 OPPS proposed rule does not directly apply SOC or site-neutral payment to oncology drug administration, CMS appears to be moving in a similar direction. The proposed rule expands prior site-neutral payment policies by applying Physician Fee Schedule-equivalent rates to certain imaging services furnished in off-campus provider-based departments. CMS estimates approximately $260 million in annual Medicare savings from this proposal.
The Hematology/Oncology Pharmacy Association (HOPA) opposes mandatory SOC steerage, arguing that oncology treatment location should be individualized based on patient safety, clinical complexity, and provider judgment, not solely payer cost-containment objectives. HOPA specifically cites concerns that SOC mandates may disproportionately affect patients with complex cancer regimens and lead to:
COA issued a Prescription for Health Care Reform position that supports site-neutral payment policies to create fairer reimbursement, stronger 340B Drug Pricing Program participation, and transparency requirements to ensure discounts reach patients.
While many factors affect what Medicare providers get paid under the fee schedule, overall hematology/oncology reimbursement is anticipated to be flat; however, variability may exist by site of service and participation in the Quality Payment Program. Merit-Based Incentive Program (MIPS) is being phased out, and participation in Advanced Payment Models (APMs) is encouraged.
The proposed rule includes a policy that would reduce payment by approximately 50% for certain secondary same-day evaluation and management (E/M) visits when furnished with procedures. Oncology patients frequently require same-day evaluation, treatment planning, diagnostic workup, symptom assessment, and procedures. The AMA filed a comment letter with CMS expressing concern over this provision, among others. Oncology patients, especially those in rural settings, may face additional burden and treatment delays for services such as same-day biopsies at the dermatologist.
Combined with the many policy changes out of Washington, DC, the proposed OPPS and PFS policies reinforce a fundamental shift in the market access landscape.
More broadly, these developments may signal a gradual convergence toward market access principles that have long shaped reimbursement decisions in Europe. While the U.S. healthcare system remains fundamentally different from markets governed by national health technology assessment (HTA) bodies, policymakers, payers, and providers are placing increasing emphasis on comparative value, affordability, real-world outcomes, and the efficient use of healthcare resources.
This point was further illustrated during sessions at the recent Association for Value-Based Cancer Care (AVBCC) meeting in NYC, where one international panel discussion that focused on the concept of “Medicare for All.” The examples and conversation were less about whether a single-payer system is desirable, and more about the trade-offs between affordability, innovation, access, and patient outcomes that U.S. stakeholders are willing to accept.
Manufacturers can no longer assume that payers will automatically cover oncology drugs without management criteria or that favorable payer coverage alone will drive therapy adoption. Providers increasingly evaluate therapies through the lens of:
For oncology manufacturers, this raises the importance of generating evidence that extends beyond clinical efficacy to demonstrate economic value, operational feasibility, and system-wide impact across multiple stakeholders.
The CMS CY 2027 OPPS and PFS provisions discussed here remain proposed, and public comment periods have closed. CMS generally publishes Final Rules in the Federal Register in early November for implementation on January 1, 2027. As a result, manufacturers should begin assessing stakeholder access priorities into their 2027 planning:
Manufacturers that integrate payer coverage, 340B dynamics and liability, provider sustainability, operational readiness, and organized customer decision-making will be better positioned to support the adoption of increasingly complex and advanced oncology therapies.
With Precision AQ’s Market Access services, we help organizations translate policy and provider economics into an actionable market access strategy. To learn more about how we can help elevate your next oncology product, contact our team today.