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Why Health Systems Must Expect More to Achieve More

Health system infusion services may be entering a period of accelerated transformation, and the window for strategic repositioning could be narrowing. The CY 2026 OPPS Final Rule, published November 21, 2025, moved multiple regulatory proposals into implemented policy, with key provisions taking effect on January 1, 2026.¹ When combined with the Inflation Reduction Act’s statutory requirements for Part B drug price negotiation beginning in 2028, the economics of hospital based infusion appear to be experiencing significant pressure across both drug acquisition margin and drug administration reimbursement. Taken together, these developments suggest more than incremental reimbursement pressure; they may reflect the potential for a structural reset of infusion economics; one that could challenge operating models built around higher drug spreads, stronger administration reimbursement, and longstanding cross subsidization patterns.

What differentiates this moment from previous regulatory cycles is the greater clarity of policy timelines. Several of the forces shaping infusion economics are no longer purely theoretical; they represent active policy frameworks with defined implementation dates already underway. As a result, strategic consideration is increasingly less about whether change may occur, and more about how health systems can most effectively adapt operating models calibrated for a reimbursement environment that appears to be moving in new directions.

These pressures are elevating infusion strategy from a primarily pharmacy-led operational function to a broader enterprise level priority, one that may require more coordinated decision-making around margin performance, capital deployment, and systemwide access strategy.  Pharmacy leaders who have long managed the clinical, operational, and economic complexity of infusion services are increasingly being engaged to help shape executive level decisions. As CFOs and senior leadership teams become more directly engaged, organizations may be better positioned to maintain margin stability and preserve clinical access when they leverage pharmacy expertise early and respond with deliberate, forward-looking adjustments.

The Perfect Storm Framework

Payer site-of-care redirection has influenced infusion delivery for years, and pharmacy leaders are well acquainted with its financial and operational implications. What is increasingly evident is the simultaneous convergence of federal policy actions across multiple domains, creating a level of coordinated pressure that has not typically been observed in prior cycles. The CY 2026 OPPS Final Rule, together with the IRA’s implementation timeline, has contributed to what can increasingly be understood as a “perfect storm” — four distinct headwinds taking shape in close succession, each exerting pressure on different components of the infusion economic model.

These forces do not operate in isolation. They often intersect with labor constraints, capital planning horizons, payer contracting cycles, and clinical access expectations, frequently without a single governance structure clearly accountable for the whole. The framework that follows seeks to organize these converging pressures into four headwinds that together describes “The Infusion Perfect Storm.”

Headwind 1: CMS Drug Acquisition-Cost Survey

Status: Enacted. Survey portal opened January 1, 2026; data submission due approximately March 31, 2026.

The CY 2026 OPPS Final Rule established a CMS led process to collect NDC level acquisition cost data from OPPS hospitals for drugs purchased between July 1, 2024, and June 30, 2025. Hospitals are asked to report acquisition costs separately for 340B and non340B drugs, and CMS has indicated that this data may help inform CY 2027 reimbursement policy.

This survey is closely aligned with the evidentiary threshold outlined in AHA v. Becerra (2022), which CMS would need to meet before making future adjustments to 340B reimbursement. Earlier surveys found 340B acquisition costs at ASP minus 34.7 percent, and from 2018 through 2022 CMS reimbursed 340B hospitals at ASP minus 22.5 percent before those reductions were set aside.² With updated data, CMS could consider adjustments based on acquisition‑cost evidence; however, no specific reimbursement actions have been proposed. Current 340B hospital margins on Part B drugs often range from 30 to 50 percent; returning to historical ASP-minus reimbursement could narrow those margins considerably, in some cases to the mid-single digits or below breakeven depending on drug category. ³ CMS’s direction is expected to become clearer with the release of the CY 2027 proposed rule in July 2026.

The survey’s data submission date falls around March 31, 2026, and CMS has noted that nonparticipation may carry implications.

While administrative in form, this survey marks a meaningful strategic moment. Once CMS has access to detailed acquisition cost data, it would have the foundation to support differentiated reimbursement, the regulatory pathway to act on it, and precedent showing the scale of adjustments that could follow. If reimbursement trends move toward acquisition cost, the impact is unlikely to be uniform: certain drugs contribute disproportionate margin, some sites carry concentrated 340B volume, and some service lines are more dependent on spreads that may be at risk. For organizations that have not mapped this exposure, July 2026 could bring sharper and potentially challenging visibility.

Headwind 2: Site-Neutral Payment for Drug Administration

Status: Enacted. Effective January 1, 2026.

Beginning January 1, 2026, drug administration services delivered in excepted (grandfathered) off campus hospital outpatient departments transitioned to Physician Fee Schedule equivalent rates, generally about 40 percent of OPPS levels. This change affects APC’s 5691-5694 (61 HCPCS codes) tied to infusion and injection services and marks a notable shift in how administration services are reimbursed. While drug payment remains unchanged, reimbursement for administration now aligns with a significantly lower rate structure. ⁴

The financial implications extend beyond the rate cut itself. Many hospital-based infusion clinics operate in these off-campus provider-based departments, where nursing, pharmacy preparation, supplies, and overhead represent substantial portions of the cost structure. Because these elements tend to be relatively fixed in the near term, the reduction in administration reimbursement could place additional pressure on operating margins, particularly where throughput or staffing flexibility is limited.

This shift also introduces precedents. By applying site neutral payment to drug administration services in excepted departments, CMS has indicated a willingness to extend site-neutral policy into outpatient care areas historically reimbursed at higher facility-based rates. While no further expansions have been finalized, the policy direction may warrant monitoring as future rulemaking could build on this foundation.

Individually, this change could present challenges for hospital infusion programs. In combination with Headwind 1 and 3, the cumulative effect may contribute to a structurally different economic environment for infusion services. Longstanding cross subsidies between drug margin and administration reimbursement may no longer hold, and organizations that rely on these relationships could see growing pressure on both sides of the revenue equation.

Headwind 3: Part B Drugs Entering Medicare Price Negotiation

Status: Enacted. CMS published the IPAY 2028 selected drug list on January 27, 2026 (statutory deadline February 1, 2026); Maximum Fair Prices effective January 1, 2028. ⁶

CMS’s publication of the IPAY 2028 list marks the first negotiation cycle to include drugs payable under Medicare Part B. With selection confirmed, the policy question shifts from which drugs could be selected to how negotiated pricing will intersect with provider‑administered therapies and infusion‑based care delivery.

Under the Inflation Reduction Act, reimbursement for selected products may transition from an ASP‑based method to an MFP‑based payment limit, with statutory discount ceilings ranging from 25 to 60 percent depending on years on the market.⁵ As a result, both the base payment amount and the associated add‑on revenue could decline relative to historical levels.

For infusion leaders, the IPAY 2028 list may matter less for its first‑cycle composition than for what it signals about the trajectory of Medicare drug policy. The inclusion of therapies commonly managed in hospital outpatient and specialty clinic settings confirms that negotiated pricing is no longer confined to self-administered or pharmacy-dispensed products; provider-administered infusions are now within scope. At the same time, the absence of certain high‑profile agents reflects the influence of statutory criteria and market dynamics, a reminder that non‑selection in one cycle provides no guarantee of future exclusion.

The implications extend beyond Medicare fee-for-service. CMS has indicated that units of selected drugs sold at the MFP may be incorporated into Average Sales Price calculations beginning in 2026. Because many commercial and Medicare Advantage contracts reference ASP, downward pressure from MFP transactions could influence non-Medicare reimbursement methods.

Timing introduces additional complexity. IRA pricing cycles reset annually and may operate on a cadence that diverges from hospital budgeting and contracting rhythms. Each cycle introduces new information that

require incorporation into financial models, and organizations without robust forecasting capabilities risk recognizing exposure only after performance has already been affected.

While the first wave of MFPs may create near-term pressure, the more enduring challenge is structural. Annual repricing, expanding drug selection, and accelerating biosimilar adoption could establish recurring volatility that diverges from traditional multi-year planning horizons. The strategic question becomes whether organizations can anticipate and absorb these shifts proactively or whether they will perpetually react to them.

Headwind 4: Some Covered Entities could face 340B eligibility challenges depending on shifts in patient mix; organizations may need to monitor DSH% closely.

While the first three headwinds carry defined timelines, exposure associated with 340B participation appears to be unfolding with greater variability. Eligibility instability may be emerging as a pressure point for organizations whose infusion performance is closely tied to 340B economics. Although scale and timing remain uncertain, early indicators suggest this area may warrant heightened executive attention.

The Immediate Driver: Coverage Loss Pressuring DSH Percentages

Ongoing Medicaid redeterminations and associated coverage losses may influence Medicaid patient proportions. Because 340B eligibility depends on exceeding a DSH% threshold (with exceptions), hospitals near that boundary could experience risk due to patient-mix shifts alone. As Medicaid enrollment declines and uninsured rates rise, DSH ratios may fall below the eligibility floor even if care delivery, service mix, and operational performance remain unchanged. For infusion programs that rely on 340B savings, loss of eligibility could remove a foundational revenue source; one that often supports, as industry trend suggest, site-of-care decisions, service line viability, and an organization’s capacity to absorb the margin compression created by Headwinds 1–3.

The Background Pressure: Program Redesign Concepts

Beyond eligibility concerns, but not formally published by HRSA or Congress, broader program redesign concepts have surfaced intermittently in federal discussions adding a layer of structural uncertainty. Among these concepts is the idea of shifting certain aspects of 340B program oversight from HRSA to CMS. While strictly a proposal and not an enacted change, its emergence may reflect, as experts observe, a growing willingness among policymakers to re-examine how the program is governed and to explore more standardized, data driven oversight models. For health systems, the relevance may not predict whether such a transition will occur, but in recognizing what it could signal: the stability of 340B as a margin engine may be increasingly influenced by federal scrutiny and administrative redesign. Even without formal action, the presence of these proposals underscores, as industry observers suggest, the structural vulnerability created when a significant share of infusion economics depends on a single federal program whose contours are under active examination.

The Compounding Effect

As coverage loss continues and eligibility thresholds fluctuate, exposure could become systemic rather than episodic. Hospitals near the DSH boundary may need to monitor their status in real time rather than relying on annual reconciliation. For programs built around 340B economics, the strategic question may be shifting from hypothetical program reform to operational survivability.  Even without legislative action, concentration risk could make heavy reliance on 340B-dependent margins increasingly fragile. The question may not be whether reform will happen, but whether your infusion model can withstand it if it does.

The Strategic Imperative

The policy environment surrounding infusion services appears to be shifting, potentially altering revenue structure and operational expectations. Three of the four major headwinds appear to carry defined implementation timelines, potentially narrowing the window for organizations to reposition their infusion programs. Together, these forces apply pressure across the two pillars of infusion economics: drug margin and drug administration reimbursement, while the fourth introduces ongoing uncertainty tied to 340B eligibility and program stability.

For enacted policies, the need may be moving beyond scenario planning to purposeful operational adjustment. Health systems that have begun, or are beginning, redesigning their infusion footprint across hospital outpatient departments, physician office settings, ambulatory infusion centers, and homebased options may be better positioned to maintain capacity, stabilize margin performance, and preserve patient access. Those that have not, may need to accelerate planning and execution to avoid potentially widening exposure.

Organizations more likely to sustain performance in this environment share several attributes: a unified enterprise infusion strategy with clear executive ownership; a diversified site-of-care footprint; data infrastructure capable of meeting new reporting requirements and supporting continuous financial modeling; and operational flexibility that enables rapid volume shifts as payment dynamics evolve. Clinical service lines that rely on predictable and financially viable infusion operations such as oncology, rheumatology, neurology, and gastroenterology may depend on these capabilities to ensure continuity of care.

Policy uncertainty may be giving way to policy reality. The question may no longer be solely whether the change will occur, but how effectively organizations can adapt.  Against this backdrop, executive teams may be facing decisions that could shape the sustainability of their infusion ecosystem for years to come. Understanding where exposure is concentrated, how operational dependencies align with emerging policy pressures, and which components of the current model may no longer hold under future conditions is increasingly viewed as essential.

The following questions are intended to help leaders assess readiness, prioritize strategic focus, and identify the areas where proactive action may be required.

Executive Questions to Consider

1. Acquisition Cost Exposure
   If CMS uses this acquisition cost survey as a reference point going forward, how confident are you that your data accurately reflects how your organization acquires, deploys, and bills Part B drugs across the sites where infusion care occurs?
2. Administration Reimbursement Compression
   Which infusion programs are operating in locations that experienced a 60 percent reduction in drug administration reimbursement on January 1, 2026? And does your infusion footprint still make financial sense in this payment environment, or was it built around a reimbursement structure that no longer exists?
3. Margin Volatility from MFP Cycles
   Are you planning around immediate, annual MFP reductions, or are you stepping back to evaluate how repeated negotiation cycles could drive a more structural break in infusion economics?
4. 340B Eligibility and Concentration Risk
   How confident are you that your infusion ecosystem’s margin structure, site of care decisions, and service line viability would remain intact if 340B eligibility tightened, contract pharmacy access narrowed, or your DSH percentage shifted?
5. Enterprise Strategy & Governance
   Does your organization have a unified enterprise infusion strategy, one that reflects new reimbursement realities across HOPDs, physician offices, AICs, and homebased models?
6. Data Infrastructure & Operational Agility
   Do your current systems support the level of cost transparency, reporting readiness, and real-time modeling now required to navigate these policy shifts?
7. Service Line Resilience & Site of Care Shifts
   How prepared are your key service lines; particularly oncology, rheumatology, neurology, and gastroenterology for shifts in site-of-care movement, such as HOPD to AIC or AIC to Home, that may accelerate as reimbursement and margin dynamics continue to evolve?

How 51Âþ»­appcan help:

McKesson’s Professional & Advisory Services team helps health system leaders translate these insights into actionable strategies; strengthening infusion performance, helping to reduce vulnerability to market headwinds, and helping to create sustainable value across the enterprise.

That is why health systems that want to achieve more choose McKesson. Because only 51Âþ»­appprovides the perspective, focus, and execution they need, so they can focus on improving patient outcomes for all.

Disclaimer: The information provided in this article is for general informational purposes only and is not intended as legal, financial, or audit advice. Readers should consult with their own legal, clinical, and financial advisors before making any decisions based on the content.

Footnotes:

1. Centers for Medicare & Medicaid Services. CY 2026 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Final Rule Fact Sheet. November 21, 2025. cms.gov. Federal Register. Inflation Reduction Act Medicare Drug Price Negotiation Program: Initial Price Applicability Year 2028 Final Guidance. November 28, 2025. federalregister.gov.
2. Centers for Medicare & Medicaid Services. CY 2026 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Final Rule— discussion of prior 340B drug acquisition cost surveys and historical payment adjustments. Supreme Court of the United States. American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022).
3. America’s Essential Hospitals. Essential Hospital Operating Margins Report, 2024. Centers for Medicare & Medicaid Services, Outpatient Prospective Payment System historical payment and acquisition cost analyses cited in the CY 2026 OPPS/ASC. Final Rule.
4. Centers for Medicare & Medicaid Services. CY 2026 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Final Rule Fact Sheet; OPPS Final Rule Regulatory Impact Analysis. November 21, 2025. cms.gov.
5. Centers for Medicare & Medicaid Services. Medicare Drug Price Negotiation Program—Selected Drugs and Negotiated Prices. cms.gov. Federal Register. Inflation Reduction Act of 2022: Medicare Drug Price Negotiation Program, Initial Price Applicability Year 2028 Final Guidance. November 28, 2025
6. Centers for Medicare & Medicaid Services. Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 (IPAY 2028) Fact Sheet. January 27, 2026. cms.gov.