A quiet but significant change is coming to the 340B Program, and it could reshape the way your practice manages high-cost specialty drugs. Starting in 2026, the Department of Health and Human Services (HHS) will test a new Rebate Model Pilot that lets drug manufacturers offer rebates instead of the traditional upfront discounts on certain 340B drugs. At first glance, this might sound like a technical policy shift. However, for specialty practices like yours, it could mean new financial pressures, administrative headaches, and cash flow challenges. Let’s break down what’s changing, why it matters, and how you can prepare.

The 340B Rebate Pilot Is Coming: What Providers Need to Know About the Shift from Discounts to Rebates

A quiet but significant change is coming to the 340B Program, and it could reshape the way your practice manages high-cost specialty drugs.

Starting in 2026, the Department of Health and Human Services (HHS) will test a new Rebate Model Pilot that lets drug manufacturers offer rebates instead of the traditional upfront discounts on certain 340B drugs.

At first glance, this might sound like a technical policy shift. However, for specialty practices like yours, it could mean new financial pressures, administrative headaches, and cash flow challenges.

Let’s break down what’s changing, why it matters, and how you can prepare.

From Discounts to Rebates: What’s Really Changing

For years, the 340B Program has allowed eligible providers to purchase outpatient drugs at steeply discounted prices, giving you more room to expand access and stretch scarce resources.

The pilot flips that model. Instead of buying drugs at a discount, you’ll purchase them at the full wholesale price and then submit data to receive a rebate equal to the 340B ceiling price.

At first glance, it might seem a slight distinction on paper. In reality, it alters the timing of cash flow, shifts risk to providers, and requires you to manage a new set of reporting requirements.

The Pilot’s Scope: Drugs, Timing, and Opt-Ins

  • Currently, the pilot applies only to the 10 drugs selected for Medicare’s price negotiation program in 2026.
  • The program is voluntary, meaning manufacturers can opt in at their discretion. If they do, rebates replace discounts for those drugs. If not, you’ll continue under the existing system.
  • Providers must submit claims data within 45 days to qualify for rebates, and payments are expected to follow within 10 business days. This timeline is tight. Any hiccups in claims submission, reconciliation, or manufacturer payment could stretch your finances thin.

HRSA has outlined a clear timeline for the rollout of the pilot.

  • Public comments were open until the end of August 2025, giving providers a brief opportunity to weigh in on how the change could affect their practices.
  • Manufacturers must submit their applications in early September.
  • HRSA expects to finalize approvals by mid-October.
  • The pilot program will launch on January 1, 2026, a date your practice should circle on the calendar now.

The Risks for Your Practice

1. Cash Flow Strain

Paying upfront at wholesale acquisition cost (WAC) requires significantly more working capital. Even short rebate delays could disrupt payroll, operations, or your ability to maintain infusion capacity.

2. Administrative Burden

Rebates aren’t automatic. You’ll need airtight processes to track dispensing, submit claims, and follow up on payments. Any missing data could mean lost revenue.

3. Future Uncertainty

While the pilot is limited to 10 drugs, it could expand. So, the question you need to ask isn’t just how you’ll handle this change in 2026, but rather how you’ll adapt if rebates become the new normal.

How to Prepare Now

This change isn’t here yet, but it’s coming soon, and you don’t want to be caught flat-footed.

Here are some steps you can take today:

  • Audit your cash flow to understand whether you can absorb temporary outlays at full WAC.
  • Evaluate your data systems to ensure you can meet HRSA’s 45-day reporting window.
  • Stay close to manufacturers to learn which ones plan to participate in the pilot.

Turning Policy Shifts into Practice Success, Together

At Altus Biologics, we know policy shifts like this don’t just live in Washington; they land in your exam rooms, infusion suites, and balance sheets. That’s why we’re here to help you:

  • Protect cash flow: With strategies to model rebate timing and minimize risk.
  • Automate the process: From claims tracking to reconciliation, so you don’t lose revenue to errors or delays.
  • Stay compliant: Making sure your submissions meet HRSA requirements, every time.
  • Plan for the future: Whether the pilot expands or evolves, we’ll help you adjust without missing a step.
Will My Rheumatology Practice Benefit from Offering In-Office Biologics?

The 340B Rebate Pilot is more than a policy test; it’s a stress test for providers. It shifts the financial risk from manufacturers to you, with implications for patient care, operations, and sustainability.

But you don’t have to face these changes alone. With the right partner, you can stay ahead of the curve, protect your practice, and keep access open for the patients who need you most.

Altus Biologics is ready to help you do just that.

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