Reimbursement and Coding for Biosimilars: How Billing Works Under Medicare Part B

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Finnegan O'Sullivan Dec 29 0

When a doctor gives a patient a biosimilar drug like Inflectra or Renflexis instead of the brand-name Remicade, the billing process isn’t as simple as handing over a generic pill. Unlike traditional generics, biosimilars don’t get lumped into one code and paid the same rate. Each one has its own billing code, its own payment rate, and a complex set of rules that determine how much the provider gets paid-and why that matters for both patients and providers.

How Biosimilars Are Different From Generics

It’s easy to think of biosimilars as just cheaper versions of biologic drugs, like how generic aspirin is to brand-name aspirin. But that’s not accurate. Biologics are made from living cells-complex proteins that are hard to replicate exactly. Biosimilars are highly similar, but not identical. That’s why the FDA treats them differently than small-molecule generics. And Medicare treats them differently too.

Generics have an AB rating. If a drug is AB-rated, pharmacists can substitute it automatically. Biosimilars don’t have that. Even if they’re approved as biosimilar, they’re not automatically interchangeable unless the FDA gives them an "I" designation. And even then, insurance rules and provider habits often block automatic switching.

This complexity shows up in the billing system. Instead of one code for all biosimilars of a drug, each one gets its own unique HCPCS code. That’s a big shift from what happened before 2018.

The 2018 Reimbursement Change: Why It Happened

Before January 2018, all biosimilars for the same reference product-say, infliximab-shared one HCPCS code: Q5101. CMS paid providers based on a blended average of all the biosimilars on the market. So if one company priced its biosimilar low, everyone else got a free ride. Why invest in a cheaper product if you’re paid the same as the more expensive one?

That system discouraged new biosimilar entry. Manufacturers had little incentive to bring down prices because their reimbursement didn’t reflect their actual cost. The result? Fewer competitors, slower price drops, and less savings for Medicare.

In 2018, CMS flipped the script. Now, every FDA-approved biosimilar gets its own product-specific code. Inflectra has J7322. Renflexis has J7323. Each gets paid based on its own Average Selling Price (ASP), plus a 6% add-on based on the reference product’s ASP.

This change fixed the "free rider" problem. Now, if a biosimilar is cheaper, the provider gets paid less-but the patient pays less too. And the manufacturer can compete on price without being penalized.

How Payment Is Calculated

Here’s how the math works for a typical biosimilar under Medicare Part B:

  • Payment = 100% of the biosimilar’s individual ASP + 6% of the reference product’s ASP
For example, if Remicade (the reference) sells for $2,500 per dose and Inflectra (the biosimilar) sells for $2,000:

  • Inflectra’s payment = $2,000 (100% of its ASP) + 6% of $2,500 ($150) = $2,150
That means the provider makes $150 in add-on revenue from Remicade, but only $120 from Inflectra ($2,000 + 6% of $2,500). The difference? $30 per dose. That’s not a huge margin, but in high-volume practices, it adds up.

This structure creates a hidden disincentive. Providers earn more per dose by using the more expensive reference product-even when the biosimilar is cheaper for the system overall. That’s why adoption rates in the U.S. lag behind Europe, where reimbursement is tied to the lowest price in the class, not the reference product’s cost.

HCPCS Codes: J-Codes and Q-Codes

Every biosimilar gets a unique HCPCS code. These are either J-codes (permanent) or Q-codes (temporary, used while data is being collected).

For example:

  • J7322 = Inflectra (infliximab-axxq)
  • J7323 = Renflexis (infliximab-abda)
  • J7324 = Cyltezo (adalimumab-adbm)
These codes are updated quarterly by CMS. If a provider uses the wrong code-say, J7322 when they gave Renflexis-the claim gets denied. That’s why clinics have to check CMS’s updated drug pricing files every three months.

The transition to individual codes in 2018 caused chaos. A 2022 survey of 217 oncology centers found that 68% had billing confusion, and 42% faced claim denials in the first six months. Many practices had to retrain staff, update EHR systems, and create new checklists.

A doctor and patient beside a floating formula showing reimbursement differences between biosimilar and brand drug.

The JZ Modifier: A New Layer of Complexity

On July 1, 2023, CMS added another layer: the JZ modifier. This modifier must be added to claims when no drug is discarded during administration.

Why? Because Medicare only pays for what’s actually used. If a vial contains 100 mg and you give 80 mg, you can bill for 80 mg. But if you throw away the remaining 20 mg, you can bill for the full vial-under certain conditions.

The JZ modifier tells CMS: "I used every drop. No waste." If you don’t use it when you should, your claim gets rejected. If you use it incorrectly, you risk an audit.

One gastroenterology practice reported a 30% increase in billing staff time just to handle JZ modifier documentation. It’s a small change, but it adds friction to an already complex system.

What Providers Are Doing to Get It Right

Successful clinics have built systems to avoid billing errors:

  • Pharmacists verify the administered product against the billing code before submission
  • Staff cross-check CMS’s quarterly ASP updates before billing
  • Electronic health records are programmed with alerts when a biosimilar is selected
  • Some practices use manufacturer-provided coding guides-Fresenius Kabi’s 2023 guide was rated "helpful" by 87% of surveyed providers
One study showed that dual verification reduced billing errors from 12-15% to under 3%. That’s not just about getting paid-it’s about avoiding penalties and audits.

Why U.S. Adoption Lags Behind Europe

In the U.S., biosimilars make up about 35% of the infliximab market after five years. In Germany or the U.K., that number is 75-80%.

Why the gap? It’s not just about price. It’s about how you pay for it.

European systems often use reference pricing: all drugs in a class are reimbursed at the same rate-the lowest price. Providers get the same payment whether they choose the brand or the biosimilar. That removes the profit incentive to stick with the expensive option.

In the U.S., the 6% add-on tied to the reference product’s ASP creates a financial wedge. Even when a biosimilar is 20% cheaper, the provider’s profit difference is still $30 per dose. That’s enough to influence prescribing habits, especially in high-revenue specialties like rheumatology and oncology.

A 2020 analysis by MIT’s Dr. Mark Trusheim estimated that removing the reference product ASP from the biosimilar add-on could boost adoption by 15-20 percentage points.

Providers divided over biosimilar adoption, with glowing vials and a looming 2025 reform proposal in the sky.

What’s Next for Biosimilar Reimbursement?

CMS is considering major changes. In February 2023, it issued an Advanced Notice of Proposed Rulemaking asking for feedback on:

  • Replacing the 6% add-on with a fixed-dollar amount
  • Eliminating the reference product ASP component for biosimilars entirely
  • Implementing a "least costly alternative" (LCA) payment model
The LCA model would pay providers 106% of the volume-weighted average price of all biosimilars and the reference product. That’s how Medicare pays for many other drugs-like statins or antivirals. It’s simpler. It’s fairer. And it’s been successful elsewhere.

MedPAC recommended applying LCA to biosimilars with three or more competitors by 2025. If that happens, adoption could jump from 35% to 65% in just a few years.

Meanwhile, the market is growing. In 2022, U.S. biosimilar sales hit $12.3 billion. There are now 32 FDA-approved biosimilars across 12 reference products. But without structural reform, experts predict adoption will plateau around 40-45%-far below Europe’s levels.

What Patients Should Know

Patients don’t need to understand HCPCS codes or ASP calculations. But they should know this:

  • Biosimilars are safe, effective, and FDA-approved
  • They’re usually cheaper than the brand-name drug
  • But your out-of-pocket cost might not reflect that savings
Because reimbursement rules affect what insurers charge patients, some Medicare Advantage plans still charge higher copays for biosimilars-even when they’re cheaper. Always ask: "Is there a biosimilar option? What will I pay?"

Bottom Line

Biosimilar billing isn’t broken-it’s just outdated. The system was designed to encourage competition, but it ended up protecting the status quo. Providers are stuck between wanting to save money for the system and needing to maintain revenue. Patients are caught in the middle, paying more than they should.

The fix isn’t complicated: stop tying biosimilar reimbursement to the price of the brand-name drug. Pay providers based on what they actually give, not what’s on the shelf.

Until then, the U.S. will keep paying more for biologics than any other country-and patients will keep wondering why the cheaper option isn’t more common.

Do biosimilars have the same HCPCS code as the reference biologic?

No. Each biosimilar has its own unique HCPCS code, either a J-code (permanent) or Q-code (temporary). The reference biologic keeps its own separate code. For example, Remicade uses J1745, while Inflectra uses J7322. This change began in 2018 to ensure accurate payment based on each product’s actual price.

Why do providers sometimes prefer the brand-name biologic over the biosimilar?

Because Medicare pays providers 100% of the biosimilar’s ASP plus 6% of the reference product’s ASP. So if the reference drug costs $2,500 and the biosimilar costs $2,000, the provider earns $150 in add-on revenue from the brand and $120 from the biosimilar-a $30 difference per dose. In high-volume settings, that adds up. This structure reduces the financial incentive to switch, even when the biosimilar is cheaper overall.

What is the JZ modifier and why is it required?

The JZ modifier is required on claims for certain biologics and biosimilars when no drug is discarded during administration. It tells Medicare that the provider used the entire vial. If you don’t use the JZ modifier when appropriate, your claim may be denied. This rule, effective July 1, 2023, applies to drugs like infliximab and its biosimilars. It adds administrative work but helps prevent overbilling.

How often are biosimilar payment rates updated?

CMS updates biosimilar payment rates quarterly, based on the Average Selling Price (ASP) data submitted by manufacturers. The most recent update occurred July 1, 2023. Providers must check CMS’s Physician Fee Schedule updates every three months to ensure they’re using the correct payment amounts and codes.

Are biosimilars covered the same way by Medicare Advantage plans?

Not always. While Medicare Part B pays 106% of ASP for biosimilars, Medicare Advantage plans (Part C) can set their own reimbursement rules. Some pay 100-103% of ASP, others use formularies that favor the reference product. Patients may face higher copays for biosimilars even when they’re cheaper, so it’s important to check your plan’s drug list before treatment.

What’s the biggest barrier to wider biosimilar use in the U.S.?

The biggest barrier is the reimbursement structure itself. By tying the add-on payment to the reference product’s price, Medicare unintentionally rewards providers for choosing the more expensive drug. This creates a financial disincentive to switch, even when biosimilars are proven safe and cost less. European countries avoid this by using reference pricing, which pays the same for all drugs in a class-leading to much higher adoption rates.