CMS Publishes Its Q2 2026 HCPCS Decisions for Drugs and Biologicals
On July 29, 2026, the Centers for Medicare & Medicaid Services posted its
2026 HCPCS Application Summary for Quarter 2,
covering drug and biological coding requests. CMS then flagged the update to the provider
community in its August 6, 2026 MLN Connects newsletter,
which pointed coders to the HCPCS Level II Coding Decisions page for the full document.
CMS reviewed 16 individual applications plus a broader initiative touching multiple
products, and the resulting code set takes effect October 1, 2026 — the start of
Medicare’s next quarterly HCPCS cycle.
For coders and RCM teams, the summary is a reminder that HCPCS churn doesn’t wait for
the annual ICD-10-CM or CPT release cycles. Drug and biological codes turn over every
quarter, and a missed update means claims going out with a deleted or soon-to-be-invalid
code, or a payer denial for a drug billed under the wrong descriptor.
15 New Codes, Concentrated in Oncology and Biosimilars
CMS established 15 dedicated product codes in this cycle, revised 2 existing codes,
and discontinued 10 — most of the discontinuations tied to a broader 505(b)(2)
initiative described below. A sample of the new codes effective October 1, 2026:
- J9186 — Injection, etoposide (Avopef), 1 mg
- J9191 — Injection, fluorouracil (Favlyxa), 10 mg
- Q5173 — Injection, denosumab-adet (Ponlimsi), biosimilar, 1 mg
- Q5172 — Injection, filgrastim-laha (Filkri), biosimilar, 1 microgram
- A9613 — Piflufolastat F-18 (Pylarify Truvu), diagnostic, 1 millicurie
A Second Biosimilar Wave
Two of the five new codes above — Ponlimsi and Filkri — are biosimilars,
continuing a trend RCM teams have tracked through 2026 as more denosumab and filgrastim
biosimilars reach the market. Each biosimilar gets its own distinct HCPCS code rather
than sharing a code with the reference product, so crosswalks built for one denosumab or
filgrastim biosimilar don’t automatically cover the next one CMS approves.
CMS Denied Revision Requests for Lutathera and Pluvicto
Not every request was granted. CMS rejected proposals to revise the existing codes for
Lutathera and Pluvicto, both radioligand therapies, which would have changed the billing
unit from “1 millicurie” to “per therapeutic dose.” CMS said it is maintaining its
“long-standing convention” of assigning the smallest billable dose unit, citing the need
to accommodate variable dosing and support accurate payment, and noted that Original
Medicare claims already cap at 999 units per line to manage that variability. For coding
and compliance teams, the denial matters as much as the approvals: it confirms CMS’s
current payment-unit policy for radioligand therapies going into Q4 2026, which affects
how claims should continue to be built and audited.
The 505(b)(2) Cleanup Behind the Discontinued Codes
Most of the 10 discontinued codes in this cycle stem from CMS’s ongoing 505(b)(2) and
not-otherwise-classified (NOC) code initiative, which consolidates or retires codes for
products that have moved through the FDA’s 505(b)(2) approval pathway. In their place,
CMS created 13 additional codes under that same initiative. The net effect is a coding
environment where a code that was valid in Q1 2026 can be gone by Q4 2026, replaced by a
more specific successor — exactly the kind of change that’s easy for a manual
crosswalk to miss between quarterly reviews.
Why Quarterly HCPCS Cycles Are a Coding-Accuracy Problem
None of this is unusual for HCPCS — CMS updates the drug and biological code set
every quarter, and coders have always had to track it. What’s changed is the volume: more
biosimilars entering the market, more 505(b)(2) reclassifications, and more narrowly
scoped diagnostic codes like the Pylarify Truvu addition above. A coding team relying on
a static crosswalk spreadsheet has to catch each MLN Connects newsletter, cross-reference
it against the full HCPCS Application Summary PDF, and update every downstream system
before October 1 — all while continuing to code current claims correctly under the
codes that are about to change.
This is the kind of update that agentic AI coding systems are built to absorb
automatically: ingesting a CMS coding decision the day it posts, flagging which existing
claims workflows reference a discontinued code, and surfacing the correct replacement
before a denial happens rather than after.
What This Means for Your October Billing
Coders and RCM teams billing chemotherapy agents, biosimilars, or radioligand
therapies should confirm three things before October 1, 2026: that any claims workflow
referencing a code CMS discontinued in this cycle has been updated to its 505(b)(2)
successor; that new biosimilar codes such as Q5172 and Q5173 are mapped to the correct
reference product in the EHR or billing system; and that Lutathera and Pluvicto claims
continue to be billed per millicurie, not per therapeutic dose, since CMS explicitly
declined to change that convention.
Manually tracking this across every quarterly HCPCS cycle, on top of annual ICD-10-CM
and CPT changes, is exactly the kind of repetitive, deadline-driven work that
Medikode’s automated medical coding platform
is built to handle — keeping claims aligned with CMS’s latest coding decisions
without waiting for a manual crosswalk update.