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HCPCS J7516 · Level II · Part B drug

HCPCS J7516: Injection, cyclosporine, 250 mg

Reviewed by QuickIntell RCM Editorial Team · Last reviewed

Data effective
Data currency: ASP payment limits October 2026 (effective October 1, 2026); MUE and NCCI edits 2026 Q4 (effective October 1, 2026); OPPS Addendum B July 2026 (effective July 1, 2026). Next CMS release: January 1, 2027 (ASP, MUE, NCCI and OPPS quarterly updates).

Key facts for J7516

Billing unit
250 MG
Inj, cyclosporine 250mg
ASP payment limit
$75.649
October 2026; +0.0% vs July 2026
Practitioner MUE
1
MAI 3
OPPS status
SI N
NCCI exposure
no PTP pairs
Coverage articles
0
none list this code

TL;DR

HCPCS J7516 is the Level II code for Injection, cyclosporine, 250 mg, billed per 250 MG. The Medicare Part B ASP payment limit for October 2026 is $75.649 per billing unit, up 0.0% from July 2026. The practitioner MUE allows up to 1 units per date of service (MAI 3). Under OPPS it carries status indicator N. J7516 is billed in units of 250 MG; the quantity administered, the NDC package and the units on the claim must reconcile, which is the check that prevents CARC 16 and 151 returns on this line. The ASP crosswalk maps 2 NDCs to it, sold as Sandimmune, Cyclosporine Injection by Novartis Pharmaceuticals Corporation, Padagis US LLC. No current Billing and Coding Article lists J7516, so coverage follows the FDA label, compendia and any applicable NCD.

Medicare Part B payment limit (ASP)

CMS sets the Part B payment limit for J7516 at $75.649 per 250 MG for October 2026, derived from manufacturer average sales price plus 6%, compared with $75.649 in July 2026. Beneficiary coinsurance is 20%.

ASP payment limits for J7516
QuarterPayment limitPerCoinsurance
October 2026$75.649250 MG20%
July 2026$75.649250 MG—
Source: CMS Medicare Part B Drug Payment Limit File. Commercial and Medicaid payers set their own rates.

NDC to HCPCS billing-unit conversion

The October 2026 ASP crosswalk maps 2 NDCs from 2 labelers to J7516. Report the NDC in the claim's drug segment and bill the number of J7516 units that equals the quantity administered divided by 250 MG; the last column gives units per full package.

NDCs that crosswalk to J7516
NDCDrug nameLabelerPackage sizeBilling units / package
00078-0109-01SandimmuneNovartis Pharmaceuticals Corporation5 × 1010
00574-0866-10Cyclosporine InjectionPadagis US LLC5 × 1010

Medically Unlikely Edits (MUE)

CMS publishes 3 MUE values for J7516. For practitioners the limit is 1 unit per date of service with adjudication indicator 3, a date-of-service clinical edit: units above the limit deny but can be paid on appeal with documentation that the quantity was medically reasonable.

MUE values for J7516 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services13 Date of Service Edit: ClinicalClinical: Data
Facility outpatient hospital43 Date of Service Edit: ClinicalPrescribing Information
DME supplier03 Date of Service Edit: ClinicalPublished Contractor Policy

NCCI edits and add-on relationships

No active practitioner PTP pair lists J7516 as a column-1 or column-2 code in v323r0. Drug supply codes are rarely bundled; the administration codes billed with them are where PTP edits usually apply.

J7516 is neither an add-on code nor a designated primary code in the 2026 Q4 NCCI add-on edit file.

Medicare coverage articles

No current Billing and Coding Article lists J7516 in its HCPCS table. Coverage then follows the drug's FDA label, compendia and any National Coverage Determination; check the Medicare Coverage Database before administering off-label.

Hospital outpatient (OPPS) status

In the July 2026 OPPS Addendum B, J7516 carries status indicator N. Status N means payment is packaged into the associated procedure and no separate OPPS payment is made.

Common denials for J7516 and how to prevent them

NDC missing, invalid or not matched to the HCPCS code

units billed exceed the MUE for the date of service

diagnosis not covered by the applicable coverage article or LCD

How QuickIntell checks J7516 before the claim leaves

QuickCode validates the NDC-to-unit conversion against the current ASP crosswalk, checks units against every published MUE setting and flags PTP and add-on conflicts on the same claim. QuickRCM routes CARC 16, 151 and 50 denials on drug lines with the matching coverage article attached so the appeal starts with evidence.

Frequently asked questions — HCPCS J7516

What does HCPCS code J7516 describe?

J7516 is defined by CMS as "Injection, cyclosporine, 250 mg". Each billing unit represents 250 MG, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J7516 in October 2026?

The ASP-based payment limit is $75.649 per 250 MG, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules. The July 2026 limit was $75.649.

How many units of J7516 can be billed per day?

The practitioner Medically Unlikely Edit is 1 units per date of service with adjudication indicator 3 (3 Date of Service Edit: Clinical). MAI 3 edits can be appealed with documentation that the units were medically reasonable. CMS cites "Clinical: Data" as the rationale.

Which NDCs map to J7516?

The October 2026 ASP crosswalk lists 2 NDCs from 2 labelers: Sandimmune (Novartis Pharmaceuticals Corporation); Cyclosporine Injection (Padagis US LLC). For example NDC 00078-0109-01 is a 5 package equal to 10 billing units. The crosswalk's billing-units-per-package figure converts each package into J7516 units.

Does J7516 have NCCI bundling edits?

No active practitioner PTP pairs list J7516 as a column-1 or column-2 code in the v323r0 release. Unit limits (MUE) and medical-necessity coverage rules still apply.

Sources

Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-01. Verify against the primary file before billing or contracting decisions.

Disclaimer

This page is an operational reference compiled from CMS publications: the Medicare Part B drug payment limit and NDC crosswalk files, NCCI MUE and add-on edit tables, aggregate PTP statistics, OPPS Addendum B and the Medicare Coverage Database. Payment limits are Medicare national amounts; commercial and Medicaid payers differ. CPT codes are shown as numbers only; CPT descriptors are copyright AMA. Nothing here is legal, clinical or billing advice.