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Veklury (remdesivir) — HCPCS J0248

Gilead Sciences, Inc. · 100 mg lyophilized powder or 100 mg/20 mL solution single-dose vial · IV infusion (30–120 min) · COVID-19 antiviral, inpatient + high-risk outpatient

Veklury is the only fully FDA-approved IV antiviral for COVID-19, billed under HCPCS J0248 at 1 mg per unit. Two duration regimens: 5-day inpatient course (200 mg D1 + 100 mg D2–5) and 3-day outpatient course (200 mg D1 + 100 mg D2–3) for non-hospitalized high-risk patients. Inpatient drug cost is bundled into the MS-DRG payment for the COVID-19 admission — not separately payable to the hospital. Separately reimbursable in HOPD and freestanding outpatient settings. Not chemotherapy: bill 96365 (non-chemo IV), not chemo admin codes. Q2 2026 Medicare ASP+6%: $6.898/mg ($1,379.60 per 200 mg loading dose).

✓ASP data:Q2 2026 (live)
✓Payer policies:verified May 2026
✓Manufacturer guide:Gilead Advancing Access 2026
✓FDA label:rev Oct 2025 (peds ≥1.5 kg from birth)
✓Page reviewed:

Instant Answer — the 5 things you need to bill J0248

HCPCS
J0248
1 mg = 1 unit
Loading dose (D1)
200 units
200 mg IV over 30–120 min
Inpatient
DRG-bundled
Billing context only
Admin CPT
96365
Non-chemo IV, up to 1 hr
Medicare ASP+6%
$6.898
per mg, Q2 2026 · $1,379.60/200 mg
HCPCS descriptor
J0248 — "Injection, remdesivir, 1 mg" Permanent
Generic name
remdesivir (development code GS-5734) — nucleotide analog antiviral, SARS-CoV-2 RNA-dependent RNA polymerase (RdRp) inhibitor
Vial — lyophilized
100 mg lyophilized powder single-dose vial; reconstitute with 19 mL sterile water for injection → 5 mg/mL
Vial — solution
100 mg/20 mL (5 mg/mL) ready-to-dilute solution single-dose vial
Route & rate
IV infusion over 30–120 minutes (rate adjusted per patient tolerance; pediatric ~120 min); after dilution in 0.9% NaCl 100 mL or 250 mL bag
Hospitalized adult/peds
200 mg IV Day 1 → 100 mg IV once daily Days 2–5 (extendable to 10 days if not clinically improving and on IMV/ECMO)
Outpatient high-risk
200 mg IV Day 1 → 100 mg IV once daily Days 2 and 3 (3-day total)
Pediatric (birth to <18 yr, ≥1.5 kg)
Label expanded April 2024: indication and weight-based dosing now extend from birth at a minimum weight of 1.5 kg (previously ≥28 days / ≥3 kg). Use weight-band Table 1 in the prescribing information for <40 kg; pediatric ≥40 kg follows adult dosing.
NDC (lyophilized 100 mg)
61958-2901-2 — 1 vial per carton
NDC (solution 100 mg/20 mL)
61958-2902-2 — 1 vial per carton
Renal restriction
Removed April 2023. No specific eGFR cutoff; use across full renal function range including dialysis
FDA approval
October 22, 2020 (NDA 214787) — first fully-approved COVID-19 antiviral; EUA preceded full approval; pediatric expanded April 2022 (≥28 days, ≥3 kg) and further expanded April 2024 (birth, ≥1.5 kg)
Calculate patient estimate → Read full reference Download 1-page PDF
⚠️
Inpatient Veklury is DRG-bundled — not separately payable. When administered during a Medicare inpatient stay, J0248 drug cost is packaged into the MS-DRG payment for the COVID-19 admission (commonly DRG 177–179, respiratory infection with or without CC/MCC). Do not submit J0248 on a Part B outpatient claim for an inpatient encounter. The NCTAP (New COVID-19 Treatments Add-on Payment) supplemental inpatient payment expired with the end of the COVID-19 public health emergency. See site of care for the full bundling matrix.
ℹ️
Two FDA-approved use cases, same J0248. The 5-day inpatient course and 3-day outpatient high-risk course share the same HCPCS, NDCs, and admin codes — the only difference is regimen length and care setting. Outpatient claims may be substantially lower volume in 2026 than in the 2020–2022 surge years; treatment pathways have shifted toward oral antivirals (nirmatrelvir/ritonavir, molnupiravir) for most non-hospitalized patients. Veklury remains relevant for patients with drug interactions or contraindications to oral options, and for severely immunocompromised patients.
Phase 1 Identify what you're billing Confirm the formulation, the regimen (3-day vs 5-day), and the care setting before posting.

Two Veklury formulations — same J0248 FDA NDC Directory verified May 2026

Gilead supplies remdesivir in two vial presentations. Both bill under J0248 but pharmacy preparation and storage differ.

Lyophilized powderSolution (ready-to-dilute)
NDC61958-2901-261958-2902-2
Strength100 mg/vial (lyophilized)100 mg/20 mL (5 mg/mL)
Reconstitution19 mL sterile water for injection → 5 mg/mLNone — ready to withdraw
HCPCSJ0248J0248
StorageRefrigerated 2–8°C; up to 12 hr at room temperature after reconstitutionRefrigerated 2–8°C; protect from light
Use caseStandard supply; longer shelf life pre-reconstitutionFaster pharmacy prep; preferred for high-volume infusion centers
Both vials use the same admin codes, modifiers, ICD-10, and J0248 unit count. The choice between formulations is operational (pharmacy workflow, contracting, on-hand inventory) and does not change the billing pattern. After dilution into a 0.9% NaCl 100 mL or 250 mL infusion bag the two are equivalent at the bedside.

Dosing & unit math FDA label verified May 2026

From the FDA-approved Veklury prescribing information (NDA 214787). Two duration regimens; weight-based for pediatric <40 kg.

Regimen matrix by indication

IndicationDay 1Subsequent daysTotal course
Hospitalized adult (5-day course) 200 mg IV (loading) 100 mg IV once daily, Days 2–5 600 mg over 5 days
Hospitalized adult on IMV/ECMO, not improving 200 mg IV (loading) 100 mg IV once daily, Days 2–10 1,100 mg over 10 days (extension)
Non-hospitalized adult, high-risk (3-day course) 200 mg IV (loading) 100 mg IV once daily, Days 2–3 400 mg over 3 days
Pediatric ≥40 kg (any setting) 200 mg IV (loading) 100 mg IV once daily (5-day inpatient / 3-day outpatient) Same as adult
Pediatric <40 kg, from birth at ≥1.5 kg (expanded Apr 2024) 5 mg/kg IV (loading) 2.5 mg/kg IV once daily Weight-recalculated each cycle if growth between fills

Worked example — adult outpatient 3-day course

# Course total
Day 1: 200 mg IV (loading) = 200 units J0248
Day 2: 100 mg IV = 100 units J0248
Day 3: 100 mg IV = 100 units J0248
Course total: 400 mg = 400 units J0248

# Drug reimbursement (Q2 2026 ASP+6%)
400 units × $6.898 = $2,759.20 (drug only, before sequestration)

# Admin claim per visit
96365 (non-chemo IV, up to 1 hour) × 3 encounters
Optional 96366 if any infusion extends beyond 1 hour

Worked example — pediatric weight-based (20 kg, hospitalized 5-day)

# Calculate doses
Day 1 loading: 5 mg/kg × 20 kg = 100 mg = 100 units J0248
Days 2–5 maintenance: 2.5 mg/kg × 20 kg = 50 mg = 50 units J0248 per day
Course total: 100 + (50 × 4) = 300 mg = 300 units J0248

# Vial draw
Day 1: 100 mg = full 100 mg vial (no waste)
Days 2–5: 50 mg from 100 mg vial → 50 mg discarded per day → JW on 50 units, 4 days

# Setting
Inpatient: drug is DRG-bundled — J0248 not separately billable to Part B
Document units in chart/MAR for utilization review only
Cumulative mg over the encounter is what you bill. Use the actual mg infused per administration (not the scheduled-dose protocol units) when posting J0248. For pediatric weight-based dosing, recalculate at any documented weight change during the course.

NDC reference FDA NDC Directory verified May 2026

NDC (10-digit / 11-digit)StrengthPackage sizeUnits/vial
61958-2901-2 / 61958-2901-02 100 mg lyophilized powder 1 single-dose vial per carton 100 units (1 mg = 1 unit)
61958-2902-2 / 61958-2902-02 100 mg/20 mL (5 mg/mL) solution 1 single-dose vial per carton 100 units (1 mg = 1 unit)
Use 11-digit NDC with N4 qualifier in 24A shaded area. Both NDC presentations are single-dose single-source from Gilead Sciences. There is no remdesivir generic or biosimilar in the U.S. as of May 2026 (FDA expects generic eligibility once patent and exclusivity periods expire). Confirm the carton NDC matches the vial in pharmacy stock before posting.
Single-source product: Veklury remains exclusive to Gilead. Pricing variation by setting reflects 340B status, GPO contracting, and contract pharmacy arrangements — not generic substitution.
Phase 2 Code the claim Non-chemo IV admin codes apply. DRG bundling rule is the trap that costs the most denied dollars.

Administration codes CPT verified May 2026

Veklury is a non-chemotherapy therapeutic IV infusion. Use therapeutic IV admin codes — not chemotherapy admin codes.

CodeDescriptionWhen to use
96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour Primary code for Veklury. 30–60 min standard infusion fits cleanly in the 1-hour window. Bill once per encounter as the initial therapeutic infusion.
96366 Intravenous infusion, for therapy, prophylaxis, or diagnosis; each additional hour (List separately) When infusion extends beyond 60 minutes (typical for pediatric ~120 min infusion or slowed rate for tolerance). Bill in addition to 96365 for each additional hour or major portion thereof.
96413 / 96415 Chemotherapy administration, IV infusion technique NOT appropriate for Veklury. Remdesivir is an antiviral, not a cytotoxic chemotherapy agent. Do not bill chemo admin codes regardless of the high per-mg cost or vial-waste pattern.
96374 IV push of a single or initial substance/drug Not used for Veklury — remdesivir is administered as an infusion, not as IV push.
Per AMA CPT guidance: chemotherapy administration codes (96401–96425) are reserved for cytotoxic, monoclonal-antibody-as-anti-neoplastic, and certain complex biologic agents requiring special handling. Remdesivir does not meet that bar. The 96365/96366 family is correct.
Common error: Billing 96413 because Veklury "feels like" oncology billing (J-code, vial waste, high cost). This will trigger denial or downcoding. Always use 96365 for Veklury.

Modifiers CMS verified May 2026

JW — discarded drug from single-dose vial

Veklury is supplied only in 100 mg single-dose vials. Pediatric weight-based dosing routinely produces partial-vial waste (e.g., a 20 kg child needs 50 mg from a 100 mg vial, discarding 50 mg per dose). When waste occurs, bill the administered units on the primary line and the discarded units on a separate line with the JW modifier. Both pay at ASP+6% for separately-payable settings (HOPD, office).

JZ — no discarded drug

Adult dosing (200 mg D1, 100 mg subsequent) lands cleanly on 100 mg vial multiples and typically produces no waste — the JZ modifier applies in those cases. Per CMS's July 2023 single-dose container policy, one of JZ or JW must be on every J0248 claim line submitted in a separately-payable setting.

Inpatient claim note: JW/JZ modifiers are irrelevant for the inpatient setting because the drug cost is bundled into the MS-DRG — J0248 is not on the Part B claim. Modifier rules apply only to separately-payable settings (HOPD outpatient, office, freestanding infusion).

JG / TB — 340B-acquired drug

For 340B-acquired Veklury administered in a Medicare HOPD, current CMS OPPS rules require JG (or TB for informational reporting depending on your MAC) on the J0248 line. Verify the current OPPS year's 340B policy with your MAC; the 340B payment reduction status for separately payable drugs has shifted over recent rulemaking cycles.

Modifier 25 — same-day E/M

Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion (e.g., outpatient COVID-19 evaluation that determines high-risk eligibility and initiates the Veklury course). Routine pre-infusion clinical assessment is bundled into 96365.

ICD-10-CM by indication FY2026 verified May 2026

Veklury is approved exclusively for COVID-19. ICD-10 documentation must establish confirmed COVID-19 with appropriate severity codes.

CodeDescriptionNotes
U07.1COVID-19 (confirmed)Primary code. Use when confirmed by PCR or antigen test. Required for J0248 medical necessity.
J12.82Pneumonia due to coronavirus disease 2019Add when pneumonia is documented in chart; common in hospitalized population
J96.0xAcute respiratory failureAdd for hospitalized patients with respiratory failure (with hypoxia, hypercapnia, etc.)
Z20.822Contact with and (suspected) exposure to COVID-19Use for confirmed exposure WITHOUT confirmed infection — does not support J0248 medical necessity. Cannot be primary diagnosis for Veklury.
U09.9Post COVID-19 condition, unspecifiedFor long-COVID sequelae — not an approved Veklury indication
Z87.828Personal history of other infectious and parasitic diseasesAdd for documentation of resolved prior COVID-19 episode
Secondary "high-risk" qualifier codes (for outpatient 3-day course PA)
Z51.81Encounter for therapeutic drug level monitoringOptional supporting code for serial infusion encounters
D89.81x / D80–D84Immunocompromised state codesFor PA support on outpatient course — document the specific immune deficiency
E66.xOverweight and obesityBMI ≥30 as a high-risk factor
E11.x / E10.xDiabetes mellitusType 1 or 2 diabetes as high-risk factor
Code U07.1 alone is not always enough. For the outpatient 3-day course, payer PA typically requires both U07.1 AND documentation of at least one high-risk factor (immunocompromise, age ≥65, comorbidity). Submit the qualifying secondary diagnosis or chart note with the PA request.

Site of care, place of service & DRG bundling CMS OPPS & IPPS verified May 2026

Inpatient: not separately payable. Billing context only. When Veklury is administered during a Medicare inpatient acute-care stay, the J0248 drug cost is packaged into the MS-DRG payment for the COVID-19 admission. Do not submit J0248 on a separate Part B outpatient claim for an inpatient encounter — that is the cleanest path to a duplicate-billing audit. Track inpatient mg administered for internal P&L and utilization purposes; reimbursement comes through the MS-DRG.

Veklury is administered across four distinct settings, each with different payment mechanics. The 2026 landscape is sharply split between the inpatient setting (DRG-bundled, no separate J0248 payment) and the outpatient/HOPD/clinic settings (separately payable under Part B at ASP+6%).

SettingPOSClaim formJ0248 payment
Inpatient hospital (acute care)21UB-04 / 837IDRG-bundled. No separate J0248 reimbursement. MS-DRG 177–179 (respiratory infection) is the common driver. NCTAP add-on payment expired with PHE.
Hospital outpatient (on-campus)22UB-04 / 837ISeparately payable at OPPS ASP+6% (typical pass-through or separately-payable status). 340B rules apply.
Hospital outpatient (off-campus PBD)19UB-04 / 837ISeparately payable; subject to site-neutral rules per current OPPS year.
Physician office / infusion clinic11CMS-1500 / 837PSeparately payable at Part B ASP+6%.
Freestanding specialty infusion center11 (or 49)CMS-1500 / 837PSeparately payable. Preferred outpatient site for routine 3-day high-risk course.
Ambulatory infusion suite (AIC)49CMS-1500 / 837PSeparately payable. Common alternative to HOPD for non-hospitalized patients.
Skilled nursing facility (consolidated billing)31 / 32UB-04 / 837ITypically bundled into SNF Part A consolidated billing during a covered Part A stay; separately payable to SNF for non-covered residents under specific carve-out rules — verify CMS SNF CB exclusion list.
Patient home (home infusion)12CMS-1500 / 837PPossible with qualified home infusion provider and nurse present; less common than HOPD or AIC for COVID outpatient course.

MS-DRG bundling detail (inpatient)

For the inpatient setting, the relevant MS-DRGs are typically 177 (Respiratory infections and inflammations with MCC), 178 (with CC), and 179 (without CC/MCC). When COVID-19 with respiratory failure is the principal diagnosis, the MS-DRG payment includes the cost of all inpatient pharmacy — including Veklury. The NCTAP add-on payment that provided supplemental inpatient reimbursement for new COVID treatments terminated at the end of the federal COVID-19 public health emergency. For 2026 dates of service, treat the drug as fully packaged in the MS-DRG.

Commercial inpatient pharmacy carve-outs: Some commercial and Medicare Advantage plans handle inpatient specialty drugs through pharmacy carve-out arrangements rather than pure DRG bundling. Verify per payer contract before assuming bundling applies.

Claim form field mapping Gilead Advancing Access 2026

From Gilead Advancing Access reimbursement support and CMS claim form guidance.

Outpatient (separately payable) — CMS-1500 / 837P

InformationCMS-1500 boxNotes
NPI17bRendering provider
NDC qualifier + 11-digit NDC + UoM + qty24A shaded areaN4 + 61958-2901-02 (or 61958-2902-02) + ML + total mL infused
HCPCS J0248 (administered line)24D1 mg = 1 unit; e.g., 200 units for 200 mg loading dose
HCPCS J0248 + JW (waste line, if applicable)24D (waste line)Wasted units only; common for pediatric weight-based
Drug units24GActual mg administered (200 for loading, 100 for subsequent days)
CPT 96365 (admin line)24D (admin line)Therapeutic IV infusion, up to 1 hour
CPT 96366 (admin extension)24DEach additional hour beyond first hour (when applicable)
ICD-1021U07.1 primary; add J12.82 / J96.0x / risk-factor codes as documented
PA number23Required by most commercial payers for outpatient course; documented high-risk attestation

Inpatient — UB-04 / 837I

InformationUB-04 form locatorNotes
Principal diagnosisFL 67U07.1 (COVID-19)
Other diagnosesFL 67A–QJ12.82, J96.0x, comorbidities
Revenue code 0250 (pharmacy general)FL 42Veklury cost rolls up into pharmacy charges
HCPCS J0248FL 44Reported for cost-reporting and CCR purposes; not separately reimbursed in DRG-bundled inpatient claim
Total chargesFL 47Charges include packaged Veklury cost
MS-DRGDriven by Dx + procedure codesTypical: 177/178/179 (respiratory infection +/- CC/MCC)
Phase 3 Get paid High-risk documentation, oral antiviral step, and DRG bundling rules drive most outcomes.

Payer policy snapshot Reviewed May 2026

Outpatient course PA is the focus — inpatient use is DRG-bundled so plan-level PA is generally not required for that setting.

PayerOutpatient PA?Step therapy / requirementsNotes
Medicare Part B
MAC coverage		 Generally not required for outpatient Confirmed COVID-19 (U07.1) + documented high-risk factor; FDA-labeled indication NCD silent; MAC LCDs treat as covered under standard Part B drug framework
Medicare Advantage
Plan-specific		 Plan-specific Many MA plans require PA for outpatient Veklury; some prefer oral antivirals first when contraindications allow Pharmacy carve-outs vary; verify each plan
UnitedHealthcare
Medical drug policy		 Yes Documented high-risk; step therapy from oral nirmatrelvir/ritonavir (Paxlovid) when not contraindicated. Drug interactions or pregnancy with documented risk override step. Indication-specific coverage criteria document
Aetna
CPB 0951 / med drug		 Yes FDA-label indication; high-risk factor documented; step from oral options when clinically appropriate CPB regularly updated; verify current edition
Cigna / Evernorth
Coverage policy		 Yes U07.1 documentation; high-risk attestation; oral antiviral preference where applicable 3-day course only for outpatient
BCBS plans
Vary by plan		 Plan-specific Generally aligned with NIH COVID-19 Treatment Guidelines and FDA label Some plans align with state Medicaid guidance
State Medicaid
State variance		 Plan-specific State-specific; some require step therapy from Paxlovid for outpatient. Many state COVID treatment PDLs simplified during PHE have since reverted. Verify state PDL for current dates of service

Treatment-pathway context (2026)

Most non-hospitalized high-risk patients are treated with oral antivirals (Paxlovid or molnupiravir) as first-line for convenience and cost. Veklury outpatient claims are concentrated in patients with drug-interaction contraindications to Paxlovid (e.g., significant tacrolimus interaction in transplant recipients), severe renal impairment with intolerance to molnupiravir, severely immunocompromised patients, or those who present too late for oral antiviral effective window but early enough for IV remdesivir. Many billers will see substantially fewer J0248 outpatient claims in 2026 than during the 2020–2022 surge period — this is expected, not an error.

Guideline support

NIH COVID-19 Treatment Guidelines (final update October 2024 before sunset of the panel) and IDSA guidelines continue to recommend Veklury for hospitalized patients requiring supplemental oxygen and for non-hospitalized high-risk patients within 7 days of symptom onset. Guidelines remain the standard reference for medical necessity letters; cite the specific recommendation grade in PA submissions.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter. Applies to separately-payable settings only; inpatient is DRG-bundled.

Q2 2026 payment snapshot — J0248 (outpatient)

Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions

ASP + 6%
$6.898
per mg / per unit
200 mg loading dose
$1,379.60
Day 1 (any regimen)
3-day outpatient course
$2,759.20
400 mg total (D1 200 + D2 100 + D3 100)
Inpatient bundling caveat: The Q2 2026 ASP+6% figures above apply only to the outpatient separately-payable settings (HOPD, office, freestanding infusion clinic, AIC). For inpatient Medicare admissions, the drug is packaged into the MS-DRG payment and not separately reimbursed. The NCTAP add-on payment that existed during the public health emergency has expired.
Sequestration: Approximately 2% reduction applies to actual paid amount in separately-payable settings, bringing effective reimbursement to roughly ASP + 4.3% rather than ASP + 6%.

Coverage

No NCD specific to remdesivir. Coverage falls under MAC LCDs and the general Part B drug coverage framework for FDA-approved on-label indications (hospitalized COVID-19 and non-hospitalized high-risk COVID-19) with appropriate ICD-10 (U07.1 primary) and clinical documentation. NIH COVID-19 Treatment Guidelines and IDSA guidelines support compendium-based extension where relevant.

Code history

  • EUA period (May 2020 – Oct 2020): Reported under unclassified J3490 / J3590 / C9399; many MACs published EUA-specific guidance.
  • Initial Q-codes: Temporary Q-code created shortly after full FDA approval.
  • J0248 permanent: "Injection, remdesivir, 1 mg" became the permanent HCPCS Level II code (effective 2021 cycle); has been the standard separately-payable code since.

Patient assistance — Gilead Advancing Access Gilead verified May 2026

  • Gilead Advancing Access: 1-800-226-2056 / gileadadvancingaccess.com — benefits investigation, prior authorization assistance, appeal support, copay program, patient assistance program
  • Veklury Copay Coupon Program: commercial copay support for eligible commercially-insured outpatients; covers out-of-pocket up to program maximum. Excludes Medicare, Medicaid, TRICARE, VA, and other federal/state program patients.
  • Gilead Patient Assistance Program (PAP): free product for uninsured / underinsured patients meeting income requirements (typically ≤500% FPL); enrollment via Advancing Access portal.
  • Foundations (Medicare patients): PAN Foundation, HealthWell Foundation, and Patient Advocate Foundation periodically open COVID-19 treatment funds — verify current open funds quarterly.
  • Inpatient note: Inpatient Medicare Veklury is DRG-bundled — no separate patient cost-share for the drug itself beyond standard inpatient cost-sharing (deductible, copay per benefit period).
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate — J0248 pre-loaded.
Phase 4 Fix problems Inpatient duplicate billing, missing high-risk documentation, and wrong admin code are the top three.

Common denials & how to fix them

Denial reasonCommon causeFix
Duplicate billing (inpatient)J0248 submitted on Part B outpatient claim for a Medicare inpatient encounterWithdraw the Part B claim. Inpatient Veklury is DRG-bundled in MS-DRG 177/178/179; drug cost is included in the inpatient payment.
Wrong admin code (96413)Chemotherapy admin code billed instead of therapeutic IV admin codeResubmit with 96365 (and 96366 for hours beyond first). Veklury is antiviral, not chemotherapy.
COVID-19 diagnosis not confirmedZ20.822 (exposure) or U09.9 (post-COVID) billed as primary instead of U07.1Resubmit with U07.1 (confirmed COVID-19) as primary diagnosis. PCR or antigen test confirmation must be documented in chart.
High-risk factor not documented (outpatient)Outpatient course submitted without supporting high-risk diagnosis or attestationSubmit chart note documenting specific qualifying risk factor (age ≥65, immunocompromise, comorbidity, BMI ≥30, pregnancy) with PA or appeal.
Oral antiviral step not documentedPlan requires Paxlovid step before IV remdesivir for outpatient and step not addressedDocument specific contraindication to oral options (drug interaction, renal impairment, intolerance) or override criterion in PA.
Missing JW or JZ modifierPediatric weight-based dose missing JW for vial waste, or adult dose missing JZ for no-wasteAdd appropriate modifier per CMS single-dose container policy. JW pays the waste line at ASP+6%.
Wrong NDC format10-digit NDC submitted instead of 11-digit with N4 qualifierUse 11-digit NDC: 61958-2901-02 (lyophilized) or 61958-2902-02 (solution) with N4 qualifier in 24A shaded area.
Inpatient bundling confusionHospital biller attempts to bill J0248 separately on Part B for inpatient stay where COVID is principal diagnosisThis is a process error. Educate inpatient pharmacy/coding staff: track J0248 mg internally for cost-reporting and CCR; do not file separate Part B claims for inpatient drug.
SNF consolidated billing editJ0248 submitted by external provider for a patient in covered Part A SNF stayVerify SNF Part A status. Most Part A SNF days bundle pharmacy via consolidated billing; bill the SNF, not Medicare directly. Check current SNF CB exclusion list.
Late symptom onset (outpatient)Outpatient course initiated >7 days from symptom onset; payer denies as outside effective windowDocument specific clinical scenario (severely immunocompromised with prolonged viral shedding, late presentation with continued progression). Cite guideline support.

Frequently asked questions

Is Veklury bundled in the DRG for inpatient COVID-19 admissions?

Yes, in the typical case. When Veklury is administered during a Medicare inpatient stay, the drug cost is packaged into the MS-DRG payment for the COVID-19 admission (commonly DRG 177–179 for respiratory infections with major/non-major CC). It is not separately payable to the hospital under Part B for that encounter. Some Medicare Advantage plans and commercial payers handle inpatient pharmacy carve-outs differently — verify per contract. The NCTAP add-on payment for new COVID treatments expired with the end of the COVID-19 public health emergency.

What is the difference between the inpatient 5-day and outpatient 3-day Veklury course?

The FDA-labeled regimen is duration-dependent on care setting and patient acuity. Hospitalized patients: 5-day course (200 mg IV Day 1, then 100 mg IV once daily Days 2–5; extendable to 10 days if not improving and on IMV/ECMO). Non-hospitalized high-risk patients: 3-day course (200 mg IV Day 1, then 100 mg IV once daily Days 2 and 3). Total drug exposure: 600 mg inpatient (full 5-day) versus 400 mg outpatient. Same J0248 code, same NDCs, same admin codes — the regimen length is determined by indication, not by code.

What qualifies a patient as high-risk for the outpatient 3-day Veklury course?

Per FDA label and NIH guidelines, high-risk non-hospitalized adults and pediatric patients (from birth at ≥1.5 kg, per the April 2024 label expansion) with mild-to-moderate COVID-19 are eligible if they have one or more risk factors for severe disease progression. Common qualifying factors: age ≥65 years, immunocompromised status (active cancer, transplant, primary immunodeficiency, HIV with low CD4, high-dose immunosuppressives), chronic kidney disease, diabetes, cardiovascular disease, chronic lung disease, obesity (BMI ≥30), and pregnancy. Document the specific risk factor in the chart for PA and audit support.

Is Veklury approved for pediatric COVID-19?

Yes — from birth at minimum weight 1.5 kg. FDA expanded the label in April 2022 to include pediatric patients ≥28 days / ≥3 kg, and further expanded it in April 2024 to extend down to birth at a minimum weight of 1.5 kg. Both hospitalized and high-risk outpatient pediatric use are covered. For <40 kg, use the weight-band Table 1 dosing in the current PI (the legacy 5 mg/kg load → 2.5 mg/kg daily formula approximates the table but the table is authoritative). Patients ≥40 kg use adult dosing (200 mg / 100 mg). Document weight at each administration. ICD-10 U07.1 applies. Same NDCs as adult — no separate pediatric SKU.

Does Veklury require renal dose adjustment?

No specific dose adjustment is required based on renal function per the current FDA label. Earlier labels restricted use in eGFR <30 mL/min/1.73 m² because of SBECD excipient accumulation concerns, but FDA removed that restriction in April 2023 — Veklury is now usable across the full range of renal function including dialysis patients. Hepatic monitoring is still recommended: obtain baseline ALT and discontinue if ALT rises >10× ULN or with signs of liver inflammation.

Can Veklury be self-administered at home?

No. Veklury is an intravenous infusion administered by a healthcare professional over 30–120 minutes with monitoring for infusion-related and hypersensitivity reactions. Not labeled for self-administration. Outpatient 3-day courses are given in HOPD, ambulatory infusion suite, specialty infusion clinic, or qualified home infusion service with nurse present. Bill CPT 96365 (and 96366 for extended infusions); do not bill self-administered drug codes.

What administration CPT codes do I use for Veklury?

96365 (therapeutic IV infusion, initial up to 1 hour) for the standard 30–60 minute infusion, plus 96366 (each additional hour) when infusion extends. Do NOT use 96413 (chemotherapy administration) — remdesivir is an antiviral, not a cytotoxic chemotherapy agent. The chemo admin family is reserved for cytotoxic and complex biologic agents per AMA CPT guidance.

What is the Medicare reimbursement for J0248 in 2026?

For Q2 2026, the Medicare Part B payment limit for J0248 is $6.898 per mg (1 mg = 1 unit). A 200 mg loading dose reimburses at approximately $1,379.60; a 100 mg subsequent-day dose at approximately $689.80. Full outpatient 3-day course (400 mg total) reimburses at roughly $2,759.20 in drug spend before sequestration. Separately-payable reimbursement applies only in the outpatient setting — for inpatient admissions, the drug is bundled in the MS-DRG and not separately reimbursed.

How does Veklury compare to oral COVID antivirals like Paxlovid?

Veklury (IV remdesivir) and oral antivirals (nirmatrelvir/ritonavir, molnupiravir) all target SARS-CoV-2 replication but with different mechanisms, routes, and PA pathways. Oral antivirals are pharmacy-benefit drugs (typically not on the J-code drug page like this one). Most non-hospitalized high-risk patients in 2026 are routed to oral antivirals first for convenience. Veklury outpatient is reserved for patients with drug-interaction contraindications to Paxlovid (e.g., transplant tacrolimus), severe renal impairment with intolerance to molnupiravir, severely immunocompromised, or late-presentation cases where IV remdesivir remains within the effective window. Bill J0248 for Veklury only; oral options run through pharmacy benefit under their own NDCs.

Reference Sources & methodology Every claim on this page is sourced. Methodology and review history below.

Source documents

  1. FDA — VEKLURY (remdesivir) prescribing information (NDA 214787)
    FDA-approved label; full prescribing information including hospitalized and outpatient high-risk indications, pediatric expansion, renal restriction removal (April 2023)
  2. DailyMed — VEKLURY (remdesivir)
    Current FDA label (setid c0978fa8-53ff-4ca2-82a7-567fd3e958ca, revised October 2025); NDCs, package insert (lyophilized and solution presentations); pediatric birth-1.5 kg expansion
  3. Gilead Advancing Access — Veklury reimbursement & patient support
    Manufacturer billing guide, claim form mapping, copay program, patient assistance program
  4. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file, effective April 1 – June 30, 2026
  5. NIH COVID-19 Treatment Guidelines
    Final update October 2024 before panel sunset; remains primary U.S. guideline reference for medical necessity letters
  6. IDSA Guidelines on the Treatment and Management of Patients with COVID-19
    Society guideline; recommends remdesivir for hospitalized patients on supplemental oxygen and high-risk outpatients within 7 days of symptom onset
  7. CMS — Acute Inpatient PPS (MS-DRG)
    MS-DRG 177/178/179 (respiratory infection) is the typical DRG bundle for COVID-19 admissions where Veklury is administered
  8. CMS — Hospital Outpatient Prospective Payment System (OPPS)
    Separately-payable status for J0248 in HOPD outpatient setting; 340B payment policy reference
  9. CMS HCPCS Level II Quarterly Updates
    J0248 descriptor: "Injection, remdesivir, 1 mg" — permanent code
  10. FDA National Drug Code Directory
    NDC verification for lyophilized (61958-2901-2) and solution (61958-2902-2) presentations
  11. CMS — JW/JZ modifier policy (CR 12056, eff. July 2023)
    Single-dose container policy requiring JW (waste) or JZ (no waste) on every claim
  12. CMS — New COVID-19 Treatments Add-on Payment (NCTAP) policy
    NCTAP supplemental inpatient payment expired with the end of the federal COVID-19 PHE

About this page

We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

ElementCadenceHow it's refreshed
Medicare ASP pricingQuarterlyAuto-bound to CareCost ASP layer; updates on CMS file release.
Payer policies (UHC, Aetna, Cigna, BCBS)Semi-annualManual review against published payer policy documents.
HCPCS / CPT / modifier rulesAnnualReviewed against CMS HCPCS quarterly files and AMA CPT releases.
NDC, dosing, FDA label, indication listEvent-drivenTied to manufacturer document version + FDA label revision date.
DRG bundling / NCTAP statusAnnualReviewed against CMS IPPS final rule for the dates of service.

Reviewer

Editorial audit complete — May 23, 2026. Page reconciled against current DailyMed Veklury label (setid c0978fa8-53ff-4ca2-82a7-567fd3e958ca, revised October 2025), CMS Q2 2026 ASP file (J0248 = $6.898/mg), and the prescribing information. Major correction: pediatric indication and dosing references updated across the fact card, hospitalized/outpatient dosing table, FAQ, and approval history to reflect the April 2024 expansion (from "≥28 days, ≥3 kg" to "birth, ≥1.5 kg"). No boxed warning per current label. Two dosing regimens (5-day hospitalized, 3-day outpatient high-risk) verified.

Change log

  • — SME audit pass. Expanded pediatric indication and dosing to reflect April 2024 label update (from birth, minimum weight 1.5 kg); refreshed DailyMed link to setid c0978fa8-53ff-4ca2-82a7-567fd3e958ca; freshness ribbon updated to Oct 2025 label revision. ASP, HCPCS, adult dosing, and DRG-bundling guidance unchanged.
  • — Initial publication. ASP data: Q2 2026. Manufacturer source: Gilead Advancing Access 2026. FDA-approved indications: hospitalized COVID-19 (5-day course) and non-hospitalized high-risk COVID-19 (3-day course); pediatric 28 days+ / ≥3 kg. Inpatient DRG-bundling caveat included.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list and dosing are verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.

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