Mircera (methoxy PEG-epoetin beta) — HCPCS J0888

CKD-only indication — the major class distinction FDA verified May 2026

Mircera is the ONE ESA without a cancer indication. Off-label use will deny.

Mircera (methoxy polyethylene glycol-epoetin beta), trade name Mircera, was approved by FDA in November 2007 for anemia of CKD only. The cancer indication was never pursued and is explicitly absent from the label. Pediatric expansion in 2018 added patients ≥5 years of age on hemodialysis converted from another ESA. This CKD-only labeling is the single most important clinical and billing distinction from Aranesp and Epogen/Procrit.

FDA-approved indications

• Anemia associated with chronic kidney disease in adults on dialysis (HDD-CKD)
• Anemia associated with chronic kidney disease in adults not on dialysis (NDD-CKD)
• Pediatric patients ≥5 years on hemodialysis converted from another ESA (FDA pediatric expansion, June 2018)

NOT indicated — do not prescribe / bill

• Chemotherapy-induced anemia (CIA) — never studied; off-label and contrary to boxed warning intent
• HIV-related anemia from zidovudine therapy — not labeled (Procrit/Epogen only)
• Reduction of allogeneic transfusion in surgery — not labeled (Procrit/Epogen only)
• MDS / anemia of chronic disease without CKD — not labeled

ESA class comparison CMS HCPCS verified May 2026

Mircera is the longest-acting ESA. Different molecules, different J-codes, different dosing intervals, different label scope.

ESA conversion protocol — switching to Mircera FDA label verified May 2026

Per Mircera prescribing information, conversion is by total weekly equivalent dose, with q4w maintenance.

Conversion from epoetin alfa (Epogen / Procrit / Retacrit) to Mircera

Conversion from darbepoetin alfa (Aranesp) to Mircera

FDA labeling does not include a formal Aranesp-to-Mircera conversion table; clinical practice uses approximately a 1:200 ratio of total weekly Aranesp mcg to total monthly Mircera mcg. Worked examples:

• 20 mcg Aranesp/week (low) → ~100 mcg Mircera q4w (round to 100 mcg syringe)
• 40 mcg Aranesp/week → ~200 mcg Mircera q4w
• 60 mcg Aranesp/week → ~200–250 mcg Mircera q4w
• 100 mcg Aranesp/week → ~360 mcg Mircera q4w (max syringe)

Maintenance after conversion

• Maintain target Hgb 10–11 g/dL
• Titrate dose at q4w intervals (do not adjust dose more frequently than the dosing interval)
• Hold dose when Hgb >11 g/dL; resume at reduced dose when Hgb falls back into target window
• Monitor Hgb more frequently for the first 2–4 cycles after conversion

Dosing & unit math FDA label (Mircera PI)

From FDA prescribing information for Mircera (BLA 125164).

CKD anemia — ESA-naive (NDD-CKD or HDD-CKD)

• Initiation: 0.6 mcg/kg SC or IV every 2 weeks
• Initiate when Hgb <10 g/dL, after iron-replete confirmation (TSAT >20%, ferritin >100 ng/mL)
• Target Hgb 10–11 g/dL (CMS / KDIGO); reduce or hold dose when Hgb >11 g/dL
• Maintenance: may extend to q4w once Hgb stable in target window
• Bill J0888 with units = actual mcg administered

Pediatric ≥5 years on HD (converted from another ESA, 2018 expansion)

• Conversion from epoetin alfa or darbepoetin alfa per pediatric conversion table in the FDA label
• Q4w maintenance dosing once stable
• Same target Hgb 10–11 g/dL

Worked example — NDD-CKD ESA-naive, 70 kg patient

Worked example — conversion from Epogen to Mircera q4w, HDD-CKD

Iron sufficiency required before ESA

Per FDA label, KDIGO, and most payer LCDs: confirm iron-replete status (TSAT >20%, ferritin >100 ng/mL for NDD-CKD; TSAT >30%, ferritin >500 ng/mL for HD) before initiating Mircera. Iron deficiency is a top cause of ESA non-response and a frequent payer denial reason if iron studies are not documented in the chart.

NDC reference FDA NDC Directory verified May 2026

Administration codes CPT verified May 2026

Mircera is supportive care, NOT a chemotherapy agent. Use therapeutic injection codes.

Modifiers CMS verified May 2026

JZ — required when no waste

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Mircera ships in single-dose prefilled syringes — if the ordered dose matches a syringe strength exactly (e.g., 200 mcg ordered for a 200 mcg PFS), append JZ to the J0888 line. Conversion-table doses (120, 200, 360 mcg) align cleanly with available syringe strengths in most cases (200 and 360 are exact PFS sizes; 120 typically uses a 150 mcg PFS with 30 mcg waste line).

JW — report wasted drug

When a weight-based dose (0.6 mcg/kg q2w) doesn't match an available syringe strength (e.g., 42 mcg ordered, 50 mcg PFS used — 8 mcg discarded), bill the administered units on the primary line and the wasted units on a separate line with JW. The wasted drug is reimbursable but must be explicitly reported. One of JZ or JW must be on every J0888 claim. JW use is rarer for Mircera than for Aranesp because Mircera maintenance doses are typically fixed (120/200/360 mcg) rather than weight-based.

AY — ESRD beneficiary, non-ESRD condition

The AY modifier theoretically applies if an ESRD beneficiary on dialysis received Mircera for a clearly non-ESRD reason. In practice, because Mircera is approved only for CKD anemia, an ESRD-bene scenario where Mircera would be billed outside the bundle is essentially nonexistent. AY use is much more common for Aranesp (J0881 + AY for CIA in ESRD bene). For Mircera, expect default PPS bundling.

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 injection. Routine pre-injection vitals + Hgb review is bundled.

340B modifiers (JG, TB)

For 340B-acquired Mircera, follow your MAC's current 340B modifier policy. Most ESRD facilities do not participate in 340B; office-based nephrology buy-and-bill may use 340B with the appropriate JG or TB modifier per payer instructions.

ICD-10-CM by indication FY2026 verified May 2026

Site of care & place of service Verified May 2026

Claim form & Type of Bill CMS verified May 2026

Setting determines form: Part B FFS (CMS-1500 / 837P) for office; ESRD facility (UB-04 / 837I, TOB 072x) for dialysis.

ESRD PPS bundling — the J0888 reimbursement reality CMS ESRD PPS verified May 2026

Effective January 1, 2011, ESAs are bundled into the ESRD Prospective Payment System per-treatment composite rate.

Before 2011, dialysis centers separately billed ESAs (J0882, J0885, J0886, J0888) as Part B drugs at ASP + 6%. The 2011 ESRD PPS folded ESAs and most ESRD-related drugs and lab tests into a single per-treatment composite payment. The PPS base rate is updated annually; for CY2026 the base rate is approximately $277 per treatment (post-budget-neutrality adjustment), with case-mix and facility-level adjusters applied.

What that means for J0888 specifically

• J0888 still appears on the ESRD claim (UB-04, TOB 072x) for reporting and audit purposes
• The drug cost is not separately reimbursed beyond the PPS composite rate
• Facilities cannot mark up J0888 above ASP and pass it through
• The economic incentive is to minimize ESA use while staying within the Hgb 10–11 g/dL window
• Mircera's q4w dosing is operationally efficient for ESRD facilities (fewer administration touches per month)

HCPCS descriptor caveat for J0888

The J0888 HCPCS descriptor literally reads "Injection, epoetin beta, 1 microgram, (for non-ESRD use)" — a CMS labeling artifact that predates the ESRD PPS era. In practice, J0888 is billed for both NDD-CKD (separately payable Part B FFS) and ESRD (bundled into PPS). The descriptor's "non-ESRD" wording does NOT prevent J0888 use on an ESRD claim; ESRD facilities use J0888 routinely under PPS bundling.

Outliers and exceptions

ESRD beneficiaries who are at home self-administering subcutaneous Mircera under home dialysis arrangements are still subject to PPS bundling. Acute kidney injury (AKI) patients receiving temporary dialysis are NOT under PPS — bill J0888 fee-for-service.

Payer policy snapshot — Hgb targets and PA Reviewed May 2026

All major payers enforce target Hgb 10–11 g/dL and require iron-replete confirmation before initiation. Q4w dosing advantage may justify Mircera over Aranesp/Epogen.

Step therapy

Some commercial payers (UHC, Cigna) require step therapy through Retacrit (epoetin alfa-epbx biosimilar, Q5105/Q5106) or Procrit before approving Mircera, on cost grounds. Q4w dosing advantage is a common appeal argument when the patient has poor adherence with a 3×/week schedule, frequent missed visits, or an HD-vintage workflow that benefits from monthly dosing. Verify per-payer; ESRD PPS facilities do not face commercial step edits.

Off-label = automatic denial

Because Mircera is approved only for CKD anemia, any non-CKD use will be denied as off-label by all major payers. Do not appeal CIA, MDS, HIV, or surgery indications — switch to Aranesp or Procrit/Epogen instead.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.

Coverage

No NCD specific to Mircera; multiple MAC LCDs cover ESAs in CKD (e.g., Novitas L34624, NGS L33616, Palmetto L36277). All MACs cover J0888 for FDA-approved CKD anemia indications with documented Hgb, iron studies, and CKD diagnosis. Hgb >11 g/dL within the billing month is a near-universal denial trigger. CIA / cancer use will deny as off-label.

Code history

• J0888 — "Injection, epoetin beta, 1 microgram, (for non-ESRD use)", permanent code, effective January 1, 2009
• Pre-2009 Mircera was billed under transitional miscellaneous codes
• 2011: J0888 brought into ESRD PPS bundle (1/1/2011)
• 2018: FDA pediatric expansion (≥5 yr on HD converted from another ESA)

Patient assistance — Vifor Pharma / CSL Vifor Vifor verified May 2026

• Vifor Patient Access: 1-855-737-2200 — benefits investigation, prior authorization assistance, appeal support, copay help, and PAP referral for Mircera.
• Mircera Co-pay Card (commercial): available for eligible commercially-insured patients; reduces out-of-pocket cost per dose. Excludes Medicare, Medicaid, and federal program patients.
• Mircera Patient Assistance Program: free product for uninsured / underinsured patients meeting income requirements (administered through Vifor's PAP).
• Foundations (Medicare patients): for CKD anemia, refer to Patient Access Network (PAN) Foundation, HealthWell, NeedyMeds — verify open CKD funds quarterly. AKF (American Kidney Fund) for dialysis-related cost-sharing assistance.
• Reminder: Mircera is NOT covered by ESA APPRISE REMS (CKD-only label); no separate REMS hotline applies.

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Mircera?

Mircera (methoxy polyethylene glycol-epoetin beta, also called CERA) bills under J0888 "Injection, epoetin beta, 1 microgram, (for non-ESRD use)." Each microgram equals one billable unit. Note that the code descriptor references non-ESRD use, but Mircera is also extensively used in ESRD on dialysis where it is bundled into the ESRD PPS per-treatment composite rate.

How is Mircera different from Aranesp and Epogen?

Mircera is the longest-acting ESA available, with q2-week initial dosing and q4-week maintenance dosing once Hgb is stable. Aranesp (darbepoetin alfa) doses q1–4 weeks; Epogen/Procrit (epoetin alfa) doses q1–3 weeks (typically 3×/week for HD). Critically, Mircera is FDA-approved ONLY for CKD anemia (NDD-CKD or HDD-CKD) and is NOT approved for chemotherapy-induced anemia — unlike Aranesp and Epogen which carry the cancer indication. Mircera also does NOT require ESA APPRISE REMS enrollment because the cancer indication is not labeled.

How many units do I bill for a 200 mcg Mircera dose?

200 units. 1 mcg = 1 unit on J0888. Mircera ships in single-dose prefilled syringes at 50, 75, 100, 150, 200, 250, and 360 mcg strengths. Match the syringe to the prescribed dose; the standard q4wk maintenance doses (120, 200, 360 mcg) align with available strengths to minimize waste.

How do I convert a patient from Epogen or Aranesp to Mircera?

From epoetin alfa (Epogen/Procrit), convert by total weekly dose: <8,000 IU/week → 120 mcg Mircera q4wk; 8,000–16,000 IU/week → 200 mcg q4wk; >16,000 IU/week → 360 mcg q4wk. From darbepoetin alfa (Aranesp), the conversion ratio is approximately 1:200 (e.g., 60 mcg Aranesp/week converts to roughly 200 mcg Mircera q4wk). Maintain target Hgb 10–11 g/dL after conversion; titrate at q4wk intervals.

What administration CPT do I use for Mircera?

For Mircera given in office or infusion suite (non-dialysis setting): CPT 96372 "Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular" for SC administration (most common in NDD-CKD), or 96365 "Therapeutic IV infusion, up to 1 hour" for IV push administration. For ESRD patients receiving Mircera during in-center HD under the ESRD PPS, the administration is bundled into the per-treatment payment — do NOT bill admin separately. Mircera is NOT a chemotherapy drug; do NOT use 96401 or 96413.

Is Mircera bundled into the ESRD PPS?

Yes. Effective January 1, 2011, all ESAs (including J0888 Mircera) administered to Medicare beneficiaries with ESRD on in-center hemodialysis or home dialysis are bundled into the ESRD Prospective Payment System (PPS) per-treatment composite rate. J0888 still appears on the ESRD claim (Type of Bill 072x) for reporting purposes but is not separately reimbursed beyond the PPS base rate. For NDD-CKD patients (not yet on dialysis), J0888 is separately payable under Part B fee-for-service.

What is the Medicare reimbursement for J0888?

For Q2 2026, the Medicare Part B payment limit for J0888 is approximately $1.033 per mcg (ASP + 6%). A standard 200 mcg q4wk maintenance dose reimburses at approximately $206.60 per dose; a 360 mcg q4wk maintenance dose reimburses at approximately $371.88 per dose. Annual cost (200 mcg q4wk × 13 doses) is approximately $2,686. Mircera ASP per mcg is lower than Aranesp ($3.072/mcg) but per-dose cost is comparable because Mircera doses are larger; the q4wk dosing interval (vs Aranesp q1–4wk and Epogen 3×/wk for HD) is the operational advantage.

Does Mircera have a boxed warning?

Yes. Mircera carries the class-wide ESA boxed warning for: (1) Increased risk of death, serious cardiovascular events, thromboembolism, and stroke when ESAs are dosed to target Hgb >11 g/dL; (2) Risk of serious cardiovascular events and shortened survival when targeting Hgb >11 g/dL in CKD patients. Note: unlike Aranesp and Epogen/Procrit, Mircera's label does NOT include the cancer-specific tumor-progression warning because Mircera is not approved for chemotherapy-induced anemia. ESA APPRISE REMS is not required for Mircera.

Is REMS required for Mircera?

No. Mircera is NOT subject to the ESA APPRISE Oncology Program REMS because Mircera is not approved for chemotherapy-induced anemia. ESA APPRISE applies only to Aranesp (darbepoetin alfa) and Procrit/Epogen (epoetin alfa) when used in cancer patients. Mircera prescribers and facilities do not enroll in ESA APPRISE for the CKD indication.

What target hemoglobin does Medicare expect for Mircera?

Medicare and most commercial payers enforce the FDA-labeled target Hgb range of 10–11 g/dL for the CKD anemia indication. Initiate Mircera when Hgb <10 g/dL, hold or reduce when Hgb >11 g/dL, and discontinue when Hgb is no longer responsive. UnitedHealthcare and Aetna will deny J0888 claims when documented Hgb >11 g/dL within the billing month. Iron-replete confirmation (TSAT >20%, ferritin >100 ng/mL) is also required before initiation.

Source documents

1. DailyMed — MIRCERA (methoxy polyethylene glycol-epoetin beta) Prescribing Information
   FDA-approved label (BLA 125164); 2018 pediatric expansion (≥5 yr on HD)
2. FDA Mircera label PDF (current revision)
   Class-wide ESA boxed warning + CKD-only indication
3. Vifor Pharma / CSL Vifor — Mircera HCP support
   Patient access program · 1-855-737-2200
4. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026
5. CMS — ESRD Prospective Payment System
   Bundling rules effective 1/1/2011; CY2026 PPS Final Rule
6. KDIGO Clinical Practice Guideline for Anemia in CKD (2012, updated)
   Target Hgb 10–11 g/dL; iron-replete prerequisites
7. UnitedHealthcare — ESA Medical Drug Policy
8. Aetna CPB 0195 — Erythropoiesis-Stimulating Agents
9. SEER CanMED — HCPCS J0888 reference
10. FDA National Drug Code Directory

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

Reviewer

Change log

• May 2, 2026 — Initial publication. ASP data: Q2 2026. Manufacturer source: Vifor / CSL Vifor 2025 (Mircera PI + Vifor patient access). FDA boxed warning class-wide 2007 (2011 strengthened). FDA pediatric expansion 2018. ESRD PPS bundling effective 1/1/2011. CKD-only indication; no ESA APPRISE REMS.

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. The CKD-only labeling, ESA conversion protocols, ESRD PPS bundling rules, target Hgb 10–11 g/dL, and ESA APPRISE REMS scope (Mircera explicitly excluded) are all verified against primary CMS, FDA, and manufacturer sources. We do not paraphrase from billing-software vendor blogs.

See also

• Aranesp (J0881 / J0882) — long-acting darbepoetin alfa, CKD + cancer
• Epogen / Procrit (J0885) — short-acting epoetin alfa, CKD + cancer + HIV + surgery
• Retacrit (Q5105 / Q5106) — epoetin alfa-epbx biosimilar
• Reblozyl (J0896) — non-ESA anemia therapy for MDS / beta-thalassemia