Evenity (romosozumab-aqqg) — HCPCS J3111

About Evenity & the romosozumab molecule FDA label verified May 2026

Romosozumab-aqqg is a humanized monoclonal antibody that binds and inhibits sclerostin — a protein produced by osteocytes that normally restrains bone formation.

Evenity (Amgen, co-marketed in the US with UCB) is a sclerostin-inhibitor monoclonal antibody with a dual effect on bone metabolism: it stimulates new bone formation by osteoblasts (the anabolic effect) and simultaneously reduces bone resorption by osteoclasts. This dual mechanism distinguishes Evenity from purely anti-resorptive osteoporosis agents (denosumab, bisphosphonates) and from purely anabolic agents (PTH analogs such as teriparatide / abaloparatide). The FDA approved Evenity on April 9, 2019 for postmenopausal women with osteoporosis at high fracture risk.

The standard regimen is 210 mg subcutaneously once monthly for 12 doses, administered as two 105 mg / 1.17 mL prefilled syringes at two separate sites at each monthly encounter. Maximum bone-formation benefit is achieved at 12 months; the FDA label limits treatment to a single 12-month course. Evenity must be followed by an anti-resorptive agent (denosumab or a bisphosphonate) to preserve the anabolic gains — without transition, bone-density gains are lost over the subsequent 12 months.

Evenity vs. Prolia and other osteoporosis injectables FDA labels + AACE 2025 verified

Evenity occupies a distinct niche — the only sclerostin inhibitor, time-limited to 12 months, with a CV boxed warning that limits eligibility. Side-by-side comparison vs. the most-likely sequencing partners.

Dosing & the 12-month course FDA Evenity label + AACE 2025

210 mg SC monthly × 12 doses, administered as two 105 mg prefilled syringes at two separate sites at each encounter. After 12 doses, transition to anti-resorptive.

Standard regimen

• Dose: 210 mg SC once monthly
• Administration: TWO 105 mg / 1.17 mL prefilled syringes at two separate sites at the same encounter
• Injection sites: abdomen, thigh, or upper arm — rotate sites
• Duration: 12 monthly doses (12-month course); maximum BMD benefit at 12 months
• Co-therapy (FDA label): calcium and vitamin D supplementation during therapy
• Follow-on: transition to anti-resorptive (denosumab 60 mg SC q6mo, or oral / IV bisphosphonate) within ~1 month of final Evenity dose — required to preserve gains

12-month course math

Pre-treatment workup checklist

Document each item before submitting the prior authorization. The boxed-warning CV history is the #1 denial pathway.

• Cardiovascular history — document NO MI or stroke within the preceding 12 months (contraindication); record any prior MI / stroke / TIA / coronary disease / heart failure
• CV risk-factor assessment — HTN, hyperlipidemia, diabetes, smoking, family history; document risk-benefit discussion in chart
• DXA scan with T-score documentation — T-score ≤ -2.5 typical; document history of osteoporotic fracture or multiple risk factors
• Postmenopausal status — explicit chart documentation; Evenity is NOT approved for premenopausal women or men
• Serum calcium — correct hypocalcemia before initiation
• Renal function (CrCl) — severe renal impairment / ESRD: monitor calcium more closely (hypocalcemia risk)
• Dental evaluation — complete planned invasive dental procedures before initiation when feasible (MRONJ class effect of anti-resorptive component)
• Step-therapy documentation — trial of (or contraindication to) oral bisphosphonate; many plans additionally require prior denosumab trial

NDC reference — 2-syringe monthly carton FDA NDC Directory + Amgen verified May 2026

Each monthly Evenity dose ships as a carton of TWO 105 mg / 1.17 mL single-use prefilled syringes. Pad to 11 digits with leading zero in the labeler segment for CMS-1500 Box 24A. Verify the NDC on the carton at billing time.

Amgen is the labeler (labeler code 55513). In the US, Evenity is co-marketed with UCB; manufacturer billing reference documents are issued through Amgen Assist 360 and the Evenity HCP portal.

Administration codes — CPT 96372 (× 1 default; × 2 commercial-only) CPT verified May 2026

Evenity is a non-chemotherapeutic subcutaneous injection given as TWO separate injections at two sites at the same encounter. Per Amgen's EVENITY Coding & Billing Guide, bill CPT 96372 × 1 by default — "applicable codes cover both injections." Bill × 2 (with modifier 59 or XS) only where the commercial payer's written policy explicitly recognizes separate-site administration of a multi-syringe dose. CMS NCCI commonly bundles the second line for Medicare and most MAPs.

Why 96372 × 1 by default — payer-policy split on the second line

The Evenity FDA label requires that each monthly 210 mg dose be delivered as two 105 mg prefilled syringes injected at two separate sites at the same encounter. Although each injection meets the CPT 96372 definition independently, Amgen's own EVENITY Coding & Billing Guide instructs that "applicable codes cover both injections" — i.e., bill 96372 × 1 per monthly dose. CMS NCCI editing commonly bundles a second same-day 96372 for the same drug even with modifier 59 or XS, so Medicare, most Medicare Advantage plans, and most commercial payers without a separate-site policy accept only one administration unit.

Some commercial payers do recognize 96372 × 2 with modifier 59 or XS when separate-site administration of a multi-syringe dose is documented. Default to 96372 × 1 for Medicare and any payer without a written policy supporting the second unit; bill × 2 only where the payer's policy explicitly supports it. Document both injection sites (e.g., "left abdomen, right thigh") and times in the chart regardless of how the admin line is billed.

Modifiers — JZ standard (59/XS only if billing × 2 commercial) CMS verified May 2026

Prefilled-syringe products at matched dose almost never trigger waste. JZ is the dominant modifier on the drug line. Modifier 59 (or XS) applies only on a second 96372 line — relevant only when a commercial payer's policy explicitly supports separate-site billing of a multi-syringe dose. The Medicare default (× 1) does not need 59/XS.

JZ — required on the drug line when no drug discarded

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For Evenity, JZ applies on every standard 210 mg dose — both 105 mg prefilled syringes are administered in full with no waste. Append JZ to the J3111 drug line.

JW — only if drug discarded

JW is rare for Evenity because each prefilled syringe delivers a matched 105 mg dose. JW would apply only if a syringe was broken, contaminated, or unable to be administered — in which case bill the discarded units on a separate line with JW and document the circumstance. CMS requires the wastage be documented in the medical record.

Modifier 59 (or XS) — only when billing 96372 × 2 (commercial-policy-specific)

For the default Medicare workflow (96372 × 1), modifier 59/XS is not used. If you have a commercial payer's written policy that explicitly supports separate-site billing of a multi-syringe SC dose, append 59 (or the more specific X{EPSU} modifier XS — separate site) on the second 96372 line. CMS NCCI commonly bundles the second line for Medicare even with 59/XS — do not appeal those denials. Document the two distinct injection sites in the chart regardless of how the admin lines are billed.

Modifier 25 — same-day E/M

Append modifier 25 to the same-day E/M code if a significant, separately identifiable evaluation occurred (CV reassessment, BP review, fracture-risk reassessment, treatment-decision encounter). Routine pre-injection check-in is bundled into the 96372 administration codes.

ICD-10-CM diagnosis matrix FY2026 verified May 2026

Evenity coverage requires postmenopausal osteoporosis at high fracture risk. Use the most specific code supported by chart documentation. Pair primary osteoporosis code with fracture-history code (Z87.310) when applicable.

Site of care & place of service Verified May 2026

SC injection from prefilled syringes fits any office setting cleanly. POS 11 (endocrinology, rheumatology, OB-GYN, or primary-care office) is the dominant Evenity site of care. Home self-administration is uncommon and discouraged because the two-site SC injection technique requires trained delivery.

Claim form field mapping Amgen Assist 360 + payer billing PDFs

CMS-1500 / 837P (physician office, POS 11) example for a 210 mg Evenity dose.

Source: Amgen Assist 360 Evenity Reimbursement Guide; Evenity HCP billing reference.

Payer policies & prior authorization Reviewed May 2026

Medicare Part B covers Evenity under MAC-specific osteoporosis articles when criteria are met. Commercial payers uniformly require prior authorization with CV-history attestation, step therapy from bisphosphonates, and explicit "high fracture risk" documentation.

CMS Medicare Part B coverage

Evenity is a buy-and-bill medical-benefit drug covered under Medicare Part B. MAC coverage articles addressing osteoporosis injectables (the same articles that cover denosumab J0897 under LCD L33394 and parallel jurisdictional articles) typically cover Evenity for FDA-approved on-label indications when criteria are met:

• Documented postmenopausal status with osteoporosis (DXA T-score ≤ -2.5) AND high fracture risk (history of osteoporotic fracture, multiple risk factors, or failure / intolerance of other osteoporosis therapies)
• No MI or stroke within preceding 12 months (boxed-warning contraindication)
• Confirmation of adequate calcium and vitamin D status (correction of deficiency before initiation)
• Renal function assessment (CrCl) for hypocalcemia risk stratification
• Step therapy: trial of (or contraindication to) oral bisphosphonates typically required
• Specialist consultation (endocrinology or rheumatology) commonly required
• 12-month treatment course limit per FDA label

Reference: CMS Medicare Coverage Database — search by MAC jurisdiction for osteoporosis injectables. Many MACs apply the L33394 framework to romosozumab; verify the specific local coverage article applied by your MAC.

Commercial payer snapshot — 2026

What to document for PA approval

• CV history attestation — no MI / stroke / TIA within preceding 12 months; baseline CV risk-factor profile
• Postmenopausal status — explicit chart documentation (Z78.0 supporting code)
• DXA T-score — report attached or summarized; T-score ≤ -2.5 typical
• High fracture risk — history of osteoporotic fracture (Z87.310 supporting code), multiple risk factors, or step-therapy failure
• Bisphosphonate trial — drug name, dose, dates, duration, outcome (intolerance / inadequate response / contraindication)
• Prior denosumab trial — when required by plan, with outcome documentation
• Calcium + vitamin D — baseline labs and supplementation plan
• Renal function — CrCl documentation
• Specialty consult — endocrinology or rheumatology evaluation when required
• Transition plan — anti-resorptive maintenance regimen documented for post-month-12 transition

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. J3111 refreshes each quarter; see the live snapshot below.

Per-dose and per-course math

Coverage

Medicare Part B covers Evenity (J3111) for FDA-approved on-label indications when criteria are met. This is a buy-and-bill medical-benefit drug — NOT Part D. MACs apply osteoporosis-injectable coverage articles (frequently the same framework as LCD L33394 for denosumab) with Evenity-specific add-ons: CV-history attestation, step-therapy from bisphosphonates, and the FDA-label 12-month course limit.

Canonical code source: CMS HCPCS quarterly update file. ASP source: CMS Medicare Part B Drug ASP Pricing File.

Patient assistance — Amgen Assist 360 / Bridge to Commercial Coverage Amgen verified May 2026

• Amgen Assist 360 — comprehensive patient-support program for Evenity. Benefits investigation, prior-authorization support, appeals support, copay assistance for eligible commercially insured patients, and patient assistance program (free drug) for qualifying uninsured / underinsured patients. Phone: 1-866-AMG-ASST (1-866-264-2778). Web: amgenassist360.com.
• Evenity Copay Card — eligible commercially insured patients may pay as little as $0 per dose (subject to annual program maximum and eligibility terms). Not valid for Medicare, Medicaid, or other government-funded programs. Enroll via Amgen Assist 360.
• Bridge to Commercial Coverage Program — Amgen's PA-pending bridge program providing temporary free drug for eligible commercially insured patients while prior authorization is in process, helping prevent therapy delays.
• Amgen Safety Net Foundation — independent 501(c)(3) PAP providing free Evenity to qualifying uninsured or underinsured patients meeting income criteria. Enroll via Amgen Assist 360.
• Independent foundations — PAN Foundation, HealthWell Foundation, Patient Advocate Foundation maintain osteoporosis-treatment funds intermittently for Medicare patients. Verify open funds quarterly.

Boxed Warning — cardiovascular risk FDA label verified May 2026

The most clinically and operationally important section of this page. CV-history attestation drives the dominant PA denial pathway.

What the ARCH trial showed

In the ARCH trial (postmenopausal osteoporosis, romosozumab vs. alendronate over 12 months followed by alendronate in both arms), patients receiving romosozumab had a numerically higher rate of major adverse cardiac events (MACE) — including myocardial infarction, stroke, and cardiovascular death — compared with patients on alendronate. The signal was not present in the FRAME trial (romosozumab vs. placebo) but was substantial enough in ARCH to prompt the FDA boxed warning at the April 2019 approval.

Practical rules for prescribers and billing teams

• Do not initiate Evenity in a patient with MI, stroke, or TIA within the preceding 12 months
• Document explicit CV-history attestation in the chart and on the prior authorization — "patient has no history of MI or stroke within the past 12 months"
• Risk-benefit discussion documentation — for patients with other CV risk factors (HTN, hyperlipidemia, diabetes, smoking, family history), document the discussion with patient and the decision rationale
• Discontinue Evenity immediately if a patient experiences MI or stroke during therapy
• Coordinate with cardiology for high-risk patients; some plans require a cardiology consult for any patient with prior CV disease

Other clinical danger zones

Hypocalcemia. Evenity can cause hypocalcemia, particularly in patients with severe renal impairment or on dialysis. Correct pre-existing hypocalcemia before initiation. Monitor calcium baseline and as clinically indicated. Patients with low calcium intake should supplement (the FDA label requires adequate calcium and vitamin D during therapy).

Medication-related osteonecrosis of the jaw (MRONJ). Reported as a class effect of bone-active agents. Complete planned invasive dental procedures (extractions, implants) BEFORE initiation when feasible. MRONJ risk with Evenity is lower than with bisphosphonates or denosumab but is not zero.

Atypical femoral fractures (AFF). Reported with anti-resorptive agents; the anti-resorptive component of Evenity carries similar theoretical risk. Bilateral hip / thigh / groin pain is the prodromal symptom — imaging of both femurs is appropriate if AFF is suspected.

Hypersensitivity reactions. Angioedema and other hypersensitivity reactions reported. Discontinue if a clinically significant hypersensitivity reaction occurs.

Common denials & how to fix them

Frequently asked questions

How is Evenity dosed and billed?

Evenity (romosozumab-aqqg) is dosed at 210 mg subcutaneously once monthly for 12 doses. Each monthly 210 mg dose is administered as two 105 mg / 1.17 mL prefilled syringes injected at two separate sites (abdomen, thigh, or upper arm). Bill 210 units of J3111 (1 unit = 1 mg) on the drug line. For administration, default to CPT 96372 × 1 per Amgen's EVENITY Coding & Billing Guide, which states "applicable codes cover both injections." Bill 96372 × 2 (with modifier 59 or XS) only where a commercial payer's written policy explicitly supports separate-site billing of a multi-syringe SC dose — CMS NCCI commonly bundles a second same-day 96372 for Medicare and most Medicare Advantage plans. Append JZ to the drug line because each prefilled syringe is delivered in full with no waste at standard dosing. After 12 monthly doses, the maximum bone-formation benefit is achieved; continue an anti-resorptive (denosumab, bisphosphonate) to preserve gains.

What is the difference between Evenity and Prolia?

Evenity (romosozumab-aqqg) is a sclerostin-inhibitor monoclonal antibody with a dual mechanism — it both stimulates bone formation and reduces bone resorption — given for only 12 monthly doses (210 mg SC monthly). Prolia (denosumab) is a RANKL inhibitor that is purely anti-resorptive, given as 60 mg SC every 6 months indefinitely. Evenity has a boxed warning for cardiovascular events (MI, stroke, CV death) and is contraindicated within 1 year of MI or stroke; Prolia does not carry a boxed warning. Evenity is typically used for postmenopausal women at very high fracture risk who have failed or are intolerant of other osteoporosis therapies; Prolia is broadly used across osteoporosis indications. The two are frequently sequenced: 12 months of Evenity followed by Prolia or a bisphosphonate to preserve the anabolic gains.

Why does Evenity have a boxed warning for cardiovascular events?

In the ARCH trial (Evenity vs. alendronate, postmenopausal osteoporosis), patients receiving romosozumab had a higher rate of serious cardiovascular events (myocardial infarction, stroke, and cardiovascular death) compared with alendronate. The FDA added a boxed warning that Evenity is contraindicated in patients who have had a myocardial infarction or stroke within the preceding 12 months, and that providers should weigh CV risk before initiating in patients with other CV risk factors. Document recent CV history, blood pressure, and risk-factor assessment at baseline; if a patient experiences MI or stroke during therapy, discontinue Evenity. This boxed-warning contraindication is the most frequent prior-authorization denial reason at commercial payers. See the boxed-warning section.

Is step therapy required before Evenity?

Yes — most Medicare LCDs and nearly all commercial payer policies (UnitedHealthcare, Aetna, Cigna, BCBS) require documented step therapy through an oral bisphosphonate (alendronate or risedronate) before approving Evenity, OR documented failure / intolerance / contraindication to bisphosphonates. Some plans additionally require failure of denosumab (Prolia) for the postmenopausal-high-fracture-risk population. The clinical rationale: Evenity is reserved for patients at very high fracture risk where the anabolic mechanism (bone formation + resorption inhibition) offers benefit beyond anti-resorptive monotherapy. Submit complete step-therapy documentation with the prior authorization to avoid denial: drug name, dose, dates, duration, outcome.

Why does Evenity require two injections at the same encounter?

Each monthly 210 mg dose of Evenity is supplied as two 105 mg / 1.17 mL prefilled syringes (each syringe contains 105 mg). The FDA label requires both syringes to be administered together as a single dose, injected sequentially at two separate sites (abdomen, thigh, or upper arm). Administration coding is payer-dependent: Amgen's EVENITY Coding & Billing Guide states "applicable codes cover both injections" — i.e., bill 96372 × 1. CMS NCCI editing commonly bundles a second same-day 96372 for the same drug even with modifier 59/XS, so Medicare and most MAPs accept only one administration unit. Some commercial payers accept 96372 × 2 with modifier 59 or XS when separate-site administration is documented. Default to × 1 unless your payer's written policy explicitly supports the second unit. Document both injection sites and times in the chart regardless of how the admin line is billed.

What happens after the 12-month Evenity course?

The maximum bone-formation benefit of Evenity is achieved at 12 months; the FDA label limits the course to 12 monthly doses. Beyond 12 months, the anabolic effect plateaus and additional dosing does not provide further benefit. The FDA label and AACE / Endocrine Society / ACR guidelines require transition to an anti-resorptive agent (denosumab 60 mg SC every 6 months, or oral / IV bisphosphonate) after the 12-month Evenity course to preserve the bone-density gains. Without a transition, the anabolic gains are lost over the following 12 months. Document the transition plan and start the anti-resorptive within ~1 month of the final Evenity dose.

Is Evenity approved for men or pediatric patients?

Evenity is FDA-approved only for postmenopausal women with osteoporosis at high fracture risk — defined as a history of osteoporotic fracture, multiple risk factors for fracture, or failure or intolerance of other osteoporosis therapies. Evenity is NOT FDA-approved for men with osteoporosis (use Prolia, bisphosphonates, or PTH analogs such as Forteo / Tymlos), is NOT approved for glucocorticoid-induced osteoporosis, and is NOT approved for pediatric patients. Off-label use in men or other populations will be denied by most payers. Coverage requires documented postmenopausal status.

Can a patient repeat an Evenity course?

The Evenity FDA label does not establish efficacy or safety beyond 12 doses; re-treatment after a 12-month course is not FDA-approved and is not supported by clinical-trial evidence. AACE / Endocrine Society guidelines do not recommend Evenity re-treatment. If a patient remains at very high fracture risk after the 12-month course and the maintenance anti-resorptive, the typical sequencing options are anti-resorptive optimization or a PTH analog (Forteo, Tymlos) — not Evenity re-treatment. Payers will deny re-treatment requests citing the FDA-label 12-month course limit.

What is the Q2 2026 Medicare reimbursement for Evenity?

Q2 2026 ASP + 6% for J3111 (romosozumab-aqqg) is approximately $12.187 per 1 mg unit. A standard 210 mg monthly dose = 210 units × $12.187 ≈ $2,559.27 before sequestration. Total 12-month course (12 doses × $2,559.27) ≈ $30,711 in drug cost before sequestration. ASP refreshes quarterly — see the live snapshot above.

Source documents

1. AAPC — HCPCS J3111 (romosozumab-aqqg)
   Code descriptor and crosswalk reference (1 unit = 1 mg)
2. FDA Evenity (romosozumab-aqqg) label — BLA 761062
   Reference prescribing information: indication, dosing (210 mg SC monthly × 12), boxed warning (MI / stroke / CV death), warnings & precautions
3. FDA Approval Announcement (April 9, 2019)
   Original FDA approval of Evenity for postmenopausal osteoporosis at high fracture risk; boxed-warning rationale (ARCH trial)
4. FRAME trial — Romosozumab vs. placebo (Cosman et al., NEJM 2016)
   Pivotal Phase 3 trial — vertebral and non-vertebral fracture reduction; no CV signal vs. placebo
5. ARCH trial — Romosozumab vs. alendronate (Saag et al., NEJM 2017)
   Phase 3 active-comparator trial — basis for the FDA boxed warning for cardiovascular events (MI / stroke / CV death)
6. BRIDGE trial — Romosozumab in men (Lewiecki et al., JCEM 2018)
   Phase 3 trial in men with osteoporosis — not FDA-approved indication; BMD efficacy demonstrated
7. AACE / ACE Postmenopausal Osteoporosis Clinical Practice Guidelines (2020, updated)
   Sequencing recommendations — Evenity (anabolic) followed by anti-resorptive (denosumab or bisphosphonate)
8. Bone Health & Osteoporosis Foundation (formerly NOF) Clinician's Guide
   Pharmacologic management of postmenopausal osteoporosis — positioning of Evenity for high-fracture-risk patients
9. ASBMR Osteoporosis Treatment Resources
   Society guidance on osteoporosis pharmacotherapy and post-Evenity sequencing
10. Evenity HCP / Amgen Assist 360
    Manufacturer dosing, billing, and reimbursement guides; Amgen Assist 360 patient-support enrollment
11. Amgen Assist 360 — patient support program (1-866-264-2778)
    Benefits investigation, prior-authorization support, copay assistance, Bridge to Commercial Coverage program
12. CMS Medicare Coverage Database
    Osteoporosis-injectable coverage articles (MACs frequently apply L33394 framework to romosozumab)
13. UnitedHealthcare — Romosozumab (Evenity) commercial medical drug policy
    2026 PA criteria: CV-history attestation, step therapy, high-fracture-risk eligibility
14. Aetna Clinical Policy Bulletin — Osteoporosis
    Coverage criteria for Evenity and other osteoporosis injectables
15. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly ASP file (J3111)
16. CMS — HCPCS quarterly update file
    Canonical HCPCS code source for J3111
17. CMS — JW / JZ modifier guidance
    Single-dose-container waste reporting (effective 7/1/2023)

Refresh cadence

Reviewer

Change log

• May 22, 2026 — SME audit + admin-coding restructure: verified BLA 761062 with latest label revision Jan 8, 2026 (DailyMed); confirmed Boxed Warning wording (MI / stroke / CV death; contraindicated within 1 year of MI or stroke). Restructured administration coding throughout the page from "96372 × 2" headline framing to "× 1 default per Amgen's EVENITY Coding & Billing Guide; × 2 only where commercial-payer policy explicitly supports separate-site billing of a multi-syringe SC dose." CMS NCCI commonly bundles a second same-day 96372 even with modifier 59/XS for Medicare and most MAPs. Updated meta description, OG / Twitter cards, hero summary, factcard admin cell, variant callout, TOC entries, fact-row, phase marker, admin-codes section (H2, sub, table, narrative, two worked examples for Medicare-default and commercial-second-line), modifiers section (H2, sub, modifier 59 H3), FAQ Q1 and Q5 (with matching JSON-LD), claim-form table, and refresh cadence row. Denials-table row already corrected in the prior audit pass. ASP data: Q2 2026 (J3111 = $12.187/mg). 12-month course limit and required anti-resorptive transition emphasized. Cross-linked to Prolia (J0897) as the canonical post-Evenity maintenance agent.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File for J3111. Payer policies are read directly from each payer’s published medical policy documents. We do not paraphrase from billing-software vendor blogs. Where manufacturer guidance and payer policy diverge (e.g., site-of-care steering, step-therapy specifics), we surface the conflict rather than picking a side.

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