Reimbursement, Coverage, and Pricing

ZYNRELEF reimbursement

Medicare

In light of the opioid crisis, Heron has engaged regulators and legislators to encourage changing payment incentives that lead to overprescribing of opioids. For Medicare patients, ZYNRELEF is reimbursed separately in both the hospital outpatient and ASC settings of care, billed using C9399 until a product-specific C-code or J-code is assigned. ZYNRELEF has more favorable Medicare reimbursement than other non-opioid postoperative pain drugs.

For additional Medicare reimbursement details, see the table below.

Table: pricing and reimbursement by setting of care, at launch, 3-year pass-through.

aHeron expects to receive transitional pass-through status for ZYNRELEF. Pass-through status is for 3 years once granted.

bZYNRELEF will be reimbursed at WAC + 3% until ASP is established.

cReimbursement comparisons do not imply safety or efficacy.

HOPD: hospital outpatient department.

AWP: average wholesale price.

ASP: average selling price.

ASC: ambulatory surgical center.

WAC: wholesale acquisition cost.

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ZYNRELEF: Separate reimbursement in HOPDs and ASCsa

Pumps, generic local anesthetics like bupivacaine HCl, and other non-opioid postoperative pain products are packaged across all settings of care (except for liposomal bupivacaine in ASCs)c

Commercial

Commercial reimbursement for ZYNRELEF varies by payer and site of care.

  • Heron is applying for a J-code to facilitate separate reimbursement
  • Like all new products, until CMS assigns a permanent code, commercial payers will require a miscellaneous code (J3490 or C9399) for ZYNRELEF
  • Heron is working with commercial payers to enable separate reimbursement of innovative non-opioids
  • Heron helps customers navigate coding and reimbursement for ZYNRELEF
  • Heron offers extended dating through selected distributors

ZYNRELEF pricing

ZYNRELEF pricing supports broad access for patients and healthcare providers. Heron offers 340B pricing to eligible institutions, which allows purchases at a minimum discount of 23.1%. ZYNRELEF is available through full-line wholesalers and specialty distributors; prime vendor discounts apply. GPO and sub-WAC pricing are also available.

ZYNRELEF is available in 2 volumes for convenience, minimum waste, and reduced average cost across the surgical mix.

ZYNRELEF pricing table: 14-mL WAC = $267.50; 14-mL 340B = $203.57; 7-mL WAC = $135.50; 7-mL 340B = $103.12.

ZYNRELEF pricing as of May 12, 2021. Confirm current pricing with your Heron representative.

Download ZYNRELEF Ordering and Pricing Information for more details.

See Dosing and Administration to see which vial size is appropriate for each indicated procedure.

Heron Connect services

Heron Connect offers customized support for ZYNRELEF billing and coding questions.

Reimbursement Counselors are available at 1-844-HERON11 (1-844-437-6611) from 8 AM to 8 PM ET, Monday through Friday.

Visit Heron Connect

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Resources for you

ZYNRELEF Reimbursement and Billing Guide

ZYNRELEF Reimbursement and Billing Guide

ZYNRELEF Coding Reference Guide

ZYNRELEF Coding Reference Guide

ZYNRELEF Ordering and Pricing Information

ZYNRELEF Ordering and Pricing Information

Find Additional Resources  

Contact your Heron representative

From answering questions about ZYNRELEF to providing updates on the reimbursement landscape, Heron representatives are here to help.

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Important Safety Information and Indication

Indication

ZYNRELEF is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.

Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Important Safety Information

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Contraindications

ZYNRELEF is contraindicated in patients with known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to any amide local anesthetic, NSAIDs, or other components of ZYNRELEF; with history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (severe, sometimes fatal, anaphylactic reactions to NSAIDS have been reported in such patients); undergoing obstetrical paracervical block anesthesia; or undergoing coronary artery bypass graft (CABG) surgery.

Warnings and Precautions

Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after application of ZYNRELEF. When using ZYNRELEF with other local anesthetics, overall local anesthetic exposure must be considered through 72 hours.

Hepatotoxicity: If abnormal liver tests persist or worsen, perform a clinical evaluation of the patient.

Hypertension: Patients taking some antihypertensive medication may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

Heart Failure and Edema: Avoid use of ZYNRELEF in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ZYNRELEF in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal failure.

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

Methemoglobinemia: Cases have been reported with local anesthetic use.

Serious Skin Reactions: NSAIDs, including meloxicam, can cause serious skin adverse reactions. If symptoms present, evaluate clinically.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): If symptoms are present, evaluate clinically.

Fetal Toxicity: Due to the risk of oligohydramnios/fetal renal dysfunction and premature closure of the ductus arteriosus with NSAIDS, limit use of ZYNRELEF between about 20 to 30 weeks gestation, and avoid use after about 30 weeks.

Hematologic Toxicity: Monitor hemoglobin and hematocrit in patients with any signs or symptoms of anemia.

Drug Interactions

Drugs That Interfere with Hemostasis: Monitor patients for bleeding who are using ZYNRELEF with drugs that interfere with hemostasis (eg, warfarin, aspirin, SSRIs/SNRIs). 

ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Beta-Blockers: Use with ZYNRELEF may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

ACE Inhibitors and ARBs: Use with ZYNRELEF in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.

Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effect.

Use in Specific Populations

Infertility: NSAIDs are associated with reversible infertility. Consider avoidance of ZYNRELEF in women who have difficulties conceiving.

Severe Hepatic Impairment: Only use if benefits are expected to outweigh risks; monitor for signs of worsening liver function.

Severe Renal Impairment: Not recommended.

Adverse Reactions

Most common adverse reactions (incidence ≥10%) in controlled clinical trials with ZYNRELEF are constipation, vomiting, and headache.

Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication

ZYNRELEF is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.

Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Please see full Prescribing Information, including Boxed Warning.