ZYNRELEF - Sample Letter of Medical Appeal - ZYNRELEF® (bupivacaine and meloxicam) extended-release solution

Sep 16, 2026

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Sample letter template requesting reconsideration of payment for a denied insurance claim related to ZYNRELEF® (bupivacaine and meloxicam) extended-release solution. The appeal explains that reimbursement was denied under a rationale stated in the EOB, and asks for review while referencing Medicare’s Non-Opioid Policy for Pain Relief, including separate-payment requirements for qualifying non-opioid treatments in HOPD and ASC settings.

LanguageEnglish

CategoryLetters

FormatPDF

Pages2

Reading Time1 min

AccessFree to download

Reconsideration Request

Claim and Patient Details

Denial Reason and Policy Basis

Eligibility Requirements for Separate Payment

Treatment Rationale and Postoperative Pain Plan

Patient History Summary

Closing, Contact Information, and Enclosures

Sample Letter of Medical Appeal [PRACTICE LETTERHEAD] [Date] [Dr/Mr/Ms][Medical Director Name] [Name of Health Insurance Company] [Insurer Address] [City], [State] [Zip Code] Re: [Patient Name] Patient Policy Number: [ ] Group Number: [ ] Date(s) of Service: [ ] Claim Number: [ ] Dear [Dr/Mr/Ms] [Contact Name]: This letter serves as a request for reconsideration of payment for a denied claim for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, a non-opioid local anesthetic (HCPCS Code J0668) used in the [Surgical Procedure] for [Patient Name] on [Date of Procedure] . Reimbursement was denied because of [Reason for Denial From EOB] . I am writing to request a review of this denial. Medicare’s Non-Opioid Policy for Pain Relief ensures separate payment for ZYNRELEF (HCPCS Code J0668) and commercial payment mechanism should be aligned. Starting January 1, 2025, the Consolidated Appropriations Act, 2023 (§4135) (P. L. 117-328) mandates separate payment for qualifying non-opioid treatments in the HOPD and ASC settings of care. Now formally recognized as the Non-Opioid Policy for Pain Relief, this policy aims to remove financial barriers that might otherwise discourage the use of non-opioid alternatives. For full details, refer to the 2025 OPPS final rule: Search the 2025 OPPS final rule for Non-Opioid Policy for Pain Relief To qualify for separate payment under this policy, the non-opioid treatment must have: • A label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body’s opioid receptors. • Demonstrated the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal. ZYNRELEF was used because of its clinical effectiveness, its length of postoperative pain reduction, and its superior efficacy compared to standard-of-care bupivacaine HCl solution.1-4 Please refer to the enclosed Prescribing Information, including Boxed Warning, which provides the approved clinical information for ZYNRELEF. Using ZYNRELEF was an important part of [Patient Name]’s postoperative pain management plan after [Surgical Procedure], as ZYNRELEF was intended to reduce pain and minimize the need for opioids. Summary of patient’s history: [Note: Consider including the information below. Exercise your medical judgment and discretion when providing a diagnosis and characterization of the patient’s medical condition.] • [Patient’s diagnosis, condition, and history/treatment] • [Patient’s postsurgical procedure condition] We appreciate your reconsideration of this claim denial and believe it is important that this treatment is reimbursed separately. Medicare’s Non-Opioid Policy for Pain Relief ensures separate payment for ZYNRELEF (HCPCS Code J0668), and commercial payment mechanisms should be structures accordingly to align with this policy. Please contact me at [Telephone Number] if you require additional information. Sincerely, [Physician Name][NPI Number][Phone Number][Fax Number] Enclosures: [List and attach the original claim form, denial/explanation of benefits, ZYNRELEF Prescribing Information, and additional supporting documentation.] Please see full Prescribing Information, including Boxed Warning and updated Warningsand Precautions for serious skin reactions caused by nonsteroidal anti-inflammatory drugs (NSAIDs) . References: 1. ZYNRELEF [package insert] . San Diego, CA: Heron Therapeutics Inc; 2024. 2. Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee G-C. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: Phase III results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019;44(7):700-706. doi:10 . 1136/rapm-2019-100531. 3. Viscusi E, Minkowitz H, Winkle P, Ramamoorthy S, Hu J, Singla N.

FAQs

What claim outcome does this letter request?

It requests reconsideration and review of a denied insurance claim so the ZYNRELEF® treatment is reimbursed separately under the applicable non-opioid policy.

Why is separate payment for ZYNRELEF referenced in the appeal?

The letter states that Medicare’s Non-Opioid Policy for Pain Relief is intended to support separate payment for qualifying non-opioid treatments, aligning reimbursement mechanisms accordingly.

What requirements must the non-opioid treatment meet to qualify for separate payment?

The letter specifies that the treatment must have an FDA-approved label indication for reducing postoperative pain or producing postsurgical/regional analgesia without acting on opioid receptors, and evidence showing it can replace, reduce, or avoid opioid use in clinical trials or peer-reviewed data.

Sep 16, 2026

Upload by Tawan