Medicare does cover Oxervate (cenegermin-bkbj), the prescription eye drop for neurotrophic keratitis. Coverage sits under Medicare Part D, every plan requires prior authorization before the first fill, and the 2025 out-of-pocket cap now limits what a beneficiary pays in a calendar year to $2,000, with a $2,100 cap scheduled for 2026.1GoodRx. Oxervate Medicare Coverage
Why Oxervate Falls Under Part D, Not Part B
Oxervate is a self-administered ophthalmic solution that patients instill at home, which places it in the Part D prescription drug benefit rather than the Part B medical benefit that covers drugs given in a physician’s office. A retrospective study of Medicare Part D claims from 2019 to 2020 confirmed active utilization under the Part D benefit, identifying 2,410 beneficiaries who filled cenegermin during that period.2American Journal of Ophthalmology. Medicare Part D Cenegermin Utilization Study
There is no national coverage determination from the Centers for Medicare and Medicaid Services specifically addressing Oxervate. Coverage decisions happen at the plan level, so each stand-alone Part D plan and each Medicare Advantage plan with drug coverage sets its own formulary placement, prior authorization criteria, and cost sharing. Oxervate is typically placed on the specialty tier.3Medical News Today. Drugs Oxervate
What Your Plan Will Require Before Approving It
Every major insurer requires prior authorization. The specific criteria vary, but a few requirements show up across most plans.
- A documented diagnosis of neurotrophic keratitis, usually at stage 2 or stage 3 on the Mackie classification scale. Stage 1 requests are approved by some plans but are more frequently denied.4Eyes on Eyecare. Prescription Drug Coverage and Prior Authorizations
- A prescription written by, or in consultation with, an ophthalmologist or optometrist.5UnitedHealthcare. PA Med Nec Oxervate
- Evidence of prior therapy failure. UnitedHealthcare, for example, requires documented failure of at least one over-the-counter artificial tear product. Other plans look for an epithelial defect that has persisted for at least two weeks despite conventional treatment.5UnitedHealthcare. PA Med Nec Oxervate
- A treatment duration limit. Approvals are generally issued for one 8-week course per affected eye. Cigna allows an additional 8-week course for recurrence, up to a 16-week lifetime maximum per eye.6Cigna. Oxervate Coverage Position Criteria
CMS regulations require Part D plans to decide a standard prior authorization within 72 hours. If the prescribing physician certifies that waiting could jeopardize your health, the plan must issue an expedited decision within 24 hours.
What You Will Actually Pay
Oxervate is expensive. A Canadian health technology assessment estimated the cost of a full 8-week course at roughly $118,230.7NCBI Bookshelf. CADTH Reimbursement Recommendation for Cenegermin Before the recent Part D reforms, the Medicare claims study found a median out-of-pocket cost of $5,791 per beneficiary.8PubMed. Cenegermin Utilization Among Medicare Beneficiaries
The Inflation Reduction Act of 2022 changed that math. Part D now carries an annual out-of-pocket cap of $2,000 for 2025 and $2,100 for 2026. Once you hit the cap, your plan covers 100% of your remaining prescription costs for the rest of the calendar year.1GoodRx. Oxervate Medicare Coverage For an Oxervate course, that effectively replaces the old $5,800 median burden with a hard ceiling.
The cap is annual, so one Oxervate fill early in the year can push you to the limit immediately. The Medicare Prescription Payment Plan lets beneficiaries spread their annual out-of-pocket costs into monthly installments rather than paying the full amount at the pharmacy counter on a single fill.9JAMA Health Forum. Medicare Prescription Payment Plan and Specialty Drug Costs Enrolling early in the year matters if you are starting a specialty drug.
Programs That Can Lower Your Share
Several programs can help cover what Medicare does not.
- The PAN Foundation’s Neurotrophic Keratitis Fund offers copay grants of up to $4,000 initially and up to $8,000 per year for patients with government-insured coverage, including Medicare. Eligibility requires adjusted gross household income at or below 500% of the federal poverty level. You can apply at panapply.org or by phone at 1-866-316-7263. PAN is moving to a new platform called TotalAssist, with services resuming at TotalAssist.org on July 1, 2026.10PAN Foundation. Neurotrophic Keratitis Fund
- Dompé CONNECT to Care, run by the manufacturer, assists with insurance verification, prior authorization, and financial resources. The program’s commercial-insurance copay support (which can reduce the cost to as little as $0) does not explicitly extend to Medicare patients, likely because federal anti-kickback rules restrict manufacturer copay cards for government-insured beneficiaries. Dompé representatives do discuss financial assistance options with enrolled patients and can refer to outside resources. The number is 1-877-422-4412.11Oxervate. Getting and Storing Oxervate
- Medicare Extra Help, the federal Low-Income Subsidy, substantially lowers copays on all Part D prescriptions for beneficiaries who qualify, including on specialty drugs.1GoodRx. Oxervate Medicare Coverage
If Your Plan Denies Coverage
Denials happen. Common reasons include coding errors, incomplete prior authorization documentation, or a plan determining the treatment is not medically necessary. You have 65 calendar days from the denial notice to file an appeal.12Counterforce Health. How To Get Oxervate Covered by Humana The Part D appeals process runs in stages:
- Redetermination, the first-level internal review, decided within 7 days.
- Reconsideration, an independent review, decided within 7 days for standard requests or 72 hours for expedited requests.
- Administrative Law Judge hearing, available if the claim value meets a minimum threshold.
- Medicare Appeals Council review, and ultimately federal court.
A few steps improve the odds. The prescribing ophthalmologist should write a medical necessity letter that includes the ICD-10 code (H16.23 for neurotrophic keratoconjunctivitis), the Mackie classification stage, objective corneal sensation test results, and a timeline of previously attempted treatments with specific dates, outcomes, and any documented side effects or intolerances.4Eyes on Eyecare. Prescription Drug Coverage and Prior Authorizations The appeal letter should quote the plan’s stated reason for denial and address it point by point. Dompé publishes a sample appeal letter guide with templates and suggested language.13Oxervate. Appeal Letter Guide If the plan requests a peer-to-peer review, the ophthalmologist should be ready to speak to the progressive nature of the disease and the risk of corneal perforation if left untreated. If Oxervate is non-formulary on your plan, a formulary exception request can be filed alongside the prior authorization, explaining why alternatives on the formulary are medically unsuitable.
How You Will Receive the Medication
Oxervate is not sold at retail pharmacies. It is dispensed only through specialty pharmacies, primarily Accredo Health Group and CoAssist Pharmacy.14Oxervate HCP. Patient Support After enrollment through Dompé CONNECT to Care and insurance approval, Accredo ships the medication directly to your home in four biweekly shipments over the 8-week course. Each shipment arrives in insulated packaging with frozen gel packs or dry ice. You must refrigerate the weekly cartons at 36°F to 46°F within five hours of delivery, and the vials should never be frozen. Each refrigerated carton remains usable for up to 14 days, and each vial is thawed at room temperature for up to 30 minutes before use. Contact lenses must be removed before instillation and can be reinserted 15 minutes afterward.11Oxervate. Getting and Storing Oxervate