Medicare does not cover sublingual immunotherapy, whether it takes the form of custom-compounded allergy drops placed under the tongue or one of the FDA-approved dissolving tablets sold under names like Grastek, Oralair, Ragwitek, and Odactra. Under a national coverage determination that has been in place since 1996, the Centers for Medicare and Medicaid Services will only pay for allergy antigens administered by injection. That leaves traditional allergy shots as the only immunotherapy option Original Medicare will reimburse.
The Rule That Blocks Coverage
The controlling policy is National Coverage Determination 110.9, “Antigens Prepared for Sublingual Administration,” effective November 17, 1996. Its language is short and unambiguous: “This kind of allergy therapy has not been proven to be safe and effective,” and “antigens are covered only if they are administered by injection.”1CMS.gov. NCD 110.9 – Antigens Prepared for Sublingual Administration
Local coverage determinations issued by Medicare Administrative Contractors repeat the rule. LCD L36408 states plainly that “Medicare does not cover sublingual immunotherapy,” calling it “investigational and experimental” and therefore “not medically necessary.”2CMS.gov. LCD L36408 – Allergen Immunotherapy Novitas Solutions’ LCD L36240 uses the same language and points back to NCD 110.9’s injection-only requirement.3CMS.gov. LCD L36240 – Allergen Immunotherapy
The exclusion applies to both categories of sublingual product. Custom-compounded drops are not FDA-approved and are considered off-label in the United States.4Johns Hopkins Medicine. Could Allergy Drops Be the Key to Allergy Relief The four approved tablets went through clinical trials and received formal FDA approval starting in 2014.5ENT Today. FDA Approves First Sublingual Allergy Immunotherapy Agents CMS does not distinguish between the two: any antigen given sublingually falls outside coverage.
A recent formal reconsideration request asked CMS to drop non-coverage language for oral, sublingual, and epicutaneous immunotherapy from LCD L36240. CMS denied it, again citing NCD 110.9’s injection requirement.3CMS.gov. LCD L36240 – Allergen Immunotherapy The 1996 national determination itself has not been reopened.
The FDA Age Limit Compounds the Problem
Even if CMS reversed course tomorrow, a separate barrier would remain. Every FDA-approved SLIT tablet on the U.S. market is labeled for patients aged 5 through 65, which is roughly the age at which Medicare eligibility begins.
- Grastek (Timothy grass pollen): the prescribing information notes “no clinical trial experience with GRASTEK in patients over 65 years of age.”6FDA.gov. Grastek Prescribing Information
- Oralair (five-grass pollen): approved for ages 5 through 65.7HHS Texas. SLIT Product Review
- Ragwitek (short ragweed pollen): “not approved for use in patients over 65 years of age because safety and efficacy have not been established.”8Drugs.com. Ragwitek Prescribing Information
- Odactra (house dust mite): safety and effectiveness “have not been established in individuals older than 65 years of age.”9FDA.gov. Odactra Prescribing Information
LCD L36408 flags this in its own text, noting that the tablets FDA approved in 2014 “are not approved by the FDA for anyone over the age of 65 years.”2CMS.gov. LCD L36408 – Allergen Immunotherapy Until manufacturers run trials in older adults and obtain expanded labeling, that gap sits between Medicare beneficiaries and coverage regardless of any policy shift at CMS.
Part D, Medicare Advantage, and Medigap
A common follow-up question is whether a Part D drug plan might cover the tablets as prescription pharmacy items. There is no indication in Medicare policy that Part D routinely covers SLIT tablets for beneficiaries. With FDA labeling excluding patients over 65 and CMS classifying sublingual delivery as non-covered, formulary inclusion would be unusual.
Medicare Advantage plans must cover at least what Original Medicare covers, and the same non-coverage determination binds them. One insurer’s medical policy specifically noted that oral allergy immunotherapy “may be considered not medically necessary by Medicare under National Coverage Determination 110.9.”10Providence Health Plan. Allergen Immunotherapy Medical Policy Some Medicare Advantage plans layer on supplemental benefits, so checking a specific plan’s evidence of coverage is worthwhile, but broad Advantage coverage of SLIT has not been documented.
Medigap policies pay the cost-sharing on services Original Medicare already covers, such as the 20% coinsurance for allergy shots. Because SLIT is not a covered benefit to begin with, Medigap does not fill the gap.
What Medicare Does Cover for Allergies
Medicare Part B covers allergy testing and subcutaneous immunotherapy when medically necessary. Skin prick testing is the preferred diagnostic method, with blood-based specific IgE testing available when skin testing is not feasible. In vitro IgE testing is limited to 30 allergens per beneficiary in any 12-month period, and routine annual retesting is not covered.11CMS.gov. LCD L36402 – Allergy Testing
On the treatment side, Part B covers allergen immunotherapy by subcutaneous injection for allergic rhinitis, allergic conjunctivitis, stable allergic asthma that has not responded to other treatments, and stinging insect hypersensitivity. Documentation that conservative therapies failed is required, and injections must be given in a clinical setting equipped to handle anaphylaxis. If a patient shows no clinical improvement after 12 to 24 months, continued treatment is treated as a failure and reimbursement stops after two years without benefit.2CMS.gov. LCD L36408 – Allergen Immunotherapy
Part B pays 80% of the approved amount for covered allergy tests and immunotherapy after the beneficiary meets the Part B deductible, leaving a 20% coinsurance.12AARP. Does Medicare Cover Allergy Tests and Drugs Self-administered injections are excluded.13CMS.gov. Billing and Coding – Allergen Immunotherapy
Paying for SLIT Out of Pocket
Beneficiaries who want sublingual immunotherapy will need to pay themselves. Johns Hopkins Medicine puts the cost of a one-year supply of custom-compounded drops at between $1,000 and several thousand dollars, depending on how many allergens are treated, with treatment typically running three to four years.4Johns Hopkins Medicine. Could Allergy Drops Be the Key to Allergy Relief A 2012 analysis estimated annual SLIT costs of $500 to $2,100, varying by practice and antigen count, and noted that once indirect costs like lost wages and travel for shot appointments are counted, the gap between SLIT and covered injection therapy narrows.14PubMed. Cost of Allergy Immunotherapy: Sublingual vs Subcutaneous Administration
A health savings account may be usable for these expenses. Johns Hopkins Medicine suggests confirming that in advance.4Johns Hopkins Medicine. Could Allergy Drops Be the Key to Allergy Relief
Is It Worth Appealing a Denial?
A beneficiary who is billed for SLIT and denied has the standard Medicare appeal rights: redetermination by the Medicare Administrative Contractor within 120 days of the Medicare Summary Notice, then reconsideration by a Qualified Independent Contractor, then an Administrative Law Judge hearing, then the Medicare Appeals Council, then federal district court. A representative can be appointed using CMS Form 1696, and the State Health Insurance Assistance Program offers free help through shiphelp.org or 1-800-MEDICARE.15CMS.gov. Medicare Parts A and B Appeals Process16CMS.gov. Medicare Appeals
Realistically, the odds are poor. Appeals succeed when a contractor made the wrong call on medical necessity for a particular patient. Here the denial is not a judgment about the patient at all; it comes from a blanket national policy that says no antigen given sublingually is covered. Winning would mean overturning NCD 110.9 rather than correcting a claim, and that is a much harder fight.