Medicare Part D provides prescription drug coverage, helping millions of beneficiaries afford outpatient medications. Although it covers a wide range of pharmaceuticals, federal law mandates that specific types of drugs cannot be covered by a Part D plan. This exclusion means the financial responsibility for certain drug classes falls entirely on the patient.
Core Statutory Exclusions
Federal statute explicitly forbids Part D plans from covering certain categories of medications, regardless of medical necessity or whether the drug is available by prescription. These exclusions are established by the Social Security Act and apply uniformly across all Part D plans. The most commonly excluded drugs are those used for conditions considered non-medical or elective.
Drugs used solely for the symptomatic relief of cough and cold are excluded from coverage. This covers various over-the-counter and prescription preparations intended to alleviate minor respiratory symptoms. Similarly, medications used to promote fertility or those prescribed for the treatment of sexual or erectile dysfunction are not covered under Part D.
Medications used for cosmetic purposes or hair growth are also statutorily excluded. However, if a drug is prescribed to treat a medical condition like severe acne or psoriasis, it may be covered. Another exclusion is for agents used for anorexia, weight loss, or weight gain. An exception exists for drugs used to treat physical wasting, such as cachexia associated with AIDS or cancer.
All non-prescription (OTC) drugs are excluded, even if prescribed by a physician. Most prescription vitamins and mineral products are also excluded, with exceptions for prenatal vitamins and fluoride preparations. Patients must pay the full cost of these excluded items out-of-pocket.
Medications Covered by Other Medicare Parts
A drug may be excluded from Part D coverage because it is covered under a different part of Original Medicare, such as Part A or Part B. This is a clarification of which program pays for the medication, not a denial of coverage. If a drug can be covered by Part A or Part B, it is excluded from Part D for that beneficiary.
Medicare Part A covers all drugs administered during a covered inpatient hospital stay or in a skilled nursing facility. Part A also covers drugs necessary for symptom control and pain relief for beneficiaries receiving hospice care. In these settings, the medication cost is bundled into the overall payment for the service.
Medicare Part B covers a limited range of outpatient drugs, primarily those that are not typically self-administered. This includes injectable or infused drugs given in a doctor’s office or clinic, such as certain chemotherapy or immunosuppressive agents. Part B also covers drugs administered through durable medical equipment like nebulizers, and preventive vaccines for influenza and pneumonia. Since Part B pays for these medications, they are excluded from Part D.
Exclusions Based on Regulatory Status
A drug can be excluded from Part D if it fails to meet specific regulatory criteria regarding its approval or intended use. To be considered a Part D-covered drug, it must be approved by the Food and Drug Administration (FDA) for sale in the United States. Furthermore, the drug must be prescribed for a “medically accepted indication.”
This requirement means the drug is used either for an FDA-approved purpose or for an off-label use supported by scientific evidence. For non-cancer drugs prescribed off-label, Medicare requires the use to be listed in one of the three recognized drug compendia. If the off-label use is not cited in one of these compendia, the Part D plan is prohibited from covering the medication.
Another regulatory exclusion applies to drugs evaluated by the Drug Efficacy Study Implementation (DESI) process and deemed less than effective. These DESI drugs are permanently excluded from Part D coverage due to a lack of demonstrated efficacy. Additionally, drugs must be available only by prescription to qualify as a Part D drug.
Patient Responsibility and Alternative Payment Options
If a prescribed medication falls into an excluded category, the beneficiary is financially responsible for the full retail cost. These costs do not count toward the Part D plan’s annual out-of-pocket spending limit. Because of the high cost of some excluded drugs, patients should explore alternative payment options, which can significantly reduce the financial burden of non-covered medications.
Patient Assistance Programs (PAPs) are offered by pharmaceutical manufacturers to provide free or low-cost brand-name medications to low-income individuals. While eligibility varies, many programs accept Medicare beneficiaries who cannot afford their excluded medications. Applications typically require proof of income and a prescription from the treating physician.
Drug discount cards, available from commercial entities, can be used to negotiate a lower price at the pharmacy counter. These cards cannot be used in combination with Part D coverage, but they offer substantial savings on excluded drugs. Lastly, some states offer State Pharmaceutical Assistance Programs (SPAPs). These programs provide “wraparound” coverage, which may help pay for Part D premiums, deductibles, or excluded medications for low-income beneficiaries.