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What Happens if Your Medicare-Covered Prescription Drug Is Found Unsafe?

October 6, 2016

As a Medicare beneficiary, you could one day be in a situation in which a prescription drug covered by your stand-alone Medicare Part D Prescription Drug Plan or Medicare Advantage Prescription Drug plan is found to be unsafe. The information below explains how prescription drugs are selected for coverage and how you will be informed if one of your medications is determined to be unsafe and removed from coverage, and what you should do.

Medicare prescription drug coverage

Medicare contracts with private insurance companies to offer Part D prescription drug coverage. There are two main types of Medicare plans offering prescription drug coverage: stand-alone Medicare Part D Prescription Drug Plans that work alongside Original Medicare (Part A and/or Part B) and Medicare Advantage Prescription Drug plans, which combine health and prescription drug coverage in a single plan.

Medicare plans with prescription drug coverage are required to cover at least two prescription drugs under each therapeutic drug category; in certain categories they must carry most prescription drugs. However, each plan may decide which prescription drugs it includes in its formulary (list of covered prescription drug), and formularies vary from plan to plan. A plan’s formulary may change at any time. You will receive notice of changes from your plan when necessary.

Each Medicare plan with prescription drug coverage must have a formulary that conforms to the required therapeutic classes, and be

  • Available only by prescription,
  • Medically necessary and for a medically accepted indication, and
  • Approved by the Food and Drug Administration (FDA) for sale in the United States.

Plans might change their formularies each year (making it important to review your plan choice each year during the fall when the Annual Election Period occurs). With some restrictions, they can also make formulary changes during the course of the year and notify you of the change as necessary. For example, Medicare plans providing prescription drug coverage usually cannot make any changes to their formularies between the plan’s Annual Election Period (AEP), which runs from October 15 to December 7 each year, and 60 days after the plan’s coverage begins. The exception to this rule is when a prescription drug is found unsafe by the U.S. Food and Drug Administration.

If your Medicare-covered drug is found unsafe

The U.S. Food and Drug Administration (FDA) will remove a prescription drug from the market if it determines that the risks of taking the medication outweigh its benefits– that is, the prescription drug has serious side effects that were not known when the drug was first approved. The FDA’s determination that a prescription drug is unsafe follows substantial scientific evidence showing that the medication had unexpected, harmful effects on users. The FDA will then inform the drug manufacturer, who, in most cases, voluntarily stops manufacturing and marketing the medication.

When the FDA labels a prescription drug unsafe, your plan will remove the medication from its formulary and notify plan members who are taking the prescription drug about the FDA’s determination of the health risks associated with the medication and its removal from the plan’s formulary. Notice is also sent to plan participating pharmacies and prescribing physicians. If you are affected by this situation, your stand-alone Medicare Part D Prescription Drug Plan or your Medicare Advantage Prescription Drug plan will send you a list of Medicare-covered prescription drugs in the same therapeutic category or class that may be safe to use as a substitute.  You should consult your prescribing physician regarding your medications and any changes as soon as possible.

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