Frequently Asked Questions
May I request a reconsideration appeal for my patient?
Yes, you may request the reconsideration appeal on behalf of your patient. An Appointment of Representative (AOR) form is not needed if the prescriber requests the reconsideration appeal on an enrollee’s behalf.
How do I request a reconsideration appeal for my patient?
You may request a standard or expedited (fast) appeal by sending a signed written request to us within 60 calendar days from the date of the notice of the plan’s redetermination, unless the time frame is extended by us for good cause. An Appointment of Representative (AOR) form is not needed if the prescriber requests the reconsideration appeal on an enrollee’s behalf. You may use the Reconsideration Request Form, but we will accept any other written document as long as it is signed and includes the following:
- Enrollee’s full name and address
- Enrollee’s Medicare Number
- Identification of the item that is being appealed, e.g., the prescription drug, including dose and quantity
- Name of the Part D plan that denied coverage
- Signature or signature of your representative, if applicable
- A prescriber statement is required if you are requesting an exception to the plan’s formulary rules. The prescriber must determine that all covered Part D drugs on any tier of the formulary for treatment of the same condition would not be as effective for the enrollee as the non-formulary drug, would have adverse effects for the enrollee, or both, and provide a written statement to this effect with the appeal request. Please address the plan’s coverage criteria as stated in the plan’s denial letter and why the drug(s) required by the plan are not medically appropriate for the patient. If the prescriber believes that waiting for a standard decision (which will be provided within seven calendar days) could seriously harm your patient’s life, health or ability to regain maximum function, you may ask for an expedited appeal by checking the box for it or including “urgent” and “expedited” in the prescriber statement.
Reconsideration Request Form - Drug Benefit (PDF)
When can I expect to receive a Part D QIC reconsideration decision?
Decisions for a valid expedited appeal are generally communicated within 72 hours by phone or fax with the written decision letter to follow by mail or fax. Decisions for a standard appeal are mailed or faxed within seven calendar days.
What supporting documentation is required for an exception to the plan’s coverage rules?
In general, a prescriber’s statement must state why the requested drug is medically necessary by addressing why the plan’s formulary alternatives have been/or may be less effective, or would be more likely to result in an adverse outcome for the enrollee. It is also helpful if the statement addresses the plan’s reason for denial. Some plans require specific information for a determination of medical necessity.
Does Medicare Part A & B cover prescription drugs?
Yes, some. If a drug is covered under Medicare Part A and B, then the same drug is not eligible to be covered under Medicare Part D. Medicare Part D does not cover any drug for which payment is available for that individual under Parts A or B of Original (or fee-for-service) Medicare. This is true whether or not the individual is actually enrolled in Medicare Part A or B. Medicare Part A or B does not cover most outpatient prescription drugs and Medicare Part A generally only pays for drugs provided to a beneficiary during a hospital or skilled nursing facility stay. For more information about Part B vs. Part D coverage, go to Appendix C in the Centers for Medicare & Medicaid Services (CMS) Internet-Only Manual (IOM), Publication 100-18, Medicare Prescription Benefit Manual, Chapter 6 (PDF).
Do I need to request coverage through Medicare Part A or B before seeking coverage under Medicare Part D?
No. The plans may not require showing that the drug will not be paid for under Medicare Part A or B. However, the plans may impose prior authorization requirements, even during the transition period, to determine whether the plan should cover a drug under Medicare Part D or whether the drug should be covered under Medicare Part A or B.
Does Medicare Part D cover drugs that have not been approved by the Food and Drug Administration (FDA)?
No. In order for a drug to be eligible for coverage under the Medicare Part D, the drug must be:
- Approved by the FDA for safety and effectiveness
- Available only by prescription (over-the-counter drugs are not covered)
- Used and sold in the United States
- Used for a medically accepted indication
Search for FDA-approved drugs
Does Medicare Part D cover drugs that are compounded?
This depends on the components of the compounded medication. A compounded prescription drug product may be covered if it contains at least one Food and Drug Administration (FDA) approved drug component, although reimbursement is limited to the compounding fees and FDA approved component(s) only. Bulk powders are not FDA approved drug products and therefore are not covered under Part D. A compounded drug must also be prescribed for a "medically accepted indication."
Are there any medications that are specifically excluded under Medicare Part D?
Yes. Medicare Part D excludes certain drugs, classes of drugs or drugs prescribed for certain medical uses. The following is a list of drugs that are excluded from coverage under Medicare Part D. Certain drugs and drug uses are not subject to the below noted exclusions list.
- Drugs used for anorexia, weight loss or weight gain
- Drugs used to promote fertility
- Drugs used for cosmetic purposes or hair growth
- Drugs used for the symptomatic relief of cough or cold
- Prescription vitamins and mineral products (except prenatal vitamins and fluoride preparations)
- Nonprescription drugs
- Drugs subject to a manufacturer tying arrangement
- Drugs used to treat sexual or erectile dysfunction
A Part D Plan may provide supplemental coverage for excluded drugs, classes of drugs or drug uses if the plan has contractually opted to provide such coverage as per its subscriber materials (e.g., Evidence of Coverage) and the Centers for Medicare and Medicare Services (CMS) has approved the benefit.
For more information about Part D exclusions, go to Appendix B in the CMS IOM, Publication 100-18, Medicare Prescription Benefit Manual, Chapter 6 (PDF), which provides additional information on Part D coverage and exclusions
Where can I obtain information about a Plan’s formulary?
Part D plans must include their current formulary and any applicable quantity limit restrictions, prior authorization criteria and step therapy criteria on their respective website. The formulary should include the tier level and description as well as the quantity limit restrictions. The formulary documents must include all prior authorization and step therapy criteria applied to each formulary drug.
How do I appeal an Unfavorable or Partially Favorable reconsideration decision or dismissal on an enrollee’s behalf ?
The reconsideration decision letter you receive from us will include steps on how to request an appeal at the next level of review, the Office of Medicare Hearings and Appeals (OMHA). If the reconsideration decision was unfavorable or partially favorable, your patient or their representative may request for an Administrative Law Judge (ALJ) Hearing. OMHA must receive the request within 60 calendar days after you received the reconsideration decision or dismissal that you are appealing. Unlike a request for reconsideration, an Appointment of Representative (AOR) form is required for a prescriber to request an ALJ Hearing on behalf of the enrollee.
Request for Administrative Law Judge (ALJ) Hearing or Review of Dismissal (PDF)
Request for Administrative Law Judge (ALJ) Hearing or Review of Dismissal (Large Print) (PDF)
My request for coverage on the enrollee's behalf was approved for the current plan year as an exception to the formulary. Do I need to appeal every year for an exception?
A plan may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins.
If a plan decides not to continue coverage under an approved exception into the subsequent plan year for a renewing enrollee, the plan must send a written notice to the enrollee at least 60 days prior to the end of the plan year, unless the plan sent an approval letter to the enrollee when it granted the exception and clearly identified the date that coverage will end in the approval letter.
If a plan is required to send a written notice to the enrollee at least 60 days prior to the end of the plan year or the date coverage ends, the notice must:
- Explain that the exception will not be extended
- Provide the date that coverage will end (e.g., on December 31, 2021)
- Explain the right to request a new exception once the current exception expires
- Provide instructions for making a new exceptions request
My request for coverage on the enrollee's behalf was approved for the current plan year; however, the plan is not providing coverage of the medication. What can I do?
The plan must authorize or provide the benefit in dispute in the timeframe specified in the reconsideration letter. If the plan does not authorize the benefit within the time specified, call the Centers for Medicare and & Medicaid Services (CMS) phone number indicated in the reconsideration decision letter.
As a pharmacist, can I appeal on behalf of my customer?
Yes; however, you must have a signed Appointment of Representative (AOR) form or other document authorizing representation from the enrollee.
A medication is currently available and has a National Drug Code (NDC) number, does that mean it is Food and Drug Administration (FDA) approved?
No. Assignment of an NDC number does not in any way denote FDA approval of the product. Neither inclusion in the NDC Directory nor possession of an NDC number is a determination that a product is an FDA-approved drug as defined by the Food, Drug, and Cosmetic Act, nor does it denote that a product is covered or eligible for reimbursement by Medicare Part D.
Are Part D covered compounded drugs eligible for a discount through the Coverage Gap Discount Program (CGDP)?
No. While a Plan can cover a compounded drug with at least one Part D covered drug, a compounded drug is not eligible for a discount through the CGDP. CMS has determined that because a compounded drug, as a whole, is not approved under a New Drug Application (NDA) or Biological Licensing Agreement (BLA), a compound does not meet the definition of an applicable drug under the CGDP. Accordingly, Plans will apply the "generic" gap cost-sharing to the Part D drug components of all Part D compounds.