Help! I Couldn’t Get My Prescription Filled:
What’s Going On and What Can I Do About It?

At some point, your Medicare prescription drug plan may not cover some of your prescriptions. You have the right to appeal your plan’s decision. Understanding the reasons for your plan’s denial of coverage and learning what you can do about it are the first steps in any decision to file an exception or an appeal. Below is HAP's step-by-step guide to help you figure out why your prescription was not filled, to assess your options, and to understand what steps you can take to get your prescription filled.

This guide is organized around five main questions:

If I can’t get my prescription filled how will I know what to do next?
What are some reasons why I couldn’t get my prescription filled?
What are my options if I can't get my prescription filled?
Who can help me get a drug through my Medicare Prescription Drug Plan when the plan has said it won’t cover the drug?
What if I lose my request for a Coverage Determination or Formulary Exception?

1. If I can’t get my prescription filled, how will I know what to do next?

Your pharmacy’s staff may explain what they saw when they entered your prescription information through the Medicare Drug Plan’s computer-based authorization process.

A pharmacist’s statement that your plan will not cover your drugs is not the same as a statement from your plan to that effect. For a definitive answer, contact your plan.

In-network pharmacies must post a generic sign explaining how to get more information from the Medicare Prescription Drug Plan if a prescription can’t be filled.

Your pharmacy’s staff may point you to these signs.
Find the sign from your Medicare Prescription Drug Plan and copy down the contact information (phone number[s] and/or the internet web site address).

You might want to ask someone for help figuring out why your prescription was not filled. For example, you could call your local State Health Insurance Assistance Program (SHIP) and ask if they can help you find out why you couldn’t get your prescription filled.
When you or your helper contacts your Medicare Prescription Drug Plan, the plan is required to tell you why it instructed the pharmacy not to fill your prescription and how to ask for a formal decision from the plan about coverage.

2. What are some reasons why I couldn’t get my prescription filled?

Your Medicare Drug Plan decided it wasn’t medically necessary for you.
It wasn’t on your Medicare Drug Plan’s formulary.
Your physician didn’t go through a utilization management protocol, such as:

"Step therapy" or mandatory therapeutic substitution of another drug
Prior approval request from your doctor to your Medicare Drug Plan for you to take the medication prescribed for you
The specific medication dosage or type (generic versus brand name) wasn’t in your Medicare Drug Plan plan’s formulary

You can’t afford the cost-sharing amounts that your Medicare Prescription Drug Plan imposes on the drug your doctor prescribed for you.
Your doctor prescribed a “unique” medication, such as a genomic or biotech product that your Medicare Drug Plan charges too much for.
Your Medicare Prescription Drug Plan removed the drug your doctor prescribed for you from the plan formulary in the middle of the year, and you can’t change to another plan.
The pharmacy you went to wasn’t in your Medicare Prescription Drug Plan’s network.
The drug your doctor prescribed isn’t a Medicare Prescription Drug Plan-covered drug.

3. What are my options if I can't get my prescription filled?

The answer to this question depends on the reason(s) why your pharmacist wasn’t able to fill your prescription.

If your Medicare Prescription Drug Plan decided it wasn’t medically necessary:

First, you must request an official decision from your Medicare Drug Plan – called a Coverage Determination – about whether the prescribed medication is necessary for you.

You do not have to use the term Coverage Determination in making your request, but it may help the plan understand what you want, and therefore respond more quickly.

You can ask anybody you authorize to make the request for the Coverage Determination on your behalf. The person who helps you is called your Authorized Representative.
Your prescribing physician may also request a Coverage Determination, but would not be considered your Authorized Representative.
How long does it take?

Standard Coverage Determination: The Medicare Drug Plan must make its decision and tell you and your prescribing physician (if your physician requested the coverage determination) what the plan’s Coverage Determination is within 72 hours (generally, 3 calendar days) after the plan receives your request for it. The first news you receive from the plan may be verbal, such as a phone call.

If the plan’s Coverage Determination denies plan coverage for the prescribed medication, the plan must give you a written notice within 72 hours after telling you the reason for the denial. The notice will also tell you how to appeal this adverse Coverage Determination.

Note: If your plan does not give you a written notice about its adverse Coverage Determination within the timeframes specified, they must send your request for a Coverage Determination to an Independent Review Entity (IRE) within 24 hours. (See 42 CFR Section 423.570[d].)

Expedited Coverage Determination (42 CFR Section 423.570): If 72 hours is too long to wait for the prescribed medication, you can request an Expedited Coverage Determination IF:

You and/or your prescribing physician believe that waiting for 72 hours for the plan’s Coverage Determination might “seriously jeopardize [your] health or life or [your] ability to regain maximum function.”
If your doctor makes the request for an Expedited Coverage Determination, or supports your request for a quicker Coverage Determination, the plan must expedite the timeframe for issuing its Coverage Determination.
If your prescribing doctor does not request (or support your request) for an Expedited Coverage Determination, your Medicare Prescription Drug Plan will decide if you qualify for an Expedited Coverage Determination.
An Expedited Coverage Determination must be made within 24 hours of the time the plan receives the request.

The plan must tell you about its Expedited Coverage Determination as soon as possible in consideration of your medical condition, but absolutely no later than the 24-hour timeframe.
Your first notification of the plan’s decision may be by telephone.
The plan must mail you a written Expedited Coverage Determination within three (3) calendar days of any oral notification you are given within the 24 hours following the plan’s receipt of your request for an Expedited Coverage Determination.

The notice must explain the plan’s reasons for reaching its decision and, if the decision is not favorable, must tell you how to appeal.

Note: If your plan does not give you a written notice about its Expedited Coverage Determination within the timeframes specified, the plan must initiate the next level of appeal by sending your request for an Expedited Coverage Determination to the Independent Review Entity (IRE).

If your doctor asked for the Expedited Coverage Determination, the plan must also notify him/her.

If the prescribed medication is not in your Medicare Prescription Drug Plan’s formulary:

You can talk to the prescribing doctor to see if there is an equivalent medication in the plan’s formulary that your doctor believes would work as well for you and the doctor is willing to prescribe for you.
If your prescribing doctor believes that you must have the medication that is not in your Medicare Prescription Drug Plan’s formulary, you will need to request a Formulary Exception from your Medicare Drug Plan. (See 42 CFR Section 423.578.)
To file a Formulary Exception you must ask your prescribing physician to contact your Medicare Drug Plan to explain why the prescribed medication is medically necessary for you. Plans may accept verbal statements, but may require the physician to provide a written statement. Each plan has its own rules. (It may be in the patient’s best interest for the physician to submit a written statement.)

In your doctor’s statement to the Medicare Drug Plan, s/he must:

State that none of the drugs used to treat your condition that are in your Medicare Drug Plan’s formulary would be as effective in treating you, and/or all of the drugs in the Medicare Drug Plan’s formulary that are used to treat your condition would cause you to experience adverse side effects. This helps to demonstrate the medical necessity of the prescribed drug.
Submit any additional medical and/or scientific evidence in support of the need for the prescribed drug. It is important to understand and follow the plan’s evidentiary requirements and procedures for submitting evidence.

In addition, the Medicare Drug Plan may require your prescribing physician to submit additional clinical and/or medical documentation to support your request for a Formulary Exception.
The Medicare Drug Plan’s Formulary Exception process must include a description of:

The factors the Medicare Plan will consider in evaluating a prescribing doctor’s statement in support of a Formulary Exception.
The plan’s procedure for reviewing relevant medical evidence on the safety of the requested medication.
How the plan will apply cost-sharing rules to you if it grants a Formulary Exception. The Medicare Prescription Drug Plan is allowed to charge you what it charges for non-preferred and brand name drugs in its formulary.

You will NOT be allowed to get the cost-sharing lowered to the amount charged for generic drugs if the plan has a separate tier of cost-sharing solely for generic drugs.

Note: You will not be allowed to request another Formulary Exception to get a lower cost-sharing decision after a Medicare Drug Plan has made a Formulary Exception to include a prescribed drug in its formulary for you.

A Formulary Exception lasts for the rest of your plan year. If you renew your enrollment in the same Medicare Drug Plan for the next year, the plan can decide whether or not to continue to cover the drug prescribed for you that was approved through a Formulary Exception. If they decide not to continue to cover the drug, you may be required to submit a new Formulary Exception request for the new plan year.

If you didn’t go through a utilization management protocol* or your plan denied coverage after application of the utilization management protocol:

You can talk to the prescribing doctor to see if s/he believes it would be medically appropriate for you to try any alternative drugs or dosages on the plan’s formulary that would have an equivalent effect in treating your medical condition.
If your prescribing doctor believes that you must have the medication or the dosage that is not in your plan’s formulary, you will need to request a Formulary Exception from your Medicare Prescription Drug Plan. See Page 4 for the Formulary Exception process.

Remember the critical role your physician will have to play in the Formulary Exceptions process.

* Utilization management protocols might include therapeutic substitutions of different drugs for preferred, generic, or less costly drugs; dosage limitations (that is, you only get 30 pills a month when your doctor has prescribed 60 per month); or prior approval that the doctor must get from the Medicare Drug Plan before the prescription can be filled.

If you can’t afford the cost-sharing amounts your Medicare Prescription Drug Plan imposes on the drug your doctor prescribed:

You can talk to your doctor to find out if s/he would prescribe a drug on your Medicare Drug Plan's offers formulary that is therapeutically equivalent and less expensive.
If the doctor believes you must have the drug previously prescribed, you will have to request a Formulary Exception to the plan’s tiered cost-sharing structure.
Your pharmacy is allowed to waive your cost-sharing on a non-routine basis under limited circumstances.

If your doctor prescribed a “unique” or very expensive medication, such as a genomic or biotech product, that you cannot afford:

You are allowed to try to get a Formulary Exception but will not be able to if the drug is not in your Medicare Prescription Drug Plan plan’s formulary.
You may not be allowed to try to get a Formulary Exception to lower your cost-sharing for high cost and unique drugs such as genomic or biotech products.

If your Medicare Drug Plan removed the drug your doctor prescribed from the plan formulary or increased the amount you must pay for your medication in the middle of the year (See 42 CFR Section 423.120):

Your Medicare Drug Plan must give you a written notice at least 60 days before the change becomes effective. Your doctor should also be notified. The notice must tell you:

What change is being made and the reason for the change
The names of other drugs in the same category, class and cost-sharing level as the drug the plan is changing
How you can ask for a coverage determination or a formulary exception.

If you do not get the prior written notice, your Medicare Drug Plan must give you a 60-day supply of the prescribed medication on the same terms as if the plan had not changed its rules. The plan must also see to it that you get a written notice when you fill our prescription.
Medicare Drug Plans are not allowed to remove drugs from their formularies or change the cost-sharing level of a drug in the plan’s formulary during the Annual Election Period (November 15-December 31 every year) or for the first 60 days of the plan year (generally, January 1-March 3 of every year).
If a drug your physician has prescribed for you is removed from the formulary or moved to a higher cost-sharing level, you can talk to the prescribing doctor to see if there is an equivalent medication in the plan’s formulary that your doctor believes would work as well for you and that the doctor is willing to prescribe for you.
If your prescribing doctor believes that you must have the medication that is not in your Medicare Prescription Drug Plan’s formulary, you will need to request a Formulary Exception from your Medicare Prescription Drug Plan.

If the pharmacy you went to wasn’t in your Medicare Prescription Drug Plan’s network (See 42 CFR Section 423.124):

You are allowed to get coverage through your Medicare Drug Plan for your prescribed drug from a pharmacy that does not participate in your Medicare Prescription Drug Plan’s network ONLY IF you could not reasonably have been expected to get to a participating in-network pharmacy.

You are not allowed to regularly fill your prescriptions at a non-network pharmacy and get coverage from your Medicare Drug Plan. Your Medicare Prescription Drug Plan is allowed to have rules to limit your use of out-of-network pharmacies.

Note: Residents of long-term care institutions, as defined by the Final Medicare Drug Plan regulations (see p. 4534, middle column), are generally not allowed to fill their prescriptions at out-of-network pharmacies.

If the drug your doctor prescribed is not a Medicare Drug Plan-covered drug:

If you can afford the cost-sharing and monthly premiums, you could look for an enhanced Medicare Drug Plan that offers supplemental coverage of the non-Medicare Prescription Drug Plan-covered drug your physician has prescribed for you.
You may need to pay out-of-pocket or look for alternate sources of drug coverage for drugs that Medicare Prescription Drug Plans are not required to cover. These are:

Drugs prescribed for weight-loss and weight-gain
Drugs prescribed for symptomatic relief of coughs and colds
Prescription vitamins (with the exception of prenatal vitamins and fluoride)
Over-the-counter drugs (with the exception of insulin)
Drugs prescribed to promote hair growth
Fertility drugs
Cosmetic drugs
Drugs that must be monitored by testing services that only the manufacturer provides, such as certain anti-psychotic medications
Barbiturates (drugs used to control seizures or used for sedation or anesthesia such as Phenobarbital or Nembutal®)
Benzodiazepines, often referred to as minor tranquilizers, used to treat anxiety or insomnia (such as Xanax®, Valium® and Ativan®)

Alternative sources of coverage for non-Medicare Drug Plan-covered drugs include:

Your state Medicaid plan.

If your state has decided to continue covering some or all of the categories of drugs specifically excluded from standard Medicare Prescription Drug Plans, the state may cover this drug for some or all categories of Medicare beneficiaries who also have “full” Medicaid. The CMS Web site has state-by-state lists of Medicaid coverage of non-Part D drugs at: http://new.cms.hhs.gov/States/EDC/list.asp#TopOfPage

Your state pharmacy assistance program (SPAP), if your state has one. Your SPAP may cover a drug specifically excluded from standard Medicare Drug Plans. Check with your SPAP.
Employer group health plans for retirees, the Veterans Administration (VA), or TRICARE.

Any prescribed drug specifically excluded from standard Medicare Prescription Drug Plans might be covered through one of these other types of coverage. Check with your alternate coverage plan.

Note: For nursing home residents who are on Medicare and Medicaid, over-the-counter medications and supplies should be covered by the Medicaid per diem payment to the nursing home or by Medicare Part A if the resident is on a Part A-covered stay. (See 42 CFR Section 483.10.)

4. Who can help me get a drug through my Medicare Prescription Drug Plan when the plan has said it won’t cover the drug?

Your prescribing physician can help you get the medications s/he has prescribed for you.
Your Appointed Representative can help you.

You can ask anyone you want, including a family member, a friend, or a SHIP counselor, to help you get the drugs you need from your Medicare Drug Plan . If this person agrees to help you, he/she is known as your "Appointed Representative."
Anyone serving as your Appointed Representative must fill out an "Appointment of Representative" form, and must submit it with each new request for a Coverage Determination or a Formulary Exception. (The form is valid for one calendar year.)
Your Appointed Representative will receive any notices sent by the plan concerning your request to get a drug covered.

Your Authorized Representative can help you.

Your Authorized Representative is anyone designated as your power of attorney or whom a court has appointed as your legal guardian.

If you have a health care power of attorney or if you live in a state with a health care proxy statute, the person you appointed or whom your state’s statute designates can be your Authorized Representative for purposes of a Medicare Drug Plan seeking a Coverage Determination or an appeal.

5. What if I lose my request for a Coverage Determination or Formulary Exception?

You can appeal a Medicare Prescription Drug Plan denial of a Coverage Determination or a Formulary Exception by asking for a Redetermination.

You must ask for a Redetermination by writing to your Medicare Prescription Drug Plan sponsor. (The notice you received explaining that your Coverage Determination or Formulary Exception was denied will tell you where to send your request for a Redetermination.)
You have 60 days from the date of the notice denying your Coverage Determination or Formulary Exception to write and ask for a Redetermination (unless you have a very good reason why you were not able to get your request to the Medicare Prescription Drug Plan within the 60 days).
If you are requesting a standard Redetermination, or if you have already paid for the drug in question, your Medicare Drug Plan must issue its decision and (if the decision is favorable to you) implement it within 7 days.

You or the doctor who prescribed the medication can ask for an Expedited Redetermination if the adverse Coverage Determination or Formulary Exception request was expedited.
If your doctor asks that your Redetermination be expedited, the plan must expedite it. If you ask for it to be expedited, however, the plan is allowed to determine if expediting the request is medically necessary.

Expedited Redeterminations must be decided within 72 hours.
You can submit evidence and legal arguments to your Medicare Prescription Drug Plan either in person or in a written submission.
Your plan must notify you (as well as your physician if s/he requested the Expedited Redetermination) of its decision if it decided against you.

If you do not agree with the Redetermination decision, you can appeal by asking for a Reconsideration.

Reconsiderations are processed by Independent Review Entities (IREs) that contract with CMS, and must be requested within 60 days of the date on the notice of your plan’s Redetermination.
The IRE must ask your prescribing physician for his/her views on the appeal and to include a written account of his/her input in the record of the Reconsideration.

Note: In order to request a Reconsideration or a Redetermination (or both) of a Formulary Exception, your physician must again state that no other drug in your plan’s formulary would be as effective for your treatment, that every other formulary drug for your condition would cause you adverse symptoms, or both.

The IRE must send you a notice of Reconsideration when it has reached its decision.
If the IRE reverses (in whole or in part) your Medicare Drug Plan’s decision regarding your benefits, the +plan must provide the benefits requested within 72 hours.
If the IRE reverses (in whole or in part) a Medicare Drug Plan’s decision regarding payment, the plan must authorize the payment within 72 hours and must make the payment within 30 calendar days.

If you disagree with the Reconsideration, you can ask for a hearing before an Administrative Law Judge (ALJ).

You must request your hearing within 60 days of the date on the notice from the IRE about your Reconsideration decision.
The amount in dispute that is the subject of your appeal must be at least $110 (as of 2006) for you to get an ALJ hearing.

If you disagree with the decision of the ALJ, you can ask the Medicare Appeals Council to review the decision of the ALJ.
If you disagree with the Medicare Appeals Council review, you can take your case to Federal Court.

The amount in dispute that is the subject of your appeal must be at least $1,090 (as of 2006) to take your dispute to Federal Court.
While not required, it is generally a good idea to have a lawyer help you with a federal court case.

Help! I Couldn’t Get My Prescription Filled: What’s Going On and What Can I Do About It?