What if I’m taking a drug that isn’t on my plan’s drug list or a step-therapy drug when my drug plan coverage takes effect?

Your drug plan will provide a one-time, temporary supply of your current drug. During your first 90 days in a plan, Medicare requires Medicare drug plans to give you and your doctor time (30 days) to find another drug on the plan’s drug list that would work as well as the drug you are taking. Different rules may apply for people who move into an institution (like a nursing home). However, if you have already tried similar drugs and they didn’t work, or if your doctor determines that because of your medical condition it’s necessary for you to take a certain drug, he or she can contact your plan to request an exception as soon as you get your initial 30-day supply. If your doctor’s request is approved, the plan will cover the drug.

If the exception isn’t approved, you can appeal.

What is an exception?

A formulary exception is a decision to cover a drug that’s not on the formulary. A tiering exception is a decision to charge you a lower tier amount for a drug that is on a non-preferred drug tier. Another exception can be a decision not to apply a limit, like a dose or quantity limit. Your doctor must send a supporting statement with the medical reason for the exception.

Can I appeal my Medicare Prescription Drug Plan’s decisions?

Yes. You have the right to get a written explanation from your Medicare Prescription Drug Plan if your request for a drug is denied. Some reasons you might ask for a written explanation are if the pharmacist tells you that your drug plan won’t cover a prescription or you are asked to pay more than you think you are required to pay. You also have the right to ask your drug plan for an exception if you and your doctor believe you need a drug that isn’t on your drug plan’s list of covered drugs.If you disagree with the information provided by a pharmacist, you can contact your plan to ask for a coverage determination. The pharmacy will give or show you a notice that  explains how to contact your Medicare drug plan.

A standard request must be made in writing unless your plan accepts requests by phone. You or your doctor can call or write your plan for an expedited (fast) request. Once your Medicare drug plan gets your request for a coverage determination, the Medicare drug plan has 72 hours (for a standard request) or 24 hours (for an expedited request) to notify you of its decision. If you are requesting an exception, your prescribing doctor must provide a statement explaining the medical reason why your request should be approved. Your plan generally has 72 hours (for a standard request) or 24 hours (for an expedited request) to notify you of its decision once your plan receives your doctor’s statement. If you disagree with your Medicare drug plan’s decision, you have the right to appeal. You must request the appeal within 60 calendar days from the date of the decision. A standard request must be made in writing unless your Medicare drug plan accepts requests by phone. You can call or write your plan for an expedited request. Once your Medicare drug plan receives your request for an appeal, the Medicare drug plan has seven days (for a standard request for coverage) or 72 hours (for an expedited request for coverage) to notify you of its decision.

If your plan doesn’t respond to your request for a drug, an appeal, or an exception, you can file a grievance with the plan sponsor, or file a complaint by calling 1-800-MEDICARE (1-800-633-4227), or both. TTY/TTD users should call 1-877-486-2048.

What is Coverage Determination?

A coverage determination is defined as any decision made by or on behalf of a FICo regarding payment or benefits (i.e., an approval or denial) to which an enrollee believes he or she is entitled, such as:

A decision not to provide or pay for a Part D drug (including a decision not to pay because the drug is not on the plan’s formulary, because the drug is determined not to be medically necessary, because the drug is furnished by an out-of-network pharmacy, or because the Part D plan sponsor determines that the drug is otherwise excluded under section 1862(a) of the Social Security Act, if applied to Medicare Part D that the enrollee believes may be covered by the plan;

• Failure to provide a coverage determination in a timely manner, when a delay would adversely affect the health of the enrollee;
• A decision concerning a tiering exception request under 42 CFR §423.578(a);
• A decision concerning a formulary exception request under 42 CFR §423.578(b); or
• A decision on the amount of cost sharing for a drug.
• The enrollee is no longer eligible for benefits under the benefit plan.
• Other requested service the enrollee believes he or she is entitled to receive under the benefit plan

A limit on the quantity (or dose) of a requested drug and the enrollee disagrees with the requirement or dosage limitation;
 
A requirement that an enrollee try another drug before the plan sponsor will pay for the requested drug and the enrollee disagrees with the requirement; and

A decision whether an enrollee has, or has not, satisfied a prior authorization or other utilization management requirement.

An enrollee, an enrollee's physician, or an enrollee's appointed representative may request a standard or expedited coverage determination by filing a request with the plan sponsor.

How to Request a Coverage Determination

Expedited requests may be filed orally or in writing.

Standard requests must be filed in writing, unless the plan sponsor accepts requests orally.

Written requests may be made by using the Coverage Determination Request Form (the pdf is attached, there needs to be a “click here for the Coverage Determination Request Form), a coverage determination request form developed by a plan sponsor or other entity, or any other written document prepared by the enrollee, the enrollee's physician, or any other person.

Physicians may also submit written requests on the Coverage Determination Request Form for Physicians (link to pdf attached on the For Providers tab – different form). This form can be used to request a coverage determination or exception, submit a statement in support of an exceptions request, or attempt to satisfy a utilization management requirement.

How a Plan Sponsor Processes Coverage Determination Requests

For coverage determinations that do not involve exceptions requests, a plan sponsor must notify an enrollee of its coverage determination within 24 hours after receiving an expedited request or 72 hours after receiving a standard request.

For coverage determinations that involve exceptions, the adjudication timeframes do not begin until the enrollee's prescribing physician submits his or her supporting statement to the plan sponsor.

If the plan sponsor's coverage determination is unfavorable, the decision will contain the information needed to file a request for redetermination with the plan sponsor.

What is an expedited coverage determination?

An expedited coverage determination will be granted at the enrollee’s or prescribing physician’s request if the drug has not yet been dispensed and it is determined that applying the standard timeframe for making a determination may seriously jeopardize the life or health of the enrollee or  the enrollee’s ability to grain maximum function.  The network pharmacy and/or Appeals Contractors must accept all information provided by the prescribing physician whether the information is provided orally or in writing.

What is the difference between a coverage determination and an appeal?

A coverage determination must first be preformed prior to the enrollee or enrollee’s appointed representative exercising the enrollee’s right to an appeal. An appeal is the re-review of a coverage determination by a person/entity other than the person/entity that made the initial coverage determination.

How to Appeal

If the plan decides against you, you can appeal the decision. There are five levels of appeal available to you.

1. Appeal through your plan (called a “redetermination”). You must request this appeal within 60 calendar days from the date of the coverage determination. You or your appointed representative must file a standard request, in writing, unless your plan accepts requests by telephone. You, your appointed representative, or your doctor can call your plan or write to them for an expedited request. Your request will be expedited if your plan determines or your doctor tells your plan that your life or health will be seriously jeopardized by waiting for a standard decision. Your plan’s address is in your plan materials. Once your plan receives your request for an appeal, the plan has seven days (for a standard request for coverage or for a request to pay you back) or 72 hours (for an expedited request for coverage) to notify you of its decision.

2. Review by an independent review entity (called a “reconsideration”). If the plan again decides against you, you can request a review by an independent review entity (IRE). You or your appointed representative must make a standard or expedited request within 60 days from the date of the decision. The request must be made, in writing, to the IRE. Your request will be expedited if the IRE determines or your doctor tells the IRE that your life or health will be seriously jeopardized by waiting for a standard decision.

Once the request for review has been filed, the IRE has seven days (for a standard request for coverage or for a request to pay you back) or 72 hours (for expedited requests for coverage) to notify you of its decision.

3. Hearing with an administrative law judge. If the IRE agrees with your plan’s decision, you or your appointed representative can request a hearing with an administrative law judge (ALJ). You must make the request in writing within 60 days from the date of the notice of the IRE decision. You must send your request to the entity specified in the IRE’s reconsideration notice. To receive an ALJ hearing, the projected value of your denied coverage must meet a minimum dollar amount (you may be able to combine claims to meet the minimum dollar amount). The IRE’s decision will include this amount.

4. Review by the Medicare Appeals Council. If the ALJ agrees with your plan’s decision, you or your appointed representative can request a review by the Medicare Appeals Council (MAC). You must make the request to the MAC, in writing, within 60 days from the date of the notice of the ALJ’s decision.

5. Review by a Federal court. If the MAC agrees with your plan’s decision, you or your appointed representative can request a review by a Federal court. You must make the request, in writing, within 60 days from the date of the notice of the MAC’s decision. You must send your request to the entity specified in the MAC’s decision notice. To receive a review by a Federal court, the projected value of your denied coverage must meet a minimum dollar amount. The MAC’s decision will include the amount.

Note: When you join a Medicare drug plan, the plan will send you information about the plan’s appeal procedures. Read the information carefully and keep it where you can find it when you need it. Call your plan if you have questions.

What is a Grievance?

A grievance is defined as any complaint or dispute, other than one that involves a coverage determination, expressing dissatisfaction with any aspect of the operations, activities, or behavior of a Part D Sponsor, regardless of whether remedial action is requested. Examples of subjects of a grievance provided in the solicitation for applications include, but are not limited to, timeliness, appropriateness, access to, and/or setting of services provided by the PDP sponsor, concerns about waiting times, demeanor of pharmacy or customer service staff, a dispute concerning the timeliness of filling a prescription or the accuracy of filling the prescription.

A grievance may also include a complaint that a Part D plan sponsor refused to expedite a coverage determination or redetermination.

Some examples of grievances are listed below (this is not an all inclusive list).

• Excessive wait times at the pharmacy to get a prescription filled
• Inappropriate, rude or abusive behavior by a pharmacist or pharmacy employee
• Inability to reach the pharmacy by phone to obtain needed information regarding how to take a prescription or potential drug interactions/allergy
• Cleanliness or condition of a network pharmacy
• Beneficiary is being encouraged to leave (disenroll from) a FICo plan
• Problems with beneficiary services received
• Problems with how long the beneficiary has to spend waiting on the phone to talk with a pharmacist
• Beneficiary disagrees with a decision not to expedite his/her request for an expedited coverage determination or redetermination.
• Notices or other written materials are difficult to understand
• Failure by the PBM to give the beneficiary a decision within the required timeframe
• Failure to forward the beneficiary’s case to the independent review entity (e.g., QIO) if FICo does not give a decision within the required timeframe.
• Failure of PBM or FICo to provided required notices to the beneficiary
• Failure of PBM or FICo to provide required notices that comply with CMS standards (e.g., appropriate language)

A “fast grievance” is defined as any grievance that due to its nature and impact upon the beneficiary requires an expedited review, and may include a decision by the plan to refuse to grant a request for an expedited coverage determination under 42 CFR §423.570 or an expedited redetermination under 42 CFR §423.584.

Appointing a representative

A party may appoint a representative if he or she wants assistance with their appeal. A physician or supplier may act as a beneficiary’s appointed representative. A party may appoint a representative to act on his or her behalf by completing Form CMS-1696, Appointment of Representative (AOR), which is available at www.cms.hhs.gov/CMSForms/CMSForms/list.asp#TopOfPage on the CMS website. A party may also appoint a representative through a submission that meets the following requirements:

• It is in writing and is signed and dated by both the party and the individual who is agreeing to be the representative;
• It includes a statement appointing the representative to act on behalf of the party and if the party is a beneficiary, authorizing the adjudicator to release identifiable health information to the appointed representative;
• It includes a written explanation of the purpose and scope of the representation;
• It contains the name, telephone number, and address of both the party and the appointed representative;
• If the party is a beneficiary, the beneficiary’s Medicare HIC number; It indicates the appointed representative’s professional status or relationship to the party; and
• It is filed with the entity that is processing the party’s initial determination or appeal.

A representative may submit arguments, evidence, or other materials on behalf of the party. The representative, the party, or both may participate in all levels of the appeals process. Once both the party and the representative have signed the AOR Form, the appointment is valid for one year from the date of the last signature for the purpose of filing future appeals unless it has been revoked.

As noted above, a beneficiary may also assign (transfer) his or her appeal rights to a physician or supplier who is not a party to the initial determination and who furnished the items or services at issue in the appeal. A beneficiary must assign appeal rights using the form CMS-20031, Transfer of Appeal Rights, available at www.cms.hhs.gov/CMSForms/CMSForms/list.asp#TopOfPage on the CMS website. A physician or supplier who accepts assignment of appeal rights must waive the right to collect payment from the beneficiary for the items or services at issue in the appeal, with the exception of deductible and coinsurance amounts and when a valid Advance Beneficiary Notice is in effect.

After an initial claim determination is made, the appeals process is as follows:

• Redetermination by Medicare Contractor;
• Reconsideration by Qualified Independent Contractor (QIC);
• Hearing by Administrative Law Judge (ALJ);
• De Novo Review by Medicare Appeals Council (MAC); and
• Judicial Review.