Medicare Part D Appeals

by: Begley Admin

Each drug plan must have an appeals process.  Expedited requests are available.

Stages of Review

1. Coverage Determination

A coverage determination is issued by the drug plan.  It may be requested by a beneficiary, the beneficiary’s appointed representative, or a prescribing physician.  The drug plan must issue a coverage determination as expeditiously as enrollee’s health requires, but no later than 72 hours (for a standard request, including when the beneficiary already paid for the drug) or 24 hours (if expedited because the standard time frame would jeopardize the life or health of the beneficiary or the beneficiary’s ability to regain maximum function).

An “exception” is a type of coverage determination.  It gets the enrollee into the appeals process.  Beneficiaries may request an exception to cover non-formulary drugs, to waive utilization management requirements, and to reduce cost-sharing for a formulary drug.  There is no exception for specialty drugs or to reduce the costs of tiered co-pay for generic drugs.  A doctor must submit a statement in support of an exception.

There are national coverage determinations (NCDs) and local coverage determinations (LCDs).  A request to issue an NCD must be made to CMS, but a request to issue an LCD must be made through the local Medicare Administrative Contractor.  An individual can file a challenge with CMS to get a policy overruled even if he or she did not receive the service.  Additionally, relief may be in the form of changing the policy, rather than awarding coverage.

A statement by a pharmacy, not by the plan, that the plan will not cover a requested drug is not a coverage determination.  Enrollees who want to appeal must contact their plan to get a coverage determination.  Drug plans must arrange with their network pharmacies to post generic notices telling enrollees to contact the plan if they disagree with information provided by the pharmacist.

2. Redetermination by Drug Plan

If a coverage determination is unfavorable, a beneficiary has 60 days to file a written request for a redetermination by the Part D drug plan.  The plan may accept oral requests.  The plan must act within 7 days for a standard appeal.  For an expedited appeal, the plan must act within 72 hours.

3. Reconsideration by Individual Review Entity (IRE)

The next level of appeal is reconsideration by the Individual Review Entity (IRE).  For a standard appeal, the beneficiary has 60 days to file a written request, and the IRE must act within 7 days.  For an expedited appeal, the IRE must act within 72 hours.

4. Hearing before Administrative Law Judge (ALJ)

The next level of appeal is a fair hearing.  As in other administrative matters, this hearing is held before an Administrative Law Judge (ALJ).  It is a quasi-judicial proceeding in which limited discovery can be taken.  The hearing before an ALJ is similar to a hearing in a civil court.  Typically, the judge will make a written decision shortly after taking testimony and listening to arguments.

5. Medicare Appeals Council Review (MAC)

After the ALJ makes a determination, there is a review by the Medicare Appeals Council Review (MAC).  This council can either uphold or reverse the determination made at the fair hearing.

6. Federal Court

The next level of appeal is with the federal court.  Pleadings must be filed shortly after the receipt of the determination of the MAC.  The court will then set forth a schedule for briefing and arguments.


Each drug plan must have a separate grievance process to address issues that are not appeals.  These grievances may be filed orally or in writing within 60 days.  Plans must resolve grievances within 30 days, or within 24 hours if the grievance arose from a decision not to expedite a coverage determination or redetermination.

Appeals Issues

1. Notice

Representatives must receive Medicare Summary Notices.

2. Evidentiary Issues

Medicare Part D appeals involve burdensome evidentiary standards.  Providers must submit evidence at reconsideration.  Beneficiaries must submit evidence at the ALJ hearing.

3. Timeliness and Time Frames

Compliance with time frames depends on who is issuing the decision.  The overall process is quite lengthy.  There are no time frames to issue ALJ decisions in Part D cases.

4. Conduct of ALJ Hearings

Individuals must request the record of a pre-hearing case review and may have to pay the costs of such.

5. Representing a Client

An appointment of representative form must be completed and signed by the beneficiary and the representative.  This form authorizes the release of identifiable health information to the representative.  It also explains the purpose and scope of the representation.  This form is filed with the entity processing the party’s initial determination or appeal.  The appointment form is valid for one year, but it remains valid if the appeal takes longer than one year.  If an individual files multiple appeals during the year, he or she must file a copy of the original form with each appeal.

Legal Fees

Below the ALJ level, legal fees are not regulated.  CMS must approve legal fees for work done at the ALJ and MAC levels; however, there is no standard fee schedule.  Attorneys’ fees are not paid out of the award to the client or out of the Medicare trust fund.