American College of Physicians: Internal Medicine — Doctors for Adults ®


Demystifying Medicare Part D's exceptions and appeals

From the April ACP Observer, copyright 2006 by the American College of Physicians.

(Updated December 2008)

By Neil Kirschner, PhD

If you're struggling to align your Medicare patients' drug needs with their new Medicare Part D drug plan, you're not alone. Physicians nationwide report that many patients can't find their currently prescribed medication on their new plan's formulary--or that the drugs come with a high copay or some form of plan approval.

To help iron out problems, here are answers to frequently asked questions:

Q: Drugs I'm prescribing aren't on my patients' formulary or are too expensive. What are my options?

A: First, consider prescribing a different but therapeutically equivalent drug on the plan's formulary. Drug formularies are available on the plan's Web site and through the formulary finder posted by the Centers for Medicare and Medicaid Services (CMS).

You can also find Part D formulary information through the Epocrates Web site. The Epocrates site provides Part D plan formularies and information on a drug's cost-sharing tier and potential therapeutic equivalents.

If you can't find a therapeutic equivalent, consider requesting an exception.

Q: What types of exceptions are available?

A: There are three different types of exceptions:

  • Formulary exception. Request a formulary exception to get coverage of a non-formulary drug if you believe that none of the formulary drugs would be as effective as the non-formulary medication you've prescribed—or if you think the formulary drugs would have adverse effects.

  • Cost-tiering exception. Most Medicare Part D plans have at least three and usually four cost-tiering levels that correspond to a beneficiary's copay requirement; the lower the tier, the less the required copay. Request this type of exception to seek lower-tier cost sharing for a formulary drug—if you believe no formulary drug in a lower cost tier would be as effective as the drug you've prescribed.

  • Cost utilization management tool exception. Request this type of exception to get a beneficiary excluded from a plan's step therapy, dose restriction or prior authorization requirement related to a formulary drug. You would ask for this exception if a patient shouldn't have to try a non-prescribed drug first (step therapy) because that patient has already tried that drug or could have an adverse reaction to it.

    You should also request this exception to get a plan to remove authorization requirements for a prescribed drug if the patient has already met those requirements.

Q: Are all Part D plans required to have an exceptions and appeals process?

A: Yes they are. The first level of exception is called a determination, and an adverse determination decision can be appealed through graduated appeal levels. Each appeal level has a specific time frame in which a decision must be provided.

Q: How do I make an initial exception request?

A: Different plans have different rules, and plans must provide information about those rules upon request.

You can request an expedited exception for enrollees suffering from a serious health condition who need quick access to the requested drug—and all plans must respond to expedited exception requests made by phone. You can find the plan's phone number on its Web site .

Q: What if that first request is turned down?

A: Your next recourse is the appeals process—and a plan must provide the person making the request with a description of that process when it denies an initial exception request. At each appeal level, decisions must be made in a specified time frame, and you can request an expedited appeal.

The exception/appeal process for a plan may require the person making the request—the prescribing physician or enrollee—to complete a written form. A coalition of medical specialty organizations, including ACP, has succesfully required plans to accept a standard form.

Q: Who can make an exception and appeal request?

A: An exception and a first-level appeal can be requested by the enrollee, the prescribing physician, or the enrollee's appointed or authorized representative, such as a staff member of a state pharmaceutical assistance program. A physician's supporting document is typically required.

Q: What happens if the plan denies both the exception and the first-level appeal?

A: Enrollees or their appointed or authorized representative can request a second-level appeal, called a reconsideration. A review agency that is independent of the Part D plan—an independent review entity (IRE)—conducts these appeals. If that request is denied, the IRE will tell you about other independent appeal levels.

Neil Kirschner, PhD, is a Senior Associate in Regulatory and Insurer Affairs in ACP's Washington office.



Part D resources

ACP's Medicare Part D Web site has a schedule of different Part D appeal levels. You also can access the site's table of contents.

The College has also created a Web site for members to e-mail specific Part D-benefit problems and get help from ACP staff. You can post questions online or call the ACP Part D helpline at 800-338-2746, ext. 4535.


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