As the May 15th deadline for enrolling into Medicare Part D has passed, millions of Medicare beneficiaries across the country are attempting to access their drugs through their Part D plan. As discussed in last edition’s article, ‘How Are People with Medicare and Medi-Cal Fairing Under Medicare Part D,’ accessing one’s prescription drugs can be fraught with difficulties, especially for those dually eligible for both programs. Although the Centers for Medicare and Medicaid Services (CMS) requires Part D plans to have a ‘transition’ policy, it only requires a plan to fill a prescription for a non-formulary drug or for a drug that requires prior authorization or other plan approval one time when the person first enrolls in the plan. After receiving the transitional first-fill, the beneficiary is expected to either go through the appeals process to get the drug paid for by the plan or get a prescription for a different drug that is on the plan’s formulary from the treating physician. Yet, many beneficiaries are not notified about this process. Pharmacies are supposed to give, or at least post, a standard notice directing beneficiaries to contact their plans about filing an appeal, but many do not. As a result, many people who have already received their first fill are leaving pharmacies without their medications and without knowing about their appeal rights. This article provides a discussion of some key differences in Part D appeals versus other Medicare appeals, a brief overview of the appeals process and some links to easy-to-read appeals flow charts.
Differences in Part D appeals
Having the option to file an appeal is a basic Medicare right. While Medicare Part D upholds that right with its own appeals process, its process differs from those in Original Medicare and Medicare Advantage in three critical ways.
- As mentioned above, beneficiaries are not automatically notified of their appeal rights when denied coverage for their prescriptions. With Original Medicare and Medicare Advantage, if an item or service is denied coverage, the beneficiary will receive a written notice stating why it is not covered and what their rights are for making an appeal. With Part D, however, beneficiaries do not receive such a notice at the pharmacy. Although pharmacists should tell or post a notice that directs beneficiaries to call their Part D plan to find out 1) why their drug was not covered, and 2) how to file an appeal, many do not. With the burden of action on the beneficiary to contact their plan and ask how to request an appeal, many beneficiaries may fall through the cracks, not exercise this right, and therefore not get the drugs they need. This situation is even more probable for those who speak limited English.
- While the basic steps in Part D appeals are the same for all plans, the details of the appeals process are not standardized. This means that each plan has its own forms and internal review criteria for granting coverage. Fortunately, in early April, the American Medical Association (AMA) and the Association of Health Insurance Plans (AHIP) along with several other advocate groups put together a standardized appeal form for physicians. This means that while review criteria for granting coverage still varies among plans, doctors now at least have access to a standardized Part D appeals form that should be able to be used in all plans.
- Many Part D appeals (those requesting an ‘exception,’ discussed below) require the participation of a physician. This requirement puts beneficiaries in a precarious situation. It takes the ability to execute an appeal out of their hands and places it into their doctors’. It relies on doctors’ uncompensated willingness, time, and effort to make these appeals on behalf of their patients. Many physicians say that it takes at least one half hour to complete an appeal request, depending on the evidence requirements for such a request. Because of this extra uncompensated burden, many doctors have patients schedule an appointment just to deal with appeals issues and/or charge fees of $5-$20 per appeal. This fee poses significant barriers to beneficiaries with low-incomes struggling just to meet the new Part D copayment amounts.
The first step in the appeals process is requesting a coverage determination. When a beneficiary is unable to get the medication she needs, she and/or an appointed representative or provider must contact her Part D plan by phone or letter to make this request. Once the plan receives the request, it has 72 hours or 24 hours to notify the beneficiary of its decision, depending on the type of request made:
- Standard Request – the plan has 72 hours to respond starting from the time they receive the request;
- Expedited Request – the plan has 24 hours to respond. Similar to Medicare Advantage appeals, a plan must expedite the expedited requests from doctors. While beneficiaries and/or their appointed representative can also request an expedited decision, plans are not required to grant such a request.
If expedited, the plan may first notify the beneficiary of its decision within 24 hours by telephone. It will also mail a written expedited coverage determination letter within three calendar days. If the plan does not give a written notice about its expedited determination within these timeframes, the plan must send the request for expedited coverage determination to the Independent Review Entity (IRE), which is discussed in Step 2 in the appeals process outlined below.
Note that for Exceptions, a type of coverage determination discussed below, the clock for standard and expedited requests does not start ticking until a beneficiary’s doctor submits supporting evidence to the plan.
As written in a memo to all Part D plans (3/30/06), the Centers for Medicare and Medicaid Services (CMS) ‘expects’ plans to give temporary supplies of non-covered drugs to affected beneficiaries when a plan is unable to meet these timeframes for coverage determinations, redeterminations (discussed below) or in forwarding cases to the IRE. CMS states that these drugs “should be given” until the case is fully resolved. Advocates and beneficiaries who come across situations where this is not happening can let CMS know by contacting their CMS Regional Office.
An exception is a type of coverage determination that requires the participation of one’s physician. While beneficiaries, appointed representatives, or doctors can request an exception, as stated above, the clock does not start ticking until the plan receives the doctor’s supporting written statement explaining why the drug is medically necessary. This requirement of physician participation is one of the key differences between the Medicare Part D appeals process and other Medicare appeals discussed earlier.
Beneficiaries can request an exception if:
- They are taking a drug that has been removed from the plan’s formulary;
- A non-formulary drug is prescribed and is medically necessary;
- A drug is on the formulary but not covered because of a plan’s cost utilization tools (such as prior authorization or step therapy);
- The cost-sharing for medically necessary prescribed drug increases;
- They are asking for the plan to cover a non-preferred drug at the preferred drug cost.
In general, an exception request must be granted for these two situations:
- When the prescribing doctor determines that all the drugs on the formulary would not be as effective as the non-formulary drug or would have adverse effects;
- When the prescribing doctor determines that the preferred drug for the treatment of the condition would not be as effective as the non-preferred drug or would have an adverse effect.
As every plan has its own exceptions forms, process and evidentiary standards, physicians must contact the plan of each beneficiary needing an exception and follow their specific guidelines. Each plan must make its exceptions and appeals forms available upon request to all enrollees and providers via U.S. mail, fax, and the internet (CMS memo to all Part D plans, 3/17/06). CMS also has a model “Coverage Determination Request Form” that beneficiaries can use. While CMS ‘recommends’ that all Part D plans accept this form, those who want to use it should first check with their plan.
Once an exception is granted, it remains in effect for the calendar/plan year (as long as the doctor continues to prescribe it). People who renew their enrollment in the same Medicare drug plan at the end of the year may be required to submit a new exception request in the new calendar/plan year.
If the drug plan denies coverage, the plan must notify the beneficiary (and her/his doctor, if he or she is the one who made the exception request) in writing within 72 hours, explaining the reason for the denial and how to continue in the appeals process.
If a plan’s coverage determination is not in the beneficiary’s favor, s/he can appeal the decision. The five levels of appeal are outlined below as well as on Calmedicare.org
Step 1: Redetermination by Plan
This step is again through the drug plan. Beneficiaries, their appointed representatives, or their doctors must request this appeal in writing within 60 calendar days from the date of the coverage determination. Redeterminations can be expedited if the plan determines, or if one’s doctor tells the plan, that her/his life or health will be seriously jeopardized by waiting for a standard decision. Once received, the plan has seven days (standard) or 72 hours (expedited) to notify the beneficiary of its decision.
Step 2: Reconsideration by Independent Review Entity (IRE)
Beneficiaries dissatisfied with the Redetermination, can request a Reconsideration by an independent review entity (IRE). A standard or expedited request must be made within 60 days from the date of the decision. It must be in writing and sent directly to the IRE. Once the request is filed, the IRE has seven days (standard) or 72 hours (expedited) to notify the beneficiary of its decision.
The IRE is required to ask a person’s prescribing doctor for his or her opinion about the appeal and include a written account of the doctor's input in the redetermination documentation. The IRE is called Maximus CHDR (Center for Health Dispute Resolution) and more information can be found at their website:http://www.medicarepartdappeals.com.
Step 3: Hearing with an Administrative Law Judge (ALJ)
Those not satisfied with the Reconsideration decision, can request a hearing with an ALJ from the federal Department of Health and Human Services. This request must be made in writing within 60 days of the IRE decision, and sent to the entity specified in the IRE's reconsideration notice. To receive an ALJ hearing, the projected value of the denied coverage must meet a minimum dollar amount ($110 in 2006). To meet the required dollar amount, beneficiaries can:
- Use the projected value of the drug (or drugs) in question over the course of the calendar year;
- Combine two or more of their appeals; or
- Combine two or more appeals with other people in the same drug plan.
Once the request has been received, the ALJ generally has 90 days to make a decision, though this timeframe can be extended for several reasons, including submission of new evidence and if the beneficiary requests an in-person hearing. Hearings are generally done over the phone or through videoteleconference. (See article on ALJ hearing changes for information on why most hearings are no longer done in person and the potential consequences of this change.)
Step 4: Review by the Medicare Appeals Council (MAC)
If a beneficiary is dissatisfied with the ALJ's decision, s/he can request a review by the MAC. The request must be made in writing to the MAC within 60 days from the date of the notice of the ALJ's decision. The MAC generally has 90 days to make a decision after receiving the request. There will generally be no hearing during this stage of appeal.
Step 5: Review by a Federal Court
Those still dissatisfied, can request a review by a Federal court. Requests must be in writing within 60 days of the date of the notice of the MAC's decision. The projected value of the denied coverage must also meet a minimum dollar amount of $1,090 in 2006.
Appeals process flow charts
Below are some links to a few good quick reference appeals flow charts.
- Health Assistance Partnership (HAP)
- Mental Health Part D Exceptions and Appeals flow chart – Created by a group of mental health organizations, this chart has a helpful exceptions and appeals flow chart geared towards physicians. It outlines the specific information doctors need to submit for three general kinds of exceptions.
As millions of beneficiaries are now enrolled in Medicare Part D, a growing number will need to access the appeals process to get the drugs they need. California Health Advocates encourages advocates to keep a close record of any challenges and glitches encountered in the appeals process, and to share these stories and ideas for solutions with CHA, their Congressional representatives, the media and staff at CMS regional offices.