THE CONTINUING SAGA OF PART D APPEALS
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Introduction
The Centers for Medicare & Medicaid Services (CMS), the agency that administers Medicare, states that everyone who enrolls in a Medicare prescription drug plan will have access to all medically necessary prescriptions. In order to have such access, however, plan enrollees may have to avail themselves of various processes established by the Part D statute and its implementing regulations to challenge a plan’s formulary decisions.
The appeals process begins with a request for a Coverage Determination by the drug plan. The term “Coverage Determination” is broad and includes such claims as a request for prior authorization by the drug plan, an exception for coverage of a non-formulary drug, and an exception to a utilization management requirement. If the Coverage Determination is unfavorable, the enrollee may appeal through four levels of review: a Redetermination by the drug plan, a Reconsideration review by the independent review entity (IRE), appeal to a Medicare administrative law judge, and review by the Medicare Appeals Council. The enrollee may ultimately appeal to federal court.
On-going experience with the Part D appeals process confirms concerns raised by the Center for Medicare Advocacy that the process does not work to promote access to medically necessary drugs.[1] Beneficiaries continue to have problems getting into the appeals system. Once in the system, they experience difficulties in moving through the different levels of review. This Weekly Alert describes several actual cases to illustrate the problems beneficiaries encounter in getting access to their prescribed medications.
Getting Into the Appeals Process
Lack of Notice: Individualized notice of the reasons for the denial and the right to file an appeal are not provided at the pharmacy counter where an enrollee first learns that the plan will not pay for or otherwise provide a requested prescription. An enrollee who wants further information or wants to appeal must first contact the plan to get a Coverage Determination that will inform him or her of any appeal rights that might ensue from the denial. Each drug plan must arrange with pharmacies within its network to either post a generic notice telling enrollees to contact the plan if they disagree with the information provided by the pharmacist or to distribute such a generic notice. Advocates continue to report that the generic notices are not posted or distributed, and if they are posted they are difficult to read. Thus, at the time they are denied access to their prescribed drugs, beneficiaries receive no information about the avenues available to them and so are unlikely to request redress from their prescription drug plan.
Grievances Versus Appeals: The Part D process, like the Medicare Appeals process, consists of both the appeals system described above, through which a beneficiary may dispute issues involving drug coverage, and a grievance system through which beneficiaries may complain about the service they have received. When a Part D plan receives a complaint, the plan must determine whether the complaint is to be treated as a Coverage Determination, the first step in seeking an appeal, or as a grievance. Unfortunately, problems arise for beneficiaries when plans treat their complaints as grievances to be handled through the plan’s grievance process. Such beneficiaries will not get a Coverage Determination that allows them to request an appeal.
Example: A drug plan did not respond, in writing or otherwise, to a plan enrollee’s letter disputing cost sharing for a drug. The enrollee’s advocate wrote to inform the plan that the enrollee’s original request was a request for a Coverage Determination, that the plan did not follow the appropriate timelines for issuing Coverage Determinations, and that the issue should have been automatically forwarded to the independent review entity (IRE) by the plan. The plan’s response to the advocate did not address the Coverage Determination request and continued to treat the issue as a grievance.
Failure to Comply with Time Frames: The Part D regulations
establish both standard and expedited time frames for plans to issue
Coverage Determinations, as well as time frames for issuing
decisions during the appeals process. They also establish time
frames for responding to grievances. If a drug plan does not issue a
timely Coverage Determination or Redetermination, the regulations
require the plan to send the claim directly to the independent
review entity. As the above example shows, some plans neither
comply with the regulatory time frames nor send cases to the IRE
when time frames are not met.
Improper Coverage Determination: A Part D drug plan is required to provide an enrollee with notice of an adverse Coverage Determination. Notice also must be provided to the prescribing physician if the prescribing physician filed the Coverage Determination request on behalf of the enrollee. The plan may initially provide oral notice when the Coverage Determination request was expedited; however, all enrollees (and physicians where appropriate) must receive a written Coverage Determination. Plans are required to use a standard Coverage Determination form developed by CMS. The form identifies the prescription at issue, explains the reason for denial, and describes the process to follow (both standard and expedited) if the enrollee wants to take further action. Despite the existence of these requirements, some plans fail to provide enrollees with the information they need to request an appeal.
Example: An enrollee whose prescribing physician filed a request for a Coverage Determination did not receive a written notice of denial. Instead, the physician received a Coverage Determination from the drug plan that was not on the CMS form and that did not include the required elements. No mention was made of the reasons for denial or of appeal rights. The Coverage Determination stated:
“Dear Prescriber, A Request for a Prior Authorization has been entered in the [plan name] System. The Request is currently Denied. Note to Prescriber: [Name of drug] is not a covered benefit under this patient’s plan. Please consider formulary alternatives [names of alternative drugs].”
Improper Redetermination Notice: A beneficiary who requests a Redetermination of an unfavorable Coverage Determination by the drug plan is entitled to receive written notice of an unfavorable Redetermination. The written notice must include the reasons for the adverse decision and the right to request a Reconsideration. CMS has developed a model Redetermination notice, as opposed to the mandatory Coverage Determination notice, for plans to use. Plans that modify the model notice are supposed to seek CMS approval of the changes. Not all plans use the model notice or comply with the approval process, however.
Example: An enrollee received a Redetermination letter with no description of further appeal rights. Instead, the letter simply stated:
“Based on the information provided in the formulary, it has been determined that this medication is not a covered benefit under your Part D coverage. Please contact you (sic) physician for alternative medications and or treatment. Please refer to you (sic) formulary for covered medications. If you have any questions regarding this matter or wish to speak with a representative, please contact the Member Services Department at [phone number].
What Should a Beneficiary or an Advocate do when Appeal Problems Arise?
First and foremost, know the Part D appeals process. Check the
regulations and the Part D manual when questions arise. Contact the
plan directly to complain and to make sure the procedures are being
followed. If the plan treats a Coverage Determination request as a
grievance, contact the plan again to reinforce that the claim is a
Coverage Determination. File an appeal to the next level of review
even if the notice received does not include information about
appeal rights.
If the plan does not comply with the proper time frames, including
when the plan treats a Coverage Determination as a grievance, file a
Reconsideration request directly with Maximus, the entity with which
CMS contracts to perform Reconsideration reviews.
Send Reconsideration requests from stand-alone prescription drug
plans (PDPs) to:
Maximus,
1040 First Avenue, Suite 200
King of Prussia, PA 19406
fax (484) 699-5601
Send Reconsideration requests from Medicare Advantage plans (MA-PDs) to:
Maximus,
50 Square Drive, Suite 120
Victor, NY 14564,
fax (585) 425-5301
Be sure to include evidence that a Coverage Determination request or a Redetermination request was filed and that the time for ruling on the request has expired.
File a complaint with the CMS regional office when a plan fails to comply with some aspect of the Part D appeals rules. Contact information for CMS regional offices is available at www.medicare.gov. Failure to comply with the appeals process violates both the Medicare regulations and the Part D plan contract with CMS. CMS has authority to take enforcement action, including imposing sanctions on plans, for violations.
The Center for Medicare Advocacy wants to hear about on-going problems with Medicare Part D appeals. Please contact attorney Vicki Gottlich in the Center’s Washington, D.C. office, vgottlich@medicareadvocacy.org, if your clients have experienced these or other difficulties when seeking a Coverage Determination or appeal.
References
42 C.F.R. §§ 423.560 – 423.638.
Chapter 18, Part D Enrollee Grievances, Coverage Determinations, and Appeals, Prescription Drug Benefit Manual; http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/PartDManualChapter18.pdf.
[1] See, e.g., V.Gottlich, Beneficiary Challenges in Using the Medicare Part D Appeals Process to Obtain Medically Necessary Drugs (Kaiser Family Foundation September 2006), http://www.kff.org/medicare/upload/7557.pdf.
Copyright © Center for Medicare Advocacy, Inc. 05/05/2008