Medicare Appeals: Part D Drug Denials. December 16, 2014

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1 Medicare Appeals: Part D Drug Denials December 16, 2014

2 2013 Appeals Statistics by Type 23,716 Part D Reconsideration Appeals* Appeals Type Percentage of Total Appeals Appeals Per Million Medicare Beneficiaries Rate of Successful Reversal Off-Formulary 13% % Drug Utilization Mgmt 12% % Cost Sharing Dispute 6% % Tier Exception 5% % Out of Network Pharmacy 4% % Non-Part D 60% % *Statistical data derived from PART D RECONSIDERATION APPEALS DATA

3 Statistical Comparison of 2012 to 2013 *Statistical data from PART D RECONSIDERATION APPEALS DATA

4 Objectives Provide a brief overview of the general structure of Medicare Appeals Take a more thorough look at how to file a Part D Drug Appeal Identify key points of decision that influence the direction of advocacy and likelihood of success Make you feel more comfortable assisting beneficiaries work out their problems

5 Basic Structure of the Medicare Appeals Process

6 Rights to Appeal You have the right to appeal when Medicare Denies a request for a health care service, supply, item, or prescription drug that you think you should get; Denies a request for payment of health care service, supply, item, or prescription drug that you already got; Denies a request to change the amount you must pay for a healthcare service, supply, item, or prescription drug; or Stops providing or paying for all or part of an item or service you think you still need

7 Medicare Appeals Each part of Medicare (A/B, C, and D) has its own appeals process. For each part, there are separate procedures for the standard and expedited (fast) appeal. There are 6 types: Standard appeal of Original Medicare (Parts A & B) Expedited appeal of Original Medicare (Parts A & B) Standard appeal of Medicare Advantage (Part C) Expedited appeal of Medicare Advantage (Part C) Standard appeal of Prescription Drug Coverage (Part D) Expedited appeal of Prescription Drug Coverage (Part D)

8

9 5 Levels of Appeal Initial Denial of Drug Coverage Determination Level 1: Redetermination Part A/B Standard Financial Intermediary, Carrier or Medicare Administrative Contractor Part A/B Expedited Quality Improvement Organization Part C Standard or Expedited (non-prescription) Health Plan Part D Standard or Expedited MA-PD/PDP

10 5 Levels of Appeal (cont.) Level 2: Reconsideration or Independent Review Part A/B Standard or Expedited Qualified Independent Contractor Part C Standard or Expedited Independent Review Entity Part D Standard or Expedited Part D Independent Review Entity Level 3: Hearing by Administrative Law Judge Parts A/B, C, & D -- Office of Medicare Hearings and Appeals Level 4: Hearing by Medicare Appeals Council (A/B, C, and D) Level 5: Hearing in Federal District Court (A/B, C, and D)

11 Part D Drug Appeal Structure

12 For Administrative Law Judge 2015 AIC is $150 For Federal District Court 2015 AIC is $1460

13 Request for Determination by PDP/MA-PD (Not yet an Appeal) In response to an initial denial, the beneficiary and/or the prescribing doctor can ask the prescription drug plan to explain its decision and issue an official Determination regarding the denial. The drug plan may have its own form or the beneficiary can complete and send in the Request for Medicare Prescription Drug Coverage Determination Form. They should contain the same information. At this time the beneficiary needs to determine and declare intention Whether to represent himself or authorize a representative Whether to pursue a standard or expedited review/appeal

14 Determination Request Pages 1 & 2

15 Determination Request Page 3

16 Level 1 Part D - Redetermination An Appeal to the Drug Plan requesting overturn of the determination denying drug benefits. File immediately or within 60 days from the date of initial coverage determination Who files: Plan must accept any written request for redetermination from you, your representative, your doctor, or other prescriber. Appeal Process: detailed on your PDP/MA-PD initial determination and in plan materials Must choose between Standard and Expedited processing Format: Must be made in writing (unless plan allows filing by phone) May complete the Medicare Redetermination Request Form (CMS 20027) OR May complete your own written request providing the following: Your name, address, contact phone number, and Medicare number Name of drug in dispute Reason for appeal If have appointed representative, include that name, proof of representation, and contact information. Any other pertinent information and/or medical records Expected Response: PDP/MA-PD responds with a Redetermination Notice Expedited within 24 hours Standard within 72 hours for coverage, 14 calendar days for payment If denied, Plan includes a Request for Reconsideration Notice with the denial notice.

17 Redetermination Request Form CMS 20027

18 Level 2 Reconsideration by a Part D Independent Review Entity (IRE) An appeal to overturn the PDP/MA-PD Redetermination decision. Complete the Request for Reconsideration Notice (CMS 20033) as specified in the Redetermination Notice and plan materials and return it to the address provided File immediately or within 60 days from the date of Redetermination Notice Who files: Beneficiary, representative, doctor, or other provider Format: Must be made in writing (unless plan allows filing by phone) Expected Response: IRE responds with a Reconsideration Notice Expedited within 72 hours Standard within 7 days

19 Level 2: Reconsideration Request Form- CMS 20033

20 Level 3 Hearing with an Administrative Law Judge (ALJ) Submit a Request for Hearing by an Administrative Law Judge (CMS A/B) immediately or within 60 days from the date of Reconsideration Notice Must involve a minimum monetary amount (Amount in Controversy). For 2014 this AIC is $140. In 2015 AIC will be $150 May be able to combine claims to reach that amount Format: phone call or video-teleconference OR in-person OR can request a decision without hearing Standard v. Expedited: continue supporting original choice Expected Response: Expedited within 10 days after the request for hearing arrives at the Office of Medicare Hearings and Appeals field office Standard within 90 days after the request for hearing arrives at the Office of Medicare Hearings and Appeals field office Last time to introduce additional arguments and evidence Tips on filing for ALJ Hearing: aring.pdf

21 Level 3: Request For Hearing by an Administrative Law Judge CMS A/B

22 Level 4 Review by Medicare Appeals Council Submit a Request for Review of an Administrative Law Judge Medicare Decision/Dismissal (DAB -101) form immediately after or within 60 days from the date of ALJ decision Medicare Appeals Council will review regardless of dollar amount. Appeal Process: Submit a written request to the Appeals Council specifying Your name, address, phone number, Medicare number, and name of your prescription drug plan (the same for your representative) Name of prescription drug in dispute Statement identifying the parts of the ALJ s decision with which you disagree AND why you disagree ALJ Appeal Case number Statement requesting expedited decision and why Signature and that of appointed representative, if any. If requesting expedited review you can make an oral request by following the instructions in the ALJ s decision notice. Expected Response: Appeals Council response Expedited generally 10 days after the request for hearing arrives. Standard generally 90 days after the request for hearing arrives.

23 Level 4: Request for Review of Administrative Law Judge Medicare Decision / Dismissal - DAB-101

24 Level 5 Judicial Review by a Federal District Court To file for a review in a Federal District Court you must follow directions in your Appeals Council decision letter. This letter provides information on contacting the court. Check with the clerk s office of the Federal District court for specific instructions on filing the appeal. Requirements: Must file within 60 days of receiving your MAC determination. Must meet the Amount in Controversy (AIC) minimum of $1430 (2014) or $1460 (2015)

25 Part D Appeals Process

26 Preparing to Launch an Appeal Prepare the arguments and collect the documents before launching the appeal Document the on-going situation Verify the problem is a drug denial Write a statement that clearly states why the exception applies and should be granted Work with your doctor to write a detailed letter of medical necessity Determine the urgency of the situation Establish criteria for appointing representatives Make and execute a plan

27 Create and Maintain a Paper Trail Be obsessive about documentation Keep copies of all correspondence Keep a date log of all contacts Names, titles, phone numbers, fax numbers, s, etc. Notes of topics covered Thoughts and plans for next steps Keep date log nearby at all times

28 Verify the Problem Investigate why Medicare won t pay Verify drug plan is active Was it trouble at the pharmacy a denial Did the pharmacist stop when sale was not approved Did he file a Request for Prescription Information or Change Did beneficiary try another pharmacy Check for simple prescription errors Misspelling or confusion of drug and/or dosage prescribed Miscoding or type of drug prescription form Incompatible dosage or frequency quantity limits Lack of preauthorization Undocumented step-therapy Was it a formal determination letter regarding denial

29 At the Pharmacy Often the Beneficiary discovers at-the-counter in the pharmacy that the drug is not covered. The Pharmacist shares information with him, shows him the explanation of denial, and the fax form that the Pharmacist can send to the prescribing doctor. This Provider Communication Form collects all the specific information necessary to proceed to clarifying an initial drug determination. Beneficiary should carefully consider before purchasing the drug that is not covered. Even though he may be reimbursed if he wins the appeal, the fact that he has filled the prescription prohibits him from having an expedited appeal.

30 Reasons to Request Determination Formulary Exception: request coverage determination to have plan cover a drug not on formulary because the other treatment options on formulary do not work for you Tier Exception: request coverage determination to have plan charge a lower amount for a drug you are taking which is on the plan s non-preferred drug tier because other treatment options in your plan s preferred drug tier do not work for you Rule Exception: request a coverage determination because your doctor/prescriber believes you cannot meet one of its coverage rules (prior authorization, steptherapy, or quantity or dosage limits). Medical Necessity: request coverage determination because the plan will not cover a drug on formulary because plan believes you do not need it.

31 Collect Supporting Documents Beneficiary s Part D Supporting Statement Doctor s Letter of Medical Necessity: when appealing or requesting an exception detailed documentation must be provided by your doctor explaining and supporting your need for this drug. Plans may require this supporting statement in writing. Sometimes they will accept phone statements followed by written documentation in order to expedite the appeal. IMPORTANT: The time that the plan has to respond to your request starts after your plan gets the supporting statement.

32 Writing a Letter of Medical Necessity: A Guide for Physicians Pennsylvania Health Law Project, Updated September

33 Your letterhead here Re: Patient name: Address DOB Health plan and ID# Template for Doctor s Drug Appeal Letter To Whom It May Concern: This is a request for coverage or prior authorization of medication for the above named patient of mine. The request is for [drug, dosage, amount, and duration] [Patient] is under my care for the treatment of [list diagnoses as appropriate]. S/he is unable to take the formulary medications/preferred medications [list medications] because of: An adverse reaction (describe) A drug-drug interaction A contraindication because of (liver) (kidney) disease A failure of a therapeutic trial (specify which formulary alternatives/preferred medications have been tried and describe results) A fixed medical belief in the power of the non-formulary medication that has persisted in the face of multiple attempts to dissuade him/her Other: S/he requires an exception to the dosing limits of the requested drug based on the following: Clinical evidence: Scientific evidence: Special physical or mental characteristics of [patient]: Special considerations likely to affect medication compliance This drug is medically necessary because without it [patient] is at risk for the following adverse consequences: Deterioration of the medical condition with risk of hospitalization, permanent disability, or death Decline in functional ability that will result in the need for assistance or institutionalization Progression of a chronic disease or disability Complications of an underlying disease process that have been previously prevented by the medication Inability to regain maximum physical and mental functioning Other This meets the following criteria for medical necessity under Pennsylvania Medical Assistance: The service or benefit will, or is reasonably expected to, prevent the onset of an illness condition, or disability The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental, or developmental effects of an illness, condition or disability. The service or benefit will assist the individual to achieve or maintain maximum functional capacity in performing daily activities taking into account both the functional capacity of the individual and those functional capacities that are appropriate for individuals of the same age. In addition to the clinical information specific to my patient, this request is supported by the following: Treatment guidelines give reference Journal article Specialty consultant opinion; consultation enclosed Other (explain): Please contact me should you require any additional information. Signature Unattribured: Source location Unknown

34 Appoint a Representative An appointed representative can help with requesting and following through with the appeals process. A family member, friend, advocate, attorney, doctor, or someone else can be your representative. Use CMS Form 1696 OR Submit a written request containing the following information: Your name, address, phone number, and other contact information Your Medicare number Statement that you are appointing someone as your representative Representative s name, address, phone number, and other contact information Professional status or relationship to you Statement authorizing release of personal and identifiable health information to the rep Statement explaining why you are being represented Your signature and date Your representatives signature and date

35 Appointment of Representative CMS1696

36 Your Doctor as Authorized Representative Your doctor or other prescriber can request a coverage determination, redetermination, or reconsideration by Part D Independent Review Entity without filing as an appointed representative Your doctor must be an appointed representative in order to request an appeal at Level 3 or above.

37 Define the Urgency: Standard vs. Expedited The content of the request determines whether the appeal is standard or expedited. An appeal will be Expedited if You have not received the prescription AND You, your doctor, or other prescriber specifically request a fast decision be made with 24 hours AND Your doctor provides a strong support statement documenting that waiting 72 hours for a standard decision may seriously jeopardize your life, health, or ability to regain maximum function. An appeal will be Standard if You have purchased the prescription and are asking for coverage and payment AND You, your doctor, or other prescriber request an exception and document medical necessity.

38 Important Points of Decision Expedite the process? Meet criteria of urgency? Need to fill the prescription? Rely on doctor to provide strong supporting statements of medical necessity? Rely on doctor to pursue expedited appeal? Represent self or appoint a representative? How far and how much energy to invest in appealing denial?

39 Making a Plan of Action Select best arguments that... Clearly state Exception(s) and goals Demonstrate Medical Necessity Specify Standard appeal or need to Expedite Support those arguments by... Keeping detailed records Maintaining a long-term on-going relationship with the doctor supporting the appeal Carefully navigating each step of the process Authorizing the strongest spokesman

40 Implementing the Plan Prepare all supporting documentation as soon as possible. Adding later delays process At the ALJ hearings require Hearing Notice Discovery MAC hearings do not allow new evidence or arguments Maintain copies of all submissions Review with your doctor his Supporting Statements Locate and use the right forms

41 The Follow Through Submit the right forms Follow instructions Evaluate each step and decision Be ready to change your plans It is okay to stop the appeal

42 Summary Medicare appeals are complicated Self-advocating is necessary Best results are obtained when you Define the problem Research the options Make a plan Carefully implement the plan Proceed only so far as the beneficiary wants

43 Resources Medicare Appeals Handbook Appeals forms Medicare and CMS: Grievances/MedPrescriptDrugApplGriev/Forms.html Request for Hearing with the Office of Medicare Hearing and Appeals

44 Thank you! Anne W. Gunter, M.A. Independent Living Advocate Information and Referral / Benefits Coordinator Progress Center for Independent Living 7521 West Madison Street Forest Park, IL V: F:

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