Looking Ahead: What Case Managers Need to Know

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Looking Ahead What Case Managers Need to Know
Mary R. Vienna Deputy Director,
HRSA/HAB/DTTA Rockville, Maryland
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Looking Ahead

• Case managers need to be prepared for
• Assisting clients with the exceptions and appeals
  process
• Changes in plan choice
• New or changing assistance with costs
• Changes in the law
• Next years choice

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Exceptions and Appeals Process

• Process to resolve issues related to a plans
  coverage determination
• Coverage determination is a decision
• Not to provide or pay for
• A Part D drug thats covered by the plan
• A non-formulary Part D drug
• On the amount of cost-sharing for the drug,
  including exceptions to the tiered structure
• Failure to provide a decision in a timely manner
  when a delay would adversely affect health is
  also considered a coverage determination
• First-level stops at the pharmacy (prior
  authorization, step therapy) are NOT coverage
  determinations made by plan itself
• Plans decision on whether to grant approval of
  the drug does constitute a coverage determination

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Exceptions Vs Grievances

• An exception is different than a grievance
• Grievance is any complaint or dispute, other than
  coverage determination
• Expresses dissatisfaction with any aspect of a
  plans operations, activities, or behavior
• Considered a grievance regardless of whether
  remedial action is requested
• Plan must inform enrollee of grievance process
• Notify enrollee of grievance decision in 30 days
• Respond within 24 hours if grievance involves a
  plans refusal to expedite an exception request

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Exceptions

• Tiering and cost-sharing exceptions
• Obtain higher-cost drug (non-preferred) at the
  lower-cost tier (preferred) rate
• To be considered when
• Tiering structure for clients drug changes
  during the year
• A non-preferred drug is medically necessary
• Drugs in tier for high-cost and unique items are
  not eligible
• Cant drop to generic tier level

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Exceptions

• Criteria for tiering exceptions
• Evaluation of prescribing physicians
  determination
• Whether there is a therapeutic equivalent on the
  formulary
• Number of drugs in same class/category on the
  formulary
• Physicians supporting statement (oral/writing)
• Lower cost drug would not be as effective as the
  requested drug
• Lower cost drug would have adverse effects
• Or both

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Exceptions

• Formulary exceptions
• Ensures that clients have access to Part D drugs
  that are not included on the formulary
• Exceptions to drugs not covered because of cost
  utilization tools (step therapy, prior
  authorization, dose restriction)
• Continued access to a drug removed from the
  formulary
• No tiering exception for non-formulary drugs

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Exceptions

• Plan is to grant a formulary exception when it is
  determined that the non-formulary drug is
  medically necessary and would be covered but for
  the fact that it is an off-formulary drug
• Physicians supporting statement (oral/writing)
• All formulary drugs on any tier would not be as
  effective as the non-formulary drug and/or have
  adverse effects
• Number of doses under dose restriction is
  ineffective and/or would affect the drugs
  effectiveness and/or patient compliance
• Drug required in step therapy is ineffective,
  and/or would affect the drugs effectiveness
  and/or patient compliance, and/or have adverse
  effects

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Physicians Supporting Statement

• Plans cannot require the physician to submit the
  written statement on a specific form
• CMS has a model Medicare Part D Coverage
  Determination Request Form that may be used by
  physicians
• www.cms.hhs.gov/MLNProducts/Downloads/Form_Excepti
  ons_final.pdf
• Submission of written supporting statement starts
  clock on decision time limits

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Appeals Process

• Requests made by enrollee or their appointed
  representative
• Defined broadly
• Could include case managers
• CMS form to establish representative status
• CMS Form 1696 Appointment of Representative
• www.cms.hhs.gov/CMSforms/downloads/CMS1696.pdf
• 60 day time limit for every step

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Appeals Process

• Process to be expedited if applying the standard
  timeframes may seriously jeopardize the life or
  health of the enrollee or their ability to regain
  maximum function
• Expedited process requested by enrollee or
  prescribing physician
• Must be expedited if prescribing physician
  indicates or supports medical necessity

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Appeals Process

• Plan determination (72 hrs/24 hrs)
• Requested by enrollee or physician
• Request expedited process
• Redetermination by plan (7 days/72 hours)
• Requested in writing by enrollee or physician
• Request expedited process
• Reviewed by persons not involved with coverage
  determination
• If denial based on lack of medical necessity,
  must be made by physician with expertise in field
  of medicine appropriate for services at issue
• Reconsideration by the independent review entity
  (IRE) (7 days/72 hours)
• If plan doesnt meet timeframes, forwarded
  straight to IRE
• Request in writing by enrollee at this and all
  higher appeal levels

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Appeals Process

• Reconsideration by IRE (7 days/72 hours)
• Contract with CMS
• IRE solicits views of prescribing physician
• Request expedited process
• Findings binding to plan
• Hearing with Administrative Law Judge (ALJ)
• Value of benefit must meet 110 threshold
  requirement (for 2006)
• Can aggregate appeals by drugs per enrollee, or
  enrollees for single drug
• Review by the Medicare Appeals Council (MAC)
• Review by a Federal court
• Amount 1,090 or higher

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Coverage Determination Appeals Process
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Coverage Determination Appeals Process
(continued)
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Exception Request Approval

• When tiering and non-formulary exceptions
  requests are approved, plan cannot require
  enrollee to request approval for a refill or
  another prescription as long as
• Physician continues to prescribe the drug
• Drug continues to be safe for treating the
  disease or condition
• Enrollment period has not expired
• Plan may choose to continue coverage into the
  subsequent year if the enrollee renews his/her
  membership

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Case Manager Role

• Get information from plan
• Explain process to client
• Assist in form completion and letter writing
• Liaison with prescribing physician
• Act as appointed representative
• How to File a Complaint, Coverage Determination
  or Appeal
• www.medicare.gov/Publications/Pubs/pdf/11112.pdf

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Changes in Plan Choice

• Dual eligibles can change plans at any time
• Beneficiary can change plans at any time
• If they move
• Error, misrepresentation or inaction of Federal
  employee or person authorized to act on its
  behalf
• Plan no longer offered in area
• Plan misrepresented provisions in marketing
• Special circumstances
• Lose creditable coverage
• Not adequately informed regarding creditable
  coverage
• Residents of Katrina-affected areas (12/31/2006)

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Importance of Plan Choice

• Impact of plan choice on standard benefit
  out-of-pocket costs for antiretroviral (ARV)
  medications are considerable
• Plan choice also affects access to and costs of
  non-ARV medication
• Greatest impact on costs
• Tier placement
• Cost of drug (after catastrophic coverage level
  reached)
• Kaiser Family Foundation Report
• The Role of Part D for People with HIV/AIDS
  Coverage and Cost of Antiretrovirals Under
  Medicare Drug Plans
• www.kff.org/hivaids/upload/7548.pdf

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Assistance with Costs

• Entities that can assist with Medicare Part D
  costs can change over time
• AIDS Drug Assistance Programs (ADAP)
• State Pharmacy Assistance Programs (SPAP)
• Drug Manufacturers Patient Assistance Programs
  (PAP)

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Changes in the Law

• Advocacy targets for change
• Penalties for late enrollment
• What counts toward TrOOP
• Co-pays for the dual eligible
• The donut hole
• Medicare as secondary payer
• All have budgetary implications

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Next Years Choice

• November 15 December 31, 2006
• New enrollment period
• New plans with new formularies
• New qualification criteria for extra help
• Must reapply for extra help if not deemed
• New premiums, deductibles, co-insurance and
  co-pays
• New TrOOP catastrophic coverage level

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Extra Help from HAB

• Medicare training on HAB website to be updated
  Sept/Oct 2006
• Updated web information on Medicare Part D costs
• Cooperative agreement with National Association
  of State and Territorial AIDS Directors (NASTAD)
• All Grantees Meeting

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Web Site Resources

• http//www.cms.hhs.gov/medicarereform/pdbma
• CMS Information about Medicare Part D
• http//www.cms.hhs.gov/partnerships/downloads/AIDS
  .pdf
• Tip Sheet Information Partners Can Use on
  People With Medicare and HIV/AIDS
• http//www.medicare.gov
• Click on Learn About Your Medicare Prescription
  Coverage Options
• Information for Medicare beneficiaries
• http//www.hrsa.gov/medicare/HIV/about.htm
• Medicare Part D webpage
• Qs As
• Powerpoint slide presentations for training
• Links

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Contact Information

• Mary R. Vienna
• 5600 Fishers Lane, Rm 7-29
• Rockville, MD 20857
• Telephone [phone]
• Email MVienna_at_hrsa.gov