Medications For Transplant Patients – The Role of Pharmacy and the TFC

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Medications For Transplant Patients The Role of
Pharmacy and the TFC

• Kristin Fox-Smith, BS, MPA
• University of Utah
• Pharmacy Administration

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Topics For Discussion

• Eligibility and Enrollment for Transplant
• Medicare Advantage Plans
• Dual Eligible Enrollment
• Limited Income Subsidy and Extra Help
• Medicare Part B vs. Medicare Part D
• Legality/Compliance Issues for Medicare Part D
• Medicare Part B vs. D Vaccines
• Changes for 2009 and Beyond

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Medicare Overview
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Eligibility and Enrollment for Medicare Part D

• Must be eligible to Medicare Part A and/or
  enrolled in Part B
• Reside in plans service area
• Enroll in Medicare drug plan, higher premium for
  delay in enrollment
• Initial enrollment Nov 15, 2005 May 15, 2006
• Enrollment 2006 and beyond Nov 15 Dec 31

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Eligibility for Medicare Covered Transplant
Patients

• Medicare eligibility for kidney transplant
  patients is automatic for 36 months following
  transplant
• Medicare eligibility for heart, lung, liver, and
  pancreas transplant patients is NOT automatic.
  Patients must be over age 65 and/or disabled to
  be eligible for Medicare benefits
• If a patient qualifies for Medicare only because
  they have end-stage renal disease, the Medicare
  coverage will end 36 months after the transplant
  and the patient won't qualify for the extension
  unless they regain eligibility at a later time

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Coverage Guidelines for Immunosuppressive
Medications

• Effective for all immunosuppressive drugs
  furnished on or after December 21, 2000, there is
  no longer any time limit for immunosuppressive
  drugs following transplantation previously 36
  months
• This policy applies to all Medicare beneficiaries
  who meet all of the other program requirements
  for coverage under this benefit
• Transplant patients with ESRD only will be
  eligible for Medicare, including Part D for 36
  months
• Transplant patients with Medicare can keep
  Medicare and Part D indefinitely if they have
  Medicare due to age or disability

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Medicare Coverage Continued

• Although Part D formularies must only have 2
  drugs per class, they must have all or
  essentially all immunosuppressants
• Covered under Part B if patient meets criteria
• Covered under Part D if on formulary and patient
  does not meet Part B criteria

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Medicare Advantage PlansMedicare Part C

• Medicare Advantage (MA)
• Medicare Advantage Part D (MA-PD)
• Average increase in payment to MA plans is 12,
  can be as high as 50
• Medicare Advantage enrollment increased by more
  than 40 percent between December 2005 and May
  2007.
• As of 2008, 23 of all Medicare beneficiaries
  were enrolled in a Medicare Advantage plan
• Treat Medicare Advantage plans like commercial
  payers, with the exception of Medicare Part B
  covered items, ALL prescriptions must be
  adjudicated at the pharmacy

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Medicare Advantage

• Local HMOs and PPOs contract with provider
  networks to deliver Medicare benefits. HMOs
  account for the majority (63) of Medicare
  Advantage enrollment. 8 of all Medicare
  Advantage enrollees are in a local PPO.

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Medicare Advantage

• Private Fee For Service Plans (PFFS) are not
  currently required to establish networks, report
  quality measures, or negotiate premiums. Since
  July 2006, PFFS enrollment has nearly tripled
  from 765,000 enrollees to 2.3 million.

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Medicare Advantage

• Special Needs Plans (SNPs), mainly HMOs, are
  restricted to beneficiaries who are dually
  eligible for Medicare and Medicaid, live in
  long-term care settings, or have certain chronic
  and disabling conditions.

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Medicare Advantage Cons

• Network restriction
• Once you enroll in a Medicare Advantage plan, you
  no longer have health coverage through Medicare
• Medicare pays the insurance company a
  pre-negotiated monthly rate as long as
  beneficiary is enrolled
• Leaves many gaps in coverage doctor visits,
  hospital visits, skilled nursing care, emergency
  services
• Physicians are restricted by plan with the level
  of care they can provide, are forced to abide by
  plans network and level of treatment

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Medicare Advantage and ESRD

• If you develop ESRD while enrolled in an MA plan
  you
• can continue your coverage in that MA plan.
  However,
• if you have ESRD and you are not already enrolled
  in a
• Medicare Advantage plan, you can not enroll in
  one,
• and insurance companies do NOT have to sell you a
  
• Medigap policy when you go on Medicare

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Special Enrollment Period

• Permanent move out of the plan service area
• Individual entering, residing in, or leaving a
  long-term care facility - 0 co-pays for patients
  accessing this benefit
• Involuntary loss, reduction, or non-notification
  of coverage as good or better than Medicare
• Other exceptional circumstances
• Dual eligibles continued enrollment, all year
  long!

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Medicare

• All individuals newly entitled to Medicare are
  given a 7 month initial enrollment period for
  Part D
• 3 months before month of eligibility Coverage
  begins on date eligible
• Month of eligibility Coverage begins the first
  of the following month
• 3 months after month of eligibility Coverage
  begins first of the month after month of
  application

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Eligibility for Extra Help

• Income
• Below 150 Federal poverty level
• 16,245 annual (1354 per month for an
  individual) or
• 21,855 annual (1821 per month for a married
  couple)
• Based on family size
• Resources
• Up to 12,510 (individual)
• Up to 25,010 (married couple living together)
• Includes 1,500/person funeral or burial expenses
• Counts savings and stocks
• Does not count home the person lives in
• Higher amounts for Alaska and Hawaii
• -Not available in
  the U.S. territories

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Extra Help
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What Limited Income Subsidy Really Means

• Individuals eligible for Limited Income Subsidy
  (LIS) are approved by Social Security, but must
  be enrolled by Center for Medicare and Medicaid
  Services (CMS)
• LIS verification MUST be provided to the Part D
  plan that the patient is signed up with, pharmacy
  can NOT make these changes, and has no power to
  override them!

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Dual Eligibles

• Individuals who are dually eligible for Medicare
  and Medicaid are entitled to the broad range of
  benefits provided by both programs
• This population, many of whom have significant
  and complex health needs and generally have a
  lower level of health literacy, rely heavily upon
  the overlapping coverage of the two programs
• Enrollment into Medicare Advantage plans for
  these individuals can create problems not
  encountered for dual eligibles who enroll in
  Original Medicare and state Medicaid

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Dual Eligibles

• Problems faced by dual eligibles in MA plans
• Many dual eligibles do not understand or are not
  informed that an MA Plan curtails how they use
  their Medicare coverage. All benefits must be
  received through an MA plan in order to be
  covered, and patients can not go outside the MA
  plan
• Dual eligibles commonly experience a lack of
  information regarding the benefits they are
  entitled to as MA enrollees. MA plans are only
  required to offer coverage for Medicare services,
  but are NOT required to offer Medicaid covered
  services or assist enrollees in accessing
  services outside the MA plan

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Dual Eligibles

• Many dual eligible enrollees are unclear about
  the Medicare and Medicaid rules and benefits
• Enrollees have experienced interruptions in
  treatment resulting in a negative impact on their
  health, due to coverage and benefit issues
• Dual eligible beneficiaries MUST see providers
  who accept BOTH Medicare and Medicaid in order to
  receive the full scope of services covered under
  both programs and to ensure continuity of care
• Medicare rules do not protect duals from paying a
  premium for the portion of the MA plan coverage
  that is not for Part D prescription drugs

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Dual Eligibles

• The least suitable option for a dual eligible is
  a PFFS plan, as they are not currently required
  to establish a network or contractual
  relationship with health care providers PRIOR to
  a beneficiaries receipt of services
• Some of the worst and most widespread marketing
  violations have involved dual eligibles who are
  sold PFFS plans
• Duals are often enticed by extra benefits that
  agents and plans say will save them money (Ex
  20 worth of OTC medications, extra hearing,
  vision, and dental coverage)

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Medicare Prescription Drug Coverage

• Prescription drugs, biologicals, insulin
• Medical supplies associated with injection of
  insulin
• When a drug is not FDA approved for an indication
  but it has clinical literature to support its use
• Vaccines not covered by Part B
• A drug plan may not cover all drugs
• Brand name and generic drugs will
  be in each formulary

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Formulary Review

• Plan formulary must be developed by a Pharmacy
  and Therapeutics Committee
• Formulary must include at least 2 drugs in each
  therapeutic category and class of covered drugs
  and in certain categories, must contain all or
  substantially all the medications

• Antiretrovirals
• Antineoplastics
• Immunosuppressants

• Antidepressants
• Antipsychotics
• Anticonvulsants

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Excluded Drugs

• Drugs for
• Anorexia, weight loss, or weight gain
• Fertility
• Cosmetic purposes or hair growth
• Symptomatic relief of cough and colds
• Prescription vitamins and mineral products
• Except prenatal vitamins and fluoride
  preparations
• Non-prescription drugs
• Barbiturates
• Benzodiazepines

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Medicare Part B Versus Medicare
PrescriptionDrug Coverage

• There WILL still be Part A and Part B drugs
• Part A drugs
• Drugs bundled together with hospital payment
• Part B drugs
• 1. Drugs delivered in MD office
• 2. Drugs delivered in by medical equipment
• 3. Few outpatient chemo and immunosupps
• 4. Hospital outpatient drugs billed separately
• 5. ESRD drugs (i.e. EPO)

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Medicare Part D

• 12 national stand-alone prescription drug plans
• Aetna
• CIGNA
• Coventry Health Care Inc. First Health
• CVS Caremark Corporation Silverscript,
  RXAmerica
• Health Net, Inc.

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Medicare Part D

• HealthSpring, Inc.
• Humana Inc.
• Medco Health Solutions, Inc.
• Torchmark Corporation First United American
  Life Insurance, United American
• UnitedHealth Group, Inc. UnitedHealthcare
• Universal American Corporation Universal
  American
• Wellpoint, Inc. Blue MedicareRX, UniCare

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Medicare Part D Statistics

• Average number of part D plans per state 49
• Percent of 0 deductible plans 55
• Percent of plans with any gap coverage 25
• Percent of people with a premium increase 88

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Medicare Parts B and D Coverage Issues

• In retail, home infusion, and long-term care
  settings, access to Medicare benefit remains the
  same
• Medicare Part B covers medications for patients
  who received Medicare covered transplants
• Medicare Part D covers medications for patients
  who did not receive a Medicare covered
  transplant, and for patients who are outside
  their 36 month coverage window

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Solutions to Medicare Part B vs. D Problems

• Implementation of mandatory note on all
  immunosuppressive prescriptions Medicare Part B
  covered drug
• This will force the pharmacy to look at the
  prescription and verify if they are a Medicare
  Part B supplier
• If prescription is filled by NON Medicare Part B
  supplier, responsibility falls back on pharmacy,
  not patient, in event of audit or retraction

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Medicare Part D Donut Hole

• The standard statutory Part D drug benefit
  provides for drug coverage for formulary drugs up
  to an initial coverage limit of 2,700
• Upon reaching this coverage limit, beneficiaries
  fall into the Donut Hole, and become responsible
  for the full cost of their formulary medications
• Beneficiaries do not get out of this coverage gap
  until they incur 4,550 in out-of-pocket costs
  for drugs on their Part D formulary (4,550
  310 deductible 630 (25 of 2520) 3610
  (donut hole))
• Also responsible for the full costs of
  non-formulary and non-covered drugs
• The deductible, initial coverage limit, and
  out-of-pocket threshold has increased yearly
  since Medicare Part D inception

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Donut Hole

• In 2007, 13 states offer no Part D plans
  providing coverage during the donut hole
• The number of seniors without access to donut
  hole coverage was 375,000 in 2006, jumped to 6.6
  million by July 2007
• Sierra Rx Plus, offering brand name coverage
  during coverage gap in 2007 (only plan available
  in the West for brand coverage) reported a 3
  million loss in January
• By February, Sierra announced that brand coverage
  would not be offered for 2008 (all three plans)
• Humana was only plan to offer this unlimited
  coverage in 2006, did not offer for 2007

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Medicare Covered Vaccinations

• Medicare Part D pays for all vaccines not covered
  under Part B
• Vaccines that require clinical review to
  determine whether Part B or Part D coverage
  Anthrax, Hepatitis A, Hepatitis B, Rabies, and
  Tetanus
• ALL other vaccines should be covered under
  Medicare Part D
• All patients receiving Zostavax must have
  coverage checked
• If Part D vaccines are not billed through Part D,
  there is no reimbursement. This is true even if
  the vaccine is given in clinic

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Vaccines Continued

• Pneumococcal and Influenza vaccines are ALWAYS
  covered by Medicare Part B
• Medicare Part B only covers Hepatitis B for
  medium-to-high risk patients please review
  handouts for the details
• Tetanus Toxoid is only covered by Medicare Part B
  if given for therapeutic reasons
• Rabies is only covered by Medicare Part B if
  given for therapeutic reasons

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Options During the Coverage Gap

• 4 generic prescription initiative started with
  WalMart in 2006, 331 generics included, this
  model now adopted at hundreds of retail
  pharmacies (Target, Kmart)
• Of the 10 most prescribed drugs in the United
  States, only Amoxicillin is available on the 4
  plan
• 4 of the top 20 prescribed medications are
  included in this 4 plan
• Multiple strengths of drugs on plan are also 4

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Coverage Gap Options

• Most manufacturers do NOT disclose income
  guidelines for patient assistance, but average
  income for household of 1 is 32,000 and
  household of 2 is 45,000
• Must prove patients inability to pay
  out-of-pocket expenses
• Coverage IS available for patients with
  commercial or Medicare Part D coverage!

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Options During the Coverage Gap

• Important that patient continue to use Medicare
  Part D card!
• Plans negotiated prices are generally lower than
  retail, result in patient savings
• Money spent on covered drugs counts towards True
  Out-Of-Pocket (TrOOP)
• Part D plan will track spending, and monitor when
  coverage gap ends, reinstating pharmacy benefits

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Changes on the Horizon

• CMS will NOT be looking at changing Medicare Part
  B and Medicare Part D covered drugs until 2011 at
  the earliest
• Patients will continue to have two deductibles
  and two co-insurance and co-pay structures
• Deductibles and co-pays must not be waived, this
  is an illegal practice and CMS can revoke a
  pharmacies ability to dispense medications for
  Medicare programs

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Successes at the University of Utah

• Patients are given detailed information about
  Medicare Part B coverage and the importance of
  using a Medicare Part B supplier
• University of Utah contacts patients each month,
  one week before refills are due, reminding them
  to refill their medications
• Mail-order system in place, all medications are
  sent by 2nd day Federal Express at no charge to
  patients

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Successes at the University of Utah

• Discharge process in place all patients are
  counseled regarding their individualized pharmacy
  benefit prior to discharge
• Discharge medications are provided by the
  University of Utah
• Medicare application assistance is provided by
  social work, financial counselors, and pharmacy
  department

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Successes at the University of Utah

• 87 of all patients receiving a transplant at the
  University of Utah continue to use our pharmacy
  services
• Compliance and customer service satisfaction are
  high, as patients are assisted through the maze
  of Medicare and commercial drug coverage by
  knowledgeable pharmacy staff
• Patients transplanted at other institutions and
  outside the state have found their way to the
  University pharmacy system as a result of
  seamless process for patients

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Successes at the University of Utah

• All primary and secondary billing handled by the
  pharmacy, patients are removed from this process
• Medicare coverage is tracked by patient from time
  of discharge, and patients are notified prior to
  Medicare ending
• If sufficient coverage is not in place, patient
  assistance and financial hardship paperwork is
  started PRIOR to Medicare ending

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Contact Information

• Kristin Fox-Smith Pharmacy Billing Manager,
  University of Utah
• Kristin.fox_at_hsc.utah.edu