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

1. Medications For Transplant Patients – The Role of Pharmacy and the TFC Kristin Fox-Smith, BS, MPA University of Utah Pharmacy Administration

2. 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

3. Medicare Overview

4. Eligibility and Enrollment for Medicare Part D • Must be eligible to Medicare Part A and/or enrolled in Part B • Reside in plan’s 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

5. 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

6. 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

7. 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

8. 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

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

10. 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.

11. Medicare Advantage • Special Needs Plans (SNP’s), mainly HMO’s, 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.

12. 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

13. 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

14. 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!

15. Medicare • All individual’s 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

16. 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

17. Extra Help

18. 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!

19. 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”

20. 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

21. 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

22. 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)

23. 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

24. 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

25. 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

26. 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 immunosupp’s • 4. Hospital outpatient drugs billed separately • 5. ESRD drugs (i.e. EPO)

27. 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.

28. 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

29. 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%

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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

37. 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 patient’s inability to pay out-of-pocket expenses • Coverage IS available for patients with commercial or Medicare Part D coverage!

38. Options During the Coverage Gap • Important that patient continue to use Medicare Part D card! • Plan’s 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

39. 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

40. 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

41. 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

42. 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

43. 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

48. Contact Information • Kristin Fox-Smith – Pharmacy Billing Manager, University of Utah • Kristin.fox@hsc.utah.edu