Kidney Medicare Drugs Awareness and Education Initiative

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Medicare How Its Changing To Help More People
Coverage Determinations, Drug Utilization
Management, and Medical Therapy Management

• Presented by
• Kidney Medicare Drugs
• Awareness and Education Initiative
• www.kidneydrugcoverage.org

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KIDNEY MEDICARE DRUGS AWARENESS AND EDUCATION
INITIATIVEA kidney community effort to help
professionals and people with kidney disease
understand Medicare prescription drug coverage
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Participating Organizations

• Abbott Laboratories
• American Association of Kidney Patients, Inc.
• American Kidney Fund
• American Nephrology Nurses Association
• The American Society of Nephrology
• Amgen
• Astellas Pharma US, Inc.
• Centers for Medicare Medicaid Services
• Central Florida Kidney Center, Inc.
• DaVita, Inc.
• DaVita Patient Citizens
• The ESRD Network of New York
• Fresenius Medical Care North America
• Gambro Healthcare US
• Genzyme Corporation
• Kidney Care Partners
• National Kidney Foundation, Inc.
• Council of Nephrology Nurses and Technicians
• Council of Nephrology Social Workers

• National Minority Health Month Foundation
• National Renal Administrators Association
• Novartis Pharmaceuticals Corporation
• People Like Us, National Kidney Foundation
• Pfizer Inc.
• Pharmaceutical Research and Manufacturers of
  America
• PKD Foundation
• Renal Care Group, Inc.
• The Renal Network, Inc.
• Renal Physicians Association
• Renal Support Network
• Roche Pharmaceuticals
• Sigma-Tau Pharmaceuticals, Inc.
• Social Security Administration
• Transplant News
• The Transplant Pharmacy Coalition
• UnitedHealth Group/Ovations
• Washington Hospital Center
• Wyeth Pharmaceuticals

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Prior Teleconferences in Series

• August 16 teleconference upcoming changes and
  extra help for those with limited income and
  resources
• September 20 teleconference coverage
  coordination
• October 18 teleconference choosing a Medicare
  drug plan
• Archived materials from teleconferences on
  www.kidneydrugcoverage.org

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Medicare Part D Overview

• November 15, 2005 (Today) First date to join a
  Medicare drug plan
• Dual eligibles can stick with the plan Medicare
  chose for them (yellow letter) or choose a
  different plan by December 31, 2005 for January
  1, 2006
• May 15, 2006 Last date for people with Medicare
  now to join
• Patients who spend a lot on drugs can start
  saving from Day 1 if they join a plan by December
  31, 2005

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Our Experts

• Moderator
• Deborah Collinsworth, Dialysis Clinic Inc. social
  worker, past executive committee member of the
  National Kidney Foundations Council of
  Nephrology Social Workers
• Speakers
• Bryan Becker, MD, nephrologist, affiliate
  assistant professor in the Division of
  Transplantation and Associate Professor of
  Medicine, University of Wisconsin
• Aaron Eaton, pharmacist, Division of Finance and
  Operations, Center for Medicare Medicaid
  Services
• Babette Edgar, Director of the Division of
  Finance and Operations in the Medicare Drug
  Benefit Group, Centers for Medicare Medicaid
  Services

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What Is a Formulary and Why Should Patients Care?

• A list of drugs a plan will cover.
• Medicare drug plans
• Dont have to cover all drugs
• Must cover two drugs per category or class (floor
  not ceiling)
• Other requirements in sub-regulatory guidance
• Patients will save money by choosing a plan that
  covers their drugs

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How Did Medicare Review of Plan Formularies?

• Medicare reviewed best practices in private
  plans, Medicaid, Federal Employees Health
  Benefits Plans
• US Pharmacopoeia
• American Hospital Formulary Service
• Two drugs per category and class
• Tier placement
• Treatment guidelines

• Therapeutic categories or pharmacologic classes
  requiring uninterrupted access
• Commonly used drugs in Medicare population
• Quantity limits
• Prior authorization
• Step therapy
• Insulin supplies vaccines
• Long-term care accessibility

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What Did Medicare Require of Formularies?

• To get CMS approval, all plans must
• Have flexibility in formularies and payment
  structure
• Allow people to get medically necessary drugs
• Not discourage any group from joining Part D by
  formulary or tiering structure
• Follow USP model (2 drugs per category/class) to
  pass 1st discrimination test
• Give 60-day notice of a change to affected people
  or provide a 60-day supply when a beneficiary
  refills a prescription.
• CMS must approve all changes.

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Drugs and Plan Formularies

• Patients with chronic illnesses should be sure
  their drugs are on any plan formulary they join
• Medicare drug plan formularies are robust so most
  beneficiaries will find a plan that covers their
  drugs
• If a plan doesnt cover all drugs, the
  beneficiary should use the exceptions process
• CMS reviewed and approved all exceptions processes

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What Drugs are Covered by Standard Medicare Part
D Plans?

• Must cover all or substantially all
• Cancer medicines
• HIV/AIDS drugs
• Anti-depressants
• Anti-psychotics
• Anti-convulsants
• Immunosuppressants to prevent organ rejection
• Plans do not have to cover every brand name or
  all doses

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What Drugs Are Excluded from Standard Medicare
Part D Plans?

• Drugs used for anorexia, weight loss or gain
• Fertility drugs
• Drugs used for cosmetic purposes (hair growth)
• Cold and cough medicines
• Non-prescription or over-the-counter
• Barbiturates (e.g. Seconal, Nembutal)
• Benzodiazepines (e.g. Restoril, Ativan)
• Vitamins and minerals
• Except prenatal vitamins, fluoride preparations,
  Vitamin D
• Enhanced plans may cover excluded drugs

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What Can a Plan Choose Under the Medicare
Modernization Act

• What drugs to cover
• What strengths and dosage to cover
• What co-payments or coinsurance

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How Do Plans Choose Drugs To Include On Their
Formulary?

• Pharmacy Therapeutics Committee
• Physicians and pharmacists
• 1 physician must have experience in care of
  elderly or disabled
• 1 physician or pharmacist on PT committee
  without any relationship to plan or
  pharmaceutical manufacturer

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What Are Some Things Plans Can Require?

• Co-payment or coinsurance
• Prior authorization
• Step therapy
• Quantity limits
• Generic substitution
• Therapeutic interchange
• Tiered cost sharing

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What Is Prior Authorization? When Should Someone
Request It?

• If a drug is not listed on the plans
  CMS-approved formulary
• Physician must obtain approval for prescribed
  drug before plan will provide it.
• Request prior authorization right away when new
  drug needed

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What Can Physicians Do When A Plan Requires Prior
Authorization?

• Complete paperwork or phone plan
• Provide medical justification for drug not on
  plan formulary or at preferred drug level
• MD should request exception before prescribing
  new drug if prior authorization is needed
• MD should request exception right away if
  pharmacist says prior authorization is needed

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What Is Step Therapy?

• Step therapy requires a patient to try other
  drugs before the prescribed drug is approved.

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What Can a Physician Do When a Plan Requires Step
Therapy?

• Acceptable if never on drug before
• New patient
• Existing patient
• May not be cost effective
• If requires switching patient from effective drug
• Physician needs to know if step therapy is
  required

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What Can New Plan Member Do to Get Needed Drug?

• Transition process
• For new plan members stabilized on non-formulary
  drug prior to joining a plan
• Allows those who didnt know drug wasnt on
  formulary to get 30-day refill to ask MD
• If a formulary drug would work as well
• To write medical justification for an exception

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What Is Tiered Cost Sharing?

• Formulary drugs have co-pays, coinsurance
• Plan can have any number of tiers, e.g.
• Tier 1 Generics
• Tier 2 Preferred brand name drugs
• Tier 3 Non-preferred brand name drugs
• Look at tier and co-payment one plans Tier 3
  may cost less than anothers Tier 2
• Plans may give 60 days notice of tiering change
  to those affected
• CMS must approve tiering change at least 60 days
  before it takes effect

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What Is Standard Medicare Part D Plan?
Plans vary by region and coverage.
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Where Can You Get an Idea of Costs?

• Medicare You
• Prescription Drug Plan Finder
• Formulary Finder

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What If Medically Necessary Drug Is At
Unaffordable Tier?

• Patients should show formulary to MD
• Patients should ask MD if lower tier drugs would
  work as well
• MD could request exception to get drug at lower
  tier

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What If Medically Necessary Drug Is On a High
Tier or Not on Plan?

• Medicare stand-alone prescription drug plans and
  Medicare Advantage drug plans must have
  exceptions process
• To request plan to allow patient to get drug and
  pay less (lower tier)
• To request plan to allow patient to take
  non-formulary drug
• Rules for coverage determinations apply

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What Is Therapeutic Substitution?

• Therapeutic substitutions replace a prescribed
  drug with another therapeutically or biologically
  equivalent and cheaper drug.
• Brand name drug ? Generic drug

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What Are Concerns About Therapeutic Substitution?

• Substitutions may be upsetting to patients
• If MD is concerned about generic substitution for
  brand name drugs for certain patients or drugs
• MD should check no substitution box
• MD should know whether his/her state law allows
  the pharmacist to substitute a generic if the
  doctor does not check that box (40 states allow)
• Patients need to be sure drugs prescribed are the
  same as drugs filled
• MD and nurses can help with exceptions

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How Does MD Justify a Formulary Exception?

• Describe medical need
• State why formulary drug would not be effective
  or cause adverse consequences
• State whether patient took other drugs before
  that didnt control condition or produced harmful
  side effects
• People with kidney disease dont do well on some
  drugs and should avoid others
• Network 8 Demo Project informed CMS

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What Is the Appeals Process?

• Several steps of appeal available if exception
  denied
• Learn steps Medicare How Its Changing to Help
  More People Grievances and Appeals at noon ET on
  December 20, 2005

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How Long CanException Decision Take?

• For those with serious health conditions up to
  24 hours
• For standard decisions up to 72 hours
• If plan doesnt meet deadline, independent review
  entity must review the request and decide

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What Happens If Plan Changes Tier Structure
During Plan Year?

• CMS must approve all formulary changes
• Patients must have 60-days notice
• Exceptions process must address tier co-pay
  changes
• If plan has generic tier, it doesnt have to
  provide non-preferred drugs at generic tier
  co-pay
• Beneficiaries cant request exception to tiering
  structure for 4th Tier or higher drug (high cost,
  unique, genomic and biotech products)
• May have to request exception yearly

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Why Care About A Pharmacy?

• Retail pharmacies may be near to your home
• Preferred retail pharmacies low cost shares
• Non-preferred retail pharmacies higher cost
  shares
• Mail order pharmacies can save money and time
• Preferred mail order pharmacies lowest cost
  shares
• Non-preferred mail order pharmacies higher cost
  shares
• Specialty pharmacies may serve transplant
  patients
• Must contract with plan
• Check with pharmacy or plan to see if in network

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What Is Medication Therapy Management Program?

• Design of MTM program left up to plan
• Targeted to certain Medicare beneficiaries
• Multiple chronic conditions
• Taking multiple covered Part D drugs
• Likely to incur costs exceeding 4,000
• Private MTM programs include education,
  consultation with pharmacist
• Review drugs
• Develop plan
• Offer tips/reminders
• Available at no cost to targeted beneficiaries

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Are Renal Vitamins Covered?

• Excluded by standard Part D
• May be covered by enhanced plan
• May be covered by Medicaid
• MD may recommend OTC vitamin
• Cost of non-covered drug is not counted toward
  3,600 in true out-of-pocket (TrOOP) expenses
• NOTE Vitamin D analogs are not excluded

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What If Transplant Drug Is At Higher Tier?

• Check other plans for tiering and co-pays
• Apply for extra help with Social Security
• www.socialsecurity.gov
• [phone]
• Ask MD to request exception to get drug at lower
  tier

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Thank You

• Moderator
• Deborah Collinsworth, Dialysis Clinic Inc. social
  worker, past member of National Kidney Foundation
  Council of Nephrology Social Workers Executive
  Committee
• Speakers
• Bryan Becker, MD, nephrologist, Division of
  transplantation and Associate Professor of
  Medicine, University of Wisconsin
• Aaron Eaton, Center for Medicare Medicaid
  Services
• Babette Edgar, Division of Medicare Drug Benefit
  Group, Centers for Medicare Medicaid Services

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Key Messages

• Medicare drug plan will help some others may not
  need it
• Most information you read is for the average
  person with Medicare
• Kidney Medicare Drugs Awareness and Education
  Initiative provides kidney-specific information
• Kidney friendly plans provide the most help
• Ask patients to bring notices to review, advise
  about creditable coverage, keep for appeals

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The right information at the right time
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Thank You For Participating

• Listen at noon ET on December 20, 2005 for
  information grievances and appeals
• Visit www.kidneydrugcoverage.org for todays
  materials
• Complete evaluation
• Print your certificate of attendance
• Ask your licensing board if certificate can be
  used for continuing education credit
• Submit questions about Medicare Part D to
  info_at_kidneydrugcoverage.org