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Kidney Medicare Drugs Awareness and Education Initiative


people with kidney disease understand Medicare prescription drug coverage ... Prescription Drug Plan Finder. Formulary Finder ... – PowerPoint PPT presentation

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Title: Kidney Medicare Drugs Awareness and Education Initiative

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

INITIATIVEA kidney community effort to help
professionals and people with kidney disease
understand Medicare prescription drug coverage
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
  • 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

Prior Teleconferences in Series
  • August 16 teleconference upcoming changes and
    extra help for those with limited income and
  • September 20 teleconference coverage
  • October 18 teleconference choosing a Medicare
    drug plan
  • Archived materials from teleconferences on

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

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
  • Babette Edgar, Director of the Division of
    Finance and Operations in the Medicare Drug
    Benefit Group, Centers for Medicare Medicaid

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

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

What Did Medicare Require of Formularies?
  • To get CMS approval, all plans must
  • Have flexibility in formularies and payment
  • 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.

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
  • If a plan doesnt cover all drugs, the
    beneficiary should use the exceptions process
  • CMS reviewed and approved all exceptions processes

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

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

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

How Do Plans Choose Drugs To Include On Their
  • 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

What Are Some Things Plans Can Require?
  • Co-payment or coinsurance
  • Prior authorization
  • Step therapy
  • Quantity limits
  • Generic substitution
  • Therapeutic interchange
  • Tiered cost sharing

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

What Can Physicians Do When A Plan Requires Prior
  • 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

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

What Can a Physician Do When a Plan Requires Step
  • 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

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

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

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

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

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

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

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

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

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

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

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
  • If plan has generic tier, it doesnt have to
    provide non-preferred drugs at generic tier
  • 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

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
  • Mail order pharmacies can save money and time
  • Preferred mail order pharmacies lowest cost
  • Non-preferred mail order pharmacies higher cost
  • Specialty pharmacies may serve transplant
  • Must contract with plan
  • Check with pharmacy or plan to see if in network

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

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

What If Transplant Drug Is At Higher Tier?
  • Check other plans for tiering and co-pays
  • Apply for extra help with Social Security
  • (800) 772-1213
  • Ask MD to request exception to get drug at lower

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

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

The right information at the right time
Thank You For Participating
  • Listen at noon ET on December 20, 2005 for
    information grievances and appeals
  • Visit for todays
  • 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