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Transitions: Moving Dual Eligibles to Medicare Prescription Drug Coverage


Title: Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Impact on States Author: CMS Last modified by: CMS Created Date: 2/23/2004 1:31:35 PM – PowerPoint PPT presentation

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Title: Transitions: Moving Dual Eligibles to Medicare Prescription Drug Coverage

Transitions Moving Dual Eligibles to Medicare
Prescription Drug Coverage
Tony Culotta, Director, Appeals and Enrollment
Group Babette Edgar, Director, Division of
Finance and Operations, Medicare Drug Benefit
Group Alissa DeBoy, Special Assistant, Medicare
Drug Benefit Group
Overall Transition Strategy

Dual Eligibles Transition to Medicare
Prescription Drug Coverage
Low-Income SubsidyProviding Extra Help
  • Mid-May Mid-June CMS low-income subsidy
    mailing for dual eligibles who are deemed
    eligible for the subsidy
  • Additional information will be available in
    October, 2005, about specific Medicare
    prescription drug plans in their area.
  • Beneficiaries will only be responsible for 0 to
    5 copayments per prescription
  • Above 100 FPL up to 2 or 5 copay
  • At or below 100 FPL up to 1 or 3 copay
  • institutionalized 0 copay

Ensuring Continuity of Coverage
Beneficiary selects a new plan
Beneficiary is enrolled into assigned plan
State Monthly File of Duals
May 2005 CMS notifies full duals of subsidy
Enrollment materials mailed to beneficiaries by
plan. 1-800-Medicare will know plan assignments
October 2005 CMS mails letter to full duals
identifying plan they will be enrolled into if
they dont choose another plan. Plans informed of
assigned enrollees
Working with States
  • Enrollment information for full-benefit dual
    eligibles including their assigned plans
  • Comparative information on Medicare prescription
    drug plans including formularies and pharmacy
  • Targeted educational and outreach materials.
  • Facilitate information sharing between States and

Establishing Safeguards
  • Formulary Review
  • Transition Process
  • Appeals and Exceptions

Protecting Special Populations
  • CMSs Long Term Care Guidance addresses
  • LTC Pharmacy Performance and Service Criteria
  • Performance and Service Criteria for Network LTC
  • Convenient Access
  • Formulary
  • Exceptions and Appeals

Outreach Campaign
  • Multi-phased message platform
  • Awareness (JanuaryJune 2005)
  • Focus on Prevention and Develop Partnerships
  • Decision (JulyDecember 2005)
  • Motivate and Educate Beneficiaries
  • Urgency (JanuaryJune 2006)
  • Target Beneficiaries that have not yet enrolled
    in order to avoid increased premiums

Outreach Strategy
  • Multi-level approach
  • National
  • Regional
  • State/local
  • Constituent organizations and Congress
  • Multi-channel approach
  • Media
  • Direct mail
  • Grassroots outreach
  • Partnerships

Formulary Review

Formulary Review Rationale
  • MMA requires CMS to review Part D formularies to
  • beneficiaries have access to a broad range of
    medically appropriate drugs to treat all disease
  • formulary design does not discriminate or
    substantially discourage enrollment of certain

Guiding Principles for Formulary Review
  • Relying on Existing Best Practices
  • Provide Access to Medically Necessary Drugs
  • Flexibility
  • Administrative Efficiency

Formulary Review Approach
  • Ensure the inclusion of a broad distribution of
    therapeutic categories and classes
  • Utilize reasonable benchmarks to check that drug
    lists are robust
  • Review tiering and utilization management
  • Identify potential outliers at each review step
    for further CMS investigation
  • Obtain reasonable clinical justification when
    outliers appear to create access problems

Formulary Review A Visual Perspective
Review of Formulary Classification Systems
PT Oversight
Review of Benefit Management Tools
Review of Drug Lists
Formulary Review Checks
  • Review of USP Categories and Classes
  • Comparison to AHFS Categories and Classes
  • Two Drugs per Category and Class
  • USP Formulary Key Drug Types
  • Tier Placement
  • Widely Accepted Treatment Guidelines
  • Therapeutic Categories or Pharmacologic Classes
    Requiring Uninterrupted Access
  • Common Drugs for Medicare Population
  • Quantity Limit Review
  • Prior Authorization Review
  • Step Therapy Review
  • Insulin Supplies and Vaccines Review
  • Long-Term Care Accessibility Review

Review of USP Categories and Classes
  • USP categories and classes will satisfy a safe
    harbor. Available at http//
  • Two drugs in each category/class

Comparison to AHFS Categories and Classes
  • Used if plan utilizes their own category and
    class system outside of the USP structure
  • AHFS- American Hospital Formulary System
  • Widely used in the pharmacy industry

Two drugs per category/class
  • Alternative classification structures will be
    compared to USP and other commonly used
    classification systems
  • All classification schemes must contain at least
    two (2) drugs per category and class

USP Formulary Key Drug Types
  • Review drug list for inclusion of at least one
    drug in each of the Formulary Key Drug Types
    identified by USP. Available at
  • Third column in USP document
  • Most best practice formularies contain one or
    more of these agents

Tier Placement
  • Review tier placement of drugs to ensure that
    access is not discriminatory
  • Looking for at least one drug to be placed in a
    lower tier for each drug class
  • Specialty tier is exempt from this requirement

Widely Accepted Treatment Guidelines
  • Review drug list for inclusion of drugs/drug
    classes from widely accepted treatment guidelines
  • Inclusion based on best practice
  • Serves as a check, not an exhaustive list

Therapeutic Categories or Pharmacologic Classes
Requiring Uninterrupted Access
Review certain drug classes to ensure that
beneficiaries being treated with these classes
have uninterrupted access to all drugs in that
class via formulary inclusion, utilization
management tools, or exceptions processes
  • Antidepressants
  • Antipsychotics
  • Anticonvulsants
  • Antiretrovirals
  • Antineoplastics
  • Immunosuppressants

Common Drugs for Medicare Population
  • Review drug list for inclusion of the most
    commonly prescribed drug classes for the Medicare
    population in terms of cost and utilization

Utilization Tools Review Checks
  • Prior authorization
  • Step therapy
  • Quantity limitations

Insulin Supplies and Vaccines Review
  • Formularies must include alcohol swabs, needles,
    syringes and gauze
  • Vaccines not covered under Part B must be covered
    under Part D

Drug List ReviewLong Term Care Accessibility
  • A review will be performed to ensure that all the
    medically necessary Part D covered products are
    included in the formularies.
  • IV drugs,
  • Compounded medications
  • Alternate dosage forms, such as, but not limited
    to liquids, crushable etc.

Drug List Review Outliers
  • CMS will identify potential outliers during the
    category and classification review, as well as
    during the drug list review
  • Outliers for each area of review will be further
    evaluated to determine if they are discriminatory
  • Plans may be asked to provide reasonable clinical
    justification to substantiate the potential

How Formulary Process Will Help Enrollee
  • Non-discriminatory formularies
  • Assure broad access to drugs
  • All or substantially all drugs are required in
    drug classes where significant negatives outcomes
    would be expected if changes in drug regimens
  • Assure efficient exceptions and appeals processes

Transition Process

Transition Changes for full-benefit dual
eligible individuals
  • They will no longer qualify for drug benefits
    under Medicaid after January 1, 2006
  • They will receive Part D drug benefits and be
    deemed eligible for the full subsidy provided to
    low-income individuals.
  • Will receive premium assistance. Will not be
    subject to a deductible.
  • Will only be charged nominal copayments, no
    matter what tiers are established by the plan.

Transition Issues Raised During the Regulatory
  • Concerns raised over access to certain types of
    drugs by individuals stabilized on medications.
  • Concerns on the need to educate providers to
    ensure appropriate changes of prescriptions when
    necessary to accommodate a plans formulary.

Transition Process
  • The final regulation requires plan sponsors to
    have a transition process for new enrollees
    prescribed Part D drugs not on the plans
  • This applies to Part D drugs.
  • CMS issued guidance on March 16, 2005.

Transition Guidance
  • General Transition Process for New Enrollees
  • Pharmacy and Therapeutics Committee role
  • Filling the gap
  • Transition Timeframes
  • Other Transition Methods
  • Residents of Long Term Care Facilities
  • Current Enrollee Transitions and Exceptions and

Other Transition Issues Affecting Current
  • Transition Issues Based on Level of Care Changes
  • Discharge from a hospital Long Term Care (LTC)
  • Discharge from a hospital to home
  • Transition from Skilled Nursing Facility-A status
    to private pay (or Medicaid) status within a LTC
  • Change from Hospice Status
  • Change from a Psychiatric Hospital to any other

Coverage of Excluded Drugs
  • Some drugs are not covered at all by Part D (e.g.
    benzodiazepines and barbiturates ).
  • They may be covered by Medicaid.

Role of Medicaid
  • During transition, states will assist CMS with
    the identification of dual eligibles and the
    education of beneficiaries regarding upcoming
  • Coverage for an extended supply in December 2005
    is an option
  • Once drug benefit is effective,
  • Medicaid may still cover excludable drugs
  • States may choose to wrap around the Medicare
    drug benefit (i.e., pharmacy plus or state only


Appeals Overview
  • Modeled after the Medicare Advantage program
  • Grievances
  • Initial Coverage Determination
  • 5 Levels of Appeal
  • Redetermination by the Part D plan
  • Reconsideration by the Independent Review Entity
  • Hearing with an Administrative Law Judge
  • Review by the Medicare Appeals Council
  • Review by a Federal court

Shorter Timeframes
  • Standard Expedited
  • Coverage determinations 72 hours 24 hours
  • Redeterminations 7 days 72 hours
  • Reconsiderations by IRE 7 days 72 hours

Coverage Determinations and Appeals
  • Involve the benefits an enrollee is entitled to
    receive or the amount, if any, that an enrollee
    is required to pay for a benefit.
  • Include decisions concerning an exception to a
    plans tiered cost-sharing structure or formulary.

Coverage DeterminationsPharmacy Notice
  • Transaction at pharmacy is not a coverage
  • General notice provided to enrollees at pharmacy.

Coverage DeterminationsExceptions
  • Tiering Exceptions Permit enrollees to obtain a
    lower-tiered drug at the more favorable
    cost-sharing terms applicable to drugs on a
    higher tier.
  • Formulary Exceptions Ensure that Part D
    enrollees have access to Part D drugs that are
    not included on a plans formulary.

Additional Safeguards
  • Plans are prohibited from requiring additional
    exception requests for refills.
  • Plans are prohibited from assigning drugs
    approved under the exceptions process to a
    special tier.
  • Plans must notify enrollees in advance if they
    intend to change their formularies or
    cost-sharing structures during a plan year.

Dual Eligibles Transition to Medicare
Prescription Drug Coverage
Questions and Answers