Transcript 0504MMACMS (Medicare Prescription Drug, Improvement, and

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
Reaching
Beneficiaries
Establishing
Appropriate
Safeguards
Ensuring Continuity
of Coverage
Protecting
Special Populations
Working with
States
Providing
Extra Help
Low-Income Subsidy:
Providing 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
State Monthly
File of Duals
Beneficiary
selects a new
plan
May 2005
CMS notifies full
duals of subsidy
eligibility
October 2005
CMS mails letter to
full duals identifying
plan they will be
enrolled into if they
don’t choose another
plan. Plans informed
of assigned enrollees
Beneficiary is
enrolled into
assigned plan
Enrollment materials
mailed to
beneficiaries by plan.
1-800-Medicare will
know plan
assignments
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 networks.
• Targeted educational and outreach materials.
• Facilitate information sharing between States and
plans.
Establishing Safeguards
• Formulary Review
• Transition Process
• Appeals and Exceptions
Protecting Special Populations
CMS’s Long Term Care Guidance addresses:
• LTC Pharmacy Performance and Service Criteria
– Performance and Service Criteria for
Network LTC pharmacies
• Convenient Access
• Formulary
• Exceptions and Appeals
Outreach Campaign
• Multi-phased message platform
– Awareness (January–June 2005)
• Focus on Prevention and Develop
Partnerships
– Decision (July–December 2005)
• Motivate and Educate Beneficiaries
– Urgency (January–June 2006)
• Target Beneficiaries that have not yet
enrolled in order to avoid increased
premiums
Outreach Strategy
• Multi-level approach
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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 ensure
– beneficiaries have access to a broad range of
medically appropriate drugs to treat all
disease states
– formulary design does not discriminate or
substantially discourage enrollment of
certain groups
Guiding Principles for Formulary
Review
•
Relying on Existing Best Practices
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Provide Access to Medically Necessary Drugs
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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
strategies
•
Identify potential outliers at each review step for
further CMS investigation
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Obtain reasonable clinical justification when
outliers appear to create access problems
Formulary Review: A Visual
Perspective
Review of Formulary
Classification Systems
P&T
Oversight
Review of
Drug Lists
Review of
Benefit
Management
Tools
Formulary Review Checks
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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://www.usp.org/pdf/drugInformation/mmg/fi
nalModelGuidelines2004-12-31.pdf
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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
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Alternative classification structures will be
compared to USP and other commonly used
classification systems
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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: www.usp.org
•
“Third column” in USP document
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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
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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
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Antidepressants
Antipsychotics
Anticonvulsants
• Antiretrovirals
• Antineoplastics
• Immunosuppressants
Common Drugs for Medicare
Population
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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 Review:
Long 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 outlier
How Formulary Process Will Help
Enrollee Transition
• 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
occur.
• 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 Process
• 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 plan’s
formulary.
Transition Process
• The final regulation requires plan sponsors to have
a transition process for new enrollees prescribed
Part D drugs not on the plan’s formulary.
• 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
Appeals
Other Transition Issues Affecting
Current Enrollees
• Transition Issues Based on Level of Care
Changes
– Discharge from a hospital Long Term Care
(LTC) facility
– Discharge from a hospital to home
– Transition from Skilled Nursing Facility-A
status to private pay (or Medicaid) status
within a LTC facility
– Change from Hospice Status
– Change from a Psychiatric Hospital to any
other status
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 changes.
• 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
programs).
Appeals
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
Coverage determinations: 72 hours
Redeterminations:
7 days
Reconsiderations by IRE: 7 days
Expedited
24 hours
72 hours
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
plan’s tiered cost-sharing structure or formulary.
Coverage Determinations:
Pharmacy Notice
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Transaction at pharmacy is not a coverage
determination.
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General notice provided to enrollees at
pharmacy.
Coverage Determinations:
Exceptions
• Tiering Exceptions: Permit enrollees to obtain a
lower-tiered drug at the more favorable costsharing 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 plan’s formulary.
Additional Safeguards
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Plans are prohibited from requiring additional
exception requests for refills.
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Plans are prohibited from assigning drugs
approved under the exceptions process to a
special tier.
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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
Reaching
Beneficiaries
Establishing
Appropriate
Safeguards
Ensuring Continuity
of Coverage
Protecting
Special Populations
Working with
States
Providing
Extra Help
Questions and Answers