Transitions: Moving Dual Eligibles to Medicare Prescription Drug Coverage

1
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
2
Overall Transition Strategy

3
Dual Eligibles Transition to Medicare
Prescription Drug Coverage
4
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

5
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
eligibility
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
6
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.

7
Establishing Safeguards

• Formulary Review
• Transition Process
• Appeals and Exceptions

8
Protecting Special Populations

• CMSs 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

9
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

10
Outreach Strategy

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

11
Formulary Review

12
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

13
Guiding Principles for Formulary Review

• Relying on Existing Best Practices
• Provide Access to Medically Necessary Drugs
• Flexibility
• Administrative Efficiency

14
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
• Obtain reasonable clinical justification when
  outliers appear to create access problems

15
Formulary Review A Visual Perspective
Review of Formulary Classification Systems
PT Oversight
Review of Benefit Management Tools
Review of Drug Lists
16
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

17
Review of USP Categories and Classes

• USP categories and classes will satisfy a safe
  harbor. Available at http//www.usp.org/pdf/drugI
  nformation/mmg/finalModelGuidelines2004-12-31.pdf
• Two drugs in each category/class

18
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

19
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

20
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
• Most best practice formularies contain one or
  more of these agents

21
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

22
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

23
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

24
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

25
Utilization Tools Review Checks

• Prior authorization
• Step therapy
• Quantity limitations

26
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

27
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.

28
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

29
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

30
Transition Process

31
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.

32
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 plans formulary.

33
Transition Process

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

34
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

35
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

36
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.

37
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).

38
Appeals

39
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

40
Shorter Timeframes

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

41
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.

42
Coverage DeterminationsPharmacy Notice

• Transaction at pharmacy is not a coverage
  determination.
• General notice provided to enrollees at pharmacy.

43
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.

44
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.

45
Dual Eligibles Transition to Medicare
Prescription Drug Coverage
46
Questions and Answers