Transcript PPT - CALegalAdvocates.org

LAAC Armchair Training
Medicare Part D: Accessing Drugs
Coverage Determinations,
Exceptions, Appeals and Grievances
March 8, 2007
Georgia Burke
National Senior Citizens Law Center
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Accessing Drugs - Topics
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Coverage Determinations/Exceptions/Appeals
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Procedures
Substance and Strategy
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Getting drugs while pursuing an exception
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Grievances
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Coverage Determinations
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Decision re “payment or benefits to which an enrollee believes
he or she is entitled.”
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Types of coverage determinations
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Most denials at pharmacy are NOT Coverage Determinations
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Exceptions—formulary, utilization mgmt, tiering
Other—Prior Auth, co-payments, out-of network pharmacy, etc.
Prior Authorization denial is a coverage determination.
Other coverage determinations must be requested
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Coverage Determinations --- Procedures
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Who can make the request
 Beneficiary
 Authorized representative or
 Prescribing physician
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How to file
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How long does an exception extend
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Call plan or go to website to find out.
Plans may have their own forms but must accept any form of written
support from doctor (model form).
Approval lasts for plan year (plan can extend).
Prior Auth can be shorter.
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Coverage Determinations -- Procedures
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Standard Timeframe
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Expedited Timeframe
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Doctor attests that standard timeframe may place “life,
health or ability to regain maximum function in serious
jeopardy.”
Plan must accept doctor’s attestation.
Not available if enrollee has paid for drugs
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Coverage Determinations -- Procedures
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Standard Requests
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For exceptions, 72 hours after receipt of physician supporting
statement
 Plan can ask doctor for more info. Request does not stop the
clock
 Plan cannot stop the clock with a temporary drug supply
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If not an exception, 72 hours from filing
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If approved:
 Must provide drugs within the 72 hour timeframe
 Must provide refund within 30 days
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Coverage Determinations -- Procedures
• Expedited Requests
• Deadline -- 24 hours or as expeditiously as enrollee’s health
requires.
• Clock starts on receipt of doctor statement showing
medical necessity.
• Oral submission OK
• If approved, must provide drugs within 24 hour response
deadline.
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Coverage Determinations -- Procedures
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What if plans miss deadlines?
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Plans must forward to IRE within 24 hours
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Emergency supply until IRE decision
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No Calif. Emergency benefit.
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Coverage Determinations -- Procedures
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Appeals
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Not automatic – must file
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Five levels of appeal
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Expedited Track
– Standard Track
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Who can appeal
Expedited redetermination (first appeal level) —doctor can
request
– All other appeals – only enrollee or authorized representative
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Coverage Determinations -- Procedures
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Level 1: Redetermination
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Written request within 60 days of coverage determination
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Another decision maker within the plan
Timing
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Some plans may accept oral requests
Standard: 7 days
Expedited (doctor must request): 72 hours
If favorable, must deliver drugs w/in decision deadlines (7
days/72 hours)
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Coverage Determinations -- Procedures
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Level 2: IRE Reconsideration
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Written request to Independent Review Entity (Maximus) within 60
days of redetermination
Maximus standard of review is unclear
Timing
 Standard: 7 days
 Expedited: 72 hours
If approved, drug available w/in 72/24 hr of notice to plan. All
appeal levels.
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Coverage Determinations -- Procedures
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Level 3: ALJ Appeal
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Appeal within 60 days of reconsideration decision
Decided within 90 days – No expedited treatment
New Medicare appeals processes apply:
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Plan and/or Maximus participation?
Amount in Controversy
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DHHS ALJs; videoconference hearings
At least $110 (2007), - include projected amount beneficiary
would spend on drug over plan year
Can add appeal amounts together
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Coverage Determinations -- Procedures
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Level 4: Medicare Appeals Council
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Appeal within 60 days of ALJ decision
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Decided within 90 days—no expedited treatment
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Coverage Determinations -- Procedures
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Level 5: Federal District Court
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Appeal within 60 days of coverage determination
Decided within 90 days
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Amount in Controversy
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Must be at least $1130 (2007), including projected amount the
beneficiary would spend on drug during plan year
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Coverage Determinations —
Substance and Strategy
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Two types of exceptions
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Formulary exception
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Cost-sharing/Tiering exception
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Coverage Determinations —
Substance and Strategy
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Formulary Exceptions:
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If approved, plan can decide level of cost-sharing for
non-formulary drugs
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Obtain Rx not on plan’s formulary
Get different dosage or form/avoid dosage restriction
Bypass Prior Auth, step therapy, therapeutic substitution
requirement
Obtain Rx for off-label use
Plan cannot create new tier or put on special tier.
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Coverage Determinations —
Substance and Strategy
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Drug not on plan formulary
Is it excluded by MMA?
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Enumerated categories –
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Prescribed for a different indication?
– Covered by Medi-Cal (e.g. benzodiazepines)
– Enhanced plans
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Part B drugs
Some off-label
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Coverage Determinations —
Substance and Strategy
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Part D Covered Drugs
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Not on plan formulary
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Other appropriate on-formulary drug?
SEP to change plans?
Utilization management tools
 Prior authorization
 Therapeutic substitution
 Step therapy (“fail first”)
 Quantity or dosage form limits
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Coverage Determinations —
Substance and Strategy
Doctor must show medical necessity:
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All on-formulary drugs are not as effective or have adverse
effects OR
Dosage restriction i. has been ineffective or ii. is likely to be
ineffective for this individual* OR
Substitute drug or step therapy required i. has been
ineffective or is likely to be ineffective* for this individual or
ii. has caused adverse reaction or likely to do so*
* Based on clinical/medical evidence
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Coverage Determinations —
Substance and Strategy
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Prior Authorization
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Step Therapy
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Pharmacy denial is coverage determination—generates
written denial
Redetermination –Exception to prior auth.
If doctor tried to meet, can still argue medical necessity
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Coverage Determinations —
Substance and Strategy
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Off-Label Use – a special case
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Show medical necessity AND
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Show use for a “medically accepted indication”
 Use is FDA approved or
 Use appears in a compendium
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American Hospital Formulary Service Drug Information
Unites States Pharmacopoeia-Drug Information
DRUGDEX Information System
Peer reviewed articles are not sufficient
Note: Exceeding FDA dosage limits does NOT require
compendium support
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Coverage Determinations —
Substance and Strategy
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Off-Label Use
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Issue sometimes comes up late
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Need for legislative fix
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Plan may not realize off-label issue
Diagnosis not on script
Plan Prior Auth and dosage limit rules in place partly
to spot off-label use
Compendium requirement too narrow
Maximus appearing to defend issue
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Coverage Determinations —
Substance and Strategy
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Tiering Exceptions
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To obtain non-preferred drug at preferred prices
 Lower cost, but not generic tier
 Some high cost and unique drugs are not eligible for tiering
exceptions (grievance, only)
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Doctor must show: “preferred drug is not as effective as requested
drug OR has adverse effects”*
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Not relevant to Low Income Subsidy recipients
* Based on clinical/medical evidence
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Emergency drugs
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Transition supplies for continuing prescriptions
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Beginning of plan year or when joining a new plan:
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Long Term Care
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30 day supply in first 90 days
60 day supply if exception not being extended
Extensions on “case by case” basis while exception or appeal is pending
31 day supply
Renewable throughout first 90 days
Transition must accommodate change of status, e.g. , discharge
prescriptions
Does not apply to new prescriptions
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Emergency drugs
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New Prescriptions
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Long term care
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31 day supply to allow time for exception
Emergency supply if plan fails to meet decision deadline
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Extends from when plan misses deadline through decision
of IRE
– Not in guidance.
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Other Options
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Ask plan to voluntarily extend supply
– Patient Assistance Programs
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Grievances
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Complaints not relating to the substance of specific coverage determinations
– E.g., service delays, wait times, phone access, misinformation, marketing
practices, failure to meet deadlines (including deadlines for coverage
determinations), plan structure
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Timeframe:
– 60 days to file – oral or written complaint is OK.
– Plan responds within 30 days
– Expedited grievances (re failure to process expedited requests)—Plan
responds w/in 24 hours
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Importance of filing grievances
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Reporting Problems
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Plans that fail to comply with the requirements for exceptions
and appeals processes may be reported to CMS:
– Central office: [email protected]
– CMS Region IX: [email protected]
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For grievances, CMS complaint tracking procedures:
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Plan
1-800-MEDICARE
Regional office
See http://www.cms.hhs.gov/partnerships/downloads/PartDComplaints.pdf
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Questions
Call with questions, problems, send client stories
National Senior Citizens Law Center
Georgia Burke
(510) 663-1055 ext. 304
[email protected]
www.nsclc.org
© 2007 National Senior Citizens Law Center. All rights reserved.
Permission to copy will be granted to non-profit entities with appropriate acknowledgment of credit.
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Resources
NSCLC Tools for Advocates
http://www.nsclc.org/areas/medicare-part-d/area_folder.2006-09-28.4596471630/area_folder.2006-1031.2079546039
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Medicare Part D Exceptions and Appeals, A Practical Guide (NSCLC)
Exceptions and Appeals: Summary of Ch. 18 of the CMS Prescription Drug Benefit Manual (NSCLC)
Exceptions and Appeals: Model Part D: Exceptions/Coverage Determination Request Form (CMS)
CMS Prescription Drug Manual, Ch. 18: Enrollee Grievances, Coverage Determinations and Appeals
(CMS)
Medicare Part D Manual—Draft of Chapter 6 (transitions)
Other Resources
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Appointment of Representative Form (CMS Form-1696):
http://www.cms.hhs.gov/CMSForms/CMSForms/itemdetail.asp?filterType=keyword&filterValue=1696
&filterByDID=0&sortByDID=1&sortOrder=ascending&itemID=CMS012207
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Patient Assistance Programs (PAP): http://www.rxhope.com/
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