1. © 2007 NSCLC 1 LAAC Armchair Training Medicare Part D: Accessing Drugs Coverage Determinations, Exceptions, Appeals and Grievances March 8, 2007 Georgia Burke National Senior Citizens Law Center

2. © 2007 NSCLC 2 Accessing Drugs - Topics Coverage Determinations/Exceptions/Appeals – Procedures – Substance and Strategy Getting drugs while pursuing an exception Grievances

3. © 2007 NSCLC 3 Coverage Determinations Decision re “payment or benefits to which an enrollee believes he or she is entitled.” Types of coverage determinations – Exceptions—formulary, utilization mgmt, tiering – Other—Prior Auth, co-payments, out-of network pharmacy, etc. Most denials at pharmacy are NOT Coverage Determinations – Prior Authorization denial is a coverage determination. – Other coverage determinations must be requested

4. © 2007 NSCLC 4 Coverage Determinations --- Procedures Who can make the request Beneficiary Authorized representative or Prescribing physician How to file 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). How long does an exception extend Approval lasts for plan year (plan can extend). Prior Auth can be shorter.

5. © 2007 NSCLC 5 Coverage Determinations -- Procedures Standard Timeframe Expedited Timeframe 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

6. © 2007 NSCLC 6 Coverage Determinations -- Procedures Standard Requests – 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 – If not an exception, 72 hours from filing – If approved: Must provide drugs within the 72 hour timeframe Must provide refund within 30 days

7. © 2007 NSCLC 7 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.

8. © 2007 NSCLC 8 Coverage Determinations -- Procedures What if plans miss deadlines? – Plans must forward to IRE within 24 hours – Emergency supply until IRE decision No Calif. Emergency benefit.

9. © 2007 NSCLC 9 Coverage Determinations -- Procedures Appeals – Not automatic – must file – Five levels of appeal – Expedited Track – Standard Track – Who can appeal – Expedited redetermination (first appeal level) —doctor can request – All other appeals – only enrollee or authorized representative

10. © 2007 NSCLC 10 Coverage Determinations -- Procedures Level 1: Redetermination – Written request within 60 days of coverage determination Some plans may accept oral requests – Another decision maker within the plan – Timing Standard: 7 days Expedited (doctor must request): 72 hours If favorable, must deliver drugs w/in decision deadlines (7 days/72 hours)

11. © 2007 NSCLC 11 Coverage Determinations -- Procedures Level 2: IRE Reconsideration – 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.

12. © 2007 NSCLC 12 Coverage Determinations -- Procedures Level 3: ALJ Appeal – Appeal within 60 days of reconsideration decision – Decided within 90 days – No expedited treatment – New Medicare appeals processes apply: DHHS ALJs; videoconference hearings – Plan and/or Maximus participation? – Amount in Controversy At least $110 (2007), - include projected amount beneficiary would spend on drug over plan year Can add appeal amounts together

13. © 2007 NSCLC 13 Coverage Determinations -- Procedures Level 4: Medicare Appeals Council – Appeal within 60 days of ALJ decision – Decided within 90 days—no expedited treatment

14. © 2007 NSCLC 14 Coverage Determinations -- Procedures Level 5: Federal District Court – Appeal within 60 days of coverage determination – Decided within 90 days – Amount in Controversy Must be at least $1130 (2007), including projected amount the beneficiary would spend on drug during plan year

15. © 2007 NSCLC 15 Coverage Determinations — Substance and Strategy Two types of exceptions – Formulary exception – Cost-sharing/Tiering exception

16. © 2007 NSCLC 16 Coverage Determinations — Substance and Strategy Formulary Exceptions: – 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 If approved, plan can decide level of cost-sharing for non-formulary drugs – Plan cannot create new tier or put on special tier.

17. © 2007 NSCLC 17 Coverage Determinations — Substance and Strategy Drug not on plan formulary Is it excluded by MMA? Enumerated categories – – Prescribed for a different indication? – Covered by Medi-Cal (e.g. benzodiazepines) – Enhanced plans Part B drugs Some off-label

18. © 2007 NSCLC 18 Coverage Determinations — Substance and Strategy Part D Covered Drugs – Not on plan formulary 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

19. © 2007 NSCLC 19 Coverage Determinations — Substance and Strategy Doctor must show medical necessity: – 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

20. © 2007 NSCLC 20 Coverage Determinations — Substance and Strategy Prior Authorization Pharmacy denial is coverage determination—generates written denial Redetermination –Exception to prior auth. Step Therapy If doctor tried to meet, can still argue medical necessity

21. © 2007 NSCLC 21 Coverage Determinations — Substance and Strategy Off-Label Use – a special case – Show medical necessity AND – Show use for a “medically accepted indication” Use is FDA approved or Use appears in a compendium 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

22. © 2007 NSCLC 22 Coverage Determinations — Substance and Strategy Off-Label Use Issue sometimes comes up late 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 Need for legislative fix Compendium requirement too narrow Maximus appearing to defend issue

23. © 2007 NSCLC 23 Coverage Determinations — Substance and Strategy Tiering Exceptions – 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) – Doctor must show: “preferred drug is not as effective as requested drug OR has adverse effects”* – Not relevant to Low Income Subsidy recipients * Based on clinical/medical evidence

24. © 2007 NSCLC 24 Emergency drugs Transition supplies for continuing prescriptions Beginning of plan year or when joining a new plan: – 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 Long Term Care – 31 day supply – Renewable throughout first 90 days – Transition must accommodate change of status, e.g., discharge prescriptions Does not apply to new prescriptions

25. © 2007 NSCLC 25 Emergency drugs – New Prescriptions Long term care – 31 day supply to allow time for exception Emergency supply if plan fails to meet decision deadline – Extends from when plan misses deadline through decision of IRE – Not in guidance. Other Options – Ask plan to voluntarily extend supply – Patient Assistance Programs

26. © 2007 NSCLC 26 Grievances 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 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 Importance of filing grievances

27. © 2007 NSCLC 27 Reporting Problems Plans that fail to comply with the requirements for exceptions and appeals processes may be reported to CMS: – Central office: prit@cms.hhs.govprit@cms.hhs.gov – CMS Region IX: rosfodbs@cms.hhs.govrosfodbs@cms.hhs.gov For grievances, CMS complaint tracking procedures: Plan 1-800-MEDICARE Regional office See http://www.cms.hhs.gov/partnerships/downloads/PartDComplaints.pdf

28. © 2007 NSCLC 28 Call with questions, problems, send client stories National Senior Citizens Law Center Georgia Burke (510) 663-1055 ext. 304 gburke@nsclc.org 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. Questions

29. © 2007 NSCLC 29 Resources NSCLC Tools for Advocates http://www.nsclc.org/areas/medicare-part-d/area_folder.2006-09-28.4596471630/area_folder.2006-10- 31.2079546039 – 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 – Appointment of Representative Form (CMS Form-1696): http://www.cms.hhs.gov/CMSForms/CMSForms/itemdetail.asp?filterType=keyword&filterValue=169 6&filterByDID=0&sortByDID=1&sortOrder=ascending&itemID=CMS012207 http://www.cms.hhs.gov/CMSForms/CMSForms/itemdetail.asp?filterType=keyword&filterValue=169 6&filterByDID=0&sortByDID=1&sortOrder=ascending&itemID=CMS012207 – Patient Assistance Programs (PAP): http://www.rxhope.com/http://www.rxhope.com/