Prior Authorization & Medical Necessity Determinations in the Military Health System

1
Prior Authorization Medical Necessity
Determinations in the Military Health System

• Shana Trice, PharmD, BCPS
• Libby Hearin, PharmD
• COL Dan Remund, USA

2
Outline

• Prior Authorizations (PAs)
• Drug selection
• Criteria development
• Types of Medical Necessity (MN) Determinations
• PA / MN process in TMOP TRRx
• Portability of PA MNs

3
Prior AuthorizationsSelecting Medications

• High risk of inappropriate use?
• Lack of clinical evidence to support use
• Evidence that a medication is ineffective for a
  given use
• Use of a high cost agent when more cost-effective
  alternatives available
• Safety issues?
• TRICARE coverage issues?
• Would a PA be cost-effective?
• High cost, substantial use, high risk of
  inappropriate use
• Do direct costs exceed costs avoided?
• Does existence of the PA cause providers to write
  fewer Rxs (the sentinel effect)

4
Prior AuthorizationsDevelopment Approval of
Criteria

• PEC develops draft criteria implementation plan
• Expert opinion (Service consultants in specialty
  areas, surveys of MTF providers)
• Industry practice
• Practical to implement
• DoD PT Committee reviews, comments on,
  recommends approval of criteria implementation
  plan
• Director, TRICARE Management Activity (TMA)
  approves after considering comments from
  Beneficiary Advisory Panel
• PEC develops PA forms other supporting
  documents in conjunction with ESI

5
Prior AuthorizationsCurrent PAs

• Phosphodiesterase-5 (PDE-5) inhibitors for
  erectile dysfunction (male pts lt 50)
• Sildenafil (Viagra), tadalafil (Cialis),
  vardenafil (Levitra)
• Coverage issue (psychogenic vs. organic cause)
• Inappropriate use (e.g., recreational, diversion)
• HA policy 98-040 recently rescinded
• QL (6 per month) still in place, PA for males lt 50

6
Prior AuthorizationsCurrent PAs

• Biologic agents for arthritis/psoriasis
• Etanercept (Enbrel), adalimumab (Humira),
  anakinra (Kineret), and efalizumab (Raptiva)
• High cost, new therapies, FDA indications tightly
  track available evidence

7
Prior AuthorizationsCurrent PAs

• Fertility agents (injectable gonadotropins)
• Coverage issue coital vs. noncoital use
  (Artificial Reproductive Technology)
• 32 CFR 199.4 (e)(34) - excludes services and
  supplies related to artificial insemination,
  in-vitro fertilization, gamete intrafallopian
  transfer and all other non-coital reproductive
  technologies
• 32 CFR 199.4 (e)(3)(B)(3) - family planning
  benefit does not include services and supplies
  related to noncoital reproductive technologies
• Reflects clinical standards when regulations
  written

8
Prior AuthorizationsCurrent PAs

• Antifungals for onychomycosis
• Ciclopirox (Penlac Nail Lacquer), itraconazole
  capsules (Sporanox), terbinafine tablets
  (Lamisil)
• Safety, inappropriate use, high cost
• Illogical to risk adverse effects and incur cost
  treating non-fungal conditions with an antifungal

9
Prior AuthorizationsCurrent PAs

• Growth hormone
• Went into effect 1 June 2004 for new patients
  only
• Coverage issue FDA approved for Idiopathic short
  stature (ISS), but TMA concluded that treatment
  of ISS is not medically necessary
• Inappropriate use Use for other conditions not
  supported by the medical literature (e.g.,
  depression, aging, weight control)

10
Types of Medical Necessity Determinations

• To provide non-formulary medication at the
  formulary copay in TMOP or TRRx
• To provide non-formulary medication at an
  MTF-for Rxs written by MTF providers-for Rxs
  written by civilian provider to whom the patient
  was referred by an MTF

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Medical Necessity to Use Non-formulary Drugs

• Use of the formulary drug is contraindicated
• Patient experiences or is likely to experience
  significant adverse effects from formulary drugs
• Formulary drugs result or are likely to result in
  therapeutic failure
• Patient previously responded to non-formulary
  drug and changing to a formulary drug would pose
  unacceptable clinical risk
• No alternative drug on the formulary

12
Types of Medical Necessity Determinations

• To cover a drug that is not normally covered
• Examples
• Brand drugs with generic equivalents
• Tretinoin (Retin A) for patients gt35
• Non-contracted statin

13
Types of Medical Necessity Determinations

• Exceptions to quantity limits
• Patient has valid clinical need for quantity
  greater than quantity limit
• Use is supported by clinical literature but
  relatively uncommon
• Example use of sildenafil for primary pulmonary
  hypertension requires exception to 6 tablet
  quantity limit

14
PA/MN ProcessA Patients Experience
Provider submits PA/MN request for the patient
Denied
Approved
Patient receives denial letter explaining 1st
level appeal rights
Patient requests 1st level reconsideration.
Different ESI group reviews PA/MN request.
Approved
Patient does not pursue appeal Rx will reject at
TRRx TMOP
Denied
PA/MN flag set in PDTS patient may fill Rx
Patient receives denial letter explaining 2nd
level appeal rights
Approved
Patient requests 2nd level reconsideration. TMA
or appeals contractor reviews PA/MN request
Denied
Patient receives final denial letter. Rx will
reject at TRRx TMOP
15
Portability of PA and MNsHow do the actions of
MTFs affect the entire MHS?

• MTF fills DO auto-generate approvals for TMOP
  TRRx in PDTS for
• Prior Authorizations
• Approval flags are medication-specific and expire
  1 year from the fill date
• Medical Necessity Determinations for drugs that
  are non-formulary on the Uniform Formulary
• Approval flags are medication-specific
  expiration date is open-ended (at least through
  life of contract)
• MTF fills DO NOT auto-generate approval for TMOP
  TRRx in PDTS for
• Medical Necessity Determinations for drugs not
  normally covered by TRICARE
• Medical Necessity Determinations for exceptions
  to quantity limits