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 P&T 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 < 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issue (psychogenic vs. organic cause) • Inappropriate use (e.g., recreational, diversion) • HA policy 98-040 recently rescinded • QL (6 per month) still in place, PA for males < 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

11. 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 >35 • 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 Patient’s 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