Covered Prescription Drug List (4-Tier Large Group HMO/POS)
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This document lists covered outpatient prescription drugs and formulary structure for Sharp Health Plan employer-sponsored Large Group HMO and POS products that use a 4-tier formulary. It affects members and providers under the listed Large Group HMO, HDHP, and POS plan codes and custom employer groups.
No material clinical or coverage changes in this revision.
Coverage Criteria and Product-Level Controls
Pharmacy Benefit Coverage Criteria
Covered when ALL of the following are met
See Member Handbook and medical benefit for physician‑administered drugs.
Nonformulary drugs require a Formulary Exception approved per plan rules.
Formulary coverage and exception criteria
Coverage and exceptions follow these requirements and timelines
See Formulary symbols and definitions.
PA** applies if Step Therapy is not met; Step Therapy Exception requests follow same timelines.
Members transitioning from another plan who are already taking the medication are not required to re‑meet Step Therapy for continuity of care.
Decisions follow PA timelines.
If approved, Nonformulary coverage is subject to designated cost share tier as stated in Formulary guidance.
Initial Coverage Criteria (Opioid ER group)
Covered when ANY of the following are met
Applies to Step Therapy Group OPIOID ER 2219‑M; documentation of prior fills (dates, agent, days' supply) required for PA/step determinations.
Short-term IR Coverage (Opioid IR combo group)
Covered under limited circumstance
Applies to Step Therapy Group OPIOID IR COMBO PRODUCTS 1358‑E; prescriber should document lack of recent opioid exposure.
Opioid ER - Initial Coverage Criteria
Covered when meeting the step therapy definitions for the opioid groups
See Step Therapy Group OPIOID ER 2219‑M for applicable products; prior authorization required where indicated.
Opioid IR Combo - Short Supply Exception
Coverage allowance for short-term IR opioids
Applies to Step Therapy Group OPIOID IR COMBO PRODUCTS 1358‑E; prescriber documentation of prior fills is required for PA determinations.
Amphetamines / Anorexiants / Anti-obesity - Coverage Criteria
Coverage for amphetamine-class stimulants, anorexiants, and select anti-obesity agents is subject to prior authorization and quantity limits.
Many products require PA for members age >= 19; prescriber must provide age and justification when requesting PA that exceeds QL.
PA and quantity limit requirements
Coverage requirements and limits as stated per product (PA, QL, MO, SP where indicated).
Refer to individual product entries for exact QL and age thresholds (PA required for age >= 19 for many agents).
Stimulant (methylphenidate) coverage
Coverage rules and limits applied to listed stimulant products
Examples include 270 tabs/75 days, 180 tabs/75 days, 90 tabs/75 days depending on strength/formulation.
Allergenic extracts/biologicals
Allergenic extracts/biologicals and related coverage controls
Specific clinical PA criteria not provided in this excerpt; follow PA submission process.
Oral immunomodulators
Specialty/immunomodulatory oral agents
Preferred indications are noted in product entries; fill via specialty pharmacy and follow PA documentation requirements.
Analgesics/NSAIDs
Analgesics and NSAIDs
Aspirin 81 mg has QL 100 tabs every 30 days with $0 copay for members capable of pregnancy aged 12‑59 at risk for preeclampsia; otherwise not covered.
General product-level coverage criteria
Coverage is contingent on the following product-specific controls and age rules
See specific product entries for exact QL and PA/ST status.
Applies to codeine, hydromorphone, morphine, tramadol and other opioid products as specified.
See product entries for exact age restrictions.
Examples include fentanyl patches and high‑mg hydrocodone or morphine ER formulations.
Formulary-specific coverage entries (examples)
Coverage depends on drug/formulation-specific controls shown (PA, ST, QL, MO, age/initial-fill limits). Example entries:
Applies per product entries.
See specific product rows for details.
Refer to product table for exact strength‑based rules.
See product entries for PA** and QL values.
Apply step therapy where indicated.
Formulary coverage flags
Coverage and restrictions are indicated per drug entry as tier and coverage requirement flags.
Coverage contingent on satisfying the indicated flags and any numeric limits.
General formulary coverage with quantity limits
Coverage applies according to listed drug tier and specified coverage requirements and limits.
No additional diagnostic clinical criteria present in this fragment; follow PA/ST processes when required.
Formulary coverage and quantity limits (partial)
Drugs are covered according to assigned tier and coverage requirement codes; quantity limits apply when specified.
Specific clinical prior authorization criteria are detailed in payer PA guidance, not in this excerpt.
Formulary listings and requirement codes
Drugs are listed by therapeutic class with assigned drug tier and coverage requirement codes; coverage is conditional per the codes (e.g., MO, PA, SP, QL).
No additional clinical criteria included in this fragment; follow product row and PA guidance.
Administrative coverage flags (PA, MO)
Coverage indicated when product-specific administrative flags are satisfied
Prescriber must submit PA with supporting clinical documentation per plan timelines.
Details of MO criteria are not specified in these chunks.
This Formulary is the current official list of covered outpatient prescription drugs for Sharp Health Plan. All previous versions are no longer in effect and the document is subject to change; updates to coverage, formulary placement, or utilization controls may occur and will supersede prior versions.
Drugs covered under the outpatient prescription drug benefit are generally dispensed through network retail, specialty, or mail-order pharmacies. Medical Benefit drugs (for example, physician‑administered or certain self‑injectable therapies) are covered under the Medical Benefit and are not processed through the outpatient prescription drug Formulary; see the Member Handbook for specific benefit and cost‑share information.
Drugs prescribed solely for cosmetic indications are not covered. Examples of exclusions include medications prescribed exclusively for cosmetic services, hair loss, sexual dysfunction, athletic performance enhancement, and anti‑aging for cosmetic purposes. Coverage for mental performance agents is limited to medically necessary treatment of diagnosed mental illness or conditions such as dementia.
When a generic equivalent is available, the brand‑name product is not covered unless prior authorization documents medical necessity to dispense the brand. Similarly, pharmacies may be required to dispense an interchangeable biologic unless prior authorization approves use of the reference product.
Aspirin 81 mg is generally not covered under the outpatient prescription benefit, except for members capable of pregnancy aged 12–59 years at risk for preeclampsia, for whom a $0 copay applies.
Certain opioid and combination products carry pediatric restrictions. Specifically, selected tramadol formulations and some acetaminophen‑with‑codeine products are not available under age 12; many opioid liquid/tablet entries also include initial short‑fill rules and pediatric initial‑fill limits.
Some RELION‑branded insulin products are explicitly listed as not covered (noted in proximity to Novolin and related insulin entries); covered insulin products are listed with their coverage requirement flags (e.g., MO) and tier assignments.
Formulary Listings, Codes, and Key Values
| N/A | Alphabetical lists and therapeutic categories shown; specific billing codes not present in this excerpt |
| 2219-M | OPIOID ER group identifier |
| 1358-E | OPIOID IR COMBO PRODUCTS group identifier |
| OPIOID ER 2219-M | Step Therapy Group name |
| OPIOID IR COMBO PRODUCTS 1358-E | Step Therapy Group name |
| phentermine hcl-topiramate cap er 24hr 3.75-23 mg | listed product; COVERAGE REQUIREMENTS AND LIMITS = PA; generic |
| phentermine hcl-topiramate cap er 24hr 7.5-46 mg | listed product; DRUG TIER = 1; COVERAGE REQUIREMENTS AND LIMITS = PA; generic |
| phentermine hcl-topiramate cap er 24hr 11.25-69 mg | listed product; DRUG TIER = 1; COVERAGE REQUIREMENTS AND LIMITS = PA; generic |
| phentermine hcl-topiramate cap er 24hr 15-92 mg | listed product; DRUG TIER = 1; COVERAGE REQUIREMENTS AND LIMITS = PA; generic |
| QSYMIA CAP 3.75-23 | brand (phentermine/topiramate); DRUG TIER = 2; COVERAGE REQUIREMENTS AND LIMITS = PA |
| QSYMIA CAP 7.5-46MG | brand; DRUG TIER = 2; COVERAGE REQUIREMENTS AND LIMITS = PA |
| QSYMIA CAP 11.25-69 | brand; DRUG TIER = 2; COVERAGE REQUIREMENTS AND LIMITS = PA |
| QSYMIA CAP 15-92MG | brand; DRUG TIER = 2; COVERAGE REQUIREMENTS AND LIMITS = PA |
| orlistat cap 120 mg | generic; DRUG TIER = 1; COVERAGE REQUIREMENTS AND LIMITS = PA |
| WEGOVY TAB 1.5MG | brand semaglutide (weight management); DRUG TIER = 2; COVERAGE REQUIREMENTS AND LIMITS = PA |
| Butalbital-Acetaminophen 50-325 mg | Butalbital-acetaminophen tab 50-325 mg — QL (48 tabs every 25 days) |
| Butalbital-Acetaminophen-Caffeine 50-325-40 mg | Butalbital-acetaminophen-caffeine tab 50-325-40 mg — QL (48 tabs every 25 days) |
| Butalbital-Aspirin-Caffeine 50-325-40 mg | Butalbital-aspirin-caffeine cap 50-325-40 mg — QL (48 caps every 25 days) |
| Codeine sulfate 30 mg | Codeine sulfate tab 30 mg — PA, QL (42 tabs every 25 days); Subject to initial 7-day limit; age 19 or younger subject to initial 3-day limit |
| Fentanyl TD patch 12-100 mcg/hr | Fentanyl td patch 72hr (12,25,37.5,50,62.5,75,87.5,100 mcg/hr) — ST or PA; QL (10 patches every 25 days); High strength requires PA |
| Hydrocodone ER/24hr & cap ER 12hr | Multiple strengths (10–120 mg) — ST or PA; QL commonly 30–60 caps/tabs every 25 days; high strength requires PA |
| Hydromorphone (liquid/tablet/ER) | Hydromorphone forms — PA, QL (various: 600 mL, 180,150,60 tabs every 25 days); initial 7-day limit; age <20 initial 3-day limit |
| Meperidine 50 mg | Meperidine oral solution and tablets — PA, QL (90 mL or 18 tabs every 25 days); initial 7-day limit; age <20 initial 3-day limit |
| Methadone (various forms) | Methadone concentrations/tablets — QL (30 mL every 25 days) indicated for opioid addiction; some formulations ST and PA with larger QLs |
| Morphine sulfate (IR/ER/soln/caps) | Many formulations and strengths — mix of ST and PA; QL examples: caps/tabs 30 caps/25 days or liquid volumes; high strength requires PA |
| Oxycodone (IR/solution) | Oxycodone tabs and solutions — PA, QL (e.g., 180 caps or 90 mL every 25 days); initial 7-day/3-day age limits |
| Oxymorphone 5-10 mg | Oxymorphone tabs — PA, QL (90–180 tabs every 25 days); initial 7-day/3-day age limits |
| Tapentadol 50-100 mg | Tapentadol tabs — PA required |
| Tramadol (IR/ER/oral soln) | Tramadol solutions and tablets — PA and QL (e.g., 1800 mL or 180 tabs every 25 days); many ER formulations ST or PA; Not available under age 12 |
| Acetaminophen w/ codeine (various) | Acetaminophen w/ codeine solutions and tablets — ST, QL (e.g., 2700 mL or 400 tabs every 25 days); PA**; initial 7-day limit; not available under age 12 |
| No codes listed |
| N/A | No CPT/HCPCS/ICD/NDC codes listed in this excerpt; only drug names, tiers, and coverage flags are present. |
| QL | Quantity limit (examples provided inline) |
| MO | Coverage requirement code (used for many listed products) |
| MO | Coverage requirement code (document lists MO for many generic and brand products) |
| SP | Specialty pharmacy requirement (appears for zuranolone) |
| PA | Prior authorization requirement (appears for zuranolone) |
| QL | Quantity limit (appears for zuranolone; specific limits provided) |
| trimipramine maleate cap 100 mg | DRUG TIER = 1; COVERAGE REQUIREMENTS AND LIMITS = MO |
| acarbose tab 25 mg | DRUG TIER = 1; COVERAGE REQUIREMENTS AND LIMITS = MO |
| acarbose tab 50 mg | DRUG TIER = 1; COVERAGE REQUIREMENTS AND LIMITS = MO |
| acarbose tab 100 mg | DRUG TIER = 1; COVERAGE REQUIREMENTS AND LIMITS = MO |
| GLYXAMBI TAB 10-5 MG | DRUG TIER = 2; COVERAGE REQUIREMENTS AND LIMITS = MO |
| GLYXAMBI TAB 25-5 MG | DRUG TIER = 2; COVERAGE REQUIREMENTS AND LIMITS = MO |
| SYNJARDY TAB and XR formulations | DRUG TIER = 2; COVERAGE REQUIREMENTS AND LIMITS = MO |
| metformin hcl tabs and ER formulations | DRUG TIER = 1; COVERAGE REQUIREMENTS AND LIMITS = MO |
| BAQSIMI ONE POW 3MG/DOSE | DRUG TIER = 2 |
| glucagon for inj 1 mg | DRUG TIER = 1 |
Prior Authorization, Step Therapy, and Documentation Requirements
Formulary includes PA, QL, ST and related controls
The formulary includes coverage controls (PA, PA**, QL, ST, SP, MO). Refer to the Step Therapy and Prior Authorization sections of the Formulary for specific requirements for each drug.
- Symbols: PA = Prior Authorization; PA** = PA if Step Therapy not met; QL = Quantity Limit; ST = Step Therapy; SP = Specialty Pharmacy; MO = Mail Order (90-day)
Obtain Prior Authorization for PA‑designated drugs
Drugs marked 'PA' in the Coverage Requirements and Limits column require a prior authorization submitted by the Prescribing Provider; approvals are based on Sharp Health Plan clinical criteria and follow PA timelines (72 hours non‑urgent; 24 hours urgent/exigent).
- Submit PA by phone, fax, or electronic Prior Authorization form.
- If denied, member/provider may file an appeal as described in the Formulary.
PA and PA** require PA submission (PA** when ST unmet)
Drugs listed with 'PA' or 'PA**' require prior authorization; PA** indicates PA is required when Step Therapy has not been met and may be requested to bypass ST when medically necessary.
- PA** is Prior Authorization if Step Therapy not met; submit clinical justification to request bypass.
Meet step therapy tied to opioid Step Therapy Group IDs
Opioid products in Step Therapy Group OPIOID ER (2219‑M) and OPIOID IR COMBO (1358‑E) are subject to step therapy; coverage requires meeting the group criteria tied to those Step Therapy Group IDs.
- Check Step Therapy Group identifiers: OPIOID ER = 2219‑M; OPIOID IR COMBO = 1358‑E.
Opioid ER: document cumulative IR/ER prior exposure
For Opioid ER group (OPIOID ER 2219‑M) prior authorization/coverage requires prior opioid exposure: a cumulative ≥7‑day supply of an immediate‑release opioid in the past 90 days OR cumulative ≥30 days of an extended‑release opioid in the past 90 days.
- Document prior fills to show either: cumulative ≥7 days IR in 90 days, or cumulative ≥30 days ER in 90 days.
Opioid IR combo: allow up to 7‑day IR supply when no recent exposure
Opioid IR combo group (OPIOID IR COMBO PRODUCTS 1358‑E) allows coverage of up to a 7‑day supply of immediate‑release opioids if the member does not have at least a cumulative 7‑day opioid supply (IR or ER) within the past 90 days.
- Coverage limited to ≤7 days when no prior cumulative ≥7‑day opioid supply in prior 90 days.
Obtain PA and adhere to QLs for amphetamine‑class products
Many amphetamine‑class stimulants and related anorexiant/anti‑obesity agents require prior authorization and have quantity limits; providers must request PA and follow QL limits noted for each product.
- QL examples: 360 tabs/75 days, 180 tabs/75 days, 90 tabs/75 days, or mL limits for oral solutions.
- PA is required for patients age ≥19 for many listed products.
Obtain PA where formulary shows 'PA' for ADHD/related agents
Multiple ADHD/amphetamine‑class products show 'Coverage Requirements and Limits = PA'; providers must obtain prior authorization where PA is indicated before coverage is granted.
- Confirm product‑specific QL and age‑based PA (PA required for age ≥19) when submitting PA.
PA required for methylphenidate ER/patch in adults (age ≥19)
Methylphenidate extended‑release products and transdermal patch formulations require prior authorization and have specified quantity limits; PA is specifically required for members age ≥19 for listed methylphenidate ER/OSM/patch entries.
- QL examples for methylphenidate ER: 270, 180, or 90 tabs per 75 days depending on strength.
- Include age verification when requesting PA for age ≥19.
Route selected specialty immunomodulators via Specialty Pharmacy with PA and QL
Select specialty immunomodulators (e.g., upadacitinib, tofacitinib, apremilast) require prior authorization and must be routed via the specialty pharmacy; quantity limits apply per product.
- These agents are flagged SP and PA; QLs shown (e.g., upadacitinib QL 12 mL every 1 day; Otezla QL 55 or 41 tabs per interval).
Obtain PA for opioid products (high‑strength require PA)
Many opioid formulations are designated PA or PA**; high‑strength formulations explicitly require prior authorization—obtain PA before dispensing to avoid denial.
- High‑strength patches/tables (e.g., fentanyl ≥50 mcg/hr, hydrocodone ER high mg) require PA.
- PA** may apply for ER/ER products when ST not met.
Follow PA/ST and initial‑fill rules for opioid and buprenorphine products
Numerous opioid and buprenorphine products require prior authorization or step therapy; providers must follow PA/ST flags and initial‑fill limits where specified.
- Many products are ST or PA**; initial 7‑day limit applies (3‑day if age ≤19) for many liquids/tablets.
- Buprenorphine buccal films may be ST with QL (e.g., BELBUCA 60 films/25 days) and PA**.
Obtain PA (and satisfy MO) for selected topical/hormonal products
Several topical and hormonal androgen/testosterone products are listed with 'PA, MO' coverage requirements; providers must obtain prior authorization and follow any MO processes required by the plan.
- Examples: METHITEST, NATESTO gel and testosterone topical gels list PA and MO.
Follow MO and QL codes; do not exceed listed quantity limits
Products marked with MO or QL carry managed coverage or quantity limits; prescribers should follow the MO process if applicable and ensure prescriptions do not exceed listed QLs.
- MO entries may require medical/other authorization per plan practice.
- Claims may be denied if QLs (e.g., inhaler or mL limits) are exceeded.
Comply with MO/QL coverage codes when present
Coverage requirement codes (MO, QL) indicate that prescribers must meet the plan's managed‑coverage or quantity‑limit processes; prior authorization may be required where MO is indicated.
- MO often denotes coverage requirements or medical override pathways; follow instructions in Formulary.
- Submit PA with supporting documentation if MO/PA noted.
Oxtellar XR entries may require PA/MO prior to coverage
Some branded extended‑release oxcarbazepine (Oxtellar XR) entries are shown with DRUG TIER = 2 and coverage requirement 'MO', implying prior authorization/management oversight may be required for coverage.
- Confirm MO/PA requirements for Oxtellar XR strengths (150/300/600 mg) when submitting authorization.
PA and Specialty Pharmacy routing required for ZURZUVAE (zuranolone)
Certain products (e.g., ZURZUVAE/zuranolone) require prior authorization and must be routed through specialty pharmacy; PA and QL enforcement apply for listed strengths.
- ZURZUVAE is flagged SP, PA, QL — QL: 2 caps/day for 20/25 mg; 1 cap/day for 30 mg.
- Submit PA and route via Sharp Health Plan specialty network (CVS Specialty) per site‑of‑care rules.
Obtain PA for selected incretin‑mimetic agents
Several incretin‑mimetic agents (Mounjaro, Ozempic, Rybelsus, Trulicity) are designated 'PA' (some also 'MO'); prescribers must obtain prior authorization for these agents before coverage.
- Mounjaro, Ozempic, Rybelsus and Trulicity list PA; some strengths also show MO.
- Include required clinical documentation with PA submission.
Step Therapy section applies to multiple classes
The Formulary includes a Step Therapy Criteria section; drugs marked 'ST' require step adherence and providers should consult the Step Therapy Criteria for class‑specific step rules.
- Step Therapy exceptions may be requested via the Prior Authorization process with clinical justification.
Require and document trials for Step Therapy; submit exceptions via PA
Sharp Health Plan may require trials of specified drugs (Step Therapy) before covering higher‑step agents; providers may submit Step Therapy Exception requests with clinical justification via the PA process.
- If ST exception is requested, decision timelines follow PA timelines (72 hours non‑urgent; 24 hours urgent/exigent).
Submit Step Therapy Exceptions via Prior Authorization with clinical justification
Providers may submit a Step Therapy Exception with clinical justification through the Prior Authorization process; Step Therapy Exception requests follow PA decision timelines (72 hours non‑urgent; 24 hours urgent/exigent).
- If Plan fails to respond within timelines, a completed request is deemed granted.
- Include clinical rationale and supporting documentation with the exception request.
Ensure member meets supply‑history thresholds under Step Therapy
Members must meet the Step Therapy supply‑history thresholds for coverage; prescribers should document prior fills and supply to demonstrate step fulfillment as defined in the Step Therapy Criteria.
- Opioid thresholds: cumulative ≥7 days IR in past 90 days or cumulative ≥30 days ER in past 90 days.
- For IR combo, document absence of prior cumulative ≥7‑day opioid supply to support a ≤7‑day allowance.
Document prior opioid exposure per opioid step therapy rules
Coverage for many opioid ER/IR agents is contingent on prior short‑term IR opioid exposure or prior ER opioid use as specified by the opioid step therapy group rules; document prior opioid use accordingly.
- Document dates, agent names, and days' supply of prior opioid fills to show step criteria fulfillment.
When Step Therapy not specified, follow PA/MO/QL flags
Some sections do not specify explicit Step Therapy rules in this extract; when ST is not shown, follow PA/MO/QL flags indicated for the product.
- If ST is not listed, check Coverage Requirements column for PA, QL, MO and follow those processes.
Submit PA with required clinical information; timelines apply
PA requests must be submitted by the Prescribing Provider (phone/fax/electronic) with supporting clinical information; determinations are made within 72 hours for non‑urgent requests and within 24 hours for urgent/exigent requests.
- Incomplete requests will trigger notification of needed information within 72 hours (24 hours if exigent).
- If Sharp Health Plan fails to respond within timelines to a completed PA request, the request is deemed granted.
Provide complete supporting documentation with PA to avoid delays
Providers must supply all required supporting clinical information when submitting a PA; incomplete or missing information will prompt a request for additional information and can delay determinations.
- Notification of missing info: within 72 hours (24 hours exigent).
- Decisions issued within 72 hours (non‑urgent) or 24 hours (urgent/exigent) after receipt of all required info.
Document cumulative opioid supply thresholds (7‑day IR or 30‑day ER within 90 days)
For opioid step therapy, documentation must show cumulative supply thresholds: at least a cumulative 7‑day supply of IR opioid within the past 90 days or at least a cumulative 30‑day supply of ER opioid within the past 90 days.
- Include prior fill dates, agent names, and days' supply to demonstrate the cumulative thresholds.
Include prior opioid fill details when requesting opioid PA
When requesting PA for opioids under step therapy, include prior opioid fill records (dates, agent, and days' supply) to demonstrate fulfillment of step criteria.
- Records should cover the prior 90‑day period and show cumulative days' supply.
Provide age and justification for amphetamine/anorexiant PA requests (age ≥19)
When requesting PA for amphetamine/anorexiant products for patients age ≥19, prescribers must provide the member's age and clinical justification supporting medical necessity.
- Age verification is required for PA (many entries state 'PA Required for age ≥19').
- If requesting quantities above QL, supply medical necessity rationale.
Supply medical necessity documentation for methylphenidate ER/patch PA
Prescribers should include clinical documentation supporting medical necessity when requesting prior authorization for methylphenidate ER/OSM/patch formulations and related PA‑designated stimulant entries.
- Include indication, prior therapies tried (if applicable), and age when member is ≥19.
Adhere to initial‑fill limits (7‑day standard; 3‑day if age ≤19)
Initial‑fill limits apply to many opioid products: a standard initial 7‑day limit for adults and an initial 3‑day limit for patients age 19 or younger; documentation may be required for overrides.
- Apply initial 7‑day limit for adult initial fills; if member is ≤19, initial 3‑day limit applies.
- Document clinical rationale if requesting override of initial‑fill limits.
Provide PA/ST documentation per product designations
Prior authorization documentation is required for PA‑designated products and for PA** or high‑strength designations; Step Therapy (ST) may require additional documentation for exception requests.
- Include clinical justification, prior treatment history, and any requested quantity rationale for PA/ST decisions.
Formulary is subject to change — verify current version
This Formulary document is subject to change and prior versions are not in effect; providers should verify current Formulary status as coverage may change with updates.
- Check the online electronic drug list for the most current Formulary updates (last updated 04/01/2026).
Risk of PA denial — appeals available
Prior Authorization requests may be denied if supporting information does not meet Sharp Health Plan clinical policies; denied requests may be appealed by the member, authorized representative, or prescribing provider.
- If PA is denied, follow the Formulary 'You Have the Right to Appeal' instructions and timelines.
Nonformulary coverage requires a Formulary Exception (appealable)
Nonformulary drugs are not covered unless a Formulary Exception is approved via the Prior Authorization/Formulary Exception process; denials of exceptions can be appealed.
- If a nonformulary drug is approved, Tier 3 cost share applies for brand‑name; Tier 1 applies for generic nonformulary approvals.
Step Therapy non‑fulfillment may cause coverage denial
Coverage may be denied if the member does not meet Step Therapy supply thresholds (e.g., no cumulative 7‑day IR opioid supply in past 90 days and not receiving cumulative 30‑day ER opioid use in past 90 days).
- Verify prior opioid supply before submitting PA for opioid ER group; absence of required prior use may trigger denial.
Opioid Step Therapy denial trigger if criteria unmet
Requests may be denied for opioid Step Therapy groups if step criteria are not met (no recent IR opioid fill ≥7 days in past 90 days or no cumulative ER opioid use ≥30 days in past 90 days).
- Ensure opioid step thresholds are documented in the PA to avoid denial.
AMPHETAMINES: PA/QL denials possible if age or QL requirements not met
Prior authorization denials for amphetamine products can occur if age requirements (PA required for age ≥19) or quantity limits are not met or supported by documentation.
- Include age and medical justification when PA required for patients age ≥19.
- Provide rationale when requesting quantities exceeding listed QLs.
Claims may be denied if PA is not obtained for PA‑flagged drugs
Coverage for products marked 'PA' may be denied if prior authorization is not obtained before dispensing; obtain PA to prevent claim denial.
- Verify PA requirement on the Formulary entry before prescribing/dispensing.
Methylphenidate ER/patch: PA required — risk of denial if not obtained
Prior authorization is a trigger for methylphenidate ER/OSM/patch products; PA is required for many strengths and for members age ≥19 — failure to obtain PA risks denial.
- Confirm PA requirement and include age/clinical justification in the PA submission.
PA required for modafinil, allergenics and certain specialty agents
PA is required for modafinil and listed allergenic biologics, and for select specialty agents (e.g., upadacitinib, tofacitinib, apremilast); lack of PA can lead to denial.
- Modafinil entries show PA and MO; specialty immunomodulators show SP and PA.
Obtain PA for select incretin agents to avoid denial
Prescriptions for select incretin mimetic agents (Mounjaro, Ozempic, Rybelsus, Trulicity) list 'PA' (and sometimes 'MO'); prescribers must obtain prior authorization before coverage is approved.
- Include required clinical information when submitting PA for incretin agents.
Initial and Start-of-Therapy Requirements
Initial therapy requirements
Initial coverage conditional on prior opioid exposure
Documentation of prior fills (dates, agent, days supply) required when submitting PA or Step Therapy Exception requests.
Opioid Initial Therapy
Opioid step therapy initial conditions
Applies to Step Therapy Groups OPIOID ER 2219‑M and OPIOID IR COMBO PRODUCTS 1358‑E.
Initial therapy limits
Initial-fill rules applied to many opioid products
Applies to hydromorphone, morphine, codeine, and similar products as noted in product entries; documentation may be required for overrides.
Initial fill constraints
Initial fill limits and pediatric initial limits applied to many opioid products.
Providers should document age and indication when requesting PA or overrides.
Continuation and Ongoing Therapy Rules
Continuation and continuity of therapy
Continuity and ongoing therapy rules
Provider should submit prior insurer medication history for continuity requests.
Step Therapy Rules and Groups
| Step Therapy Topic | Summary |
|---|---|
| Step Therapy Criteria section exists | The formulary contains a Step Therapy Criteria section that applies to multiple therapeutic classes; drugs marked 'ST' require prior trial of specified alternatives before coverage unless an approved exception is provided. |
| Program purpose | Step Therapy is used to encourage safe, cost‑effective medication use by requiring a 'step' approach (trial of a proven, cost‑effective drug) before covering higher‑step therapies. |
| Exception process | Providers may submit a Step Therapy Exception with clinical justification via the Prior Authorization process; requests must be decided within 72 hours for non‑urgent or 24 hours for exigent requests (deemed granted if not decided within those timeframes). |
| Requirement | What the Formulary Requires |
|---|---|
| Formulary-designated Step Therapy (ST) | Drugs with the ST symbol require trial of specified alternative(s) (as listed on the Formulary) before coverage of higher‑step drugs; prior authorization may be required if ST not met (PA** applies). |
| Exception consideration | Sharp Health Plan will consider Step Therapy exceptions when the provider documents that the required step drug is inconsistent with good professional practice or when medically necessary; follow the Prior Authorization/Step Therapy Exception process. |
| Continuity of care | Members who transfer from another plan and are currently taking a medication will not be required to satisfy Step Therapy to continue that medication; provider may need to submit documentation to ensure continuity of coverage. |
| Action | Provider must do |
|---|---|
| Submit Step Therapy Exception via Prior Authorization | Prescribing provider must submit a Step Therapy Exception request through the Prior Authorization process with supporting clinical justification when the required step drug is unsuitable or medically unnecessary. |
| Required documentation | Include clinical documentation demonstrating why the step drug is inconsistent with good professional practice or evidence of medical necessity to support the exception request. |
| Decision timeline | Sharp Health Plan must make a determination on completed non‑urgent Step Therapy Exception requests within 72 hours (24 hours for exigent/urgent requests); incomplete requests will trigger a notification of needed information within those same timeframes. |
| Opioid Step Group | Supply threshold for coverage |
|---|---|
| OPIOID ER (2219-M) | Member must have filled a cumulative 7‑day or greater supply of an immediate‑release opioid within the past 90 days OR have been receiving an extended‑release opioid for a cumulative 30 days or greater within the past 90 days for coverage under the Opioid ER group. |
| OPIOID IR COMBO (1358-E) — short IR allowance | Coverage provided for up to a 7‑day supply of immediate‑release opioids if the member does not have at least a cumulative 7‑day supply of an opioid (IR or ER) within the past 90 days. |
| Opioid Group | Prior exposure requirement / Initial fill allowance |
|---|---|
| Opioid ER group (2219-M) | Requires prior opioid exposure: cumulative ≥7 days IR within past 90 days OR cumulative ≥30 days ER within past 90 days to qualify for coverage of ER agents. |
| Opioid IR combination products (1358-E) | Allows up to a 7‑day supply of immediate‑release opioid if member lacks a cumulative 7‑day opioid supply in the past 90 days (short‑supply exception). |
| Initial short‑fill limits | Many opioid liquids and tablets are subject to an initial 7‑day limit (initial 3‑day limit for members age 19 or younger) unless criteria for continuation are met. |
| Formulation types | Step Therapy flag |
|---|---|
| Extended‑release tablets / transdermal patches (selected) | Certain ER formulations and patches (e.g., fentanyl patches, hydromorphone ER, select morphine ER/tramadol ER) are flagged ST or require failure of preferred agents prior to coverage. |
| High‑strength formulations | High‑strength patches and ER products frequently require PA and/or are subject to ST as indicated in product entries (see specific drug listings). |
| Scope | Requirement |
|---|---|
| ST applies where listed | Products marked 'ST' in the Coverage Requirements and Limits column must follow the Step Therapy criteria (trial of specified alternatives) before coverage is granted; providers may request exceptions per the prior authorization/step therapy exception process. |
| Examples | Selected opioid combination products, certain buprenorphine/buccal films and select ER opioid formulations are shown with ST flags in the formulary entries and require step compliance prior to coverage or PA** when step not met. |
| Product | Routing / Authorization |
|---|---|
| ZURZUVAE (zuranolone) — 20 mg / 25 mg / 30 mg | Requires Specialty Pharmacy (SP) routing and Prior Authorization (PA); quantity limits apply (QL: 2 caps/day for 20 mg and 25 mg; 1 cap/day for 30 mg) as listed in the formulary. |
| Agent class / Examples | Requirement |
|---|---|
| Incretin‑mimetic agents (GLP‑1 / GIP) — examples | Multiple incretin‑mimetic agents (e.g., Mounjaro, Ozempic, Rybelsus, Trulicity) are listed with 'PA' in the Coverage Requirements and Limits column; prior authorization is required before coverage. |
| Example (brand vs generic) | Implication |
|---|---|
| BRIVIACT (brand) vs brivaracetam (generic) | Brand BRIVIACT entries are assigned to a higher drug tier (tier 2) while generic brivaracetam products are tier 1; tiering suggests preference for generics first which may act as a step before covering higher‑tier brand formulations. |
| Product (Xcopri / Xcopri packaging) | Formulary note |
|---|---|
| Xcopri (cenobamate) — multiple pack sizes and tablet strengths | Cenobamate products (Xcopri) are listed at drug tier 2 with 'MO' indicated for many formulations, signifying utilization management oversight; while MO is shown, explicit step‑therapy algorithms are not detailed in the excerpt but utilization management is implied. |
Quantity Limits and Supply Rules
Dispensing Sites and Specialty Pharmacy Routing
Use network retail, specialty, or mail order pharmacy for coverage
Outpatient prescription drugs are covered only when dispensed through network retail, specialty, or mail‑order pharmacies; specialty drugs must be filled by the Sharp Health Plan specialty network pharmacy (CVS Specialty) and are limited to 30‑day supply per fill.
- Specialty fills: route via CVS Specialty; mail order for maintenance drugs via CVS Caremark (90‑day eligible).
Specialty Pharmacy requirement and 30‑day supply limit
Specialty drugs must be dispensed through the Sharp Health Plan specialty network pharmacy (CVS Specialty) and are limited to a 30‑day supply per fill; ensure specialty routing for SP‑flagged products.
- Enroll at CVSspecialty.com for specialty drug fulfillment; SP entries also often require PA and QL.
Formulary Terms and Abbreviations
Policy Background and Scope
The Formulary lists FDA‑approved outpatient prescription drugs covered under Sharp Health Plan and clarifies the pharmacy outpatient benefit versus the Medical Benefit. The Pharmacy & Therapeutics Committee evaluates clinical effectiveness, safety, and value in maintaining the Formulary. Members and providers may request a Formulary Exception when a nonformulary medication is determined to be Medically Necessary.
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