Prior Authorization Required

Prior Authorization Required: Many drugs in this formulary require prior authorization (PA). The plan may deny payment if PA is not obtained before dispensing. Providers should confirm PA requirements before prescribing or filling.

• If a drug line shows PA in the Requirements/Limits field, prior authorization is required.
• Failure to obtain PA may result in claim denial or member liability.

PA Required for Flagged Products

Prior Authorization Required for Flagged Products: Products flagged with PA, LD (limited distribution), SP (specialty), QL (quantity limit), or ST (step therapy) typically require prior authorization and may have distribution or quantity restrictions.

• Examples: many oncology, biologic, and specialty products show LD, PA, QL, SP (e.g., TRIKAFTA, KALYDECO, TEZSPIRE).
• Limited distribution (LD) items may only be available from select pharmacies and require coordination with the plan.

PA Required When 'PA' Listed

Prior Authorization When 'PA' Is Listed: When a formulary entry displays 'PA' in Requirements/Limits, providers must submit a prior authorization request with supporting clinical documentation. Check the drug's requirements in the index and the member Certificate of Coverage for plan-specific rules.

• Locate drug-level requirements using the formulary index (starts on page 84) and verify member coverage via the Certificate of Coverage or member portal.
• If PA is listed with QL or LD, include quantity justification and any specialty-distribution details with the request.

PA for Many Specialty Agents

Prior Authorization for Many Specialty Agents: Most specialty, biologic, and high-cost agents require prior authorization and often have additional controls (limited distribution, quantity limits, specialty pharmacy). Expect PA plus QL/LD/SP for agents across oncology, rare disease, immunology, and gene/biologic therapies.

• Examples: specialty oncology agents (ALECENSA, BRUKINSA, LENVIMA) and biologics (HUMIRA, ENBREL analogs, ADALIMUMAB biosimilars) are PA + QL + SP.
• Specialty drugs may require enrollment with a specialty pharmacy and monitoring documentation.

Authorization for Contraceptives & Select Products

Authorization for Contraceptives and Select Products: Some contraceptives and select agents may require authorization or are marked AC (Affordable Care Act) with special coverage treatments. Review the Requirements/Limits field for plan-specific indications.

• AC indicates coverage under ACA—verify member eligibility and plan rules.
• Contraceptives and certain vaccines may be listed with QL or AC; consult the Certificate of Coverage for cost-sharing details.

PA for Select GLP‑1 / Tirzepatide Agents

PA for Select GLP‑1/Tirzepatide Agents: Several GLP‑1 receptor agonists and tirzepatide (weight‑loss or diabetes agents) are subject to PA and quantity limits. Provide indication and prior treatment history when requesting authorization.

• Examples: MOUNJARO (tirzepatide), OZEMPIC (semaglutide), TRULICITY (dulaglutide) show PA and QL requirements.
• Include diagnosis (diabetes vs weight management) and prior therapy/failure documentation if applicable.

PA and Distribution Requirements

Prior Authorization and Distribution Requirements: Many products carry combined requirements: PA plus limited distribution (LD), specialty pharmacy (SP), and quantity limits (QL). Coordination with the designated distributor or specialty pharmacy is required for coverage and dispensing.

• When LD is indicated, prescriptions may need to be filled at specific pharmacies—verify arrangements before prescribing.
• PA requests should note required distribution channel (LD/SP) and the intended pharmacy.

PA for Specialty / High‑Tier Products

PA Requirement for Specialty / High‑Tier Products: High‑tier and specialty items (e.g., TEZSPIRE, XOLAIR, TRIKAFTA, KALYDECO, ORKAMBI) commonly require PA and may have QL and LD designations. Ensure prior approval and supply logistics are in place to avoid treatment delays.

• Examples from the formulary: TEZSPIRE (LD, PA, QL, SP), KALYDECO (LD, PA, QL, SP), TRIKAFTA (LD, PA, QL, SP).
• Document clinical necessity and any prior therapies when submitting PA.

PA Required for Select Agents

Prior Authorization Required for Select Agents: Individual formulary lines indicate PA and other controls—review each drug's Requirements/Limits entry before prescribing.

• Example: tasimelteon 20 mg is listed with PA and QL.
• Many antiviral and specialty antiviral agents list PA and QL (e.g., HARVONI, MAVYRET).

PA Required for Many Entries

PA Required for Many Entries: Numerous biologic and high‑cost agents across therapeutic classes are flagged for PA (and often QL/SP). Confirm authorization rules at the drug level.

• Biosimilars and biologics (adalimumab products, HUMIRA, ENBREL-type entries) show PA + QL + SP.
• Where QL is present, supply/quantity justification must be provided with PA.

PA Denial Triggers

Prior Authorization Denial Triggers: PA requests can be denied if required documentation is missing, criteria are not met, step‑therapy requirements are unmet, or quantity/distribution limits are exceeded. Denials may result in non‑coverage and member financial liability.

• Common denial reasons: absence of PA, failure to document prior therapy or clinical rationale, exceeding QL, or not using required LD/SP channels.
• Providers and members may request an exception or appeals per plan procedures.

Authorization & Distribution Restrictions

Authorization & Distribution Restrictions: Claims for items flagged with PA, LD, or SP may be denied without required approvals or when filled outside authorized channels. Follow plan-specified specialty pharmacy and limited distribution instructions.

• If a drug is LD/SP, confirm the appropriate dispensing pharmacy prior to submission.
• Ensure PA approval explicitly covers the dispensing site and quantity authorized.

Prior Authorization Indicated

Prior Authorization Indicated: Where the formulary indicates 'PA' (or combined flags like LD, QL, SP), submit a prior authorization request with clinical documentation and specify intended supply arrangements.

• Many oncology therapy packs and specialty injectables list PA and QL — include regimen and dosing schedule in the request.
• Check the Certificate of Coverage and member portal for plan-specific submission contacts.

How to Find Drug‑Level Requirements

How to Find Drug‑Level Requirements: Use the formulary index (page 84) to locate drugs and review the Requirements/Limits field in each line. For plan-specific coverage, consult the member's Certificate of Coverage or the member portal (my.emblemhealth.com).

• Index shows brand/generic formatting and directs you to each drug entry.
• Certificate of Coverage contains final coverage, cost‑share, and exception/appeal processes.

Documentation for QL / LD / SP Drugs

Documentation for QL/LD/SP Drugs: When QL, LD, or SP flags appear, providers must document quantity rationale, frequency, and any specialty distribution arrangements. Submission must include clinical indication and prior treatment history where relevant.

• Examples: PA requests for LD/SP products should include dosing schedule, anticipated duration, and reason LD/SP is clinically appropriate.
• If QL is expressed as tablets/30 days or syringes/28 days, requests must justify need beyond the stated limit.

PA & Quantity‑Limit Documentation

PA and QL Documentation: For drugs with PA plus QL, include clinical notes that support the requested quantity (dose and days supply), prior therapy attempts or contraindications, and monitoring plans.

• Examples: testosterone products and certain antidiabetics list PA + QL — include labs, diagnosis, and prior treatments.
• For oncology/specialty agents list planned cycles, total supply needed, and supportive care requirements.

Quantity Limit Documentation

Quantity Limit Documentation: Quantity limits (QL) are expressed per time period (e.g., 30 tablets/30 days). When requesting override or exception, provide objective clinical justification, duration of need, and prior treatment history.

• Examples: FARXIGA QL 30 tablets/30 days; JANUMET-like products QL examples appear in antidiabetics.
• For chronic therapies, indicate maintenance dose and monitoring to support higher quantities.

Example Documentation Expectations

Example Documentation Expectations: Some entries show typical documentation needs—e.g., testosterone products require PA plus QL, with supporting labs and diagnosis; specialty oncology agents require regimen details and distribution plan.

• Testosterone: include baseline labs, diagnosis, and previous treatment trials.
• Oncology agents: include diagnosis, line of therapy, stage, and planned cycles.

Documentation Expectations (General)

Documentation Expectations (General): Across PA/LD/QL/SP flags, submit complete clinical rationale, previous therapy history, and specify dispensing channel. Missing or incomplete documentation increases denial risk and processing delays.

• Include contact information for the dispensing pharmacy when LD/SP applies.
• Attach relevant labs, imaging, or specialist notes that support medical necessity.

Required Documentation Examples

Required Documentation Examples: The formulary lists drugs with typical required documentation—e.g., NEXLETOL/NEXLIZET require PA and QL; many specialty drugs require LD/SP arrangements and evidence of prior authorization.

• NEXLETOL/NEXLIZET: PA and QL (30 tablets/30 days) — include indication and prior therapy.
• Biologics (adalimumab variants): PA plus QL (syringes/pens per 28 days) and SP — include diagnosis and prior DMARD history.

Required Submission Items

Required Submission Items: When submitting PA for LD/PA/QL/SP drugs, include prescriber details, diagnosis code, clinical rationale, prior therapies/trials, requested quantity/days supply, and preferred dispensing pharmacy.

• For specialty injectables, include weight-based dosing if applicable and administration schedule.
• If step therapy (ST) applies, document trials of required first‑line agents or provide justification for exception.

Required Documentation for PA / LD / SP

Required Documentation for PA/LD/SP: Prescribers must supply prior authorization forms and any supporting documentation requested by the plan for drugs marked PA, LD, or SP. Items filled outside required channels or without approved PA may be denied.

• Confirm PA approval covers the quantity, duration, and dispensing site.
• For LD items, attach evidence the chosen pharmacy participates in the limited distribution program.

Documentation Expectations (Specialty)

Documentation Expectations (General) — Specialty Emphasis: High‑cost biologics and specialty agents require comprehensive submission packets: diagnosis, prior treatment history, monitoring plan, dosing schedule, and confirmation of specialty pharmacy enrollment when required.

• Examples: OMVOH, SKYTROFA, and other specialty biologics show LD/PA/QL/SP — include specialty pharmacy details.
• Incomplete specialty documentation commonly causes denials or delays.

Step Therapy / Step Edits

Step Therapy / Step Edits: Step therapy (ST) applies to select formulary entries. When ST is present, the plan may require trials of preferred or lower‑cost agents before authorizing higher‑tier drugs. Providers can request exceptions with clinical justification.

• Examples of ST: FOSRENOL and select analgesics/neurologic agents list ST.
• If ST applies, document prior trial(s) and reasons for failure or intolerance when requesting exception.

Limited Distribution & Controls

Limited Distribution and Controls: LD indicates limited distribution channels—these products often require coordination with specific specialty pharmacies and may have PA/QL requirements. Plan prior approval must reflect LD constraints.

• When LD is listed, verify the authorized dispenser and include that pharmacy in the PA request.
• LD items commonly overlap with SP and PA flags; plan approval often requires adherence to the designated supply pathway.

Step Therapy Flags Present

Step Therapy Flags Present: Several products show ST in the Requirements/Limits field — these require documentation of trial/failure of step agents or an exception justification.

• Examples: KERENDIA shows ST; select psychiatric and analgesic agents also show ST.
• Provide dates, agents tried, duration, and reason for discontinuation when submitting PA under ST.

Step Therapy Flag

Step Therapy Flag (Example): Kerendia (finerenone) is listed with a step therapy flag — prescribers should document required prior trials or provide rationale for an exception.

• KERENDIA — Requirements/Limits = QL (30 tablets/30 days), ST.

Step Therapy Presence

Step Therapy Presence: Many drugs annotated LD/PA/SP may also have step requirements — verify each drug line for ST and supply required supporting documentation.

• Examples across therapeutic areas show combined ST with QL and PA.
• Failure to meet ST conditions can be a basis for denial.

Step Therapy Present for Select Drugs

Step Therapy Present for Select Drugs: The formulary indicates ST for several specific drugs (examples include Fetzima, Savella, certain antipsychotics and analgesics). Document prior preferred-agent trials or exception rationale.

• Examples: FETZIMA, SAVELLA, RISPERIDONE ODT show ST in Requirements/Limits.
• Include dates and outcomes of prior therapy trials when submitting an exception request.

Step Therapy Requirements (Examples)

Step Therapy Requirements (Examples): Where ST is shown, coverage may require documented failure/intolerance of preferred alternatives before authorizing non‑preferred agents.

• FOSRENOL entries show ST and QL; SAVELLA lists ST and QL requirements.
• Provide clinical notes supporting why first‑line agents are contraindicated or ineffective.

Step Therapy Applies to Some NSAIDs

Step Therapy Applies to Some NSAIDs: A small subset of NSAIDs (e.g., KETOPROFEN ER, MECLOFENAMATE) are marked ST; check requirements and document prior therapy trials when applicable.

• KETOPROFEN ER — Requirements/Limits = ST.
• MECLOFENAMATE SODIUM — Requirements/Limits = ST.