Obtain Prior Authorization for PA‑marked drugs

Obtain prior authorization before prescribing or dispensing any drug annotated with 'PA' on the formulary; failure to obtain PA may result in the plan not covering the drug.

• Applies to all products with Requirements/Limits = PA.
• Follow EmblemHealth's PA submission process and include required clinical justification.

Prior Authorization for select specialty agents

Submit PA for high‑cost specialty antiviral and antifungal agents that list 'PA' (e.g., posaconazole formulations, ledipasvir‑sofosbuvir) prior to claim adjudication.

• Examples: NOXAFIL (posaconazole) lists Requirements/Limits = PA.
• HARVONI (ledipasvir‑sofosbuvir) lists Requirements/Limits = PA, QL, SP.

Submit authorization requests for PA‑marked products

Do not dispense drugs marked 'PA' without prior authorization; submit an authorization request with supporting clinical documentation when required.

• Many line items are explicitly marked 'PA' in the Requirements/Limits column.
• Providers/pharmacies must supply documentation to support PA requests.

PA for specialty oncology agents (PA + SP)

Prior authorization is required for specialty oncology/targeted oral agents annotated with 'PA' and often 'SP' — obtain PA and ensure specialty pharmacy routing when indicated.

• Examples include abiraterone (PA, QL, SP) and multiple agents in chunks 61–73 with LA/PA/QL/SP flags.
• Specialty oncology oral agents often require SP dispensing in addition to PA.

Obtain PA for many listed drugs

For many listed specialty and oral oncology drugs, obtain PA before coverage; check each line item's Requirements/Limits for PA and QL details.

• Line items show PA and specific QL windows (e.g., 28 tablets/28 days).
• Coverage is contingent on PA being completed where indicated.

Obtain PA and respect Quantity Limits

When a product shows 'PA' and a QL, obtain prior authorization and ensure dispensed quantity does not exceed the listed quantity limit.

• Examples: HARVONI PA with QL (28 tablets/28 days).
• Claims exceeding QL or missing PA may be denied.

MOUNJARO: PA required; observe pen‑count QL

MOUNJARO requires prior authorization and is subject to a quantity limit (QL) — either 4 pens/180 days or 4 pens/28 days depending on strength; obtain PA and authorize the correct QL.

• MOUNJARO (tirzepatide) Requirements/Limits = PA, QL (4 pens/180 days or 4 pens/28 days).
• Include supporting clinical justification with the PA request.

GLP‑1/DPP‑4 agents: PA and QL enforcement

GLP‑1 and DPP‑4 agents (e.g., OZEMPIC, TRULICITY, RYBELSUS) list PA and/or QL — obtain prior authorization and follow the product‑specific quantity limits.

• OZEMPIC Requirements/Limits = PA, QL (1 pen/28 days or 3 pens/28 days).
• RYBELSUS and TRULICITY similarly list PA/QL requirements in the formulary.

PA and specialty pharmacy routing for endocrine agents

Specialty endocrine agents (e.g., GALAFOLD, FOLLISTIM AQ, ACTHAR) require prior authorization and are often designated SP; obtain PA and process through specialty pharmacy when required.

• GALAFOLD Requirements/Limits = LA, PA, QL (14 capsules/28 days), SP.
• FOLLISTIM AQ lists PA, QL (varies), SP; ACTHAR lists LA, PA, SP.

PA required for listed specialty and LA drugs

Obtain prior authorization for specified specialty and limited‑access drugs listed (e.g., GENOTROPIN, FOLLISTIM AQ) before dispensing; follow PA and SP routing noted per line item.

• GENOTROPIN Requirements/Limits = PA, SP.
• FOLLISTIM AQ cartridges require PA and QL and are SP handled.

PA may apply to select non‑specialty products

Some non‑specialty products (e.g., nimodipine oral solutions) may also require PA; check the Requirements/Limits column and submit PA when PA is listed.

• NYMALIZE/NIMODIPINE entries show QL and PA in the Requirements/Limits field.
• Even conventional therapies may carry PA requirements.

Obtain PA whenever indicated on line item

When the Requirements/Limits field indicates PA, the provider must obtain prior authorization before the drug is covered; this applies across therapeutic classes where PA is shown.

• Many entries specify PA alongside QL, LA or SP; provider must obtain PA when PA is listed.
• Coverage depends on completion of payer PA procedures.

PA required for listed PA drugs — verify per line item

Prior authorization is required for the PA‑annotated products listed throughout the formulary; check each product's Requirements/Limits for exact PA status and quantity limits.

• Entries marked 'PA' require authorization; some also indicate LA, QL, or SP.
• Providers should review the specific product line for PA and QL details before prescribing.

PA for select specialty agents (Esbriet, CF modulators, biologics)

Select specialty agents (e.g., Esbriet, CF modulators, biologics) require prior authorization; submit PA and adhere to any QL/SP directions shown for those products.

• Esbriet (pirfenidone 801 mg) Requirements/Limits = PA, QL (90 tablets/30 days), SP.
• CF modulators TRIKAFTA/SYMDEKO list LA, PA, QL and SP handling.

PA for select specialty/orphan drugs (PROCYSBI, FILSPARI, VANRAFIA)

Certain branded specialty/orphan drugs (e.g., PROCYSBI, FILSPARI, VANRAFIA) require prior authorization and may be limited‑access and specialty‑dispensed; obtain PA and route to specialty pharmacy.

• PROCYSBI Requirements/Limits = LA, PA, SP.
• FILSPARI Requirements/Limits = LA, PA, QL (30 tablets/30 days), SP.

PA required for numerous specialty agents (e.g., MAVENCLAD)

Many specialty agents (e.g., MAVENCLAD, MAYZENT, LUMRYZ) are annotated with PA and QL and require prior authorization and specialty pharmacy processing; obtain PA and confirm QL before dispensing.

• MAVENCLAD Requirements/Limits = LA, PA, QL (8–14 tablets/301 days), SP.
• LUMRYZ Requirements/Limits = LA, PA, QL; specialty handling indicated.

Obtain PA where annotated

Obtain prior authorization for products annotated 'PA' wherever the Requirements/Limits column indicates it — verify each product line before prescribing or dispensing.

• PA is required where annotated 'PA' in the Requirements/Limits column.
• Check the formulary line item for precise PA/Q L/SP flags.

Follow Step Therapy (ST) requirements where indicated

Step therapy (ST) requires trial of preferred first‑line drugs before the plan will cover higher‑tier or alternative agents; follow ST rules where 'ST' is indicated and submit exceptions if clinically appropriate.

• ST means the member must try specified drugs first; examples: FETZIMA, FLUOXETINE DR, FANAPT show ST.
• Exceptions to ST may be requested per payer processes.

Step therapy sequences not specified in extract — verify per item

No explicit step therapy sequences are listed in this extract for most products; check individual formulary entries for 'ST' annotations before applying step edits.

• Most entries show PA/QL/LA/SP but not detailed step sequences.
• Verify product‑level details where ST may apply.

Follow payer authorization processes and contact member services as needed

When a PA/QL/LA/SP/ST requirement applies, follow the plan's authorization processes, provide necessary clinical documentation, and contact Member Services for benefit questions.

• Member Services phone is listed in the plan materials (see member ID card or portal).
• Follow PA submission instructions and include clinical justification as requested.

Palforzia: confirm enrollment/site and specialty dispensing for levels

Palforzia dosing levels are annotated with LA and SP — providers should confirm required enrollment and site‑of‑care or dispensing constraints (e.g., specialty pharmacy or clinic administration) before initiating therapy.

• PALFORZIA LEVELS 0–11 list Requirements/Limits = LA, SP.
• Levels include initial/starter, titration, and maintenance packets with LA/SP flags.

Step therapy not listed here — verify full policy for ST rules

Step therapy details are not listed for most products in this extract; where step therapy is not shown, rely on PA/QL/LA/SP flags and check full policy or contact the plan for ST requirements.

• Many products use PA/QL/LA/SP flags rather than explicit step sequences.
• For agents marked 'ST' consult the formulary line item for specifics (e.g., KERENDIA).

Verify ACA and LA flags for contraceptives

Contraceptives designated ACA/LA may have special coverage considerations; verify ACA status for no‑cost coverage and LA for limited availability before prescribing.

• Examples: ANNOVERA and other contraceptives list Requirements/Limits = ACA, some also show LA or FF.
• ACA flag may indicate preventive coverage under applicable rules.

Review flags and provide required supporting documentation

Providers should review the formulary entries for step therapy, PA, QL, LA, and SP annotations and supply documentation accordingly when requesting coverage or prior authorization.

• The Requirements/Limits column lists flags (PA, QL, LA, SP, ACA, FF) adjacent to drug entries.
• Submit clinical justification and any required forms with PA requests.

Apply step therapy for agents annotated 'ST' (KERENDIA example)

KERENDIA and some other agents explicitly list 'ST' — ensure member has met step therapy requirements before requesting coverage or include rationale in a PA if requesting an exception.

• KERENDIA Requirements/Limits = QL (30 tablets/30 days), ST.
• If ST not met, submit exception rationale with PA.

Act on utilization management flags shown per product

Observe utilization management flags (ACA, LA, PA, QL, SP) shown in the Requirements/Limits column and act accordingly when submitting PA requests or routing prescriptions.

• Some agents carry ACA designations indicating preventive coverage; others carry LA/SP that limit site or channel.
• Check each product line for the specific flag set.

No ST details in this segment — use PA/QL guidance or contact plan

Step therapy sequences are not explicitly detailed in many segments of this formulary; where ST is not annotated, rely on PA/QL rules and contact the plan for clarification if needed.

• The formulary primarily uses PA/QL/LA/SP flags rather than step algorithms in these chunks.
• Contact EmblemHealth for complete ST policy when required.

Confirm Limited‑Access (LA) requirements and document in PA

Limited‑access (LA) indicators denote restricted dispensing or additional criteria; confirm LA requirements and include necessary documentation in PA requests when LA is shown.

• Examples: GATTEX and LIVMARLI show LA flags in Requirements/Limits.
• LA often accompanies PA and SP, requiring extra steps for coverage.

Verify step therapy trials for ST‑marked agents

For agents annotated with ST (e.g., AUVELITY, FETZIMA, TRINTELLIX), confirm prior trial of first‑line therapies per step therapy or include justification in a PA to request coverage.

• FETZIMA Requirements/Limits = QL (30 capsules/30 days), ST.
• AUVELITY and others listed with ST require step edits prior to coverage.

Apply ST for gabapentin/HORIZANT where annotated

Some gabapentin formulations and HORIZANT are marked with 'ST' — ensure step therapy requirements are met for these products before coverage is requested.

• Gralise (gabapentin once‑daily) entries show QL and ST flags.
• If ST not met, include clinical rationale when requesting PA.

Step therapy applies where annotated (Imitrex StatDose example)

When a product is annotated with 'ST' (e.g., Imitrex StatDose), follow the step therapy requirement before coverage or document clinical reasons for exception in the PA submission.

• Imitrex StatDose system annotated with Requirements/Limits = QL (12 doses/30 days), ST.
• Submit exception rationale if member has not completed required steps.

Contact Member Services and verify member benefits before prescribing

Contact Member Services for benefit questions and member eligibility; verify coverage, PA process, and any site‑of‑care or specialty pharmacy routing before initiating therapy.

• Member should check Certificate of Coverage or call the number on their ID card.
• Providers can use member portal my.emblemhealth.com for plan details.

Provide required clinical documentation with PA/QL submissions

Include supporting clinical documentation with PA/QL requests — demonstrate medical necessity, prior therapies tried, and intended dose/quantity so the PA can be processed timely.

• Prescribers/pharmacies must supply documentation supporting PA where 'PA' is indicated.
• Supply records showing prior therapy trial when ST or PA criteria apply.

Reference formulary flags and include item‑specific documentation in PA

Documentation should reference the Requirements/Limits flags on the formulary line (PA, QL, LA, SP) and include details needed to meet the plan's authorization criteria.

• The formulary displays PA/QL/LA/SP flags adjacent to drug entries.
• Ensure PA requests reference the exact product and its listed limits.

Document and adhere to specified Quantity Limits

When quantity limits are specified (e.g., tablets/30 days or pens/28 days), document intended dispense quantities to match the listed QL and include that in the PA or claim.

• Abiraterone lists QL 120 tablets/30 days or 60 tablets/30 days depending on strength.
• Ensure dispense quantity on the claim does not exceed the listed QL.

Route SP products through specialty pharmacy and include PA documentation

Route prescriptions through the designated specialty pharmacy channel when a product is marked 'SP'; specialty routing and PA documentation are required for SP agents.

• Products marked SP must be dispensed through specialty pharmacy per formulary.
• Examples include many specialty endocrine and biologic agents.

Include diagnosis and treatment details with PA/QL requests

Include required documentation for PA and QL on authorization requests — provide diagnosis, prior treatments, dose, and requested quantity per the formulary line item.

• Prescriptions with 'PA' must include clinical justification per payer PA process.
• PA requests should reference the product's QL (e.g., 4 syringes/28 days) when applicable.

Obtain PA and ensure specialty pharmacy handling for SP agents

Specialty products often require both PA and specialty pharmacy handling (e.g., ACTHAR, CARBAGLU, SENSIPAR); obtain PA and ensure SP enrollment or routing as listed.

• ACTHAR Requirements/Limits = LA, PA, SP.
• CARBAGLU and SENSIPAR list PA and SP requirements.

Address PA/LA/QL/SP flags in authorization documentation

When a drug is flagged with any of PA/LA/QL/SP, include documentation addressing those specific requirements in the PA submission to expedite processing.

• Providers must supply documentation to satisfy PA, LA, QL, or SP requirements as requested by the plan.
• Reference the formulary line item's flags in the PA submission.

Document formulation and adhere to formulation‑specific QL

For products with formulation‑specific QL (e.g., liquids, oral solutions, starter kits), document the requested formulation and match the dispense quantity to the listed QL on the claim or PA.

• Examples: QBRELIS lisinopril oral solution QL 1200 mls/30 days; esomeprazole suspension packets QL 60 packets/30 days.
• Document bottle/pack size and days' supply to align with QL.

Supply medical necessity and SP routing details for PA/SP products

For drugs requiring PA and SP, supply medical necessity documentation and evidence of specialty pharmacy routing where requested to support approval.

• Prescribers must supply documentation supporting medical necessity when requesting PA for 'PA' and 'SP' drugs.
• Examples include NUCALA and GALAFOLD which list LA/PA/QL and SP handling.

Dispense only within listed Quantity Limits

Confirm and adhere to the quantity limits specified for each product; dispensing beyond the listed QL may cause claim denial or require additional justification.

• Quantity limits are specified for many products (e.g., ELIMIRON QL 90 capsules/30 days).
• Exceeding QL may trigger denial or require justification (e.g., JYNARQUE therapy pack QL 56/28 days).

Adhere to specified QL on claims and PAs

Adhere to the specified quantity limit listed for each product on the formulary; ensure claim submission reflects the allowed amount and timeframe.

• Prescribers must submit PA where 'PA' is listed and adhere to QL and SP routing shown for each product.
• Examples: ELIMIRON QL 90 capsules/30 days; various specialty products list QL and SP.

Obtain PA and respect QL to avoid noncoverage

Obtain prior authorization when required and ensure dispensed quantities do not exceed the formulary's QL; failure to obtain PA or exceed QL may result in noncoverage or denial.

• Failure to obtain required PA may result in the plan not covering the drug.
• Claims exceeding QL or missing PA/SP/LA routing may be denied.

Risk of denial if PA/QL/ST/LA/SP not followed

Failure to obtain required prior authorization or to comply with utilization management flags (PA, QL, ST, LA, SP) may result in the plan denying coverage for the drug.

• Utilization management restrictions are applied as indicated next to drug names.
• Denial risk increases when PA is not obtained or QL/ST requirements are unmet.

Denial risk for exceeding QL or missing PA/SP/LA

Claims that exceed quantity limits, lack required PA, or are not routed through required site/program channels (SP/LA) may be denied; verify limits and obtain PA prior to dispensing.

• Requests exceeding QL or lacking PA/SP/LA may be denied per formulary rules.
• Ensure prescriptions are processed through the designated specialty pharmacy when SP is listed.

Products with PA/QL/LA/SP flags may trigger denials if unmet

Products flagged with PA, QL, LA, or SP may trigger denial if the corresponding requirements are not met during claim or authorization processing; verify and document compliance.

• PA, QL, LA, SP flags commonly accompany specialty agents and oncology products.
• Claims for these products should include documentation of PA and appropriate dispensing channel.

PA/SP/LA/QL flags trigger authorization requirements for specialty agents

Authorization requirements for specialty agents are triggered by flags such as 'PA', 'QL', 'LA', or 'SP' — obtain PA and route through specialty pharmacy when shown to avoid denial.

• Many specialty agents list PA and SP; lack of PA or SP enrollment may trigger coverage denial.
• Examples include GALAFOLD, FOLLISTIM AQ, and other specialty endocrine agents.

Confirm PA/QL/SP to avoid denials for listed drugs

Requests for listed drugs without PA, exceeding QL, or not routed to specialty pharmacy (SP) may be denied per plan requirements; confirm and document authorization prior to dispensing.

• The formulary states coverage contingent on PA completion and adherence to QL and SP where indicated.
• Providers should confirm authorization prior to dispensing specialty or restricted products.

PA required for GLP‑1/related agents — obtain PA to prevent denial

Drugs listed with PA, LA+PA, or PA+QL (e.g., MOUNJARO, OZEMPIC, TRULICITY) require prior authorization and may be denied if PA is not obtained.

• MOUNJARO Requirements/Limits = PA, QL (pen counts per timeframe).
• OZEMPIC and TRULICITY list PA and QL in the formulary entries.

PA and Specialty Pharmacy enrollment required for SP products

Specialty products that require both PA and SP enrollment may be denied if either requirement is not met; ensure PA approval and specialty pharmacy routing before dispensing.

• Lack of required PA or SP enrollment may trigger coverage denial for listed specialty products.
• Examples include GENOTROPIN and ACTHAR which list PA and SP.

Exceeding Quantity Limits may trigger denial

Exceeding a product's specified Quantity Limit (e.g., JYNARQUE therapy pack QL 56 tablets/28 days) may trigger denial or require additional justification; verify QL before dispensing.

• JYNARQUE therapy pack Requirements/Limits = QL (56 tablets/28 days).
• Exceeding QL may prompt denial or request for justification.

Noncompliance with PA/QL/SP may lead to claim denial

Claims for drugs marked with PA, QL, or SP that do not meet the listed authorization criteria may be denied — obtain PA and ensure dispense quantities and routing conform to the line item.

• Many products (e.g., MAVENCLAD, ADALIMUMAB biosimilars) list PA and QL and require SP handling.
• Verify and document that PA is approved and that the specialty pharmacy is used when required.

Denial risk for missing PA/ST or other utilization flags

Failure to obtain PA, to follow ST where indicated, or to comply with QL/SP/LA flags can result in claim denial; confirm authorization status before initiating specialty or restricted therapies.

• Claims for drugs listed with PA or ST may be denied without prior approval.
• Confirm PA and enrollment in required programs for LA/SP drugs.

PA and QL enforcement may result in denials if unmet

Prior authorization and quantity‑limit requirements are enforced; claims for drugs listed with PA or exceeding QL may be denied if authorization is not obtained or limits exceeded.

• The formulary repeatedly notes PA and QL enforcement across many line items.
• Obtain PA and ensure dispense quantities match QL to avoid denial.

Confirm infusion center or specialty pharmacy routing for LA/SP drugs

Products flagged as SP or requiring PA may also be limited to specialty pharmacy or infusion/clinic settings; confirm site‑of‑care or specialty pharmacy routing and include that information in PA requests.

• Certain agents flagged LA or SP indicate administration/dispensing under specific programs or sites (infusion center or specialty pharmacy).
• Many specialty products require SP handling and may be restricted to infusion centers when LA is present.

Dispense SP‑designated products via specialty pharmacy

If a product is designated SP, route dispensing through the plan's specialty pharmacy channel; many listed specialty products are managed under SP programs.

• Products marked SP must be dispensed through specialty pharmacy channels per the formulary.
• Specialty oncology oral agents and biologics are commonly managed via SP.

Oncology oral agents: manage via specialty pharmacy and PA

Many specialty oncology oral agents are managed under specialty pharmacy programs; ensure PA approval and specialty pharmacy dispensing for SP‑annotated oncology agents.

• Oncology oral agents in chunks 61–92 frequently carry PA, QL, LA, and SP flags.
• Specialty pharmacy distribution is indicated for numerous oral oncology products.

Ensure specialty pharmacy handling for SP agents

Most specialty agents require specialty pharmacy handling and PA; confirm specialty pharmacy enrollment and route orders accordingly for SP medications.

• Many specialty agents (e.g., GENOTROPIN, IMCIVREE) require PA and SP handling.
• Specialty pharmacy routing is required for agents marked SP.

Manage SP products via specialty channels; some LA products restricted to infusion sites

Specialty‑designated products are dispensed through specialty channels and some infusible/IV products are restricted to infusion sites; confirm the appropriate dispensing site when SP or LA is shown.

• Products marked SP are managed as specialty pharmacy; some flagged LA may be restricted to infusion or limited sites.
• TYVASO, TREPOSTINIL and similar products list LA/PA/QL and SP handling.

Verify PA and SP routing for specialty‑designated products

Numerous products across the formulary are designated as specialty (SP); verify PA and specialty pharmacy routing for these items before prescribing or dispensing.

• Many specialty‑designated products are listed with PA/QL/SP flags.
• Examples include biologics and complex specialty therapies in chunks 180–190.

Follow site‑of‑care restrictions for LA/SP products

When a product is marked LA or SP, follow site‑of‑care routing implications — some must be administered in infusion centers or dispensed only via specialty pharmacy programs.

• Products marked 'SP' are managed as specialty pharmacy; some products also flagged 'LA' indicate limited access or specific site requirements.
• Check the line item for infusion center or specialty pharmacy restrictions.