Medicare Part D Prior Authorization Criteria (selected drugs)
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Defines prior authorization requirements for specified prescription drugs on Independent Health's 2025 Medicare Advantage Part D formularies; applies to prescribers and pharmacy staff submitting authorizations for Medicare Advantage members.
No material clinical or coverage changes in this revision.
Product-level Coverage Criteria
OHTUVAYRE Initial Therapy
Covered when ALL of the following are met:
Attestation or documentation of prior therapy required.
ABILIFY MYCITE Initial Therapy
Covered when ALL of the following are met:
PA applies to new starts only.
ARIKAYCE Initial Therapy
Covered when ALL of the following are met:
Microbiology documentation required.
PA applies when covered as Part D.
NEXLETOL / NEXLIZET Initial Therapy
Covered when ALL of the following are met:
Document prior statin history for approval and reauthorization.
Document ongoing use or intolerance for reauthorization.
Biologic preferred-agent requirement
Covered when ALL of the following class-level step requirements are met:
Baseline latent TB screening required prior to initiation for most agents; yearly TB screening or chest X‑ray for reauthorization when exposure risk exists.
PA applies to all drugs in this class except where noted.
CABLIVI Initial Therapy
Covered when ALL of the following are met:
Recurrence-based denial rule applies.
PA applies to all.
BRUKINSA Initial Therapy
Covered when ALL of the following are met:
PA applies to new starts only; coverage duration 1 year.
CAMZYOS Initial and Maintenance
Covered when ALL of the following are met (initial and maintenance):
CFTR Modulators
Covered when ALL of the following are met:
Mutation confirmation required; lack of appropriate testing triggers denial.
PA applies to new starts only; coverage duration 1 year.
CGRP Inhibitors Initial Therapy
Covered when ALL of the following are met:
PA applies to all.
DOPTELET Indication-based Criteria
Covered when the applicable INDICATION branch is met:
PA applies to all.
Thrombocytopenia (procedure) and ITP criteria
Covered when ALL of the following are met (procedure branch example):
PA applies to all.
Dupilumab (indication-specific criteria)
Covered when ALL applicable, indication‑specific requirements are met:
Initial coverage 6 months then 1 year; objective response required for continuation.
Prescriber restricted to pulmonology or relevant specialty; objective response needed for reauthorization.
EVRYSDI (spinal muscular atrophy)
Covered when ALL of the following are met:
Prescriber restricted to neurology; initial 6 months then 1 year; maintenance or improvement in motor score required for reauthorization.
Example enzyme replacement / genetic-condition product criteria
Covered when ALL of the following are met (example enzyme‑replacement product):
Age and prescriber restrictions apply; severe renal impairment (eGFR <30) or ESRD on dialysis excluded.
Coverage duration 1 year; PA applies to new starts only.
Targeted oncology agents — required genetic/tumor testing and prior therapy
Covered when ALL of the following are met (oncology/targeted therapy pattern):
Lack of appropriate molecular testing will trigger denial.
Prescriber restricted to oncology; PA typically applies to new starts; coverage duration 1 year.
Exclusions for strong CYP3A interactions and uncontrolled hypertension where specified.
GLP-1/diabetes products
Covered when ALL of the following are met:
Attestation patient is not receiving another GLP‑1 agonist; PA applies to all; off‑label weight management excluded.
PA applies to all.
Immune globulin clinical criteria
Covered when ALL of the following are met (IG product general rules):
For IV formulations, site‑of‑care details determine Part B vs Part D coverage; acute starts 3 months, chronic renewals 1 year; clinical response documentation required for continuation.
Hereditary angioedema prophylaxis criteria
Covered when ALL applicable, product‑specific prophylaxis vs acute‑use requirements are met:
Prescriber restricted to allergy/dermatology/hematology/immunology; PA applies to new starts only; coverage duration 1 year.
Lab- and safety-dependent product criteria
Covered when ALL of the following baseline lab and safety screening criteria are met:
Dose increases or continuations often require interim test results (eg, reduction in ALP after 6 months for elafibranor; 24‑hour UFC for Isturisa/Recorlev).
Product-level PA criteria (summary)
Covered when ALL of the following general product‑level PA documentation and restrictions are met:
PA applies to new starts unless otherwise noted; coverage durations vary by product (commonly 1 year).
JOENJA
Covered when ALL of the following are met:
Initial authorization 6 months then 1 year; objective benefit required for reauthorization.
MG 5 MG
Covered when ALL of the following are met:
Initial authorization 6 months then 1 year; reauthorization requires LDL reduction documentation; not approved for heterozygous familial hypercholesterolemia.
KERENDIA
Covered when ALL of the following are met:
For CKD with T2DM must document trial of Farxiga or Jardiance prior to approval.
KISQALI
Covered when ALL of the following are met:
Coverage duration 1 year.
Lidocaine 5% patch / LIVTENCITY
Covered when ALL of the following are met:
Coverage duration 1 year.
PA applies to all.
Ledipasvir-sofosbuvir
Covered when ALL of the following are met (ledipasvir‑sofosbuvir example):
Documentation of cirrhosis status and HBV testing (HBsAg and anti‑HBc) required.
PA applies to all.
Hepatitis C product requirements
Covered when ALL of the following are met (HCV product general rules):
Coverage durations follow AASLD‑IDSA guidance; PA applies to all.
NUCALA coverage criteria
Covered when ALL applicable indication criteria are met:
PA applies to all; objective data required for reauthorization.
Initial 6 months then 1 year; objective response required for continuation.
Orilissa coverage and duration constraints
Covered when ALL of the following are met (Orilissa constraints):
Duration limits apply (eg, up to 24 months depending on indication); requests >2 years will not be approved.
Narcolepsy agent initial therapy requirements
Covered when ALL of the following are met:
PA applies to all; prescriber restrictions to neurology/sleep medicine for some agents.
PCSK9 inhibitors prior therapy criteria
Covered when ONE of the following is met:
Documentation of prior statin history required for initial approval.
PALYNZIQ initial and reauthorization criteria
Covered when ALL of the following are met:
Documentation of at least 30 days of prior sapropterin therapy and reduction in Phe required for reauthorization.
Pemazyre approval criteria
Covered when ALL of the following are met:
Prescriber restricted to oncology; PA applies to new starts only; coverage duration 1 year.
Recorlev initial criteria and monitoring
Covered when ALL of the following are met:
PA applies to all; initial 6 months then 1 year; continuation requires clinically relevant response (eg, UFC).
Eltrombopag indication-specific criteria
Covered when the applicable indication branch is met:
Improvement in platelet count required for reauthorization after 12 weeks.
Relistor initial criteria
Covered when ALL of the following are met:
Confirmation patient remains on opioid required for reauthorizations.
RET-targeted therapy (RETEVMO)
Covered when ALL of the following are met:
Age and indication‑specific restrictions apply; prescriber restricted to oncology; PA applies to new starts only; coverage duration 1 year.
KMT2A-targeted therapy (REZLIDHIA/REZUROCK entries)
Covered when ALL of the following are met:
PA applies to new starts only; coverage duration 1 year.
Rare metabolic disorder therapies
Covered when ALL of the following are met (representative rare metabolic disorder criteria):
Initial 6 months then 1 year; reauthorization requires clinically relevant response (reduced Uox or plasma oxalate).
Prescriber and age restrictions as per product labeling.
Atypical antipsychotics
Covered when ALL of the following are met:
For schizophrenia or acute mania/mixed bipolar I, patient must have tried and failed or been intolerant to aripiprazole and at least one other generic second‑generation atypical antipsychotic as specified.
Sedative-hypnotic restriction for older adults
Covered when ALL of the following are met:
PA applies to new starts only; coverage duration 1 year.
HCV direct-acting antiviral criteria
Covered when ALL of the following are met (HCV DAA example):
Coverage duration per product and clinical scenario (commonly 12 weeks).
The following supplemental exclusions and coverage notes summarize recurrent, medium‑importance conditions across product entries in this index and are intended to guide authorization decisions and documentation submissions. These are not exhaustive; reviewers must refer to each drug’s product‑specific section for definitive exclusion language and required supporting evidence.
- Pregnancy and female reproductive risk: Several products list pregnancy as an absolute exclusion or require a negative pregnancy test and contraception attestation for females of childbearing potential; pregnancy status must be submitted where indicated. (Examples: multiple oncology, genetic, and endocrine agents.)
- Severe hepatic impairment and specific liver disease states: Multiple products are excluded for Child‑Pugh class B or C or active/decompensated cirrhosis; liver function tests and Child‑Pugh scoring are required where noted. (See entries requiring LFTs or noting cirrhosis exclusions.)
- Renal function limits: Several therapies exclude use with eGFR <30 mL/min/1.73 m2 or end‑stage renal disease; creatinine clearance or eGFR must be submitted when prompted to establish eligibility. Certain formulations (or indications) also have age or eGFR minimums.
- Drug‑drug interactions and enzyme‑mediated exclusions: Coadministration with strong CYP3A4 inducers or inhibitors, P‑gp inhibitors, or other specified interacting drugs is a common exclusion; therapy will be denied if prohibited concomitant medications are present. Product pages specify which interactions are disqualifying.
- QT interval and cardiac exclusions: History of congenital long QT syndrome, torsades de pointes, significant baseline QTcF above the stated threshold, uncorrected electrolyte abnormalities, or unstable cardiac disease are frequent exclusions for QT‑prolonging drugs; an ECG (QT/QTcF) and electrolytes may be required.
- Indication‑specific noncoverage: Several products will not be authorized for certain off‑label uses under Medicare Part D (for example, GLP‑1 agonists for weight management and specified tadalafil strengths for erectile dysfunction per the index). Other exclusion examples include non‑refractory disease states (e.g., ARIKAYCE for non‑refractory MAC lung disease) or indications lacking evidence (e.g., metreleptin for generalized obesity not due to congenital leptin deficiency).
- Mechanical or structural contraindications: Known or suspected mechanical gastrointestinal obstruction is an exclusion for agents affecting GI motility; prior cholecystectomy or biliary obstruction may exclude other products. These anatomic or structural risks must be documented when relevant.
- Genotype/molecular exclusions: Lack of confirmatory testing for required molecular markers (CFTR, RET, FGFR, ALK/ROS1, PIK3CA, KMT2A, etc.) is an automatic basis for non‑approval; when genetic or tumor testing is required, the specific assay result must be submitted.
- Prior‑therapy and step‑requirements: Many approvals require documented trials and failures (or intolerance/contraindication) of one or more listed prior therapies — e.g., statin/ezetimibe for certain lipid agents, specific non‑CGRP migraine preventives prior to CGRP inhibitors, and preferred biologic agents before more costly targeted immunomodulators. Failure to document these trials is a common denial risk.
- Safety‑monitoring prerequisites and short course limits: Some agents require controlled initiation environments and monitoring (e.g., tolvaptan initiation with close sodium monitoring and a 30‑day limit; rifaximin 550 mg is restricted to specified course durations such as 14‑day courses for IBS‑D/SIBO with annual course limits).
Indexed Product Coding & Key Numeric Thresholds
| XPOVIO (various oral tablet therapy pack doses) | Multiple XPOVIO oral tablet therapy pack dose/frequency presentations listed in document |
| LENVIMA (10 MG DAILY DOSE) | listed in index (see source) |
| LENVIMA (12 MG DAILY DOSE) | listed in index (see source) |
| LENVIMA (14 MG DAILY DOSE) | listed in index (see source) |
| NEUPOGEN INJECTION SOLUTION 300 MCG/ML | listed in index (see source) |
| NEUPOGEN INJECTION SOLUTION PREFILLED SYRINGE | listed in index (see source) |
| dasatinib oral tablet 100 mg, 140 mg, 20 mg, 50 mg, 70 mg, 80 mg | Listed product strengths as presented |
| N/A | No explicit CPT/HCPCS/ICD codes listed in this extract |
| dasatinib oral tablet 100 mg, 140 mg, 20 mg, 50 mg, 70 mg, 80 mg | Listed product strengths as presented |
| No codes listed |
| VENCLEXTA ORAL TABLET 10 MG, 100 MG, 50 MG | Product listed under PA criteria |
| VEOZAH | Product listed under PA criteria |
| VERQUVO ORAL TABLET 10 MG, 2.5 MG, 5 MG | Product listed under PA criteria |
| VIBERZI | Product listed under PA criteria |
| VIJOICE ORAL PACKET / TABLET | Product listed under PA criteria |
| VITRAKVI ORAL CAPSULE / SOLUTION | Product listed under PA criteria |
| VIVJOA | Product listed under PA criteria |
| VIZIMPRO ORAL TABLET 15 MG, 30 MG, 45 MG | Product listed under PA criteria |
| AUSTEDO (various) | Product listed under PA criteria |
| VONJO | Product listed under PA criteria |
| VOQUEZNA ORAL TABLET 10 MG, 20 MG | Product listed under PA criteria |
| VORANIGO ORAL TABLET 10 MG, 40 MG | Product listed under PA criteria |
| LENVIMA (10 MG DAILY DOSE) | listed in index (see source) |
| LENVIMA (12 MG DAILY DOSE) | listed in index (see source) |
| LENVIMA (14 MG DAILY DOSE) | listed in index (see source) |
| NEUPOGEN INJECTION SOLUTION 300 MCG/ML | listed in index (see source) |
| NEUPOGEN INJECTION SOLUTION PREFILLED SYRINGE | listed in index (see source) |
| NEXLETOL | listed in index (see source) |
Prior Authorization, Documentation & Denial Triggers
General prior authorization requirement
Prior authorization is required for drugs listed with a 'PA' on the Independent Health Medicare Advantage Part D formularies; approval must be obtained before the prescription is filled.
OHTUVAYRE: spirometry and prior LABA–LAMA documentation
OHTUVAYRE prior authorization requires post-bronchodilator spirometry showing FEV1/FVC < 0.72 and FEV1% predicted between 23%–85%; documentation of current dual LABA–LAMA therapy (with or without ICS) or documentation that dual or triple therapy was ineffective, not tolerated, or contraindicated; restricted to pulmonology and age ≥18.
- Provide post-bronchodilator FEV1/FVC and FEV1% predicted.
- Document current dual LABA–LAMA use or prior trial/failure/intolerance of dual/triple therapy.
- Prescriber must be pulmonology; patient age ≥18.
ABILIFY MYCITE: prior trial of generic aripiprazole required
ABILIFY MYCITE PA applies to new starts only and requires documentation of at least a one-month trial of generic aripiprazole (solution, tablets, or ODT) prior to approval; prescriber restricted to psychiatry and age ≥18.
- Submit records documenting ≥1 month trial of generic aripiprazole formulation.
- Prescriber must be psychiatry; patient age ≥18.
- PA applies to new starts only; coverage duration 1 year.
BRONCHITOL / BRUKINSA / CABLIVI: prescriber & safety documentation
PA is required for Bronchitol, Brukinsa, and Cablivi with product-specific prescriber, safety, and prior-therapy documentation requirements: Bronchitol requires passing the Bronchitol Tolerance Test and pulmonology prescriber; Brukinsa requires diagnosis, pregnancy status, and prior systemic regimen documentation as specified; Cablivi requires confirmation of plasma exchange plus immunosuppressive therapy and submission of prior aTTP recurrences (coverage denied if >2 recurrences while on therapy).
- Bronchitol: documentation of passed Bronchitol Tolerance Test; pulmonology prescriber; age ≥18; PA for new starts.
- Brukinsa: submit diagnosis and pregnancy status; for follicular lymphoma submit ≥2 prior systemic regimens tried/failed; hematology/oncology prescriber; age ≥18.
- Cablivi: confirm plasma exchange + immunosuppression; submit prior on-therapy recurrences if not first use; coverage not authorized if >2 recurrences.
CFTR modulators & CGRP inhibitors: mutation testing and prior therapy trials
CFTR modulators require submission of CFTR mutation testing confirming drug-specific responsive mutation(s) and are restricted to pulmonology; CGRP inhibitors require baseline headache frequency and documentation of failure of at least two non‑CGRP alternatives (or one if contraindicated) prior to approval.
- CFTR modulators: submit CFTR mutation test demonstrating responsive mutation per requested drug; pulmonology prescriber; PA for new starts only.
- CGRP inhibitors: submit baseline headache days/month; document failure of ≥2 non‑CGRP prophylactic agents (or 1 if contraindicated); age ≥18; initial 3 months then reauthorization criteria.
DOPTELET: platelet thresholds, prescriber rules, and duration
DOPTELET PA requires indication‑specific platelet documentation: for procedure-related thrombocytopenia submit platelet count <50 x10^9/L; for ITP submit platelet count <30 x10^9/L (or <50 x10^9/L with symptomatic bleeding) plus documentation of splenectomy and/or failure of two different ITP therapies; age ≥18 and prescriber specialty restrictions apply; PA applies to new starts and typical durations vary by indication (procedure: 5 days; ITP: initial 6 months then 1 year).
- Procedure‑related: platelet count <50 x10^9/L and scheduled procedure; coverage 5 days.
- ITP: platelet count <30 x10^9/L (or <50 x10^9/L with bleeding), documentation of splenectomy and/or failure of two ITP therapies; initial 6 months then 1 year for continuation.
- Restricted prescribers: gastroenterology, hematology, hepatology, surgery; age ≥18.
GLP‑1 agents: PA applies; weight‑management excluded
GLP‑1 agonist agents require prior authorization for all uses and will not be approved for off‑label weight management under Medicare Part D; diabetes diagnosis documentation per specified lab/chart criteria and attestation patient is not receiving another GLP‑1 are required.
- Submit documentation of type 2 diabetes (medical record/chart, ICD‑10, or labs such as HbA1c ≥6.5% or fasting plasma glucose ≥126 mg/dL).
- Attest patient is not receiving another GLP‑1 agonist; PA applies to all; weight‑management use excluded.
General oncology/patch/metreleptin/NUCALA PA and continuation rules
Prior authorization applies to listed oncology, topical, metreleptin, NUCALA and other specialty products with continuation requirements: approvals are typically for new starts only and reauthorization often requires objective documentation of response (examples: metreleptin requires updated weight/metabolic labs annually; NUCALA requires objective response data for continuation).
- PA commonly applies to new starts only; typical coverage duration 1 year.
- Metreleptin: PA for all uses; updated weight and metabolic labs required for annual reauthorization.
- NUCALA: PA applies to all uses; continuation requires objective documentation of positive response and maintenance intranasal corticosteroid confirmation for CRSwNP.
NUEDEXTA & specialist PA exemptions: ECG/QT and electrolytes required
NUEDEXTA PA requires submission of ECG/QT interval and baseline electrolytes (potassium, magnesium) as part of required documentation; some drugs in the index are exempt from PA when prescribed by specified specialists—confirm specialist exemption when applicable.
- For NUEDEXTA submit ECG (QT interval) and baseline potassium and magnesium.
- Check product page for specialist PA exemptions (some drugs exempt when prescribed by listed specialists).
TAVALISSE, Tolvaptan, Venclexta, Veozah: lab and prior‑therapy PA rules
TAVALISSE PA requires submission of baseline platelet count (<30 x10^9/L or <50 x10^9/L with bleeding risk) and documentation of prior splenectomy and failure of two different ITP therapies; Tolvaptan (hyponatremia) PA requires evidence of serum sodium <125 mEq/L (or symptomatic <135 mEq/L resistant to fluid restriction) and is limited to 30 days; Venclexta and Veozah require diagnosis and supporting labs plus prior therapy documentation per product pages.
- TAVALISSE: submit platelet counts and prior ITP therapy history; prescriber restricted to hematology.
- Tolvaptan (hyponatremia): submit serum sodium meeting thresholds; treatment limited to 30 days and initiated where sodium can be closely monitored.
- Venclexta/Veozah: submit diagnosis, supporting labs and prior therapy failures as specified.
Indexed PA references and preferred‑agent step requirement
Indexed PA references and step‑therapy expectations: prior authorization requirements are indexed by drug and formulation; for many biologic/targeted immunomodulators a preferred‑agent step is required (patient must try and fail the listed preferred agents where possible).
- Consult the indexed product policy page for drug‑specific PA requirements.
- For biologics (except Otezla and Velsipity) document trials of ≥2 preferred agents prior to approval where possible.
Denial risks from missing prior‑therapy / step‑therapy documentation
Prior‑therapy, step‑therapy, and denial triggers: failure to document required prior therapies or comparator trials (e.g., statin/ezetimibe for PCSK9 inhibitors, trials of non‑CGRP alternatives for CGRP inhibitors) or missing documentation are common reasons for denial.
- PCSK9 agents require statin+ezetimibe use or documentation of ≥2 statin failures including a hydrophilic statin.
- CGRP inhibitors require failure of ≥2 non‑CGRP prophylactic agents (or one if contraindicated) with baseline headache days submitted.
- Absence of required prior therapies or documentation may result in denial.
Consult individual drug policy pages for full PA requirements
Index limitations and provider instruction: this index is an index only and does not contain complete documentation instructions — providers must consult each drug's specific policy page for exact required supporting tests, thresholds, and prior‑therapy lists.
- Refer to the individual drug policy page referenced in the index for full documentation requirements.
- Do not rely solely on the index for detailed lab thresholds, mutation testing, or step‑therapy lists.
Initial Authorization Criteria (Selected Products)
Reauthorization & Continuation Requirements
Required Prior Therapy & Step Rules
| Step therapy rule | Applies to / examples | Required prior trial(s) or condition |
|---|---|---|
| Preferred-agent class-level step | Biologic and targeted immunomodulators (class-level) — general policy | Patient must have tried and failed at least two preferred agents (e.g., adalimumab biosimilar, Cosentyx, Enbrel, Humira, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz/XR) prior to approval (except Otezla and Velsipity). Baseline latent TB screening required; yearly TB screening/chest x‑ray for reauthorization when exposure risk exists. |
| Lipid‑therapy step | NEXLETOL / NEXLIZET | Patient must currently be using a statin plus ezetimibe OR have tried and failed/been intolerant to at least two statins or one statin plus ezetimibe; at least one previously tried statin must be hydrophilic. PA applies to new starts only. |
| CGRP inhibitor non‑CGRP alternative step | CGRP monoclonal antibodies for migraine prevention (Aimovig, Ajovy, Emgality, others) | Failure of at least two non‑CGRP FDA‑approved or compendial alternatives (propranolol, timolol, topiramate, valproic acid, amitriptyline, etc.) required (or one if contraindicated). Emgality prevention additionally requires prior failure of Aimovig and Ajovy. Initial approval 3 months then 1 year. |
| Antipsychotic step | Certain second‑generation/atypical antipsychotics (schizophrenia, bipolar indications) | For schizophrenia/acute manic/mixed bipolar I: trial and inadequate response or intolerance to aripiprazole and at least one other generic second‑generation atypical antipsychotic required prior to approval. |
| Biosimilar / Zarxio step (granulocyte colony‑stimulating factors) | Neupogen/filgrastim use (most indications) — Zarxio preferred | Trial and failure or intolerance to Zarxio required before approval of Neupogen for indications other than hematopoietic syndrome of acute radiation syndrome. |
| C5 inhibitor prerequisite | C5 inhibitor‑treated conditions (e.g., PNH entries) | Documentation of prior use/intolerance/failure of a C5 inhibitor (eculizumab or ravulizumab) required where specified before other products will be approved. |
| ROS1 sequencing/prior TKI requirement | ROS1‑positive tumor targeted agents | For initial authorization, patient must have tried and failed crizotinib or entrectinib or have contraindications to both prior to approval; tumor ROS1 positivity test required. |
| Line‑of‑therapy requirements (hematology) | Select hematology/oncology agents (mantle cell lymphoma, CLL/SLL, others) | Documentation that patient tried and failed at least two prior systemic therapies; for mantle cell lymphoma one prior line must include a BTK inhibitor; for CLL/SLL prior lines must include BTK and BCL‑2 inhibitors where specified. |
| Therapy‑experience affects duration | HCV direct‑acting antivirals (ledipasvir‑sofosbuvir, others) | Treatment‑experienced patients with genotype 1 and compensated cirrhosis may require longer duration (e.g., 24 weeks) versus 12 weeks for others; prior therapy status must be documented. |
| Prior stimulant / wakefulness agent trials | Solriamfetol and other wakefulness agents (narcolepsy/excessive daytime sleepiness) | Authorization only if patient previously tried and had inadequate response, intolerance, or contraindication to armodafinil or modafinil (solriamfetol also requires prior trial of armodafinil/modafinil per policy). Baseline BP required. |
| Statin + ezetimibe / PCSK9 prerequisite (lipid agents) | PCSK9 inhibitors (Repatha, Praluent) and related lipid therapies | Patient must be currently using a statin plus ezetimibe OR have tried and failed at least two statins or one statin plus ezetimibe; at least one prior hydrophilic statin trial required. |
| Maximally‑tolerated RAS inhibitor + SGLT2 step | VANRAFIA and primary IgA nephropathy agents; select nephrology products | Initial authorization requires patient currently using (or contraindicated to) maximally‑tolerated ACE inhibitor or ARB AND tried and failed or been intolerant to at least one SGLT‑2 inhibitor (e.g., dapagliflozin, empagliflozin); biopsy confirmation and proteinuria thresholds required. |
| Background PAH therapy requirement | Pulmonary arterial hypertension (PAH) therapies | Member must be using, unless contraindicated, at least one drug in at least two of these classes: nitric oxide pathway mediator, endothelin receptor antagonist, and prostacyclin pathway agonist prior to approval; baseline hemodynamics (PCWP ≤15 mm Hg and PVR ≥5 Wood units) and functional tests required. |
| Antibiotic trial requirement for SIBO/IBS‑D | Rifaximin 550 mg (SIBO, IBS‑D, HE) | For SIBO require positive carbohydrate breath test and trial/failure of at least two prior antibiotics; for IBS‑D require failure of at least one antidiarrheal/antispasmodic/tricyclic; course limits apply (14‑day courses, maximum two per 365 days for IBS‑D). |
| Tyrosine kinase inhibitor sequencing | SCEMBLIX and other TKIs with mutation‑specific sequencing | For T315I mutation patients, must have tried and failed or been intolerant to ponatinib; for non‑T315I use must have tried and failed two or more other TKIs as specified. |
| Prior systemic therapy documentation required (oncology examples) | Various oncology targeted agents (e.g., tovorafenib pediatric, MET/RET/ALK/ROS1 agents) | Submission of prior systemic therapies tried/failed and relevant molecular testing (BRAF, MET, RET, ALK, ROS1, NTRK etc.) required for initial authorization; PA typically applies to new starts only. |
| Hydrophilic statin requirement noted (lipid step) — cross‑reference | NEXLETOL/NEXLIZET, PCSK9 pathways | At least one previously tried statin must be a hydrophilic statin when documenting prior statin failures per lipid‑therapy step rules. |
| Stimulant/solriamfetol sequencing for refractory cases | Pitolisant / other narcolepsy agents in some pathways | Some excessive daytime sleepiness approvals require documentation of trials of armodafinil/modafinil and solriamfetol (sequencing varies by drug); updated labs (electrolytes) may be required for certain agents. |
Quantity Limits and Place-of-Service Guidance
Site‑of‑care: Part B vs Part D and infusion vs pharmacy
Site‑of‑care determinations affect coverage (Part B vs Part D): confirm whether the drug will be administered in‑office/infusion center or self‑administered and document site‑of‑care details, since some drugs (e.g., ARIKAYCE, immune globulins) may be Part B when administered in provider settings but Part D when dispensed through pharmacy.
- ARIKAYCE: Part B coverage except for enrollees in long‑term care facilities; when dispensed under Part D follow Part D PA rules.
- For immune globulins and similar agents, provide administration setting to determine Part B vs Part D coverage.
- If therapy is to be self‑administered after training or filled at pharmacy and delivered to office by patient, Part D coverage may apply.
Key Definitions & Clinical Thresholds
Policy Background & Scope
This policy index defines clinical prerequisites and explicit exclusions that apply across many high‑cost and specialty drugs on Independent Health’s Medicare Advantage Part D formularies. Providers must obtain prior authorization (PA) when a product is designated with PA on the formulary; lack of an approved PA may result in the drug not being covered for the Medicare Advantage Part D enrollee. Many entries require submission of objective baseline data (for example, creatinine clearance or eGFR, ECG/QTcF, LFTs, 24‑hour urine tests, tumor or genetic testing, or disease‑specific measures such as FEV1 or platelet counts) and confirmation of pregnancy status for females of childbearing potential. (See product‑specific sections for exactly which tests and thresholds are required.)
Where applicable, this index emphasizes common exclusion criteria that will trigger denial: moderate–severe hepatic impairment (Child‑Pugh B or C), severe renal impairment or eGFR <30 mL/min/1.73 m2, coadministration with specified strong CYP3A4 inducers or inhibitors, recent non‑selective MAOI use, congenital long QT syndrome or prolonged QTcF above stated limits, known mechanical GI obstruction for certain agents, and pregnancy when listed as an exclusion. Other frequent denial triggers include absence of required molecular or genetic testing (e.g., CFTR, RET, FGFR, ALK/ROS1), failure to document mandated prior therapy trials or step‑therapy attempts, and requests for uses explicitly excluded under Medicare Part D (for example, GLP‑1 agonists for weight management or tadalafil for erectile dysfunction under the listed product entry).
The index also summarizes administrative expectations: PA commonly applies to new starts only, typical initial coverage durations are short courses (14–90 days) or up to 6 months for some agents with subsequent annual reauthorization, and many chronic specialty drugs are authorized for 1 year when required documentation is provided. Prescriber specialty restrictions (oncology, pulmonology, cardiology, nephrology, endocrinology, etc.) and site‑of‑care considerations (Part B vs Part D determinations when a product is administered in‑office or self‑administered) are noted and must be satisfied to determine coverage pathway and to complete the PA request.
Revision History
Prior Authorization Criteria list effective for Independent Health Medicare Advantage Part D formularies; document current as of 10/1/2025.
Multiple product-specific prior authorization requirements, exclusions, and required documentation items summarized and indexed for 2025 formulary; examples include OHTUVAYRE, ARIKAYCE, CFTR modulators, and many oncology and specialty agents.
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