CurrentIndependent HealthPolicy N/A

Medicare Part D Prior Authorization Criteria (Pharmacy Benefit Dimensions)

Defines prior authorization requirements for drugs on the 2026 Pharmacy Benefit Dimensions PDP Part D formulary; applies to prescribers, pharmacists, and Medicare Part D members under Pharmacy Benefit Dimensions/Independent Health.

Policy Summary

PayerIndependent Health

PolicyMedicare Part D Prior Authorization Criteria (Pharmacy Benefit Dimensions)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization before dispensing PA-designated drugs and submit required documentation (diagnosis, labs or genetic testing, and pregnancy status where applicable).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PDP Part DApplies to

1 yearCommon coverage duration

ManyPrior therapy required

SpecialtyPrescriber restrictions

~20+Products listed (partial)

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Coverage Criteria and Product-Level Rules

Sedative hypnotics — age-based PA

Covered when ALL of the following are met:

ALL of the following

Patient is 65 years of age or older (PA applies to patients 65+; does not apply to patients 64 or younger).>= 65 years
Diagnosis of a condition for which a sedative-hypnotic is indicated confirmed in the medical record.
Documentation that at least two of the following medications were tried and deemed ineffective or intolerable: Belsomra, doxepin tablets, ramelteon, or trazodone.
Prescriber attests awareness that sedative-hypnotics are high-risk medications in older patients due to increased risks of cognitive impairment, delirium, unsteady gait, syncope, falls, fractures, and motor vehicle accidents.

Sofosbuvir-velpatasvir

Covered when ALL of the following are met:

ALL of the following

Diagnosis of chronic hepatitis C virus (HCV) infection confirmed by laboratory testing and HCV genotype documentation.
Attestation that patients with decompensated cirrhosis will receive concomitant ribavirin therapy unless ribavirin is contraindicated.
Prescription is for sofosbuvir-velpatasvir with a planned treatment duration consistent with prescribing information (coverage duration: 12 weeks).

Teriparatide (high fracture risk) — initial authorization criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of osteoporosis or other FDA‑approved indication with documentation patient is at high risk for fracture as defined by one of the following: (1) history of hip or vertebral fracture regardless of BMD; (2) prior fracture of proximal humerus, pelvis, or distal forearm with T‑score between -1.0 and -2.5; (3) T‑score ≤ -2.5 at total hip, femoral neck, spine, or distal radius; or (4) T‑score between -1.0 and -2.5 with FRAX 10‑year hip fracture probability ≥ 3% or major osteoporotic fracture probability ≥ 20%.
Documentation of baseline serum calcium and postmenopausal status where applicable.
Patient has tried and failed to have an adequate response to or had an intolerance/contraindication to at least one bisphosphonate, unless contraindicated.
Total prior lifetime duration of parathyroid hormone analogs and related peptides is documented; therapeutic use beyond recommended duration is justified if requesting >2 years coverage.

Tolvaptan (hyponatremia)

Covered when ALL of the following are met (note: treatment limited to 30 days):

ALL of the following

Diagnosis of clinically significant hyponatremia defined as either: (1) serum sodium < 125 mEq/L, or (2) serum sodium < 135 mEq/L that is symptomatic and has resisted correction with fluid restriction.
Documentation that treatment will be initiated in a setting where serum sodium can be monitored closely.
Prescriber attests the patient does not have underlying liver disease, hypovolemia, anuria, inability to sense or respond to thirst, or other exclusionary conditions, and is not taking strong CYP3A inhibitors/inducers or desmopressin.
For initial authorization, coverage duration is limited to 30 days to reduce risk of liver injury; tolvaptan will not be approved for ADPKD in this formulation.

Initial approval criteria — general template

Initial authorization — covered when ALL of the following general conditions are met:

ALL of the following

Diagnosis of the covered use is documented in the medical record and aligns with the requested product's FDA‑approved indication.
Required medical information and baseline tests specific to the product (e.g., genotype or biomarker testing, laboratory values, imaging, right heart catheterization data) are submitted as described in the product‑specific criteria.
Prescriber meets any specialty restrictions required for the product (e.g., oncology, cardiology, pulmonology).
Any prerequisite therapies or prior treatments required by the product‑specific criteria have been tried and documentation of intolerance, contraindication, or therapeutic failure is provided when applicable.

Product Codes, Diagnostic Thresholds, and Numeric Criteria

Listed product dosing/detailsmixed

COMETRIQ (100 MG DAILY DOSE)	ORAL KIT 80 & 20 MG
COMETRIQ (140 MG DAILY DOSE)	ORAL KIT 3 X 20 MG & 80 MG
COMETRIQ (60 MG DAILY DOSE)
COPIKTRA	ORAL CAPSULE 15 MG, 25 MG

GLP-1 agonists and formulationsmixed

MOUNJARO	SUBCUTANEOUS SOLUTION AUTOINJECTOR 10 MG/0.5ML, 12.5 MG/0.5ML, 15 MG/0.5ML, 2.5 MG/0.5ML, 5 MG/0.5ML, 7.5 MG/0.5ML
OZEMPIC	SUBCUTANEOUS SOLUTION PEN-INJECTOR (0.25 OR 0.5 MG/DOSE; 1 MG/DOSE; 2 MG/DOSE)
RYBELSUS	ORAL TABLET (FORMULATION R2) 1.5 MG, 4 MG, 9 MG; ORAL TABLET 14 MG, 3 MG, 7 MG
TRULICITY	SUBCUTANEOUS SOLUTION AUTOINJECTOR

Product listing (examples)mixed

PEMAZYRE ORAL TABLET 13.5 MG, 4.5 MG, 9 MG

Listed product name and strengths as in document

Psychiatry product listingmixed

CAPLYTA ORAL CAPSULE 10.5 MG, 21 MG, 42 MG	Product name and strengths
REXULTI ORAL TABLET 0.25 MG, 0.5 MG, 1 MG, 2 MG, 3 MG, 4 MG	Product name and strengths

Covered products (examples)mixed

not specified

Affected product group: sedative hypnotic medications; examples listed (Belsomra, doxepin, ramelteon, trazodone) — no billing codes provided in this chunk.

Tolvaptanmixed

not specified

Tolvaptan formulations listed (tolvaptan 15 mg, tolvaptan 30 mg) — no billing codes provided in this chunk.

Pulmonary arterial pressure / wedge pressure — PAH hemodynamic thresholds

Hemodynamic thresholdsMean pulmonary arterial pressure > 20 mm Hg; pulmonary arterial wedge pressure ≤ 15 mm Hg

Documentation requiredRight heart catheterization data confirming values and WHO Group classification

Age restriction18 years or older (for listed PAH products)

Pulmonary vascular resistance (PAH)

PVR threshold (PAH)Pulmonary vascular resistance (PVR) > 2 Wood units

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Pharmacy Benefit Dimensions requires prior authorization (PA) for drugs listed with a 'PA' on the Pharmacy Benefit Dimensions PDP Part D formulary. If prior authorization is not obtained for a PA-designated drug, coverage may be denied.

PA drugs are identified by 'PA' on the formulary and require approval before dispensing.
Contact Medicare Member Services for questions: 1-800-667-5936 (TTY 711).

Prior Authorization

Cablivi — PA specifics

Cablivi (caplacizumab) will only be authorized when the request documents the diagnosis of aTTP and confirms caplacizumab will be administered with plasma exchange and immunosuppressive therapy. If the request is for subsequent use, submit prior aTTP recurrences while on caplacizumab; coverage will not be authorized for >2 recurrences while on therapy. Initial coverage duration is 3 months; prescribers restricted to cardiology, hematology, or immunology; patient age ≥18.

Must document concomitant plasma exchange and immunosuppressive therapy.

Initial Authorization / Prior Therapy Requirements

Additional initial‑therapy considerations reinforce common exclusion triggers and documentation needs. Before approving initial therapy, check for pregnancy status where required, confirm absence of severe hepatic impairment (Child‑Pugh B or C) when specified, and verify renal function against product‑specific thresholds such as CrCl <= 50 mL/min for dalfampridine or eGFR < 40 mL/min for deferasirox. These parameters are required elements of the medical information submitted with the prior authorization request and affect both initial approval and reauthorization.

Reauthorization and Continuation Requirements

Step Therapy Requirements and Tables

Requirement	Details
Biologic preferred-agent step
For initial authorization of drugs in the biologic/immunomodulator group (except Otezla and Velsipity), patient must have tried and failed or been intolerant to at least two preferred agents where possible (examples listed: adalimumab biosimilar, Cosentyx, Enbrel, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz/XR). Baseline latent TB screening (PPD or IGRA) required; if positive, treatment must be completed before approval.

Requirement

Details

Biologic preferred-agent step

For initial authorization of drugs in the biologic/immunomodulator group (except Otezla and Velsipity), patient must have tried and failed or been intolerant to at least two preferred agents where possible (examples listed: adalimumab biosimilar, Cosentyx, Enbrel, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz/XR). Baseline latent TB screening (PPD or IGRA) required; if positive, treatment must be completed before approval.

Requirement	Details
Caplacizumab prior-use history
If the request is not for the patient’s first use of caplacizumab, submit previous aTTP recurrences while on caplacizumab; coverage will not be authorized if the patient has had more than two recurrences while on therapy. Also confirm drug will be administered with plasma exchange and immunosuppressive therapy.

Requirement	Details
Copiktra prior systemic therapies
Authorization requires submission of at least two prior systemic therapies tried and failed. Requests as first- or second-line therapy are excluded; submit pregnancy status and attest to PJP (and CMV if necessary) prophylaxis.

Requirement	Details
Imkeldi prior therapy trial
Initial authorization for Imkeldi requires the patient to have tried and failed or been intolerant to crizotinib or entrectinib unless contraindicated; submit test confirming tumor where applicable and prior/current therapies used to treat the condition.

Requirement	Details
Dronabinol for CINV prior trial
For treatment of nausea and vomiting associated with cancer therapy, patient must have tried and failed or been intolerant to at least one 5‑HT3 receptor antagonist (e.g., granisetron, ondansetron); submit current or previous therapies used to treat the condition.

Requirement	Examples / Details
Prior trial/failure required where specified
Examples: ROS1-targeted therapies — trial/failure or intolerance to crizotinib or entrectinib required; INREBIC — trial/failure or intolerance to ruxolitinib required (delay if thiamine low until repletion); l‑glutamine for sickle cell — trial/use of hydroxyurea required.

Requirement	Details
Document prior failure or intolerance to listed alternatives
For initial authorization of certain products, provider must document that the patient tried and failed or was intolerant to specified comparator drugs (examples: Nubeqa requires prior Erleada and Xtandi; Caplyta requires trial/failure of listed antipsychotics). Submit current or previous therapies used to treat the condition.

Requirement	Details
Documentation of trials required for patients ≥65
Prior authorization applies to sedative‑hypnotic medications for patients 65 years or older; document diagnosis and that at least two alternatives (Belsomra, doxepin tablets, ramelteon, trazodone) were tried and deemed ineffective or intolerable.

Requirement	Details
Prior trials required for sedative hypnotics in patients ≥65
For sedative hypnotic medications in older patients, prerequisite therapy is required: documentation that at least two listed alternative medications were tried and found ineffective or intolerable before approval.

Requirement	Details
Vonoprazan prior PPI trials
For erosive esophagitis and non‑erosive GERD, vonoprazan (voquezna) initial authorization requires prior failure of two different proton pump inhibitors or documented contraindication to the PPI class; submit current or previous therapies used to treat the condition.

Requirement	Details
No prerequisite therapy required
For certain products (policy entries note where applicable), no prerequisite therapy is required. Example: products listed in chunk 90 require diagnosis, ALK‑positive test and pregnancy status but have 'Prerequisite Therapy Required: No'.

Quantity Limits and Site-of-Care Notes

Tolvaptan quantity limit

Quantity limit (tolvaptan)30 days (treatment limited to 30 days)

Applicable formulationstolvaptan oral tablets 15 mg and 30 mg (hyponatremia) — quantity reflects days of therapy

Monitoring requirementInitiation in setting where serum sodium can be closely monitored

VOWST quantity limit

Quantity limit (VOWST)Quantity 1 (single course) approved

Course lengthVOWST is a single-course therapy (refer to product dosing for duration)

Prescriber restriction

Background and Scope

This policy document defines prior authorization requirements for drugs listed with a 'PA' designation on the Pharmacy Benefit Dimensions Prescription Drug Plan (PDP) Part D formulary. It explains the clinical documentation required for review (diagnosis, laboratory or genetic testing when applicable, pregnancy status for females of childbearing potential), common exclusion criteria used to deny requests, prescriber restrictions for specialty therapies, and procedural details for initial authorization and reauthorization.

Plan identifier and scope

Plan identifierPharmacy Benefit Dimensions PDP (Independent Health)

ScopeApplies to drugs listed with 'PA' on the Pharmacy Benefit Dimensions PDP Part D formulary (Medicare PDP)

ImplicationPrior authorization required before dispensing or coverage may be denied

Diagnostic confirmation examples

Site-of-Care Considerations and Limitations

Note

Tolvaptan initiation requires monitored site‑of‑care (hospital outpatient)

Treatment initiation for tolvaptan should occur in a setting where serum sodium can be closely monitored (hospital outpatient) to mitigate rapid sodium changes and liver safety risks.

Policy Summary

PayerIndependent Health

PolicyMedicare Part D Prior Authorization Criteria (Pharmacy Benefit Dimensions)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization before dispensing PA-designated drugs and submit required documentation (diagnosis, labs or genetic testing, and pregnancy status where applicable).

SourceLink

On This Page

Prescriber attests patient does not have pre‑existing hypercalcemia, an underlying hypercalcemic disorder (e.g., primary hyperparathyroidism), or conditions that increase osteosarcoma risk (e.g., Paget's disease).

Patient does not meet any product‑specific exclusion criteria (e.g., pregnancy, severe hepatic impairment, contraindicated concomitant medications such as strong CYP3A inducers).

Required for WHO Group 1 (PAH) diagnostic confirmation

DocumentationSubmit PVR measured at right heart catheterization

Pulmonary vascular resistance (CTEPH)

PVR threshold (CTEPH)Pulmonary vascular resistance (PVR) > 3 Wood units

ContextRequired for WHO Group 4 (CTEPH) diagnostic confirmation

Additional evidencePlus evidence of chronic pulmonary embolism by CT or V/Q and attestation of inoperable or persistent/recurrent disease after pulmonary thromboendarterectomy

Statin concomitant dosing limits

Pravastatin dosing limitConcomitant pravastatin utilization > 40 mg/day is exclusionary

Simvastatin dosing limitConcomitant simvastatin utilization > 20 mg/day is exclusionary

ContextApplies when used concomitantly with certain agents (see product-specific criteria)

Creatinine clearance threshold for dalfampridine exclusion

Creatinine clearance cutoffCreatinine clearance ≤ 50 mL/min excludes use

Associated productDalfampridine ER (exclusion criterion)

DocumentationSubmit creatinine clearance (or serum creatinine, weight, height to calculate CrCl)

Baseline LVEF requirement (cobimetinib)

Baseline LVEF requirement>= 50% baseline left ventricular ejection fraction required for patients using cobimetinib

ContextSubmit LVEF for patients receiving cobimetinib per product-specific requirements

Prescriber restrictionRestricted to oncology

QTc interval requirement (vemurafenib)

QTc requirement (vemurafenib)QT interval ≤ 500 milliseconds at baseline required for vemurafenib users

ContextSubmit QTc interval and pregnancy status for females of childbearing potential

ExclusionsLong QT syndrome and uncorrectable electrolyte abnormalities exclude therapy

eGFR threshold for deferasirox exclusion

eGFR cutoff (deferasirox)Estimated glomerular filtration rate (eGFR) < 40 mL/min is an exclusion

Associated exclusionsAlso excludes severe hepatic impairment and platelet count < 50 x 10^9/L

DocumentationSubmit CBC, LFT, ferritin, and eGFR from previous 3 months

Platelet count threshold for deferasirox exclusion

Platelet count cutoff (deferasirox)Platelet count < 50 x 10^9/L is an exclusionary criterion

Associated exclusionsAlso excludes severe hepatic impairment and eGFR < 40 mL/min

DocumentationSubmit recent platelet count as part of CBC within previous 3 months

QTcF interval (treatment initiation exclusion)

QTcF initiation exclusionQTcF interval ≥ 450 msec excludes treatment initiation

ContextApplies at treatment initiation; submit baseline QTcF, serum potassium, magnesium, and WBC as required

Prescriber restrictionRestricted to hematology and oncology where specified

Serum electrolytes — exclusion for uncorrected hypokalemia or hypomagnesemia

Serum electrolyte exclusionUncorrected hypokalemia or hypomagnesemia excludes treatment initiation

DocumentationSubmit serum potassium and serum magnesium levels at baseline

Associated QT riskElectrolyte abnormalities contribute to QT prolongation risk and may be exclusionary for QT‑sensitive agents

eGFR/creatinine clearance requirement for LODOCO

Renal function requirement (LODOCO)>= 15 mL/min eGFR or creatinine clearance required for LODOCO

DocumentationSubmit eGFR or creatinine clearance (or serum creatinine, weight, height to calculate)

ExclusionsRequests for gout or renal failure are excluded

24-hour urinary oxalate (Uox) excretion threshold for RIVFLOZA

24-hour urinary oxalate threshold24-hour urinary oxalate (Uox) excretion ≥ 0.7 mmol (normalized to body surface area if patient <18 years)

Diagnostic requirementAGXT mutation confirmation by liver enzyme analysis or genetic testing required

ExclusionseGFR < 30 mL/min/1.73 m^2 excludes therapy

QTcF interval exclusion for REVUFORJ initiation

QTcF exclusion (REVUFORJ)QTcF interval > 450 msec excludes treatment initiation for REVUFORJ

DocumentationSubmit baseline QTcF interval prior to initiation

Associated labsAlso submit baseline serum electrolytes and WBC as required

Serum sodium thresholds for clinically significant hyponatremia

Serum sodium thresholdsClinically significant hyponatremia defined as serum sodium <125 mEq/L OR <135 mEq/L if symptomatic and resistant to fluid restriction

Treatment contextRequired evidence of clinically significant hyponatremia for tolvaptan prior authorization

MonitoringTreatment should be initiated where serum sodium can be closely monitored

Tolvaptan treatment duration limit

Treatment duration limitTolvaptan treatment limited to 30 days

RationaleLimit imposed to reduce risk of liver injury; initiation should occur where sodium can be monitored closely

Coverage noteNot approved for ADPKD formulation under this policy (ADPKD formulation requires REMS)

Teriparatide coverage duration and lifetime limit note

Initial coverage durationInitial teriparatide coverage = 2 years

Reauthorization requirementReauthorization beyond 2 years requires evidence the patient remains at high risk for fracture and updated serum calcium

Lifetime use noteUse of parathyroid hormone analogs generally not recommended for more than 2 years during a patient's lifetime

If not first use, submit prior aTTP recurrences on caplacizumab; >2 recurrences while on therapy = no authorization.

Coverage duration: 3 months initial.

Documentation Required

Prior authorization — required documentation

Most products in this section require prior authorization. Requests must include the diagnosis and the specific required clinical documentation (labs, genetic or mutation testing where applicable). Failure to provide required information may delay or deny coverage.

Submit current or previous therapies used to treat the condition where requested.
Provide pregnancy status for females of childbearing potential when noted.
Include baseline labs or testing specified for the product (e.g., LFTs, CBC, mutation testing).

Prior Authorization

CHOLBAM — prior authorization requirements

CHOLBAM prior authorization requires a diagnosis of the covered use and submission of liver function testing. Prescriber specialties limited to gastroenterology, hepatology, and pediatric gastroenterology. Initial coverage is 3 months, then 1 year for subsequent authorizations. For first reauthorization, document liver function improvement without complete biliary obstruction or persistent/worsening cholestasis; annual LFTs are required thereafter.

Initial authorization: 3 months; subsequent: 1 year.
Required: liver function testing at initial request and updated LFTs for reauthorization.
Prescriber restriction: gastroenterology/hepatology/pediatric gastroenterology.

Prior Authorization

ROS1-positive therapy — prerequisite and documentation

For ROS1-positive tumor therapies, submit a test confirming ROS1-positive status and pregnancy status for females of childbearing potential. For initial authorization, the patient must have tried and failed to have an adequate response to, or had intolerance/contraindication to, either crizotinib or entrectinib unless contraindicated.

Submit documentation of ROS1-positive tumor testing.
Attestation of prior trial/failure or intolerance to crizotinib or entrectinib, or documentation of contraindication to both.
Prescriber restriction: oncology; age ≥18.

Prior Authorization

LIVTENCITY — authorization requirements

LIVTENCITY authorization requires documentation of diagnosis and a documented history of hematopoietic stem cell or solid organ transplant when applicable. The patient must have tried and failed at least one of cidofovir, foscarnet, ganciclovir, or valganciclovir prior to approval. Prescribers must be in hematology, infectious diseases, oncology, or transplant specialty. Coverage duration is 8 weeks.

Submit history of transplant when applicable.
Document prior failure of at least one of cidofovir, foscarnet, ganciclovir, or valganciclovir.
Prescriber restriction: hematology, infectious disease, oncology, or transplant specialty; age ≥12.

Denial Risk

GLP-1 agonists — off‑label exclusion for weight management

GLP-1 agonists and related products will not be approved for weight management under Medicare Part D (off-label exclusion). When covered uses apply (e.g., diabetes), submit documentation of the covered diagnosis and attest the patient is not receiving another GLP-1 agonist for the treatment of any condition if required by the product-specific criteria.

Off-label use for weight management is excluded under Medicare Part D.
For diabetes indications, provide diagnostic evidence (medical record, ICD-10, or lab results such as A1c).
Attestation if required that the patient is not receiving another GLP-1 agonist for treatment.

Denial Risk

VOQUEZNA/vonoprazan — prior PPI trial requirement and denial risk

VOQUEZNA/vonoprazan (TAVNEOS/vanoprazan entries) — for erosive esophagitis and non-erosive GERD prior authorization requires documentation that the patient tried and failed two different proton pump inhibitors (PPIs) unless contraindicated. Failure to document these prior PPI trials may delay or result in denial of coverage.

Initial authorization for erosive esophagitis/non-erosive GERD: trial/failure of two different PPIs required.
Non-erosive GERD initial coverage 4 weeks with option to extend; H. pylori treatment limited to a single 14-day course when applicable.
Risk: missing documentation of prior PPI trials may delay or deny coverage.

Documentation Required

PAH documentation — right heart catheterization and related data

Pulmonary arterial hypertension (PAH) therapy PA requests must include right heart catheterization data: mean pulmonary arterial pressure (mPAP), pulmonary arterial wedge pressure (PAWP), and pulmonary vascular resistance (PVR). Also submit WHO Group classification, creatinine clearance (or serum creatinine with weight/height), pregnancy status, and current or previous therapies used to treat the condition.

Required hemodynamics: mean PAP >20 mm Hg, PAWP ≤15 mm Hg, and PVR >2 Woods units for WHO Group 1 PAH.
For CTEPH (WHO Group 4) provide PVR >3 Woods units and evidence of chronic pulmonary embolism with attestation of inoperable or persistent/recurrent disease after surgery.
Prescriber restrictions: cardiology or pulmonology; age ≥18.

Documentation Required

CERDELGA — required testing and exclusions

CERDELGA (eliglustat) PA requests must include diagnosis, CYP2D6 metabolizer status from genotype testing, and liver function testing or a Child‑Pugh score. Exclusions include ultrarapid CYP2D6 metabolizers, pre-existing cardiac disease, moderate/severe hepatic impairment, long QT syndrome, and coadministration with Class Ia or Class III antiarrhythmics. Annual reauthorization requires updated LFTs or Child‑Pugh score.

Submit CYP2D6 genotype and metabolizer status.
Provide baseline and updated liver function testing or Child‑Pugh score for reauthorization.
Do not approve for ultrarapid CYP2D6 metabolizers or those with listed cardiac/hepatic exclusions.

Documentation Required

EoHILIA — diagnostic and prior-therapy documentation

EoHILIA (eosinophilic esophagitis therapy) PA requires diagnostic confirmation by upper endoscopy with biopsy showing ≥15 eosinophils per high-power field (or 60 eosinophils/mm2), documentation of relevant signs/symptoms, and evidence the patient tried and failed at least an 8‑week course of PPI therapy. Age minimum is 11; prescribers restricted to allergy, gastroenterology, immunology, or ENT. Coverage limited to 12 weeks (one course per 365 days).

Submit upper endoscopy biopsy demonstrating required eosinophil count.
Document symptoms (e.g., dysphagia, food impaction, reflux, chest/abdominal pain, nausea/vomiting).
Confirm prior 8‑week PPI trial and that EoE is unrelated to GERD.

Documentation Required

Ensacove — required tumor testing and attestation

Ensacove (ALK‑targeted agent) PA requires submission of a test confirming an ALK‑positive tumor, attestation that the patient has not previously received an ALK inhibitor, and pregnancy status for females of childbearing potential. Prior ALK‑inhibitor use and certain drug interactions are exclusionary.

Submit ALK testing confirming ALK‑positive tumor.
Attest patient has not received prior ALK‑inhibitor therapy.
Prescriber restriction: oncology; age ≥18.

Documentation Required

Baseline thiamine and platelet requirements

For agents with risks related to thiamine depletion or platelet effects (example: INREBIC/Imkeldi), submit baseline thiamine level and baseline platelet count. If thiamine is low, coverage will be delayed until repletion is documented.

Baseline thiamine level required and baseline platelet count where specified.
If thiamine deficiency is detected, provide documentation of repletion prior to approval.

Documentation Required

RIVFLOZA — diagnostic documentation and reauthorization

RIVFLOZA prior authorization requires documentation of AGXT mutation confirmed by liver enzyme analysis or genetic testing, submission of 24‑hour urinary oxalate excretion (≥0.7 mmol, normalized for BSA if under 18), eGFR, and attestations that the patient has not received a prior kidney or liver transplant and will not use RIVFLOZA with lumasiran. Initial coverage is 6 months then 1 year; first reauthorization requires evidence of clinically relevant response.

Submit AGXT mutation confirmation (enzyme analysis or genetic testing).
Provide 24‑hour urinary oxalate excretion ≥0.7 mmol (normalize for BSA if <18).
Attest no prior kidney/liver transplant and no concomitant lumasiran use.

Documentation Required

Somavert — baseline labs and reauthorization attestations

Somavert (pegvisomant) PA requires documentation that surgery/radiation was not curative or is not an option, submission of baseline IGF‑1 and baseline liver function testing including bilirubin with transaminases ≤3× ULN. For first reauthorization submit IGF‑1 improvement from baseline, LFTs with transaminases <5× ULN, and attestation of no signs/symptoms of liver injury; annual reauthorization requires documented maintenance/improvement of IGF‑1.

Baseline IGF‑1 and baseline LFTs including bilirubin required; transaminases must be ≤3× ULN at baseline.
First reauthorization: updated IGF‑1 showing improvement and LFTs with transaminases <5× ULN; attest no clinical liver injury.
Prescriber restriction: endocrinology; age ≥18.

Documentation Required

Teriparatide — high fracture‑risk documentation required

Teriparatide (and similar anabolic agents) PA requires documentation the patient is at high risk for fracture. Provide fracture history, T‑scores, FRAX score, or other evidence supporting high fracture risk. For reauthorization beyond recommended durations, submit updated serum calcium and ongoing high‑risk evidence.

Document high‑risk criteria: prior fragility fracture, T‑score thresholds, or FRAX risk supporting anabolic therapy.
For annual reauthorization beyond 2 years, submit serum calcium and evidence the patient remains high risk.

Documentation Required

TEPMETKO — diagnostic testing requirement

TEPMETKO prior authorization requires submission of testing confirming the presence of a MET exon 14 skipping mutation and pregnancy status for females of childbearing potential. Prescriber restriction: oncology; age ≥18.

Submit test confirming MET exon 14 skipping mutation.
Provide pregnancy status for females of childbearing potential.

Documentation Required

Required medical information for oncology and specialty agents

Required medical information across oncology agents includes submitted diagnostic confirmation (e.g., tumor mutation testing such as ALK, ROS1, RET, EGFR where specified), pregnancy status for females of childbearing potential, and documentation of current or previous therapies used to treat the condition. Lack of required medical information may delay or deny approval.

Submit tumor mutation test results when requested (ALK, ROS1, RET, EGFR, IDH1/2, etc.).
Provide treatment history and rationale when prior‑therapy requirements apply.
Include pregnancy status for females of childbearing potential.

Prior Authorization

Copiktra — prior therapy requirement

COPIKTRA prior authorization requires submission of the diagnosis and documentation that at least two prior systemic therapies were tried and failed. Prescriber restriction: hematology and oncology; patient age ≥18.

Submit list and dates of at least two prior systemic therapies and reasons for failure/intolerance.
Attest prophylaxis for PJP and CMV monitoring as required.

Step Therapy

Imkeldi / ROS1‑class step requirement

Imkeldi/other ROS1‑style step requirements: for initial authorization of select agents the patient must have tried and failed to have an adequate response to or had an intolerance/contraindication to crizotinib or entrectinib prior to approval unless contraindicated. Prescriber restriction: oncology.

Document trial/failure or intolerance to crizotinib or entrectinib for ROS1‑targeted agents.
If contraindicated to those agents, provide rationale and supporting documentation.

Prior Authorization

Dronabinol — prior therapy requirement for CINV

For dronabinol when used for chemotherapy‑induced nausea and vomiting (CINV), prior authorization requires documentation that the patient has tried and failed or was intolerant to at least one 5‑HT3 receptor antagonist (e.g., granisetron, ondansetron). If the medication will replace IV antiemetic therapy within 48 hours of cancer treatment, indicate Part B coverage intent on the prescription.

Submit prior antiemetic therapy trial and failure/intolerance (at least one 5‑HT3 antagonist).
To request Part B coverage, prescribing physician must indicate the medication is a full replacement for IV antiemetic therapy within 48 hours of cancer treatment.

Step Therapy

Sickle cell step therapy — l‑glutamine prerequisite

Sickle cell therapy (L‑glutamine) initial authorization requires documentation the patient is using, tried and failed to have an adequate response to, or had an intolerance/contraindication to hydroxyurea. Prescriber restriction: hematology.

Document hydroxyurea use/trial and failure or intolerance/contraindication.
Prescriber restriction: hematology.

Step Therapy

Nubeqa — step therapy requirement

Nubeqa (darolutamide) authorization requires documentation the patient tried and failed or had intolerance to both Erleada (apalutamide) and Xtandi (enzalutamide) prior to approval for indicated uses.

Submit prior trials/failures or intolerances to both apalutamide and enzalutamide.
Prescriber restriction: oncology or urology as applicable.

Step Therapy

Opsumit — step therapy requirement

Opsumit (macitentan) authorization requires trial/failure or intolerance to ambrisentan or bosentan prior to approval where step therapy is specified.

Document trial/failure/intolerance to ambrisentan or bosentan prior to Opsumit approval.
Provide current PAH therapy history and hemodynamics as required.

Step Therapy

Caplyta — step therapy for bipolar I depressive episodes

Caplyta (lumateperone) initial authorization for depressive episodes of bipolar I disorder requires documentation that the patient tried and failed or had intolerance to at least two alternatives (e.g., cariprazine, lurasidone, olanzapine, quetiapine). For other indications, include therapy history per product criteria.

Submit trials and reasons for failure/intolerance to at least two specified alternatives for bipolar I depression.
Prescriber restriction: psychiatry; submit prior therapy history.

Step Therapy

Sedative‑hypnotics — step requirement for patients ≥65

Sedative‑hypnotics (eszopiclone, zaleplon, zolpidem) PA applies to patients age 65 and older. Documentation must show at least two alternative medications were tried and deemed ineffective or intolerable (e.g., Belsomra, doxepin tablets, ramelteon, trazodone). Failure to provide this documentation may delay or deny authorization.

PA applies only to patients ≥65 years of age.
Document trial and failure/intolerance of at least two listed alternatives.
Explain clinical rationale if alternatives are contraindicated or unsuitable.

Restricted to oncology or as specified in product entry where applicable

vonoprazan quantity/duration limits

Quantity/duration (vonoprazan)Up to 32 weeks depending on indication; for H. pylori maximum 14-day course

Initial therapy requirementFor erosive esophagitis and non‑erosive GERD, prior failure of two different PPIs required

Reauthorization limitsNon-erosive GERD: initial 4 weeks with option to reauthorize additional 20 weeks (total 24 weeks); other indications up to one 32-week course per 365 days

Billing Rule

Initiate tolvaptan where serum sodium can be closely monitored

For tolvaptan initiation, treatment should occur in a setting where serum sodium can be closely monitored, such as hospital outpatient, to ensure safe initiation and monitoring.

Initiation site‑of‑care: hospital outpatient recommended for close sodium monitoring

ALK-positive tumor confirmation; CFTR mutation test confirming CFTR gene mutations; PAH hemodynamics (mean PAP, PAWP, PVR)

DocumentationSubmit test results (e.g., genetic tests, right heart catheterization) and pregnancy status for females of childbearing potential

PurposeRequired to verify covered use and support prior authorization decisions

CFTR mutation test definition requirement

CFTR mutation test requirementCFTR modulators require submission of a CF mutation test confirming presence of CFTR gene mutations as specified per product (e.g., Kalydeco, Orkambi, Symdeko, Trikafta)

Product-specific criteriaTesting requirements vary by drug (see product-specific Other Criteria) including responsiveness per prescribing information or in vitro data

Prescriber restrictionRestricted to pulmonology for CFTR modulators

BRAF V600 mutation verification definition

BRAF V600 verificationGenetic testing confirming BRAF V600 mutation (or BRAF gene fusion/rearrangement where applicable) is required where indicated (e.g., vemurafenib/cobimetinib, tovorafenib)

ContextSubmit BRAF testing results and pregnancy status for females of childbearing potential

Programmatic noteTesting may be required for pediatric indications and to document prior systemic therapies as applicable

Thiamine repletion requirement (INREBIC)

Thiamine repletion requirementIf baseline thiamine level is low for INREBIC, coverage will be delayed until thiamine is repleted

DocumentationSubmit baseline thiamine level and baseline platelet count with PA request

Prerequisite therapyInitial authorization requires prior trial/failure or intolerance/contraindication to ruxolitinib

Long-acting paliperidone prerequisites

Long-acting paliperidone prerequisites3-month injection: documentation of ≥4 months' treatment with 1‑month formulation; 6‑month injection: documentation of ≥4 months' treatment with 1‑month formulation OR at least one 3‑month injection

ExclusionDementia-related psychosis is excluded

Coverage duration1 year (reauthorization requires continued documentation)

High risk for fracture definition (teriparatide eligibility)

High risk for fracture definitionHistory of hip or vertebral fracture regardless of BMD; or proximal humerus/pelvis/distal forearm fracture with T‑score between -1.0 and -2.5; or T‑score ≤ -2.5; or T‑score -1.0 to -2.5 plus FRAX hip ≥3% or major fracture ≥20%

DocumentationSubmit baseline serum calcium and prior bisphosphonate therapy details (duration, response)

Therapy limitsPrior parathyroid hormone analog use and total months must be reported; generally not recommended >2 years lifetime

ALK-positive tumor confirmation definition

ALK-positive tumor confirmationSubmission of test confirming presence of ALK-positive tumor is required prior to approval

DocumentationInclude pregnancy status for females of childbearing potential and diagnosis of covered use

Prescriber restrictionRestricted to oncology for ALK-targeted therapies