Medicare Part D Prior Authorization Criteria — 2026 Formulary (Medicare C‑SNP Part D)
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Prior authorization requirements for drugs on Independent Health's 2026 Medicare Advantage C‑SNP Part D formulary describing clinical, prescriber, age, and documentation criteria for coverage decisions.
No material clinical or coverage changes in this revision.
Product-Specific Coverage Criteria
ACTIMMUNE (example)
Covered when ALL of the following are met:
May require description to determine Medicare Part B vs Part D coverage (self‑administration vs provider administration).
Pulmonary Hypertension (PAH/CTEPH) Criteria
Covered when ALL of the following are met:
Submit WHO group classification, creatinine clearance, pregnancy status; prescriber specialty restrictions apply; initial PAH authorization requires trial/failure or intolerance to both a PDE5 inhibitor (sildenafil or tadalafil) and an ERA (ambrisentan or bosentan).
Biologic initiation and reauthorization
Covered when ALL of the following are met:
For initial authorization many biologics require trial and failure of ≥2 preferred agents where possible; if TB test positive, treat latent TB prior to initiation; annual TB screening/chest X‑ray may be required for ongoing exposure risk.
Initial authorization typically 6 months for some products (per product details) then 1 year; reauthorization requires documentation of clinical benefit or maintenance of previously achieved benefit.
AUSTEDO criteria
Covered when ALL of the following are met:
For Huntington chorea initial authorization requires prior trial and failure or intolerance to tetrabenazine; annual reauthorization for tardive dyskinesia requires documentation of symptomatic improvement or maintenance.
BYLVAY criteria
Covered when ALL of the following are met:
Initial coverage initially 6 months then 1 year; initial authorization requires trial/failure or intolerance to at least two agents among cholestyramine, naltrexone, rifampin, and ursodiol; first reauthorization requires attestation of symptomatic improvement and LFTs including bilirubin.
Cablivi criteria
Covered when ALL of the following are met:
Coverage duration 3 months; if request is not for first use submit previous aTTP recurrences on caplacizumab — do not authorize if patient had >2 recurrences while on therapy.
Cholestasis-related therapy criteria
Covered when ALL of the following are met:
Initial authorization requires trial/failure/intolerance to at least two of cholestyramine, naltrexone, rifampin, or ursodiol; prescriber restricted to gastroenterology/hepatology; initial coverage 6 months then 1 year; first reauthorization requires improvement in pruritus and LFTs including bilirubin; subsequent annual reauthorizations require maintenance of clinical benefit and LFTs.
Caplacizumab (CABLIVI) criteria
Covered when ALL of the following are met:
If request is not first use, submit prior aTTP recurrences while on caplacizumab; coverage will not be authorized if >2 recurrences occurred while on therapy; coverage duration 3 months.
CAMZYOS criteria
Covered when ALL of the following are met:
Initial authorization requires prior trial and failure or intolerance to both a beta‑blocker and a non‑DHP calcium channel blocker; annual reauthorization requires confirmation of symptomatic/clinical improvement or maintenance.
CFTR modulators criteria
Covered when ALL of the following are met:
Coverage duration 1 year; Trikafta has exclusion for severe hepatic impairment; submit mutation test per product labeling or in‑vitro responsiveness data.
Migraine biologics (Emgality, Aimovig, others) criteria
Covered when ALL of the following are met:
Coverage duration for acute migraine 1 year.
Prescriber restrictions may apply.
DOPTELET criteria
Covered when ALL of the following are met:
Prescriber restrictions apply; exclude if platelet normalized before procedure.
Initial authorization requires failure/intolerance to ≥2 ITP therapies from different classes; first reauthorization requires platelet improvement ≥50 x10^9/L after ≥4 weeks on max tolerated dose.
Dupilumab Initial and Reauthorization Criteria
Covered when ALL of the following are met:
Initial coverage initially 6 months then 1 year; reauthorization requires documentation of clinical benefit or maintenance of previously achieved benefit and updated objective tests as indicated (e.g., FEV1, blood eosinophils, endoscopy/biopsy for EoE).
Eltrombopag Criteria
Covered when ALL of the following are met:
Coverage duration varies by indication (e.g., ITP initially 12 weeks then 1 year; AA 6 months); reauthorization requires updated platelet count showing improvement and maintenance of clinical benefit.
ENSACOVE Criteria
Covered when ALL of the following are met:
Exclusion for prior ALK‑inhibitor use and for coadministration with moderate/strong CYP3A4 or P‑gp inhibitors/inducers or in severe hepatic impairment; coverage duration 1 year.
EOHILIA Criteria
Covered when ALL of the following are met:
Coverage duration 12 weeks; maximum one 12‑week course every 365 days; age ≥11 years.
FABHALTA Criteria
Covered when ALL of the following are met:
Prescriber restricted to hematology/nephrology; coverage 1 year; reauthorization requires documentation of clinical response or maintenance of benefit.
FILSPARI Criteria
Covered when ALL of the following are met:
Coverage duration 1 year; annual reauthorization requires clinically relevant response (stabilization or improvement in UPCR).
Diabetes Agents Criteria
Covered when ALL of the following are met:
Coverage duration 1 year; off‑label use for weight management excluded from Medicare Part D.
Norditropin Criteria
Covered when ALL of the following are met:
Coverage duration 1 year; annual reauthorization requires updated labs and evidence of clinical improvement or maintenance.
GLP-1 agents (Mounjaro, Ozempic, Rybelsus, etc.)
Covered when ALL of the following are met:
Coverage duration 1 year; off‑label weight management use excluded under Medicare Part D.
Hereditary angioedema agents (HAEGARDA, TAKHZYRO)
Covered when ALL of the following are met:
Coverage duration 1 year; requests for acute (on‑demand) HAE therapy may be excluded for certain products as specified.
Product-specific coverage summaries
Covered when ALL of the following are met (per‑product summaries):
Coverage typically 1 year; many products exclude coadministration with strong/moderate CYP3A4 inducers or QT‑prolonging drugs and require pregnancy status for females of childbearing potential.
Acute conditions: 3 months; chronic conditions: 1 year; IV formulations administered at home for primary immune deficiency may be Part B.
Antifungal coverage (example)
Covered when ALL of the following are met:
Coverage duration 6 months; excludes treatment of fungal meningitis or infections of skin or nails.
Oncology targeted therapy (KOMZIFTI)
Covered when ALL of the following are met:
Prescriber restricted to oncology; exclusions include congenital long QT, QTcF ≥450 msec, uncorrected electrolyte abnormalities, strong CYP3A4 inducers or QT‑prolonging drugs; coverage duration 1 year.
Lapatinib coverage
Covered when ALL of the following are met:
Prescriber restricted to oncology; for lapatinib with capecitabine prior therapy with an anthracycline, a taxane, and trastuzumab required; coverage 1 year.
Sickle cell therapy (l-glutamine)
Covered when ALL of the following are met:
Prescriber restricted to hematology; coverage duration 1 year.
PARP inhibitor coverage
Covered when ALL of the following are met:
Coverage duration 1 year; coadministration with moderate/strong CYP3A inducers may be exclusionary.
Initial authorization (product-group example)
Covered with prior authorization when ALL of the following are met:
See product‑specific nodes for lab and prior therapy requirements; reauthorization requires documentation of clinical benefit or maintenance of prior benefit.
Biomarker-confirmed indications
Covered when ALL of the following are met:
Requirements and tests are product‑specific; prescriber specialty restrictions and prior therapy prerequisites may also apply.
Reauthorization
Reauthorization covered when ALL of the following are met:
Specific reauthorization metrics vary by product (examples include reductions in exacerbation rate, improved lab values, decreased proteinuria, or histologic improvement).
Time-limited use
Covered when ALL of the following are met:
Example: some products have initial shorter authorizations (e.g., 6 months) then annual reauthorization; ORIAHNN use >2 years not approved for safety reasons.
Inbrija (levodopa inhalation) authorization criteria
Covered when ALL of the following are met:
Annual reauthorization requires confirmation of symptomatic or clinical improvement or maintenance of previously achieved improvement.
Pemazyre authorization criteria
Covered when ALL of the following are met:
Submit pregnancy status for females of childbearing potential; coverage duration 1 year.
Prolastin-C authorization criteria
Covered when ALL of the following are met:
Coverage duration 1 year; reauthorization requires confirmation of symptomatic or clinical improvement or maintenance of benefit; Part B vs Part D determination may depend on site-of‑care and administration details.
Repatha authorization criteria
Covered when ALL of the following are met:
Prescriber restricted to cardiology/endocrinology/lipid specialists; age ≥10 years for some indications; coverage duration 1 year.
REVUFORJ Initial Therapy
Covered when ALL of the following are met:
Coverage duration 1 year; exclusions include QTcF >450 msec at initiation, WBC >25 x10^9/L, uncorrected hypokalemia/hypomagnesemia, or coadministration with moderate/strong CYP3A4 inducers.
REZDIFFRA Initial and Reauthorization
Covered when ALL of the following are met:
Coverage duration 1 year; exclusion for decompensated cirrhosis or moderate/severe hepatic impairment; first reauthorization requires documentation of resolution or improvement/stabilization of fibrosis; annual reauthorizations require maintenance of clinical benefit.
RIVFLOZA Initial and Reauthorization
Covered when ALL of the following are met:
Initial coverage 6 months then 1 year; first reauthorization requires clinically relevant response (reduced Uox or plasma oxalate); annual reauthorization requires maintenance of benefit.
Antipsychotics Initial Therapy and Step Therapy
Covered when ALL of the following are met:
Prescriber restricted to psychiatry; coverage duration 1 year; other indication‑specific step requirements apply.
Simvastatin Prior Use Requirement
Covered when ALL of the following are met:
Not recommended as initial therapy; prior lower‑dose failure criteria apply; coverage duration 1 year.
SIGNIFOR Initial and Reauthorization
Covered when ALL of the following are met:
Exclusion for severe hepatic impairment (Child‑Pugh C) or uncorrected hypokalemia/hypomagnesemia; first reauthorization requires documentation of clinically relevant response; annual reauthorization requires maintenance of benefit; coverage 1 year.
General authorization criteria
Covered when ALL of the following are met:
This template applies to multiple products; see product‑specific nodes for required tests, prior therapies, and exclusions.
ATTR cardiomyopathy
Covered when ALL of the following are met:
Prescriber restricted to cardiology; age ≥18; coverage duration 1 year; reauthorization requires documentation of symptomatic/clinical improvement or maintenance.
Molecularly targeted oncology agents
Covered when ALL of the following are met:
Prescriber restricted to oncology; exclusions and safety labs (e.g., QTcF, electrolytes) required per product; coverage typically 1 year.
Tolvaptan (indication-specific criteria)
Covered when ALL of the following are met:
Exclusions include significant liver impairment, inability to sense thirst, hypovolemia, urinary obstruction, anuria, coadministration with strong CYP3A modulators; coverage duration 1 year.
Treatment limited to 30 days to reduce risk of liver injury; exclusions similar to above; this formulation not approved for ADPKD.
Parathyroid hormone analogs / osteoporosis
Covered when ALL of the following are met:
Coverage duration typically 2 years; use beyond 2 years generally not recommended unless patient remains high risk and updated serum calcium provided for reauthorization.
VEOZAH (vasomotor symptoms)
Covered when ALL of the following are met:
Prescriber restrictions apply; coverage duration 1 year; annual reauthorization requires documentation of symptomatic improvement or maintenance.
VERQUVO (heart failure)
Covered when ALL of the following are met:
Exclusions include pregnancy and concomitant use of another sGC stimulator or a PDE‑5 inhibitor; coverage duration 1 year; annual reauthorization requires confirmation of clinical benefit or maintenance.
General product authorization logic
Covered when ALL of the following are met:
Pattern applies across many products; see per‑product entries for specificity.
Wegovy (MASH / MACE) criteria
Covered when ALL of the following are met:
Initial authorization 32 weeks then 1 year; prescriber and prior therapy documentation required; not approved for weight management under Medicare Part D.
Initial 32 weeks then 1 year.
Voydeya coverage criteria
Covered when ALL of the following are met:
Standalone therapy excluded; initial authorization 6 months then 1 year; reauthorization requires documentation of clinical benefit or maintenance.
Xifaxan criteria
Covered when ALL of the following are met:
Coverage durations differ: HE 1 year; IBS‑D and SIBO typically 14 days per course.
PAH criteria
Covered when ALL of the following are met:
Initial authorization often 6 months then 1 year; prescriber restricted to cardiology/pulmonology; exclusions include pregnancy and specified drug interactions.
Omalizumab — initial and reauthorization criteria (examples)
Covered when ALL of the following are met:
Reauthorization requires documentation of clinical benefit (reduction in exacerbations, symptom scores, nasal polyp score, itch/hive counts) or maintenance of prior benefit; prescriber restrictions and age limits per product.
Product-specific initial authorization and reauthorization criteria
Covered when ALL of the following are met (selected product examples):
Coverage duration 1 year; age ≥18.
Initial coverage 6 months then 1 year; reauthorization requires clinical improvement and maintenance.
Product‑specific exclusions such as QT prolongation, hepatic impairment, or strong CYP3A interactions apply.
This policy requires prior authorization for pulmonary hypertension agents and specifies several exclusionary safety conditions. Coverage is contingent on diagnostic confirmation by right heart catheterization with submission of WHO group classification and hemodynamic data including mean pulmonary arterial pressure >20 mm Hg and pulmonary arterial wedge pressure ≤15 mm Hg; for PAH (WHO Group 1) PVR >2 Woods units is required and for CTEPH (WHO Group 4) PVR >3 Woods units plus imaging evidence of chronic pulmonary embolism and attestation of inoperable or persistent/recurrent disease. Exclusions that may trigger denial include pregnancy, severe hepatic impairment (Child‑Pugh class C), creatinine clearance <15 mL/min or dialysis, and contraindicated co‑medications such as nitrates/nitric oxide donors or phosphodiesterase inhibitors. Prescriber specialty is restricted (cardiology or pulmonology) and typical coverage duration is 1 year. Initial PAH authorization additionally requires prior inadequate response, intolerance, or contraindication to both a PDE5 inhibitor (sildenafil or tadalafil) and an ERA (ambrisentan or bosentan).
AQNEURSA (for Niemann‑Pick disease type C) is excluded when patients do not have neurologic manifestations consistent with the diagnosis or when pregnancy is present. Prior authorization requires documentation of the neurologic signs or symptoms attributable to Niemann‑Pick type C and submission of pregnancy status for females of childbearing potential. Reauthorization requires confirmation of symptomatic or clinical improvement (or maintenance of previously achieved improvement). Coverage is generally limited to patients aged 18 years or older where specified and prescriber access is restricted to neurology.
Chenodal is excluded for patients who are pregnant or who have known hepatocyte dysfunction, significant bile duct abnormalities (including intrahepatic cholestasis, primary biliary cirrhosis, or sclerosing cholangitis), radiopaque gallstones, or a nonvisualizing gallbladder after two consecutive dye doses; safety beyond 24 months has not been established and extended use will not be authorized. Prior authorization requires documentation of the diagnosis and submission of liver function testing; prescriber specialty is limited to gastroenterology or hepatology. Coverage duration in the policy is limited to 24 months for this agent.
Cerdelga (eliglustat) coverage excludes patients who are ultrarapid CYP2D6 metabolizers and those with pre‑existing cardiac disease or long QT syndrome, and it is not recommended in moderate or severe hepatic impairment. Prior authorization requires submission of CYP2D6 genotype/metabolizer status and liver function testing or a Child‑Pugh score. These safety exclusions and required baseline tests must be reviewed before approval; typical coverage duration when authorized is 1 year.
Prior Authorization, Documentation & Denial Risks
Prior authorization required
Prior authorization (PA) is required for drugs listed with “PA” on the Medicare Advantage Part D formulary; approval must be obtained before filling prescriptions to be eligible for coverage. Failure to obtain prior authorization may result in the drug not being covered.
- Obtain approval prior to dispensing to be eligible for coverage.
- Drugs appear with ‘PA’ in the Requirements/Limits column on the formulary.
Therapy trial required for some agents
Document prior trial and failure or intolerance to required therapies when specified (example: AUSTEDO initial authorization for Huntington chorea requires trial/failure or intolerance to tetrabenazine).
- Include dates, doses, and reason for discontinuation (failure or intolerance).
- If prerequisite therapy cannot be used, document contraindication or intolerance.
Cholestasis drug PA — initial 6 months then annual
For cholestasis-related products, initial authorization is limited to 6 months (then annual reauthorization) and requires the prescriber be gastroenterology/hepatology; submit molecular genetic testing and documentation of cholestasis and prior trials of at least two listed agents.
- Submit molecular genetic test confirming diagnosis and evidence of cholestasis (e.g., total serum bile acid > age‑adjusted ULN, conjugated bilirubin, GGT elevation, fat‑soluble vitamin deficiency, or intractable pruritus).
- Document failure/intolerance to at least two of: cholestyramine, naltrexone, rifampin, ursodiol; first reauthorization requires LFTs and attestation of symptomatic improvement.
Caplacizumab PA and recurrence limit
Caplacizumab (CABLIVI) requires prior authorization; patient must be ≥12 years, prescriber restricted to cardiology/hematology/immunology, and coverage duration is 3 months. If not first use, submit prior aTTP recurrences; do not authorize if >2 recurrences while on therapy.
- Confirm drug will be given with plasma exchange and immunosuppressive therapy.
- If request is for subsequent use, submit number of prior aTTP recurrences while on caplacizumab; coverage denied if >2 recurrences.
CAMZYOS PA — cardiology prescriber and prior trials required
CAMZYOS prior authorization is required; restricted to cardiology prescribers, age ≥18, initial coverage 1 year, and initial authorization requires prior trial and failure or intolerance to both a beta‑blocker and a non‑DHP calcium channel blocker.
- Submit attestation of NYHA class II–III exertional symptoms, LVOT gradient ≥50 mm Hg (rest/Valsalva/exercise), LV wall thickness ≥15 mm (or ≥13 mm if familial), and current LVEF.
- Annual reauthorization requires confirmation of symptomatic improvement or maintenance.
CFTR modulators — mutation confirmation and pulmonology prescriber
CFTR modulators require submission of CFTR mutation testing confirming the specific mutation(s) responsive per drug labeling and are restricted to pulmonology prescribers; coverage duration is 1 year.
- Attach CFTR mutation test results showing mutation(s) responsive to the requested drug (per prescribing information or in vitro data).
- Prescriber must be pulmonology; annual reauthorization requires documentation per product.
Migraine biologics — baseline/headache and prior triptan/biologic trials
CGRP monoclonal antibodies for migraine prevention require documentation of baseline headache days and prior acute therapy trials; Emgality prevention specifically requires prior failure or intolerance to Aimovig and initial prevention authorization is 3 months then 1 year.
- For prevention: document baseline headache days/month (<15 for episodic prevention) and submit on‑treatment headache days at first reauthorization demonstrating improvement.
- For acute treatment: document trial/failure or contraindication to one triptan.
Antiemetic products PA (age ≥18)
Prior authorization is required for listed antiemetic products for patients aged ≥18; coverage duration is 1 year. If used as a full replacement for IV antiemetic therapy within 48 hours of cancer treatment, prescriber must indicate Part B on the prescription.
- For cancer‑related use, submit prior/current antiemetic therapies and prescriber attestation for Part B coverage when replacing IV therapy within 48 hours.
- Typical PA duration: 1 year for outpatient use.
Dupilumab PA — initial 6 months then annual; submit diagnostics/prior therapy
Dupilumab requires prior authorization with initial coverage typically 6 months then 1 year; submit indication‑specific diagnostic confirmation and prior/concomitant therapy per indication (e.g., topical steroid trial for AD; GINA‑recommended maximal inhaled regimen for asthma; intranasal corticosteroid for CRSwNP; biopsy for EoE).
- For each indication, attach the required objective tests (e.g., FEV1 and blood eosinophils for asthma; endoscopy/biopsy showing ≥15 eos/HPF for EoE).
- Provider must attest continuation of background therapies where required; first reauthorization requires documentation of clinical benefit or maintenance.
Eltrombopag PA — diagnosis, platelet thresholds, prior therapies
Eltrombopag prior authorization requires documentation of diagnosis, indication‑specific platelet count thresholds, submission of prior therapies tried and failed (for ITP), and updated platelet counts for reauthorization; durations vary by indication.
- For ITP initial: platelet count <30 x10^9/L or <50 x10^9/L with increased bleeding risk and trials of ≥2 ITP therapies (or splenectomy status).
- For reauthorization, submit platelet response (≥50 x10^9/L after ≥4 weeks on max tolerated dose) and maintenance documentation.
ENSACOVE PA — ALK+ confirmation and no prior ALK inhibitor
ENSACOVE (ALK inhibitor) prior authorization requires documentation of an ALK‑positive tumor test, attestation of no prior ALK‑inhibitor use, pregnancy status, prescriber restricted to oncology, and coverage duration 1 year; prior ALK‑inhibitor use is exclusionary.
- Submit tumor testing confirming ALK positivity and attest patient has not previously received an ALK inhibitor.
- Do not approve if prior ALK‑inhibitor use is documented; include pregnancy status for females of childbearing potential.
EOHILIA PA — biopsy confirmation, prior PPI trial, prescriber limits
EOHILIA prior authorization requires upper endoscopy with biopsy showing ≥15 eos/HPF (or 60 eos/mm2), documentation of signs/symptoms, prior 8‑week PPI trial, prescriber specialty restrictions, and allows a single 12‑week course every 365 days (coverage duration 12 weeks).
- Attach endoscopy pathology showing eosinophilic criteria and documentation of prior PPI trial and symptoms.
- Prescriber must be allergy, gastroenterology, immunology, or ENT; maximum one 12‑week course per 365 days.
EPIDIOLEX PA — neurology prescriber required
EPIDIOLEX prior authorization requires prescriber be neurology and coverage duration is 1 year; PA is required for FDA‑approved indications.
- Submit diagnosis of covered indication and neurology prescriber information.
- Annual reauthorization requires documentation per product.
FRUZAQLA PA — QTc/electrolyte/hepatic exclusions and baseline labs
FRUZAQLA PA requires baseline QTc and electrolytes and excludes patients with QTc >450 msec, significant electrolyte abnormalities, severe hepatic impairment, coadministration with strong CYP3A4 inhibitors, or recent MAOI use; submit baseline QTc, potassium, magnesium, and LFTs.
- Do not initiate if QTc >450 msec or congenital long QT syndrome; correct hypokalemia/hypomagnesemia prior to initiation.
- Avoid coadministration with strong CYP3A4 inhibitors and MAOI within 14 days.
FABHALTA PA — diagnostic confirmation and prior therapy required
FABHALTA prior authorization requires diagnostic confirmation (e.g., flow cytometry for PNH), relevant labs, prescriber specialty restrictions to hematology/nephrology, and prior therapy failure for indicated uses; coverage duration 1 year.
- For PNH: submit flow cytometry confirming PNH clones and evidence of inadequate response to eculizumab or ravulizumab.
- For IgAN: submit UPCR ≥1.5 g/g and documentation of failure/intolerance to maximally‑tolerated ACEi/ARB and atrasentan or sparsentan.
FILSPARI PA — biopsy confirmation, UPCR thresholds, prior ACEi/ARB
FILSPARI prior authorization requires biopsy‑confirmed primary IgA nephropathy, specified urine protein thresholds, eGFR and liver testing, prescriber restriction to immunology/nephrology, and prior maximally tolerated ACE inhibitor/ARB use; annual reauthorization requires clinically relevant response.
- Submit kidney biopsy confirming IgAN and either 24‑hour urine protein ≥0.5 g/day or UPCR ≥0.8 g/g, with eGFR and liver tests.
- Document trial and inadequate response or intolerance to a maximally‑tolerated ACE inhibitor or ARB prior to initiation.
Oncology‑related products — prescriber, labs, exclusions, prior therapy
Oncology and other specialty agents frequently require prior authorization with prescriber specialty restrictions to oncology/hematology, baseline labs (e.g., QTc, K/Mg, LFTs), exclusions for interacting drugs or comorbidities, and documentation of prior systemic therapies when specified.
- Submit tumor/mutation testing as required (e.g., FGFR, KMT2A, FLT3) and baseline safety labs (QTcF, potassium, magnesium, LFTs) when requested.
- Confirm prescriber specialty matches policy requirement (hematology/oncology) to avoid denial.
GLP‑1 agents PA — diabetes diagnosis required; weight‑loss use excluded
GLP‑1 receptor agonists and related diabetes agents require documentation of type 2 diabetes diagnosis (medical record, ICD‑10, or lab results); prior authorization is required with coverage duration 1 year; off‑label use for weight management is excluded under Medicare Part D.
- Attach evidence of type 2 diabetes (A1c, fasting glucose, OGTT, or medical record).
- Do not request GLP‑1 products for weight management under Medicare Part D—this use will be denied.
Norditropin PA — growth failure documentation and labs
Norditropin prior authorization requires documentation of growth failure and relevant labs (IGF‑1, height/weight, creatinine clearance or serum creatinine, fasting glucose, bone age if applicable); prescriber restricted to endocrinology/nephrology and annual reauthorization requires updated monitoring.
- Submit IGF‑1 levels, growth measurements, creatinine clearance (or serum creatinine), fasting glucose, and bone age when applicable.
- Prescriber must be endocrinology or nephrology; include updated labs on reauthorization.
HAE agents PA — prophylaxis documentation, prescriber limits
HAE prophylaxis agents require prior authorization, coverage duration 1 year, and prescriber restriction to allergy/dermatology/hematology/immunology; requests for acute HAE attack therapy or prophylaxis where excluded must be avoided.
- Submit objective or subjective documentation that prophylactic therapy is medically necessary (attack frequency, disease activity, QoL).
- Ensure the request is for prophylaxis in an approved product; some HAE products exclude prophylaxis or acute therapy—verify product‑specific rules.
Antifungal PA — baseline labs and 6‑month initial coverage
Certain antifungal agents (example: KISQALI entries) require prior authorization and baseline labs (ALT, AST, total bilirubin, alkaline phosphatase, PT/INR); coverage duration is 6 months for these entries and infections of skin or nails or fungal meningitis are excluded.
- Submit culture‑proven diagnosis for systemic mycoses listed and baseline LFTs and coagulation studies.
- Do not request these antifungal agents for fungal meningitis or cutaneous/nail infections—these are excluded.
KOMZIFTI PA — tumor testing and safety labs required
KOMZIFTI prior authorization requires oncology prescriber, age ≥18, submission of genetic tumor testing confirming HR‑positive, HER2‑negative primary tumor, QTcF and electrolyte labs within prior 6 months, pregnancy status, and coverage duration 1 year.
- Attach genetic tumor testing confirming HR+/HER2‑ status and recent QTcF, serum potassium and magnesium.
- Attest concomitant use of an aromatase inhibitor or fulvestrant as indicated.
PA requirement overview — submit diagnosis, labs, and prescriber specialty
Prior authorization is required for the listed specialty products generally; providers must meet exclusion criteria, submit required medical information (diagnosis, labs, mutation testing, pregnancy status), and adhere to prescriber/age restrictions to obtain approval.
- Failure to submit required baseline labs, mutation tests, or pregnancy status may trigger denial.
- Confirm patient meets age and prescriber specialty requirements before submission.
Limited‑duration PA — monitored initiation (e.g., tolvaptan 30 days)
Some agents have limited‑duration prior authorizations and must be initiated in monitored settings (example: tolvaptan for hyponatremia is limited to 30 days and must be started where serum sodium can be closely monitored).
- For tolvaptan hyponatremia formulation: submit evidence of clinically significant hyponatremia (serum Na <125 mEq/L or symptomatic <135 mEq/L resistant to fluid restriction).
- Document setting of initiation (hospital/outpatient monitored setting) and plan for sodium monitoring.
Prior therapy requirement — document trials/failures or intolerance
Prior authorization typically requires documentation of prior therapies tried and failed (or intolerance) before approval (examples include BYLVAY, BYLVAY‑class cholestasis agents, many biologics, and oncology agents).
- Provide dates, doses, and reasons for discontinuation of prior therapies; where product requires ≥2 prior agents, list each trial and outcome.
- If a required prior therapy was not used, document contraindication or intolerance.
Rifaximin prerequisite — lactulose trial required for HE
Rifaximin (XIFAXAN) authorization for hepatic encephalopathy requires trial and inadequate response or intolerance to lactulose before approval; for IBS‑D and SIBO, document prior therapy courses and testing as specified.
- For HE: document lactulose trial and inadequate response/intolerance.
- For IBS‑D: document number of prior 14‑day rifaximin courses in lifetime; for SIBO: positive carbohydrate breath test and prior courses in previous 365 days.
Document prerequisite/background therapy and attestation
Providers must document prerequisite/background therapies and attest that guideline‑recommended background therapies will be continued where specified (examples: asthma biologics require maximally‑tolerated ICS+LABA+LAMA; HFrEF/PAH products require use of guideline background therapies).
- Include attestation that background therapies will continue after biologic initiation when required.
- For HFrEF or PAH agents, document current guideline background regimen and doses.
Index entries — consult product‑specific sections for PA rules
Index entries in this extract list drug names and formulations but do not state specific prior authorization requirements; individual drug sections elsewhere in the policy contain the requirements and must be referenced for PA submission.
- When using the index, navigate to the product‑specific section for PA rules, required documentation, and exclusions.
- Do not rely on index alone for authorization — submit product section evidence.
Preferred‑agent step requirement for biologics
For many biologic/immunomodulator agents, initial authorization requires trials of at least two preferred agents where possible prior to starting the requested biologic (document each preferred‑agent trial and reason for failure/intolerance).
- List preferred agents tried, durations, outcomes, and reasons for discontinuation.
- If preferred agents cannot be used, provide documentation of contraindication or intolerance.
Codes, Thresholds, and Key Clinical Values
| N/A | Product listings for MOUNJARO, OZEMPIC, RYBELSUS, TRULICITY and related formulations (no billing codes provided in this excerpt) |
| 10 mg | VALTOCO 10 MG DOSE |
| 15 mg | VALTOCO 15 MG DOSE NASAL LIQUID THERAPY PACK 2 X 7.5 MG/0.1ML |
| 20 mg | VALTOCO 20 MG DOSE NASAL LIQUID THERAPY PACK 2 X 10 MG/0.1ML |
| 5 mg | VALTOCO 5 MG DOSE |
| REPATHA | REPATHA products (including Pushtronex, SureClick) |
| NDC/HCPCS not listed | Specific product strengths and formulations listed (e.g., teriparatide pen 560 mcg/2.24 mL) but no billing codes provided in this section. |
| No codes listed |
| N/A | This window contains no explicit CPT/HCPCS/ICD-10/NDC codes; product names and formulations are listed instead. |
| No codes listed |
Initial Authorization / Start-of-Therapy Rules
Reauthorization / Ongoing Use Requirements
Step Therapy & Prior-Use Requirements
| Step therapy rule | Requirement |
|---|---|
| Preferred-agent step requirement | |
| For initial authorization of many biologic/immunomodulator agents the patient must have tried and failed to have an adequate response to or been intolerant to at least two preferred agents (examples: adalimumab biosimilar, Cosentyx, Enbrel, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz/Xeljanz XR), where possible. |
| Step therapy rule | Requirement |
|---|---|
| AUSTEDO prior trial requirement | |
| For initial authorization of AUSTEDO for chorea associated with Huntington disease, the patient must have tried and failed to have an adequate response to or had an intolerance/contraindication to tetrabenazine. |
| Step therapy rule | Requirement |
|---|---|
| Cholestasis step therapy | |
| For initial authorization the patient must have tried and failed to have an adequate response to or been intolerant of at least two agents among cholestyramine, naltrexone, rifampin, or ursodiol; documentation of cholestasis and molecular genetic testing is required. |
| Step therapy rule | Requirement |
|---|---|
| CGRP biologic prior trial | |
| For initiation of Emgality for migraine prevention the patient must have tried and failed to have an adequate response to or been intolerant of Aimovig prior to initial authorization. |
| Step therapy rule | Requirement |
|---|---|
| Examples of step therapy or prior trials required | |
| Step therapy or prior trial of listed agents is required before approval in many product‑specific indications (examples include: moderate‑strength topical corticosteroid trial ≥4 weeks for dupilumab in AD; failure of maximally‑tolerated ACE inhibitor/ARB ± additional agents prior to FABHALTA or FILSPARI; prior systemic therapy failures as specified for oncology agents). |
| Step therapy rule | Requirement |
|---|---|
| Endocrine/oncology step requirement (PIQRAY example) | |
| For PIQRAY initial authorization the patient must have tried and failed to have an adequate response to an endocrine‑based regimen; documentation of prior endocrine therapy and rationale is required. |
| Step therapy rule | Requirement |
|---|---|
| Prior lines / prior‑therapy line requirements | |
| Some agents require failure of specified prior lines of therapy before initial authorization (examples: mantle cell lymphoma or CLL/SLL agents require failure of two prior lines including a BTK inhibitor; lapatinib with capecitabine requires prior anthracycline, taxane, and trastuzumab). |
| Step therapy rule | Requirement |
|---|---|
| Documentation of prior therapies | |
| Providers must submit documentation of current or previous therapies used to treat the condition when step therapy or prior‑therapy requirements apply; this includes dates, agents tried, and reason for discontinuation (failure or intolerance) where applicable. |
| Step therapy rule | Requirement |
|---|---|
| Document trials and reasons for failure/intolerance | |
| When step therapy is required, the request must include documentation of trials and clinical reasons for failure or intolerance to required prior therapies (e.g., inadequate response, adverse effects, contraindication). |
| Step therapy rule | Requirement |
|---|---|
| Prior trials documentation required | |
| Authorization requires documentation that the member tried and had inadequate response to, or was intolerant/contraindicated to, required prior therapies; examples include maximal inhaled therapy for mepolizumab or trials of two different classes for Inbrija. |
| Step therapy rule | Requirement |
|---|---|
| Required unless contraindicated | |
| Certain step‑therapy trials are required for initial authorization unless a contraindication or intolerance is documented (example: Inbrija requires trials of at least two different medication classes unless contraindicated). |
| Step therapy rule | Requirement |
|---|---|
| General required for initial authorization | |
| Many products require prior trial(s) of specified therapies before initial authorization; prescribers must attest prior therapies were tried and provide objective supporting documentation when requested (lab values, diagnostics, prior medication records). |
| Step therapy rule | Requirement |
|---|---|
| Antipsychotic prior trials | |
| Initial authorization for antipsychotics (e.g., schizophrenia, bipolar) requires documented trials and failures or intolerance to specified generic second‑generation antipsychotics (examples include aripiprazole and another generic agent); for Caplyta in bipolar depression, failure/intolerance to two listed alternatives is required. |
| Step therapy rule | Requirement |
|---|---|
| Prior trial of specified therapies from different classes | |
| Some indications require trials of therapies from different medication classes prior to approval (example: vasomotor symptom agents require failure of at least two prior systemic hormone or non‑hormonal therapies from different classes). |
| Step therapy rule | Requirement |
|---|---|
| Required prior/concurrent guideline background therapies | |
| For some disease states (e.g., HFrEF, PAH), prior or concurrent use of guideline‑recommended background therapies at maximally‑tolerated doses is required before authorization (examples: ACEi/ARB or sacubitril/valsartan, beta‑blocker, MRA for HFrEF; nitric oxide pathway mediator plus endothelin receptor antagonist for PAH). |
| Step therapy rule | Requirement |
|---|---|
| Voyxact prior‑use requirement | |
| For voyxact coverage (IgAN example), the patient must have tried and failed to have an adequate response to or been intolerant of maximally‑tolerated ACE inhibitor/ARB (and other specified agents where applicable) prior to initial authorization. |
| Step therapy rule | Requirement |
|---|---|
| Document prior trials and failures (general) | |
| For products with step therapy requirements, providers must document prior trials and failures or intolerance to specified therapies as described in product‑specific criteria (e.g., ZILBRYSQ, ZORYVE examples). |
Coverage by Site of Care (Part B vs Part D Considerations)
Policy Scope and Background
This document establishes prior authorization rules tied to clinical indications and requires submission of specific diagnostic confirmation, prescriber specialty, age limits, and exclusion checks before coverage is approved. Providers must submit required objective data (for example, hemodynamics for pulmonary hypertension, genetic or biomarker tests for mutation‑directed therapies, and baseline labs or ECG when QT risk is present) and attest to prior therapy trials when required. Failure to obtain prior authorization or to provide requested documentation (including pregnancy status for females of childbearing potential) may result in denial of coverage. Coverage durations are typically 1 year unless otherwise specified, and many agents are restricted to specialty prescribers per the policy.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.