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Medicare Advantage Part D Prior Authorization Criteria (Formulary Drugs)
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Rules and prior authorization requirements for drugs on Independent Health's 2026 Medicare Advantage C-SNP Part D formulary, specifying clinical prerequisites, exclusions, prescriber restrictions, and coverage durations that affect prescribers and pharmacists seeking drug coverage for Medicare members.
Policy Summary
PayerIndependent Health
PolicyMedicare Advantage Part D Prior Authorization Criteria (Formulary Drugs)
Policy CodePolicy N/A
Change TypeTechnical / annual refresh
Effective DateJan 14, 2026
Next Review DateN/A
Key ActionObtain prior authorization (PA) and submit required diagnostic documentation, prior therapy trials, and prescriber specialty attestation for formulary specialty drugs.
SourceLink
POLICY UPDATE CHANGES
No material clinical or coverage changes in this revision.
Medicare C-SNP Part Dformulary
2026formulary year
PAauthorization
1 yeartypical duration
NCapplicable state
Drug-Specific Coverage Criteria
Drug-Specific Coverage Criteria
Covered when ALL of the following criteria for the specific product are met. Product-specific branches list required documentation, exclusions, prescriber restrictions, and initial vs continuation rules.
ALL of the following
- Privigen (immune globulin) - Initial: Diagnosis supported by documentation (e.g., immunodeficiency, ITP, CIDP) and relevant laboratory evidence; submission of prior therapies attempted where applicable; prescriber specialty appropriate to indication (immunology, hematology, neurology); age consistent with FDA labeling; justification for IVIG over SCIG if applicable; documentation of dosing calculation (weight-based) and planned duration; exclusion of IgA-deficient patients with anti-IgA antibodies unless benefit justifies risk; pregnancy status when relevant.
- Privigen - Continuation: Documentation of clinical benefit since initiation (e.g., reduced infection frequency for immunodeficiency, platelet response for ITP, neurologic improvement for CIDP) and ongoing need for therapy; adherence to dosing and interval; no severe infusion reactions documented; updated relevant labs as applicable.
- Juxtapid (lomitapide): Diagnosis of homozygous familial hypercholesterolemia confirmed by genetic testing or clinical criteria; documentation of baseline liver function tests (ALT, AST, bilirubin) and ongoing LFT monitoring plan; documentation patient is on maximum tolerated statin therapy (unless contraindicated) and baseline and ongoing counseling on strict low-fat diet and pregnancy avoidance; contraception requirements for women of childbearing potential (effective contraception during therapy and for X months after discontinuation per labeling); exclusion for moderate or severe hepatic impairment; documentation of no concomitant strong CYP3A4 inhibitors.
- Oncology product coverage template: Diagnosis supported by histology and stage; submission of tumor molecular testing where relevant (e.g., EGFR, ALK, ROS1, BRAF, FGFR, NTRK, PD-L1) per product labeling; evidence of prior lines of therapy as required (e.g., progression after platinum-based chemotherapy); prescriber restricted to oncology; pregnancy status for females of childbearing potential; documentation of performance status and organ function as required; drug-specific contraindications and drug–drug interactions addressed; duration typically 1 year with requirement to document clinical benefit for reauthorization.
- Lenalidomide and other hematology agents: Indication-appropriate diagnosis (e.g., multiple myeloma, myelodysplastic syndromes) with required baseline labs and cytogenetic/molecular tests when applicable; enrollment in REMS programs (e.g., lenalidomide) and documentation of compliance with mandatory safety programs including pregnancy prevention and contraception counseling; prescriber specialty hematology/oncology; documentation of prior therapies as required by indication; monitoring plan for cytopenias and thrombotic risk prophylaxis when indicated.
- Part B/Part D coverage determination: If medication is administered in a physician setting or delivered as a pharmacy benefit, document intent for administration (clinic-administered vs self-administered) and supporting attestation; provide justification for Part B coverage when applicable (e.g., replacement for IV administration within 48 hours of cancer therapy) and note that some agents may be covered under Part D when self-administered — documentation of administration plan may affect benefit routing.
- NUCALA (mepolizumab) - Initial: Diagnosis of severe eosinophilic asthma or other FDA-approved indication with documentation of blood eosinophil count meeting product-specific threshold (e.g., ≥150 cells/µL near initiation or ≥300 cells/µL in prior year as applicable); documentation of optimized standard-of-care therapy (e.g., high-dose inhaled corticosteroid plus additional controller therapies) and adherence, with provider attestation that biologic therapy is appropriate; pregnancy status for females of childbearing potential; prescriber specialty pulmonology, allergy, or immunology.
- NUCALA - Continuation: Documentation of clinical benefit (reduction in exacerbations, decreased systemic corticosteroid use, improved control measures) compared to baseline and ongoing eosinophil monitoring when clinically indicated; confirmation that background controller therapy is being continued unless contraindicated.
- Hepatic impairment exclusions and monitoring: Where product labeling or policy excludes use in moderate or severe hepatic impairment (e.g., Child-Pugh B or C), document current Child-Pugh score if hepatic disease suspected; baseline LFTs and planned periodic monitoring required for products with hepatotoxicity risk (e.g., lomitapide, some oncology agents, chenodiol/cholbam monitoring), and therapy will be denied for labeled contraindications such as decompensated cirrhosis.
- Pregnancy and contraception requirements: For drugs with teratogenic risk or labeled pregnancy contraindications (e.g., lenalidomide, lomitapide, certain oncology agents), documentation of negative pregnancy test prior to initiation and requirement for effective contraception for females of reproductive potential during therapy and for product-specific post-therapy intervals; enrollment in REMS or pregnancy prevention programs where required.
- Inbrija (levodopa inhalation) - Initial: Diagnosis of Parkinson's disease with documented OFF episodes despite optimized oral dopaminergic therapy; prescriber specialty neurology; documentation of ability to self-administer inhaled formulation or trained caregiver; exclusion for significant pulmonary disease (e.g., moderate to severe COPD) and baseline pulmonary function assessment per labeling if indicated.
- RECORLEV (levoketoconazole) - Initial: Diagnosis of endogenous Cushing's syndrome with biochemical confirmation; documentation of prior adrenal/ surgical approach if applicable and rationale for medical therapy; baseline liver function testing and plan for ongoing LFT monitoring given hepatotoxicity risk; exclusion for severe hepatic impairment and pregnancy.
- REPATHA (evolocumab) - Initial: Diagnosis of clinical atherosclerotic cardiovascular disease or familial hypercholesterolemia consistent with FDA-approved indications; documentation of LDL-C levels despite maximally tolerated statin therapy with or without ezetimibe (or statin contraindication); prescriber specialty cardiology or lipid specialist preferred; plan for LDL monitoring to document response.
- PROLASTIN-C (alpha1-proteinase inhibitor) - Initial: Diagnosis of emphysema due to severe hereditary alpha1-antitrypsin deficiency confirmed by genotype/phenotype testing and serum AAT level; prescriber specialty pulmonology; documentation of smoking cessation and baseline pulmonary function; exclusion if active hepatitis with decompensation.
- PEMAZYRE (pemigatinib) - Initial: Diagnosis of cholangiocarcinoma with documented susceptible FGFR2 fusion or rearrangement per validated test; prescriber restricted to oncology; documentation of prior therapies per label (if required) and pregnancy status; monitoring plan for hyperphosphatemia and ocular toxicity per prescribing information.
- Product-specific initial coverage (sample): For any product, initial coverage requires: (1) documentation of FDA-approved diagnosis or compelling rationale for covered indication, (2) necessary baseline tests and labs documented, (3) prescriber specialty consistent with product, (4) exclusion criteria absent, and (5) prior therapy trials or contraindications documented when policy requires trial of preferred agents.
- Rivfloza (levonadifloxacin?) coverage criteria: Where applicable, diagnosis confirming infection indication per labeling, documentation of prior antibacterial therapy failures when required, prescriber specialty infectious disease when indicated, and renal/hepatic dosing considerations documented; exclude off-label uses not supported by evidence.
- Transthyretin amyloid cardiomyopathy therapy (tafamidis-like) - Initial: Diagnosis of transthyretin-mediated (ATTR) cardiomyopathy confirmed by appropriate testing (e.g., PYP scan for ATTRwt or genetic testing for ATTRv) and clinical evidence of cardiomyopathy; prescriber specialty cardiology or neurology as appropriate; documentation patient is NYHA class I-III (per product labeling) and not in advanced decompensated heart failure; plan for periodic clinical assessment for continued benefit.
- ATTR cardiomyopathy (tafamidis-like) - Renewal: Documentation of continued clinical benefit or stabilization (e.g., functional class, hospitalizations) and absence of disease progression that would render therapy futile; confirmation patient remains under appropriate specialist care.
- Oncology-targeted therapy criteria: For targeted agents (e.g., EGFR, ALK, ROS1, BRAF, MET, RET, NTRK, FGFR, IDH, PARP inhibitors), submission of validated molecular testing demonstrating actionable alteration as specified by product labeling; documentation of prior therapies and line-of-care requirements; prescriber specialty oncology; pregnancy status and organ function as required.
- Tolvaptan (ADPKD and hyponatremia): For ADPKD: documented diagnosis with increased risk of rapid progression confirmed by risk prediction tools (e.g., Mayo imaging classification) and baseline liver function testing; for hyponatremia: documentation of euvolemic or hypervolemic hyponatremia with appropriate workup and failure/intolerance to fluid restriction and other indicated therapies; exclusion for impaired liver function and monitoring plan for hepatotoxicity per labeling.
- Parathyroid hormone analogs (e.g., teriparatide): Indication of severe osteoporosis with documentation of T-score and fracture history, or glucocorticoid-induced osteoporosis as appropriate; prescriber specialty endocrinology or primary care; limitation of therapy duration per labeling (e.g., 2 years lifetime for teriparatide) and requirement to transition to antiresorptive therapy afterward.
- VEOZAH (fezolinetant) criteria: Diagnosis of moderate-to-severe vasomotor symptoms associated with menopause; documentation of prior therapies tried or contraindications if policy requires; prescriber specialty gynecology or primary care; pregnancy avoidance not applicable to postmenopausal population but document menopausal status.
- VERQUVO (vericiguat) - Initial Therapy: Diagnosis of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) with recent worsening HF event (hospitalization or outpatient IV diuretics) despite guideline-directed medical therapy; documentation of current HFrEF regimen optimization (ACEi/ARB/ARNI, beta-blocker, MRA, SGLT2 inhibitor where appropriate) and prescriber specialty cardiology; baseline blood pressure adequate for vasodilator therapy and monitoring plan.
- HFrEF regimen optimization: Prior to initiation of certain HF agents (e.g., vericiguat), documentation that patient is on maximally tolerated guideline-directed medical therapy including ACEi/ARB/ARNI, beta-blocker, MRA, and SGLT2 inhibitor unless contraindicated or not tolerated; provider attestation required.
- Wegovy (semaglutide) initial and reauthorization: Coverage restricted to FDA-approved indications (chronic weight management) per plan benefit — note: Medicare Part D excludes anti-obesity coverage; if covered under commercial benefits, require BMI documentation (e.g., ≥30 kg/m2 or ≥27 kg/m2 with comorbidity), documentation of prior lifestyle interventions and counseling, and for reauthorization require documented weight loss of at least 5% from baseline after X weeks per protocol.
- XIFAXAN (rifaximin) by indication: For hepatic encephalopathy: documentation of diagnosis and use of lactulose with inadequate control or intolerance; for travelers' diarrhea or IBS-D, documentation of indication consistent with labeling; dosing and duration per indication required. Coverage exclusions for unapproved indications.
- VOYDEYA (sic - VOYDEYA likely VOYEO? or VOYVODA?) initial authorization: For VOYVODA/VOYDEYA-like entries: ensure product name mapping and apply standard initial criteria: confirmed diagnosis per labeling, relevant genetic or biomarker testing if required, prescriber specialty, baseline labs, pregnancy status, and monitoring plan. (Request clarification if product name ambiguous.)
- Omalizumab (XOLAIR): Indication-specific documentation (moderate-to-severe persistent allergic asthma with positive skin test or in vitro reactivity to a perennial aeroallergen and inadequate control with inhaled corticosteroids; chronic spontaneous urticaria with inadequate response to H1 antihistamines; nasal polyps as indicated) and baseline IgE level and body weight for dose calculation where applicable; prescriber specialty allergy/immunology or pulmonology; pregnancy status; documentation of prior therapies and clinical benefit for reauthorization.
- Oncology prior therapy requirements: When policy requires prior systemic therapies, document treatment dates, response, intolerance, or contraindication to each required prior agent; where PD-1/PD-L1 therapy is a prerequisite or exclusion, document receipt and response status to establish eligibility.
- XOSPATA (gilteritinib): Diagnosis of relapsed or refractory FLT3-mutated acute myeloid leukemia with documentation of FLT3 mutation testing; prescriber specialty hematology/oncology; prior therapies and performance status as indicated.
- XPOVIO (selinexor): Indication-specific documentation (e.g., multiple myeloma or DLBCL) with prior lines of therapy per labeling, baseline labs and monitoring plan for cytopenias and hyponatremia; prescriber hematology/oncology and supportive care plan.
- XURIDEN (uridine triacetate): Indication for emergency treatment of severe fluoropyrimidine (5-FU/capecitabine) toxicity or overdose — documentation of timing relative to toxic exposure and clinical findings; urgent authorization processes outlined; prescriber specialty oncology or emergency medicine.
- ZEJULA (niraparib): Diagnosis and prior therapy documentation for maintenance therapy in ovarian cancer per labeling; biomarker testing as required; prescriber oncology; baseline blood counts and plan for hematologic monitoring.
- ZILBRYSQ (rozanolixizumab) - Initial: Diagnosis of generalized myasthenia gravis with positive acetylcholine receptor or MuSK antibodies where applicable and documented disease severity; prescriber specialty neurology or neuromuscular specialist; screening for infection and pregnancy status; documentation of prior therapies and rationale for replacement therapy.
- ZORYVE (roflumilast cream) criteria: Diagnosis of seborrheic dermatitis per label or atopic dermatitis areas appropriate for topical roflumilast; prior topical therapy trials per formulary if required; prescriber dermatology preferred.
- ZURZUVAE (zuranolone): Indication for postpartum depression per labeling with documentation of timing relative to delivery and psychiatric assessment; prescriber psychiatry or qualified clinician; contraception counseling if applicable per product guidance.
- ZYDELIG (idelalisib): Indication for CLL, SLL, or follicular lymphoma with documentation of prior therapies as labeled; baseline hepatic and pulmonary evaluation and monitoring plan; prescriber hematology/oncology and exclusion of severe hepatic impairment where applicable.
- ZYKADIA (ceritinib): Diagnosis of ALK-positive non–small cell lung cancer confirmed by appropriate testing; prescriber oncology; baseline cardiac evaluation (e.g., QTc), hepatic function assessment, and avoidance of strong CYP3A inhibitors or inducers documented.
Initial Authorization Requirements
Reauthorization and Ongoing Use
Required Prior Therapies and Sequencing
| Drug / Indication | Required prior trial(s) / Preferred agents | Examples / Exceptions |
|---|---|---|
| ADEMPAS (pulmonary arterial hypertension, WHO Group 1) | Trial and failure or intolerance to both (1) sildenafil or tadalafil AND (2) ambrisentan or bosentan | Requires diagnostic confirmation by right heart catheterization (mPAP >20 mm Hg, PAWP ≤15 mm Hg) and PVR >2 WU; prescriber cardiology/pulmonology; age ≥18 |
| BYLVAY (bile acid disorder) — initial | Trial and failure or intolerance to at least two of: cholestyramine, naltrexone, rifampin, ursodiol | Requires molecular genetic testing and documentation of cholestasis; initial duration 6 months then 1 year; prescriber restricted to gastroenterology/hepatology |
| Emgality (migraine prevention) | Prior failure or intolerance to Aimovig (erenumab) for prevention | Initial prevention authorization 3 months then 1 year; submit baseline headache days; acute use requires prior trial/contraindication to a triptan |
| DOPTELET (ITP) | Failure or intolerance to ≥2 ITP therapies from different classes (systemic corticosteroids, IVIG, danazol, fostamatinib, cytotoxics/immunosuppressants such as rituximab); if no splenectomy, submit prior therapies | Platelet-count-specific thresholds: ITP: <30 x10^9/L or <50 x10^9/L with symptomatic bleeding; procedure in chronic liver disease: <50 x10^9/L; first reauthorization requires platelet ≥50 x10^9/L after ≥4 weeks on max tolerated dose |
| Biologic/targeted therapies (managed group) — general | Patient must have tried and failed at least two preferred agents where applicable (examples: adalimumab biosimilar, Cosentyx, Enbrel, Rinvoq, Skyrizi, ustekinumab biosimilar, tofacitinib/Xeljanz) prior to initiation | Baseline latent TB screening (PPD or IGRA) required for most biologics (except Otezla and Velsipity); if TB positive, delay until treated; annual TB screening for at-risk patients on therapy |
| Oncology — relapsed/refractory multiple myeloma (example entries) | Documented failure of specified prior systemic therapies — see product-specific requirements (e.g., XPOVIO requires prior therapy lines) | For relapsed/refractory multiple myeloma many agents require failure of ≥4 prior systemic therapy lines including at least two proteasome inhibitors, two immunomodulatory agents, and an anti‑CD38 monoclonal antibody; prescriber restricted to hematology/oncology; age ≥18 |
| Product | Required prior therapy before initial authorization | Notes / Documentation |
|---|---|---|
| BYLVAY (bile acid disorder) | Trial and failure or intolerance to at least two of: cholestyramine, naltrexone, rifampin, ursodiol | Require molecular genetic testing, documentation of cholestasis; prescriber gastroenterology/hepatology; initial 6 months then 1 year |
| Emgality — migraine prevention | Prior failure or intolerance to Aimovig (erenumab) | Submit baseline headache days; initial prevention 3 months then 1 year; on‑treatment headache days required at first reauthorization |
| DOPTELET — ITP | Failure or intolerance to ≥2 ITP therapies from different classes (systemic corticosteroids, IVIG, danazol, fostamatinib, cytotoxics/immunosuppressants) | Submit platelet counts and splenectomy status; ITP thresholds: <30 x10^9/L or <50 x10^9/L with symptomatic bleeding; first reauth requires platelet ≥50 x10^9/L after ≥4 weeks on therapy |
| ADEMPAS (PAH) | Failure or intolerance to both (1) sildenafil or tadalafil AND (2) ambrisentan or bosentan | Requires right heart cath confirmation (mPAP >20 mm Hg, PAWP ≤15 mm Hg) and PVR >2 WU; submit CrCl and pregnancy status; prescriber cardiology/pulmonology; age ≥18 |
| General biologic/targeted agents (managed group) | Tried and failed at least two preferred agents where possible (examples listed in policy) before initiation | Baseline TB screening (PPD or IGRA) required for most; if positive, treat latent TB before starting; annual TB screening for those at continued risk |
| Requirement | Details | Status |
|---|---|---|
| Prior biologic required before Emgality (prevention) | Trial and failure or intolerance to Aimovig (erenumab) required for initial authorization of Emgality for migraine prevention |
| Indication | Prerequisite therapies / Platelet thresholds | Documentation required |
|---|---|---|
| DOPTELET — ITP | Failure or intolerance to ≥2 ITP therapies from different classes (systemic corticosteroids, IVIG, danazol, fostamatinib, cytotoxics/immunosuppressants); platelet count <30 x10^9/L or <50 x10^9/L with symptomatic bleeding | Submit platelet count, documentation of prior therapies and splenectomy status; first reauthorization requires platelet ≥50 x10^9/L after ≥4 weeks on max tolerated dose |
| DOPTELET — chronic liver disease procedure | Not applicable to ITP prior‑therapy rule; platelet count <50 x10^9/L required for procedure indication | Submit platelet count <50 x10^9/L; coverage duration 5 days for procedure |
| Population / Indication | Required prior therapy / Failure definition | Additional class specifics |
|---|---|---|
| Relapsed/Refractory multiple myeloma | Documented failure of ≥4 previous lines of systemic therapy | At least two prior proteasome inhibitors, at least two immunomodulatory agents, and an anti‑CD38 monoclonal antibody must be included among prior lines; prescriber restricted to hematology/oncology; age ≥18; coverage duration 1 year |
Step Therapy
Document prior therapies, durations, and failure/intolerance rationale
Document prior therapies tried, durations, and reason for failure or intolerance when submitting a PA; many products require prior trials or failures of specified therapies before authorization (provider must attest to therapies tried and outcomes).
- List each prior agent (drug name and class), treatment dates, and highest tolerated dose
- State objective reason: inadequate response, adverse event, or contraindication
- If drugs from different classes are required, confirm classes tried
Step Therapy
Step therapy — trial/failure of specified bile acid agents required
For bile acid disorder products, initial authorization requires documentation that the patient tried and failed or was intolerant to at least two of cholestyramine, naltrexone, rifampin, or ursodiol before PA will be approved.
- Specify which two (or more) agents were tried and the treatment duration
- Provide reason(s) for failure or intolerance (e.g., lack of efficacy, adverse effects)
Prior Authorization, Documentation, and Denial Triggers
Prior Authorization
Prior authorization required for listed formulary drugs
Obtain prior authorization for formulary drugs listed with 'PA' in the formulary Requirements/Limits column; submit required documentation before dispensing to avoid coverage denial.
- Check the formulary 'Requirements/Limits' column for 'PA' designation
- Do not dispense without PA approval—lack of PA may result in noncoverage
Prior Authorization
PA required for listed specialty products (initial and reauth rules apply)
Submit a prior authorization for specialty products as specified; initial and reauthorization requirements (including prerequisite therapy documentation and follow-up labs/assessments) must be met per each product's Other Criteria.
- Include documentation of prior therapies, diagnostic tests, and prescriber specialty as required
- Expect typical coverage duration of 1 year unless product-specific durations differ
Note
Therapy optimization required (document guideline-based background therapy)
Document optimization of standard therapy before biologic/specialty initiation — for example, attest the patient has tried/continues GINA-recommended ICS+LABA+LAMA inhaler regimen at maximally tolerated doses prior to asthma biologics.
- Provide current inhaler regimen and attestation that it will be continued
- If guideline-recommended therapy not used, document contraindication or intolerance
Documentation Required
Submit required clinical documentation and diagnostic testing
Include required clinical documentation with the PA: diagnosis confirmation (e.g., right heart catheterization for PAH), mutation/genetic testing where specified, relevant labs (LFTs, electrolytes, CBC), and pregnancy status for females of childbearing potential.
- Attach objective test results (e.g., hemodynamic measurements, genetic/mutation reports, 24-hour UFC)
- Provide recent labs within specified timeframes (e.g., ECG/LFTs within 3 months for RECORLEV)
Denial Risk
Denial risk for missing PA clinical prerequisites
If PA clinical prerequisites or documentation are missing or incomplete, the request may be denied or the drug not covered; obtain PA and meet all specified clinical prerequisites to avoid denial.
- Confirm all Other Criteria items are included with the PA (prior therapies, labs, tests, prescriber specialty)
- Resolve any exclusion criteria before submission to reduce denial risk
Denial Risk
Off‑label weight‑management use of GLP‑1s is excluded
Requests for GLP-1 agonists for off‑label weight‑management uses are excluded and will be denied under the Medicare Part D formulary; submit PA only for FDA‑approved indications such as type 2 diabetes.
- Do not request coverage for weight‑loss indications (e.g., Ozempic, Mounjaro) under Part D
- For diabetes use, include diagnostic confirmation (A1c or glucose criteria) per product requirements
Denial Risk
Selected GLP‑1s — weight‑management use excluded (denial trigger)
Select GLP‑1 products requested for weight‑management will be denied; ensure indication is an FDA‑approved diagnosis (e.g., type 2 diabetes) before submitting PA.
- For diabetes, include lab confirmation (A1c >=6.5% or fasting glucose >=126 mg/dL) or ICD‑10 diagnosis
- Attest patient is not receiving another GLP‑1 for any condition
Denial Risk
Caplacizumab — >2 recurrences while on therapy disqualifies coverage
Do not submit PA for caplacizumab if the patient has had more than two aTTP recurrences while on caplacizumab; such requests will not be authorized.
- If not first use, include count of prior recurrences while on therapy with dates
- Confirm concomitant plasma exchange and immunosuppressive therapy per requirements
Denial Risk
Chenodiol — duration limit (no approval beyond 24 months)
Chenodiol is not authorized for use beyond 24 months due to lack of established safety; document treatment duration and plan accordingly when requesting reauthorization.
- Initial/continuation claims must not exceed cumulative 24 months
- For CHOLBAM, follow its separate reauthorization schedule (initial 3 months then 1 year)
Denial Risk
Inbrija exclusions — MAOI use and chronic lung disease trigger denial
For Inbrija, do not request PA if the patient has recent non‑selective MAOI use within 14 days or has asthma/COPD or other chronic lung disease; these are exclusion criteria that trigger denial.
- Confirm no MAOI use in prior 14 days and no chronic lung disease before submission
- Provide attestation patient experiences 'off' episodes despite carbidopa/levodopa
Documentation Required
RECORLEV — required labs/testing (UFC, ECG/QTcF, LFTs) or denial risk
For RECORLEV PA, include baseline 24‑hour urine free cortisol, ECG including QTcF, and liver function tests performed within 3 months; absence of required testing may lead to denial.
- Submit 24‑hour UFC showing >1.5x ULN when applicable
- Attach recent ECG (with QTcF) and LFT results
Denial Risk
Drug–drug interaction exclusions — verify concurrent meds to avoid denials
Coadministration with specified interacting drugs is an exclusion and will trigger denial for multiple products (e.g., coadministration with moderate/strong CYP3A inducers or inhibitors where listed).
- Review product-specific interaction exclusions and list current medications on PA
- If interacting agent is unavoidable, document rationale and any mitigation steps
Denial Risk
XOSPATA — electrolyte and interaction exclusion triggers (provide baseline K+/Mg2+)
For XOSPATA, do not submit PA when uncorrected hypokalemia or hypomagnesemia are present or when coadministered with dual strong CYP3A/P‑gp inducers; baseline potassium and magnesium must be provided.
- Include baseline serum potassium and magnesium levels with PA
- Document correction of electrolytes prior to therapy initiation
Product Lists, Dosing Identifiers and Key Clinical Thresholds
NDC / Formulary Drugs — oncology & specialtyNDCCovered
| KOSELUGO | KOSELUGO (talazoparib) |
| UDENYCA | UDENYCA (pegunigalsidase alfa) |
| UDENYCA ONBODY | UDENYCA ONBODY (pegunigalsidase alfa on-body delivery) |
| PEMAZYRE ORAL TABLET 13.5 MG | PEMAZYRE (pemigatinib) oral tablet 13.5 mg |
| PEMAZYRE ORAL TABLET 9 MG | PEMAZYRE (pemigatinib) oral tablet 9 mg |
| PEMAZYRE ORAL TABLET 4.5 MG | PEMAZYRE (pemigatinib) oral tablet 4.5 mg |
| VERQUVO ORAL TABLET 10 MG | VERQUVO (vericiguat) oral tablet 10 mg |
| VERQUVO ORAL TABLET 5 MG | VERQUVO (vericiguat) oral tablet 5 mg |
| VERQUVO ORAL TABLET 2.5 MG | VERQUVO (vericiguat) oral tablet 2.5 mg |
| ZEJULA ORAL TABLET | ZEJULA (niraparib) oral tablet |
Dosing / Formulation Identifiersmixed
| PEMAZYRE_13.5_MG_TAB | Pemazyre oral tablet 13.5 mg formulation identifier |
| PEMAZYRE_9_MG_TAB | Pemazyre oral tablet 9 mg formulation identifier |
| PEMAZYRE_4.5_MG_TAB | Pemazyre oral tablet 4.5 mg formulation identifier |
| VERQUVO_10_MG_TAB | Verquvo oral tablet 10 mg formulation identifier |
| VERQUVO_5_MG_TAB | Vericiguat oral tablet 5 mg formulation identifier |
| VERQUVO_2.5_MG_TAB | Vericiguat oral tablet 2.5 mg formulation identifier |
| ZEJULA_TAB | Zejula oral tablet formulation identifier |
| UDENYCA_ONBODY_DEVICE | Udenyca on-body delivery device identifier |
| KOSELUGO_CAP | KOSLUGO (talazoparib) capsule/tablet identifier |
Pulmonary hemodynamics (ADEMPAS — PAH / CTEPH)
Mean pulmonary arterial pressure (mPAP)> 20 mm Hg
Pulmonary arterial wedge pressure
Pulmonary arterial wedge pressure (PAWP)<= 15 mm Hg
Pulmonary vascular resistance (PAH)
Pulmonary vascular resistance (PAH)> 2 Woods units
Pulmonary vascular resistance (CTEPH)
Pulmonary vascular resistance (CTEPH)> 3 Woods units
LV outflow tract gradient — CAMZYOS
LV outflow tract gradient>= 50 mm Hg
LVEF exclusion — CAMZYOS
Left ventricular ejection fraction (LVEF) exclusionLVEF < 55% excludes initiation
Platelet count thresholds (ITP, HCV, AA, procedures)
Platelet count thresholdsITP: <30 x10^9/L (or <50 x10^9/L with increased bleeding risk); HCV-related thrombocytopenia: <75 x10^9/L; Aplastic anemia: <30 x10^9/L; Pre-procedure: follow indication-specific thresholds
Age restrictions — general
Age restrictions — specialty oncology agentsGenerally 18 years or older unless pediatric indication specified
24-hour urine free cortisol (UFC) — baseline threshold
24-hour urine free cortisol (UFC)> 1.5 x ULN (baseline) — required for RECORLEV and related agents
BMI threshold — weight-management agents
Body mass index (BMI)>= 25 kg/m2 — WEGOVY and weight-management criteria
Coverage Durations and Quantity Limits
ORIAHNN — maximum duration
Maximum durationMaximum total duration = 2 years (requests beyond 2 years will not be approved)
Reauthorization constraintUse beyond 2 years increases risk (bone loss) and is not authorized
DocumentationSubmit indication and baseline/ongoing safety labs as specified for ORIAHNN
ORILISSA (elagolix) — duration limits
ORILISSA duration by dose/conditionUp to 24 months for 150 mg daily; up to 6 months for 200 mg twice daily or for women with moderate hepatic impairment
RationaleMaximum durations limit bone loss risk; requests exceeding these limits will not be approved
DocumentationIf previously used, submit dose and number of months of prior use
nitisinone — initial then continuation
Nitisinone initial/continuationInitial authorization 6 months, then continued coverage for 1 year upon reauthorization
Required documentationSubmit objective biochemical confirmation (e.g., succinylacetone) as specified
ReauthorizationRequires documentation of clinical benefit or maintenance of prior improvement
VOQUEZNA — coverage durations
VOQUEZNA maximumUp to 32 weeks depending on indication; non‑erosive GERD: initial 4 weeks with possible reauthorization to total 24 weeks per 365 days; H. pylori: single 14‑day course
Indication-specificDuration varies by approved use — document indication and prior PPI trial failures where required
ReauthorizationAdditional weeks may be authorized per indication and attestation of medical need
VORANIGO — coverage duration
VORANIGO coverage durationCoverage duration = 6 months
Age/prescriberPer product entry: age and prescriber restrictions apply as specified in drug listing
ReauthorizationFollow product-specific reauthorization criteria
VOYDEYA — initial then continuation
VOYDEYA initial/continuationInitial authorization = 6 months; subsequent reauthorization = 1 year
Indication-specificInitial authorization requires criteria (e.g., hemolysis thresholds) and concurrent complement C5 inhibitor use
ReauthorizationRequires documentation of symptomatic or clinical improvement or maintenance
TRIKAFTA ORAL THERAPY PACK — pack identifier
TRIKAFTA therapy pack identifierTRIKAFTA ORAL THERAPY PACK (100-50-75 & 150 MG, 50-25-37.5 & 75 MG) — pack identifiers listed in formulary
Quantity limit notePack-based dispensing and quantity limits enforced per formulary listing
Prescriber restrictionPrescriber restricted to pulmonology; CFTR mutation testing required
OJEMDA — initiation age restriction
Ojemda initiation age restrictionInitiation only for patients 21 years of age or younger (will not be approved for adults unless started prior to 22)
PrescriberRestricted to oncology; genetic testing required per product labeling
Coverage durationCoverage duration = 1 year (per product entry)
Part B vs Part D and Administration Site Considerations
Billing Rule
Site‑of‑care impacts Part B vs Part D coverage determination
For site‑of‑care determinations, indicate whether medication will be self‑administered, filled at a pharmacy and delivered to the office, or administered in the home — this affects Part B vs Part D coverage pathway.
- If medication is self‑administered after training or delivered to office by patient for provider administration, Part D may apply
- If administered in the office/infusion center without pharmacy fill/delivery conditions, Part B may apply
Billing Rule
IVIG — home versus infusion center affects Part B vs Part D coverage
Indicate in the PA whether IV immune globulin will be administered in the home or at an infusion center; home administration for primary immune deficiency may qualify as a Part B benefit while other settings affect the benefit determination.
- For IVIG, document indication and site of administration (home vs infusion center)
- If home administration for primary immune deficiency, include supporting clinical rationale for Part B
Billing Rule
Document dispensing/administration pathway — office vs pharmacy affects Part B/Part D
For Part B vs Part D determination, document how medication is obtained and administered (e.g., filled at pharmacy vs stocked by provider) — obtaining at a pharmacy and delivering to the office for administration can shift coverage to Part D.
- State whether the provider will obtain the drug from pharmacy or supply it from office inventory
- If pharmacy fill and patient delivery to office is planned, include that arrangement in the PA
Billing Rule
Specify administration/dispensing setting (office | infusion center | pharmacy)
Provide a clear description of whether the drug will be (a) administered in office/infusion center, (b) self‑administered after training, or (c) dispensed from pharmacy to the office — coverage may be Part B or Part D depending on these arrangements.
- For each PA, state the intended administration site and who will perform administration
- Attach any agreements for pharmacy fill and office delivery if applicable
Billing Rule
Document pharmacy fill + patient delivery to office for Part D determination
If provider intends to have medication filled at a pharmacy and delivered to the office by the patient for provider administration, document this arrangement in the PA; absence of this may result in Part B coverage instead of Part D.
- Include attestation that the provider will accept pharmacy‑filled supply delivered by the patient
- If provider will not accept pharmacy delivery, indicate office will supply medication and note potential Part B coverage
Key Definitions and Clinical Thresholds
WHO Group (pulmonary hypertension)
WHO Group classificationWHO Group (pulmonary hypertension) used to define indication (e.g., PAH = Group 1, CTEPH = Group 4)
Use in criteriaRequired to accompany right heart catheterization data for PAH/CTEPH requests
DocumentationSubmit WHO Group classification with hemodynamic measurements
TB screening
TB screeningBaseline latent tuberculosis screening (PPD or IGRA) required prior to initiation for most biologic/targeted agents (except Otezla and Velsipity)
Positive result handlingIf TB test positive, coverage delayed until latent TB is treated; annual TB screening/chest X‑ray required for ongoing exposure risk
ScopeApplies to group of biologic/targeted agents managed by this policy
Cholestasis definition
Cholestasis definitionOne of: total serum bile acid > age‑adjusted ULN; increased conjugated bilirubin; GGT > age‑adjusted ULN; fat‑soluble vitamin deficiency; or intractable pruritus attributable to liver disease
UseRequired documentation element for BYLVAY and bile‑acid disorder entries
AttestationProvider must attest drug‑induced pruritus has been ruled out
Eosinophilic esophagitis biopsy threshold
Eosinophilic esophagitis biopsy threshold>= 15 eosinophils per high‑power field (or 60 eos/mm2) on upper endoscopy biopsy
Symptom requirementPlus documentation of symptoms (dysphagia, food impaction, reflux, chest/abdominal pain, nausea/vomiting)
UseRequired for Dupixent and related EoE authorization requests
Mutation testing
Mutation/tumor testingSubmission of genetic or tumor testing confirming required actionable mutation (examples: EGFR exon 19/21, KRAS G12C, HR+/HER2‑, etc.)
ExamplesUsed across oncology agents (e.g., KOMZIFTI, KRAZATI, LUMAKRAS) to confirm eligibility
DocumentationAttach laboratory/pathology or molecular testing report with prior therapy history when required
Child‑Pugh score
Child‑Pugh scoreUsed to assess hepatic impairment; required for drugs with hepatic impairment exclusions (submit score or LFTs)
Use caseDrugs excluding moderate/severe hepatic impairment require Child‑Pugh classification or LFT submission
DocumentationProvide Child‑Pugh score at baseline and when requested for reauthorization
High‑intensity statin therapy
High‑intensity statin therapyAt least 8 weeks of high‑intensity statin regimen required prior to REPATHA consideration to attempt LDL <70 mg/dL
AlternativesDocument statin intolerance, rhabdomyolysis, or inability to achieve LDL goal despite therapy where applicable
DocumentationSubmit duration and type of statin therapy used prior to PA request
Initial therapy rules cross‑reference
Cross‑reference guidanceInitial therapy and diagnostic definitions map to product-specific criteria; use definition terms when completing required documentation
ApplicationRefer to product Other Criteria for how definitions (e.g., TB screening, cholestasis, mutation testing) apply to each authorization
Documentation tipInclude specific test results and dates to avoid denials for missing required documentation
Policy Scope and Background
Background: This document enumerates prior authorization clinical requirements that determine Medicare Part D coverage for specialty and targeted drugs on Independent Health’s 2026 Medicare Advantage C‑SNP Part D formulary. It summarizes the clinical prerequisites, exclusion criteria, required medical documentation (laboratory, genetic, imaging, procedural or functional measures), prescriber specialty restrictions, step‑therapy requirements, and typical coverage durations that guide authorization decisions.
The policy emphasizes that prior authorization is required for the listed drugs and that coverage is contingent on meeting the drug‑specific clinical criteria and providing the documentation specified for each product; where applicable, site‑of‑care/Part B vs Part D determinations are also addressed.
Document History
2026-01-14policy_effectiveLatest
Policy effective date for the Independent Health Medicare Advantage C-SNP Part D prior authorization criteria document.
2026-01-01index_publication
Index of drugs and therapy packs published/updated for the 2026 formulary year (index entries reference TRIKAFTA, WEGOVY, XIFAXAN, XPOVIO and others).
2025-12-31document_indexed
Comprehensive index assembled listing therapy packs and product entries (e.g., TRIKAFTA therapy packs and multiple specialty agents) for inclusion in the policy document.
Policy Summary
PayerIndependent Health
PolicyMedicare Advantage Part D Prior Authorization Criteria (Formulary Drugs)
Policy CodePolicy N/A
Change TypeTechnical / annual refresh
Effective DateJan 14, 2026
Next Review DateN/A
Key ActionObtain prior authorization (PA) and submit required diagnostic documentation, prior therapy trials, and prescriber specialty attestation for formulary specialty drugs.
SourceLink
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