Prior Authorization Criteria for Medicare Part D Formulary Drugs
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Lists prior authorization (PA) requirements for drugs on Independent Health's 2026 Medicare Advantage Part D formulary; applies to providers and pharmacists seeking coverage for listed medications for Medicare members.
No material clinical or coverage changes in this revision.
Coverage Criteria and Drug-Specific Authorization Rules
Biologic/immunomodulatory drugs — initial authorization
Covered when ALL of the following are met for biologic/immunomodulatory drugs (except Otezla and Velsipity):
Applies to all drugs managed by this biologic/immunomodulatory group except Otezla and Velsipity; annual TB screening or chest X‑ray may be required for ongoing therapy in patients at risk.
Pulmonary hypertension (PAH) — initial authorization
Covered when ALL of the following are met for pulmonary hypertension agents (example: ADEMPAS):
Prescriber restricted to cardiology or pulmonology; age ≥18; coverage duration 1 year.
ARIKAYCE — initial authorization
Covered when ALL of the following are met for ARIKAYCE (MAC lung disease):
Coverage duration 1 year; ARIKAYCE is not covered for non‑refractory MAC disease.
Caplacizumab — initial authorization
Covered when ALL of the following are met
Prescriber restricted to cardiology, hematology, or immunology; coverage duration 3 months.
Mavacamten (CAMZYOS) — initial authorization
Covered when ALL of the following are met
Prescriber restricted to cardiology; coverage duration 1 year.
CFTR modulators — initial authorization
Covered when ALL of the following are met
Prescriber restricted to pulmonology; coverage duration 1 year; mutation‑specific requirements apply per product (e.g., ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor, elexacaftor/tezacaftor/ivacaftor).
Emgality — migraine
Covered when ALL of the following are met
Initial prevention authorization 3 months then 1 year; acute migraine initial authorization 1 year; first reauthorization for prevention requires on‑treatment headache days demonstrating improvement.
Dupilumab — indication-specific criteria
Covered when ALL of the following are met (indication-specific criteria apply)
dupilumab_general
- AD: Atopic dermatitis: objective documentation of ≥10% body surface area involvement AND trial and inadequate response or contraindication to at least a moderate‑strength topical corticosteroid for ≥4 weeks (or documentation why topical steroid is not advisable).4 weeks
- Asthma: pre‑bronchodilator FEV1 <80% predicted (adults) or <90% (children) AND either blood eosinophils ≥150 cells/mcL within 6 weeks OR documentation that patient requires daily oral corticosteroid for control; patient must be on GINA‑recommended regimen (maximally‑tolerated ICS + LABA + LAMA) prior to biologic and provider must attest therapy will continue after starting dupilumab.FEV1 and eosinophil thresholds per node
Reauthorization requires continued background therapy and evidence of benefit.
- COPD: post‑bronchodilator FEV1/FVC <0.7 and post‑bronchodilator FEV1 30–80% predicted AND blood eosinophils ≥300 cells/mcL within 6 weeks AND symptomatic disease defined by mMRC ≥2 OR CAT ≥10; must be on stable ICS+LABA+LAMA for ≥90 days pre‑initiation and provider must attest therapy will continue.>=90 days; mMRC >=2 OR CAT >=10
Reauthorization requires maintenance of benefit and continued triple therapy.
- CRSwNP: Chronic rhinosinusitis with nasal polyps: evidence of nasal polyps and symptomatic nasal congestion AND trial of intranasal corticosteroid for ≥2 months (or contraindication) with provider attestation intranasal steroid will continue after starting dupilumab.2 months
Reauthorization requires documentation of clinical benefit or maintenance.
- EoE: Eosinophilic esophagitis: upper endoscopy with biopsy showing ≥15 eos/hpf or 60 eos/mm2 AND documentation of signs/symptoms (e.g., dysphagia) AND failure of an 8‑week PPI trial.>=15 eos/hpf; failed 8‑week PPI
Reauthorization requires documentation of clinical benefit.
- PN: Prurigo nodularis: pruritus ≥6 weeks and presence of multiple pruriginous firm nodular lesions with documentation of prior therapies tried; reauthorization requires documentation of clinical benefit.6 weeks
DOPTELET — indications and requirements
Covered when ALL of the following are met
Prescriber specialties limited to gastroenterology, hematology, hepatology, surgery; coverage duration varies by indication.
Initial authorization — Atopic dermatitis (AD)
Covered when ALL of the following are met for indication-specific initial authorization (examples provided):
Provider must document prior topical therapy or contraindication.
Initial authorization — Asthma
Covered when ALL of the following are met for asthma initial authorization:
Provider attestation required; reauthorization requires documentation of clinical benefit or maintenance.
Initial authorization — COPD
Covered when ALL of the following are met for COPD initial authorization:
Both medication stability and symptom threshold required; prescriber specialty as listed per product.
Initial authorization — CRSwNP
Covered when ALL of the following are met for chronic rhinosinusitis with nasal polyps (CRSwNP) initial authorization:
Prescriber specialty restrictions apply; reauthorization requires documentation of clinical benefit or maintenance.
Reauthorization criteria
For reauthorization of chronic conditions (examples):
Required at each reauthorization; prescriber must submit objective measures per product guidance.
Required at each reauthorization.
Required at each reauthorization.
Required at each reauthorization.
Eltrombopag (examples)
Covered when ALL of the following are met for eltrombopag indications (examples):
Initial authorization 12 weeks then 1 year; prescriber specialties restricted to gastroenterology/hematology/hepatology/infectious disease as applicable.
Coverage duration 1 year.
Coverage duration 6 months as specified.
Eosinophilic esophagitis
Covered when ALL of the following are met for eosinophilic esophagitis:
Age ≥11 years; coverage duration 12 weeks with a maximum of one 12‑week course per 365 days.
ALK-positive oncology agents
Covered when ALL of the following are met for ALK-positive oncology agent initial authorization:
Prescriber restricted to oncology; age ≥18; exclusion criteria (e.g., severe hepatic impairment, interacting drugs) absent.
FILSPARI — primary IgA nephropathy
Covered when ALL of the following are met for FILSPARI (IgA nephropathy):
Prescriber restricted to immunology or nephrology; annual reauthorization requires documentation of response (stabilization or improvement of UPCR); coverage duration 1 year.
Oncology prior therapy requirements
Covered when ALL of the following are met for specified oncology agents:
Prescriber restricted to oncology; age ≥18; coverage duration 1 year.
Prescriber restricted to oncology; age ≥18; coverage duration 1 year.
Product-specific authorization criteria (summary)
Covered when ALL of the following product-specific conditions are met (per product):
Product‑specific prior therapy, laboratory, or mutation requirements must also be met as detailed in each product entry.
LENVIMA coverage criteria
Covered when PA criteria for the specific drug are satisfied with required documentation and absence of exclusions
Adhere to product exclusions such as pregnancy; prior therapy prerequisites apply per indication.
LYNPARZA coverage criteria
LYNPARZA coverage requires specific genetic testing and prior therapy attestations depending on indication
Genetic/tumor testing must be submitted per indication.
NUCALA coverage criteria (asthma, CRSwNP, EGPA, HES)
NUCALA covered when clinical and laboratory criteria are met for the specific eosinophilic conditions
LORBRENA coverage criteria
Covered when PA criteria for the specific drug are satisfied with required documentation and absence of exclusions
Adhere to product‑specific exclusions and prior therapy requirements where applicable.
Example: Nuedexta initial and reauthorization criteria
Covered when ALL of the following are met for drugs with QT risk (example: NUEDEXTA):
Coverage duration 1 year; annual reauthorization requires updated potassium/magnesium and documentation of symptomatic or maintained improvement.
Targeted oncology therapy criteria
Covered for targeted oncology agents when ALL of the following apply:
Coverage duration generally 1 year; product‑specific testing and prior therapy requirements must be provided.
Prolastin-C criteria
Covered for Prolastin-C when ALL of the following are met:
Reauthorization requires confirmation of symptomatic or clinical improvement or maintenance; Part B vs Part D determination may apply depending on administration setting; coverage duration 1 year.
Pulmonary arterial hypertension agents - initial authorization
Covered when ALL of the following are met (example: pulmonary arterial hypertension agents)
Coverage duration 1 year; includes product‑specific hepatic/renal exclusions as applicable.
Cushing's syndrome agents - initial and reauthorization
Covered when ALL of the following are met (example: agents for Cushing's syndrome)
Coverage duration 1 year; exclusion for baseline AST/ALT >3× ULN or prolonged QTcF >470 msec; reauthorization requires documentation of clinically relevant response or maintenance.
Oncology targeted therapies - diagnostic confirmation required
Covered when ALL of the following are met (oncology targeted therapies)
Excludes uncontrolled hypertension and coadministration with moderate/strong CYP3A inducers where specified.
Excludes coadministration with moderate/strong CYP3A inducers or QT‑prolonging drugs as specified.
PCSK9 inhibitors - Repatha
Covered when ALL of the following are met (PCSK9 inhibitors example)
Coverage duration 1 year; prior therapy documentation required per indication.
Reauthorization and monitoring requirements
Reauthorization requires demonstration of ongoing benefit for several agents
Applies to agents treating fibrosis/NASH per product entry.
Prescriber restricted to endocrinology.
Drug-specific medical necessity requirements (aggregate)
Covered when all specified drug-specific requirements are met (diagnosis, required testing, prescriber restriction, and absence of listed exclusions).
Apply product‑level details found in each product’s section (chunks referenced).
Teriparatide criteria
Teriparatide (subcutaneous pen-injector) initial and reauthorization criteria
Coverage typically limited to 2 years; annual reauthorization beyond 2 years requires updated serum calcium and evidence patient remains at high fracture risk.
See product guidance.
Tolvaptan (ADPKD vs hyponatremia)
Tolvaptan coverage differs by indication
Coverage duration 1 year; ADPKD formulation subject to REMS/distribution program as applicable.
Treatment limited to 30 days to reduce risk of liver injury.
Targeted oncology agents
Targeted oncology agents require mutation confirmation and prior therapy documentation where applicable
Product‑specific prior therapy documentation required.
Product‑specific exclusions and interaction cautions apply.
Prescriber restricted to hematology/oncology; coverage duration 1 year.
Primary IgA nephropathy - Initial Authorization
Covered when ALL of the following are met for primary IgA nephropathy:
Annual reauthorization requires documentation of stabilization or improvement of UPCR.
Verquvo (vericiguat) - Initial Authorization
Covered when ALL of the following are met for vericiguat in HFrEF:
Prescriber restriction to cardiology typically applies; documentation of prior therapies required.
Coverage duration 1 year.
Rifaximin (Xifaxan) - Indication-specific criteria
Rifaximin coverage by indication:
Prescriber restricted to gastroenterology/hepatology.
Prescriber restricted to gastroenterology/hepatology.
Prescriber restricted to gastroenterology/hepatology.
Vitrakvi (larotrectinib) - Coverage criteria
TRK inhibitor coverage (Vitrakvi):
Prescriber restricted to oncology; coverage duration 1 year.
Multiple myeloma — prior therapy criteria
Products with specified prior therapy and documentation requirements are covered when ALL of the following are met:
Prescriber restricted to hematology/oncology; coverage duration 1 year.
Ovarian cancer — platinum response and BRCA testing
Oncology product coverage when ALL of the following are met:
Prescriber restricted to oncology; coverage duration 1 year.
Postpartum depression — limited duration
Products with short-course limits or postpartum indications:
Coadministration exclusions (e.g., strong CYP3A4 inducers) must be absent.
Reauthorization monitoring
Monitoring and reauthorization requirements:
Prescriber and lab submissions per product guidance required.
Coverage for Besremi will be excluded when the patient has a history or current presence of serious psychiatric conditions or other listed high-risk comorbidities. Specifically, approvals are not permitted for patients with severe active central nervous system lupus or those currently receiving other biologic therapies or intravenous cyclophosphamide. Coverage also excludes patients with moderate to severe hepatic impairment (Child-Pugh B or C), immunosuppressed transplant recipients, unstable cardiovascular disease, recent stroke or myocardial infarction within 6 months, and severe renal impairment. Providers must submit the diagnosis and current therapies; annual reauthorization requires confirmation the patient remains on some form of standard therapy unless contraindicated.
Ayvakit (avapritinib) is excluded when given with moderate or strong CYP3A inducers or strong CYP3A inhibitors. For advanced or indolent systemic mastocytosis, requests are excluded if the patient’s platelet count is 50 x 10^9/L. Prior to approval, providers must submit the diagnosis and pregnancy status for females of childbearing potential; for GIST indications a PDGFRA exon 18 mutation test result is required. Age and prescriber limits apply (age ≥18; prescribers restricted to allergy, hematology, immunology, and oncology).
CABOMETYX and similar targeted kinase agents list severe hepatic impairment and uncontrolled hypertension among exclusion criteria. Product-specific exclusions vary but commonly include significant liver dysfunction and clinically unstable cardiovascular conditions; providers must submit baseline blood pressure and pregnancy status where applicable and confirm prior therapies as required by the specific product entry.
Several agents with known QT-prolonging potential are exclusionary for patients with congenital long QT syndrome, history of torsades de pointes, or elevated QT intervals at baseline. For example, CAPRELSA-related entries exclude congenital long QT syndrome and torsades; other oncology agents require a baseline QTcF threshold (commonly >450 msec or other drug-specific thresholds) to be absent before approval. Submission of ECG/QTcF and electrolyte levels is required when QT risk is present.
Use of GLP-1 receptor agonists for the purpose of weight management is excluded from coverage. The policy explicitly states these products will not be approved for off-label weight management under Medicare Part D; approvals are limited to FDA‑approved indications with required diagnostic documentation.
Requests for prophylactic hereditary angioedema (HAE) therapy are excluded in certain circumstances per product-specific language. For HAE therapies, the policy distinguishes prophylactic versus acute treatment and requires objective documentation that prophylactic therapy is medically necessary (disease activity, attack frequency, and impact on quality of life) before authorizing prophylactic use.
Pregnancy is an explicit exclusion for select agents. The policy lists pregnancy as an exclusionary condition for products such as ERIVEDGE; providers must submit pregnancy status for females of childbearing potential and coverage will not be authorized when pregnancy is present.
Product Codes, Numeric Thresholds, and Key Clinical Metrics
| 50-75 & 150 MG, 50-25-37.5 & 75 MG | TRIKAFTA ORAL THERAPY PACK |
| 140 MG/ML, 70 MG/ML | AIMOVIG SUBCUTANEOUS SOLUTION AUTOINJECTOR |
| 300 MG DOSE | EMGALITY 300 MG DOSE |
| LENVIMA (4 MG DAILY DOSE) | LENVIMA product/dose listed |
| LENVIMA (8 MG DAILY DOSE) | LENVIMA product/dose listed |
| LENVIMA (10 MG DAILY DOSE) | LENVIMA product/dose listed |
| LENVIMA (12 MG DAILY DOSE) | LENVIMA product/dose listed |
| LENVIMA (14 MG DAILY DOSE) | LENVIMA product/dose listed |
| LENVIMA (18 MG DAILY DOSE) | LENVIMA product/dose listed |
| LENVIMA (20 MG DAILY DOSE) | LENVIMA product/dose listed |
| LENVIMA (24 MG DAILY DOSE) | LENVIMA product/dose listed |
| LORBRENA ORAL TABLET 100 MG | LORBRENA 100 mg tablet |
| LORBRENA ORAL TABLET 25 MG | LORBRENA 25 mg tablet |
| LYTGOBI (12 MG DAILY DOSE) | LYTGOBI product/dose |
| LYTGOBI (16 MG DAILY DOSE) | LYTGOBI product/dose |
| LYTGOBI (20 MG DAILY DOSE) | LYTGOBI product/dose |
| No codes listed |
| No codes listed |
Prior Authorization, Documentation, Step Therapy, and Denial Triggers
Authorization requirement
Prior authorization is required for certain Medicare Advantage Part D formulary drugs; listed drugs are marked 'PA' on the formulary. Failure to obtain prior authorization may result in the drug not being covered.
- Drugs on the Independent Health Medicare Advantage Part D formulary marked 'PA' require prior authorization.
- Contact Medicare Member Services at 1-800-665-1502 (TTY 711) with questions.
Biologic group prior authorization and TB screening
Drugs in the biologic/immunomodulatory group generally require baseline latent tuberculosis (PPD or IGRA) screening (except Otezla and Velsipity) and initial authorization commonly requires failure or intolerance to at least two preferred agents as specified.
- Baseline TB screening (PPD or IGRA) required for biologic group except Otezla and Velsipity.
- Initial authorization usually requires trial/failure or intolerance to ≥2 preferred agents (e.g., adalimumab biosimilar, Cosentyx, Enbrel, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz) where applicable.
- If TB test is positive, coverage may be delayed until latent TB is treated; annual re‑screening or chest X‑ray may be required for ongoing therapy if exposure risk exists.
Caplacizumab prior authorization and recurrence limit
Caplacizumab prior authorization requires documentation of diagnosis and treatment context; use limits apply for recurrences.
- Submit diagnosis of covered use and confirmation drug will be given with plasma exchange and immunosuppressive therapy.
- If request is not for first use, submit previous aTTP recurrences while on caplacizumab.
- Coverage will not be authorized if the patient has had more than 2 recurrences of aTTP while on therapy.
- Coverage Duration: 3 months.
CFTR modulators prior authorization and required mutation testing
CFTR modulator (ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor, elexacaftor/tezacaftor/ivacaftor) prior authorization requires confirmatory CFTR mutation testing per prescribing information.
- Submit cystic fibrosis mutation test confirming presence of CFTR gene mutations appropriate for the requested drug: e.g., ivacaftor‑responsive mutation per PI for Kalydeco; F508del homozygous for Orkambi; responsive mutations per PI or in vitro data for Symdeko/Trikafta.
- Prescriber restriction: pulmonology.
- Coverage Duration: 1 year.
PA requires diagnosis, prior therapy, and attestation
Prior authorization requests must include diagnosis, prior therapy history, and prescriber attestation of concomitant or continued standard therapies when required.
- Document the diagnosis of covered use and submit current or prior therapies used to treat the condition where required.
- Provider attestation that background or concomitant standard-of-care therapies will be continued after initiation of the requested agent (e.g., ICS‑LABA‑LAMA for COPD, triple inhaler regimen for asthma) when applicable.
- Missing prior therapy or lab documentation is a common denial trigger.
Authorization and prior therapy requirements for oncology/specialty agents
Certain oncology and specialty agents require prerequisite therapy or prior targeted agents before approval; documentation of mutation testing or prior lines of therapy is frequently required.
- Examples: ICLUSIG requests require documentation of T315I mutation status or resistance/intolerance to ≥2 prior kinase inhibitors for CP‑CML (non‑T315I).
- GAVRETO and similar agents require tumor ROS1 or NTRK testing as applicable.
- Many agents require documented failure/intolerance to specific prior therapies (e.g., crizotinib or entrectinib before GAVRETO; prior VEGFR inhibitor for FILSPARI).
- Prescriber specialty restrictions often apply (oncology, hematology).
IMBRUVICA — prior authorization and hepatic/interaction exclusions
IMBRUVICA prior authorization requires hepatic assessment and prior therapy documentation for some indications; several cardiac and drug interaction exclusions apply.
- Submit diagnosis and liver function testing or Child‑Pugh score; pregnancy status for females of childbearing potential.
- For chronic graft‑versus‑host disease, document treatment failure with another systemic immunosuppressive agent.
- Exclusions: severe hepatic impairment (Child‑Pugh class C) and coadministration with strong CYP3A inducers.
- Prescriber restriction: hematology, oncology, transplant specialties.
ICLUSIG — prior authorization and interaction/exclusion triggers
ICLUSIG prior authorization requires mutation testing, blood pressure monitoring, and exclusion of newly diagnosed CP‑CML without appropriate prior therapy; drug interaction and cardiovascular exclusions apply.
- Submit diagnosis and documentation of T315I mutation status (present or absent).
- Provide baseline blood pressure reading and pregnancy status for females of childbearing potential.
- Exclusions: newly diagnosed CP‑CML, uncontrolled hypertension.
- For non‑T315I CP‑CML, document resistance or intolerance to at least two prior kinase inhibitors.
- Prescriber restriction: hematology and oncology.
LENVIMA — prior authorization and required documentation
LENVIMA prior authorization requires documentation of diagnosis, baseline vitals/labs, pregnancy status, and indication‑specific prior therapies or coadministration attestations.
- Submit diagnosis, baseline blood pressure, and pregnancy status for females of childbearing potential.
- For thyroid cancer: attest radioactive iodine‑refractory or ineligible.
- For renal cell carcinoma: attest coadministration with pembrolizumab or everolimus; if with everolimus, submit prior anti‑angiogenic therapy tried and failed.
- Exclusions include uncorrected electrolyte abnormalities and uncontrolled hypertension.
- Prescriber restriction: oncology. Coverage Duration: 1 year.
Part B vs Part D coverage determination
Part B vs Part D coverage depends on intended use and administration setting; provide documentation about how the drug will be used and whether it will be self‑administered or administered in a provider setting.
- If medication will be self‑administered after training or the provider agrees to have it filled at a pharmacy and delivered to the office by the patient for provider administration, it may be covered under Part D; otherwise it may be covered under Part B.
- Include a description of how the drug will be used/obtained to determine Part B vs Part D coverage.
PA and reauthorization requirements
Reauthorization criteria commonly require evidence of clinical benefit or maintenance of previously achieved benefit and ongoing documentation of required background therapies and monitoring.
- Reauthorization frequently requires documentation of symptomatic or clinical improvement (or maintenance of prior improvement), objective measures (e.g., labs, FEV1, exacerbation rates), or ongoing use of required background therapy.
- Examples: dupilumab reauthorization requires continued use of background therapies and demonstration of benefit for asthma/COPD; QINLOCK reauthorization requires clinically relevant response in 24‑hour UFC for Cushing's syndrome.
Prior authorization and coverage duration
Prior authorizations typically specify a coverage duration (commonly 1 year) though some products have different limits (e.g., 12 weeks, 3 months, 30 days).
- Common coverage duration for specialty drugs: 1 year.
- Exceptions: HCV regimens often 12 weeks; caplacizumab coverage duration 3 months; tolvaptan for hyponatremia limited to 30 days to limit liver injury.
- Document duration on the PA request and monitor reauthorization timing.
Tolvaptan (hyponatremia) PA rules
Tolvaptan for clinically significant hyponatremia requires initiation in a monitored setting, short‑term use only, and specific laboratory documentation to support the indication.
- Submit evidence of clinically significant hyponatremia: serum sodium <125 mEq/L or symptomatic serum sodium <135 mEq/L resistant to fluid restriction.
- Treatment must be initiated in a setting where serum sodium can be closely monitored.
- Coverage is limited to 30 days to prevent liver injury; this formulation is not approved for ADPKD under this policy.
General prior authorization requirements
General prior authorization requirements: submit diagnosis, relevant baseline labs, pregnancy status for females of childbearing potential, prescriber specialty, and prior therapy history when applicable.
- Common baseline labs: liver function tests/Child‑Pugh, serum transaminases, bilirubin, ALP, CBC with differential, serum potassium and magnesium, ECG/QTc (or QTcF) when QT‑prolonging risk exists.
- Provide pregnancy status for females of childbearing potential.
- Attach documentation of prior therapies and line/step therapy trials when required; missing labs or prior therapy documentation can trigger denial.
Verquvo prior authorization requirements
Verquvo (vericiguat) prior authorization requires documentation of recent HF hospitalization or IV diuretic use, reduced LVEF, and prior therapies for HFrEF.
- Submit diagnosis including either hospitalization for HFrEF within previous 6 months or outpatient IV diuretic use within previous 3 months.
- Provide left ventricular ejection fraction (<45%) and pregnancy status for females of childbearing potential.
- Submit current or previous therapies used to treat HFrEF; prescriber restriction: cardiology.
Exclusion criteria and denial triggers (drug interactions, hepatic, cardiac, electrolyte, pregnancy, cosmetic)
Certain products have specific exclusion triggers such as drug interactions, hepatic impairment, QT prolongation risk, electrolyte abnormalities, pregnancy, or age limits; presence of exclusions may result in denial.
- Drug interaction exclusions: examples include prohibition of moderate/strong CYP3A inhibitors/inducers with ICLUSIG, GAVRETO, VANFLYTA, and others; proton pump inhibitors/H2 antagonists exclude some agents (e.g., certain TKIs).
- Hepatic exclusions: severe hepatic impairment (Child‑Pugh C) excludes many agents (IMBRUVICA, Trikafta severe hepatic impairment, others).
- Cardiac/QT exclusions: baseline QTc >450–470 msec depending on product, congenital long QT, history of torsades de pointes; require baseline ECG/QTcF and electrolytes (K+, Mg2+).
- Electrolyte and hematologic exclusions: uncorrected hypokalemia/hypomagnesemia, neutropenia thresholds, platelet/ANC minima for some therapies.
- Pregnancy and reproductive status: many agents require pregnancy status; teratogenic agents require negative pregnancy testing and counseling.
- Age and indication‑specific exclusions may apply; cosmetic uses (e.g., topical retinoids for cosmetic indications) are excluded.
Required diagnostic and laboratory documentation; missing tests cause denials
Submit required diagnostic testing and objective disease measures when indicated (genetic/tumor testing, pulmonary hemodynamics, microbiology, ECGs, and key labs). Missing required tests is a frequent cause for denial.
- PAH: submit right heart catheterization results, WHO Group classification, mean pulmonary arterial pressure >20 mm Hg, PAWP ≤15 mm Hg, PVR thresholds, creatinine clearance, and pregnancy status.
- MAC lung disease (e.g., ARIKAYCE): document multi‑drug MAC regimen tried and failed for ≥6 months and positive sputum culture obtained after treatment.
- Cardiac/QT‑risk drugs: submit ECG/QTcF, serum potassium, and serum magnesium.
- Oncology/targeted therapies: submit tumor mutation testing (ALK, ROS1, NTRK, BRCA, IDH2, FGFR, RET, etc.) and prior lines/agents used.
- Dupilumab: submit diagnosis and current background therapy and provider attestation that background therapy will continue where required.
Prior therapy, step therapy, and course limits
Some drugs and indications require specific prerequisite or step therapy trials and documented failure/intolerance to alternative agents before approval; ensure documentation of duration and outcome of prior trials.
- Examples: AUVELITY requires failure of standard therapies prior to approval; Opsumit initial authorization requires prior failure/intolerance to ambrisentan or bosentan.
- PCSK9 inhibitors (Repatha) typically require ≥8 weeks of high‑intensity statin therapy with inadequate LDL response, or documented statin intolerance or rhabdomyolysis.
- Oncology agents frequently require prior chemotherapy lines or specific prior targeted therapy as detailed per drug entry.
- Document trial durations (e.g., MAC regimen ≥6 months) and reasons for discontinuation (intolerance, lack of efficacy).
Initial Authorization / Step Therapy Requirements
| Requirement | Example documentation |
|---|---|
| Documentation that patient has used prior statin therapy (or current statin use unless contraindicated) | Medication history showing statin name, dose, duration; evidence of intolerance or inadequate LDL response |
| If applicable, documentation of prior statin trials including at least one hydrophilic statin previously tried and failed | Clinical notes or lab results showing LDL levels before and after statin therapy or notes explaining intolerance (e.g., rhabdomyolysis) |
| Required before initial authorization of CAMZYOS | Documentation/examples |
|---|---|
| Trial and inadequate response or intolerance to both a beta-blocker and a non‑DHP calcium channel blocker | Provider attestation that both classes were tried and patient had inadequate response or intolerance |
| Clinical medication list showing agents, doses, and treatment dates for beta‑blocker and non‑DHP CCB trials | Cardiology evaluation documenting persistent NYHA II–III symptoms despite trials; echocardiogram or hemodynamic data confirming LVOT gradient and LV wall thickness per criteria |
| Emgality prevention step | Example documentation |
|---|---|
| Trial and inadequate response or intolerance to Aimovig (erenumab) prior to Emgality for migraine prevention | Statement that Aimovig was tried and failed or was contraindicated |
| Medication history showing Aimovig prescription dates and reason for discontinuation (lack of efficacy or adverse events) | Baseline headache days per month from chart and documentation of lack of improvement on Aimovig |
Reauthorization and Monitoring Requirements
Step and Failure Requirements
| Step therapy — prior trials required | Documentation/examples |
|---|---|
| For ITP: documentation of failure of at least two ITP therapies from different classes prior to DOPTELET (e.g., systemic corticosteroids, IVIG, danazol, fostamatinib, cytotoxics/immunosuppressants) | Submission of current platelet counts meeting threshold criteria per indication |
| Medication records showing prior ITP therapies tried, dates, doses, and reasons for discontinuation or lack of efficacy | Laboratory results showing platelet counts before and after prior therapies and at time of request |
| Step therapy — CAMZYOS prerequisite | Documentation/examples |
|---|---|
| Trial and inadequate response or intolerance to both a beta‑blocker and a non‑DHP calcium channel blocker prior to mavacamten initiation | Provider attestation that both classes were used and were ineffective or not tolerated |
| Medication history listing specific beta‑blocker and non‑DHP CCB agents, doses, treatment duration, and reason for discontinuation | Cardiology assessment documenting symptomatic NYHA II–III status and supporting echocardiographic measurements (LVOT gradient, LV wall thickness) per CAMZYOS criteria |
| Emgality step requirement — migraine prevention | Required documentation |
|---|---|
| Documentation Aimovig (erenumab) was tried and had inadequate response before Emgality for prevention | If Aimovig contraindicated, clinical rationale for contraindication must be provided |
| Medication history showing Aimovig treatment dates and clinical response; headache diary or charted headache days per month pre‑ and on‑therapy | For first reauthorization: on‑treatment headache days demonstrating improvement from baseline |
| DOPTELET step requirement — ITP prior trials | Required documentation examples |
|---|---|
| Failure of at least two ITP therapies from different classes before initial DOPTELET authorization | Platelet count meeting ITP threshold (<30 x10^9/L or <50 x10^9/L with symptomatic bleeding) documented |
| Records of prior ITP therapies with dates, doses, and reasons for failure/intolerance (e.g., corticosteroids, IVIG, rituximab) | Platelet count lab reports before and after prior therapies and at request time; splenectomy status if applicable |
| Oncology & specialty agents — prior trials/failures | Documentation/examples |
|---|---|
| Documentation of trials and failures or intolerances to specified prior agents or classes as listed in each product section (e.g., prior VEGFR inhibitors, prior chemotherapy regimens, prior ALK/ROS1 inhibitors) | Attestation that listed prior therapies were tried and failed or were contraindicated/intolerable |
| Oncology med history with regimen names, dates, responses, and reason for discontinuation; pathology/genetic testing confirming target (e.g., ROS1, ALK) | Relevant labs and safety data (e.g., baseline BP, LFTs, Child‑Pugh score) when required per product |
| Generic step examples — documentation to include | Examples of acceptable evidence |
|---|---|
| Document prior therapies tried and the specific reason for failure or intolerance where required by policy | Include medication names, doses, start/stop dates, and clinical rationale for switching or stopping therapy |
| Laboratory data, imaging, or specialist notes supporting lack of efficacy or intolerance (e.g., LDL levels, liver tests, blood counts, ECGs) | For biologics: documentation of trials of preferred on‑formulary alternatives and TB screening or other baseline tests where required |
Course Limits and Quantity Restrictions
Administration Site, Part B vs Part D, and Initiation Requirements
Policy Background and Scope
This document enumerates the clinical and administrative prerequisites required to obtain prior authorization for prescription drugs on Independent Health’s Medicare Advantage Part D formulary. It summarizes product-specific coverage rules, required diagnostic or laboratory documentation, prescriber restrictions, age limits, prerequisite therapy or step‑therapy requirements, and exclusions (for example, pregnancy, severe hepatic impairment, certain drug–drug interactions, or specified QT/electrolyte abnormalities). Providers must submit the requested objective test results and attestations (e.g., pregnancy status, baseline labs, prior therapy trials, right‑heart catheterization data for PAH, CFTR mutation testing for CFTR modulators, or biopsy results where indicated) when filing a PA; failure to obtain PA or to provide required documentation may result in denial.
Clinical Definitions and Thresholds
Document Updates
Policy effective date updated to 2026-01-14 for the Independent Health Medicare Advantage Part D prior authorization index and criteria.
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