2026 Medicare Part D Prior Authorization Requirements — Part D prior authorization and coverage criteria
Customize your policy alerts
Sign up for all HealthPartners policy alerts
Know when HealthPartners releases new policies or updates existing guidance.
Monitor payer policy activity
Rules governing prior authorization, coverage criteria, exclusions, and required documentation for multiple Part D drugs on the HealthPartners Part D formulary effective March 1, 2026; applies to Medicare Part D claims under HealthPartners.
No material clinical or coverage changes in this revision.
Coverage Criteria (Initial & Renewal — product-specific)
Patient selection: patient must not have an FDA‑labeled limitation of use or contraindication to therapy. This is a universal exclusion applicable to requests across the product entries in this section and will result in denial when present. Providers must document the FDA‑approved diagnosis and any required test results or genetic testing where specified (e.g., abiraterone genotype guidance or other product‑specific testing) to demonstrate the request meets initial authorization requirements. (See product‑specific entries for required prior therapy, diagnostic confirmation, dosing limits, and coverage duration.)
Actemra (tocilizumab) authorization: Actemra may not be used concurrently with other biologic therapies. Initial approval requires documentation of a labeled indication (examples: rheumatoid arthritis with inadequate response to at least two preferred agents, polyarticular JIA after failure of two preferred drugs, giant cell arteritis after failure of one preferred agent, systemic sclerosis‑associated ILD after inadequate response to mycophenolate). Requests should include prior therapy history and prescriber specialty or consultation (rheumatologist or pulmonologist). Coverage is typically authorized for 12 months and dosing is limited to FDA‑labeled ranges.
Adbry (tralokinumab) coverage requirements: Adbry may not be used concurrently with another monoclonal antibody therapy. Initial authorization for atopic dermatitis requires documentation of moderate‑to‑severe disease (for example ≥10% body surface area or involvement of critical sites), evidence of intractable symptoms (pruritus, oozing/cracking/bleeding), and failure or contraindication to at least one prescription‑strength topical corticosteroid or one topical calcineurin inhibitor. Prescriber specialty (allergist, immunologist, or dermatologist) and objective prior‑therapy documentation are required; dosing must follow FDA labeling and typical approvals are for 12 months.
Pulmonary arterial hypertension (PAH) therapies: concurrent use exclusions and diagnostic confirmation. Many PAH agents are contraindicated with nitrates, nitric oxide donors, phosphodiesterase (PDE) inhibitors, or non‑specific PDE inhibitors; requests that propose concurrent use with these agents will be denied. Initial authorization for WHO Group 1 PAH requires right heart catheterization demonstrating hemodynamics with mean pulmonary arterial pressure ≥20 mmHg, PCWP ≤15 mmHg, and PVR >2 Wood units, and prescriber must be or consult a cardiologist or pulmonologist. Renewal generally requires the patient be seen within the prior 12 months and evidence of clinical benefit; dosing is limited to FDA‑labeled ranges and coverage is typically for 12 months.
Alpha‑1 antitrypsin augmentation: eligibility and required testing. Authorization requires a confirmed diagnosis of alpha‑1 antitrypsin deficiency with clinically evident emphysema and documentation of pretreatment AAT level below the policy threshold (for example <11 micromoles/L or the equivalent mg/dL thresholds specified by assay). Providers must also document continuation of conventional emphysema therapies. Approvals are dose‑limited to FDA labeling and usually authorized for 12 months.
Initial Therapy — Product-specific Decision Nodes
Continuation / Renewal Criteria
Step Therapy / Prior Therapy Requirements
| Drug / Scenario | Required prior trials / step therapy |
|---|---|
| Actemra (selected indications) | Medical contraindication or inadequate response to at least two preferred drugs (examples: Hadlima, Simlandi, Rinvoq) for RA or polyarticular JIA; for giant cell arteritis inadequate response to at least one preferred drug |
| Actemra — systemic sclerosis‑associated ILD | Inadequate response to mycophenolate (medical contraindication or failure) prior to approval |
| Drug class / example | Prior trial requirement |
|---|---|
| Selected neurology and psychiatry agents (examples) | Inadequate response or contraindication to two preferred/alternative agents (e.g., two antiseizure meds for certain agents) prior to approval |
| Antidepressant/antipsychotic new starts (examples) | Inadequate response or contraindication to two preferred alternative antidepressants or antipsychotics as listed in product-specific sections |
| Drug | Required prior alternatives (examples) |
|---|---|
| AUSTEDO (new‑start patients) | Inadequate response or contraindication to two listed alternatives (examples: lurasidone, risperidone, ziprasidone, olanzapine, quetiapine, aripiprazole) prior to approval |
| Drug / Indication | Required prior agents |
|---|---|
| BENLYSTA SC — SLE indication | Inadequate response or contraindication to two of: hydroxychloroquine, immunosuppressive agents (mycophenolate, azathioprine, methotrexate, cyclophosphamide), or oral corticosteroids prior to approval |
| BENLYSTA SC — lupus nephritis | Inadequate response or contraindication to mycophenolate mofetil or cyclophosphamide prior to approval |
| Drug / Indication | Required prior preferred drugs |
|---|---|
| CIMZIA (certolizumab pegol) — various inflammatory indications | Medical contraindication or inadequate response to at least two preferred drugs listed per indication (preferred lists provided per diagnosis) prior to approval |
| Context | Step therapy expectation |
|---|---|
| Biologic and specialty agents (general) | Many biologic approvals require prior inadequate response or medical contraindication to multiple preferred agents; exact required agents vary by product and indication |
| Enbrel / adalimumab pathway examples | Documented failure or contraindication to at least one preferred adalimumab drug (Hadlima, Simlandi) required unless exception applies |
| Scenario | Required trial |
|---|---|
| Lipid management prior to certain specialty lipid therapies (example: NEXLETOL/REPATHA prerequisites) | Trial of one high‑intensity statin plus ezetimibe concomitantly for a minimum of 8 weeks (or documented statin intolerance) before approval when LDL remains >70 mg/dL |
| Drug (requesting STELARA) | Step requirement |
|---|---|
| STELARA (ustekinumab) — patients requesting STELARA | Patient must have trialed both SELARSDI and YESINTEK prior to STELARA approval (step requirement) per product-specific PA rules |
| Drug / Indications (examples) | Prior trial requirement |
|---|---|
| TYENNE (selected RA / polyarticular JIA examples) | Prior inadequate response or contraindication to at least two preferred agents (examples listed such as Hadlima, Simlandi, Rinvoq) required before TYENNE approval; prescriber specialty indicated |
| Context | Prerequisite therapy flag / note |
|---|---|
| Index / formulary entries and select product records | Some product entries indicate 'Prerequisite Therapy Required: Yes' (e.g., Zurzuvae maintenance listing); prerequisite therapy may be required for some products — documented per product entry |
Quantity Limits and Dosing Constraints
Provider Actions — Prior Authorization, Documentation & Denial Risks
Abiraterone — prior authorization required
Abiraterone (250 mg or 500 mg) requires prior authorization. For new starts submit: diagnosis of an FDA‑approved indication (e.g., metastatic high‑risk castration‑sensitive or metastatic castration‑resistant prostate cancer); genetic testing results when required and evidence the agent is appropriate; confirmation patient has no FDA‑labeled limitation of use or contraindication; and if 500 mg tablet is requested provide a rationale why the 250 mg tablet cannot be used. Dose must be within FDA‑labeled dosing. Initial approval length: 6 months; renewal requires positive response.
- Diagnosis must match an FDA‑approved indication
- Provide genetic testing results when required
- If requesting 500 mg tablet, explain why 250 mg tablet is not suitable
- Dose limited to FDA‑labeled dosing; initial approval 6 months
Actemra — prior authorization and step requirements
Actemra requires prior authorization. Submit documentation of a diagnosis consistent with listed indications (RA, polyarticular JIA, giant cell arteritis, systemic juvenile idiopathic arthritis, or systemic sclerosis‑associated ILD) and evidence of inadequate response or contraindication to the specified number of preferred drugs per indication. Actemra may not be used concurrently with other biologic therapies; prescriber must be or consult a rheumatologist or pulmonologist. Coverage duration: 12 months.
- Diagnosis matching listed Actemra indications
- Prior inadequate response or contraindication to required preferred agents
- Do not use concurrently with other biologic therapies
- Prescriber: rheumatologist or pulmonologist; coverage 12 months
Adbry — prior authorization and prerequisite therapy
Adbry (subcutaneous) for atopic dermatitis requires prior authorization. Provide documentation of moderate‑to‑severe disease (≥10% BSA or involvement of face/neck/hands/feet/genitals/intertriginous areas) with intractable pruritus or oozing/cracking, and evidence of inadequate response or contraindication to one prescription‑strength topical corticosteroid or one topical calcineurin inhibitor. Adbry may not be used concurrently with another monoclonal antibody; prescriber specialty required. Coverage 12 months.
- Moderate‑to‑severe atopic dermatitis (≥10% BSA or critical site involvement)
- Failure or contraindication to one prescription topical corticosteroid or one topical calcineurin inhibitor
- No concurrent monoclonal antibody therapy; specialist prescriber
- Coverage duration 12 months
PAH therapies — RHC confirmation and PA required
Pulmonary arterial hypertension (PAH) therapies require prior authorization with right heart catheterization confirmation. Submit pretreatment RHC demonstrating mean PAP ≥20 mmHg, PCWP ≤15 mmHg, and PVR >2 Wood units (or ≥3 WU per some entries), documentation of negative acute vasodilator response or trial/failure/contraindication to calcium channel blockers when applicable, and that prescriber is or consulted a cardiologist/pulmonologist. Many PAH agents prohibit concurrent use with nitrates, nitric oxide donors, or PDE inhibitors. Coverage typically 12 months.
- Right heart catheterization: mean PAP ≥20 mmHg; PCWP ≤15 mmHg; PVR >2 (or ≥3) Wood units
- Document negative acute vasodilator test or CCB trial/failure when required
- Prescriber: cardiologist or pulmonologist; no concurrent nitrates/PDE inhibitors
- Coverage duration 12 months
AIMOVIG — prior authorization and renewal limits
AIMOVIG (CGRP antagonist) requires prior authorization for migraine prevention. Documentation must show ≥4 migraine days per month. Initial authorization is for 6 months; renewal is 12 months and requires positive response. AIMOVIG must not be used concurrently with other CGRP antagonists.
- ≥4 migraine days per month required for initiation
- Initial approval 6 months; renewal 12 months with documented benefit
- Do not use concurrently with other CGRP preventive agents
Sleep disorder agents — diagnostic documentation required
Prior authorization for sleep/wake disorder agents requires diagnosis of an FDA‑approved indication and condition‑specific diagnostic documentation: for OSA, sleep study showing ≥15 obstructive events/hour OR ≥5 events/hour plus listed symptoms; for narcolepsy, polysomnography plus MSLT unless not feasible. Renewal requires positive response to therapy.
- OSA: sleep study with ≥15 events/hour OR ≥5 events/hour plus symptoms
- Narcolepsy: polysomnography plus MSLT documentation (unless not feasible)
- Do not use concurrently with another target agent (e.g., modafinil)
- Renewal requires positive response
ATTRUBY — diagnostic confirmation and PA requirements
ATTRUBY (ATTR‑CM) prior authorization requires confirmed ATTR‑CM by cardiac biopsy with Congo red and ATTR confirmation OR specified noninvasive criteria (negative light‑chain testing plus 99mTc‑PYP myocardial uptake >1.5 H/CL ratio or visual grade ≥2). Also document heart failure history and NYHA class I–III and exclude light‑chain amyloidosis. Renewal requires prescriber visit within 12 months and evidence of continued efficacy.
- Cardiac biopsy with Congo red and ATTR confirmation OR serum/urine immunofixation + free light chain ratio and 99mTc‑PYP uptake >1.5 or grade ≥2
- Document HF history and NYHA I–III
- Exclude AL (light‑chain) amyloidosis; renewal: seen within 12 months and continued efficacy
BENLYSTA SC — PA with lab confirmation and prior therapy
BENLYSTA subcutaneous requires prior authorization. Provide evidence of autoantibody‑positive SLE (anti‑dsDNA >30 IU/mL, low complement, or anti‑Smith) or active lupus nephritis with required lab confirmation, and documentation of inadequate response or contraindication to specified standard therapies (e.g., hydroxychloroquine, immunosuppressants, or corticosteroids). Renewal requires positive response and a visit within the last 14 months.
- Anti‑dsDNA >30 IU/mL or low complement or anti‑Smith for SLE
- Inadequate response or contraindication to two listed standard therapies
- Renewal: positive response and prescriber visit within 14 months
- Do not use concurrently with another biologic
BONSITY — PA and prior therapy requirement
BONSITY prior authorization requires diagnosis of an FDA‑approved osteoporosis indication and prior inadequate response or contraindication to another osteoporosis therapy (e.g., bisphosphonates). Coverage is limited to 2 years unless the patient remains or returns to high fracture risk.
- Diagnosis of FDA‑approved osteoporosis indication
- Prior inadequate response or contraindication to another therapy such as a bisphosphonate
- Coverage limited to 2 years unless ongoing high fracture risk
Bosentan — PA with RHC and liver test requirements
Bosentan (for Group 1 PAH) prior authorization requires RHC confirmation of Group 1 PAH (mPAP ≥20 mmHg, PCWP ≤15 mmHg, PVR >2 WU) and baseline liver tests showing ALT/AST not >3×ULN and bilirubin increase <2×ULN. Prescriber should be or consult cardiology/pulmonology. Bosentan may not be used with cyclosporine A or glyburide.
- RHC: mPAP ≥20 mmHg; PCWP ≤15 mmHg; PVR >2 Wood units
- ALT/AST ≤3×ULN and bilirubin increase <2×ULN at baseline
- Do not use concurrently with cyclosporine A or glyburide
- Prescriber: cardiologist or pulmonologist; coverage 12 months
BRUKINSA — prior authorization and indication documentation
BRUKINSA prior authorization requires documentation of the FDA‑approved hematologic diagnosis (e.g., MCL after ≥1 prior therapy; WM; CLL/SLL; relapsed MZL after anti‑CD20; relapsed FL after ≥2 lines with obinutuzumab) and that the patient has no FDA‑labeled limitation or contraindication. Coverage duration typically 6 months; renewal requires positive response.
- Diagnosis and prior therapy documentation per indication (e.g., MCL after ≥1 prior therapy)
- No FDA‑labeled limitation/contraindication
- Coverage 6 months; renewal based on response
Cosentyx — prior authorization and step therapy
Cosentyx requires prior authorization with diagnosis‑specific criteria (psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, non‑radiographic axial spondyloarthritis, enthesitis‑related arthritis, hidradenitis suppurativa) and documentation of inadequate response or contraindication to required prior therapies. Cosentyx may not be used concurrently with other biologic therapies; prescriber specialty and coverage 12 months.
- Diagnosis consistent with listed indications and prior therapy failure/contraindication as specified
- May not be used with other biologics
- Prescriber specialty (dermatologist/rheumatologist) as applicable; coverage 12 months
Dupixent — PA with indication‑specific lab and prior therapy evidence
Dupixent prior authorization requires indication‑specific documentation: for atopic dermatitis show moderate‑to‑severe disease (≥10% BSA or special‑site involvement) and failure/contraindication to one prescription‑strength topical corticosteroid or one topical calcineurin inhibitor; for eosinophilic or steroid‑dependent asthma submit pre‑treatment eosinophil count ≥150 cells/mcL and evidence of inadequate control despite medium/high‑dose inhaled steroid plus another maintenance agent and defined exacerbation history. Dupixent may not be used concurrently with another monoclonal antibody.
- Atopic dermatitis: ≥10% BSA or critical site involvement + failure of topical prescription steroid or topical calcineurin inhibitor
- Asthma: pre‑treatment eosinophils ≥150 cells/mcL and inadequate control on inhaled steroid + another maintenance medication with exacerbation history
- Do not use with another monoclonal antibody; coverage and renewal per indication
MAVYRET / HCV DAA — PA with RNA, interaction screening, specialist
HCV DAA regimens (including MAVYRET) require prior authorization aligned with current AASLD/IDSA guidance. Submit diagnosis of HCV, HCV RNA within the past 6 months, medication‑interaction screening (patient must not be taking listed interacting drugs), documentation of no prior failure of an NS5A+protease inhibitor DAA regimen, and absence of moderate/severe hepatic impairment (Child‑Pugh B/C). Prescriber should be or consult GI/hepatology/ID/transplant specialist. Coverage duration per regimen (e.g., 8–16 weeks).
- HCV RNA within 6 months and adherence to AASLD/IDSA guidance
- Avoid listed interacting medications (e.g., carbamazepine, rifampin, certain statins, cyclosporine >100 mg/day, EPCLUSA/HARVONI/VOSEVI/ZEPATIER)
- No prior NS5A + protease inhibitor DAA failure; no Child‑Pugh B/C
- Specialist prescriber or consultation; coverage per guideline (8–16 weeks)
REVCOVI — diagnostic confirmation and PA requirements
REVCOVI prior authorization (for ADA‑deficient SCID) requires confirmed ADA deficiency by one of the listed laboratory or genetic tests (e.g., decreased erythrocyte ATP, biallelic ADA1 mutation, absent ADA in cells/plasma, or positive TREC screening) and documentation that the patient is not a candidate for or has failed hematopoietic stem cell transplant. Initial coverage six months; renewal requires annual visit and provider attestation.
- Laboratory/genetic confirmation of ADA deficiency (one of listed tests)
- Documentation that HSCT is not an option or has failed
- Initial approval six months then 12 months if renewal criteria met
VOWST — PA, preparatory steps, and limits
VOWST prior authorization requires documentation of recurrent CDI defined as three or more prior episodes treated with antibiotics (e.g., vancomycin), completion of the antibiotic therapy 2–4 days before initiating VOWST, and completion of recommended magnesium citrate preparation the day before (and at least 8 hours prior) to dosing. Coverage is limited to a single treatment course of 10 days; use for non‑recurrent CDI or not meeting the recurrent definition risks denial.
- Recurrent CDI: three or more prior antibiotic‑treated episodes
- Completed antibiotic therapy 2–4 days prior to VOWST
- Completed magnesium citrate prep day before and ≥8 hours prior to dosing
- Coverage limited to single 10‑day treatment course
VOWST — denial risk if recurrent CDI criteria or prep steps not met
VOWST exclusion risk: requests that do not meet the policy definition of recurrent CDI (three or more prior episodes treated with antibiotics) or that request VOWST for primary CDI will be denied. Ensure documentation of the required prior episodes and completion of antibiotic and prep steps before submission.
- VOWST is restricted to recurrent CDI (3+ prior antibiotic‑treated episodes)
- Use for primary CDI or without required preparatory steps will be denied
XIFAXAN — indication‑specific PA and dose/retreatment limits
XIFAXAN prior authorization is indication‑specific. For IBS‑D the dose is limited to 550 mg three times daily for 14 days with retreatment limited to patients with prior benefit (maximum two 14‑day courses); travelers’ diarrhea limited to 3 days; hepatic encephalopathy requires lactulose intolerance/limited dosing and routine follow‑up. Provide indication‑specific prior therapy failure or contraindication documentation per the listed rules.
- IBS‑D: 550 mg TID for 14 days; retreatment limited and max two 14‑day courses
- Traveler’s diarrhea: 3‑day course after failure/contraindication to listed antibiotics
- Hepatic encephalopathy: lactulose dose limitation and prescriber follow‑up; coverage durations vary by indication
XOLAIR — baseline testing and PA requirements
XOLAIR prior authorization requires baseline diagnostic/laboratory evidence per indication (e.g., allergic asthma: positive allergen testing and baseline IgE ≥30 IU/mL; chronic urticaria: inadequate response to maximally tolerated H1 antihistamine). XOLAIR may not be used concurrently with another monoclonal antibody; renewal requires evidence of positive response. Prescriber specialty required for many indications.
- Allergic asthma: positive skin/blood allergen test + baseline IgE ≥30 IU/mL and inadequate control on inhaled steroid + another maintenance med
- Chronic urticaria: failure of maximally tolerated H1 antihistamine
- Do not use concurrently with another monoclonal antibody; renewal requires documented benefit
Index cross‑references — consult formulary product pages
Where a formulary index entry directs to a product page (e.g., Kesimpta pen, Kerendia, Kalydeco), consult the referenced formulary page for the product‑specific prior authorization, coverage, and billing details. Index cross‑references list the formulary page number to find the full PA and documentation requirements.
- Use index page references to locate product‑specific PA criteria in the formulary
- Index entries do not contain the full PA criteria — open the referenced page
Coding, Clinical Thresholds & Index References
| N/A | No explicit CPT/HCPCS/ICD-10 codes listed in this excerpt |
| N/A | Document lists product names and criteria; no discrete CPT/HCPCS/ICD-10/NDC codes provided in these chunks. |
| FID: 26132 | HealthPartners Part D Formulary identifier |
Site of Care and Part B vs Part D Determinations
Definitions & Diagnostic Thresholds
Formulary Index & Coding References
| N/A | Index and product listing entries in the formulary extract; no billing codes provided in the referenced fragments. |
| FID: 26132 | HealthPartners Part D Formulary identifier referenced in index lines |
Biosimilar / Preferred Agent Notes
Background — Scope and Policy Purpose
This section summarizes the clinical and diagnostic prerequisites HealthPartners uses to determine Medicare Part D coverage and prior authorization for specialty and other formulary drugs. Key requirements recurring across product entries include confirmation of an FDA‑approved diagnosis (or compendia‑supported indication), documentation of required diagnostic tests or biomarker results where specified (for example, genetic testing or right heart catheterization hemodynamics), evidence of prior trial/failure or contraindication to specified preferred therapies when step therapy is required, prescriber specialty or consultation when indicated, adherence to FDA‑labeled dosing, and avoidance of excluded concurrent therapies or FDA‑labeled contraindications. Failure to meet these specified elements may result in denial of coverage or a determination that the request is not medically necessary.
Revision History
HealthPartners Part D prior authorization requirements and coverage criteria became effective (formulary FID: 26132).
Published comprehensive Medicare Part D prior authorization guidance including product-specific PA criteria, diagnostic requirements, and coverage durations (examples: abiraterone coverage duration six months; many biologics 12 months).
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.