2026 Medicare Part D Prior Authorization Requirements — Specialty & Part D Drugs
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
Defines prior authorization, coverage criteria, exclusions, prescriber and duration rules for Medicare Part D prescription drugs on the HealthPartners formulary; affects prescribers and pharmacists submitting Part D PA requests for affected products.
No material clinical or coverage changes in this revision.
Coverage Criteria — Product-specific Requirements
Abiraterone: Initial Therapy
Covered when ALL of the following are met:
Renewal requires documented positive response to therapy; initial coverage duration six months.
Actemra: Initial Therapy
Covered when ALL of the following are met:
Coverage duration 12 months
Adempas: Initial Therapy
Covered when ALL of the following are met:
Coverage duration 12 months
Testosterone products: Initial Therapy
Covered when ALL of the following are met:
Coverage duration 12 months
Armodafinil — Initial/renewal
Covered when ALL of the following are met for initial therapy:
Initial coverage six months; renewal requires documented positive response and then coverage may be extended to 12 months.
ATTRUBY — Initial/renewal
Covered when ALL of the following are met for initial therapy:
Coverage duration 12 months
BENLYSTA SC — Initial/renewal
Covered when ALL of the following are met for initial therapy in active SLE or lupus nephritis:
Coverage duration 12 months
BONSITY — Indications/limits
Covered when ALL of the following are met:
Prescribe and monitor per FDA labeling; coverage limited to 2 years unless continued high fracture risk documented.
Bosentan — PAH criteria
Covered when ALL of the following are met for Group 1 PAH:
Coverage duration 12 months
Specialty oncology/metabolic/infec agents — Initial/renewal
Covered when product‑specific FDA‑approved indication is present and other product‑specific requirements are met:
Prescriber specialty and prior therapy documentation required where specified; see individual product entries for details.
CIMZIA — Indications/step therapy
Covered when ALL of the following are met for labeled autoimmune indications:
Renewal requires treatment goals met; coverage duration 12 months
CIMZIA Initial Therapy
Covered when ALL of the following apply for the listed indication
Applies per‑indication with specific preferred drug lists
CIMZIA Renewal
Renewal covered when
Coverage duration 12 months
COSENTYX Initial Therapy
Covered when ALL of the following apply for the listed indication
Renewal requires treatment goals met; coverage duration 12 months
COSENTYX Renewal
Renewal covered when
Coverage duration 12 months
Dupixent Initial Therapy
Covered when ALL of the following apply for the indicated condition
Renewal requires evidence of positive response per product guidance
Dihydroergotamine Initial Therapy
Covered when ALL of the following apply
Renewal requires documented positive response; coverage duration 12 months
Deferasirox Initial Therapy
Covered when ALL of the following apply
Coverage duration 12 months
Deferiprone Initial Therapy
Covered when ALL of the following apply
Coverage duration 12 months
Dalfampridine Initial Therapy
Covered when ALL of the following apply
Initial coverage six months then 12 months if positive response
Fidaxomicin (Dificid) Initial Therapy
Covered when ALL of the following apply
Coverage duration 10 days
Cromolyn Initial Therapy
Covered when ALL of the following apply
Coverage duration six months then 12 months if positive
Cystaran Initial Therapy
Covered when ALL of the following apply
Coverage duration 12 months
Cresemba Initial Therapy
Covered when ALL of the following apply
Initial coverage three months then six months if positive response
Initial criteria for Dupixent (and similar specialty products) and other listed drugs
Covered when ALL of the following are met for the specified indication (examples below reflect product‑specific criteria as listed):
Applies across listed biologic/specialty products
See product‑specific documentation
See product‑specific entries for renewal and prescriber requirements
Requests may be denied if the patient has an FDA‑labeled limitation of use or contraindication to the requested therapy. For products with explicit language stating this requirement, coverage is only considered when the documented diagnosis and supporting information demonstrate the drug is appropriate and no labeled limitation/contraindication applies (examples: abiraterone initial criteria require absence of unsupported FDA limitations of use; LYNPARZA and other oncology agents include similar clauses).
When submitting a Part D prior authorization, include documentation that addresses any FDA‑labeled limitations or contraindications cited by the product entry (e.g., supporting genetic test results for agents that require testing, or documentation that an FDA limitation is supported by NCCN/compendia if that is to be relied upon).
Several agents explicitly prohibit concurrent use with other targeted or biologic therapies. Examples include armodafinil/modafinil (may not be used concurrently with the other targeted wakefulness agent), and multiple biologics such as BENLYSTA and CIMZIA, which state they may not be used concurrently with another biologic agent for the same therapeutic purpose.
Prior authorization requests should document current and recent therapies; concurrent use with a disallowed agent is an exclusion and will typically result in denial unless clear documentation supports a permitted exception.
For bosentan used in Group 1 pulmonary arterial hypertension, therapy is excluded when liver tests exceed safety thresholds. Specifically, do not authorize bosentan if the patient has ALT or AST > 3× ULN or an increase in bilirubin ≥ 2× ULN. Documentation of baseline and recent hepatic laboratory values is required to confirm eligibility.
Coverage for ATTRUBY (for transthyretin-mediated amyloid cardiomyopathy) requires exclusion of light‑chain amyloidosis. The patient must be documented as negative for light‑chain (AL) amyloidosis (per the diagnostic pathway: cardiac biopsy with ATTR confirmation, or the listed nonbiopsy criteria including serum/urine immunofixation and free light chain testing plus 99mTc‑PYP findings). Requests that do not show negative evaluation for AL amyloidosis will not meet the coverage criteria.
Initial Therapy — Entry Requirements
inv-388: Initial therapy examples
Initial approvals require diagnosis and prior therapy trials where specified.
See individual product entries for precise required trials and diagnostic thresholds
inv-389: Armodafinil initial
Covered when ALL of the following are met for initial therapy:
Coverage duration six months then 12 months if renewed
inv-390: ATTRUBY initial
Covered when ALL of the following are met for initial therapy:
Coverage duration 12 months
inv-391: Initial Therapy Requirements (summary)
Initial therapy requirements vary by drug but consistently require diagnosis and prior trial/failure or contraindication to specified therapies
Providers must submit supporting documentation per product
inv-392: Initial therapy rules
Initial therapy is authorized when the product‑specific clinical entry requirements and prerequisite therapy failures or contraindications are documented.
Applies across listed specialty products
inv-395: INCRELEX - Initial criteria
Covered when ALL of the following are met
Coverage duration 12 months
inv-394: Inqovi initial
Covered when ALL of the following are met:
Coverage duration six months
inv-396: Initial therapy examples
Examples of initial therapy requirements
Prescriber specialty required; renewal requires evidence of clinical benefit
inv-397: OFEV initial
Nintedanib (OFEV) criteria
Coverage duration 12 months
Renewal and Continuation — Evidence of Benefit
inv-405: Renewal requirements
Renewal generally requires evidence of benefit or positive response.
Specific renewal criteria are product‑dependent
inv-406: Renewal examples
Renewal/continuation requirements (examples):
Step Therapy / Prerequisite Trials
| Step therapy requirement | Examples / affected products | Required documentation |
|---|---|---|
| Trial and failure of preferred agents required prior to approval | ||
| Actemra: inadequate response or contraindication to at least two preferred drugs (examples: Hadlima, Simlandi, Rinvoq); many biologics/JAK inhibitors: prior trials of listed preferred drugs | ||
| Document prior trials and reason for inadequate response or contraindication; prescriber specialty/consultation as specified (e.g., rheumatologist or pulmonologist for Actemra) |
| Step therapy requirement | Examples / affected products | Required documentation |
|---|---|---|
| Trial of two preferred drugs required prior to coverage | ||
| Antiseizure and some antidepressant agents: inadequate response or contraindication to two alternatives (examples listed include several antipsychotics/antiseizure/antidepressant therapies) | ||
| Document trials of two specified preferred agents with durations and reasons for failure or contraindication; specialist prescriber notation when required |
| Prerequisite therapy | Requirement details | Coverage threshold / duration |
|---|---|---|
| High-intensity statin + ezetimibe trial | ||
| Trial of one high-intensity statin concomitantly with ezetimibe for a minimum of 8 weeks, or documented statin intolerance to atorvastatin and rosuvastatin | ||
| Used when LDL remains >70 mg/dL after the 8-week trial; coverage duration 12 months; dosing limited to FDA labeling |
| Prerequisite therapy | Requirement details | Coverage / exclusions |
|---|---|---|
| High-intensity statin + ezetimibe trial (or documented statin intolerance) | ||
| Trial of one high-intensity statin plus ezetimibe for 8 weeks with LDL remaining above goal, or documented statin intolerance (rhabdomyolysis to one statin or intolerance to both atorvastatin and rosuvastatin) | ||
| Required for Repatha approval for HeFH/ASCVD; Repatha may not be used concurrently with Praluent or Leqvio; coverage duration 12 months; dosing limited to FDA labeling |
| Requirement type | Examples / affected agents | Notes / documentation |
|---|---|---|
| Trial and failure or contraindication to specified prior therapies required | ||
| CIMZIA, Stelara, many JAK/biologic agents, Nurtec, Kisqali and other products — specific lists of preferred drugs or prior therapies are provided per indication (e.g., CIMZIA: failure/inadequate response to at least two preferred drugs) | ||
| Providers must document prior therapies tried, durations, and reason for inadequacy or contraindication; genetic testing results when required for oncology agents; prescriber specialty as specified |
| Prerequisite therapy required? | Requirement details | Documentation / duration |
|---|---|---|
| Yes | ||
| VUMERITY requires inadequate response or contraindication to one listed disease-modifying therapy (teriflunomide, dimethyl fumarate, fingolimod, or glatiramer acetate) | ||
| Document trial and inadequate response or contraindication to at least one listed DMT; coverage duration 12 months; dosing limited to FDA labeling |
| Prerequisite therapy required? | Requirement details | Documentation / duration |
|---|---|---|
| Yes | ||
| VERQUVO requires inadequate response or contraindication to at least two guideline-directed heart failure therapies (ACE/ARB/ARNI, beta-blocker, aldosterone antagonist, or SGLT2 inhibitor) and additional clinical criteria (EF <45%, NYHA II–IV, recent HF hospitalization or outpatient IV diuretics) | ||
| Document EF <45%, NYHA class II–IV, prior HF hospitalization within 6 months or outpatient IV diuretic within 3 months, and trials/intolerance to listed guideline therapies; coverage duration 12 months; cardiology prescriber or consult recommended |
| Prerequisite therapy required? | Requirement details | Documentation / exclusions |
|---|---|---|
| Yes | ||
| XELJANZ requires inadequate response or contraindication to at least two preferred drugs for the specific indication (PsA, RA, UC, polyarticular JIA, AS) | ||
| Document trials of at least two preferred agents and reasons for failure or contraindication; XELJANZ must not be used concurrently with other biologic therapies; prescriber specialist consultation required; coverage duration 12 months |
Formulary and Product Coding
| FID: 26132 | HealthPartners Part D Formulary identifier |
| CIMZIA | CIMZIA; CIMZIA POWDER FOR RECONST; CIMZIA STARTER KIT |
| COSENTYX | COSENTYX (2 SYRINGES); COSENTYX PEN; COSENTYX PEN (2 PENS); COSENTYX SUBCUTANEOUS SYRINGE 150 MG/ML, 75 MG/0.5 ML; COSENTYX UNOREADY PEN |
| DUPIXENT | DUPIXENT PEN SUBCUTANEOUS PEN INJECTOR 200 MG/1.14 ML, 300 MG/2 ML; DUPIXENT SYRINGE SUBCUTANEOUS SYRINGE 200 MG/1.14 ML, 300 MG/2 ML |
| deferasirox | deferasirox |
| deferiprone | deferiprone |
| fidaxomicin | DIFICID ORAL SUSPENSION FOR RECONSTITUTION; fidaxomicin |
| FID: 26132 | HealthPartners Part D Formulary identifier referenced for multiple products |
| IMBRUVICA ORAL CAPSULE 140 MG | IMBRUVICA ORAL CAPSULE 140 MG |
| IMBRUVICA ORAL CAPSULE 70 MG | IMBRUVICA ORAL CAPSULE 70 MG |
| IMBRUVICA ORAL SUSPENSION | IMBRUVICA ORAL SUSPENSION |
| IMBRUVICA ORAL TABLET 140 MG | IMBRUVICA ORAL TABLET 140 MG |
| IMBRUVICA ORAL TABLET 280 MG | IMBRUVICA ORAL TABLET 280 MG |
| IMBRUVICA ORAL TABLET 420 MG | IMBRUVICA ORAL TABLET 420 MG |
| INBRIJA INHALATION CAPSULE | INBRIJA INHALATION CAPSULE, W/INHALATION DEVICE |
| alcohol pads | alcohol pads |
| NOVO PEN NEEDLE | NOVO PEN NEEDLE |
| GAUZE PADS 2 X 2 | GAUZE PADS 2 X 2 |
| EMBECTA INSULIN SYRINGE | EMBECTA INSULIN SYRINGE |
| EMBECTA PEN NEEDLE | EMBECTA PEN NEEDLE |
| KERENDIA | KERENDIA |
| KESIMPTA PEN | KESIMPTA PEN |
| KINERET | KINERET |
| KISQALI FEMARA CO-PACK | KISQALI FEMARA CO-PACK ORAL TABLET |
| KISQALI | KISQALI ORAL TABLET |
| lidocaine topical adhesive patch, medicated 5% | lidocaine topical adhesive patch,medicated 5 % |
| linezolid | linezolid |
| linezolid in dextrose 5% | linezolid in dextrose 5% |
| LINEZOLID-0.9% SODIUM CHLORIDE | LINEZOLID-0.9% SODIUM CHLORIDE |
| LIVTENCITY | LIVTENCITY |
| alosetron | alosetron |
| VENCLEXTA ORAL TABLET 10 MG | product listed in formulary entry |
| VENCLEXTA ORAL TABLET 50 MG | product listed in formulary entry |
| VENCLEXTA ORAL TABLET 100 MG | product listed in formulary entry |
| VENCLEXTA STARTING PACK | product listed in formulary entry |
| XALKORI ORAL CAPSULE | formulary product |
| XALKORI ORAL PELLET 150 MG, 20 | formulary product |
Provider Actions — Prior Authorization & Documentation
Product-specific prior authorization required
Prior authorization is required for Part D drugs listed in this section; initial and renewal clinical criteria are specified per product and commonly include confirmation of an FDA‑approved diagnosis, required prior therapy trials or documented contraindications, relevant diagnostic or lab testing, and prescriber specialty when applicable.
- PA applied per product-specific entry (see product sections for exact initial/renewal requirements and documentation).
- Coverage durations are specified per product (commonly 6 or 12 months).
PA requires documented trials or contraindications to preferred therapies
Prior authorization approvals require submitted documentation of the diagnosis and evidence of inadequate response to—or contraindication for—specified preferred therapies when step requirements apply (number of required trials varies by indication).
- Document which preferred agents were tried, treatment durations, and reason for failure or intolerance.
- If product requires two preferred-drug failures, provide records showing trials of two listed alternatives.
PA required for listed specialty drugs with indication‑specific criteria
Prior authorization is required for the specialty drugs listed; initial approval requires meeting the indication‑specific entry criteria (FDA‑approved diagnosis, required lab/genetic testing if specified, not excluded from Part D) and submission of the supporting clinical documentation noted in each product section.
- Examples: oncology, CFTR modulators, biologics, PAH agents and other listed specialty products require indication‑specific documentation.
- Follow the product entry for required prescriber specialty and dosing limits.
Prior authorization per HealthPartners Part D Formulary (FID: 26132)
These Part D drugs require prior authorization per the HealthPartners Part D Formulary (FID: 26132); PA criteria are applied to FDA‑approved indications and product‑specific rules listed in the formulary.
- When submitting a PA, reference Formulary FID: 26132 to ensure the request aligns with the formulary entry and applicable PA rules.
PA applies to initial and renewal requests; durations vary
Initial and renewal prior authorization requirements apply for listed Part D drugs; coverage durations are specified per product (commonly 6 months for many oncology/short-course agents and 12 months for chronic biologic or maintenance therapies).
- Review the product entry for the exact initial duration (examples: abiraterone 6 months, many biologics 12 months).
- Renewal typically requires evidence of clinical benefit and recent prescriber follow‑up.
Initial PA documentation required (example: abiraterone)
For new starts submit documentation of the FDA‑approved diagnosis, required genetic testing results when indicated, absence of unsupported FDA‑labeled limitations of use, and prior therapy details showing trials/failures or that the patient previously benefited from the agent where applicable (example: abiraterone).
- Abiraterone initial PA: diagnosis of an FDA‑approved indication, genetic testing if required, no unsupported FDA limitations, and dosing limited to FDA labeling; coverage duration six months.
- Provide rationale if requesting a non‑preferred strength/formulation (e.g., abiraterone 500 mg vs 250 mg tablet).
Include right heart catheterization hemodynamics for PAH agents
For PA requests for pulmonary arterial hypertension agents, include right heart catheterization data documenting hemodynamics (mean PAP, PCWP, PVR) that meet the PAH criteria when required by the product entry.
- Right heart cath thresholds in entries: mean PAP ≥20 mmHg, PCWP ≤15 mmHg, and PVR >2 (or ≥3) Wood units as specified by the product.
- Prescriber specialty (cardiology or pulmonology) is typically required.
Submit use/setting details when Part B vs Part D determination may apply
When a drug may be covered under Part B or Part D depending on setting or use, submit information describing the intended use and dispensing setting so HealthPartners can determine the appropriate benefit and process the PA accordingly.
- Examples: some immunoglobulins, Retacrit, and certain injectables may require setting details (infusion center, outpatient hospital, home) to assign Part B vs Part D coverage.
- Provide documentation of the administration site and clinical rationale for outpatient drug vs physician‑administered benefit.
Denial risk — FDA‑labeled limitations of use or contraindications
Requests will be denied if the patient has an FDA‑labeled limitation of use or a contraindication to the requested therapy when the product entry explicitly states the patient must not have such limitations.
- Confirm the patient does not meet any FDA‑labeled exclusion (e.g., abiraterone entries require absence of unsupported labeled limitations).
- If an FDA contraindication exists, do not submit a PA unless documentation shows the contraindication does not apply and is supported by guidelines.
Denial risk — concurrent disallowed or interacting therapies
Therapy may be denied if requested concurrently with another product that the formulary explicitly prohibits for simultaneous use (e.g., concurrent biologic/monoclonal antibody therapies, CFTR modulators, or interacting antivirals).
- Examples: CIMZIA, COSENTYX, DUPIXENT, and other biologics may not be used concurrently with another biologic; Livtencity may not be used with ganciclovir/valganciclovir/foscarnet/cidofovir.
- Arm providers must document discontinuation of excluded concurrent agents before PA approval.
Common denial triggers — missing tests, contraindications, or concurrent disallowed therapy
Common denial triggers include failure to meet initial criteria (missing required genetic testing or diagnostic confirmation when specified), presence of an FDA‑labeled limitation/contraindication, or documentation of concurrent prohibited therapies.
- Ensure required tests (genetic, hemodynamic, eosinophil counts, HCV RNA, etc.) are attached when indicated.
- Document prior therapy trials and objective evidence of inadequate response or intolerance as specified in the product section to avoid denial.
Quantity and Dosing Limits
Site-of-Care Determinations (Part B vs Part D)
Clinical Definitions and Diagnostic Thresholds
Background and Scope
This section of the Part D prior‑authorization document summarizes the clinical prerequisites used to determine medical necessity for specialty and other outpatient drugs covered under HealthPartners Part D. Criteria emphasize that coverage is limited to FDA‑approved indications (unless otherwise supported by compendia), that prescribed dosing must be within FDA‑labeled dosing, and that prior authorization requires submission of the diagnosis and supporting clinical documentation (for example, genetic testing when required, baseline labs, prior therapy trials, or procedure results).
The rules also outline common exclusion and denial triggers — for example, presence of an FDA‑labeled limitation of use or contraindication, or concurrent use of prohibited therapies — and describe typical PA administrative expectations such as prescriber specialty requirements and coverage durations (commonly 6 or 12 months depending on the product).
Revision History
HealthPartners Part D Formulary (FID: 26132) effective date for this document extract
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.