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Tufts Health One Care (Medicare-Medicaid Plan) 2025 Prior Authorization Medical Necessity Guidelines

Part 1 of Tufts Health One Care (Medicare-Medicaid Plan) 2025 prior authorization medical necessity guidelines listing multiple drugs/products with their covered indications, required medical information, prescriber restrictions, coverage duration, and exclusions as specified for each product in this section.

Policy Summary

Payerharvard pilgrim health care

PolicyTufts Health One Care (Medicare-Medicaid Plan) 2025 Prior Authorization Medical Necessity Guidelines

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review Date

Key ActionSubmit documented diagnosis, required prior therapy history, mutation/lab confirmation where specified, and prescriber specialty documentation to obtain prior authorization per drug.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes noted for this part (has_material_change=false).

~150+Drugs listed in Part 1 (approximate)

2 yearsTypical coverage duration (most products)

6 monthsInitial approval (some agents)

MultipleRequire oncologist prescriber

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Coverage Summary & Scope

This policy is Part 1 of the Tufts Health One Care (Medicare‑Medicaid Plan) 2025 Prior Authorization Medical Necessity Guidelines and is effective 2025-12-01. Part 1 is a partial index containing the first segment of products and indication-specific requirements; the document lists numerous drugs with product-specific criteria. Most products in this part specify a standard coverage duration of 2 years. Note: some items require determining whether coverage is under Medicare Part B vs Part D depending on use/setting as described in the policy.

Coverage thresholds / limits

Coverage Duration (default)2 years (most products in Part 1 list 2 years as standard coverage duration)

Increlex age2 to 18 years

Koselugo age2 to 17 years

Livtencity weight>= 35 kg

Kalydeco granules age>= 1 month

Zelvysia initial authorizationInitial authorization: 8 weeks; subsequent: 2 years

Prolia T-score thresholdT score <= -2.0 (or high fracture risk defined by history of osteoporotic fracture or multiple risk factors with T score <= -2.0)

Initial Approval Criteria (by product)

Initial therapy / Covered when ALL...

Render initial-therapy / "Covered when ALL..." criteria trees for listed products. Each top-level node encodes the AND/OR structure from the brief; where the brief text is truncated the node text is included as provided and a note indicates truncation.

Abilify Mycite Maintenance Kit / Starter Kit

Documented diagnosis of bipolar I disorder, major depressive disorder, or schizophrenia
Documentation of worsening symptoms with oral aripiprazole
Prescribing physician is a psychiatrist
Coverage duration: 2 years

Abiraterone Acetate / Abirtega

Documented diagnosis of metastatic castration-resistant prostate cancer (CRPC) or metastatic high-risk castration-sensitive prostate cancer
Abiraterone is being used in combination with prednisone
Prescribing physician is an oncologist or urologist
Coverage duration: 2 years

Aimovig (initial criteria)

Initial: Documented diagnosis of migraine
Initial: Inadequate response after a 4-week trial of or contraindication to antidepressants, antiepileptic drugs (AEDs) or beta blockers
Coverage: Initial approval: 6 months

Akeega

Diagnosis of metastatic, castration-resistant prostate cancer
Deleterious or suspected deleterious BRCA-mutated (BRCAm)
ONE of
- Used in combination with a gonadotropin-releasing hormone (GnRH) analog
- Patient has had a bilateral orchiectomy
Requested drug is being used in combination with prednisone
Prescriber must be an oncologist

Alecensa

Documented diagnosis of ALK-positive metastatic NSCLC or use as adjuvant treatment following tumor resection of ALK-positive NSCLC
Prescribing physician is an oncologist
Coverage duration: 2 years

Alosetron Hydrochloride

Diagnosis of severe diarrhea-predominant irritable bowel syndrome in female
Coverage duration: 2 years

Alunbrig

Documented diagnosis of ALK-positive metastatic NSCLC
Prescribing physician must be an oncologist
Coverage duration: 2 years

Arcalyst

Documented diagnosis of Cryopyrin-associated periodic syndromes (including Familial Cold Autoinflammatory Syndrome or Muckle-Wells Syndrome)
Deficiency of interleukin-1 receptor antagonist: documented diagnosis and used for maintenance of remission in patients >=10 kg
Recurrent Pericarditis: documented diagnosis and being used to reduce risk of recurrence
Coverage duration: 2 years

Arikayce

Diagnosis of Mycobacterium avium complex (MAC) lung disease
Used as part of a combination antibacterial drug regimen
Used in patients who do not achieve at least two negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen
Prescribed by or in consultation with an infectious disease specialist or pulmonologist
Coverage duration: 2 years

Armodafinil / Modafinil tablets

Documented diagnosis of narcolepsy, excessive sleepiness associated with obstructive sleep apnea, or shift-work sleep disorder
Coverage will not be approved for generalized fatigue, jet lag, or sleep-deprivation not associated with a covered diagnosis
Coverage duration: 2 years

Augtyro

Diagnosis of locally advanced or metastatic ROS1-positive NSCLC OR NTRK gene fusion-positive solid tumors that are locally advanced/metastatic or where resection likely results in severe morbidity and have progressed following treatment or lack satisfactory alternative therapy
Prescribing physician must be an oncologist
Coverage duration: 2 years

Austedo / Austedo XR

Documented diagnosis of chorea associated with Huntington's Disease OR documented diagnosis of Tardive Dyskinesia
Coverage duration: 2 years

Avmapki Fakzynja Co-pack

Diagnosis of recurrent low-grade serous ovarian cancer (LGSOC)
Presence of a KRAS-mutation
Patient has received prior systemic therapy (e.g., chemotherapy)
Coverage duration: 2 years

Ayvakit

GIST (PDGFRA Exon 18 including D842V): Documented diagnosis of PDGFRA Exon 18 mutation-positive unresectable or metastatic GIST; prescriber is an allergist, immunologist, or oncologist; coverage duration: 2 years
Advanced Systemic Mastocytosis (AdvSM): Documented diagnosis of AdvSM (ASM, SM-AHN, or MCL); prescriber is an allergist, immunologist, or oncologist; coverage duration: 2 years
Indolent Systemic Mastocytosis (ISM): Documented diagnosis of Indolent Systemic Mastocytosis; prescriber is an allergist, immunologist, or oncologist; coverage duration: 2 years

Balversa

Documented diagnosis of locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
Member progressed during or following at least one line of prior systemic therapy
ONE of
- Member had been treated with prior PD-1 or PD-L1 inhibitor (e.g., nivolumab, pembrolizumab, avelumab)
- Member is not a candidate for PD-1 or PD-L1 inhibitor therapy
Prescriber must be an oncologist or urologist
Coverage duration: 2 years

Benlysta (belimumab) INJ 200MG/ML

Documented diagnosis of active, autoantibody-positive systemic lupus erythematosus (SLE) or active lupus nephritis
Member is concurrently taking standard therapy (e.g., antimalarials, corticosteroids, or immunosuppressives)
Prescribing physician must be a nephrologist or rheumatologist
Exclusions: Benlysta will not be approved as monotherapy, for members with severe active lupus nephritis or severe active CNS lupus, for autoantibody-negative members, or in combination with other biologics or IV cyclophosphamide
Coverage duration: 2 years

Berinert

Documented diagnosis of Hereditary Angioedema
Prescribing physician must be an allergist or immunologist
Coverage duration: 2 years

Besremi

Documented diagnosis of polycythemia vera
Coverage duration: 2 years

Bexarotene GEL

Documented diagnosis of cutaneous T-cell lymphoma with refractory or persistent disease after other therapies or intolerance to other therapies
Prescribing physician must be an oncologist or dermatologist
Coverage duration: 2 years

Bosulif

Chronic phase Ph+ CML: Documented diagnosis of chronic phase Ph+ CML, newly-diagnosed or resistant or intolerant to prior therapy; prescriber hematologist or oncologist; coverage 2 years
Accelerated or blast phase Ph+ CML: Documented diagnosis of accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy; prescriber hematologist or oncologist; coverage 2 years

Braftovi CAPS 75MG

Exclusion: Not indicated for wild-type BRAF melanoma or wild-type BRAF CRC
Metastatic CRC: Documented metastatic CRC with BRAF V600E mutation after prior therapy and taken in combination with cetuximab
Melanoma: Unresectable or metastatic melanoma with BRAF V600E or V600K mutation and taken in combination with binimetinib
NSCLC: Metastatic NSCLC with BRAF V600E mutation and taken in combination with binimetinib
Prescribing physician must be an oncologist

Brukinsa

ONE of the following diagnoses: Mantle Cell Lymphoma (MCL) with at least one prior therapy; Relapsed/refractory Marginal Zone Lymphoma (MZL) with at least one anti-CD20-based regimen; Waldenstrom's Macroglobulinemia; CLL; SLL; Relapsed/refractory follicular lymphoma in combination with obinutuzumab after two or more lines of systemic therapy
Prescribing physician must be a hematologist or oncologist
Coverage duration: 2 years

Cabometyx

Advanced RCC: Documented diagnosis of advanced renal cell carcinoma (RCC); prescriber oncologist; coverage duration: 2 years
Differentiated Thyroid Cancer (DTC): Documented locally advanced or metastatic DTC progressed following prior VEGFR-targeted therapy and are radioactive iodine-refractory or ineligible; prescriber oncologist; coverage 2 years
Hepatocellular Carcinoma (HCC): Documented HCC with documented failure, contraindication, or intolerance with sorafenib; prescriber oncologist; coverage 2 years

Calquence

CLL or SLL: Documented diagnosis of CLL or SLL; prescriber hematologist or oncologist; coverage 2 years
Mantle Cell Lymphoma (MCL): Documented diagnosis of MCL and has received at least one prior therapy OR is previously untreated and ineligible for autologous hematopoietic stem cell transplantation; prescriber hematologist or oncologist; coverage 2 years

Caplyta

Documented diagnosis of schizophrenia or bipolar depression
Prescribing physician must be a psychiatrist
Coverage duration: 2 years

Caprelsa

Documented diagnosis of symptomatic or progressive medullary thyroid cancer with unresectable locally advanced or metastatic disease
Prescribing physician must be an endocrinologist or oncologist
Coverage duration: 2 years

Carglumic Acid

Documented diagnosis of chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency
Documented diagnosis of acute hyperammonemia due to NAGS deficiency and requested drug is being used as adjunctive therapy
Coverage duration: 2 years

Cayston

Diagnosis of cystic fibrosis (CF)
Patient has evidence of Pseudomonas aeruginosa in the lungs
Coverage duration: 2 years

Cholbam

Bile Acid Synthesis Disorder: documented diagnosis of bile acid synthesis disorders due to single enzyme defects (SEDs)
Peroxisomal Disorders (PDs): documented diagnosis of PDs with manifestations of hepatic disease, steatorrhea, or complications from decreased fat soluble vitamin absorption and Cholbam is being used as adjunctive therapy
Exclusion: Cholbam will not be approved for members with extrahepatic manifestations of either bile acid synthesis disorders due to SEDs or peroxisomal disorders (PDs), including Zellweger spectrum disorders
Coverage duration: 2 years

Cobenfy / Cobenfy Starter Pack

Documented diagnosis of schizophrenia
Prescribing physician must be a psychiatrist
Coverage duration: 2 years
Approve for continuation of prior therapy

Cometriq

Documented diagnosis of progressive, metastatic medullary thyroid cancer
Prescribing physician must be an oncologist
Coverage duration: 2 years

Copiktra

Documented diagnosis of relapsed or refractory CLL or SLL
Member has received at least two prior therapies
Prescribing physician must be a hematologist or oncologist
Coverage duration: 2 years

Cosentyx (and devices)

Ankylosing Spondylitis: Documented diagnosis of active ankylosing spondylitis
Plaque Psoriasis: Documented moderate-to-severe plaque psoriasis and failed/intolerant to listed topical therapies
Psoriatic Arthritis: Documented diagnosis of psoriatic arthritis
Non-radiographic Axial Spondyloarthritis: Documented active non-radiographic axial spondyloarthritis with objective signs of inflammation and trial/failure/contraindication/intolerance to two NSAIDs at maximally indicated doses for minimum one month
Prescriber:

Cotellic

Exclusion: Not indicated for treatment of patients with wild-type BRAF melanoma
Melanoma: Unresectable or metastatic melanoma with BRAF V600E or V600K mutation and being taken in combination with Zelboraf (vemurafenib)
Histiocytic neoplasm being used as monotherapy
Prescriber: Prescribing physician must be an oncologist
Coverage duration: 2 years

Danziten

Documented diagnosis of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML)
Coverage duration: 2 years
Approve for continuation of prior therapy

Continuation / Reauthorization Criteria

Subsequent / continuation / reauthorization criteria

Render continuation / subsequent / reauthorization trees where continuation language appears in the brief (e.g., subsequent approval, reauthorization, or "Approve for continuation of prior therapy").

Aimovig - Subsequent Approval: Subsequent: Clinically significant reduction in migraine days per month from baseline

Subsequent approval 2 years per brief

Emgality - Subsequent Approval: Subsequent Approval: The member has had a clinically significant reduction in migraine days per month or frequency of weekly cluster headache attacks from baseline

Initial approval 6 months; Subsequent approval Life of Plan per brief

GLP-1 Agonists - Reauthorization: Reauthorization: Patient demonstrates positive clinical response to therapy

Applies to Mounjaro, Ozempic, Rybelsus, Trulicity (Type 2 diabetes)

Cobenfy / Cobenfy Starter Pack - Continuation: Approve for continuation of prior therapy

Per brief

Copiktra - Initial/Continuation: Documented diagnosis of relapsed or refractory CLL or SLL and member has received at least two prior therapies; coverage duration 2 years

(Included because many disease entries include continuation language elsewhere)

Genotropin - Continuation: Pediatric GHD continuation: documentation of medical history, growth chart, continuing care plan and improvement in annualized pre-treatment growth rate after first 6 months

Approve continuation criteria present in brief

Gomekli - Continuation: Approve for continuation of prior therapy

NF1 with plexiform neurofibromas per brief

Hernexeos - Continuation: Approve for continuation of prior therapy

HER2-mutant NSCLC entry includes continuation language

Ibtrozi - Continuation: Approve for continuation of prior therapy

ROS1-positive NSCLC entry includes continuation language

Imkeldi - Continuation: Patient is unable to swallow generic imatinib tablet due to age or physical impairment; Approve for continuation of prior therapy

Per brief

Itovebi - Continuation: Approve for continuation of prior therapy

PIK3CA-mutated HR+ HER2- breast cancer entry includes continuation language

Iwilfin - Continuation: Approve for continuation of prior therapy

High-risk neuroblastoma entry

Jakafi - Subsequent Authorization: For myelofibrosis: subsequent authorization requires documentation of spleen size reduction or symptomatic improvement

Per brief

Modeyso - Continuation: Approve for continuation of prior therapy

Diffuse midline glioma entry

Opipza - Continuation: Approve for continuation of prior therapy

Per brief

Prevymis - Transplant prophylaxis continuation: Documentation of HSCT or kidney transplant status to support prophylactic use; coverage duration 2 years

Listed as transplant-related continuation conditions

Revuforj - Continuation: Approve for continuation of prior therapy

Relapsed/refractory acute leukemia with KMT2A translocation entry

Romvimza - Continuation: Approve for continuation of prior therapy

Symptomatic TGCT entry

Rubraca - No concurrent chemo approval note (continuation context): Rubraca will not be approved for concurrent use with other chemotherapy agents

Also used to determine continuation only for indicated maintenance settings

Vowst - Course duration: Coverage duration: 14 days for indicated recurrent CDI treatment; follow-up/continuation per specialist guidance

Per brief

Zelvysia - Continuation: Initial authorization 8 weeks; subsequent authorization 2 years; coverage for continuing therapy if member has experienced improvement

Per brief

Many products - Approve for continuation of prior therapy (general note): Where brief includes 'Approve for continuation of prior therapy', continuation/reauthorization requests are acceptable with prior therapy documentation

Examples across the part include numerous oncology and specialty products

Common continuation rules across products: authorization is typically issued for 2 years for ongoing therapy; some agents have shorter initial approval periods (e.g., 6 months) for initial trials. Reauthorization commonly requires documentation of treatment effect or a positive clinical response, and many continuation requests must include prior therapy history, trial/failure documentation, or prior authorization records to support ongoing use.

Exclusions, Not-Approved Uses, and Denial Triggers

Exclusion / Not-Approved Uses

Covered uses will not include the following exclusions or not-approved uses. Each leaf below is an explicit exclusion — these will be considered denial reasons when present in the request.

ALL of the following

Icatibant: requests for indications explicitly excluded by clinical criteria or formulary guidance (e.g., uses outside hereditary angioedema acute attacks) will not be approved.
Ponatinib (Iclusig): not approved for newly diagnosed chronic phase chronic myeloid leukemia (CML) — requests for first-line newly diagnosed chronic phase CML will be denied.
Quinine: use for nocturnal leg cramps or generalized cramp symptoms is not covered and will not be approved.
Mekinist (trametinib) single-agent use after prior BRAF inhibitor therapy where policy excludes single-agent use will not be approved (per product-specific exclusion statements).
Rubraca (rucaparib): concurrent use with specified chemotherapy agents when policy states concurrent chemotherapy use is excluded will not be approved.
Benlysta (belimumab): will not be approved as monotherapy, for members with severe active lupus nephritis or severe active CNS lupus, for autoantibody-negative members, or in combination with other biologics or IV cyclophosphamide.

Denial Risk

Common denial risks — examples

Prior authorization is required for many specialty and select products. Requests missing required documentation, molecular/genetic or laboratory confirmation, prescriber specialty, or prior therapy history are at high risk for denial.

Prior Authorization Required: Prior authorization is required per product — submit a PA request before dispensing specialty drugs or as indicated by the product listing.
Required Medical Information & Prescriber Specialty: Include a documented diagnosis, relevant clinical history, required laboratory or molecular/genetic test results, and prescriber specialty (e.g., oncologist, urologist, psychiatrist, infectious disease specialist) as specified by the product criteria.
Prior Authorization with Diagnosis & Prior Therapy History: Provide the documented diagnosis and a detailed prior therapy history including trials, durations, and outcomes; many agents require prior trial/failure of specific therapies before approval.
Molecular/Genetic & Laboratory Confirmation: Where indicated (e.g., BRCA, FGFR3, PDGFRA, ALK, NTRK, PD-L1, D842V), include test reports showing mutation or biomarker positivity and pertinent lab values.
Prior Therapy Trials Required / Therapy Trial Failure Requirements: Document trials of required prior therapies (drug names, dates, reason for discontinuation/ failure). Lack of documented trials is a common denial reason.
Specialist Prescriber Restrictions: Some products require prescribing by or in consultation with a specialist (oncologist, pulmonologist, infectious disease specialist, psychiatrist, allergist/immunologist); attest to specialty in the request.

Applicable Codes & Billing Notes

Drugs listed in this part (product/brand names)mixedCovered

Fruzaqla	Product name listed with metastatic colorectal cancer criteria
Gavreto	RET fusion-positive NSCLC and thyroid cancer
Gilotrif	EGFR-mutant NSCLC / squamous NSCLC
Mounjaro	GLP-1 agonist - Type 2 Diabetes
Ozempic	GLP-1 agonist - Type 2 Diabetes
Rybelsus	GLP-1 agonist - Type 2 Diabetes
Trulicity	GLP-1 agonist - Type 2 Diabetes
Gomekli	NF1 plexiform neurofibromas
Genotropin	Growth hormone
Genotropin Miniquick	Growth hormone

1–10 of 65

1/7

No specific billing codes listed in Part 1mixed

No codes listed

No CPT/HCPCS/ICD-10 codes listed in this partmixed

No codes listed

Part B vs Part D determination notemixed

coverage_setting

Some drugs may be covered under Medicare Part B or Part D depending upon circumstances; information on use and setting may be required to determine coverage.

Additional product list (X-Z and parenteral/infusion list)mixed

product_list

Extensive product list including but not limited to: Xdemvy, Xeljanz, Xermelo, Xgeva, Xifaxan 550mg, Xolair, Xospata, Xpovio (60 mg/80 mg twice weekly), Xtandi, Zejula, Zelboraf, Zolinza, Ztalmy, Zurzuvae, Zydelig, Zykadia and an extended parenteral/infusion list (Acetylcysteine SOLN; Albuterol Sulfate NEBU; Aminosyn II INJ; Aprepitant; Arformoterol Tartrate; Azathioprine TABS; Bivigam INJ; Budesonide SUSP; Clinimix formulations; Cromolyn Sodium NEBU; Cuvitru; Cyclophosphamide; Cyclosporine formulations; Dronabinol; Engerix-b; Envarsus XR; Everolimus tabs; Flebogamma; Formoterol Fumarate; Gammagard Liquid; Gammaplex; Gengraf; Granisetron; Heplisav-b; Hizentra; Intralipid; Ipratropium; Levalbuterol; Mycophenolate formulations; Octagam; Ondansetron formulations; Pentamidine inhalation; Plenamine; Prehevbrio; Premasol; Privigen; Prograf; Pulmozyme; Recombivax HB; Sirolimus; Tacrolimus; Travasol; Trophamine; etc.)

Billing Rule

Part B vs Part D determination

Provide the drug use setting and administration information when requesting authorization for parenteral/infusion products so the plan can determine whether coverage is under Medicare Part B or Part D.

Specify whether the drug is being administered in a clinic, hospital outpatient, physician office, or at home
Indicate if the product is an infusion or parenteral formulation
Include documentation of the indication and who will administer the drug

Prior Authorization & Documentation Requirements

Billing Rule

Coverage duration reporting

Report the requested coverage duration in the authorization request using the policy-specified periods (commonly 2 years; some products have different initial or short durations). Also include age and weight information when limits are specified.

Coverage duration: most products list 2 years (use that value unless the product lists a different initial/subsequent duration)
Age/weight limits must be documented where present (examples: Increlex age 2–18 years; Koselugo age 2–17 years; Livtencity weight >= 35 kg; Kalydeco granules >= 1 month)

Prescriber specialty restrictions are frequent: many oncology, neurology, allergy/immunology, endocrinology, pulmonology/cardiology and psychiatric specialties are required to prescribe or cosign requests where indicated. When a specialist is required, include a specialist attestation or documentation of consultation in the authorization request.

Clinical Evidence Notes

This part contains no trial-level quantitative metrics distinct from the summary statistics; coverage aligns with FDA‑approved indications and often requires molecular testing or laboratory confirmation (for example, RAS/RET/EGFR/ROS1/ALK/IDH/FGFR/PIK3CA/BRCA testing) where specified in product criteria.

Background & Definitions

This document is part of Tufts Health One Care (Medicare‑Medicaid Plan) 2025 prior authorization medical necessity guidelines listing numerous products and the medical criteria required for coverage authorization. This Part 1 contains the first segment of products and their indication‑specific requirements.

Glossary: Coverage Duration = "Period for which authorization is approved as listed per product (commonly 2 years unless otherwise noted)."

Revision History

2025-12-01Effective DateLatest

Effective date / policy part effective

Policy Summary

Payerharvard pilgrim health care

PolicyTufts Health One Care (Medicare-Medicaid Plan) 2025 Prior Authorization Medical Necessity Guidelines

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review Date

Key ActionSubmit documented diagnosis, required prior therapy history, mutation/lab confirmation where specified, and prescriber specialty documentation to obtain prior authorization per drug.

SourceLink

On This Page

Coverage duration: 2 years

Prescribed by or in consultation with a dermatologist or rheumatologist

Coverage duration: 2 years

Continuation of Prior Therapy: For continuation/renewal requests, document prior authorization number or previous approval, dates of therapy, and response/tolerability information.

Exclusion-based Denials (examples): Icatibant (non-HAE uses), Iclusig (first-line newly diagnosed chronic phase CML), Kalydeco — note: approvals may be limited to specific genotypes (e.g., homozygous F508del may have product-specific guidance), Quinine not for nocturnal leg cramps, Rubraca concurrent chemotherapy exclusions.

Age and Weight Limits: Provide patient age and weight when listed as criteria (pediatric weight minimums or geriatric limits may apply).

Product-Specific Documentation: Include product-specific forms, prior authorization questionnaires, or manufacturer enrollment data when required.

Denial Risk for Non-specified Indications or Missing Tests: Requests for indications not specified in the policy or missing required diagnostic tests (e.g., biomarker reports) are high risk for denial.

Part B vs Part D Coverage Determination: Indicate whether the drug will be billed under Part B or Part D where relevant; missing payer/benefit pathway information can delay or affect coverage.

Clinical Documentation Required: Attach clinical notes, imaging, pathology, and lab reports supporting the requested indication and demonstrating medical necessity.

Prior Authorization Required Per Drug/Product: Ensure the PA request specifies the exact product and formulation; some molecules have different criteria by indication or formulation.