harvard pilgrim health care Part D Prior Auth Policy | OpenPayer
Currentharvard pilgrim health carePolicy N/A
Tufts Health One Care (HMO D-SNP) 2026 Part D Prior Authorization Medical Necessity Guidelines (partial)
Prior authorization medical necessity criteria for multiple Part D pharmacy and specialty drug products, listing product-specific required diagnoses, prescriber specialty requirements, prerequisite Part D therapy when applicable, coverage durations, and exclusions to guide Part D prior authorization requests.
Policy Summary
Payerharvard pilgrim health care
PolicyTufts Health One Care (HMO D-SNP) 2026 Part D Prior Authorization Medical Necessity Guidelines (partial)
Policy CodePolicy N/A
Change TypeNo material changes
Effective DateFeb 1, 2026
Next Review DateN/A
Key ActionProviders must submit required clinical documentation (diagnosis, prior therapies and failures, specialty prescriber or consultation, and applicable Part D prerequisite therapy) with all prior authorization requests.
~120+drug product entries in this part (partial document)
2 yearsmost standard coverage duration listed
Mosttypical coverage duration specified
Severalproducts with oncologist prescriber restriction
Many
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products require specialist prescriber
Product- and Indication-Specific Medical Necessity Criteria
General product-level medical necessity/authorization criteria (per drug)
Each listed product has a set of required medical information and additional constraints. Approvals are typically conditional on meeting ALL of the listed product-specific criteria:
ALL of the following
Documented diagnosis appropriate to the requested drug (varies by product; see product-specific entries)
Prescriber restrictions when specified (e.g., must be an oncologist, psychiatrist, dermatologist, rheumatologist, hematologist/oncologist, allergist/immunologist, nephrologist, pulmonologist, infectious disease specialist)
Prerequisite therapy requirement: either 'Criteria DOES require use of a prerequisite Part D drug' or 'Criteria DOES NOT require use of a prerequisite Part D drug' as specified per product
Coverage duration limits — typically 2 years (some exceptions: migraine initial 6 months, Cresemba 1 year, Emgality subsequent 'Life of Plan')
Product-specific exclusions or limitations when listed (e.g., Benlysta not approved as monotherapy or for autoantibody-negative SLE; Arikayce required as part of combination regimen and after failure to achieve 2 negative sputum cultures after min 6 months)
Example nested criteria — Cosentyx (illustrative of detailed criteria style)
Cosentyx approval requires ALL of the following per indication-specific requirements:
ALL of the following
Indication (ONE of)
Ankylosing Spondylitis: documented diagnosis of active ankylosing spondylitis
Plaque Psoriasis: documented diagnosis of moderate-to-severe plaque psoriasis AND failure/intolerance to at least one topical therapy (examples listed)
Psoriatic Arthritis: documented diagnosis of psoriatic arthritis
Non-radiographic Axial Spondyloarthritis: documented diagnosis of active non-radiographic axial spondyloarthritis with objective signs of inflammation (e.g., elevated CRP and/or sacroiliitis on MRI) AND prior trial/failure/contraindication/intolerance to two NSAIDs for at least one month at maximally indicated doses
Used as part of a combination antibacterial drug regimen
Patient did not achieve at least two negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen (e.g., macrolide, rifamycin, ethambutol)
Prescribed by or in consultation with an infectious disease specialist or pulmonologist
Coverage duration: 2 years
Example nested criteria — Abiraterone (and similar androgen-axis agents)
Abiraterone approval requires ALL of the following:
ALL of the following
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 must be an oncologist or urologist
Coverage duration: 2 years
Prerequisite therapy: Criteria DOES NOT require use of a prerequisite Part D drug
Example nested criteria — Benlysta (belimumab)
Benlysta approval requires ALL of the following:
ALL of the following
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: not approved as monotherapy, not for autoantibody-negative patients, not in combination with other biologics or IV cyclophosphamide
Coverage duration: 2 years
Product-specific coverage criteria (extracts)
Each product is covered when the listed required medical information, prescriber restriction and any prerequisite therapy requirements are met. Below are parsed criteria for products present in this part.
Empaveli (PNH)
Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
Prescribed by or in consultation with a hematologist, oncologist, or nephrologist
Coverage duration: 2 years
Reauthorization: patient demonstrates positive clinical response to therapy
Prerequisite Part D drug: NOT required
Enbrel (etanercept) formulations
General product-level coverage requirements (repeated pattern)
For each listed product, coverage is allowed when the member meets the product-specific required medical information and any listed prerequisites/prescriber restrictions:
ALL of the following
Documented diagnosis consistent with the product-specific indication (details below per product)
If listed, prescriber must be the specified specialty or in consultation with that specialty
Prescriber restrictions present for multiple oncology, neurology, cardiology, rheumatology, and other specialty drugs
If listed, prerequisite Part D drug trial required
Many but not all products require prior Part D drug trial(s); specific products indicate whether a prerequisite Part D drug is required or not
Coverage duration: typically 2 years unless otherwise noted (some 1 year)
Examples — Product-specific criteria extracted from this part
Each product below lists the specific required medical information and any unique constraints.
Empagliflozin (part shown at top) / general SGLT2-like entry
Member must have documented diagnosis of chronic kidney disease associated with type 2 diabetes OR heart failure with left ventricular ejection fraction (LVEF) >= 40%
Coverage duration: 2 years
Prerequisite therapy: No prerequisite Part D drug required
Kesimpta
Diagnosis of relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting disease, active secondary progressive disease)
Remaining criteria trees and product-specific entries (excerpts)
Additional product and indication-specific criteria from the document. Each block below preserves the operator logic and leaf criteria as listed in the source.
ALL of the following
Arikayce: Diagnosis of Mycobacterium avium complex (MAC) lung disease
Used as part of a combination antibacterial drug regimen
Patient did 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
Numeric and Clinical Thresholds Used in Criteria
Arikayce sputum culture responseDid not achieve at least two negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen
Cosentyx NSAID trialMinimum duration of one month trial and failure, contraindication, or intolerance to two NSAIDs at maximally indicated doses
Migraine biologics initial approvalInitial approval duration 6 months; subsequent approval based on clinically significant reduction in migraine days per month as determined by prescriber
Jynarque hepatic monitoringIf on therapy ≤18 months: ALT/AST/bilirubin measured prior to initiation, at 2 and 4 weeks after initiation, then monthly for first 18 months; if >18 months: ALT/AST/bilirubin measured at least every 3 months
Genotropin pediatric height thresholdHeight at initiation > 2 standard deviations below normal mean for age and sex
Providers must obtain prior authorization for specialty and Part D drugs and submit the required medical information per product. Documentation should include the specific diagnosis, prior therapies (failures/contraindications/intolerances), and prescriber specialty when required; submit any product-specific medical information requested for the drug being dispensed.
Include diagnosis, prior therapies (failures/contraindications/intolerances), and prescriber specialty when applicable
Submit required medical information per product to support PA adjudication
Documentation Required
Specialty prescriber documentation
When a product lists a prescriber restriction, the ordering clinician must be the specified specialist or document consultation with one; specialty involvement must be included in the prior authorization submission.
This document is part of the Tufts Health One Care (HMO D-SNP) 2026 Prior Authorization Medical Necessity Guidelines for Part D drugs and provides product-specific clinical criteria to support prior authorization adjudication for high-cost and specialty medications. It enumerates required medical information for each product, including the documented diagnosis necessary to justify use, any prescriber specialty restrictions or requirements for consultation with a specialist, and specified prerequisite Part D drug therapy requirements where applicable. The guidance also specifies standard coverage durations (typically 2 years, with noted exceptions such as migraine initial approvals of 6 months, Cresemba 1 year, and certain subsequent approvals like Emgality listed as Life of Plan). Finally, the part lists product-level exclusions and limitations that may result in denials (for example, certain agents not approved as monotherapy, genotype-based exclusions, or explicit excluded uses), and is intended to direct provider submissions of diagnosis, prior therapy history, specialty involvement, laboratory or mutation testing, and monitoring data required to evaluate medical necessity under the Part D prior authorization process.
Terms Defined in This Part
Criteria DOES require use of a prerequisite Part D drugIndicates the product requires prior trial/use of a specified Part D medication before approval; documentation of that prior therapy must be provided.
Criteria DOES NOT require use of a prerequisite Part D drugIndicates no prerequisite Part D drug trial is required for authorization of this product.
Prerequisite Part D drugIndicates whether the policy requires trial/use of a formulary Part D medication prior to approval of the requested specialty drug.
ReauthorizationCriteria required to continue previously authorized therapy, often requiring evidence of clinical response.
TF/C/ITrial and failure, contraindication, or intolerance
Part D drugMedications covered under Medicare Part D / the insurer's prescription drug benefit
PPFEV1
Policy Dates & Changes
2026-02-01Effective DateLatest
Policy effective date per document header
No material changes provided in this part.
Policy Summary
Payerharvard pilgrim health care
PolicyTufts Health One Care (HMO D-SNP) 2026 Part D Prior Authorization Medical Necessity Guidelines (partial)
Policy CodePolicy N/A
Change TypeNo material changes
Effective DateFeb 1, 2026
Next Review DateN/A
Key ActionProviders must submit required clinical documentation (diagnosis, prior therapies and failures, specialty prescriber or consultation, and applicable Part D prerequisite therapy) with all prior authorization requests.
Enthesitis-related Arthritis (ERA): documented diagnosis of active ERA AND prior trial/failure/contraindication/intolerance to two NSAIDs for at least one month
Hidradenitis Suppurativa: documented diagnosis (details truncated in this part)
Prescribed by or in consultation with a dermatologist or rheumatologist
Coverage duration: 2 years
Prerequisite therapy: Criteria DOES require use of a prerequisite Part D drug
Prerequisite therapy: Criteria DOES require use of a prerequisite Part D drug
Prerequisite therapy: Criteria DOES NOT require use of a prerequisite Part D drug
Diagnosis-specific requirements
Ankylosing spondylitis: documented diagnosis of active disease
Plaque psoriasis: documented moderate-to-severe plaque psoriasis AND failure/intolerance to at least one topical option (listed examples)
Rheumatoid arthritis: documented RA AND trial and failure, contraindication, or intolerance to ONE of methotrexate, leflunomide, or sulfasalazine
Polyarticular juvenile idiopathic arthritis: documented PJIA AND trial/failure/contraindication/intolerance to ONE of methotrexate, leflunomide, or sulfasalazine
Psoriatic arthritis: documented diagnosis (text truncated in source)
Prescribed by or in consultation with a dermatologist or rheumatologist
Coverage duration: 2 years
Prerequisite Part D drug: REQUIRED
Epidiolex
Diagnosis: seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC)
Prescriber must be a neurologist
Coverage duration: 2 years
Prerequisite Part D drug: NOT required
Erivedge (vismodegib)
Diagnosis: metastatic basal cell carcinoma or locally advanced basal cell carcinoma recurrent after surgery or patient not a surgical candidate and not a candidate for radiation
Prescriber must be a dermatologist or oncologist
Coverage duration: 2 years
Prerequisite Part D drug: NOT required
Prescribing physician must be a neurologist
Coverage duration: 2 years
Prerequisite therapy: No prerequisite Part D drug required
Kineret
Rheumatoid arthritis (initial)
Diagnosis of moderately to severely active RA
ANY of the following
Trial and failure, contraindication, or intolerance (TF/C/I) to two of: Enbrel, one formulary adalimumab product, Orencia, Rinvoq, Xeljanz/XR OR attestation that trial is inappropriate
Or continuation of prior therapy
NOMID (initial)
Diagnosis of NOMID
Confirmation by NLRP-3/CIAS1 gene mutation
ALL of the following
Two clinical symptoms from: urticaria-like rash, cold/stress triggered episodes, sensorineural hearing loss, musculoskeletal symptoms, chronic aseptic meningitis, or skeletal abnormalities
Prerequisite therapy: Criteria DOES require use of a prerequisite Part D drug (for certain uses)
Kisqali (and Kisqali Femara dosing variants)
Diagnosis of HR-positive, HER2-negative advanced or metastatic breast cancer AND used in combination with an aromatase inhibitor as initial endocrine-based therapy OR with fulvestrant as initial endocrine-based therapy or after progression on endocrine therapy
Prescriber must be an oncologist
Coverage duration: 2 years
Prerequisite therapy: Criteria DOES require use of a prerequisite Part D drug
Prerequisite therapy: Criteria DOES require use of a prerequisite Part D drug
Benlysta (belimumab) — summary
Documented diagnosis of active, autoantibody-positive SLE or active lupus nephritis
Concomitant standard therapy (antimalarials, corticosteroids, or immunosuppressives)
Prescriber specialty: nephrologist or rheumatologist
Not approved as monotherapy; not for autoantibody-negative patients; not in combination with other biologics or IV cyclophosphamide
Coverage duration: 2 years
Prerequisite therapy: Criteria DOES NOT require use of a prerequisite Part D drug
AIDS wasting definitionWeight loss ≥10% from baseline OR BMI < 20
Left ventricular ejection fraction>= 40%
Minimum weight for Livtencity>= 35 kg
Rezdiffra fibrosis stagingFibrosis stage F2 or F3 confirmed by serum + imaging biomarker OR FAST/MAST/MEFIB/liver biopsy within 12 months
Trikafta age/formulation thresholdsGranule packets: 2 to <6 years; Tablets: ≥6 years
Xpovio DLBCL prior therapies>= 2 lines of systemic therapy
Document the specialist name or attach consultation notes with the PA request
Prior Authorization
Prerequisite therapy verification
If the product entry indicates 'Criteria DOES require use of a prerequisite Part D drug', providers must document prior use of the required Part D therapy and rationale for change when applicable.
Document dates, agents, and reason for discontinuation of the prerequisite Part D drug
If the brief specifies 'Criteria DOES require use of a prerequisite Part D drug', include prior Part D drug history on the PA
Denial Risk
Denial risk for off-label/unlisted indications
Requests for drug use that do not match a listed product-specific indication or that fall into explicitly excluded uses risk denial; review product exclusions before submitting a PA.
Kalydeco is not effective for patients homozygous for F508del — such requests may be denied
Icatibant will not be approved for acquired angioedema or patients concurrently taking an ACE inhibitor
Quinine will not be approved for treatment or prevention of nocturnal leg cramps
Tadalafil is excluded for erectile dysfunction (ED); coverage limited to BPH criteria
Rubraca will not be approved for concurrent use with other chemotherapy agents
Documentation Required
Diagnosis and prior therapy documentation
Provide diagnostic documentation and prior therapy history as required by the product-specific criteria; include molecular testing results and prior lines of systemic therapy where specified.
Submit molecular/genetic test reports when indicated (e.g., EGFR, RET, ROS1, IDH2, PIK3CA, BRCA, MET exon 14)
List prior systemic therapy lines, dates, and evidence of failure/intolerance when required
Prior Authorization
Authorization duration and reauthorization requirements
Initial authorizations are commonly issued for up to 2 years; some products have different initial durations (for example, sapropterin initial authorization is 8 weeks). Reauthorization requires submission of evidence of clinical benefit as specified in the product criteria.
Typical authorization duration = 2 years
Sapropterin: initial authorization 8 weeks; subsequent authorization 2 years with evidence of improvement
For reauthorization, submit documented clinical response measures per product (e.g., symptom reduction, biomarker improvement, radiographic response)
Prior Authorization
Prescriber specialty restriction
When a prescriber specialty is specified, the prescribing clinician must be of that specialty or a documented consultation must be provided; the prescriber's specialty should be evident in the submitted medical records or referral/consult notes.
If the product requires an oncologist, neurologist, pulmonologist, rheumatologist, cardiologist, gastroenterologist, allergist/immunologist, nephrologist, dermatologist, or other listed specialist, document that specialty on the PA
If another clinician initiates therapy, include consultation notes from the required specialist
Billing Rule
Setting of drug may affect benefit (Part B vs Part D)
For some drugs the benefit or claim processing may depend on the drug setting (Part B vs Part D); include information about the place of administration and clinical setting to support correct benefit determination.
Provide details about administration setting (e.g., physician office, infusion center, outpatient hospital) when submitting the PA
Include clinical justification if billing under Part B is anticipated or appropriate
Percent predicted forced expiratory volume in one second
Coverage durationStandard authorized duration for therapy before reauthorization is required; most entries specify 2 years unless otherwise noted.
Prerequisite Part D drug (alt)A previously required Part D medication trial specified by the policy for certain products; entries indicate whether such a prerequisite is required or not.
TF/C/I (duplicate)Trial and failure, contraindication, or intolerance
Prerequisite Part D drug (def) repeatedA previously required medication covered under Medicare Part D that must have been tried before the requested specialty drug will be approved (documented when specified).