ModifiedWPS Health InsurancePolicy N/A

New-to-Market Medical Benefit Drug Policy and Medical Policy Updates

Governs how newly launched, provider-administered medications reimbursable under the medical benefit are handled (placement on New-to-Market list, coverage exclusion pending review) and summarizes recent Medical Policy Committee updates across multiple policies affecting WPS Health Insurance members and providers.

Policy Summary

PayerWPS Health Insurance

PolicyNew-to-Market Medical Benefit Drug Policy and Medical Policy Updates

Policy CodePolicy N/A

Change TypeMaterial additions and clarifications

Effective Date

Next Review Date

Key ActionSubmit prior authorization requests for medications on the New-to-Market Medication List; claims will be denied without approval.

SourceLink

POLICY UPDATE CHANGES

A Medical Benefit Drug Policy to manage newly launched, provider-administered, FDA-approved medications reimbursable under the medical benefit was introduced and defines review and exclusion processes.

Aduhelm (aducanumab) listed as a New-to-Market medication.

Fecal microbiota transplant to treat adults with ulcerative colitis will be denied as experimental, investigational, and unproven.

Spinal cord stimulator requests for complex regional pain syndrome do not require a preceding surgical consultation.

Temporary telehealth/telemedicine policy extended to March 31, 2022.

Added specific varicose vein treatment techniques (KAVS catheter, cryostripping/cryotherapy) to Limitations of Coverage as excluded items.

Added multiple items to Non-Covered Services and Procedures (examples include absorbable nasal implants, AspireAssist, colon capsule endoscopy, On-Q for post-cesarean pain, and others).

Removed several items from Non-Covered Services and Procedures (examples include Altis sling system, PRECICE limb-lengthening system, Superficial Radiation Therapy, TTVR).

Genetic and genomic tests and panels require prior authorization before testing; multi-gene panels considered experimental/investigational unless approved during prior authorization.

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Coverage Criteria and Non-Covered Services

New-to-Market Medication Coverage

Covered only after review and approval

New-to-Market coverage logic: Medication is FDA-approved, provider-administered, and reimbursable under the medical benefit and is not on the New-to-Market list OR it has been reviewed and an authorization issued following review against plan benefits and medical necessity.

Medications placed on the New-to-Market List are excluded until reviewed by the Clinical Policy and Process Committee (CPPC) or the Medical Policy Committee (MPC) or until a utilization management strategy is communicated (or by Dec. 31 of the following calendar year, whichever is earliest). Claims for listed medications will be denied unless approved after review.

Non-Covered Services — Additions

The following services and procedures are listed as non-covered by WPS:

Non-covered items: Absorbable nasal implants for the treatment of nasal valve collapse (Latera, etc.); Amniotic allografts (ocular indication added); Annular closure for prevention of lumbar disc reherniation; AspireAssist (aspiration therapy for weight loss); BioCartilage for articular defect repair; Bone substitute injection for subchondral cysts; Canvas Dx for autism diagnosis; Colon capsule endoscopy (including patency capsule and small bowel patency indication); Computerized Dynamic Posturography; Erector Spinae Plane (ESP) Block for chronic thoracic pain; External Trigeminal Nerve Stimulation (Monarch eTNS); EyeBOX for concussion/MTBI; Freespira Digital Therapeutic for panic disorder; Impella System during certain percutaneous interventions; Liposuction for lymphedema; Mucosal Integrity Testing with MiVu for GERD; Noncontact real-time fluorescence wound imaging (e.g., MolecuLight i:X) hand-held devices for point-of-care wound fluorescence imaging; On-Q (Avanos) for cesarean incisional pain; Percutaneous Epidural Adhesiolysis (e.g., Racz procedure); Percutaneous Neuromodulation Therapy (PNT/PENS) (opioid withdrawal indication added); Peripheral Field/Peripheral Nerve Stimulation (PNS) and related implantable neuromodulation devices (knee pain indication added); Pre-eclampsia screening (PerkinElmer); Quantitative Electroencephalography to predict psychotropic treatment response (non-epilepsy indications); ReddyPort for oral care with non-invasive ventilation; Signatera liquid biopsy for monitoring/detection of cancer; SpeechVive for Parkinsons-related speech disorders; Subchondral calcium phosphate injections for knee; Synchrony/Synchrony 2 cochlear implant for unilateral pediatric hearing loss; TenJet System for plantar fasciitis; TissueCypher Barrett's Esophagus Assay; Topical oxygen therapy for chronic wound healing.

Each listed item is designated non-covered per the Non-Covered Services and Procedures policy.

Non-Covered Services — Removals

The following items have been removed from the Non-Covered Services and Procedures list:

Removed non-covered items: Altis single incision sling system; Billing for 3D interpretation and reporting of imaging studies; Hydrodissection for treatment of neuropathic pain; ibs-smart for known or suspected irritable bowel syndrome; Mi eye 2 camera-enabled probe for joint evaluation; neoGEN Series System for neuropathic pain; PRECICE intramedullary limb-lengthening system; Remote Dielectric Sensing (ReDS) System for CHF monitoring; Superficial Radiation Therapy for non-melanoma skin cancer; Transcatheter Tricuspid Valve Replacement (TTVR).

These items are no longer listed as non-covered.

Limitations of Coverage — Additions

New limitations of coverage have been added for certain venous procedures:

Limitations added: Endovenous catheter-directed chemical ablation with balloon isolation [catheter-assisted venous sclerotherapy (KAVS catheter)] and cryostripping (including cryoablation, cryofreezing, cryotherapy, transilluminated cryosurgery) have been added to Limitations of Coverage.

These procedures are now subject to specified limitations within the Limitations of Coverage section.

Medications identified as newly launched, provider‑administered, FDA‑approved, and subject to this policy are placed on the New‑to‑Market Medication List and are excluded from coverage until reviewed. Requests for coverage of New‑to‑Market medications will be evaluated against the member's health plan benefits and for medical necessity using a WPS‑approved medical benefit drug policy, FDA labeling, compendia (if available), and current evidence‑based standards of care. Claims for medications on the New‑to‑Market Medication List will be denied unless an approval is issued following review. Aduhelm (aducanumab) is specifically listed on the New‑to‑Market Medication List.

Fecal microbiota transplant (FMT) to treat adults with ulcerative colitis is considered experimental, investigational, and unproven to affect health outcomes and is therefore denied under this policy.

The policy adds specific venous procedure techniques to the Limitations of Coverage. Endovenous catheter‑directed chemical ablation with balloon isolation (catheter‑assisted venous sclerotherapy — KAVS catheter) and cryostripping (including cryoablation, cryofreezing, cryotherapy, and transilluminated cryosurgery) are now enumerated with limitations and are addressed as excluded or limited per the policy.

A set of services and procedures listed in the Non‑Covered Services and Procedures section have been newly added and are excluded from coverage. Examples include absorbable nasal implants for nasal valve collapse; AspireAssist aspiration therapy for weight loss; colon capsule endoscopy; On‑Q for cesarean incisional pain; Percutaneous Neuromodulation Therapy (PNT/PENS); Peripheral Field/Peripheral Nerve Stimulation and related implantable neuromodulation devices for knee pain; and topical oxygen therapy for chronic wound healing. See the policy's Non‑Covered Services and Procedures list for the complete enumerated items.

Because FMT for adult ulcerative colitis is determined to be experimental, investigational, and unproven, requests for this treatment do not meet medical necessity criteria and will be denied as not medically necessary under this policy.

The Medical Policy Committee's position is that multi‑gene test panels are considered experimental, investigational, and unproven to affect health outcomes unless the panel is specifically approved through prior authorization. All genetic and genomic tests and panels require prior authorization before testing is completed, and coverage determinations will be made based on analytical and clinical validity, clinical utility, and evidence of positive impact.

Provider Requirements and Prior Authorization

Prior Authorization

Pre-determination recommended

New-to-market medical benefit medications require pre-approval before coverage. Medications placed on the New-to-Market Medication List are excluded from coverage and claims will be denied unless a pre-service review and approval have been completed. Providers are strongly encouraged to request pre-determination to avoid later denials.

New-to-Market medications are excluded from coverage until reviewed by CPPC or MPC and a utilization management strategy is communicated.
If a pre-determination is not requested, WPS may later deny the service as not medically appropriate or not covered.

Prior Authorization

New-to-Market drugs: Prior Authorization Required

All new-to-market drugs are subject to utilization management and require prior authorization when placed on the New-to-Market Medication List. Prior authorization requests will be reviewed against member benefits and medical necessity.

Medications on the New-to-Market Medication List will be denied at claim submission unless prior approval is granted.

Definitions and Lists

New-to-Market Medication List

DefinitionNew-to-Market Medication List — list of newly launched, provider‑administered, FDA‑approved medications that are subject to temporary exclusion and review.

Coverage status while pending reviewMedications placed on the New‑to‑Market Medication List are excluded from coverage until reviewed by the Clinical Policy and Process Committee (CPPC) or the Medical Policy Committee (MPC) or until a utilization management strategy is communicated, or by Dec. 31 of the following calendar year, whichever is earliest.

ApplicabilityApplies to medications that are FDA‑approved, health care provider administered, and reimbursable under a customer’s medical benefit.

Provider action recommendedProviders are strongly encouraged to request a pre‑determination for any new‑to‑market medication subject to review to ensure coverage; lack of pre‑determination may result in denial.

Review sourcesMedications will be reviewed against available clinical evidence, including applicable Medical Benefit Drug Policies and Optum PA Manager Clinical Criteria Compendium as available.

Policy Background and Scope

This policy governs newly launched, provider‑administered, FDA‑approved medications that are reimbursable under the medical benefit. Such medications are placed on the New‑to‑Market Medication List and remain excluded from coverage until reviewed and authorized by WPS or until utilization management strategies are established or the medication is added to the Prior Authorization List.

Prior Authorization

Genetic testing prior authorization

Genetic, genomic, pharmacogenetic, pharmacogenomic, molecular genetic, mRNA, DNA, chromosome, telomere, SNP, gene sequencing, gene expression profile tests and multi-gene panels require prior authorization BEFORE testing is performed. Coverage determinations are based on analytic and clinical validity, clinical utility, and evidence of impact on patient care.

Prior authorization is required before performing genetic/genomic/molecular tests or panels.
Multi-gene test panels are considered experimental/investigational/unproven by the MPC unless approved during prior authorization review.
Coverage assessment considers analytic validity, clinical validity, and clinical utility.

Documentation Required

Review documentation and evidence sources

Requests for coverage are reviewed against the member's benefit plan and WPS-approved clinical policies. Decisions incorporate FDA labeling, compendia, current standard of care, and available clinical evidence to determine medical necessity. Services determined experimental, investigational, unproven, or not medically necessary are typically not covered.

Coverage review will use WPS-approved medical benefit drug policies when available.
Medical necessity reviews consider FDA labeling, compendia, and evidence-based literature.
The MPC may deem multi-gene panels experimental absent supporting evidence.

Multi‑Gene Test Panels

DefinitionMulti‑gene test panels — genetic, genomic, molecular and related multi‑gene panels and tests used for analysis of DNA, RNA, SNPs, gene expression, sequencing, and related analyses.

Prior authorization requirementAll genetic/genomic/pharmacogenetic/molecular tests and panels require prior authorization BEFORE testing is completed.

Coverage determination criteriaCoverage is determined based on assessment of analytical and clinical validity, clinical utility, and evidence demonstrating a positive impact on care.

Default coverage stanceThe Medical Policy Committee considers multi‑gene test panels experimental, investigational, and unproven to affect health outcomes unless otherwise determined during prior authorization review.