On February 25, 2025, Health Alliance Medical Plans (“Health Alliance”) and FirstCarolinaCare (“FCC”) shared with you that Carle Health (“Carle”) had decided to cease health plan operations for its Health Alliance and FCC commercial lines of business as of January 1, 2026, while still evaluating its Medicare Advantage line of business.

After careful review of the healthcare and insurance landscape, Carle Health has made the difficult decision to discontinue Medicare Advantage lines of business effective December 31, 2025. Like many provider-owned health plans across the country, we’ve faced increasing challenges in continuing to offer Medicare Advantage coverage in a way that is sustainable long term.

Medicare Advantage members will continue to receive full access to benefits and services through the end of the year. As our trusted partner we also want to assure you that there will be no changes for the remainder of the year. You can continue to provide high-quality care to our members across all product lines.

Health Alliance and FCC remain dedicated and committed to providing high-quality health insurance services to members, employers, providers, and community agencies through this transition.

To this end, Health Alliance and FCC will assure adequate levels of operations after 2025, to support claims processing and to meet ongoing business needs, regulatory mandates and contractual obligations relating to the provision of health care services initiated and/or completed prior to January 1, 2026.

Our team members at every level are here to support you with information, training, education and any other assistance you may need to care for our members. Our Provider Relations teams are available to help with claims inquiries, access to the provider portal and other operational matters. We hope this communication will help you prepare to meet your patient’s needs.

Pharmacy Updates

April 15, 2025

All Plans

Dermatology

 New Drug Reviews / Policies

• Ebglyss (lebrikizumab)—Treatment of moderate to severe atopic dermatitis in adults and pediatric patients ≥12 years of age weighing ≥40 kg whose disease is not adequately controlled with topical prescription therapies
  • Formulary placement recommendations
    • Commercial—Preferred Specialty Pharmacy with PA and MDL (4mL/28 days)
    • Medicare—Non-Formulary
  • Sofdra (sofpironium)—Treatment of primary axillary hyperhidrosis in adults and pediatric patients ≥9 years of age
    • Formulary placement recommendations
      • Commercial—Non-Preferred Brand with PA and MDL (4mL/28 days)
      • Medicare—Non-Formulary
    • Nemluvio (nemolizumab)—Treatment of moderate to severe atopic dermatitis in adults and pediatric patients ≥12 years of age AND Treatment of prurigo nodularis in adults
      • Formulary placement recommendations
        • Commercial—Non-Formulary
        • Medicare—Non-Formulary

Gastroenterology

New Drug Reviews / Policies

• Iqirvo (elafibranor)—Treatment of primary biliary cholangitis, in combination with ursodeoxycholic acid (UDCA), in adults who have had an inadequate response to UDCA
  • Formulary placement recommendations
    • Commercial—Non-Formulary
    • Medicare—Non-Formulary
  • Livdelzi (seladelpar)—Treatment of primary biliary cholangitis, in combination with ursodeoxycholic acid (UDCA), in adults who have had an inadequate response to UDCA
    • Formulary placement recommendations
      • Commercial—Non-Formulary
      • Medicare—Non-Formulary
    • Rezdiffra (resmetirom) policy
      • Remained Non-Formulary when presented at P&T last year
      • Now putting on formulary based on volume overturn rate and AASLD recommendations
      • Formulary placement recommendations
        • Commercial—Non-Preferred Specialty with PA and MDL of #30/30 days
        • Medicare—Non-Formulary (no change)

Commercial

Dermatology

Criteria Changes

• Spevigo
  • Added criteria for subQ formulation
• Livmarli
  • Updated age criteria based on FDA approval
• Vtama
  • Added criteria for atopic dermatitis

Gastroenterology

Criteria Changes

• Ocaliva
  • Added additional liver function criteria based on new boxed warning
• Tenapanor Products
  • Added trial with Velphoro

Brand Stelara Formulary Removal Update

Summary

• Covered biosimilars include: Wezlana (LW), Otulfi, Selarsdi, Yesintek, Steqeyma and Pyzchiva
• Cost difference (average)
  • Stelara: $25,912/script
  • Biosimilar: $5,274/script

Policies Affected (biosimilars replace mention of brand Stelara in criteria)

• Crohn’s Disease Immunomodulator Policy
  • Also added Omvoh and Tremfya since they are now FDA-approved for treatment of Crohn’s
• Plaque Psoriasis Immunomodulator Policy
• Psoriatic Arthritis Immunomodulator Policy
• Remicade and Infliximab Biosimilars Policy
• Tysabri Policy
• Ulcerative Colitis Immunomodulator Policy

Formulary Changes

• Positive Changes
  • Kesimpta and Vumerity
    • Downtier from Non-Preferred Specialty to Preferred Specialty
    • 31 members on Kesimpta
    • 17 members on Vumerity
  • Negative Changes
    • Altabax and Xepi topicals
      • Remove from formulary
      • No member utilization
      • Products have been discontinued

The P&T Committee meets bimonthly, and formulary changes and criteria changes can occur during the meetings. Negative formulary changes are generally made effective on 1/1 and 7/1, while positive formulary changes are effective immediately to better serve our members and providers. Upcoming negative formulary and criteria changes can be found online at the following website: https://www.firstcarolinacare.com/documents/960/2022. Drug coverage and policies in the following categories will be reviewed during the remainder of 2025 and changes may be made:

• June Meeting: Cardiology, Endocrinology, Pulmonology.
• August Meeting: Neurology, Psychiatry, Pain.
• October Meeting: Ophthalmology, Urology, Rare Diseases.
• December Meeting: Specialty and Medicare.

We have a new fax number: (888) 259-0102.

 In the past, some providers who routinely fax Inpatient Notification of Admissions, SNF Prior Authorization requests and other associated clinical information have had difficulty faxing our Utilization Management Department. To resolve this issue, we’re happy to announce that we have a new fax number. Effective immediately, please use our new toll-free fax number of (888) 259-0102. Thank you for your valued partnership.

 FirstCarolinaCare.com/Providers

Effective April 1, 2025, Stelara (ustekinumab) will be a nonformulary medication, and all non-Medicare patients will need to switch to an ustekinumab biosimilar for covered treatment.

Several biosimilars have been approved by the Food and Drug Administration (FDA) over the last several months, and they’re now covered on our formulary at the preferred specialty tier with prior authorization. Per the FDA, these products have no clinically meaningful differences and they share the same indications as Stelara. Covered products include select NDCs of Wezlana, Otulfi, Selarsdi, Yesintek, Steqeyma and Pyzchiva. Wezlana, Selarsdi, Yesintek and Pyzchiva have patient-assistance programs which may lower the monthly cost for eligible patients.

To better facilitate this transition, no new prior authorizations will be needed to switch products as long as the member has been filling Stelara consistently or has an active prior authorization on file. Patients and prescribers impacted have already received individualized letters notifying them of this change.

Providers should begin to substitute patients to a covered ustekinumab biosimilar in advance of the 4/1/25 Stelara formulary removal. This will ensure a smooth transition and decrease any therapy disruptions.

Thank you for your valued partnership.

IMPORTANT

Upcoming Changes to Coverage Criteria for Weight Loss Medications;

FirstHealth of the Carolinas’ Covered Health Plan Participants Only

Effective May 1, 2025, weight loss medication prescriptions will be covered for FirstHealth of the Carolinas Employee Group members only when:

1. Requested and written by a designated FirstHealth weight management provider; and
2. Filled through the FirstHealth Outpatient Pharmacy.

Important Notes:

• These changes are in addition to the medical necessity criteria already in place.
• Weight loss medication authorizations for FirstHealth Employee Group members from alternate providers will be honored for their current duration.

Contact Information:

• Members should be referred to the FirstHealth Weight Management clinic at (910) 715-8950 to set up an appointment.
• The FirstHealth Outpatient Pharmacy can be reached at (910) 715-4250.
• If you have any questions regarding weight loss medication coverage, please call the FirstCarolinaCare Department of Pharmacy Services at (866) 267-5835.

Carle Health has announced after careful consideration, as of January 1, 2026, our health plans will cease operating all lines of business except for Medicare Advantage.

Throughout the remainder of 2025, the health plans will maintain a level of operations to support claims processing and meet ongoing business needs, regulatory mandates, and contractual obligations.

As a leader in healthcare, Carle Health has an obligation to set the standard for excellence. We continually evaluate and expand on successful components of our organization while addressing areas that may fall short. Every action and strategy we pursue is rooted in our mission to be a trusted partner in healthcare decisions, ensuring we effectively utilize our resources to best serve our patients, families, and communities.

As our trusted provider partner, we want to assure you that nothing will change for the remainder of the year. You can continue to provide high-quality care to our members across all product lines. Our team members at every level are here to support you with information, training, education, and any other assistance you may need to care for our members.

Health Alliance and FirstCarolinaCare remains dedicated and committed to providing high-quality health insurance services to members, employers, providers, and community agencies through this transition.

Our Provider Relations team remains available to help with claims inquiries, access to the provider portal and other operational matters.

Oncology / Hematology

New Drug Reviews / Policies

• Beqvez (fidanacogene elaparvovec)—Treatment of moderate to severe hemophilia B (congenital factor IX deficiency) in adults who currently use factor IX prophylaxis therapy or have current or historical life-threatening hemorrhage or have repeated, serious spontaneous bleeding episodes and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid
  • Formulary placement recommendations
    • Commercial—Non-Preferred Specialty Medical with PA
    • Medicare—Part B with PA
  • Hympavzi (marstacimab)— Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII [FVIII] deficiency) without FVIII inhibitors, or hemophilia B (congenital factor IX [FIX] deficiency) without FIX inhibitors
    • Formulary placement recommendations
      • Commercial—Non-Preferred Specialty Pharmacy/Medical with PA and MDL (#4/28 days)
      • Medicare—Non-Formulary
    • Alhemo (concizumab)— Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors, or hemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors
      • Formulary placement recommendations
        • Commercial—Non-Preferred Specialty Pharmacy with PA
        • Medicare—Non-Formulary
      • Piasky (crovalimab)—Treatment of paroxysmal nocturnal hemoglobinuria in patients ≥13 years of age and ≥40 kg
        • Formulary placement recommendations
          • Commercial—Non-Formulary
          • Medicare—Non-Formulary
        • Note: Medicare Piasky placement and criteria are pending CMS review
      • Voydeya (danicopan)—Treatment of extravascular hemolysis, as add-on therapy to ravulizumab or eculizumab, in adults with paroxysmal nocturnal hemoglobinuria
        • Formulary placement recommendations
          • Commercial—Non-Preferred Specialty Pharmacy with PA and MDL (#180/30)
          • Medicare—Non-Formulary
        • Vafseo (vadadustat)—Treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least 3 months
          • Formulary placement recommendations
            • Commercial—Non-Formulary
            • Medicare— Non-Formulary

Commercial

Oncology / Hematology

Criteria Changes

• Ultomiris
  • Added criteria for NMOSD, added vaccination criteria per package insert

Miscellaneous Policy Changes

• Fabhalta
  • Added exclusion for IgAN indication, updated reauthorization criteria
• Filspari
  • Drug was previously excluded from formulary
  • Created coverage criteria because FDA approval changed from Accelerated to Traditional Approval
• Ivermectin
  • Retiring policy and removing PA since no longer seeing large quantity of inappropriate usage
• Spravato
  • Removed augmentation requirement and removed conjunction antidepressant requirement due to updated indication approval
• Wegovy
  • Added Virta requirement for SOIL members
• Zepbound
  • Policy was created given the new FDA indication for obstructive sleep apnea (OSA)
• Weight Loss Medications
  • Adjusted FirstHealth criteria so that requests will only be approved from a FirstHealth Weight Management Center physician
• Medicare Part B Policy for Qalsody
  • Policy was created after CMS ruled that drug cannot be excluded from Medicare coverage due to Accelerated Approval status

The P&T Committee meets bimonthly, and formulary changes and criteria changes can occur during the meetings. Negative formulary changes are generally made effective on 1/1 and 7/1, while positive formulary changes are effective immediately to better serve our members and providers. Upcoming negative formulary and criteria changes can be found online at the following website: HealthAlliance.org/Documents/960/2022. Drug coverage and policies in the following categories will be reviewed during the remainder of 2025 and changes may be made:

• April Meeting: Rheumatology, Gastroenterology, Dermatology.
• June Meeting: Cardiology, Endocrinology, Pulmonology.
• August Meeting: Neurology, Psychiatry, Pain.
• October Meeting: Ophthalmology, Urology, Rare Diseases.

December Meeting: Specialty and Medic

For Medicare Advantage Plans

With the action taken by Congress in late 2024, telehealth requirements for Medicare Advantage patients will remain the same for the first part of 2025. Providers should continue to bill claims as they have in the past for those services and not utilize the new 98000-98015 CPT codes that became effective on January 1, 2025. There is now a reimbursement guide on our website that serves as a reference for defining telehealth and how to properly bill those services. There may be further Congressional action that will impact this later in 2025. FirstCarolinaCare will not reimburse any Medicare Advantage telehealth services billed with CPTs 98000-98015 for 2025 dates of service. Acceptable places of service are 02 and 10 for these services.

For Commercial Plans

Only the new CPT codes should be utilized when billing for telehealth services for Commercial plan patients. A reimbursement guide is available on our website to guide providers on what is and is not acceptable for billing telehealth services for Commercial patients. FirstCarolinaCare will no longer accept telehealth services billed with CPTs outside of 98000-98015.  Acceptable places of service are 02 and 10 for these services.

Pharmacy Updates

January 14, 2025

All Plans

New Drug Review

• Cobenfy (xanomeline/trospium— Treatment of schizophrenia in adults
  • Formulary placement recommendations
    • Commercial—Non-Preferred Brand with PA and QL (#60/30 days)
    • Medicare—Non-Formulary

Commercial

Criteria Changes

• Dupixent
  • Added coverage criteria for COPD indication
• Zoryve
  • Added coverage criteria for atopic dermatitis
• Diabetes Medications
  • Added step through preferred GLP-1s to Victoza
• Polyarticular Juvenile Idiopathic Arthritis Immunomodulator Therapies
  • Added Cimzia to policy
• Ankylosing Spondylitis Immunomodulator Therapies
  • Added Bimzelx to policy
• Non-Radiographic Axial Spondyloarthritis Immunomodulator Therapies
  • Added Bimzelx to policy
• Psoriatic Arthritis Immunomodulator Therapies
  • Added Bimzelx to policy removed DMARD step
• Plaque Psoriasis Immunomodulator Therapies
  • Removed body surface area (BSA) requirement and updated step criteria

Formulary Changes—Commercial

Positive Changes (effective 1/1/2025)

Estradiol 0.01% cream – Down tier to Preventive

• New legislation requiring a vaginal estradiol product be covered without cost-share

Negative Changes (effective 2/1/2025)

Compounding kits and Wound dressings – Remove from formulary

• No member utilization
• Most products have over the counter equivalents

 Negative Changes (effective 4/1/2025)

BRAND Sprycel – Remove from formulary

• Equivalent generic product now available

Diclofenac 25mg immediate release products – Remove from formulary

• Rarely prescribed as most prefer delayed release formulations

Stelara Brand Removal (effective 4/1/2025)

• Several biosimilars have been approved by the FDA in the past several months and will launch in early 2025
  • Expect 6-8 products to launch within the first 3 months of 2025
  • These biosimilars have no clinically meaningful differences and share the same indications as Stelara
  • Several products will have interchangeability designation
• Policies Affected
  • Crohn’s Disease Immunomodulator Policy
  • Plaque Psoriasis Immunomodulator Policy
  • Psoriatic Arthritis Immunomodulator Policy
  • Remicade and Infliximab Biosimilars Policy
  • Tysabri Policy
  • Ulcerative Colitis Immunomodulator Policy

The P&T Committee meets bimonthly, and formulary changes and criteria changes can occur during the meetings. Negative formulary changes are made effective on 1/1 and 7/1, while positive formulary changes are effective immediately to better serve our members and providers. Upcoming negative formulary and criteria changes can be found online at the following website: HealthAlliance.org/Documents/960/2022. Drug coverage and policies in the following categories will be reviewed during the remainder of 2025 and changes may be made:

• February Meeting: Oncology, Hematology, Infectious Disease.
• April Meeting: Rheumatology, Gastroenterology, Dermatology.
• June Meeting: Cardiology, Endocrinology, Pulmonology.
• August Meeting: Neurology, Psychiatry, Pain.
• October Meeting: Ophthalmology, Urology, Rare Diseases.
• December Meeting: Specialty and Medicare.

Updates to High Cost Medical Drugs List

See the table below for changes to the High Cost Medical Drugs List with effective dates.

The full list is available here: High Cost Medical Drugs List.

Note: Medications removed from the High Cost Medical Drugs List may still require prior authorization.

Note: This article/table only applies to our Health Alliance^TM branded Commercial plans.

Note: This article/table does not apply to any of our Medicare plans (no matter what their brand/name).

Effective 7/1/24, FirstCarolinaCare added Omnipod insulin pods to the Medicare Part D formulary. Coverage of Omnipods does require prior authorization.

Requests for prior authorization should be submitted to the Health Alliance Pharmacy department through the GuidingCare portal. Members will be approved for coverage if they meet the CMS Local Coverage Determination criteria for external infusion pumps as well as if the member meets medical necessity for the need of a tubeless pump.

Requests for the use of an Omnipod for Medicare members should NOT be submitted to the Health Alliance Utilization Management department.
Commercial members will continue to submit requests to Health Alliance Utilization Management.

Please reach out to your Provider Relations Specialist with any questions.