NC Medicaid: Cell & Gene Therapy Access Model & Prior Authorization

North Carolina healthcare providers can now participate in a new program designed to improve access to potentially life-changing cell and gene therapies for Medicaid enrollees, officials announced this week. The state’s participation in the federal Cell and Gene Therapy (CGT) Access Model, facilitated through a Cooperative Agreement funding program, aims to reduce healthcare costs while ensuring timely access to these innovative treatments.

The move comes as gene therapies, offering the potential for cures to previously intractable diseases, continue to gain traction. However, the high cost of these therapies has presented significant barriers to access for many patients. The CGT Access Model seeks to address this challenge through a value-based approach, linking payment to patient outcomes.

Prior Authorization is Key

To ensure appropriate utilization and adherence to clinical guidelines, providers participating in the program are required to obtain prior authorization before administering cell and gene therapies to members of UnitedHealthcare Community Plan. According to a notice to providers, billing for services provided without prior authorization, or for those subsequently denied, will not be permitted.

Providers must comply with North Carolina Medicaid’s Clinical Coverage Policy 1S-13 when submitting requests. The policy outlines specific criteria for coverage and the documentation required for prior authorization.

The launch of this program in North Carolina is part of a broader national effort by the Centers for Medicare & Medicaid Services (CMS) to expand access to gene therapies. CMS recently rolled out a value-based gene therapy model specifically for sickle cell disease, signaling a shift towards innovative payment models that reward positive patient outcomes.

The timing of this announcement also aligns with broader discussions about the future of Medicaid and the challenges of balancing access, budgets, and evolving healthcare needs. KFF recently published an analysis examining the current state of Medicaid and potential changes on the horizon.

The implementation of the CGT Access Model in North Carolina represents a significant step towards making these potentially curative therapies available to a wider range of patients. The program’s success will likely be closely watched by other states considering similar initiatives. The move also reflects a growing recognition of the need for innovative financing mechanisms to address the high cost of gene therapies and ensure equitable access to these groundbreaking treatments.

the CMS is actively reshaping payment models across the healthcare landscape. Recent reports indicate that CMMI (the Center for Medicare & Medicaid Innovation) is cutting participation in some payment models, estimating savings of $750 million. This suggests a continued focus on value-based care and a willingness to refine existing programs to maximize their impact.

The new approach to covering gene therapies, starting with sickle cell disease, is being hailed as a potential game-changer. As reported by the Oklahoma Voice, this new method aims to provide states with a more sustainable way to finance these expensive therapies.