Reaching Patients Where They Are: Moving CGT Care into the Community

Cell and gene therapy (CGT) research and development continues to advance at a remarkable pace. The late-stage pipeline remains robust in oncology, while also expanding into new disease states where therapies could benefit much larger patient populations. Scientific advancements and growing clinical evidence are accelerating the transition of these therapies from investigational to real-world use.

Despite the exciting advances in science, access to CGT remains a very real challenge. Access to approved CGTs remains highly concentrated at large academic medical centers (AMCs) in major metropolitan areas. That distribution creates a stark geographic divide, with approximately 60 million Americans living in smaller cities and rural areas with limited access to qualified CGT treatment centers.¹

Expanding CGT care into community settings is crucial to improve patient access to care and prepare for the expected increase in commercially available CGTs. However, several challenges are slowing this expansion, including limited resources, administrative burdens, policy requirements, and reimbursement challenges. Developing scalable solutions to address these challenges is both possible and urgently needed. Expanding the capabilities of community care sites can improve access to advanced therapies.

The concentration of CGT care in major metropolitan areas is one of the biggest barriers to patient access. A study from Avalere Health found that more than 70% of potential CAR T-cell therapy candidates across indications live more than 30 minutes from a treatment site.² For patients who live 2 to 4 hours from the nearest treatment center, the likelihood of receiving CAR T-cell therapy drops by 40%.³ For too many patients, geographic proximity, rather than clinical eligibility, often dictates access to CGTs.

For patients living in “CGT deserts,” accessing treatment may require traveling across the country, taking extended time away from work, arranging childcare, and leaving their support systems behind. Out-of-pocket costs for transportation, lodging, and meals add up quickly and can be prohibitive for many families. In many cases, medical guidelines for CGTs can require a prolonged stay near the treating hospital with a caregiver for up to 2 weeks. Even when CGTs are the best treatment option available, these barriers may be prohibitively disruptive or financially burdensome for patients.

Offering CGTs at community sites may help to ease these points of friction. When treatment and monitoring are available closer to home, patients are more likely to start and complete therapy, caregivers can remain engaged without untenable burdens, and referring providers stay more connected to the patient’s journey. From a health care system perspective, distributing care across a wider network also frees scarce capacity at AMCs, which will be essential as the number of approved CGT products and eligible patients grows.

That growth is coming. The US CGT pipeline remains robust, with more than 178 new oncology-focused candidates entering late-stage development in the past year.⁴ Scientific momentum is also expanding beyond oncology into autoimmune diseases, diabetes, and congestive heart failure—disease areas with far larger patient populations. Without expanded access, the clinical and societal benefits of CGTs may be delayed.

Policy changes are also accelerating the need to build referring-provider capacity. The US Food and Drug Administration’s (FDA) decision to remove the Risk Evaluation and Mitigation Strategy (REMS) requirements for some CGTs and to reduce the recommended patient stay near treatment centers from 4 weeks to 2 can ease some of the travel and lodging burdens on patients and caregivers. But these changes also make community-based capabilities more important, because referring oncologists are increasingly responsible for critical post-treatment monitoring periods. Building local capacity is not optional; it’s foundational to safe, scalable access.

Several factors make administering CGTs in community settings a challenge. Overcoming these barriers will require collaboration and innovative thinking across all stakeholders.

The Challenge: Resource constraints at community sites. Community hospitals and practices often operate with tighter budgets than large academic centers. Establishing CGT capabilities requires investments in specialized facilities and equipment, recruitment and hiring of physicians with specialized experience, and training teams for complex infusion workflows and post-treatment monitoring. In our research, more than half of community oncologists say that not having enough physicians with the training to administer CGTs is a key barrier to their institution’s ability to administer CGTs, and more than one-quarter say that not having the physical facilities to support CGT administration is also an obstacle.⁴ That data reflects the reality on the ground: community providers want to participate in CGT, but resource limitations often stand in the way.

The Solution: Hub-and-spoke collaboration. AMCs and integrated health systems can extend their expertise by partnering with community providers in a hub-and-spoke model. In this approach, the AMC retains responsibility for the highest-risk steps, such as complex manufacturing coordination and initial infusion for certain products, while enabling community-based sites to deliver defined aspects of care (eg, workup, eligibility, apheresis at qualified centers, step-down care, and post-treatment monitoring) under clear clinical pathways. Standardized guidelines, shared order sets, remote consults, and 24/7 escalation lines support safe decentralization. Over time, as capabilities mature and positive outcomes data accumulate, additional responsibilities can be transferred to community sites. This model also facilitates a smoother transition between care sites as patients transition from the AMC back to the community setting for post-treatment monitoring.

The Challenge: Complex accreditation and standards. Before a site can administer a given CGT, it must obtain relevant accreditations from industry organizations and complete the manufacturer’s extensive qualification and onboarding processes specific to each product. Industry certifications, such as the Foundation for the Accreditation of Cellular Therapy (FACT) accreditation, can take up to a year or longer, and managing the process requires extensive time and resources.⁵ Therapy-specific standards add to the administrative burdens for providers, demanding resources that are often scarce for community treatment sites. However, many of the qualifications and onboarding requirements are identical across manufacturers and therapies, covering everything from staff competencies and pharmacy handling to documentation, adverse event management, and audit readiness. Nearly one-half (46%) of community providers in our research cite simplifying treatment center qualification as an urgent need to expand access.⁴

The Solution: Standardize and streamline where possible. While meticulous onboarding is essential for safety and efficacy, there is room to reduce administrative burden without compromising standards. Recognition of industry-wide accreditations can streamline manufacturer-specific onboarding processes. For example, organizations such as the American Society of Health-System Pharmacists (ASHP) and the Association for the Advancement of Blood & Biotherapies (AABB) are developing new standards for handling CGTs, with AABB recently releasing the “Cell and Gene Therapy Standards for Pharmacy” to provide clear standards in pharmacy settings.⁶ Additionally, the American Society for Transplantation and Cellular Therapy (ASGCT) created an “80/20 Task Force” to encourage streamlining and collaboration between manufacturers and sites of care when possible to reduce duplicative requirements.⁷ Accrediting bodies should continue to look for ways to streamline their qualification process to enable new treatment centers to onboard faster, while still maintaining strict quality standards.

The Challenge: Payer policies and site-of-care preferences. Payers often require CGTs to be administered at AMCs that have extensive resources and CGT experience. However, even when community sites of care develop the necessary capacity and demonstrate proficiency, payers may still deny coverage for some patients unless they travel to an AMC. After becoming an approved site, community providers may still find themselves navigating lengthy, complex approval processes for individual patients, adding to the cost to serve and potentially delaying treatment.

The Solution: Data-led collaboration and transparency. In our recent payer survey, including representatives from national, regional, and Medicaid or Medicare managed care plans, payers are looking for greater transparency from treatment sites to evaluate clinical decision-making and patient outcomes. To build broader payer confidence, community providers should engage early with both manufacturers and payers to establish clear lines of communication and an understanding of the requirements for securing reimbursement. Additionally, industry-wide recognition of accreditations such as FACT as a qualification could enhance clarity when payers evaluate site readiness. Collaboration with AMCs or large hospitals to establish emergency protocols in case of adverse events could also assuage payer concerns.

The Challenge: Reimbursement delays and operating cash flow. Many CGTs are reimbursed through a medical benefit “buy-and-bill” model, where treatment centers front the therapy cost and wait for reimbursement. While this model works for many providers, it can create a financial burden for community hospitals administering CGTs. Delayed reimbursement timelines could leave millions of dollars in accounts receivable tied up for months, which can be too burdensome for community providers with limited operating budgets. As treatment centers onboard more CGTs, this cashflow problem creates a stacking effect that will be unsustainable over time.

The Solution: Specialty pharmacies. Adopting a specialty pharmacy model, rather than “buy and bill”, provides a more sustainable alternative for CGT purchases. In this model, the provider purchases the treatment through the pharmacy, and the pharmacy bills the insurance company, enabling the treatment center to avoid carrying the cost on its own books. The treatment center only bills the payer for ancillary services related to the treatment. Manufacturers can provide both a “buy-and-bill” and a specialty pharmacy option to meet the needs of all potential treatment centers and maximize the potential reach of the therapy.

Moving CGT care into the community is essential to equitable access, but it is only one piece of a complex ecosystem. Value chain complexity, regulatory evolution, and financing models all intersect with the question of where care happens. To keep pace with scientific and clinical progress, we need to prioritize community expansion now.

The imperative is clear. Patients should not be limited by their zip code. By enabling qualified community sites—supported by AMC hubs, aligned with payer expectations, and equipped with the right training, digital tools, and financial mechanisms—we can shrink CGT deserts, reduce burdens on families, and free capacity at academic centers for the most complex cases. This approach is how we translate breakthrough scientific innovation into scalable real-world outcomes.

1. America Counts Staff. What is rural America? US Census Bureau. Published August 9, 2017. Accessed February 28, 2025. https://www.census.gov/library/stories/2017/08/rural-america.html
2. Gustafson K, Gillen EM, Williams C, Oleson MW. Social determinants may affect access to CAR-T treatment. Avalere Health. Published August 29, 2024. Accessed November 3, 2025. https://advisory.avalerehealth.com/insights/social-determinants-may-affect-access-to-car-t-treatment
3. Ahmed N, Karmali R, Nath R, et al. Chimeric antigen receptor T-cell access in patients with relapsed/refractory large B-cell lymphoma: association of access with social determinants of health and travel time to treatment centers. Transplant Cell Ther. 2024;30(4):190-198. doi:10.1016/j.jtct.2024.04.017.
4. InspiroGene by McKesson. 2025 Cell and Gene Therapy Report: Advancing the Future of Medicine. Published October 6, 2025. https://inspirogene.com/cgt-report/
5. Foundation for the Accreditation of Cellular Therapy. Accreditation Process Requirements. FACT website. Accessed September 9, 2024. https://factglobal.org/accreditation-process/ct-accreditation-process-requirements/#Eligibility
6. AABB. Cell and Gene Therapy Standards for Pharmacy. Accessed November 14, 2025. https://www.aabb.org/standards-accreditation/standards/cell-and-gene-therapy-standards-for-pharmacy
7. Nikiforow S, Bachier C, Chhabra S, et al. Paving the road for chimeric antigen receptor T cells: American Society for Transplantation and Cellular Therapy 80/20 Task Force consensus on challenges and solutions to improving efficiency of clinical center certification and maintenance of operations for commercially approved immune effector cell therapies. Transplant Cell Ther. 2023;29(4):203-212. doi:10.1016/j.jtct.2023.01.017. 

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