The Biden-Harris Administration announced today that sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, which was initially announced in February 2023. The model is designed to improve health outcomes, increase access to cell and gene therapies, and lower health care costs for some of the nation’s most vulnerable populations.

Sickle cell disease is an extremely painful condition, which disproportionately impacts Black Americans and has had limited treatment options. In the United States, more than 100,000 people live with SCD. Individuals with the disease have a shorter life expectancy, by more than 20 years, compared to someone living without SCD. Additionally, many long-term health complications from SCD — including stroke, acute chest syndrome, and chronic end-organ damage — can lead to higher rates of emergency department visits and hospitalizations. Patients with SCD experience challenges with access to quality and affordability of care. This model has the potential to help improve health outcomes for patients and families with SCD while also ensuring taxpayer dollars are being used more effectively.

“HHS is using every tool available to us to increase access to high-quality, affordable health care and lower health care costs,” said HHS Secretary Xavier Becerra. “Many of the more than 100,000 Americans with sickle cell disease face difficulty accessing effective health care and groundbreaking treatments. While medical advancements bring us closer to cures, too many individuals with sickle cell disease and their loved ones still face challenges obtaining the care they need. With increased investment, we can improve the quality of life for people affected by this disease and find new, potentially transformative treatments.”

The CGT Access Model is part of the Administration’s broader effort to further drive down prescription drug costs and was developed in response to an executive order that President Biden issued in October 2022 directing the Department of Health and Human Services to consider developing models that increase access to novel therapies and lower the high cost of drugs. The model, led by the Centers for Medicare & Medicaid Services’ (CMS’) Innovation Center, will test outcomes-based agreements (OBAs) for groundbreaking CGTs. Successful OBAs will increase affordable access to potentially lifesaving and life-changing treatment. This model will begin in 2025 and may be expanded to other types of CGTs in the future.

“Gene therapies for sickle cell disease have the potential to treat this devastating condition and transform people’s lives, offering them a chance to live healthier and potentially avoid associated health issues,” said CMS Administrator Chiquita Brooks-LaSure. “Increasing access to these promising therapies will not only help keep people healthy, but it can also lead to savings for states and taxpayers as the long-term costs of treating sickle cell disease may be avoided.”

Approximately 50% to 60% of people living with SCD are enrolled in Medicaid. Hospitalizations and other health episodes related to SCD cost the health system almost $3 billion per year. Gene therapies for the treatment of SCD, as well as other complex conditions, hold significant potential to improve patient outcomes and therefore reduce long-term health spending, but they can also pose challenges to state budgets due to the high cost of the therapy.

Over the next year, CMS will partner with participating states and manufacturers to build a framework that expands access to gene therapies for the treatment of SCD. Under the model, CMS will negotiate an OBA with participating manufacturers, which will tie pricing for SCD treatments to whether the therapy improves health outcomes for people with Medicaid. Negotiations will also include additional pricing rebates and a standardized access policy. Participating states will then decide whether to enter into an agreement with manufacturers based on the negotiated terms and offer the agreed-upon standard access policy in exchange for rebates as negotiated by CMS. As part of the CGT Access Model, CMS will negotiate financial and clinical outcome measures with drug manufacturers and then reconcile data, monitor results, and evaluate outcomes. The CGT Access Model will begin in January 2025, and states may choose to begin participation at a time of their choosing between January 2025 and January 2026.

“The goal of the Cell and Gene Therapy Access Model is to increase access to innovative cell and gene therapies for people with Medicaid by making it easier for states to pay for these therapies,” said Liz Fowler, CMS Deputy Administrator and Director of the CMS Innovation Center. “By negotiating with manufacturers on behalf of states, CMS can ease the administrative burden on state Medicaid programs so they can focus on improving access and health outcomes for people with sickle cell disease.”

CMS anticipates addressing additional care delivery gaps and other hurdles for people receiving cell and gene therapy during the OBA negotiation process, including requiring manufacturers to include a defined scope of fertility preservation services when individuals receive gene therapy for treatment of SCD. CMS will also offer optional funding to states that engage in activities that increase equitable access to cell and gene therapies and promote multi-disciplinary, comprehensive care for people with Medicaid with SCD receiving gene therapy. These activities may include expanding or increasing reimbursement rates for optional Medicaid benefits and services, such as behavioral health or care management services.

For additional information see the fact sheet and CGT model page.

The Centers for Medicare & Medicaid Services (CMS) announced increased participation in CMS’ accountable care organization (ACO) initiatives in 2024, which will increase the quality of care for more people with Medicare. Of note, CMS is announcing that 19 newly formed accountable care organizations (ACOs) in the Medicare Shared Savings Program (Shared Savings Program) are participating in a new, permanent payment option beginning in 2024 that is enabling these ACOs to receive more than $20 million in advance investment payments (AIPs) for caring for underserved populations. An additional 50 ACOs are new to the program in 2024, and 71 ACOs renewed their participation, bringing the total to 480 ACOs now participating in the Shared Savings Program, the largest ACO program in the country. CMS also announced that 245 organizations are continuing their participation in two CMS Innovation Center models — ACO Realizing Equity, Access, and Community Health (ACO REACH) and the Kidney Care Choices (KCC) models.

“One of CMS’ top priorities is to expand access to quality, affordable health coverage and care,” said CMS Administrator Chiquita Brooks-LaSure. “Accountable care initiatives – which give more tools to health care providers to deliver better care and help people receive more coordinated care – through programs like the Medicare Shared Savings Program and the Innovation Center accountable care initiatives are critical to achieving this vision.”

Accountable care organizations are groups of doctors, hospitals, and other health care professionals that work together to give patients high-quality, coordinated service and health care, improve health outcomes, and manage costs. ACOs receiving AIPs are required to invest in health care infrastructure, staffing, and providing accountable care for underserved beneficiaries. These 19 new ACOs are hiring community health workers, utilizing health assessment and screening tools, and implementing quality improvement activities, such as case management systems, patient registries, and electronic quality reporting.

In 2024, three innovative ACO initiatives continue to grow, enabling higher quality care for people with Traditional Medicare: The Shared Savings Program, the permanent ACO program; the ACO REACH Model, which intends to increase access to and improve care for underserved populations, including those in rural areas; and the Kidney Care Choices model, which focuses on coordinating care for people with Medicare with chronic kidney disease and end-stage renal disease so more people can live fuller and longer lives.

Overall, in 2024 there are about 13.7 million people with Traditional Medicare aligned to an ACO. ACOs are now serving nearly half of the people with Traditional Medicare, a 3% increase since 2023. This growth in ACOs is important since ACOs have been shown to have superior quality performance compared to similar physician groups not participating in an ACO, and ACOs have generated year-over-year savings for the Medicare Trust Fund.

In the 2023 Physician Fee Schedule final rule, CMS took several actions in the Shared Savings Program to better align value-based programs, drive growth in accountable care, and create a more equitable health care system including scaling components from an Innovation Center model test that was shown to produce savings and maintain quality in the Medicare program writ large. After CMS observed that the ACO Investment Model drove increased ACO participation in rural and underserved areas and saved dollars for the Medicare Trust Funds, CMS incorporated the most important elements into the Shared Savings Program as AIPs. Already in the first year of implementation, CMS is seeing increased participation among health care providers from rural and underserved areas, just like in the model test — yet another example of the value that the Innovation Center brings to CMS and the public.

These actions build on parts of previous ACO model tests, such as the Pioneer ACO Model and the Medicare ACO Track 1+ Model (Track 1+ Model), that have already been incorporated into the Shared Savings Program by informing the development of the higher risk tracks, which are selected by 65% of ACOs in the Shared Savings Program today.

As a result, for 2024, the Shared Savings Program has 480 ACOs with 634,657 health care providers and organizations providing care to over 10.8 million people with Traditional Medicare. With the addition of the ACOs receiving AIPs, ACOs are delivering care to people with Traditional Medicare in 9,032 Federally Qualified Health Centers, Rural Health Clinics, and critical access hospitals, an increase of 27% from 2023.

“The new advance investment payments will enable health care providers in rural and other underserved areas to build the staffing, infrastructure, and care delivery improvements they need to succeed as ACOs providing high quality, equitable, accountable care to their communities,” said Meena Seshamani, M.D., PhD, Deputy Administrator and Director of the Center for Medicare. “Everyone deserves access to the type of whole-person care delivered by ACOs.”

For 2024, the ACO REACH Model has 122 ACOs with 173,004 health care providers and organizations providing care to an estimated 2.6 million people with Traditional Medicare. This model has 1,042 Federally Qualified Health Centers, Rural Health Clinics, and Critical Access Hospitals participating in 2024 — more than a 25% increase from 2023. Increasing the number and reach of ACOs in underserved communities will help close racial and ethnic disparities that have been identified among people with Traditional Medicare in accountable care relationships.

For 2024, the KCC model includes 123 Kidney Contracting Entities (KCEs) and CMS Kidney Care First (KCF) Practices, which are accountable for the quality and care of their aligned people with Medicare. The KCC Model has more than 9,227 participating health care providers and organizations, a 10% increase from 2023, serving 282,335 people with Medicare who have chronic kidney disease and end stage renal disease in 2024.

“The strong participation in our accountable care models in 2024 will help more people access high-quality, coordinated health care that will improve their quality of life,” said CMS Deputy Administrator and Innovation Center Director Liz Fowler. “The ACO REACH and KCC models are a cornerstone of our strategy to transform the health care system, focus on equity in everything we do, and deliver person-centered care that meets people where they are.”

• To view the Shared Savings Program Public Use Files, visit: Data.cms.gov
• The Shared Savings Program is releasing Public Use files on  ACOs,  ACO Participants, ACO SNF Affiliates and Advance Investment Payment Spend Plans.
• To view the Shared Savings Program fast fact sheet, visit: https://www.cms.gov/files/document/2024-shared-savings-program-fast-facts.pdf
• To view the ACO REACH Participants List, visit: https://www.cms.gov/files/document/aco-reach-py2024-participants.pdf
• To view the ACO REACH Quarterly Summary of Quality Performance, Financial Performance, and Model Payments, visit: https://www.cms.gov/priorities/innovation/media/document/aco-reach-gpdc-quarterly-transp-report
• To view the KCC Model Fact Sheet, visit: https://www.cms.gov/files/document/kcc-model-fs-cy2024.pdf
• To view the KCC Model Participants List, visit: https://www.cms.gov/files/document/kcc-model-participants-cy2024.pdf
• To view the KCC Participants Lists and Dialysis Facility Affiliation, visit: https://www.cms.gov/files/document/kcc-model-participants-affiliations-cy2024.pdf

The U.S. Preventive Services Task Force released a final recommendation statement on screening for speech and language delay and disorders in children. The Task Force determined that more research is needed to recommend for or against screening all children aged 5 years and younger. To view the recommendation, the evidence on which it is based, and a summary for clinicians, please go here.

The Centers for Medicare and Medicaid Services (CMS) finalized on Jan. 17, 2024, the CMS Interoperability and Prior Authorization Final Rule, to improve the electronic exchange of health information and prior authorization processes for medical items and services for Medicare Advantage organizations, fee-for-service, and managed Medicaid, Children’s Health Insurance Program plans, and issuers of Qualified Health Plans offered on the federally facilitated exchanges. Beginning in 2026, the rule requires payers to streamline prior authorization by setting deadlines for decisions, providing justification for denied requests, publicly reporting metrics, and implementing an application programming interface (API). Payers must also expand their current Patient Access API to include prior authorization information and implement a Provider Access API to broaden provider access to patient information beginning in 2027. These policies are expected to result in approximately $15 billion of estimated savings over ten years. Read More.

In the ever-evolving healthcare landscape, prioritizing employee satisfaction has become a critical factor in delivering exceptional patient care and ensuring the success of healthcare organizations. Staff satisfaction surveys have emerged as powerful tools, providing invaluable data to drive positive change, optimize policies, and enhance employee retention. This new STAR² Center infographic is designed to support health center teams as they focus on staff resiliency, wellness, satisfaction, and engagement by guiding teams through the process of conducting staff satisfaction surveys. Click here to access this new resource!

KFF News reports that the suicide rate for Hispanic people in the United States has increased significantly over the past decade. The trend is seen coast to coast, and in both rural and urban communities. For Hispanic children 12 and younger, the rate increased 92.3% from 2010 to 2019. Read more.

Duquesne University is celebrating the opening of its new College of Medicine building. Officials and partners convened last week at a ribbon cutting for the medical college that will welcome its inaugural class of students in July. Duquesne President Ken Gormley said, “the medical school will promote equitable access to health care, especially in urban and rural underserved areas, by educating and training the next generation of physicians for this region and beyond.” The college will start by enrolling 85 students, with the plan to increase annual enrollment to 170 a year beginning in 2026. Duquesne University hopes the school will attract a large and competitive national pool of several thousand applicants. North Side Christian Health Center in Pittsburgh has announced it will partner with the new Duquesne School of Medicine, serving as a clinical rotation site for third- and fourth-year medical students.

Visit HHS’ Poverty Guidelines webpage for the 2024 guidelines.