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

From Healthcare Dive

Dive Brief:

• The HHS released voluntary cybersecurity goals for healthcare and public health organizations on Wednesday, as the industry grapples with increasing large data breaches and ransomware attacks.
• The performance goals, broken down into essential and enhanced safeguards, aim to help organizations prevent cyberattacks, improve their response if an incident occurs and minimize remaining risk after security measures are applied.
• The resources come after the HHS released a concept paper in December, which detailed plans to create hospital cybersecurity requirements through Medicare and Medicaid and eventually update the HIPAA rule.

Dive Insight:

Healthcare data breaches — particularly those stemming from hacking — have risen over the past decade, exposing hundreds of millions of patients’ sensitive personal information or protected health data.

Breaches can be costly for healthcare organizations to manage, but cyberattacks that interrupt hospital operations are also a risk to patient safety.

Ransomware, where criminals demand payment in exchange for restored access to sensitive information and critical systems, can disrupt normal care for weeks.

Ardent Health Services, which runs facilities in multiple states, was hit by a ransomware attack on Thanksgiving, forcing the hospital operator to take its network offline and divert incoming ambulances. Ardent restored access to its electronic health record in early December and fully recovered its patient portal in January.

The new cybersecurity goals from the HHS aim to help healthcare organizations build layered protection against cyberattacks — so if one defense fails, another can serve as a backup — which the agency said is key to building resilience and protecting patients.

“We have a responsibility to help our health care system weather cyber threats, adapt to the evolving threat landscape, and build a more resilient sector,” HHS Deputy Secretary Andrea Palm said in a statement. “The release of these cybersecurity performance goals is a step forward for the sector as we look to propose new enforceable cybersecurity standards across HHS policies and programs that are informed by these CPGs.”

The essential goals, which include safeguards like email security, multifactor authentication and basic cybersecurity training for employees, create a base to help organizations manage common vulnerabilities.

The enhanced protections, like establishing processes to discover and address threats at vendors, separating critical assets into discrete network segments and cybersecurity testing, aim to help health systems mature their defenses.

Hospitals cheered the voluntary goals, with American Hospital Association president and CEO Rick Pollack recommending in an email statement that “all components of the healthcare sector implement these practices including third party technology providers and business associates.”

But the trade and lobbying group has previously argued that mandated cybersecurity standards tied to funding — which media reports suggest could be coming down the pike soon — could remove hospital resources that could be used to shore up their cyber defenses.

U.S. Department of Agriculture (USDA) Rural Development Pennsylvania State Director Bob Morgan announced investments of more than $211,000 in four Community Facilities or CF projects in four counties in Pennsylvania.

“These investments in public safety and healthcare are vital to the quality of life for rural Pennsylvanians in these communities,” Morgan said. “We are glad we can play a small part in providing these facilities and law enforcement organizations the equipment they need to provide the best services possible.”

The healthcare project at the Fulton County Medical Center was awarded a $60,000 CF grant to purchase new exercise and education equipment for the wellness and clinical center.

The public safety projects were awarded in Mercer, Allegheny, and Mifflin counties.

Greenville Borough in Mercer County received a CF loan and grant of $38,500 and $83,600 to purchase three new police interceptor utility vehicles for the borough’s police department.

Munhall Borough in Allegheny County received a CF grant of $19,500 to purchase a new police responder vehicle. The vehicle is needed to replace one of the borough’s current vehicles that has reached the end of its useful life. This equipment will allow the police department to provide better public services and safety to the community.

Armagh Township in Mifflin County received a CF grant of $47,900 to two new police vehicles with necessary accessories.

In 2023, USDA Rural Development in Pennsylvania invested $119 million through its Community Facilities programs.

Rural Development provides loans, grants and loan guarantees to help expand economic opportunities, create jobs and improve the quality of life for millions of Americans in rural areas. This assistance supports infrastructure improvements; business development; housing; community facilities such as schools, public safety and health care; and high-speed internet access in rural, Tribal and high-poverty areas.

To subscribe to USDA Rural Development updates, visit GovDelivery subscriber page.

CMS is pleased to announce the availability of a new public use file on Socio-demographic and Health Characteristics of Medicare Beneficiaries Living in the Community by Dual Eligibility Status in 2021.  This public use file uses data from the Medicare Current Beneficiary Survey and contains estimates on socio-demographic characteristics, functional limitations, chronic conditions, mental health, and oral health of people with Medicare living in the community as well as those with both Medicare and Medicaid.

New infographics are available as well:

• Select Socio-Demographic Characteristics of Medicare Beneficiaries by Dual Eligibility Status
• Prevalence of Chronic Conditions and Limitations in Activities of Daily Living Among Medicare Beneficiaries by Dual Eligibility Status
• Effects of poverty on health care for people with Medicare (PDF).

The Pennsylvania Broadband Development Authority (PBDA) has opened the application period for the COVID-19 ARPA Multi-Purpose Community Facilities (Facilities) Program and it will close 4.20.24 at 12:00 PM. We’d like to remind you as well that the PBDA and the Department of Community & Economic Development (DCED) Customer Service team are hosting two Office Hour Sessions to review FAQs for the Facilities Program and the DCED Electronic Single Application (ESA) System, next week.

Details to attend the Office hours as well as the recording of the Facilities Program overview and the DCED Electronic Single Application (ESA) system walkthrough can be viewed at the links below. The presentation is also available on this same page.

• Office Hours Session 1
• Office Hours Session 2
• Facilities Program Page and Webinar Recordings

Today, the Department of Health and Human Services (HHS) announced that, together with the Centers for Medicare & Medicaid Services (CMS), it will launch a series of actions to educate the public about their rights to emergency medical care and to help support efforts of hospitals to meet their obligations under the Emergency Medical Treatment and Labor Act (EMTALA). As part of this comprehensive plan, the Department will:

• Publish new informational resources on CMS’s website to help individuals understand their rights under EMTALA and the process for submitting a complaint if they are denied emergency medical care;
• Partner with hospital and provider associations to disseminate training materials on providers’ obligations under EMTALA;
• Convene hospital and provider associations to discuss best practices and challenges in ensuring compliance with EMTALA; and
• Establish a dedicated team of HHS experts who will increase the Department’s capacity to support hospitals in complying with federal requirements under EMTALA.

The Department developed this comprehensive plan in response to a growing number of inquiries from patients and providers to CMS about how they can ensure that federal obligations were being met. CMS remains committed to helping all individuals—including patients who are experiencing pregnancy loss and other pregnancy-related emergencies—have access to the emergency medical care required under federal law.

The Biden-Harris Administration remains focused on working with doctors, hospitals, and patients to promote patient access to the care that they are entitled to under federal law and has long taken the position that this required emergency care can, in some circumstances, include abortion care. The U.S. Department of Justice is currently defending that understanding before the Supreme Court.