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ACI Monthly (March 2024)

March 2024

Volume 1, Issue 3


Inside this issue

31st Drug Manufacturer

30th Drug Manufacturer


Benefits of Contract Pharmacy


Special points of interest

Two new manufacturers adding restrictions to contract pharmacy program

SUSTAIN 340B Act as a means to strengthen and stabilize the 340B Program

Breakdown of State bills being passed, cleared and introduced

The utilization of multiple contract pharmacies within the 340B program plays a critical role in enhancing patient care and rural healthcare


Breaking Down the 340B PATIENTS Act: Transforming Healthcare Access Nationwide

In a bid to revolutionize healthcare accessibility across the United States, legislators unveiled the 340B Program Advancing Therapy and Improving Access Now for Patients (PATIENTS) Act on March 12, 2024. This federal bill represents a pivotal step towards addressing systemic barriers to healthcare and expanding the reach of the 340B Drug Pricing Program. In this article, we  examine the core components and potential implications of the 340B PATIENTS Act, shedding light on its significance for patients, providers, and policymakers alike.


Key Provisions of the 340B PATIENTS Act:

1. Expanded Patient Access: The bill proposes to broaden patient eligibility criteria, allowing more individuals to benefit from the discounted medications provided through the 340B Program. By extending coverage to underserved populations, including those in rural and remote areas, the legislation aims to improve health outcomes and reduce disparities.


2. Enhanced Program Oversight: Recognizing the importance of accountability and            transparency, the 340B PATIENTS Act introduces measures to strengthen program        oversight. This includes increased reporting requirements for participating entities and enhanced audit procedures to ensure compliance with program guidelines. By promoting transparency, the legislation seeks to safeguard the integrity of the 340B Program.


3. Streamlined Administrative Processes: To alleviate administrative burdens on healthcare providers, the bill streamlines certain program processes, such as eligibility verification and recertification. By simplifying administrative tasks, the legislation aims to empower        providers to focus more resources on patient care and community outreach initiatives.


Potential Impact on Healthcare Delivery: The 340B PATIENTS Act has the potential to usher in a new era of healthcare delivery characterized by greater equity and accessibility. By expanding patient access and strengthening program oversight, the legislation seeks to address disparities in healthcare access and improve health outcomes for vulnerable populations. Moreover, streamlined administrative processes are poised to enhance operational efficiency, enabling providers to maximize the impact of limited resources.


As the 340B PATIENTS Act gains traction among lawmakers and stakeholders, its transformative potential in advancing healthcare access cannot be overstated. By prioritizing patient needs, promoting transparency, and streamlining administrative processes, the legislation paves the way for a more inclusive and patient-centered healthcare system. Moving forward, collaboration and engagement among policymakers, providers, and advocacy groups will be crucial to ensure the effective implementation of the 340B PATIENTS Act and its lasting impact on healthcare delivery nationwide.


Genetech Joins Ranks: 31st Drug Manufacturer to Implement Contract Pharmacy Restrictions

In the ever-evolving landscape of pharmaceuticals and healthcare, the dynamics between drug manufacturers, pharmacies, and patients continue to shift. Recently, Genetech, a prominent player in the biotechnology industry, made headlines by   becoming the 31st drug manufacturer to impose contract pharmacy restrictions. There hasn’t been a formal push regarding their contract pharmacy restrictions, but it is said that it will be officially posted April 1st.


The restrictions will be in effect on May 1st, which include all their products except for Hemlibra and Evrysdi.


Restriction Guidelines: Covered entities may designate a single contract pharmacy location if the covered entity does not operate an in-house pharmacy.


For Genetech, a company renowned for its innovative therapies targeting cancer, autoimmune disorders, and other serious medical conditions, the decision to implement contract pharmacy restrictions carries significant implications. While the specifics of Genetech's restrictions have not been disclosed publicly, the broader industry trend suggests a tightening of control over distribution channels.


One of the primary concerns raised by critics of contract pharmacy restrictions is the potential impact on patient access to essential medications. By limiting the pharmacies where patients can obtain their prescriptions, these restrictions may inadvertently create barriers to treatment, particularly for individuals with limited mobility or those living in underserved areas. Additionally, patients may face delays or challenges in accessing their medications, further exacerbating health disparities.


Moreover, the implementation of contract pharmacy restrictions has sparked debates regarding transparency and accountability within the pharmaceutical industry. Some argue that these restrictions could obscure pricing practices and  hinder efforts to promote fair competition among pharmacies. Others express concerns about the influence of pharmaceutical manufacturers over the healthcare decisions of patients and providers.


In response to these concerns, advocates for patient access and healthcare equity have called for greater transparency and oversight regarding contract pharmacy restrictions. They emphasize the importance of ensuring that such policies prioritize patient well-being and uphold the principles of affordability and accessibility.

As Genetech joins the ranks of drug manufacturers imposing contract pharmacy restrictions, the pharmaceutical industry faces heightened scrutiny and calls for reform. Balancing the interests of manufacturers, pharmacies, healthcare providers, and patients remains a complex challenge, requiring   ongoing dialogue and collaboration across stakeholders.


Ultimately, the impact of contract pharmacy restrictions on patient care and healthcare delivery will continue to be a subject of debate and scrutiny. As the healthcare landscape evolves, it is imperative to prioritize policies and practices that promote equitable access to medications and support the well-being of individuals and communities.


Liquidia Joins Ranks: 30th Drug Manufacturer to Implement Contract Pharmacy Restrictions

Liquidia, a pharmaceutical company specializing in developing therapies for respiratory and pulmonary conditions, has announced restrictions on the participation of certain pharmacy within the 340B Program. These restrictions take effect on April 1st for Yutrepia, as well as pulmonary arterial hypertension (PAH) to locations registered as a 340B covered entity or eligible child site location affiliated with that covered entity.

Their letter states that, “Covered entity and federal grantee contract pharmacies will no longer be eligible recipients for bill to / ship to replenishment orders.” However, they are offering options for those covered entities that do not have their own in-house pharmacy.

Restriction Guidelines:

  • Covered entities may designate a single contract pharmacy location if the covered entity does not operate an in-house pharmacy or if the covered entity agrees to provide 340B claims data for its in-house pharmacies

  • 340B claims are required for all designated contract pharmacies

  • 45 Day Look Back Period: 340B claims must be submitted within 45 days of the date of dispense to be considered a valid claim submission

In order to avoid disruption to the 340B ceiling price, designations need to be put into effective by March 22 and allow for 10 business days for eligibility to show within the 340B ESP platform.


The SUSTAIN 340B Act: Balancing Sustainability and Access in the 340B Program

The 340B Drug Pricing Program has long been a cornerstone of healthcare affordability, ensuring access to vital medications for vulnerable populations across the United States. However, recent concerns regarding program integrity and sustainability have prompted legislative action. One such proposal, the SUSTAIN 340B Act, aims to address these issues while preserving the program's core mission. This article explores the potential impact of the SUSTAIN 340B Act on the 340B Program and its stakeholders.

Background: Enacted in 1992, the 340B Program requires drug manufacturers to provide discounts on outpatient drugs to eligible healthcare organizations serving low-income and underserved communities. These savings are intended to support these entities in expanding access to affordable medications and comprehensive healthcare services. Over the years, the program has grown significantly, encompassing a wide range of covered entities, including hospitals, clinics, and community health centers.

Challenges Facing the 340B Program: Despite its noble objectives, the 340B Program has faced criticism and scrutiny from various stakeholders. Critics argue that the program lacks transparency and accountability, leading to potential misuse and diversion of discounts. Moreover, concerns have been raised about the program's financial sustainability, particularly in light of increasing prescription drug costs and evolving healthcare dynamics.

The SUSTAIN 340B Act: In response to these challenges, policymakers have proposed the SUSTAIN 340B Act as a means to strengthen and stabilize the 340B Program. The legislation aims to enhance program integrity through increased oversight and reporting requirements, ensuring that participating entities use savings to benefit patients directly. Additionally, the SUSTAIN 340B Act seeks to address concerns about the program's financial sustainability by establishing a fair and transparent pricing framework.

Potential Impact on Stakeholders: The SUSTAIN 340B Act would have far-reaching implications for stakeholders involved in the 340B Program. Covered entities may face greater scrutiny and compliance burdens as they navigate new reporting and accountability measures. However, these entities would also benefit from enhanced transparency and guidance, enabling them to optimize their participation in the program while fulfilling their mission of serving vulnerable populations.

Drug manufacturers, on the other hand, may experience increased pressure to negotiate fair prices and comply with program requirements. The legislation's emphasis on accountability and oversight could incentivize greater collaboration between manufacturers and covered entities, ultimately fostering a more sustainable and equitable healthcare ecosystem.

As discussions around the SUSTAIN 340B Act continue, it is essential to strike a balance between sustainability and access within the 340B Program. By addressing concerns related to program integrity and financial viability, the proposed legislation holds the potential to strengthen the program's impact on underserved communities while promoting transparency and accountability across the healthcare landscape. Moving forward, policymakers must engage with stakeholders collaboratively to ensure that the SUSTAIN 340B Act achieves its intended goals while preserving the core principles of the 340B Program.


Current Status on State Bills and Laws that Prohibit Drugmaker 340B Contract Pharmacy Restrictions


The Benefits of Multiple Contract Pharmacies in the 340B Program

The 340B Drug Pricing Program has been instrumental in ensuring access to affordable medications for vulnerable populations across the United States. One of the key strategies within the program is the utilization of multiple contract pharmacies, which play a vital role in expanding patient access to discounted medications, particularly in rural areas. In this blog post, we will explore the significance of multiple contract pharmacies and their benefits to patients and rural healthcare within the framework of the 340B program.

Expanding Access to Medications in Rural Areas: Rural communities often face significant challenges in accessing healthcare services, including pharmacies. Limited availability of pharmacies in remote areas can lead to increased travel times and costs for patients seeking medications. However, by leveraging multiple contract pharmacies, healthcare facilities participating in the 340B program can extend their reach and provide access to discounted medications in underserved regions. This expansion of pharmacy services helps alleviate barriers to care and ensures that patients in rural areas receive the medications they need to manage their health conditions effectively.

Improving Medication Adherence and Health Outcomes: Access to affordable medications is essential for medication adherence, which is crucial for managing chronic conditions and preventing disease progression. Studies have shown that medication non-adherence is a significant issue, particularly among rural populations. By partnering with multiple contract pharmacies, healthcare providers can offer convenient access to discounted medications closer to where patients live, thereby increasing the likelihood of adherence. Improved medication adherence ultimately leads to better health outcomes, reduced hospitalizations, and lower healthcare costs for both patients and healthcare systems.

Enhancing Patient Choice and Convenience: The use of multiple contract pharmacies in the 340B program also provides patients with greater choice and convenience when it comes to filling their prescriptions. Patients can select a pharmacy that is convenient for them, whether it be a local community pharmacy or a chain pharmacy with extended hours. This flexibility empowers patients to take control of their healthcare and encourages them to remain engaged in their treatment plans. Moreover, by offering multiple options for prescription fulfillment, healthcare providers can better meet the diverse needs and preferences of their patient population.

Supporting Sustainability of Rural Healthcare Facilities: For many rural healthcare facilities, participating in the 340B program and leveraging multiple contract pharmacies is not only about improving patient care but also about ensuring their own financial sustainability. The revenue generated through the program allows these facilities to reinvest in essential services, such as staffing, equipment, and infrastructure improvements. By strengthening the financial viability of rural healthcare facilities, the 340B program helps safeguard access to care for underserved populations and contributes to the overall health and well-being of rural communities.

The utilization of multiple contract pharmacies within the 340B program plays a critical role in enhancing patient care and rural healthcare. By expanding access to discounted medications, improving medication adherence, and offering greater choice and convenience to patients, multiple contract pharmacies contribute to better health outcomes and increased sustainability of rural healthcare facilities. Moving forward, continued support and expansion of the 340B program, including its use of multiple contract pharmacies, are essential for addressing healthcare disparities and promoting equitable access to medications for all Americans, regardless of where they live.


ACI 340B Management

Our mission is to take the burden of the 340B program off you and your already taxed staff. “You manage your hospital, and we will manage your 340B program.”

Our experienced team supplements your staff by implementing, evaluating, and managing your 340B program while providing measurable benefits to you and your community. We understand the operations, regulations and technology required for program compliance.

ACI’s vendor-neutral approach ensures that your hospital will be matched with an administrator and technology vendor that best suits your hospital’s needs. Our team proactively monitors your program to catch problems before they happen. We are your ultimate 340B resource and are here to support your hospital in any way possible.

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