IRVING, TX — Vizient, Inc. hosted a policy briefing on Capitol Hill titled, "Medicare (DIS)Advantage: How MA Plans are Implementing Policies to Limit Access to Care," at the Rayburn House Office Building. The event featured remarks from Reps. Jasmine Crockett (D-TX) and Marc Veasey (D-TX), with recorded remarks provided by Rep. Valerie Foushee (D-NC) and was sponsored by Rep. Jake Ellzey (R-TX). The briefing, attended by a standing-room only crowd of more than 80 congressional staff and industry stakeholders, focused on the disruptions caused by Medicare Advantage (MA) organizations and how hospitals are navigating the myriad challenges to provide timely and seamless care to MA beneficiaries.

"Having recently met with healthcare providers in Texas's 30th district, I am acutely aware of the challenges posed by Medicare Advantage's problematic policies," said Rep. Crockett. "It's imperative we resolve these issues to prevent unnecessary delays or denials of care. Safeguarding patient access to essential healthcare services remains a top priority, ensuring our hospitals are supported, not hindered, by administrative burdens. I appreciate Vizient's leadership in facilitating this important discussion to help drive meaningful change."

Jenna Stern, associate vice president of regulatory affairs and public policy at Vizient, moderated a discussion featuring a distinguished panel of key healthcare leaders, including:

• Christopher K. Dorman, MA, MBA-HCM, FACHE, president & CEO, Southwell – Tift Regional Health System, Inc.
• Jeff Francis, MBA, vice president & CFO, Methodist Health System
• Janet Hadar, MSN, MBA, FACHE, president, UNC Hospitals

The panel of experts highlighted the ongoing challenges with certain MA plans, such as confusion among beneficiaries about their coverage, excessive prior authorization denials, reimbursement issues and gaps in data reporting to CMS. The panelists proposed several solutions to enhance patient access and care delivery. Recommendations included requiring MA plans to have provider access comparable to Medicare, streamlining the prior authorization process, reducing timelines for responding to denials, and improving MA data reporting on prior authorizations and denials, among other recommendations.

UPPER NYACK, NY — The Global Healthy Living Foundation (GHLF) published a policy paper authored by Robert Popovian, PharmD, MS, GHLF’s Chief Science Policy Officer. The paper, titled “Challenges in Adult Vaccination: Policy Strategies for Sustaining Access and Supply,” details the benefits associated with the current vaccine access and payment model for adult vaccination in the United States. It highlights the potential negative consequences if Pharmacy Benefit Managers (PBMs) subvert the vaccine reimbursement landscape, which would in turn undermine the important public health role that pharmacists play.

Dr. Popovian's report addresses practices of PBMs that can limit patient access and disrupt the vaccine supply. The paper explains that PBMs complicate the vaccine distribution process by enforcing restrictive policies involving delayed payments, complex authorization processes, or insufficient reimbursement rates. These practices not only jeopardize the financial stability of pharmacies but also limit the range of vaccines that pharmacies can offer.

"Pharmacists are tasked with providing essential health services, including vaccinations,” said Dr. Popovian. “Suppose PBMs are allowed to impose access restrictions by providing inadequate reimbursement for the sole purpose of profiteering. Such actions would disrupt the current vaccination ecosystem in pharmacies, which ensures strong patient access, and critically, could endanger the long-term vaccine supply.”

Pharmacists as Accessible Health Providers

Highlighting the crucial role of pharmacists, the report points out that they are often the most readily available healthcare providers, especially in underserved communities.

"Pharmacists are on the front lines, particularly in areas where other health care services might be limited,” said National Association of Chain Drug Stores President and CEO Steven C. Anderson. “It is vital for the people whom pharmacists serve that PBMs are not permitted to manipulate or restrict access to vaccines, medications or services that are imperative for public health."

The paper details how current PBM policies, if allowed, will undermine this accessibility, particularly affecting low-income neighborhoods and minority communities where pharmacies play a critical role in vaccination.

Call-to-Action for Competitive Market Reforms

The paper calls for safeguards preventing PBMs from limiting competition and restricting vaccine access. It also highlights the continued coverage of all adult vaccines by private and public insurers, maintaining the current payment model for easy vaccine access and allowing patients to receive vaccinations at community pharmacies without incurring out-of-pocket costs.

Dr. Popovian further emphasized the broader impact of these reforms. “Implementing these policies will not only enhance vaccine accessibility but also strengthen the overall health care system,” he stated.

To learn more, download the full report.

St. Louis-based nonprofit and Catholic healthcare network Ascension, that operates 140 hospitals across more than a dozen states and Washington, DC, detected unusual activity in their network systems on May 8th and determined it was a cybersecurity incident. According to the news release, their team responded immediately, notified the appropriate authorities as well as business partners, and engaged Mandiant, a third-party expert, to assist in the investigation and remediation process.

“Safely caring for patients remains our highest priority as we navigate this cybersecurity incident,” per the release. “We are actively supporting our ministries as they continue to provide safe, patient care with established downtime protocols and procedures, in which our workforce is well trained. It is expected that we will be utilizing downtime procedures for some time. Patients should bring to their appointment notes on their symptoms and a list of current medications and prescription numbers or the prescription bottles so their care team can call in medication needs to pharmacies. We are working around the clock with internal and external advisors to investigate, contain, and restore our systems following a thorough validation and screening process. Our investigation and restoration work will take time to complete, and we do not have a timeline for completion.”

Systems that are currently unavailable include electronic health records system, MyChart (which enables patients to view their medical records and communicate with their providers), some phone systems, and various systems utilized to order certain tests, procedures and medications. The release stated that they have implemented established protocols and procedures to address these particular system disruptions in order to continue to provide safe care to patients.

Certain non-emergent elective procedures, tests and appointments have been temporarily paused. Due to downtime procedures, several hospitals are currently on diversion for emergency medical services in order to ensure emergency cases are triaged immediately.

SAN FRANCISO, CA — Otsuka America, Inc. (OAI) announces Otsuka Precision Health, Inc. (OPH), a company that will serve as a catalyst for delivering the right interventions at the right time along patients’ and caregivers’ unique health journeys, ranging from connected health solutions to digital therapeutics, all powered by advanced analytics tools like artificial intelligence. OPH will focus on the patient experience as a core piece of improving how better outcomes might be achieved across nephrology, mental health, and beyond.

The recent U.S. Food and Drug Administration (FDA) clearance of Rejoyn™ is the first prescription digital therapeutic authorized for the adjunctive treatment of major depressive disorder (MDD) symptoms. OPH will serve to commercialize Rejoyn™.

“Changes are needed to realize the potential of technology in health, and we’re ready to boldly address the barriers patients face in receiving care by taking a fundamentally new approach,” said Sanket Shah, president of OPH. “This Company will allow us to build on our commitment to the digital and technology space and continue building momentum with products such as, Rejoyn™, in a way that traditional pharmaceutical companies have not been able to explore.”

Combining the evidence-based rigor of pharma with a data-first focus on a more individualized approach to supporting patients, OPH has a unique opportunity to bring promising innovations to market quickly. Otsuka is deepening its commitment to the meaningful role technology can play in the lives of patients and the care teams that surround them.

“At this time there is a great desire for alternative therapies and treatments in the mental health space, especially given the outpaced demand in recent years,” said Shah. “New interventions that better connect, engage, and personalize care will be welcomed by patients and providers.”

CHARLOTTE, NC — Premier, Inc. announced a strategic partnership with AstraZeneca called Uncover CKD - Care Collective aiming to identify patients with undiagnosed clinical chronic kidney disease (CKD); raise awareness of undiagnosed CKD among healthcare providers; and inform U.S. health systems that want to improve or develop and implement their strategies for CKD diagnosis, treatment and management.

In the U.S., more than 37 million adults have CKD, and the prevalence is rising. Of these adult patients, 90 percent do not know they have CKD. Total inflation-adjusted Medicare expenditures for patients with end-stage renal disease increased to $53 billion in 2019. Among CKD patients, the cost of preventable hospitalizations is $79 million.

Through collaborative initiatives and scalable solutions from across the Premier enterprise, including its PINC AI™ technology and services platform, the Uncover CKD - Care Collective is addressing undiagnosed and rising CKD and the resulting economic burden to the U.S. healthcare system. The partnership with AstraZeneca demonstrates a commitment to implement and learn about innovative approaches to driving optimization of guideline-directed medical therapy for patients.

“We’re thrilled to be working with AstraZeneca and Premier member health systems to help solve the myriad challenges CKD presents to patients and our healthcare system,” said Leigh Anderson, Chief Operating Officer, Premier. “The Uncover CKD - Care Collective initiative highlights the impact collaborative partnerships across life sciences organizations and health systems – coupled with actionable real-world data (RWD), artificial intelligence (AI)-powered clinical and operational solutions, and best-practice consulting and collaboratives – can have in improving the care and cost of treating chronic diseases. As our collective work moves the needle on the rate of CKD diagnosis, those patients previously undiagnosed can begin to be treated and their conditions managed, limiting down-the-line costs associated with more severe disease stages.”

The Uncover CKD - Care Collective is poised to make significant strides in improving CKD diagnosis and advancing patient care through the utilization of:

• PINC AI™ Applied Sciences (PAS) RWD leveraging the PINC AI™ Healthcare Database, laboratory data and technology to identify high-volume areas of unidentified, at-risk patients; screen undiagnosed CKD patients, estimate prevalence and report hospital-specific patient counts; and describe patient characteristics and the clinical and economic outcomes of undiagnosed CKD. This discovery phase work has been completed and findings disseminated to characterize the burden of CKD across the health systems, prioritize and focus hospital-level initiatives, and commit to sustainable organizational change.
• PAS Improvement Science’s Health System Awareness Package, including provider and patient education, provider resources and workflow processes as well as support for participating health systems through provider engagement – all created to be scaled broadly across Premier’s health system network.
• PINC AI™ Stanson AI-powered technology, including clinical decision support and real-time alerts integrated into the provider workflow, to help strategically modify provider behavior to improve CKD screening, diagnosis and care quality.
• PINC AI™ Advisory Services to actively engage physicians, foster mutual accountability and drive clinical transformation and quality improvement efforts around CKD diagnosis, treatment and management throughout the health systems.
• Premier Pharmacy and Group Purchasing Organization resources to optimize medication management protocols and streamline operational processes for enhanced efficiency and positive patient outcomes.
• PINC AI™ Population Health Management Collaborative, including member Accountable Care Organizations (ACOs) and those on the transformation to value-based care, to facilitate idea exchange and best practice sharing.
• Health system collaboration to share project outcomes, publish a white paper, develop a poster presentation for the National Kidney Foundation and present findings at Premier’s 2024 Breakthroughs Conference & Exhibition.

“Through commitment to AstraZeneca’s medical missions of putting patients first and following the science, the Uncover CKD program is applying RWD to create urgency to diagnose and treat patients with CKD. With this innovative partnership we are leveraging relationships with health systems to improve care for 2.8 million patients identified to benefit from earlier CKD diagnosis and treatment,” said Rachele Berria, Vice President and Medical Head, US BioPharmaceuticals, AstraZeneca.

Health System Selection Criteria

In the selection of target health systems for the Uncover CKD - Care Collective, the project team considered disease burden, patient composition (e.g., age, sex, race, ethnicity), payer composition (e.g., Medicaid, Medicare, uninsured), hospital region (geographic diversity), urbanicity of served population, teaching status and hospital size. Priority was given to health systems serving many socially disadvantaged patients (i.e., health equity). For patient outreach efforts, the project team provided screening algorithms to the target sites so that they can identify socially disadvantaged patients with undiagnosed CKD for targeted outreach.

Hospitals and health systems in the U.S. can request access to the online PINC AI™ Community “Chronic Kidney Disease (CKD): Diagnosis and Mgmt.” to obtain outreach materials that have been developed as part of the Uncover CKD Project such as educational resources and tools for patients and healthcare professionals. Premier will work with respective hospitals or health systems to provide relevant resources, based on needs.

DALLAS, TX — Atrial fibrillation, or AFib, is the most common type of irregular heartbeat, estimated to affect about 12.1 million U.S. adults by 2030. The abnormal firing of electrical impulses causes part of the heart to quiver, or fibrillate, often leading to complications and up to a fivefold increased risk of stroke. ​To help ensure all patients with AFib receive the most appropriate care, the American Heart Association is launching a new effort to educate and engage pharmacists, an important but underrepresented voice in AFib care.

“Pharmacists are an integral part of the multidisciplinary team to optimize care for individuals with atrial fibrillation,” said Cody Parsons, APh, PharmD, BCCCP, manager of clinical operations for Stanford Health Care's cardiovascular health service line. “The insight of pharmacists in evaluating the medical complexity and use of multiple medications is essential in facilitating safe and effective anticoagulation and ultimately preventing life-altering medical consequences of AFib.”

This new effort, being conducted through June 2025, is the latest phase of the Association’s Four Fs of Atrial Fibrillation initiative, supported by Bristol Myers Squibb-Pfizer Alliance. The Four Fs are patient health concerns impeding guideline-directed anticoagulant therapy, including:

• fear of falling,
• fear of bleeding,
• forgetfulness, or cognitive dysfunction and
• frailty.

Pharmacists are often not consulted in the decision-making conversations for Afib patients during the patient care journey. During this next phase of the initiative, the Association will convene pharmacists in a roundtable event to identify gaps and opportunities related to AFib in this field. The Association then will share resources and insights nationally across thousands of hospitals and outpatient clinics.

AFib is often only detectable during physical examination, although some affected people may experience fatigue, rapid and irregular heartbeat or other discomfort.​ ​The use of anticoagulant therapy to reduce stroke risk is supported by science, but many patients remain untreated or undertreated.

WASHINGTON, DC — The American Hospital Association (AHA) released a new report showing that hospitals and health systems continue to experience significant financial pressures that challenge their ability to provide 24/7 care for the patients and communities they serve. 

“As this report clearly highlights, increased expenses, workforce challenges, and growing administrative burden are unsustainable and creating headwinds and obstacles that threaten access to care for millions of Americans,” said AHA President and CEO Rick Pollack. “The AHA urges Congress and the Administration to take action to strengthen hospitals and health systems and bolster access to care for all patients and communities.”

In 2023, data show that hospitals and health systems continued to face substantial challenges due to higher costs for labor, drugs, and supplies. At the same time, reimbursements from Medicare and Medicaid did not keep pace with these mounting costs, and hospitals and health systems increasingly encountered challenges navigating onerous commercial insurer practices such as denying and delaying access to and payment for patient care. These headwinds persist in 2024 and have been further exacerbated by the recent unprecedented Change Healthcare cyberattack, forcing many hospitals to dip into their diminishing cash reserves to maintain operations.

Key findings from the report include:

• Economy-wide inflation grew by 12.4% between 2021 and 2023, more than double the 5.2% growth in Medicare reimbursement for hospital inpatient care. This makes it harder for hospitals to maintain access to care and invest in cybersecurity and cutting-edge treatment.
• Hospitals and health systems incurred significant underpayments for several essential and complex health care services in 2023, including:
  • Payments for inpatient behavioral health services were on average 34% below costs across all payers.
  • In the outpatient setting, payments for costly burn and wound services were on average 43% below costs across all payers.
• Hospitals and health systems face mounting administrative burden and costs due to certain commercial health insurer practices like prior authorization and denials. At the same time, health insurance premiums grew twice as fast as hospital prices in 2023.
• Increasing drug prices and workforce challenges continue to cause hospitals financial stress.
  • In 2023, the median annual list price for a new drug was $300,000, an increase of 35% from the prior year.
  • 2023 saw the most drug shortages in over a decade; there were an average of 301 drugs in shortage per quarter, an increase of 13% from the previous year.
  • Hospitals’ labor costs, which on average accounts for 60% of a hospital’s budget, increased by more than $42.5 billion between 2021 and 2023.

The full report is available here, along with a one-page executive summary.

DALLAS, TX — Steward Health Care, a national fully integrated value-based healthcare system and the largest physician-led hospital operator in the United States, announced that it has commenced an in-court restructuring process through the filing of voluntary petitions for relief under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of Texas. The Company is finalizing the terms of debtor-in-possession financing from Medical Properties Trust for initial funding of $75 million and up to an additional $225 million upon the satisfaction of certain conditions acceptable to Medical Properties Trust. 

Steward took this voluntary step today as a necessary measure to allow the company to continue to provide necessary care to its patients in their communities without disruption. Steward does not expect any interruptions in its day-to-day operations, which will continue in the ordinary course throughout the Chapter 11 process. Steward’s hospitals, medical centers and physician’s offices are open and continuing to serve patients and the broader community and our commitment to our employees will not change. 

“Steward Health Care has done everything in its power to operate successfully in a highly challenging health care environment. Filing for Chapter 11 restructuring is in the best interests of our patients, physicians, employees, and communities at this time,” said Dr. Ralph de la Torre, Chief Executive Officer of Steward. “In the past several months we have secured bridge financing and progressed the sale of our Stewardship Health business in order to help stabilize operations at all of our hospitals. With the delay in closing of the Stewardship Health transaction, Steward was forced to seek alternative methods of bridging its operations. With the additional financing in this process, we are confident that we will keep hospitals open, supplied, and operating so that our care of our patients and our employees is maintained. By working collaboratively with stakeholders in this court-supervised controlled environment, and having the benefit of our earlier strategic efforts, Steward will be better positioned to responsibly transition ownership of its Massachusetts-based hospitals, keep all of its hospitals open to treat patients, and ensure the continued care and service of our patients and our communities.” 

The other primary factor driving this voluntary Chapter 11 case is, in large part, due to Steward continuing to face challenges created by insufficient reimbursement by government payors as a result of decreasing reimbursement rates while at the same time facing skyrocketing labor costs, increased material and operational costs due to inflation, and the continued impacts of the COVID19 pandemic. It is Steward’s goal to resolve the Chapter 11 process as quickly as possible, with the help of the court, with a view to the long-term and sustainable financial health of the system

RESEARCH TRIANGLE PARK, NC and BOSTON, MA — G1 Therapeutics, Inc., a commercial-stage oncology company, and Pepper Bio, the world’s first transomics drug discovery and development company, announced a global licensing agreement (excluding the Asia-Pacific region) for lerociclib for all indications except for certain radioprotectant uses. As Pepper Bio’s first in-licensed therapeutic, lerociclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). The therapeutic has previously demonstrated impressive efficacy in clinical studies across various cancer types, including two completed Phase 3 clinical trials in HR+/Her2- metastatic breast cancer.

Today, the most common type of liver cancer, hepatocellular carcinoma (HCC), is the third leading cause of all cancer-related deaths. Using Pepper Bio’s transomics platform, COMPASS, the company was able to identify CDK4 and CDK6 as potentially important targets in treating HCC. Pepper Bio then tested lerociclib in preclinical models, which showed superior efficacy over standard of care during and after dosing. With this in-licensing deal, lerociclib will be Pepper Bio’s first therapeutic on its way to Phase 2 clinical trials.

Pepper Bio’s platform, COMPASS, translates layers of biological maps, including genomics (genes), transcriptomics (RNA), proteomics (proteins), and phosphoproteomics (function of proteins), to offer researchers a complete picture of how diseases impact biology. Setting Pepper Bio apart from other drug discovery platforms is its unprecedented ability to look at the real-time function of proteins in a biological system, as opposed to the current methods of only measuring the presence, type, and quantity of proteins. COMPASS unveils the intricate functions of these proteins, which significantly impact how drugs are built and developed.

"Liver cancer is a real and devastating diagnosis for hundreds of thousands of patients each year. Adding lerociclib into our pipeline is a significant step forward in our mission to find treatments for untreatable diseases," said Jon Hu, Chief Executive Officer and co-founder of Pepper Bio. “Lerociclib holds tremendous promise as a cornerstone of our oncology portfolio, and we are excited to leverage its potential to bring life-saving treatments to those in need."

Pepper Bio will gain exclusive rights to develop, manufacture, and commercialize lerociclib for all indications except for certain radioprotectant uses in the US, Europe, Japan, and all other global markets, excluding the Asia-Pacific region, which G1 has already licensed to Genor Biopharma. G1 Therapeutics and Pepper Bio will collaborate closely to ensure a seamless transition and advance the development of lerociclib through clinical trials and regulatory approval processes. Pepper Bio is now poised to initiate clinical development programs for lerociclib, with the ultimate goal of obtaining regulatory approvals and making lerociclib available to patients as quickly as possible.

Under the terms of the agreement, G1 is expected to receive upfront payments totaling mid-single-digit millions within 12 months and is eligible to receive a maximum of $135M upon achievement of development and commercial milestones in up to three indications. In addition, Pepper Bio will pay G1 a double-digit royalty on aggregate annual net sales of lerociclib.

"Pepper Bio’s commitment to innovation makes them the right partner for advancing lerociclib through the next stages of clinical development,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “This agreement is consistent with our corporate strategy to form partnerships that enable global access to our promising oncology therapies; with Pepper Bio, we look forward to the opportunity to realize the full therapeutic potential of lerociclib across new oncology indications."

BENTONVILLE, AR — Walmart made the decision to close all 51 health centers across five states and shut down their virtual care offering, noting that the challenging reimbursement environment and escalating operating costs create a lack of profitability that make the care business unsustainable for them at this time.

From Walmart's news release: "Our priority will be ensuring the people and communities who are impacted are treated with the utmost respect, compassion and support throughout the transition. We do not yet have a specific date for when each center will close but will share as soon as decisions are made. While we will no longer operate health centers, we will take what we learned as we provide trusted health and wellness services across the country through our nearly 4,600 Pharmacies and more than 3,000 Vision Centers. For 40 years, we have provided these high quality, accessible and affordable points of care that are integral to their respective communities."

Over the past few years, the importance of Pharmacies has continued to grow, and Walmart has expanded the clinical capabilities of the services they provide. They will continue to offer immunizations and have grown to provide testing and treatment services, access to specialty pharmacy medication and care, as well as other essential services such as medication therapy management and a variety of health screenings. With more than 4,000 stores in medical provider shortage areas, Walmart stated that their pharmacies are often the front door of healthcare.

Walmart states that they are focused on continuity of care for patients and providing impacted associates with respect and assistance as they begin the closing process of the health care centers. Read the full release here.