Category: Health

  • The State of Patient Access 2024

    The State of Patient Access 2024

    The State of Patient Access 2024

    The State of Patient Access 2024 is the fourth in a series of patient and provider surveys that began in 2020. This year’s report compares how patients experience access to care and providers’ perceptions of those experiences. The new report highlights findings from a survey conducted in February 2024 of 200 providers and more than 1,000 patients.

    The study finds that perceptions of access to care are improving. It’s a positive sign that providers are moving in the right direction—but we still have mountains to climb. What remains the same from prior surveys is that providers believe access to care is much better than what their patients are truly experiencing.

    The survey showed 55% of healthcare providers believe patient access has improved. It’s a big jump from 2022, when just 27% of doctors felt access increased. What’s striking, however, is that patients don’t completely agree. Only 28% say patient access improved in 2023, an 11% increase from the prior year. Over half (51%) of patients and 26% of providers say patient access has remained fairly static.

    While the findings show access is improving, there is still a gap between patient experience and provider perception. How can providers improve care access and make their perceptions a reality for their patients?

    Download The State of Patient Access 2024 report to get the perspectives from patients and providers on their perceptions of access to healthcare.

    Myths vs. realities of patient access

    The good news from the survey is that most providers and patients agree access to care isn’t worsening. Despite increasing patient volumes and chronic staff shortages, patient access is better than before the pandemic. The findings are a sharp reversal from last year’s report, where almost one-half of providers and one-fifth of patients reported care access had grown more challenging.

    • Patient access is:
      • Better
        • Patients: 28%
        • Providers: 55%
      • The same
        • Patients: 51%
        • Providers: 26%
      • Worse
        • Patients: 22%
        • Providers: 20%

    Consistently, across these annual surveys, providers believe access to care delivery is better than what their patients experience. The survey highlights opportunities to bridge this gap by using digital technologies to align the patient experience and provider assumptions.

    Opportunity 1: Provide accurate upfront financial estimates

    • 96% of patients want an accurate upfront estimate of treatment costs.
    • 88% of providers agree an accurate upfront estimate contributes to successful patient payments.

    The survey showed upfront cost estimates are central to a better patient experience. A high percentage of patients (96%) said an accurate estimate of treatment costs is essential before service—so crucial that 43% said they would cancel their procedure without it. Yet 64% of patients did not receive a cost estimate before care, despite increasing state and federal regulations that require this transparency.

    Perhaps even more troubling, the accuracy for those estimates is questionable. Of the 31% of patients who received a pre-procedure cost estimate, 14% reported the final cost was much higher than anticipated. At the same time, 85% of providers say their estimates are accurate most or all the time. The gap in provider perception and patient reality come together at the point of understanding the need for accurate cost estimates. Understanding what is covered by insurance helps patients manage their healthcare costs. Providers are invested in getting estimates correct because they are a key part of getting paid on time, in full.

    Patient payment estimates software can automatically create a more accurate picture of costs, reducing the burden on healthcare staff and eliminating unwelcome patient surprises. Consolidating service pricing estimate data from multiple sources empowers patient accountability and decision-making. One health system used these digital tools to increase point of service patient collections by nearly 60%, producing estimates that were 80 to 90% accurate.

    Opportunity 2: Improve data collection at patient intake

    • 85% of patients dislike repetitive paperwork during the intake process.
    • Almost half (49%) of providers say patient information errors are a primary cause of denied claims.

    The survey showed patients and providers are frustrated with the data collections process during registration. More than eight of 10 providers say automation could improve this process. Yet, in practice, intake remains primarily manual. Patients complain they shouldn’t have to complete the same paperwork at each visit. Providers know these manual tasks lead to errors that cause big headaches for claims departments later. However, only 31% consider improving the speed and accuracy of collecting patient information a priority.

    The top reasons for claim denials are paperwork inaccuracies and missing or incomplete claim information. Human errors cause challenges when it’s time for providers to get paid. Up to 50% of claims denials stem from a paperwork processing error at patient intake. As a result, in 2022 alone, healthcare providers spent nearly $20 billion pursuing reimbursement denials. Everyone agrees that providers must do all they can to prevent errors. Providers understand claims denials are a significant roadblock to cash flow. Patients grow frustrated when account balances remain in limbo long after their procedure is complete.

    Digital technology can streamline patient access and transform the healthcare revenue cycle. Experian Health’s Patient Access Curator solutioncan check eligibility, COB, MBI, demographics, insurance coverage, and financial status in less than 30 seconds, in one click, speeding up the laborious human intake process that creates anxiety—and errors—for patients and providers.

    Opportunity 3: Give patients online self-service options

    • 89% of patients said the ability to schedule appointments anytime via online or mobile tools is important.
    • 63% of providers have or plan to implement self-scheduling options.

    According to this year’s survey, self-scheduling is hot; waiting on hold with a call center is not. Digital and paperless pre-registration is increasingly important to patients and there is evidence that providers are finally starting to listen. For example, 84% of the providers strongly agreed that digital and mobile access is important to patients.

    However, self-scheduling did not make the list of the top three provider priorities for improving patient access to care. But the data tells us patients hold out hope for a mobile-first online scheduling process that puts them in the driver’s seat to control their access to care.

    Convenient online scheduling software gives patients control over booking, canceling, and rescheduling appointments. It’s a digital front door that’s easy to use across any device. Automated notifications can remind patients of annual health exams, replacing the need for staff calls and closing any gaps in preventative care. These tools can reduce time spent scheduling patients by 50% and significantly decrease appointment no-shows. More importantly, they give patients the digital experience they demand.

    Digital technology brings together patient experience and provider perceptions

    The State of Patient Access 2024 survey illustrates a narrowing gap between what providers perceive and patients experience. That’s good news because a lack of access to healthcare is a contributing factor to a sicker population, which costs much more in the long run. According to Deloitte, barriers to accessing healthcare in this country will grow to a $1 trillion problem by 2040. Patients will continue to experience care access issues in the coming years, from staffing shortages and a lack of rural providers, higher co-pays and more.

    Can we bridge these future gaps? The answer is a resounding yes—while there’s still work to do, the survey showed 79% of providers plan to invest in patient access improvements soon.

    Download The State of Patient Access 2024 to get the full survey results, or contact us to see how Experian Health can help your organization improve patient access. 

  • Demystifying Coding Compliance: 3 Key Strategies for Navigating the Regulatory Waters of RCM

    Demystifying Coding Compliance: 3 Key Strategies for Navigating the Regulatory Waters of RCM

    Noncompliant coding is a more significant risk to the revenue cycle than providers may realize, accounting for $36 billion in annual lost revenue, denials, and fines. In 2019 alone, the CMS and the HHS Office of Inspector General (OIG) imposed fines and penalties for coding noncompliance of $2.5 billion and $3.7 billion, respectively.  

    What is coding compliance?

    Coding compliance includes the processes that ensures the “coding of diagnosis, procedures and data complies with all coding rules, and regulatory guidelines.” Because lack of coding compliance falls under the “fraud and abuse” category of the American Medical Association’s Principles of CPT® Coding, it is an area that is highly scrutinized by payers and subject to increasingly stringent government regulations.

    In addition to the risk of audits and penalties, coding inaccuracies will impact revenue through an increase of denied claims. In 2022, 11% of all claims were denied. A recent survey of healthcare leaders found that coding inaccuracies were among the top three causes of denials.

    Numerous healthcare regulations impact coding and noncompliance can put patients and entire organizations at risk. 

    Three key strategies for improving coding compliance

    There are three essential strategies that organizations should implement to reduce the risk and financial impact of noncompliance: Education, internal audits, and automation technology.

    Education

    One of the most strategic, impactful steps organizations can take to improve coding compliance is implementing a comprehensive education program for the coding team. Maintaining an optimal level of coding knowledge can be challenging, even for the most seasoned coders. Ongoing, rigorous education and industry certification are imperative. 

    According to the AAPC, there are seven essential skills coders need to develop to be successful. Organizations should build their curriculum around these elements, which include the following items:

    • Attention to detail
    • Medical terminology
    • Knowledge of coding systems
    • Analytical skills
    • Communication skills
    • Knowledge of insurance policies and
    • Time management.

    Internal audits

    Internal audits are essential to maintaining coding compliance as they help identify coding issues and problematic trends so they can be proactively addressed and process improvements put in place. According to the Medical Group Management Association, audits need to include samples of patient encounters as they were coded and billed. “To design an audit, identify strategic initiatives, such as performance measures, validation of coded claims, prevalence of diseases, and treatments and adherence to policies and procedures to ensure compliance.” 

    As part of the auditing initiative, coding leadership should communicate regularly with the organization’s Chief Compliance Officer or Compliance Committee to work in collaboration to monitor compliance. The goal should be to detect, prevent, and remediate noncompliance. This should include risk assessments with the following actions:

    • Creating an investigation process, 
    • Developing risk-based plans and training,
    • Action-based compliance program, including readjustments and reallocations, and
    • Self-disclosures, cooperation, and remedial action.

    Automation technology

    Automation technology such as artificial intelligence (AI), machine learning (ML), natural language processing (NLP), and robotic process automation (RPA) are invaluable tools for audits and for improving day-to-day coding accuracy. They can perform regular analysis on charts, clinical documentation, and overall coding with limited human intervention. Automated triggers can be applied to various processes to generate specific actions. Once a human becomes involved, much of the work to investigate and identify a coding issue will have already been completed. 

    When to get help

    Organizations that lack the internal resources necessary to conduct ongoing education or to implement automation technology can benefit by partnering with industry experts who utilize automated systems. In this way, organizations can achieve a faster return on their compliance investment. When choosing a partner, organizations should select one with an advanced degree of coding expertise, deep coding and compliance knowledge, 

    Success story

    A health system with poor coding quality experienced increased payer scrutiny and poor revenue performance. By implementing a coding quality and compliance program, they were able to elevate coder performance and improve reimbursement accuracy and timeliness. The health system significantly reduced third-party audits and findings while elevating reimbursement profiles. 

    Coding quality initiatives implemented included:

    • Pre-hire online skills assessment for new team members
    • Pre-production competency testing through initial and transitional quality reviews
    • Monthly quality reviews with feedback and educational alignment
    • Targeted and ad-hoc audits for root cause analysis and defect avoidance
    • Pre- and post-billing audits in key focus areas
    • Detailed reporting, analysis, and feedback

    Maintaining compliance in an ever-changing regulatory environment

    Of all the revenue cycle processes that have the potential to impact the bottom line, coding is at the top of the list. But it’s not just about submitting claims and getting paid. Errors in the coding process can lead to payer audits, takebacks, and significant penalties and can even harm an organization’s brand reputation. Therefore, organizations must take a proactive approach by implementing a comprehensive education program, internal audits, and automation technology. When that approach isn’t possible, partnering with industry experts is an excellent option.

    Photo: Nuthawut Somsuk, Getty Images


    Deborah (Debby) Cornett has been with Conifer in various leadership roles since 2012. In 2014, Debby was promoted to Vice President of Clinical Revenue Integrity with primary focus on Coding and CDI. In 2017, she moved into a senior leadership role as Vice President of Clinical Revenue Integrity for the Hospital Revenue Cycle Management business line. In this role, she oversees areas of client performance and experience, clinical documentation integrity, and CRI audit and education for both the Hospital Revenue Cycle Management and Physician Services business units.
    Debby brings more than 25 years of progressive strategic and operational leadership in all areas of the revenue cycle to her current role. Prior to joining Conifer in 2012, she was the Corporate Director of Health Information Management, Coding, CDI, Scheduling, and Patient Access at Jewish Hospital & St Mary’s HealthCare.

  • Experts Aren’t Surprised About Optum Closing Its Virtual Care Business

    Experts Aren’t Surprised About Optum Closing Its Virtual Care Business

    Optum is shutting down its virtual care business after a three-year run. Industry experts aren’t very surprised by the news.

    Healthcare leaders agree that this closure reflects broader trends in the telehealth market, in which saturation and differentiation challenges are leading some providers to struggle. In the future, experts believe the most successful virtual care companies will be those that provide personalized patient experiences and focus on niche community needs — as well as those that adapt to a hybrid model of care rather than relying solely on virtual.

    What happened?

    Optum’s virtual care unit offers virtual urgent and primary care visits and prescription refills across all 50 states. Optum, which is owned by UnitedHealth Group, founded its virtual care business in April 2021 — when pandemic restrictions were still prevalent and telehealth enthusiasm levels were high.

    Former Amazon executive Kristi Henderson served as CEO of the virtual care unit until last June, when she departed to take over as CEO of musculoskeletal care provider Confluent Health.

    News of the unit’s closure first emerged last week when Optum employees began posting on social media about layoffs at the company. Optum confirmed the news in a Tuesday email to MedCity News.

    An Optum spokesperson wrote that virtual care “has been and will continue to be a core part” of the company’s integrated care delivery model.

    “As an enterprise, we are committed to providing patients with a robust network of providers for virtual urgent, primary and specialty care options. We continually review the capabilities and services we offer to meet the growing and evolving needs of our businesses and the people we serve. As always, we will support affected team members with job placement resources and seek to deploy them where possible to any open roles within the company,” the spokesperson wrote.

    At UnitedHealth Group’s investor conference last November, Optum Health CEO Amar Desai declared that Optum has nearly 90,000 employed or affiliated physicians, as well as another 40,000 advanced practice clinicians. Optum has not disclosed how many of these healthcare workers will be affected by the shutdown.

    Has the telehealth hype worn off?

    Health systems’ data shows that virtual visit volume has been decreasing since 2021, and market research reports released the past couple years have predicted the trouble in the telehealth space.

    For example, a Trilliant Health report from August showed that the telehealth market is becoming oversaturated, making it harder for companies to stand out. Essentially, the boom of telehealth providers that came in 2020 and 2021 was a result of pandemic-era forced telehealth adoption — and now the market has to pick up the pieces, the report said.

    Sanjula Jain — author of the report and Trilliant’s chief research officer — said that Optum’s decision to shutter its virtual care business comes as no surprise.

    “The data suggests that virtual care is used by a niche segment of the population and within that small population, nearly half of users only used it once,” she said. “Moreover, more than 60% of telehealth visits were for behavioral health-related reasons with a small proportion of utilization attributed to primary care services.”

    Jain also said it’s important to note that 30% of non-behavioral health virtual visits result in the patient needing to schedule a follow-up in-person visit for the same reason, which suggests a degree of service duplication or friction. 

    When considering these data points in tandem with the fact that employers are questioning the value that virtual care services are providing to their workers, it is “no surprise that Optum was likely struggling to generate a return on their investments in virtual care,” she declared.

    Another healthcare exec — Anu Sharma, CEO of hybrid maternity care startup Millie — agreed with Jain.

    “There was a lot of excitement around virtual care, especially with the surge in adoption during Covid. But there are very few use cases for virtual-only care, and patients like to establish long-term care where they can also be seen in person when needed. The future of healthcare is hybrid, not virtual,” Sharma wrote in an email.

    Optum’s virtual care unit is certainly not the only telehealth provider that has struggled to find its footing in a post-pandemic world. For instance, two of the nation’s largest virtual care providers have already enacted significant job cuts this year. Teladoc Health laid off staff in January following a round of job cuts in 2023, and Amwell announced it had let go of about 10% of its workforce in February.

    ‘All virtual care is not created equally’

    In the post-pandemic market, the virtual care providers that succeed will be the ones that personalize the patient’s experience around their needs and preferences, according to Define Ventures Partner Chirag Shah.

    “Healthcare is incredibly personal, yet the average healthcare experience is often deeply impersonal. We have always believed in the power of virtual care to reach people beyond the four walls of a clinic, but all virtual care is not created equally,” he remarked.

    This belief is reflected in the telehealth companies Define Ventures has chosen to invest in, Shah added. For instance, Tia offers care tailored to women’s needs, Found provides personalized weight loss programs, and Folx Health delivers individualized care to the LGBTQ+ community, he noted. Found and Folx offer virtual-only care, and Tia provides hybrid care.

    In an email to MedCity News, Faatin Chaudhury, head of payer strategy and partnerships at Folx Health, pointed out that while telehealth adoption has decreased compared to the early days of the pandemic, usage remains higher than pre-pandemic levels overall. 

    In her view, telehealth providers aren’t headed into a world of doom — they just need to tailor care to the communities they service and recognize the importance of optimizing the patient experience.

    “The virtual health industry has seen significant growth and evolution over the past few years, playing a crucial role in expanding access to care for many, especially for LGBTQ+ and marginalized communities. Virtual care is often a lifeline, providing accessible and inclusive healthcare to those who face barriers accessing traditional healthcare services,” Chaudhury wrote.

    Because Folx provides care tailored to the LGBTQ+ community, it provides a differentiated experience to its users. More than half of transgender people in the U.S. live in states that are mainly rural — and where telehealth is critical for access — Chaudhury pointed out. 

    Not all telehealth providers have that kind of niche patient focus, though — Optum’s virtual care unit didn’t. That could be a key reason why the company has chosen to shut the business down, according to another healthcare leader. Rishi Gowda — CEO of healthcare AI company Crosby Health — agreed with Chaudhury, saying there is a noticeable trend of virtual care providers emphasizing their patient experience amid growing competition. That said, it seems that Optum is strategically adjusting its focus to “enter markets where it can have a larger footprint,” he wrote in an email. 

    “Given UnitedHealth Group’s partnerships with multiple virtual care providers across different specialties, it’s understandable that the organization is honing in on its approach to care management. By selecting specific lanes and refining its ongoing care strategy, I would believe UnitedHealth Group is aiming to improve the member experience by offering a more tailored and seamless virtual care service,” Gowda stated.

  • Labcorp Makes Another Acquisition, Plucking Invitae Assets From Bankruptcy Auction

    Labcorp Makes Another Acquisition, Plucking Invitae Assets From Bankruptcy Auction

    Invitae’s business operations are heading to a new home. Under a bankruptcy auction, Labcorp was selected as the winning bidder for the firm’s genetic testing services, digital health solutions, and health data services.

    Invitae described the bid as covering “substantially all” of its assets, adding that the transaction will ensure continuity for the company’s customers and partners. Labcorp characterized the purchase as “selected assets of Invitae.” Because the bid came as part of Invitae’s bankruptcy process, the purchase still needs court approval. A hearing is scheduled for May 7.

    The tests of San Francisco-based Invitae are used in clinical areas that include oncology, women’s health, and rare disease. In 2022, Invitae announced a corporate realignment to streamline its operations and its product portfolio. The restructuring cut more than 1,000 employees. The cost-saving measures were not enough. In February, Invitae filed for chapter 11 bankruptcy protection. The bankruptcy filing lists $535.1 million in assets and more than $1.6 billion in total debt.

    Labcorp’s winning bid for the Invitae assets comes nearly a month after the Burlington, North Carolina-based laboratory testing giant agreed to pay $237 million to acquire the clinical diagnostics and reproductive women’s health business of BioReference Health. Those assets generate about $100 million in annual revenue, Labcorp said. This transaction is expected to close in the second half of this year.

    The Labcorp portfolio already covers oncology and genetic testing as well as some rare diseases. The company calculates that the Invitae assets will generate between $275 million and $300 million in annual revenue. But one concern might be Invitae’s high rate of business spending. In a research note sent to investors, William Blair analyst Andrew Brackmann said that if Labcorp can stem this high cash burn, the incoming assets could become compelling additions to its portfolio, leveraging the lab testing company’s existing infrastructure to expand in oncology and rare diseases.

    “What is notable, in our view, is that Labcorp is being aggressive in its M&A strategy, announcing the deployment of over $475 million on acquisitions over the last few months,” Brackmann said. “And while we do not see these as accelerating top-line segment growth by more than one percentage point over the coming years—hence the questions on profitability—adding scale and solutions for the long term is critical in this evolving landscape, and these acquisitions could certainly open new customer doors for the company.”

    Photo: utah778, Getty Images

  • Healthcare Gridlock: How Bed Blocking Hinders Hospital Efficiency and How Modern Communication Tools Can Be the Key

    Healthcare Gridlock: How Bed Blocking Hinders Hospital Efficiency and How Modern Communication Tools Can Be the Key

    No one enjoys being in the hospital. They want to go home as soon as possible. In fact, the hospital actually wants patients to go home too – or to whatever the next step in care is for their situation – as soon as possible. Leaving helps patient recoveries, and it also helps the hospital’s financial health to move patients through the system as efficiently as possible, from admission to discharge. Collaboration among caregivers, administration and support staff is the only way for patients to move through that system efficiently.

    Unfortunately, that smooth process seldom happens. Healthcare faces a critical bottleneck: “bed blocking.” This occurs when patients who are medically stable and ready for discharge remain hospitalized due to factors beyond their health situations. These discharge delays can be caused by issues such as incomplete discharge paperwork, a breakdown in communication with the receiving facility, a last-minute medication or test order, or other internal coordination challenges that prevent a bed from being turned. When communication relies on a patchwork of pages, phone calls, emails and other modalities, there exists a lack of transparency and accountability, making it easy for staff to stall with little urgency. This is often the case with nurses who are burnt out and overworked, as taking new patients adds to their burden. Transportation is also a consistent culprit in causing delays because it’s simply unavailable – even seemingly simple things like getting a wheelchair to the patient’s room. Unfortunately, the repercussions of bed blocking are far-reaching.

    The cost of congestion

    Bed blocking happens because of a host of delays, glitches and confusions that prevent effective collaboration among staff and departments. We have coined the term Collaboration Waste to describe these activities because even though they might seem disconnected – a glitch here, a delay there – they are part of the same operational fabric. Time, money, staff abilities and more are wasted as patient throughput stalls.

    Bed blocking can impact every part of the healthcare experience, from degrading patient care and pushing the needle on nurse and physician burnout to severe financial ramifications for the hospital. A recent Massachusetts Health and Hospital Association report paints a grim picture. Staffing shortages and the lingering aftershocks of the pandemic are creating intense logjams in transitioning patients to post-acute care facilities. 

    Delayed hospital discharge can have an array of negative impacts on patient care. Prolonged hospitalization can expose patients to a higher risk of hospital-acquired infections, sleep deprivation, and other physical impacts, which can further extend their stay. A lack of available hospital beds also disrupts patient flow, overcrowding emergency rooms and straining staff, furthering the impact of clinician burnout and the possibility for medical errors. These delays cause discomfort for patients and families and significantly strain hospital resources and finances. 

    Low staffing levels in hospitals exacerbate Collaboration Waste and create a vicious financial cycle. With fewer staff, hospitals can’t treat as many patients, leading to lost revenue. Additionally, discharge delays due to staffing limitations eat into profit margins even for patients they see. This rising cost of care and lower patient volume further strain already stressed hospital finances. Data from New York State reveals a staggering cost: discharge delays resulted in a collective loss of $169 million for 52 hospitals in just three months. Peak seasons compound the situation with surges in hospitalizations witnessed, particularly amid the ongoing challenges posed by Covid-19, influenza, and respiratory syncytial virus (RSV) cases. 

    Hospitals must adopt strategies to address Collaboration Waste and optimize care coordination processes amid this tumult. Thankfully, technology equipped with modern communication methods is ready to help break the bottleneck and mitigate the risks of bed blocking.

    The cure: Streamlining communication

    One solution to enhancing care coordination is through effective clinical communication and collaboration (CC&C) platforms. These modern communication tools foster information exchange – via multi-modalities such as text, voice and video – between all stakeholders involved in a patient’s care journey, seamlessly integrating with existing electronic health records and clinical systems and allowing for faster collaboration and interventions. Healthcare staff, external care facilities, and families can access real-time updates on patient status, discharge plans, and any logistical or care-related roadblocks. These secure platforms offer features like role-based messaging and smart routing, ensuring messages reach the right person or team. Staff don’t need to know each team member’s name—identifying their role, like “hospitalist,” is enough to route your message to the on-call individual. Integration with scheduling systems further ensures the right person receives alerts. Beyond improved care, CC&C platforms boost a hospital’s financial health and unlock the full potential of existing investments in EHRs and scheduling systems by unifying these siloed tools into a cohesive environment for clinicians.

    Technology plays a significant role in helping improve healthcare communication, both externally by facilitating coordinated patient transfers between facilities and internally by streamlining communication between staff in the ER, main hospital floor, and other departments. Many people are involved in the internal transfer of a patient from the ER to the main hospital floors – bed control, head nurses, transport, the receiving physician, etc. That means there are opportunities for miscommunication and resulting delays. This is where technology becomes a critical ally. 

    In this case, the right clinical communication system can help locate the proper professional or patient quickly rather than relying on phone calls. Additionally, the person sending the initial communication can see what messages have been viewed and received, making it easier to communicate with all constituents and providing more transparent communication, ultimately driving better accountability and reducing patient transfer delays.

    The path forward: A proactive approach to healthcare

    The current healthcare landscape demands proactive solutions. As patient volumes rise and resources remain strained, effective communication strategies are no longer optional; they’re essential. Collaboration Waste takes its toll on patient, staff and hospital financials.

    Modern CC&C platforms empower hospitals to break through bed-blocking gridlock, fostering a more streamlined and cost-conscious healthcare system. By harnessing technology’s potential, these systems dismantle communication silos, eliminate delays, and pave the way for efficiency. Ending Communication Waste can unlock the full potential of our healthcare ecosystem, ensuring timely interventions and a smoother path to patient recovery.

    Photo: FS Productions, Getty Images


    Will O’Connor, M.D. is TigerConnect’s chief medical information officer. He’s an industry-known physician executive with more than 20 years of healthcare experience focused on operations, strategic planning, consulting, client delivery, and thought leadership across the healthcare industry.As an orthopedic surgeon, Dr. O’Connor has significant provider experience as well as deep commercial experience, having worked for multiple companies, including McKesson, Allscripts/Eclipsys, and PriceWaterhouseCoopers. He specializes in assisting large health systems, academic medical centers, community hospitals, and payers leverage healthcare information technology and operational improvements to advance their clinical and financial outcomes.Additional experience includes EHR and HIE implementations, clinical communication and collaboration, clinician adoption, analytics, clinical decision support, provider operational analysis, and clinical process redesign.

  • Using Virtual Reality to Improve Communication and Collaboration in Nursing Teams

    Using Virtual Reality to Improve Communication and Collaboration in Nursing Teams

    The nursing profession today is faced with a rising demand for care for an aging Baby Boomer population while simultaneously experiencing shortages related to a lack of educators, workforce geographic distribution, and high turnover. The American Association of Colleges of Nursing (AACN) reports that nursing schools are struggling to expand capacity to meet these increasing demands.

    Nursing is a profession that requires not only technical skills, but also soft skills such as critical thinking, decision making, empathy, confidence, teamwork, and smooth communication. These skills are essential for collaborating with other healthcare professionals in providing safe and high-quality patient-centered care. Additionally, they are vital for coping with the challenges and stresses inherent in the nursing role.

    Many nurses, especially younger nurses newly entering the workforce, have had limited opportunities to hone the communication and collaborative skills that contribute to productive workplace relationships — shown to influence job satisfaction, workplace commitment, and career longevity. Younger generations of nurses often have less experience collaborating in-person and may be more accustomed to digital forms of communication. With one-third of the nursing workforce reaching retirement age in the next dozen years, availability is diminishing for informal mentoring and on-the-job training opportunities, which are crucial for developing interpersonal skills.

    The Covid-19 pandemic has also led to fewer in-person training and collaborative learning opportunities. Without deliberate efforts to develop communication abilities, novice nurses may struggle with team efforts such as coordinating patient transfers, tracking treatment and medicines, executing provider orders, and facilitating shift handoffs. Poor communication during these activities can lead to treatment delays, redundant or missed tasks, and compromised patient safety.

    Changing relationships

    Nursing collaboration isn’t only about nurses reporting to providers. Reflecting on my own experience since graduating from nursing school in the late 1990s, there was a distinct hierarchy within the doctor-nurse dynamic. Today, we’re breaking that barrier down. It’s an interprofessional team, where doctors and providers rely on the care team — including physical therapists, case managers, and pharmacists, as well as nurses — to provide critical input about the patient to help direct the plan of care. Collaboration also involves communicating appropriately and empathetically with patients and their families in care decisions, along with administrators and other staff.

    Nurses often serve as the primary point of contact between patients and their medical teams, acting as the eyes and ears of busy providers who may only have time for a brief snapshot of the patient’s condition. I see it happen all the time with patients, where the provider enters the room, asks, “How are you feeling today?” and the patient says, “I feel fine.” Then as soon as the provider leaves, the patient shares with the nurse, “I’ve been having a pain in my abdomen for three days.”

    Patients often feel a bit more relaxed with nurses they’re around all day than with their providers, so the nurse may be privy to vital cues about the patient’s condition. They can act as an advocate for patients when collaborating with nursing colleagues and clinical professionals, ensuring that important details on patient history, current treatment strategies, and any changes to a patient’s status are shared and accurate.

    This is why it’s so critical that nurses are able not only to communicate empathetically with the patient, but also clearly communicate with other members of the healthcare team. Effective communications and teamwork result in more efficient care, fewer errors, lower costs, and improved satisfaction for the patient, as well as improved learning opportunities, higher satisfaction, and reduced anxiety among nurses.

    Practice, practice, practice


    As a result of medical practitioner shortages, there’s more pressure than ever to manage higher patient loads. Nurses have more responsibility now for conducting basic triage to gather assessments and develop hypotheses around root causes to relieve pressure on shorthanded providers. As a result, novice nurses may also take on more responsibility with critically complex patients. But how can less experienced nurses develop their soft skills in terms of judgment, communication, and teamwork for better patient outcomes?

    In my years as a nurse educator, I loved nurturing my groups of eight to ten students in a clinical setting and providing opportunities for them to practice their skills. After a time, I realized that nurse learners were usually relegated to observer status when the patients became unstable. That’s an understandable move to avoid risking patient safety, but it inadvertently restricts students’ chances to engage in critical decision-making, take proactive measures, and effectively communicate with healthcare team members during urgent care scenarios. If the nurse learner were to make a mistake, there would be no time to discuss it or re-do it, or for the learner to figure out on their own how to correct it.

    Like the old joke about how to get to Carnegie Hall, becoming a confident and capable nurse in a high-stakes situation requires practice, practice, practice. In a November 2023 survey of 957 nursing instructors done by my company, we found that 31% expressed concern over their ability to train nurse learners for high-acuity, low-occurrence events.

    A way to address this gap is to provide opportunities for realistic simulations and hands-on experiences. Simulations can involve virtual reality (VR) software programs, manikins, standardized patient actors, or a combination of methods. Simulations allow nurses to practice and improve clinical reasoning, teamwork, and resilience in a realistic, controlled, high-pressure but safe environment. That’s the value of simulation; it’s a chance to make mistakes, analyze and reflect on performance, determine the possible fixes, and build muscle memory without real-world consequences from errors.

    Unfortunately, demand exceeds the available capacity in many nursing institutions. In fact, 84% of the nursing instructors we surveyed affirmed their nursing program has denied acceptance to qualified applicants because of a lack of simulation facilities and resources.

    This alarming statistic underscores a critical bottleneck in addressing the nursing shortage, highlighting the urgent need for investment in and expansion of simulation-based educational infrastructure. By enhancing simulation capabilities, nursing programs can not only accommodate more students but also equip them with the essential skills required to meet the complex demands of the healthcare industry.

    Sample VR scenarios

    In VR, nurse learners are immersed in simulated collaborations with realistic virtual patients and healthcare colleagues. Compared to traditional training methods, immersive VR simulations can be accessed anytime and anywhere, reducing the need for personnel and physical equipment in special labs beyond the VR headset and handheld controllers.

    Here are a few examples of practice scenarios that could be simulated in VR to help nurses improve their teamwork and communication skills:

    • Conducting assessments on patients experiencing rapid deterioration
    • Ensuring timely interprofessional communication regarding changes in the patient’s condition
    • Coordinating treatment protocols
    • Providing therapeutic communication, support, education and advocacy to patients
    • Communicating key information during a shift change report
    • Collaborating during patient admission, discharge, or transport
    • Managing de-escalation of agitated patients or family members
    • Administering compassionate palliative care at the end of life

    A 2023 Pennsylvania College of Technology study found that full-immersion VR simulations decreased nursing student anxiety levels about communication skills. Multiplayer VR platforms can foster collaborative skills by allowing learners to function in virtual teams. Learners get real-time feedback, reflect on their own performance, and participate in debriefing opportunities with other students and instructors.

    Transformative technology

    Virtual reality simulations have the potential to provide a transformative solution to many of today’s challenges in nursing education, improving on-the-job competence, coordination, and resilience. To increase satisfaction and longevity in the workforce, McKinsey research found that nurses need more time and opportunities for training, peer-to-peer teaching, and feedback.

    VR has shown to be a cost-effective supplement to in-person clinical experiences in educational institutions of all sizes. Realistic simulations in a safe environment help nurse learners develop the clinical judgment skills essential to delivering safe and quality care to patients, and to improving Next Generation NCLEX nursing licensing examination scores.

    Forward-looking nursing schools may want to follow the recommendation of a new study in Taiwan, that communication simulations in VR “should be arranged as early as possible in fundamentals of nursing practice courses.”

    Photo: Nikada, Getty Images


    Christine Vogel, MSN, RN, CHSE, CHSOS, is a lead nurse educator at UbiSim , where her passion for innovation in nursing education drives her to design, pilot, and evaluate evidence-based immersive virtual reality (VR) simulations for nurse learners. With a distinguished career that extends over 25 years in nursing, including more than a decade dedicated to academic roles, her work is inspired by a commitment to enhance the educational journey of nurse learners and improve patient care.

  • BMI: A Flawed Measure of Health

    BMI: A Flawed Measure of Health

    Body Mass Index (BMI) has long been regarded as a standard measure for assessing weight-related health risks and, more recently, determining eligibility for anti-obesity medications like GLP-1 receptor agonists semaglutide (Wegovy) and tirzepatide (Zepbound), according to the FDA. 

    BMI, calculated from weight and height, offers a simplistic yet flawed assessment of health. It was initially designed for non-Hispanic white populations and overlooks nuances like muscle mass, fat distribution, and ethnic background, which can influence certain risk factors. It’s an antiquated measure that perpetuates inequities in healthcare and misses the mark for calculating cardiometabolic conditions.

    The perception that a “normal” BMI is ideal and an “overweight to obese” BMI is not ideal only exacerbates bias within the medical community and complicates our efforts to solve the obesity crisis. Individuals with an overweight to obese BMI that is, > 25 and>30, respectively, may be healthy. At the same time, those within the “normal” BMI range may not be. They could have excess visceral fat (the dangerous type that sits around the organs) and the associated health risks. Moreover, as people age, their expected fat accumulation further complicates BMI’s reliability. We can’t judge health based solely on BMI.

    Recognizing these limitations, the American Medical Association (AMA) acknowledged in June 2023 that BMI is an imperfect measure and that measuring waist circumference in addition to BMI may be a better way to predict weight-related risk. 

    While BMI may be suitable as a population health measure, it doesn’t work well at the individual level to determine the need for drastic — and expensive — interventions like GLP-1s for weight loss.

    AOM prescribing and cardiovascular risk

    With the rising popularity of GLP1s for weight loss, we’ve seen a surge in patients visiting their PCPs in search of prescriptions. FDA labeling for anti-obesity medications (AOMs) requires BMI criteria of >30 or >27 with at least one weight-related comorbidity to qualify for a GLP-1. This criteria may be adjusted for the Asian phenotype, who tend to accumulate higher visceral fat over subcutaneous fat.

    However, GLP-1 agonists aren’t appropriate for every patient who qualifies for an AOM based on BMI criteria alone. These drugs are expensive, and they come with side effects and other risks. A recent study showed that nearly two-thirds of the people prescribed a GLP-1 receptor agonist, self-discontinued in year two. It’s obvious we’re not effectively treating obesity by simply writing prescriptions.

    The recent surge in GLP-1 prescribing is expected to increase employer healthcare costs by 5.4 percent this year alone. We need to more carefully select whom we prescribe these intensive drugs if we want to reduce costs and optimize long-term success for our patients. We should look at various clinical metrics and lean on other evidence-based interventions to yield a clinically meaningful weight loss of 5-10% of total body weight. Other evidence-based interventions could include medical nutrition therapy a registered dietitian provides and other less expensive medications that can treat obesity, like Contrave, Metformin, or Topiramate, Zonisamide, Qsymia, and Orlistat.

    Focusing on the maximum amount of weight loss is not the way to solve our obesity problem, nor is it the most appropriate objective when other cardiometabolic risk factors exist. Fundamentally, we should prioritize reducing cardiovascular and metabolic risk, which can often be achieved through 5-10% weight loss. 

    If we want to reduce rates of hypertension, high LDL, and type 2 diabetes, we need to look closer at other measurements like blood pressure and waist circumference. Waist circumference is associated with a higher amount of visceral fat when >35 inches for women and >40 inches for men and can be a high indicator of poor metabolic health. 

    Bias and stigma associated with BMI in healthcare

    We also need to consider the bias and stigma created by the widely accepted assertion that BMI correlates to health. Weight bias is dangerous: The psychological stress that comes from living in a larger body and experiencing bias from and within the medical community increases the risk of depression, anxiety, substance abuse, poor body image, and missed diagnoses. In many cases, physicians are prone to anti-obesity bias, which can lead them to dismiss the medical concerns of someone who is living with obesity. 

    We need to take a more nuanced view of how BMI varies across populations, ethnicities, and athletes when we use it as a health metric. Training clinicians to recognize inherent bias around weight stigma is crucial to moving past the idea that weight correlates to health and further that BMI is enough to determine who is unhealthy enough to get on medication.

    Comprehensive, whole-person-focused treatment is the solution

    It’s time we move beyond BMI and adopt a holistic approach to truly gauge health. That may look like measuring blood pressure, LDL cholesterol, and A1C, alongside factors like body composition, metabolic health, and mental health before determining the right interventions. 

    Integrated, personalized treatment that goes beyond weight and addresses mental and physical health should be the gold standard for determining who gets a GLP-1. Helping patients heal from the trauma, bias, and stigma that they may have encountered requires a compassionate and empathetic approach. Clinicians trained in cognitive behavioral techniques can help patients foster a positive relationship with food and body while also screening and triaging to therapy when other more complex mental health conditions are present.  Further, clinicians must undergo ongoing training to recognize and mitigate weight bias, fostering an environment of inclusivity and equitable care.

    Successful treatment requires interdisciplinary collaboration, integrating medical, nutrition therapy, and psychological interventions tailored to individual needs. Working with registered dietitians to optimize nutrition, focus on food quality versus just quantity and calories, and achieve an ideal and realistic body weight is crucial. Eating the right foods and optimizing nutrition when only small meals are tolerated is crucial to overall health and the prevention of rapid weight and lean body mass loss. 

    Conclusion

    BMI’s shortcomings as a health measure necessitate a paradigm shift in healthcare practices. Overprescribing GLP-1 based on BMI criteria alone overlooks crucial aspects of individual health and perpetuates inequities within healthcare. Moving forward, we must embrace more comprehensive, personalized treatment strategies that transcend BMI and address holistic health factors. We can ensure equitable healthcare access and improved patient outcomes by prioritizing inclusivity, empathy, and evidence-based practices.

    Photo: aykut karahan, Getty Images


    Gretchen Zimmermann is the Head of Cardiometabolic Care & Prescribing at Vida Health.

  • Driving Safer Care for All with Connected Healthcare Operations

    Driving Safer Care for All with Connected Healthcare Operations

    It’s no secret the healthcare industry has rapidly evolved in recent years, fueled by significant medical and technological advancements that have elevated the standard of care. Although the healthcare industry should be proud of its momentum, there’s still work to be done. Hospitals and health systems continue to grapple with core systemic issues that directly impact care quality and patient safety. Preventable harm, which includes medication errors, unsafe surgical procedures, healthcare-associated infections, diagnostic errors, patient falls, patient misidentification and more remains at an all-time high. Despite the progress made in patient safety in the last two decades, medical harm is still a leading cause of death worldwide. 

    Globally, medical errors are responsible for three million patient deaths per year. Over the course of an hour, 70 hospitalized patients will die or suffer serious injuries due to medical errors and mistakes. These errors are often the result of system or process failures, not a direct reflection of individual healthcare workers’ practices. 

    This is why addressing preventable harm starts with breaking down the data silos that exist within the healthcare landscape and pulling disparate systems together through connected healthcare operations. Disjointed systems hinder the flow of data and important information critical to preventing similar incidents from recurring in the future. By harnessing actionable data and analytics across all operations, hospitals and health systems can identify risk and build a culture of safety that better serves patients, families, healthcare workers and the organization at large. 

    Disparate systems impede decision-making

    The healthcare industry overall has a massive amount of data at its fingertips, and this amount is only expected to grow as technologies continue to advance, the industry innovates and the patient population grows. Healthcare generates 30% of the world’s data and that data doubles every three years. This wealth of information is a gateway to enhancing quality care and patient safety, but with 97% of the available data being unused or disregarded, advancements are being stifled as a result of disconnected operations. 

    When healthcare operations are not aligned, information is compartmentalized and siloed, hindering health systems’ ability to predict and prevent future safety incidents. To address preventable harm properly and holistically, healthcare organizations need information from across all operations. However, pure access to this data is not enough. Healthcare organizations need the right technology solutions that can take data and turn them into actionable insights, enabling their organization to make safer, better-informed decisions across the board. 

    The value of connected healthcare operations

    Today’s standard operations technologies remain largely disconnected and often fall short of meeting the modern challenges and demands of our healthcare ecosystem. Connecting disparate technologies enables health systems to do more with their data and leverage real-time insights that drive safer patient care. Imagine a system where all backend software operates and communicates consistently and transparently, where information flows from all departments across risk and safety, provider management, compliance and workforce management. 

    By connecting disparate systems, hospitals and health systems can understand the complete picture, reducing variability and risk and ensuring that every healthcare interaction is as safe and efficient as possible. By improving collaboration across all operations, we can create a stronger, more united culture around patient safety, one that is centered around learning and proactivity.

    Take incident reporting, for example — one important piece of the overall system. Proper recording of patient safety incidents is critical to making the right technological and organizational changes to improve safety. Many health systems are effectively operating in the dark as, unfortunately, not all patient safety incidents are recorded. Without knowledge of every patient safety incident within their organization, hospitals and health systems cannot enact efficient and effective change at the systemic level. Leveraging an advanced incident reporting software that not only makes it easier to capture all incident data, but also enables data sharing and the flow of operational insights across all departments, is crucial to achieving safer care. 

    The future of safer care

    In recent years, the topic of safer healthcare has gained more attention in the media, especially with the evolving role of artificial intelligence (AI) in healthcare and the growing conversation around regulations. As hospitals and health systems continue to explore its implementation, we are beginning to see how AI can help break down those data silos and improve efficiencies, serving as an assistive tool to enhance the humans behind our workforce. Referring to the incident reporting example, generative AI can make it easier for healthcare workers to log incidents. In the future, AI and machine learning can be used to help identify trends from incident reports, enabling better prediction and prevention of future events. 

    As healthcare leaders, we must seize the moment and enact true change to ensure patient safety is always at the forefront. At a national level, we’re already seeing an organized response around leveraging the latest technology to enhance safer care. Recently, a coalition of leading healthcare organizations and experts proposed a new federal board dedicated to patient safety, housed in the Department of Health and Human Services: the National Patient Safety Board (NPSB). The NPSB would focus on developing technology and AI-driven solutions to patient safety issues including medication errors, wrong-site surgeries, errors in pathology labs and issues in transition from acute to long-term care, relieving the burden of data collection at the frontline while also detecting precursors to harm. I’m hopeful there will be a day when holistic prevention of adverse patient events can occur, and a truly connected healthcare system exists.

    Patients everywhere deserve great care. Connecting disparate technologies and building a just culture open to tracking, analyzing and learning from adverse events enables health systems to reduce preventable harm and achieve high reliability and prevention.

    Photo: Dilok Klaisataporn, Getty Images


    Jeff Surges has 30 years of executive experience managing high-growth healthcare technology companies. As the CEO of RLDatix, he is responsible for overseeing and driving the strategic growth of RLDatix across 20+ countries. Throughout his career, Jeff has led multiple public and private companies as a C-suite executive, founder, board member, investor and entrepreneur – a wide range of roles that have given him unique operating experience and deep healthcare industry knowledge. Jeff received a BA from Eastern Illinois University.

  • Johns Hopkins Is Teaming Up With Healthy.io to Improve Diabetic Patients’ Wound Care

    Johns Hopkins Is Teaming Up With Healthy.io to Improve Diabetic Patients’ Wound Care

    Diabetes is one of the most prevalent chronic conditions in the U.S., with more than 37 million Americans living with the disease. The condition is often associated with chronic wounds, as about a quarter of diabetes patients develop foot ulcers or other chronic wounds in their lifetime.

    To improve chronic wound care for diabetic patients, Johns Hopkins Hospital teamed up with Healthy.io, a startup that was founded in 2013. Healthy.io — which is based in Boston, London and Tel Aviv — offers smartphone-based technology for better wound care management.

    The company’s wound care solution allows users to scan their chronic wound with a standard smartphone camera. Based on the scan, Healthy.io’s provides documentation, as well as wound monitoring services.

    “Following each scan, the app leverages proprietary color processing algorithms to normalize images taken under a variety of lighting conditions. Next, the app runs a set of computer-vision and deep-learning algorithms to analyze the data and translate it into clinical outputs. These include a 3D reconstruction of the wound area, a breakdown of the tissues and the wound’s exact measurements, including width, length, depth and total wound area,” explained Healthy.io CEO Geoff Martin.

    This data, along with the visual record of the wound’s progression, gets stored on a portal, facilitating collaboration among healthcare teams, he added. Specialists can then access this digital wound analysis remotely, which can help them make informed decisions and form personalized treatment plans. 

    The technology is designed to enhance analysis accuracy and identify deteriorating wounds, prompting timely intervention from the care team, Martin said.

    By harnessing the capabilities of smartphones, Healthy.io aims to overcome barriers such as limited access to care and transportation obstacles, while also confronting systemic health inequities and the increasing cost of care, he declared.

    In the wound care space, Healthy.io’s main competitors are Swift and Tissue Analytics, Martin stated. 

    “Compared to our competitors, we offer more seamless collaboration, as we work with providers and healthcare systems and integrate into their existing systems, helping alleviate traditional strains on the system while improving access to care. This flexibility and commitment to care allows us to provide meaningful health insights around the world by empowering people to test at their own convenience,” he remarked.

    But it isn’t just Martin who thinks Healthy.io’s technology is a winner. Dr. Caitlin Hicks, a director of research at Johns Hopkins, told MedCity News that she learned about Healthy.io’s technology from a colleague and “was immediately impressed.”

    Johns Hopkins began collaborating with Healthy.io on a pragmatic trial about 18 months ago, she said. She expects the trial to run for another six months or so, ultimately aiming to enroll 120 patients.

    Half of patients undergo standard diabetic wound care, which means biweekly in-person clinic appointments, and the other half use Healthy.io’s app to monitor their wound, Dr. Hicks explained. Patients are enrolled for three months or until their wound heals, whichever one happens first.

    With this trial, Johns Hopkins is seeking to determine how patients can achieve better wound healing outcomes without the burden of having to attend frequent in-person visits, she noted.

    “The primary aim of the study is wound healing, and this is designed as a non-inferiority trial,  which means we are trying to show that outcomes are relatively similar between the two groups. We are also assessing patient satisfaction, quality of life and healthcare costs, the latter of which we expect to be lower among patients who use the wound app because they theoretically will not need to attend clinic visits so frequently,” Dr. Hicks stated.

    Martin said that he hopes the results of the collaboration will enrich the body of research on digital approaches to diabetic wound care management.

    The beginning phases of this trial have already shown promising results, he pointed out. For 36% of patients using Healthy.io, the platform prompted significant clinical adjustments in their care plan, such as establishing a different daily treatment regimen or scheduling earlier clinic appointments.

    Photo: Dmitrii_Guzhanin, Getty Images

  • Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B

    Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B

    Pfizer’s first FDA-approved gene therapy is the second such treatment for the inherited bleeding disorder hemophilia B, introducing some competition to a therapeutic area that now has two of the most expensive medicines in the world.

    The FDA approval announced Friday covers the treatment of adults with moderate-to-severe hemophilia B. Known in development as fidanacogene elaparvovec, the Pfizer therapy will be marketed under the brand name Beqvez. The company expects this therapy will become available to patients later in the current quarter.

    Hemophilias stem from genetic mutations that lead to abnormally low levels of clotting proteins. These disorders mainly affect males and make patients susceptible to bleeding events that can be life-threatening. Standard treatment is prevention of bleeding episodes through frequent infusions of clotting proteins that are either engineered in a lab or sourced from healthy donors. Hemophilia B affects the clotting protein factor IX (FIX). It’s rarer than hemophilia A, which is the most common form of the disorder. The world Federation of Hemophilia estimates that more than 38,000 people in the world have hemophilia B.

    Beqvez uses an adeno-associated virus (AAV) to deliver a functional copy of the FIX gene to a patient’s liver cells, enabling them to produce FIX protein. It’s a one-time treatment that potentially eliminates the need for frequent FIX infusions. The FDA approval covers the treatment of patients who are currently receiving FIX therapy or have a history of life-threatening or serious bleeding events. Before receiving the therapy, patients must first be tested to make sure they do not have any antibodies against the AAV used to deliver the gene. Those antibodies can be identified with an FDA-approved companion diagnostic.

    The FDA decision for Beqvez is based on the results of an open-label Phase 3 clinical trial that evaluated the gene therapy in adult males with moderate-to-severe hemophilia B. First, participants received standard of care FIX therapy for six months in a lead-in study that served as the control group for the clinical trial. Patients then received Beqvez, which is administered as an intravenous infusion according to body weight.

    The clinical trial’s main goal was to measure annualized bleeding rates. Results showed that bleeds were eliminated in 60% of patients in the Beqvez arm compared to 29% in the standard of care arm. The median annual bleeding rate in the treatment arm was 0 compared to 1.3 for the standard of care. The therapy was well tolerated by patients. The most common adverse reaction was higher levels of liver enzymes, which can be a sign of drug toxicity. The liver enzymes were managed with corticosteroids. Beqvez’s label does not carry a black box warning, but elevated liver enzymes are included in the “Warnings and Precautions” section of the document. The label advises clinicians to monitor a patient’s liver enzyme and FIX levels once or twice weekly for at least four months after administering the gene therapy.

    Pfizer set a $3.5 million price for Beqvez, which is on par with Hemgenix, a hemophilia B gene therapy developed by CSL Behring and uniQure. That product’s 2022 approval made it part of a portfolio of CSL hemophilia products. Hemgenix has yet to become a blockbuster seller. Sales of the gene therapy are not big enough for CSL to break out individually, but company financial reports show its top hemophilia product continues to be Idelvion, a FIX replacement therapy for hemophilia B. Idelvion’s sales have been growing despite the commercial availability of a gene therapy that could obviate the need for FIX replacement. Meanwhile, BioMarin Pharmaceutical has had difficulty gaining market traction for Roctavian, the first FDA-approved gene therapy for hemophilia A. The market performance of both Hemgenix and Roctavian suggests Pfizer could face similar challenges persuading patients to choose its new gene therapy.

    When Hemgenix was approved in 2022, its price tag made it the most expensive medicine in the world (a status since surpassed by Kyowa Kirin’s Lenmeldy, a $4.5 million gene therapy approved in January for treating a rare enzyme deficiency). CSL said at the time that the hefty price reflects the value of reducing the economic burden of frequent FIX infusions and caring for bleeding episodes over the lifetime of a patient. To offset the financial risk of covering the therapy, CSL offers insurers a value-based agreement that ties reimbursement to a patient’s achievement of certain goals or outcomes.

    Value-based programs are becoming common for pricey gene therapies, and Pfizer’s version is a warranty that guards against the risk that Beqvez does not work. In an email, Pfizer said this warranty is based on the durability of the therapy’s effect and will provide payers with greater certainty while also maximizing access to the therapy for eligible patients. For commercially insured patients, their coverage under the warranty will continue even if they change insurance plans after receiving the gene therapy.

    “This was informed by pre-approval information exchange discussions we have had with payers to understand how we can best ensure access,” Pfizer said. “The program speaks to the confidence that we have in both our medicine’s ability to deliver for patients as well as value that it can offer the healthcare system.”

    Pfizer licensed Beqvez from Spark Therapeutics in 2014. That company, now a subsidiary of Roche, is eligible for milestone payments and royalties from Pfizer’s sales of Beqvez. The gene therapy won its first regulatory approval in Canada in January. Pfizer has more in its hemophilia pipeline. Marstacimab, an antibody drug developed to treat both hemophilia A and B, is under regulatory review in the U.S. and Europe; an FDA decision is expected in the fourth quarter of this year. Full Phase 3 results for marstacimab were presented last December during the annual meeting of the American Society of Hematology. In gene therapy, Pfizer’s pipeline includes giroctocogene fitelparvovec for hemophilia A and fordadistrogene movaparvovec for Duchenne muscular dystrophy.

    Public domain image by Flickr user SciTechTrend