Category: Health

Are you a healthcare startup in health tech, diagnostics, medtech, or biotech? If so, you should consider applying to the MedCity News startup pitch contest at the MedCity INVEST conference at the Ritz Carlton in Chicago, May 21-22. The deadline to submit applications is February 29.

To submit an application, click here.

The Pitch Perfect contest has four tracks geared to a specialty in each category:

Biopharma
Startups focused on oncology

Devices & Diagnostics 
Startups focused on cardiology

Healthtech: Consumer/Employer
Startups addressing women’s health

Healthtech: Payer/Provider
Startups addressing burnout and operational efficiency

Six finalists will be selected for each track and will have the opportunity to present to an audience of investors. The investor judges in each track will hear each pitch and ask questions of each presenter before selecting a winner.

There is no fee to apply. Startups that have been a finalist and pitched at any INVEST event in the past 12 months are not eligible to apply. Startups should apply to only one track. Startups must be registered for the conference in order to participate in the pitch contest. The startup rate is $695 and a code will be sent to those selected to pitch.

Investment professionals will review applications and selections will be announced starting March 31, 2024.

Disclaimer: Each Pitch Track winner will receive a $20,000 advertising credit to be used on MedCityNews.com. The advertising opportunities that are available to select from include: display advertising, sponsored post, sponsored text ad, dedicated and targeted email blast, executive interview, and video spotlight. A MedCity News media kit will be provided to each winner to reference the rate for each opportunity included above. Advertising credit must be used by May 21, 2024, cannot exceed $20,000 in value, and may not be combined with any other offers or discounts.

To submit an application, click here.

Photo: Laurence Monneret, Getty Images

The uptick in malevolent data breaches at hospitals has been a worrying trend for the U.S. health system. From 2018-2022, there has been a 93% increase in large breaches reported to the Department of Health and Human Services’ Office for Civil Rights (OCR) (369 to 712). The 278% increase in large breaches involving ransomware was especially concerning, according to data from the Department of Health and Human Services’ Office for Civil Rights.

In response to the upward trend in these attacks and the risks they pose to patient care, the Department of Health and Human Services, through the Administration for Strategic Preparedness and Response, released voluntary health care specific cybersecurity performance goals (CPGs) last month as well as a new gateway website. They are intended to help healthcare and public health sector organizations implement high-impact cybersecurity practices and ease access to the considerable cybersecurity resources HHS and other federal partners offer.

The CPGs include 10 essential goals and 10 enhanced goals

The 10 essential goals include:

• Mitigate known vulnerabilities that could be exploited by bad actors
• Reduce risk from common email-based threats, such as email spoofing, phishing, and fraud
• Add multi-factor authentication to protect assets and accounts directly accessible from the Internet
• Provide basic cybersecurity training
• Deploy strong encryption
• Revoke credentials for departing workforce members, including employees, contractors, affiliates, and volunteers
• Provide basic incident preparedness and planning to ensure safe and effective organizational responses to, restoration of, and recovery from significant cybersecurity incidents
• Use unique credentials inside organizations’ networks to prevent attackers from moving across the organization
• Separate user and privileged accounts
• Identify, assess, and mitigate risks associated with third party products and services

Mari Savickis, Vice President of Public Policy with CHIME, will be moderating a panel discussion as part of the Cybersecurity Pavilion at the ViVE 2024 event in Los Angeles, scheduled for February 25-28. She said her organization anticipates several developments addressing cybersecurity this year.

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To register for ViVE 2024, click here.

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“We know HHS is re-opening the HIPAA Security Rule this fall and it is widely anticipated that we will see CPGs make an appearance in there. We are also watching for any possible requirements included in Medicare Conditions of Participation (CoP). While we strongly support improving the cyber posture of our sector, we believe using the CoP is not the way to tackle this,” Savickis said in an email.

Savickis added that during her panel discussion, speakers on the panel who are members of the Health Sector Coordinating Council’s Cybersecurity Working Group (HSCC CQG) will be making a big announcement. The announcement is intended to help improve the posture of the health sector by working together. This effort is led by Greg Garcia, executive director, Erik Decker, chair, and Chris Tyberg, the vice chair of the working group.

Here’s a look at some of the sessions that will be featured at the Cyber Pavilion at ViVE 2024 in the Los Angeles Convention Center. The sessions are scheduled for Monday, February 26, through Tuesday, February 27.

Bridging the Cybersecurity and Healthcare Chasm

The increased reliance on technology harbors inherent risks, especially for the healthcare sector, which is considered highly vulnerable to cyberattacks. With so much to lose in its databases, coupled with limited resources on staff, the healthcare sector is a prime target. Between the reliance on telehealth that took shape during Covid-19, the sensitive data that online medical records hold, and the incredible technological advances that keep people alive, our medical community is under immense pressure to keep patients safe online and in person. Deputy Director Nitin Natarajan of the Cybersecurity and Infrastructure Security Agency will discuss what makes the healthcare sector so susceptible to cyberattacks, what those in healthcare can do to prepare and what CISA has to offer in terms of free resources.

Time: 9 am to 9:45 am Monday, February 26

Healthcare Cybersecurity 2029: From Critical to Stable Condition in Five Years

In 2017 an HHS task force diagnosed healthcare cybersecurity to be in “critical condition” because of relentless cyber attacks on the healthcare system that cause patient safety, financial, operational and public confidence impact. In 2024 the Health Sector Coordinating Council – the industry-run critical infrastructure advisory council to the federal government and the health sector, is releasing its five-year Health Industry Cybersecurity Strategic Plan as a wellness formulary for how the industry can upgrade its security and resiliency prognosis from “critical” to “stable.” Forged over 18 months by health sector leaders in consultation with government partners, the Strategic Plan identifies the cybersecurity challenges posed by broad trends in the healthcare industry over the next five years and how we need to prepare for them. The leadership of the HSCC and government officials will take the stage to discuss the strategy with a call to action to the health industry to invest in the collective imperative that “cyber safety is patient safety”.

Moderator: Mari Savickis, VP Public Policy with CHIME

Speakers:

• Greg Garcia, Executive Director (HSCC), Health Sector Coordinating Council, Cybersecurity Working Group
• Erik Decker, CISO, Intermountain Healthcare, Chairman of Health Sector Coordinating Council, Cybersecurity Working Group
• Chris Tyberg, CISO, Abbott, Vice Chairman of Health Sector Coordinating Council, Cybersecurity Working Group
• Linda Ricci, Deputy Director, Office of Strategic Partnerships and Technology Innovation, FDA
• Brian Mazanec, Deputy Assistant Secretary, Office of Security, Intelligence, and Information Management, HHS

Time: 9 am— 9:45 am, February 27

Spiders, and Pandas, and Bears (and Adversarial AI!): An update on the bad guys attacking healthcare

Embark on a journey through the historical evolution of healthcare as a prime target for cyber threats as we explore artificial intelligence and cybersecurity. Plunge into the intricate details of cyber adversaries, exploring their organizational structures and increasing sophistication, with a focus on their utilization of AI to exploit data. Gain valuable insights into crafting robust security programs capable of effectively thwarting breaches, as we discuss innovative ideas and strategies to fortify healthcare systems against the evolving landscape of cyber threats. Join us for an engaging exploration that aims to empower professionals in building resilient defenses against the dynamic challenges posed by cyber adversaries in the realm of healthcare.

Speaker: Todd Felker, Executive Healthcare Strategist @ CrowdStrike

Time: 10:05 am to 11:05 am

Authors of “AI and Cybersecurity Handbook for Healthcare Boards”

These authors are partnering with leaders in diverse healthcare fields to create a series of guidebooks for boards, venture capital, informatics, and physician leaders aimed at improving Health, Care and Cybersecurity. The Trustworthy Technology and Innovation in Healthcare book series coming from publisher Taylor & Francis, is built to onboard technical and business leaders to the regulated sector of healthcare while upskilling clinicians and building trust, respect, and shared language, objectives across medicine, IT, legal, and cybersecurity–built by dozens of the brightest minds internationally across medicine, hospital administration, IT, business, engineering/bioengineering, information security, privacy, law, informatics, leadership, and project/program management. They’re resources to industry-leading standards and certification, designed to help health systems, medical device companies, investors, and other stakeholders identify and drive ongoing success with technology and innovation.

Speakers:

• Keith Duemling, Sr. Director of Cybersecurity Technology Protection, Cleveland Clinic
• Brad Marsh, EVP Government Health Security & Technology, First Health Advisory
• Mari Savickis, VP of Public Policy, CHIME

Time: 5pm to 6pm, Tuesday February 27

To register for ViVE 2024, click here.

 

Photo: Traitov, Getty Images

The mpox outbreak is a memory, but Bavarian Nordic, maker of the only FDA-approved vaccine for the pathogen behind this viral infection, turned skyrocketing demand for its product into record revenue. With that growth comes a need to focus, and the pure-play vaccines company is getting out of the business of developing vaccines for cancer.

Bavarian Nordic’s lone cancer vaccine candidate, TAEK-VAC, had reached Phase 1 testing as a potential treatment for chordoma or HER2-positive breast cancer. But this program had also reached the point where further investment is needed, and Bavarian Nordic decided it needs to focus its R&D efforts on infectious disease, the Denmark-based company said Wednesday in its announcement of preliminary 2023 financial results.

“As a consequence, the TAEK-VAC project will not be continued, and the company has no further plans to invest in immuno-oncology vaccine development,” Bavarian Nordic said.

A cancer vaccine is a type of immunotherapy that gets the body’s immune system to seek out and destroy cancer cells. Bavarian Nordic’s cancer vaccine candidate was developed with the same proprietary platform technology that yielded its other vaccines, including Jynneos, the company’s approved vaccine for protecting against infection from both mpox and smallpox.

Within two years of Jynneos’s 2019 approval for mpox (formerly known as monkey pox), it became Bavarian Nordic’s top-selling product. Sales surged during the 2022 mpox outbreak, and demand for the product is continuing. In its report of third quarter 2023 financial results, Bavarian Nordic listed 2.9 billion Danish krone (about $420 million) in Jynneos revenue for the nine months ended Sept. 30, a 316% increase in sales compared to the same period in the prior year.

Bavarian Nordic’s preliminary financial results for 2023 do not break out revenue by product. But the company said Wednesday that its preliminary revenue for the year topped 7 billion Danish krone (about $1 billion) a more than 124% increase compared to 2022. The company attributed this growth in part to the surge in sales of Jynneos. While the company acknowledged that demand is decreasing as the number of mpox cases falls, this vaccine is still finding traction as a product sold to government bodies and organizations that respond to outbreaks. Preliminary public preparedness revenue in 2023 topped 5 billion Danish krone (about $730 million).

By dropping its cancer R&D, Bavarian Nordic avoids potential competition with companies further along in cancer vaccine development. Before BioNTech found success with its Pfizer-partnered vaccine for Covid-19, the company’s messenger RNA research focused on cancer. BioNTech’s most advanced cancer vaccine candidate is in mid-stage testing as a potential treatment for advanced melanoma. Moderna has two mRNA vaccines in pivotal testing for melanoma under a 50/50 partnership with Merck. Moderna also has wholly owned mRNA cancer vaccines in early clinical development. Meanwhile, Gritstone Bio’s most advanced cancer vaccine is in Phase 2/3 testing in colorectal cancer.

Public domain image by the National Institute of Allergy and Infectious Diseases

Elektra Health, a digital health company for women going through menopause, has secured $3.3 million in extended seed funding, which it will use to expand its care to more patients, it announced Wednesday.

New York City-based Elektra Health, founded in 2019, offers virtual clinical care for menopause in New York, Connecticut and Florida (and soon Massachusetts and Pennsylvania). This clinical care includes a personalized care plan, labs, prescriptions and virtual visits with a care team. Across all 50 states, the company also offers educational content, messaging with a menopause guide, a personalized wellness plan and community support. Elektra Health works with health plans, including Mass General Brigham Health Plan and EmblemHealth. The company also works directly with some employers and offers a cash pay option for consumers.

“The healthcare system today privileges the reproductive window and really anything related to family building and maternal health. … I fully agree that we need much better care and support for the maternal health journey, but it should not come at the exclusion of how we care for women so that they can live in good health and have good quality outcomes for those years that follow that menopause transition,” said Jannine Versi, co-founder and COO of the company, in an interview.

The $3.3 million in funding was led by UPMC Enterprises, the venture capital arm of UPMC. Wavemaker 360, Flare Capital Partners and Seven Seven Six Fund also participated in the funding round. In total, the company has raised $7.6 million.

UPMC chose to invest in Elektra Health because of its aim to fill an unmet need in women’s health.

“UPMC is interested in investing in solutions that focus on empowering women and Elektra proved to have all the elements UPMC values in this space: evidence-based education and care that prioritizes women’s health needs and drives outcomes,” said Kathryn Heffernan, senior director of strategic product management at UPMC Enterprises, in a statement. “The goal of the Elektra platform is to fill a gap and provide innovative opportunities to strengthen the doctor-patient relationship as women move through the menopause transition.”

With the financing, Elektra Health is focused on two areas: partnering with more payers and expanding its footprint to provide clinical care to more patients, Versi said. The company is also growing its team.

Just about every woman will go through menopause, but only 20% of OB/GYN residency programs in the U.S. provide menopause training. Women experiencing menopause face a range of symptoms, including hot flashes, trouble sleeping, brain fog and mood changes. In addition, recent research from Mayo Clinic shows that menopause costs $1.8 billion in lost work time per year.

But menopause care has been gaining more traction recently. Recognizing the need among female workers, more and more employers are looking to offer menopause support. Several other virtual providers are also in the space and are dedicated to menopause treatment, including Evernow, Gennev and Midi Health. And there is a growing recognition that women’s health is not a “monolith,” Versi said.

“As with every other part of healthcare, we can’t sort of lump together the healthcare services and needs of 50% of the population and call it a day,” Versi declared. “I think this funding represents a sophistication in the market as it relates to investors and stakeholders who think about women’s health over the lifespan.”

Photo: :Peter Dazeley, Getty Images

The current standard for medication tracking within healthcare systems demands a large amount of active human engagement, from scanning barcodes to manually counting units of medication. The manual nature of this work leaves room for errors and unsafe practices that can impact care and potentially endanger patients. Newer medication management systems, like those made possible with passive, seamless RFID-based technology, can provide insight into the location, status, and quality of medications throughout their lifecycle, helping hospitals and healthcare practitioners (HCPs) maintain the highest standards for patient safety.

Visibility: The cornerstone of safe medications

Visibility into the entire drug lifecycle, from manufacture to administration, is crucial for the well-being of patients, HCPs, and healthcare systems.

The protocols and pressures that exist within healthcare systems are unique. Seamless medication management requires input and collaboration across multiple departments, from physicians to pharmacists, nurses, and hospital operations teams. Each of these disciplines faces its own challenges, from long working hours to multifaceted regulatory standards. The complexity of medications further complicates this system––medications don’t exist in a vacuum. They can get recalled, expire, become less accessible due to a shortage, or be counterfeited. Drugs can also be intentionally diverted from the healthcare system—a problem exacerbated by the ongoing opioid crisis.

Current medication management systems rely on barcodes that pharmacists and other professionals must manually scan within a healthcare facility to track the status of medications and maintain an accurate inventory. This system, however, provides limited insight into the lifecycle of medications. It also relies on humans to operate at peak accuracy, creating opportunities for mistakes and intentional malfeasance. In fact, trends over the last few years have indicated that a lack of traceability and dependency on manual, human monitoring furthers the drug diversion problems within facilities and pharmacies.

Ultimately, a lack of visibility into where medications have been, who has handled them, and their current status can have a direct impact on patients, putting them in danger of receiving expired, tampered, or counterfeited drugs––if they can access the medications at all.

The next evolution of medication management technology

Hospital systems need medication management systems and processes that cater to the mounting complexities of the healthcare environment. Better technology will allow the complex web of stakeholders within healthcare systems to work together to protect the safety of the most vulnerable group: patients. Ultimately, patients should have confidence in their medications and the system they exist in, medical staff should have the time and energy to focus on patients instead of medication tracking, and pharmacists should have adequate information to ensure medications are kept in supply.

Seamless, RFID-based medication management systems are one tool that can play an active role in mitigating the medication problems facing healthcare systems. Current RFID technology uses small tags or smart labels to store digital data, including unique identification and expiration information. This means RFID tags can allow medications to be tracked at an individual unit level, increasing the resolution of insight available to pharmacists and adding layers of protection against counterfeiting and diversion.

Unlike traditional barcode technology, which requires a direct line of sight between the scanner and the barcode, RFID technology uses radio waves to transmit information. This means data can be transmitted without the scanner coming into direct contact with, or even in sight of, the tag. Crucially, this allows for bulk scanning of medications. For example, an entire tray of medicines destined for a crash cart can be scanned in bulk in a matter of seconds. Paired with cloud-based management software, these systems enable healthcare facilities to closely track the location and status of medications with less manual work.

The potential of this technology is well-documented in other industries. Retailers, for example, increasingly use RFID-based tagging and tracking systems to maintain the visibility of inventory. Examples include the expansion of RFID tagging within stores of a variety of apparel retailers and Walmart, along with Amazon’s implementation of RFID to support cashier-less checkout systems.

Increased confidence with seamless medication management

As technology advances, seamless medication management systems have the potential to do more than just save time on inventory counts and provide identifying information. Effective medication management systems could help to improve confidence across the healthcare system, taking pressure off providers and allowing them to focus on patients. With cloud-based integrations possible across large segments of the care pipeline, information related to medications can be digitized and shared more seamlessly within a system. This helps medications and the providers handling them to be tracked and supported as needed. Imagine, for example, the complex situation that arises when a product is recalled, or a patient experiences an adverse effect. Hospital staff empowered by a fully integrated RFID-tracking system could know the exact vial of medication administered to a specific patient. Digitization could also help hospital systems keep a closer eye on their inventory across multiple facilities, helping them manage limited inventories, reduce waste, and improve cost savings.

The increased visibility possible with RFID-based medication management also provides support to medical systems as they navigate regulatory compliance. The US Food and Drug Administration (FDA)’s Drug Supply Chain Security Act (DSCSA) governs many of the medication management regulations within the U.S. Within this law, the US FDA has set requirements for electronic, interoperable systems to be implemented by November 2024 to identify and trace certain controlled prescription drugs as they are distributed throughout the United States. RFID-based systems can help healthcare systems meet this requirement, providing another layer of confidence in medication management.

The path forward

In many ways, the protection of patient safety through seamless, RFID-based medication management can be compared to the safety features in a motor vehicle. Drivers and passengers have trust that the safety features in vehicles, such as airbags and seatbelts, will help limit or prevent injury during an accident. These features were a necessary addition to vehicles, helping cut down on fatal injuries and making drivers feel safer. Patients deserve similar expectations of safety for their medications––they shouldn’t have to wonder if the medications they’re being administered are expired or counterfeited. The system in place should be an asset healthcare professionals can rely on to help protect patients when the time arises. In the same way that airbags were a natural evolution of vehicle safety technology, seamless, RFID-based systems are the next evolution of medication management technology.

As seamless, RFID-based medication management technology improves and becomes more widely implemented throughout the supply chain, its implications for digitization, regulatory compliance, and supply chain management are widespread. Together, these benefits feed directly into patient safety, allowing patients to feel confident that medications they are prescribed are safe, effective, and available.

Photo: zorazhuang, Getty Images

The country’s treatment modalities for chronic conditions are “completely backwards,” according to HealthSnap CEO Samson Magid. Four million Americans age into the Medicare program every year, and most of them have two or more chronic conditions — resulting in billions of dollars annually in preventable healthcare costs — he pointed out.

This hulking problem is why Magid helped found HealthSnap in 2015. The Miami-based company helps healthcare providers reinvent their approach to chronic conditions management through home-based remote patient monitoring. On Wednesday, the company announced that it had closed a $25 million Series B financing round led by Sands Capital.

The round brings HealthSnap’s total funding to date to $48.5 million. Other investors included Comcast Ventures, Acronym Venture Capital, Florida Opportunity Fund, Asclepius Growth Capital, Florida Funders, MacDonald Ventures and TGH Ventures.

The company’s technology helps providers remotely monitor and manage chronic conditions, as well as seeks to empower patients by providing them with greater access to care and their own health data, Magid explained.

“HealthSnap’s remote patient monitoring and chronic conditions management programs shift the care delivery paradigm from one that’s typically reactive, episodic and delivered in a bricks-and-mortar clinic to a model that’s proactive, ongoing and deliberately in the home,” he declared.

The company’s platform gives providers ready access to various workflows they need to launch and scale a remote patient monitoring and chronic conditions management program. It has tools to manage more than 100 chronic conditions in both primary and specialty care, Magid noted.

He also pointed out that the platform can integrate into more than 80 EHRs. Magid said that this ensures the solution is easy to set up and allows care teams to be armed with actionable patient data in case they need to proactively escalate care between office visits.

Once patients get enrolled in the program, HealthSnap sends pre-configured, cellular-enabled health devices to their homes.

“So if someone has high blood pressure, they’ll receive a blood pressure cuff,” Magid explained. “And I always use the grandma test — if a grandma can’t use the technology properly, then it wouldn’t pass the test. For HealthSnap, all of our devices are simply taken out of the box and just used right away. The patient doesn’t need a smartphone, and they don’t need WiFi.”

Each patient is also assigned a nurse as their care navigator. On a monthly basis, these care navigators call the patient to go over their readings, gauge whether care needs to be escalated, schedule preventive appointments and close any care gaps, Magid added.

HealthSnap’s customer base comprises more than 150 healthcare organizations, including UnityPoint Health, Prisma Health, Tampa General Hospital, Montefiore Medical Center and Virginia Cardiovascular Specialists. The company charges a per-patient per-month fee for its platform.

“With our services, our partners are generating new revenue streams for their healthcare systems, without the need to build these service lines in-house,” Magid remarked.

He added that 25% of all Medicare fee-for-service dollars are estimated to move to the home by 2025. HealthSnap’s programs generate $300 in reimbursement per patient per month for its provider customers, he said.

But HealthSnap is certainly not the only company helping providers implement remote patient monitoring programs into patients’ homes — competitors include Cadence, Optimize Health and Validic.

Magid believes HealthSnap helps set itself apart through its three patents for remote patient monitoring-specific revenue cycle automation, as well as the fact that its platform can integrate with dozens of EHRs. He added that HealthSnap is a full-service offering that handles all care management services, logistics and shipping.

Photo: blackCAT, Getty Images

As President & CEO of a rural Vermont health system, I’ve witnessed many of our offerings evolve, from expanded access to medical technology to our specialty care. But one thing has remained the same – our commitment to provide access to high-quality, comprehensive, and affordable health care for rural communities and patients.

Unfortunately, however, this care is becoming more and more challenging to provide as health care labor, supply chains, and operating costs continue to rise while Medicare and Medicaid payments continue to lack the necessary coverage for the costs hospitals incur to provide care.

That’s why our organization and countless other hospitals around the country rely on a critical program – the 340B Drug Pricing Program – to support our mission. The 340B program enables hospitals and health systems like ours to access prescription pharmaceuticals at a reduced price. This, in turn, allows our organization and other 340B hospitals nationwide to offer more comprehensive services to our communities and patients—many of whom are low-income, seniors, and medically vulnerable individuals. This includes financial assistance programs as well as a range of innovative, community-based health care offerings and services.

Like most 340B hospitals, the vast majority of the patients we serve are older or individuals with disabilities covered by government programs. In fact, more than 70% of the care we provide is for patients enrolled in either Medicare or Medicaid. These government programs chronically underpay for care, which alone puts significant financial pressure on hospitals like ours that serve a disproportionately larger share of these patients.

As our nation’s aging population continues to grow, the demand for health care targeting the unique needs of senior patients will only increase—putting an even greater strain on 340B hospitals like ours. Maintaining, protecting, and strengthening the 340B program is critically important to help offset the losses hospitals face due to underpayments.

Moreover, savings from the 340B program help support and fund critical workforce development programs as well as specialty and primary care services that allow us to recruit and retain the professional support needed to meet the many complex care needs of the patients and communities we serve.

That includes a transitional care nursing program that provides patients with at-home support services after being discharged from the hospital. By meeting patients where they are and proactively addressing health needs, the program has significantly reduced hospital readmission rates and the average hospital length-of-stay, allowing patients to recover and rehabilitate safely in their own homes while maintaining their quality of life.

Additionally, our organization has expanded access to critical oncology services by using 340B savings to help sustain our regional cancer center, which is accredited by the American College of Surgeons Commission on Cancer. This regional facility helps bring cancer care closer to patients’ homes, improving access and reducing costs while eliminating the need for our rural patients to travel long distances to access oncology care.

As with many rural communities, the patients we serve often struggle to access primary care. The 340B program has been essential in allowing us to expand primary care access by opening several clinics in communities with particularly high rates of chronic diseases—again, helping meet patients’ needs in their local communities rather than forcing patients to travel to the emergency room.

The 340B program has also helped our organization improve our health care staffing pipeline and address the workforce shortages in our community and throughout the country. Leveraging 340B savings, we have been able to pilot several innovative programs—partnering with local colleges, allowing nursing students to complete clinical rotation, and supporting existing staff interested in transitioning to a career in nursing by paying them while they complete their academic studies—all aimed at developing a stronger, more robust health care workforce.

In short, our organization could not sustain itself or the programs we provide to improve the health and well-being of our community without savings from the 340B program. We are incredibly proud of the work we have done to meet the unique health care needs of our community for over 100 years. To ensure that rural hospitals like ours can continue delivering high-quality, comprehensive health care, the federal government must support and protect the 340B Drug Pricing Program that enables us to do what we do best.

Photo: ipopba, Getty Images

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The healthcare industry has notoriously struggled with disconnected data systems and a lack of interoperability. When health information cannot be easily exchanged between different systems and providers, it leads to fragmented care, medical errors and delays in treatment — not to mention an incredible amount of frustration and inconvenience for both providers and patients.

Software developers have been working hard in recent years to create tools and data sharing standards that foster a more cohesive and integrated approach. However, these tools have a serious adoption problem, experts said last week during a virtual panel held by Reuters Events.

Alistair Erskine, Emory Healthcare’s chief information and digital officer, pointed out that most provider referrals are still done by fax, even though there are tools available to send them digitally. Most providers use EHRs that are able to pull a patient’s health information and transport it to the EHR of the new provider to whom they’ve been referred, he said.

Despite data sharing standards like FHIR and DICOM — and despite “the fact that the data has already been digitized” — completing a provider referral is still not a smooth process, Erskine remarked. He stated that 98% of referrals are done by fax even though they could “of course” be done electronically.

“Even though the standards are there, we have to make sure that people safely log into their systems, and we have to make sure that people are able to find their patient in their systems. And if you navigate from one system to the next, that presents a barrier to entry. It’s easier to just take a piece of paper, write what you need and send it in a fax,” Erskine explained.

Healthcare leaders shouldn’t assume that providers are using interoperability tools simply because these tools are available, he declared.

That’s why Emory is trying to make it as easy as possible for providers to conduct referrals electronically, Erskine remarked. He said the health system is embedding links into its systems for single sign-on and in-context patient lookups so that “providers don’t have to log into anything” and can quickly find their patients’ information. He also mentioned that Emory is testing ways to use direct messaging to better connect doctors across systems.

Another panelist — Micky Tripathi, head of The Office of the National Coordinator for Health Information Technology (ONC) — agreed with Erskine’s remarks.

“When it’s easier to fax something, people will continue to fax things. There are adoption issues,” Tripathi stated.

He described a recent experience he had with his mother to illustrate the healthcare industry’s interoperability adoption problem. His mother had recently undergone a medical procedure in an acute care hospital and was getting transferred to a rehabilitation hospital “less than a mile” down the road, he noted.

Tripathi said that he knows these two hospitals exchange patients “all the time.” He also said that he knows one hospital operates on Epic’s EHR, and the other on Cerner’s.

“I know they’re connected on the back end with an interoperability network called Carequality. I know they are for a fact. And yet, when they discharged my mom, they printed off the record and handed it to me,” Tripathi declared.

This shows that healthcare workers don’t find it easy to transfer patients’ information electronically, he pointed out. 

In Tripathi’s view, health systems and other provider organizations should do more to encourage their doctors to stop faxing — both by training staff on how to use electronic referral tools and making these tools easy to use within the EHR.

Photo: LeoWolfert, Getty Images

Rapt Therapeutics aim to bring patients oral alternatives to injectable or infused immunology medications has hit a setback. A Rapt drug candidate in mid-stage clinical development in atopic dermatitis and asthma has been placed under an FDA clinical hold after a serious adverse event reported in a study participant, the company announced Tuesday.

The patient, a participant in the atopic dermatitis study, experienced liver failure. According to Rapt, the cause of the liver failure is unknown but has been characterized as potentially related to the company’s experimental drug, zelnecirnon. South San Francisco-based Rapt said the FDA verbally notified the company of the clinical hold on the atopic dermatitis and asthma clinical trials. A formal letter is forthcoming. Meanwhile, dosing of the once-daily tablet has been halted in both studies, which have also stopped enrolling new trial participants.

Many of the new drugs for immunological conditions are large molecule biologics, which can’t be made into oral drugs the way small molecules can. Rapt discovers and develops small molecules capable of addressing immune responses in immunology and oncology. Zelnecirnon, formerly known as RPT193, is Rapt’s lead inflammation drug candidate. This molecule is designed to target CCR4, a cell surface receptor that plays a role in the migration and homing of immune cells to tissues in the body. Zelnecirnon is intended to selectively inhibit the migration of type 2 T helper cells into inflamed tissues.

“We chose to pursue atopic dermatitis as the first indication for RPT193 because we believe the characteristics of the disease present an opportunity to rapidly demonstrate RPT193’s anti-inflammatory effect with the potential for good translatability to later-stage clinical trials,” the company said in its 2022 annual report.

In Phase 1b clinical trial testing of zelnecirnon in 31 patients with moderate-to-severe AD, results reported in 2021 showed that those who received the experimental drug showed greater improvement from baseline compared to the placebo group measured by several standard assessments of the disease’s severity. The company proceeded to separate Phase 2 tests in moderate-to-severe atopic dermatitis and moderate-to-severe asthma.

Across all three zelnecirnon studies so far, Rapt said about 350 patients have been enrolled. No participants have shown evidence of liver toxicity, nor has that safety signal turned up in animal or laboratory tests, the company added. According to Rapt, the patient had a complex medical history. In addition to an allergy to Dupixent, the blockbuster Sanofi and Regeneron Pharmaceuticals immunology drug, this patient had an autoimmune disease that required thyroid replacement therapy. Furthermore, the patient used an herbal supplement known to be associated with liver failure and also reported a Covid-19 infection while experiencing the liver failure.

“This is an unfortunate and unexpected event, and we are working diligently to get more information on this case,” Rapt President and CEO Brian Wong said in a prepared statement. “Patient safety is our top priority and we will work with the FDA to resolve this as quickly as possible.”

Rapt said the clinical hold does not affect the company’s ongoing Phase 1/2 test of tivumecirnon, formerly known as FLX475, in cancer.

Shares of Rapt closed Tuesday at $6.88 each, down more than 73% from Friday’s closing stock price.

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