With a Medicare-supported model as a blueprint, health systems are finding a lot to like in an acute care at home strategy. But they also have plenty of room to be creative.
Healthcare is embracing the trend of shifting care from the hospital to the home, and forward-thinking health leaders are finding there's plenty of room for flexibility.
Hundreds of hospitals across the country have launched an acute care at home program, focused on treating patients at home versus in a hospital bed. Many of those hospitals are following the Acute Hospital Care at Home model developed by the Centers for Medicare & Medicaid Services (CMS), which sets strict guidelines for in-person care to qualify for Medicare reimbursement.
This strategy, which combines virtual care with in-person services, could be a mainstay in healthcare. But it's a complex process, with an ROI that may take years to show itself.
At a recent HealthLeaders NOW virtual summit, participants from eight different health systems said the future may lie in modifying the model to suit each organization's specific care needs and resources, even if that means bypassing Medicare reimbursement for now.
"We're constantly tweaking it," said Eve Dorfman, vice president of NYU Langone Health, which stood up an acute care at home program less than a year ago that focuses solely on acute care rather than post-acute care. "It's very much a hybrid model."
Dorfman said it took a while to iron out the wrinkles, including infection prevention at home and remote patient monitoring. The health system even used a simulation lab to help nurses "look at the healthcare delivery model differently."
"This is a collaboration," she said. "It is different."
While acute care at home programs have been around for more than a decade (one of the first was launched at Brigham and Women's), the strategy burst onto the mainstream during the pandemic, when health systems created programs to treat COVID-19 patients at home and reduce stress on overtaxed inpatient services.
The CMS Acute Hospital Care at Home program was launched in November 2020 to address those needs. The program sets rigid rules for Medicare reimbursement and requires hospitals to apply for a waiver of the Hospital Medicare Conditions of Participation, which mandate round-the-clock nursing coverage on the premises.
More than 270 hospitals in more than 120 health systems are currently following that model, with the CMS waivers remaining in place until the end of 2024. Lobbying efforts are underway to make those waivers permanent, but the uncertainty of continued Medicare support is affecting how health systems map out scalability and sustainability.
Because the concept is so new, some states haven't caught up to it yet. Eve Cunningham, MD, MBA, group vice president and chief of virtual care at Providence, said its program was almost shut down before it started because Washington state law has strict definitions on hospital-level care. And Penni Kyte, digital care strategy officer for Ballad Health, said her health system had more problems working with Tennessee state officials to OK a program than they did with CMS.
Lauren Hopkins, MPH, assistant vice president of virtual care and community engagement at Augusta University Health, said the health system started with an all-virtual platform to treat COVID-19 patients and has since pivoted to focus on the transition from acute care to post-acute care, including chronic care management. The health system hasn't applied for CMS waivers yet, she said, because Georgia hasn't amended its state laws to accommodate the care model.
With the uncertain policy and regulation landscape as a backdrop, health systems are developing their own acute care at home programs. Some are using their own nurses for home visits, while others are partnering with home health or mobile integrated health programs. Some are monitoring patients around the clock, while others are collecting data from patients at certain times of the day. Some are using wearables, and some are integrating pharmacists, physical rehab, even health and wellness services to address social drivers of health.
And not everyone is going with the CMS model. Cunningham says some programs are seeing success with bundled payment models and other services that payers are willing to reimburse.
In a separate interview with HealthLeaders, Tina Burbine, vice president of care innovation and enterprise analytics at HealthLink Advisors, which has advised many health systems—including negotiating with payers—to set up these types of programs, said there's no set definition of acute care at home.
"There are many different flavors of care at home," she said. "And hospitals are seeing a lot of success … as long as they mindful of incorporating their value-based care goals."
"There's so much learning that has to happen" with the CMS model, adds Burbine, who recommends that hospitals start small and build up their program slowly and incrementally with lesser-acuity patients, to see whether high-acuity care will work for them. "This has become such a competitive market that we're even seeing payers compete with health systems."
Some say the acute care at home model will evolve significantly as COVID-19 fades away and hospitals take back some of those inpatient services to bolster their bottom line. In that scenario, the platform shifts more toward post-acute care, including rehabilitation and chronic care management.
Jared Conley, MD, PhD, MPH, associate director of the Healthcare Transformation Lab at Massachusetts General Hospital, said during the HealthLeaders virtual summit that acute care at home may eventually surpass inpatient care as the highest quality acute care platform. The challenge lies in navigating the complexities to create a program that fits well within the health system.
"Think of this as building another brick-and-mortar hospital," he added. "It is very challenging work, but it is so beneficial."
"They've really been helping to drive this," he said of KP's provider base. "There's a general excitement to do this."
Burbine says the model could someday replace the rehabilitation center as a better and more cost-effective post-acute care pathway and create better alternatives to skilled nursing facilities. It might also be used in prisons, substance abuse treatment programs, and for other populations where hospitalization is difficult.
"Ideally, we want our patients' care to be managed by their health system," she said. "And we're seeing new ideas [for] how that can be done. It changes not only the definition of a hospital, but the definition of a home."
According to the Entertainment Software Association, 70% of gamers surveyed say games could be used for medical treatment, and many see the benefits in addressing mental health and isolation.
A new survey of video game players finds that a pastime enjoyed by some 212 million Americans could be used to improve healthcare access and treatment—particularly in mental health.
Those are good numbers for an entertainment genre that has danced along the edge of the healthcare market for many years, with companies like Akili Interactive, Level Ex, and Deepwell Digital Therapeutics offering a broad array of games aimed not only at patients but providers. Gaming technology and video and interactive games have long shown promise in addressing key pain points like engagement, chronic care management and adherence.
And they're popular. The survey estimates that 65% of Americans play video games.
“Video games remain a mainstay in American households, as they have for decades,” Stanley Pierre-Louis, president and CEO of the Washington DC-based ESA, said in a press release highlighting the survey results. "Playing video games has become the norm, as those who first learned to play on early consoles now share their joy of play with their own children and grandchildren, resulting in an expansive and diverse player community. The Essential Facts report demonstrates that video games not only connect us, but also enhance our sense of wellbeing.”
Among the results highlighted by the survey, which was distributed online in April 2023 and taken by roughly 4,000 respondents, were the effects of gaming on mental health and wellness. About 90% of those responding said video games provide mental stimulation and stress relief, while 88% said games help improve cognitive skills, 81% said they help build problem-solving skills, and 75% said they help boost collaboration skills.
They can also be used to address isolation and loneliness. Some 88% of survey respondents said games expand their social circles and 82% said they were introduced to new friends and relationships through game platforms (half of those responding said they met a good friend, spouse or significant other through games). In addition, 60% said video games help them stay connected to friends and family, and 71% reported developing a feeling of community through gaming.
Finally, while video games and gaming are most people among the younger generations, a significant number of seniors are playing them as well—and seeing specific healthcare benefits. According to the survey, 62% of adults play video games (32 is the average age of a player) and roughly three-quarters of adults play games with their children.
Healthcare leaders are interested in video games because they offer a mobile platform that allows users to access content at the time and place of their choosing. They also provide an entertaining platform to learn new ideas, along with rewards to foster engagement and metrics that would enable executives to measure progress and continued adherence.
The New York-based health system is using telemedicine to triage calls from three outlying hospitals so that ED doctors can assess patients with burn injuries and either treat or transport them to a burn center.
Northwell Health has launched a telemedicine program aimed at helping care providers triage burn victims.
The teleburn program connects specialists at Staten Island University Hospital's Regional Burn Center to three outlying hospitals in the New York City area to help providers determine whether a patient can be treated on site or transported to the burn center.
“With this technology we can tell pretty quickly the different depths of burns, how large the burns are and what the treatments should be,” Michael Cooper, MD, the burn center's director, said in a recent press release. “This information is vital to provide the most accurate assessment of a burn injury which can lead to the best outcome for the patient.”
The program is the latest example of a hub-and-spoke telemedicine platform, which connects specialists at the central hospital to providers in distant, more remote locations, such as hospitals, clinics and health centers. The model gives providers in outlying areas the clinical decision support they need to either care for their patients or schedule an emergency transport, reducing the time spent on consults and speeding up the time to treatment.
“With this technology, we can have a quick evaluation by a physician who is miles away and who can help us make decisions about care and whether we need to transfer a patient to that site,” Christopher Calandrella, DO, chair of emergency medicine at Long Island Jewish Forest Hills, one of the three spoke hospitals piloting the program, said in the press release.
When a burn patient is brought into Long island Jewish Forest Hills in Queens or Long Island Jewish Valley Stream and Long Island Medical Center, both in Long Island, ED providers can open an audio-visual telemedicine link with a specialist at the burn center to assess the severity of the burns. If the wounds are deemed severe, or if the hospital doesn't have the inpatient capacity or staff on site to treat other injuries like sever smoke inhalation, an ambulance or helicopter transport can be ordered.
Other examples of hub-and-spoke telemedicine networks include telestroke services, telpsych consults and school-based telehealth networks.
Memorial Sloan Kettering Cancer Center is replacing an often manual process with a tech platform that streamlines data transfer and verification from its EHR to platforms used by clinical trial sponsors.
Memorial Sloan Kettering Cancer Center (MSK) is embracing new technology designed to enable clinical trial sponsors to quickly and easily pull relevant patient data from MSK's EHR.
The New York City health system is partnering with IgniteData, a UK-based developer of electronic data transfer solutions, to provide data integration between MSK's EHR platform and the platforms used by two major clinical trial sponsors. The company will deploy its Archer technology through the MSK Innovation Hub.
The goal is to streamline and improve what is often a manual process of pulling and verifying data from sometimes different EHRs to support cancer research, boosting the efficiency of these trials, improving the process for selecting and monitoring participants, and eventually leading to better outcomes.
The technology is designed to enable research staff to quickly transfer regulatory grade data such as vital signs and labs—which typically account for as much as half of the data needed—into the sponsor's study database, reducing data entry errors and source data verification and query resolution times.
“Today, a typical phase 3 oncology study generates an average of 3.6 million data points," Dan Hydes, IgniteData's co-founder and CEO, said in a press release. "More than half of this eSource data already exists in patients’ electronic medical records, yet it is still being painstakingly transcribed into study databases, burdening research staff and creating inefficiencies and delays."
“This collaboration aspires to automate the routine tasks performed by our research teams and quicken the pace of clinical trial execution, driving us toward our ultimate goal of changing how the world treats cancer through research," added Joseph Lengfellner, MSK's senior director of clinical research informatics.
Once the process is worked out, officials said they would expand interoperability to other clinical trial platforms.
Researchers in Pittsburgh found that an AI tool outperformed the three most common practices for analyzing ECGs of patients being treated for chest pain, reclassifying one of every three patients.
An AI tool used in three Pittsburgh hospitals was able to diagnose and reclassify 33% of patients being treated for chest pain, improving on the standard practice for identifying heart attacks and potentially saving lives.
The technology, developed by researchers in Toronto, analyzes ECG readings for subtle clues that are often overlooked, leading to delays in detection and treatment. Researchers from the University of Pittsburgh compared the model against the three gold standards for assessing cardiac events and found that the AI tool performed better than all three.
“When a patient comes into the hospital with chest pain, the first question we ask is whether the patient is having a heart attack or not," Salah Al-Zati, PhD, RN, an associate professor in the Pitt School of Nursing and of emergency medical and cardiology in the School of Medicine, said in a press release issued by UPMC. "It seems like that should be straightforward, but when it’s not clear from the ECG, it can take up to 24 hours to complete additional tests. Our model helps address this major challenge by improving risk assessment so that patients can get appropriate care without delay.”
Al-Zaiti was part of the team that tested the technology on 4,026 patients treated for chest pain at the Pittsburgh hospitals and co-authored the results of the study, which was recently published in Nature Medicine. Those results were independently validated with 3,287 patients from a different health system.
The study compared the technology against experienced clinician interpretations of an ECG, commercial ECG algorithms, and the HEART score, which factors in age, risk factors, and other considerations prior to diagnosis. The model outperformed all three standards, reclassifying one of every three patients into low, intermediate, or high risk.
The study has implications not only for ED treatment, but for those who are first on the scene to treat patients with chest pain.
“This information can help guide EMS medical decisions such as initiating certain treatments in the field or alerting hospitals that a high-risk patient is incoming,” Christian Martin-Gill, MD, MPH, chief of the Emergency Medical Services division at UPMC and co-author of the study, said in the press release. “On the flip side, it’s also exciting that it can help identify low-risk patients who don’t need to go to a hospital with a specialized cardiac facility, which could improve prehospital triage.”
Martin-Gill and his team are testing that concept in the next phase of their research. They're working with the City of Pittsburgh Bureau of Emergency Services to deploy the model through the cloud to hospital command centers, which can direct risk assessments back to EMS teams in the field for more timely diagnosis and treatment.
EHR platforms are complex and costly and require a lot of planning to make sure they're a good fit for a health system. Here are 8 recommendations for organizations looking to transition from one EHR to another.
Electronic Health Records platforms have been around since the first EHR was unveiled by the Regenstrief Institute in 1972. And while there are just as many horror stories related to EHRs as successes, there's little doubt that the technology is integral to a health system's growth and development.
As with any technology, EHRs have evolved considerably since their first iteration, with new tools and capabilities that can address key healthcare pain points, both administrative and clinical, and address new capabilities like interoperability, virtual care, and even AI. The market has also grown, with new companies that can tailor EHRs to specific specialties.
With that in mind, health systems need to think carefully about their EHR investment, whether they're purchasing a new platform or transitioning from one to another. It's an expensive undertaking, not only for the initial software purchase but also in staffing, training, and workflow adjustment, as well as down time and the inevitable problems that come with a new tech installation.
Many health systems are now considering switching EHRs, either because they've outgrown the legacy platform they started with or they're not satisfied with the product.
"Such a transition requires a substantial investment in planning, preparation, and execution," says Ezio Castellani, vice president of healthcare and life sciences at IT consultancy company DataArt. "The prices of purchasing the new system, hiring additional staff, and providing training increase, and healthcare organizations’ budgets may not have room for large-scale IT projects. Furthermore, it will likely significantly impact patient care and the hospital's financial performance, so the decision needs thorough consideration and budget planning."
Key to that transition is data migration. Health system leaders need to develop a reasonable timeline for the transition, he says, with the understanding that this will be time-consuming. Aside from integrating all of a health system's technology, from software platforms to devices, into the new system, they also have to adjust workflows and train everyone on the new system.
"Rushing the switch to a new system can lead to errors and negatively impact patient care, while prolonged transition can increase costs and frustrate staff," Castellani says.
For healthcare organizations considering this move, Castellani offers eight recommendations:
Develop a detailed plan before beginning. Include detailed timelines, roles, and responsibilities for everyone involved, and be sure to build in contingency plans and time considerations for the inevitable unexpected issues and delays.
Consider outsourcing integration assistance. Not all health systems have the technical expertise on hand to manage a project this complex. A third-party system integrator can assist with or even handle many of the tasks associated with the transition, from project management to data migration to customizations. It's vital that this be considered early on in the process, so that time spent reviewing vendors and associated costs are included in the budget.
Get everyone involved. Key stakeholders, including physicians, nurses, and IT staff, need to be part of the process from the planning stages, so that everyone understands the transition and can offer input on how it will affect their departments. There are plenty of stories about new technologies that have failed because the end-user wasn't included in the planning process.
Test, then test again. Technology installations rarely go as planned. Putting the new platform through repeated tests enables everyone involved to see how the technology will work and spot potential issues or pain points. This includes testing data migration, user interfaces, functionality, and customizations.
Don't skimp on training. Make sure everyone who will use the new platform gets the training needed to understand how it works, including instruction on what to do when something goes wrong. A fully prepared workforce reduces the lag time when the new platform is launched and improves the chances of a smooth transition.
Ensure data integrity. Perhaps the most important aspect of the transition is ensuring that all data moves from one platform to the other, and that it can be located and used accurately and consistently in the new system. This is not only a functionality issue, but a patient safety issue as well. Have protocols in place to ensure that all data has migrated, with no gaps or errors, and have procedures in place for data backup and recovery.
Keep an eye on the EHR. Once the new platform is up and running, it's essential to monitor how it's working and how it's used. Establish processes and protocols that will enable management to quickly spot and address any issues before they become much larger problems.
Create a support network. Establishing a help desk and/or technical support team ensures that anyone using the EHR knows who to contact in an emergency. This will cut down on a lot of the stress and frustration associated with using the technology and ensure that problems are quickly addressed.
"Changing EHRs can be challenging and require extensive planning, preparation, and execution," Castellani points out. "Healthcare organizations must carefully consider the challenges and potential risks of transitioning to a new system before deciding to do so. Adequate planning, training, and budgeting can help mitigate potential risks and ensure a successful transition."
The agency says the innovative program that allowed EMS providers to seek alternative care pathways instead of the routine ED transport didn't get enough participants or interventions.
An innovative alternative payment model for emergency transports is ending early due to a lack of participants and interventions.
The Centers for Medicare & Medicaid Services (CMS) has announced it will shut down the Emergency Triage, Treat, and Transport (ET3) Model at the end of this year, two years earlier than planned.
"Current and projected number of interventions are lower than the number anticipated when the Model was designed," the agency said in a notice to participants. "This affects the cost of operating the Model relative to its expected benefits, the ability of CMS to conduct a robust quantitative evaluation of the Model’s impact, and the Model’s ability to achieve the estimated Medicare savings in the Model’s design. For these reasons, CMS has determined that it is not in the public interest to test the Model in Performance Year 4 (Calendar Year 2024) through Performance Year 5 (Calendar Year 2025) and has good cause to unilaterally amend the Agreement to modify its Performance Period."
Unveiled in 2021, the five-year project was designed to give EMS providers more flexibility in addressing the emergency care needs of their patients. Participants, ranging from EMS and healthcare providers to local governments, were encouraged to identify alternatives to the standard ED transport, such as urgent care centers, physician offices, and telehealth.
In March of 2021, CMS unveiled a list of 184 public and private ambulance providers and suppliers selected to take part in the program, as well as plans to seek $34 million in funding to support the model.
Participating ambulance providers and suppliers are paid by Medicare based on the level of service provided— Basic Life Support (BLS-E) or emergency Advance Life Support, Level 1 (ALS1-E) rate—plus mileage and quality adjustments. The qualified healthcare practitioner is also paid the current Medicare rate if the practitioner can treat the beneficiary in place.
The model had been delayed by one year due to the pandemic, and CMS adjusted the model to include more locations for transports during the public health emergency (PHE).
CMS' decision doesn't affect participation in the model or the ability to bill for ET3 interventions or receive performance-based payments through the end of this year.
"Emergency Medical Services remain an area of focus for CMS, and we believe that the lessons learned from the ET3 Model can aid in the development of potential future initiatives," the agency said.
The executive vice president and chief information & innovation officer at Children's Hospital & Medical Center is committed to an innovation strategy that will keep the Omaha-based hospital on the cutting edge of children's care.
Healthcare innovation might seem like a slow and steady process, marked by methodical pilots that gather data and lead to system-wide adoption.
Jerry Vuchak would like you to know that isn't the case in pediatric care.
"We frequently want to go faster than [technology vendors] want to go," says the executive vice president and chief information & innovation officer at the Omaha, Nebraska–based Children's Hospital & Medical Center. "We're moving forward at a pace that they're not used to."
There's a reason for that. Roughly $22 billion was raised globally in 2020 for digital health innovation, according to StartUp Health's annual report, yet only $167 million, or less than 1%, was set aside for children's digital health. And a quick online search of "children's hospitals" and "healthcare innovation" finds that many of the 250 or so children's hospitals in the U.S. are actively trying to raise funds that they aren't getting from the National Institutes of Health or other resources.
Whatever the reason for this lack of representation, Vuchak is quick to point out that innovation is alive and well at Children's Hospital & Medical Center. That's because so many care pathways and treatments for children can be made better.
Consider, for example, alarms within the hospital. They're vital to alerting care teams when patients are in distress, yet in children's hospitals they can also be distressing to patients, many of whom are scared to be in a hospital. With that in mind, Vuchak, says, Children's is working on designing new alarms that can alert providers without adding to a patient's discomfort.
Jerry Vuchak, executive vice president and chief information & innovation officer at Children's Hospital & Medical Center. Photo courtesy Children's Hospital & Medical Center.
"Innovation is our first value," he points out. "And it's not just words on a page. We're always thinking about how we can do things better because it's in our culture. It has a huge impact on our patients and their families."
Vuchak's view is shared by many innovation executives at pediatric hospitals across the country. Because so much of the activity in healthcare innovation is geared toward the adult patient, pediatric-based health systems are forging their own paths, creating innovative tools and strategies that apply directly to their young and fragile patients and their families.
This, in turn, makes pediatric healthcare innovation a dynamic arena.
"It's much harder in the pediatric environment," Vuchak says, noting the hospital has even had to build pediatric content into its EHR platform. "But that also makes it much more rewarding."
In many cases, children in pediatric hospitals and their parents are eager to embrace innovation. That's seen in Children's Hospital & Medical Center's digital front door. While national estimates place the number of patients using digital health tools to access care at between 30% and 40%, Vuchak says more than 70% of their patients are digitally active.
"Consumer engagement and experience is [a key factor to] our digital front door strategy," he says. "So it's very important to us that we know if we're thinking about the right things. That's how we'll build our roadmap out beyond 2023."
This roadmap includes mobile health apps that give care providers access to the latest information on chronic diseases like asthma, as well as up-to-date information on the patient, including medications and other treatments; and remote patient monitoring programs that ease the transition from the hospital to the home. One such program focused on young children who've had heart surgery within their first six months. The program boosted clinical outcomes 10%–20% by giving providers access to data that enabled them to intervene more quickly when a patient started trending downwards.
"We're prioritizing access to services," Vuchak says, meaning both how patients and their families can access healthcare and how providers can access resources to improve care. "We have a strategy council, and we have more ideas than we can actually take on."
Aside from augmented and virtual reality, in which Vuchak says "we're just scratching the surface," Children's Hospital & Medical Center is exploring how AI can be integrated into both provider workflows and care programs, and how wearables might be used in pediatric care—a challenge, again, because so many wearables are designed for adults.
Vuchak says he's surprised that so many companies in the healthcare technology space don't have a good innovation strategy. That's why he'll look far and wide for partners that have the right philosophy, and who will pivot quickly and adjust to meet specific and important patient needs.
As with all areas of healthcare innovation, the pandemic was a driving force in the adoption of new ideas and technologies, especially virtual care. For Children's Hospital & Medical Center, there was another unexpected benefit: the shift to working from home opened up 10,000 square feet of space within the health system, which is now being turned into a center for innovation.
This, he says, will help Children's to develop tools and platforms that address not only the patient, but the surrounding support team, including family, friends, and providers. It will also help as the hospital dives into the challenges around social drivers of health and the myriad causes of health inequity and outcomes, which healthcare organizations are now finding ways to address.
"You don't want to slow down because there's so much that can be done," Vuchak says. And that's both an important skillset and a challenge to working in pediatric healthcare.
The Midwest health system has developed new algorithms to help its nurse navigators manage their workflows, reducing stress and burnout and improving care management for cancer patients.
OSF Healthcare has designed an AI platform that improves care management for cancer patients by monitoring and adjusting the workflows of nurse navigators.
The Illinois-based health system developed an algorithm that combs through the electronic health record platform and other data sources to map out each cancer patient's journey for the coming week, including new patients. The technology then assigns the new patients to nurse navigators according to characteristics like cancer specialty and a care navigator's existing workload.
The platform not only improves care management for patients by ensuring they're matched with the most appropriate navigator, but also reduces stress and burnout among navigators by helping them manage their workloads.
"Our cancer patient nurse navigators are highly dedicated, and their workload can sometimes be overwhelming," Jonathan Handler, a senior fellow in innovation for OSF Healthcare, said in a press release. "They never want to shortchange the patient, so they shortchange themselves, working extra hours and sacrificing their own well-being to help patients. We hope our system can even out those workloads and improve their work-life balance."
The technology was developed by a team that consisted of researchers from OSF Healthcare and the OSF Innovation group, the University of Illinois College of Medicine Peoria, the University of Illinois Urbana-Champaign, and the Northwestern University Feinberg School of Medicine. It was funded by a grant from Jump ARCHES (Applied Research for Community Health through Engineering and Simulation), a collaborative that includes OSF Healthcare, the University of Illinois College of Medicine at Peoria, and the University of Illinois Urbana-Champaign.
The team's work was recently published in the American Society of Clinical Oncology's Journal of Cancer Informatics (JCO). That report noted that this may be the first time a project like this focused on the individual—including anticipated patient needs, navigator experience, and existing workload--rather than shifts, and the model they created "significantly outperforms the random distribution approach that approximates our current distribution methodology."
"Better workload management may reduce CPN burnout and lead to more effective and efficient navigation assistance for patients with cancer, allowing greater scalability of this vital resource to all oncology patients in need, regardless of geography," the study concluded.
The health system will next introduce the technology into its cancer care program through its OSF Community Connect workflow automation platform.
The proposed Transitional Coverage for Emerging Technologies (TCET) pathway is designed to facilitate Medicare coverage for new treatments that usually need time to develop data proving their value.
Federal officials are proposing an expedited pathway for Medicare coverage of new medical technologies.
In a notice posted in the Federal Register, the Centers for Medicare & Medicaid Services (CMS) is proposing a voluntary Transitional Coverage for Emerging Technologies (TCET) pathway for designated Breakthrough Devices. Officials say the new pathway, developed in a partnership with the Agency for Healthcare Research and Quality (AHRQ), should speed up the process to bring new treatments to Medicare beneficiaries while ensuring those treatments still meet rigorous review guidelines.
"As part of our commitment to fostering innovation and ensuring patient-centered care, CMS created the TCET pathway to provide a mechanism for coverage for certain new, innovative technologies with limited or developing evidence in the Medicare population using a transparent and predictable evidence generation framework that, when appropriate, not only develops reliable evidence for patients and their physicians to make healthcare decisions but also provides safeguards to ensure that Medicare beneficiaries are protected and continue to receive high-quality care," the agency said in a press release.
Officials said the new pathway was developed through feedback from a wide range of sources and based on requests "for CMS to utilize a more agile, iterative evidence review process that considers fit-for-purpose study designs, including those that make secondary use of real-world data."
Candidates for the TCET pathway will include devices that are:
Certain FDA-designated Breakthrough Devices;
Determined to be within a Medicare benefit category;
Not already the subject of an existing Medicare NCD; and
Not otherwise excluded from coverage through law or regulation.
Key elements to the TCET pathway include an evidence preview, or focused literature review, and an evidence development plan (EDP), which would be drafted by the developer to address any evidence gaps spotted in the evidence preview.
Once a treatment has qualified for this pathway, Medicare coverage will remain in place "only as long as needed to facilitate the timely generation of evidence that can inform patient and clinician decision making," along with an additional year to allow manufacturers to finish their analysis. CMS would then launch its updated evidence review.
Public comments on the proposal will be accepted for the next two months.
