The health system has announced a partnership with technology vendor Signify Health, beginning next year, to leverage advanced analytics technology to strengthen the ACO into a population health services organization (PHSO). The strategy is designed to assist the rural network in its shift to risk-based payment arrangements and better manage total cost of care for Iowa Medicare patients.
Leading the charge is Derek Novak, who joined MercyOne's ACO a decade ago and became president of the MercyOne PHSO in February 2019. He says MercyOne selected Signify Health as a partner after realigning its care management model and the organization powering it.
"We took a long look at our overall care management approach," he says. "Rather than just layer on more technology, what we did as an organization is look at it as an opportunity to redesign, really our care management and operation infrastructure."
Technology, nevertheless, plays a role.
"We have a lot of different, disparate data systems across our very broad network of providers," Novak says. "Technology can serve as a vital connection point to those organizations or those systems, being intentional about where it does support those processes for care management and engagement of our members."
Derek Novak, president of MercyOne's population health services organization. Photo courtesy MercyOne.
Numerous factors go into running the PHSO successfully, Novak says.
"While we've been doing accountable care organization work, or value-based work, since 2012, it certainly looks a lot different today than it did then," he says.
"We were very oriented in the beginning of how we perform on our particular contract, on things like improved quality or improved costs. Where we've changed our mindset over the years is, how do we build on that knowledge and that experience of what it took to be successful in those programs, to really transform what does it take to establish competency in performing better no matter what the program is."
For example, the ACO went through various accreditations for its care management plans.
"While we were very oriented on which levers to pull under programs, we now have an accredited program where we apply that methodology across any value-based contract that we bring into our population health services, really standing up an organizational approach to population health," Novak says.
To date, MercyOne has about 300,000 patients in its value-based care program, spanning urban and rural geographics.
As the organization improves its outcomes year over year, he says, both in terms of quality and finances, a shift to operating the ACO as an organization, rather than a program, has allowed the MercyOne PHSO to see more of an upward trajectory.
Another success factor is Novak's background, which doesn't read like a run-of-the-mill healthcare executive bio. Prior to entering the healthcare industry, he worked for industrial manufacturing conglomerate Textron, where he earned a Lean Six Sigma Black Belt certification, useful for keeping tabs on a substantial supply chain.
Five years into his tenure at MercyOne, Novak started bringing those Lean Six Sigma methodologies to bear on the health system, implementing the improvements ushered in by the Affordable Care Act to form its first ACO and move into value-based care.
By 2019, when Novak was named president of the ACO, he headed up the organization's community health and wellbeing initiatives, as well as its business solutions division, determining how MercyOne collaborates and works with employers looking for value-based care arrangements.
A key aspect of the Signify partnership will be extending the same level of ACO support throughout MercyOne's network of rural critical access hospitals and rural health clinics participating in the PHSO program.
MercyOne took time during the pandemic to examine "how do we provide the same level of support to our rural network throughout the MercyOne PHSO that we were also providing to our urban counterparts," Novak says. "Ultimately, that led us to exploring opportunities to bring in a partner like Signify Health."
Novak says MercyOne is fortunate because it has already built out much of the infrastructure that will aggregate population health data from these rural partners--data that will now populate the dashboards that Signify Health will present to clinicians.
The need to realize a short-term return on investment from this new alliance is secondary to the overall PHSO mission.
Officials at the New York health system say future pandemic tracking will benefit from this digital framework.
Mount Sinai has shared details of a new employee contact tracing database developed to control the spread of COVID-19.
Writing in the November issue of The Lancet Digital Health, researchers form the New York-based health system describe the creation of the Mount Sinai Employee Health COVID-19 REDCap Registry, a cloud-based digital framework using a web application known as Research Electronic Data Capture.
The tool is intended to track and reduce the spread of the virus across the Mount Sinai Health System, which includes eight hospitals and more than 400 outpatient clinics.
The database powering the tool assigns unique identification codes for each exposure without intentionally linking each exposure to previous events for that same person or department.
In this way, Mount Sinai can associate events to assist investigations in identifying patterns of the disease's spread. This design also adjusts and responds to changes in the COVID-19 disease as variants such as delta and omicron emerge.
The Employee Health COVID-19 REDCap Registry provides secure, easy to use forms for employee health collection and workflow-monitored contact-tracing information for employees. It also provides qualitative analysis of employee interviews and integrated genomic sequencing.
So far, the initiative has yielded 50,000 employee interviews and more than 500 framework revisions, according to researchers.
The registry is available through mobile and desktop devices connected to the internet, and remote access allows integration at all Mount Sinai Health System clinics and hospitals. The web forms enable swift follow-up from employee health services.
The contact-tracing function captures employee demographics, length of quarantine, which personal protective equipment the employee used, and a recent history of testing for COVID-19. An exposure matrix provides risk scores based on the type of exposure. Supervised machine learning predicts exposure outcomes, according to the researchers.
The registry allowed Mount Sinai employee health services to trim case follow-up times from days to hours.
The Memorial Healthcare System is focusing on food, housing, and transportation to help reduce unnecessary ED visits and boost care quality.
A Florida health system is putting social determinants of health (SDOH) right into the electronic health record problem list, where doctors can see and act on them.
Spearheading this initiative is Jennifer Goldman, DO, chief of Memorial Primary Care at the six-hospital Memorial Healthcare System, based in Hollywood, Florida. In this interview with HealthLeaders, Goldman explains how SDOH is embedded in the EHR and used to improve outcomes. This interview has been lightly edited for brevity and clarity.
HealthLeaders: How important is the role of data these days in the practice of medicine?
Jennifer Goldman: It's inseparable for primary care as we've transitioned from a fee-for-service to a value-based care approach. It's imperative that our teams know what's going on with those patients.
[In the past], it wasn't that we didn't care, but we didn't have the data, and we also didn't have the payment structure to make it possible. Now with value-based care, we have both. The care teams utilize that information to reach out to patients who haven't had an appointment and ensure that they come in. It's that kind of proactive management that is inseparable from data and data analytics.
Jennifer Goldman, DO, chief of Memorial Primary Care, Memorial Health System. Photo courtesy Memorial Health System.
As a result of having that data, we started something called a shadow schedule, where instead of booking directly on a provider's schedule and needing to have an open slot for a walk-in, we would have an empty schedule every single day that we just set out for walk-ins, for same day appointments, whether that was telehealth or face to face.
We've noticed a sharp increase not only in the number of patients that were requesting appointments via that system, but we also saw over 830 walk-in patients, same-day patients, in the last month alone. And we noticed a commensurate decrease in the number of ED visits. We would only be able to have that insight and that information because of the data that we proactively looked for.
HL: A JAMIA report from 2021 found there is no consensus on which SDOH measures should be captured in the EHR. How do you decide which ones to add?
Goldman: That's an ongoing discussion in our system. We utilize Epic, which has a social determinants of health wheel, which is just a graphic representation of the varieties of determinants of health that somebody is dealing with. And the major challenge for us in our organization was to determine which ones we were going to prioritize and start with.
We don't know if all of them truly impact health equally, but we do know that there are three that are a priority not only for us, but for Medicaid. If we can do something about these, we can probably impact more in a person's health than if we address resources elsewhere. Those are food, housing, and transportation. Substance abuse is a huge social determinant of health, but we already have a process for that, where we already screen everybody for that when they come in. The three social determinants of health we focus on are traditionally outside the wheelhouse of any physician. Those are things that we just did not ask people.
HL: How do you capture the data about the need, and how do you match the need with the actual service?
Goldman: We utilize the Epic release social determinants of health wheel. And we ask first our health coaches, our nurse navigators, and in some cases our social workers to review these determinants for the patients that were on their high-risk panel, patients that have significant ER visits or who are ill with multiple different chronic conditions.
We focused first on that population. Case managers were asking some of those questions anyway, but they were asking them in a non-capturable, non-standardized way. We standardized the way that we were capturing that data so that we could run analytics on it and show that information in the EHR to physicians. If our providers don't know that the patient they're treating right now is homeless or doesn't have access to healthy food or doesn't have access to transportation, that would probably impact their decision-making in terms of what treatment they were going to prescribe for that person.
We built something called an alert or a best practice advisory, where if somebody screened positive for homelessness, food insecurity, or transportation need, that would pop up [in front of] the clinician. And we took that a step further, because sometimes pop-ups in the EHR are negatively looked at. I never wanted to have an empty best practice advisory, where the doctor would have to do five more clicks to document that in the EHR. We drop the code for that specific social determinant of health into the problem list and into what we call a visit diagnosis.
We also included documentation that the patient was going to be automatically sent to our care team for follow-up in terms of how to access resources. We did that by having an automated in-basket so that it didn't hinge on a physician or a nurse practitioner or PA remembering to involve a social worker. This would happen automatically. We work with our community resources, such as the Broward County Task Force on Homelessness, and many other housing resources, as well as transportation assistance. With food, we work with multiple local food banks. We do direct connections with people we call and get those resources for them, instead of just handing a piece of paper to a patient.
HL: When did these processes go live, and what are the outcomes like so far?
Goldman: These alerts went live six months ago, and the outcomes have been significant. We've tripled the number of ICD-10 codes in the EHR for social determinants of health. That means that our physicians are documenting three times more on homelessness and food insecurity and transportation than they were previously. So we know that it's being captured.
We know that interventions are being done because we can track that as well. And we know that all those social determinants of health that we're screening for, all those patients ended up getting a referral to the care team and the care team contacted them and gave them the resources that they need. We're in the process of measuring outcomes, which ultimately is the most important thing. We're looking at data for no-show rates for appointments.
HL: What are the success factors for you in your job as a leader in this effort?
Goldman: Number one is making a difference in the community that we treat. Having the data to show that we are making a difference in our community is a success factor that's huge. More granular than that is ensuring that all our physicians are on board with this, number one, and number two, understand the why behind asking all of these soft issues in a medical visit, and make it easy for everybody to screen and document patients for social determinants of health without our doctors feeling like they have extra work to do.
Third would be our performance in our value-based care contracts. How successful are we in our quality measures, which we have done successfully every year, also ensuring that our patients are not utilizing services that they don't need, making sure that we're available so that people don't need to seek care in the emergency room for something that's not an emergency, and also ensuring that we're making sure that people don't need to go unnecessarily to specialists for care if the primary care doctor can address those issues.
HL: What about the other social determinants of health -- child care, money for medication, and so on?
Goldman: We absolutely want to expand into that. There are ways to do that over time. For every appointment, our medical assistants are now going to be screening for the social determinants of health. We're also moving into a way that our patients can answer these questions in the lobby, as they're waiting for their appointment, or at home as they're waiting for their telehealth appointment. And I want to be careful not to put forth technology to replace human beings in these questions that we're asking when not everybody has access to that technology just yet.
The Federal Trade Commission is weighing options to respond to health data winding up in the wrong hands.
Companies receiving healthcare data through avenues like mHealth applications on mobile devices should be regulated further, according to a trade association of healthcare CIOs.
"A recent estimate by IQVIA Institute for Human Data Science pegged the number of health-related apps at 350,000," Russell P. Branzell, president and CEO of CHIME, said in the organization's letter to the FTC. "Given the explosion in mobile apps and data aggregation practices, it is entirely possible that the amount of health data held by entities who are not required to comply with HIPAA exceeds the data held by those who are HIPAA-covered entities, certainly a concerning development."
The FTC is seeking comments on whether it should implement new trade regulation rules or other regulatory alternatives concerning the ways in which companies collect, aggregate, protect, use, analyze, and retain consumer data, as well as how they transfer, share, sell, or otherwise monetize that data in ways that are unfair or deceptive.
CHIME said it supports these efforts, using existing authority under the Health Breach Notification Rule to hold non-HIPAA-covered third parties, such as vendors of personal health record (PHR) software and apps, responsible when they illegally disclose – intentionally or not – covered information.
"Actions from the FTC will make a consumer’s data more secure and help ensure that those entities who have a breach of this crucial private data are held accountable," Branzell said. "Not only does it hold bad and unsecure actors accountable, but it also creates a disincentive that urges all businesses with PHR and PHR-related entities to strengthen their data security practices."
An AHIMA white paper recommends more use of artificial intelligence and automation.
A white paper from a leading health IT education and advocacy group recommends more use of artificial intelligence and automation in healthcare to keep up with changing consumer demands.
"A Watershed Moment: Recommendations and Insights for the Health Information Profession to Meet the Emerging Needs of the Modern Healthcare Consumers," based on interviews with health system leaders, insurers, health technology companies, health information exchanges, academic institutions, patient advocacy groups, and trade associations, has been released by the American Health Information Management Association (AHIMA).
"Health information professionals must be prepared to leverage and embrace new technology to meet the demands of consumers," Keith Olenik, AHIMA's chief member relations and service officer said in a press release. "It is essential for the healthcare industry to harness the infinite amount of data being captured today. Health information professionals can turn this data into valuable information, empowering consumers to impact their health and wellbeing."
The report makes five core recommendations to support the healthcare field and other organizations in meeting consumer expectations:
Prepare the health information field for more analytical capabilities and roles.
Prepare the profession to be increasingly involved in governance and management of healthcare data.
Develop strategies and resources allowing health information professionals and clinicians to improve the user experience of consumers—and address the social determinants of health.
Increase health information personnel participation in external advocacy and policy efforts.
Prepare the health information field to be open to more direct future interactions with patients.
The report recommends that health information personnel coordinate closely with clinicians to improve the design and delivery of data capture. It also calls for increased advocacy to support improved processes and regulatory changes to ease the exchange of information between entities.
The white paper was prepared by Kaufman Hall, a healthcare consulting firm, at the request of AHIMA.
Aetna Better Health of Florida aims to bend the cost curve for Medicaid patients living with chronic and complex conditions.
Aetna Better Health of Florida is bringing a different cost-saving approach to its Medicaid members through a combination of in-home care with telemedicine and remote monitoring.
Earlier this month, the insurer announced it is collaborating with Emcara Health, the value-based medical group of PopHealthCare, to deliver this approach to members.
Starting in the Tampa Bay, Orlando, and Miami-Dade areas, Emcara Health will deploy physician-led multidisciplinary teams to ramp up integrated, person-centered primary care for members in their homes, or wherever they call home, the two companies announced.
Chief Executive Officer Jennifer Sweet is leading this initiative at Aetna Better Health of Florida. After a decade in the Florida Medicaid industry, including a stint at PopHealthCare, she joined the company in February 2020.
Jennifer Sweet, chief executive officer of Aetna Better Health of Florida. Photo courtesy Aetna Better Health of Florida.
As a CVS Health company, Aetna Medicaid operates Aetna Better Health Medicaid plans in 16 states: Arizona, California, Florida, Illinois, Kansas, Kentucky, Louisiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, and West Virginia.
During the pandemic, which began weeks after Sweet's arrival in February 2020, Aetna Better Health of Florida employees quickly pivoted to working from home. But even so, Sweet says, the business was changing rapidly.
"The state eventually changed a lot of the policies required in our Medicaid contract, so we were reorganizing our operations tremendously," she says. "Things are largely back to normal, but we're in a new normal. As utilization went down, telemedicine went up, and it has stayed up in the behavioral space."
What the pandemic didn't change was the health plan's aggressive pursuit of value-based care, Sweet says.
"We've continued to have more and more of our members getting care under providers who are in value-based contracts with us," she says.
The partnership with Emcara Health represents "a big step forward for us," Sweet says. "It combines much more hands-on direct care, that we are comanaging with them in many ways, than under a standard value-based agreement."
A huge component of that co-management is the sharing of data between Emcara Health and Aetna Better Health of Florida, Sweet says.
"We start with the medical conditions that our members have," she says. "That would qualify them as good candidates for the Emcara program."
There were some false starts, due to stringent security protocols that protect each entity's data. Sweet says that challenge was overcome by building appropriate data-sharing infrastructure and staffing to manage it.
"It can be a slow process, a very resource-rich proposition," she says.
Part of that process was automating data transfers.
"It was tactical," she says. "The setup can be complex--not to the IT people who do it, but to those of us asking for something to happen, making sure we have the right resources to actually deliver on building those processes."
After building a set of baseline data, the partners began moving toward sharing data in near real time, Sweet says. Governance also consists of leaders from both organizations meeting quarterly.
"The evidence is there," she says. "Nobody is saying, I saw 10 of your members. It's all right there. We can pull it up, slice and dice, and see what services are administered. On our end, we are adding the care [members] are receiving from non-Emcara providers, to paint the full picture for us both to discuss. The real time exchange of status is very important to this program."
Although the Medicaid plan does have numerous children under its care, the cohort selected by the health plan for the Emcara Health program consists of only adults, all of whom have chronic or complex conditions that improve with close management of their medical conditions.
"We believe that with the kind of activities the Emcara team delivers to members, all of that can be used to create better outcomes for the members, to give them a better quality of life, and a more positive experience of being in the healthcare world," Sweet says. "Probably because of their conditions, many of them are likely to have a lifetime ahead of being in the healthcare world. Teaching them at the same time how to lead their own healthcare journey, it's pretty well-proven from studies everywhere that this is an effective way to reduce the total cost of care. That's the approach we're taking with the Emcara program."
The initiative will also address social determinants of health.
"We have a social team, feet on the street, out there meeting with community-based organizations and other resources, maintaining and updating the database that CVS has established of community resources," Sweet says.
The partnership announcement followed by days the arrival of Hurricane Ian in southwest Florida, but this program has not been impacted by Ian, Sweet says.
"I'm in Tampa, and the devastation south of me was enormous," she says. "We're still out on the street, delivering supplies, doing everything we can with our community partners. We had always intended to expand the program over time, but we will cross that bridge when we get to it in those areas."
The Seattle-based provider is now offering same-day telehealth appointments for a flat-rate membership fee in California and Texas.
A Seattle-based virtual care provider aimed specifically at the Latino population has expanded to California and Texas.
Zócalo Health, which launched in Washington earlier following a $5 million seed funding round, offers virtual care visits and care navigation services in what the company calls "an improved and long overdue healthcare experience built on trust, relationships, and culture."
Latinos experience disparate barriers to healthcare access, especially in primary care, where the average wait time to see a doctor is 24 days. This long delay, combined with fewer in-person appointments, high-deductible plans, and high out-of-pocket fees, results in many Latino patients avoiding treatment, using informal networks (family/friends), or waiting for hours in expensive emergency rooms to seek care.
The COVID-19 pandemic and resulting economic impact exacerbated health inequities for the Latino community, particularly when it comes to accessing high-quality primary care and preventative services.
Members can access various services and care options familiar in primary care settings, including evaluation of mental health conditions, preventative and lifestyle needs, chronic disease management, and more specific health conditions, as well as urgent care.
Zócalo Health's primary care model employs community health workers (CHWs)--known in the Latino community as promotores de salud. They're hired from the community to foster patient engagement and community health.
Company officials site research showing the crucial role of CHWs in connecting patients to local resources and care. They work one-on-one with members to coordinate care with a team of physicians, nurses, and mental health therapists, and connect members to useful resources across the community.
Once a relationship has been established with Zócalo Health, members have 24/7 access to care and can receive individual guidance on personal health goals and needs.
"As a kid, I remember the long waits in the community health clinic to see a doctor who often did not speak Spanish," Zócalo Health CEO Erik Cardenas said in a press release announcing the virtual care service. "I had to act as a translator for my mom about my own care and help her navigate next steps. I felt guilty that my mom had to take time off from work for my appointment and pay for any prescriptions or additional care needed. For my family, no work meant no pay, so a doctor’s visit was a heavy burden on everyone."
Zócalo Health memberships start at $40 per month or at a discounted rate of $420 a year when paid in advance. The provider has plans to expand to other states in 2022 and later.
Recent wildfires are a fresh reminder of the value of the real-time dashboard, which allows health systems to manage resources and transfer patients as needed.
The wildfires flaring this week are a reminder that Oregon is one of the only states in the country with the technology to provide healthcare officials with a real-time, statewide dashboard of staffed hospital beds, ventilators, and resources such as negative pressure rooms.
For Staci Sparks, vice president of nursing at Asante, a three-hospital system in southern Oregon, the dashboard is a welcome tool. Just two years ago, the evacuation zone for one wildfire included Asante Rogue Regional Medical Center.
"At that point, we were trying to figure out if we need to evacuate people," she says. "There was nowhere else for them to go here. We were in a high-capacity situation, and we're somewhat geographically isolated. This system gave us a state look to see what hospitals had beds and capability, and where to get them to the right place."
Staci Sparks, vice president of nursing, Asante. Photo courtesy Asante.
The system was established in 2020, using GE Healthcare Command Center technology to address hospital capacity issues during the COVID-19 pandemic. With funding from the state, it has not only continued and grown past the peak of the pandemic, but was spun out of its incubator at Oregon Health & Science University to become Apprise Health Insights.
The company continues to seek funding from Oregon and the US Centers for Disease Control and Prevention (CDC), says CEO Andy Van Pelt, who also serves as executive vice president of the Oregon Association of Hospitals and Health Systems (OAHHS), under which Apprise Health Insights is operated as a for-profit subsidiary and data arm of the organization.
The real-time dashboard facilitates the quick transfer of patients to appropriate facilities as needed, and is gradually replacing the state's older tech platform. So far, Van Pelt says, the new system has automated 85% of the 300 data fields in the legacy system.
That migration speeds up all reporting, while freeing up staff previously dedicated to the manual reporting processes in the older system, he adds.
"The governance committee is made of health system patient coordination and patient flow folks that represent the seven trauma regions around the state of Oregon," Van Pelt says. "They meet regularly with the state, we come up with policies and procedures and workflows, and how and when the data can be used, and for what purposes."
Apprise Health Insights hosts the system and online dashboard, monitors all data feeds, and conducts all education and onboarding of users of the dashboard, he says.
And that's been a relief for Asante.
"Getting through the pandemic was a little bit easier than post pandemic, because there was this burning platform," says Sparks. The end of the staffed bed crunch "gave us some time afterwards to go back and say, how would we do this differently from a local perspective and also from a state perspective? And learn those lessons and apply them to other scenarios that could occur."
Part of that is understanding what a system driven by data uploads from electronic medical records can offer, and what its limitations are.
"Electronic medical records don't always have the best reputation in the industry," Sparks says. "In the future, we need to view technology as a tool, which is what it is. The intent is to make it easy to do the right thing for patient care, and to make it easy to do the right thing for our employees' workloads."
"This is really an exercise in trust building," Van Pelt says. "It creates an actionable data set that at the end of the day really impacts a patient's care [to make it] quicker, more efficient, and more appropriate. … During the Labor Day fires in September of 2020, we had to evacuate five hospitals in a 24-hour period. We were grateful to have the first version of this."
Andy Van Pelt, vice president, Oregon Association of Hospitals and Health Systems, and CEO, Apprise Health. Photo courtesy Apprise Health.
Apprise Health Insights is talking to about a dozen states about adopting this technology. In addition, Van Pelt says, Oregon Senator Jeff Merkley has introduced legislation to modernize real-time data for hospital data and emergency response nationwide.
Alaska's chief medical officer Ann Zink "is a good friend of ours and is looking at potential legislation to modernize capacity-type data around the country," Van Pelt says.
As for Sparks, the dashboard helps her grow into her new role as vice president of nursing at Asante, the first such vice president over the entire system.
"My learning curve has been steep for the first four months," she says. "It's doing more listening and observing than acting or decision making. In six or 12 months, that will shift. You need to understand what you're working with before you can ask people to make changes or before you can make decisions that really impact their work."
EHNAC and CARIN have collaborated on a guide for healthcare providers, insurers, developers, and app developers.
Two influential developers of healthcare data standards have created a common code of conduct to help consumers control the exchange of their health data.
The CARIN Code of Conduct Accreditation Program (CCCAP) brings CARIN's code of conduct together with the criteria review process of EHNAC to accelerate health data exchange activities of health plans, health systems, EHR vendors, implementers of HL7 FHIR-based application programming interfaces (APIs), and third-party app developers.
The collaboration is intended to support additional levels of trust related to consumer access to health data.
The CARIN Alliance works with more than 80 stakeholders to enable consumers to obtain, use, and share their digital health information as they desire. The Electronic Healthcare Network Accreditation Committee (EHNAC) is a standards development organization that develops criteria for standards and accredits organizations that exchange healthcare data via electronic means.
“We envision a future where any consumer can choose an application of their choice to retrieve both their complete health record and their complete claims information from any provider or plan in the country using HL7 FHIR APIs, and the CARIN Code of Conduct has been instrumental in helping to advance these efforts,” Ryan Howells, program manager for the CARIN Alliance and principal at Leavitt Partners, CARIN's convener, said in a press release.
This past July, the Centers for Medicare & Medicaid Services (CMS) commenced enforcement of key components of the Interoperability and Patient Access final rule – a key federal initiative intended to accelerate the ability for individuals to access their personal health information via an application of choice leveraging HL7 FHIR APIs. As part of the rule, CMS gave payers the option to implement an attestation framework asking developers to describe the data practices and privacy provisions of the applications that are connecting to the HL7 FHIR APIs.
This new voluntary certification program builds on the CARIN code of conduct self-attestation approach, but is not required by CMS or CARIN, the organizations said.
“Since the CARIN Alliance launched MyHealthApplication.com, which provides the ability for applications to self-attest to the CARIN code of conduct, it’s been important to continue to collaborate on implementing and fostering adoption of an industry-wide consumer-facing application attestation and certification framework," said Lee Barrett, executive director and CEO of EHNAC. "This includes focusing on providing the highest level of stakeholder trust for all healthcare stakeholders – patients, providers, health plans, third-party app developers, and many others."
Stakeholders who attain CARIN code of conduct accreditation will be listed on the CARIN My Health Application site and the EHNAC Accredited Companies page. Already, multiple consumer-facing applications who have attested to the CARIN Code of Conduct are listed on the MyHealthApplication.com website
In the second of a two-part interview, Brian Clear MD, chief medical officer of Bicycle Health, talks about treatment details and regulatory challenges.
Editor's note: This is the second of a two-part interview. The first part was posted on Wednesday, October 12.
Brian Clear, MD, has been chief medical officer of Bicycle Health since March 2021. In part 1 of this conversation with HealthLeaders, he discussed his journey from residency to his current role, why the company's opioid treatment method is underutilized, how the program works, the role telemedicine plays, and the support it has received by medical societies.
HealthLeaders: What does a typical Bicycle Health session involve?
Clear: Patients see our provider for an hour on the first day where they're establishing the diagnosis, talking through treatment options, making sure that the patient is on board with the telehealth-based treatment option, and then starting treatment the same day. There's a quick check-in with the patient the very next day to make sure they're doing well. Follow-ups are either 20 or 30 minutes.
Providers check in with the patient at least every week until we know that they're stable on early treatment, meaning they're comfortable on the correct dose of buprenorphine and they're able to give us a drug screen that supports that the medication is effective, meaning no illicit opioids and presence of buprenorphine.
It's a once-daily medication taken at home. Quite simple. We make sure every patient has a stock of at-home urine drug screens, and we use a random text messaging system to prompt the patient when to complete one of these screens, kind of like uploading photos of a check to your bank for deposit. Our app walks the patient through the process of completing a sample, then taking a series of photographs so that our provider can interpret the results of the drug screen.
Brian Clear, MD, Chief Medical Officer of Bicycle Health.
We're also testing for fentanyl, specifically, for patients who can become pregnant. We're also doing home pregnancy tests. We can also do saliva-based testing where, if needed, we can directly observe sample collection and watch the whole test on camera if we have reason to believe a patient might be using someone else's sample. But we've done a genetic matching study on our urine tests and find that less than 3% of our patients in the study provided a false or tampered sample. So, we have high confidence in the urine test for most patients.
HL: Can they overdose at home on buprenorphine?
Clear: It's a problem more of the patient worrying about accidentally having taken too much or accidentally missing the dose. Buprenorphine as a medication is very, very forgiving of accidental mis-dosing. It has what's called a ceiling effect where, beyond a certain point, the medication actually stops having any additional effect because it saturates all the opioid receptors in the body. Once all the receptors are saturated, more medication doesn't have any receptor to bind to.
So it's essentially impossible for an adult who has a tolerance to opioids to overdose on buprenorphine. Similarly, patients can miss one or two days of dosing usually without experiencing considerable withdrawal. If they miss three more days, that's when opioid withdrawal starts to set it.
HL: What total population are you affecting at this point?
Clear: We have treated over 20,000 patients. When I say treated past tense, that's not the goal; treatment needs to be ongoing for the benefits of treatment to be ongoing. This medication reduces death and disability rates from opioid use disorder for as long as it continues. But just like if you stop your blood pressure medication, your blood pressure goes back up, we find that for most patients who stopped, they're likely to return to illicit opioid use within a year or two. So we have currently active in our program about 8,000 patients.
HL: And they're all being seen via telehealth through Bicycle Health doctors?
Clear: Yes, every one of our physicians is double-boarded in either family medicine or internal medicine and in addiction medicine. We also work with advanced practice clinicians. Those are nurse practitioners and physician assistants who have at least two years full time experience working with patients with opioid use disorder.
HL: How does this integrate with their other care, such as a local primary care provider?
Clear: About half of patients who come to us are established with a local primary care provider, and of those, about half of those patients are willing to give us permission to coordinate care with that local primary provider. We strongly encourage all patients to establish with a primary care doc if they don't have one already, and strongly encourage all patients to let us coordinate.
We'll send visit notes to that primary care doc. If they have questions or concerns, we'll make time to get on the phone with that primary care doc or their mental health home and make sure that that doctor is informed of the treatment that we're offering and also why, and the benefits that it offers to patients.
A lot of our patients do struggle with fear of informing their primary care doctor or their mental health professional of their opioid use disorder treatment, and it's a rational fear. We still running into issues where doctors who are not fully informed about correct opioid use disorder treatment will stigmatize patients when they become aware that they're receiving this treatment. In some extreme cases doctors will decline to continue working with the patient, which frankly is unconscionable. We do still run into that. But we believe that through communicating very proactively, we can help primary care docs and mental health docs understand that this is beneficial treatment for their patients.
HL: How does what you have learned compare to the new JAMA study?
Clear: What they found is very consistent with my experience of developing a telehealth-based program for opioid use disorder. We would have been happy if we could have done just as well as in-person programs, but what we've achieved are much better outcomes than we know is the norm in in-patient programs.
What the JAMA study looked at, and what is probably the most important thing to look at in determining how successful a program is with treating opioid use disorder, is how many patients stay engaged after a certain amount of time. The JAMA study looked at a year and a half, which is great. Most programs measure three months of engagement and don't look too far beyond that.
JAMA found that when you're looking at a group of patients before telehealth-based care for opioid use disorder existed and compare them to a group of patients after telehealth-based care for opioid use disorder existed, for patients who had telehealth as an option, and about 20% of them actually use telehealth, we find that their overdose rates go down considerably compared to patients engaged only in in-person care, and also their engagement rates and treatment after a year and a half go up considerably, by about a third compared to in-person treatment only.
And that's what we find in our program, too. We find that 70% of patients who start with us are still engaged with us after a year. That compares to my experience in in-person programs where if you've got more than 45% of patients engaged after a year, you're doing a really good job. 70% is kind of unfathomable.
HL: What's your biggest challenge?
Clear: The biggest challenge is regulatory. It's working to offer this care in states that currently ban it. And there are quite a few states that still ban it because, as I mentioned earlier, buprenorphine is not separated out from other opioids in the law, like it should be. The DEA has changed that at the federal level, but some states have been slower to follow suit and still have restrictions either on use of buprenorphine or on use of telehealth in general.
HL: What's the largest such state that still is problematic?
Clear: We were practicing in Alabama until about six months ago, and they enacted a new law banning the use of telehealth to provide treatment for opioid use disorder. We had to leave Alabama. And that was one of our states of greatest need.
HL: Are the payers on board for the long-term nature of this care?
Clear: Payers are very much on board. A couple of years ago, when I first started presenting to payers, it was common to have to lay out and explain the evidence for why we strongly recommend continuation of opioid use disorder treatment long-term. But now, I think that evidence is prevalent enough to where payers understand.
I rarely must have that conversation of convincing them of why ongoing treatment is recommended. The task is just to demonstrate that we can and that we do a good job of offering ongoing treatment for opioid use disorder.