Six healthcare organizations have been selected to implement and test the TEFCA standards as the next step in becoming Qualified Health Information Networks (QHINs), the latest stage in the development of a nationwide healthcare information exchange.

Federal officials have named six healthcare organizations as qualified to implement the Trusted Exchange Framework and Common Agreement (TEFCA), the latest step in the effort to create a nationwide healthcare information exchange.

At a news conference Monday, US Health and Human Services Secretary Javier Becerra presented certificates to the CommonWell Health Alliance, eHealth Exchange, Epic TEFCA Interoperability Services, Health Gorilla, Kno2, and KONZA. Those organizations are now qualified to implement and test TEFCA standards on their way to being designated Qualified Health Information Networks (QHINs).

"This is a significant step for the US health system and one that will advance interoperability at scale for patients, health care providers, hospitals, public health agencies, health insurers, and other authorized health care stakeholders," Micky Tripathi, PhD, the HHS' National Coordinator for Health IT (ONC), and Mariann Yeager, CEO of the Sequoia Project, said in a blog. "Strong privacy and security protections are required of QHINs and their expanded connectivity will help improve the quality, safety, affordability, efficiency, and equitability of health care across the country. Nearly every American that uses the health care system will eventually experience the benefits."

Tripathi and Yeager, whose organization is the TEFCA Recognized Coordinating Entity, said the six networks cover most the nation's hospitals and tens of thousands of providers and process billions of healthcare transactions each year.

Federal officials unveiled the TEFCA guidelines in January 2022, fulfilling requirements of both the 21^st Century Cures Act and HITECH Act that called for a clear infrastructure model and governing approach for a nationwide health information exchange. The Trusted Exchange Framework is a set of non-binding principles for health information exchange, and the Common Agreement is a legal contract that highlights those principles.

The Sequoia Project will sign the Common Agreement with each QHIN, after which the QHINs will set up the new connectivity framework, using as a guide the QHIN Technical Framework, which lays out the functional and technical requirements. At the same time, the ONC and Sequioa Project are also developing a TEFCA Health Level Seven (HL7) FHIR Roadmap to ensure interoperability.

The University of Virginia Health System is using a federal grant to expand stroke treatment and telehealth training, as well as access to its iTREAT telestroke platform, to six rural Virginia counties.

The University of Virginia Health System is spearheading a new digital health program aimed at improving emergency treatment of strokes in rural areas.

UVA Health is using a $1.5 million grant from the US Health Resources and Services Administration (HRSA) to launch a three-year telemedicine program to educate and train rural healthcare providers on pre-hospital emergency care and post-discharge follow-up care for stroke patients. The program will also link ambulances in those counties to the health system's iTREAT telestroke platform, which connects EMS crews treating a suspected stroke victim in real-time with specialists.

"This will help us render excellent care not only for sudden strokes but also for the prevention and follow-up treatment of stroke,” Nina Solenski, MD, a stroke neurologist at UVA Health’s Comprehensive Stroke Center and the program’s director, said in a press release. “This is urgently needed. Buckingham County, for example, has nearly twice the rate of stroke deaths in non-Hispanic Black individuals compared to the national average. Reversing these types of disparities in our own surrounding communities is our goal and it’s a team effort with all different types of healthcare providers.” 

The program's training element will focus on three areas. Paramedics and other EMS providers will be given instruction on community paramedicine strategies, which will enable them to treat more 911 calls at the scene and reduce unnecessary ED transports. Through a Project ECHO telemedicine platform, they'll be educated on the latest methods for identifying and treating patients suspected of suffering a stroke from specialists. And they'll also be taught how to use telemedicine for stroke treatment and care management.

“This is an important goal of the program," George Lindbeck, MD, an emergency medicine physician at UVA Health and the program’s co-director, said in the press release, noting the education resources will also be made available to students at the Charlottesville-Albemarle technical Education Center and nursing students at UVA Wise. "We want to encourage the development of these trainees and get them excited about joining a team of technology-savvy healthcare professionals dedicated to ensuring healthy lives for all.”

One of the longer-running and most documented telemedicine services, telestroke has been proven to boost clinical outcomes and save lives in both urban and rural regions. The service centers on a secure and reliable audio-visual telemedicine platform that gives emergency responders an on-demand link to a stroke specialist who can identify and diagnose stroke symptoms and prescribe clot-busting drugs. The sooner that a stroke id diagnosed and those drugs are administered, the better chance the patient has of avoiding brain damage and death.

The platform is widely used in telemedicine programs that link smaller, rural hospitals and healthcare sites to a larger hospital with stroke speciialists, with the goal of improving clinical outcomes in rural and remote areas where it takes much longer to reach a specialist and administer medication. Some cities and health systems have also used vehicles fitted with telemedicine technology and deployed solely for stroke vicitims, though the price tag for those vehicles is high. As the technology improves, a more likely approach will be to include telemedicine in ambulances and EMS vehicles.

While some waivers have been extended for two years, other freedoms—including an important Ryan Haight Act provision—will end soon, forcing some providers to take action now.

With the Biden Administration announcing the end of the COVID-19 public health emergency (PHE) on May 11, healthcare organizations are assessing how their digital health and telehealth programs will be affected. While Congress put in place a temporary reprieve in its budget bill, certain freedoms and waivers will end soon.

"This is going to be a trying time" for health systems, says Jacob Harper, a partner in the Morgan Lewis law firm who focuses on the healthcare industry. "It's kind of a double-edged sword. Without knowing [what will happen with the extended waivers], it's really hard to evaluate what the future looks like when you don't know the long-term outcomes."

When the PHE was created in January of 2020 to help the nation deal with the growing pandemic, a  number of waivers and exemptions were put in place by federal and state regulators to help healthcare organizations expand and be reimbursed for digital health and telehealth services. The idea behind this was to allow providers to use virtual and connected health tools and platforms to reduce the spread of the virus and make sure consumers were able to access needed healthcare services.

As a result, telehealth use soared during the height of the pandemic, as providers launched new services and programs and consumers enjoyed the benefits of virtual on-demand healthcare. While in-person care is mounting a comeback, health systems are now adjusting to hybrid workflows that allow for in-person and virtual care.

But many programs are buoyed by those PHE waivers, especially those launched by the Centers for Medicare & Medicaid Services (CMS). A growing concern among healthcare executives is that many of these new programs won't be able to stand up on their own without the waivers or new regulations that improve telehealth use and coverage. Those programs may have to be shut down, cutting off patients from important healthcare services.

With the recent Congressional passage of the Consolidated Appropriations Act of 2023, several of those CMS waivers have been extended until the end of 2024. The wavers include that::

• Healthcare providers can bill Medicare for telehealth services regardless of the location of both the patient and provider (including the home)
• Audio-only telehealth services, such as phone calls, are reimbursable
• Federally qualified health centers (FQHCs) and rural health clinics (RHCs) can be reimbursed through Medicare for telehealth services as a distant site provider
• Hospice care providers can use telehealth to recertify their eligibility
• The list of healthcare providers allowed to bill Medicare for telehealth services is expanded to include physical and occupational therapists and speech language pathologists and audiologists
• Members of high-deductible health plans (HDHPs) and health savings accounts (HSAs) can use "first dollar coverage" for telehealth visits without first having to meet a deductible
• CMS' acute hospital care at home program remains in place

Harper says this is a reprieve in one sense, but it mainly kicks the can down the road.

"I don't think you can relax," he says, noting those waivers will still end in two years unless CMS or Congress takes further action. "You can't really take your foot off the gas pedal."

Other waivers and freedoms, meanwhile, will end on May 11. Chief among them is a waiver of the Ryan Haight Act's in-person exam requirement. Passed into law in 2008, the Ryan Haight Online Pharmacy Consumer Protection Act severely restricts the prescription of controlled substances, and requires an in-person exam by a qualified provider before those drugs can be prescribed via telemedicine. Enforcement is handled by the US Drug Enforcement Agency (DEA).

Writing in their Health Care Law Today blog, Thomas Ferrante and Rachel Goodman, partners with the Foley & Lardner Law Firm and members of the firm's Telemedicine & Digital Health Industry Team, say the waiver of the in-person exam during the PHE ensured that "millions of both established and new patients were able to receive medically necessary prescriptions via telemedicine."

"There have been efforts to amend the Ryan Haight Act and encourage the DEA to activate the telemedicine special registration rule before the PHE expires, including pending federal legislation," they wrote. "However, to date, the Ryan Haight Act has not been changed and the DEA has not activated the telemedicine special registration rule." 

"Thus, when the PHE expires on May 11, without further action on the part of the DEA, the in-person requirement is set to revert, without any special registration rule or other process established to ensure continuity of care," Ferrante and Goodman conclude. "Therefore, continued prescribing of controlled substances for patients never seen in-person, and only through virtual means during the PHE, will be prohibited and these patients would either need to be seen in-person or have their care transitioned to a local provider."

Because the pandemic coincided with—and helped propel—a surge in substance abuse and mental health issues, the last few years have seen a marked increase in telemental health and opioid and substance abuse programs using telehealth and digital health. The key to the success of those programs is the ability to prescribe medications via telehealth.

"I don't know how many of [those programs] are going to survive," Harper says.

Among those calling for action is the American Telemedicine Association (ATA).

"The ATA and [its lobbying group] ATA Action implore our government leaders to provide a sense of certainty to a huge cohort of individuals requiring access to important medications for substance use disorders and other necessary drugs via telehealth after May 11," Kyle Zebley, the organization's senior vice president of public policy and executive director of ATA Action, said in a press release. "Without a plan in place, these vulnerable populations will be left out in the cold, and we are quite sure this is not the intent of our government leaders."

“The ATA and ATA Action have been urging the [DEA] to release its rules for special registration for telemedicine, which will hopefully be a new pathway to continue providing this care post-pandemic," Zebley continued. "However, we are extremely concerned as those rules have been required since the original Ryan Haight Act was passed in 2008 and reiterated in statute by Congress in 2018, but we have yet to see them published. There is now an extreme sense of urgency with the public health emergency ending in only a few months.”

Other changes that will take place with the end of the PHE, according to Ferrante and Goodman, include:

Medicare payment parity. During the PHE, CMS increased reimbursement for telehealth services outside the hospital setting, such as in a patient's home, essentially allowing providers to receive the same payment for a telehealth service as they would for an in-person service. That will end with the PHE, thus reducing telehealth reimbursements outside the healthcare setting. This may prompt some providers to curb their telehealth services or focus more on in-person services.

Telehealth and remote patient monitoring (RPM) co-payment waivers. The US Department of Health and Human Services' Office of the Inspector General (OIG) issued a policy statement during the PHE that they would not enforce sanctions under the Anti-Kickback Statute for cutting or waiving deductibles and co-payments (cost-sharing) for telehealth or RPM services for Medicare patients.

"The guidance documents expressly tie this waiver to the duration of the PHE," Ferrante and Goodman wrote in their blog. "Thus, unless the OIG issues additional guidance or an extension, after May 11, healthcare providers offering telehealth or RPM services to Medicare beneficiaries may no longer reduce or wave any cost-sharing obligations that patients may owe for such services. Digital health companies without payment and collection mechanisms for these payments will need to act swiftly to operationalize new process to ensure these amounts are charged and collected."

RPM program expansion. During the PHE, CMS allowed RPM programs to expand beyond established patients and include (and bill for) new patients. That ends on May 11, and providers will have to conduct new patient evaluation and management services before adding anyone to their RPM programs. This could slow the growth of RPM adoption.

Virtual direct supervision. CMS also changed direct supervision guidelines during the PHE to allow a "supervising professional" to use audio-visual telemedicine to remotely supervise a procedure. CMS did not extend this policy beyond this year in its 2023 Physician Fee Schedule, so virtual direct supervision will no longer be allowed after 2023.

HIPAA enforcement. According to Ferrante and Goodman, the HHS Office for Civil Rights (OCR) relaxed its enforcement of the Health Insurance Portability and Accountability (HIPAA) rules during the PHE,  enabling providers to use telehealth in good faith even if they didn't meet HIPAA standards (for example, the use of certain technologies for virtual visits). After May 11, the OCR has said it will resume enforcing those guidelines.

School districts across the country are partnering with local health systems and telehealth companies to give students access to primary and chronic care services, along with much-needed behavioral and mental health services.

Healthcare has become a vital resource in schools, alongside the familiar staples of reading, writing, and arithmetic. But schools are moving beyond delivering care through a school nurse or staff member with rudimentary medical training. They're using telehealth and digital health tools to give students and staff on-demand access to healthcare providers, offering everything from primary care to chronic care management and behavioral health services.

Providing telehealth to a school or school district can be complex, often because of the costs involved. Schools don't have a lot of money to spend on healthcare, so they rely on grants, federal and state appropriations, or partnerships with local health systems or telehealth companies.

The benefits are numerous. Access to telehealth in the school can reduce both staff and student absenteeism, improve morale and even boost test scores, while also improving clinical outcomes. In many rural and underserved communities, a school's telehealth program may be the only care provider-for students whose families can't afford or travel to any other healthcare services.

In South Dakota, Avel eCare, a telehealth company spun off from Avera Health, is providing virtual care services to students living with Type 1 diabetes in roughly 100 schools in several states. The program was launched as a demonstration project by Avera Health, the Juvenile Diabetes Research Foundation, and the Helmsley Charitable Trust.

Sheila Freed, RN, BSN, NCSN, Avel eCare's school health director and a nurse with some 20 years of experience, says many rural schools don't have a nurse on hand, don't have the money to hire one and wouldn't be able to find one even if they had the funding. 

"There's a huge gap there that someone has to fill," she says. "Some nurses are driving from school to school, maybe 60 to 100 miles a day, and they're spending more time behind a windshield than with a student."

Providing the technology for a virtual visit isn't that complicated. A small room is needed for privacy, and many programs use a PC or laptop to establish an audio-visual connection with a care provider. The Avel eCare program uses a telemedicine device developed by Tyto Care to capture vital signs and other biometrics during the virtual visit.

Freed says the Avel eCare program operates as a hub-and-spoke telemedicine network, with the care provider at one location offering services to a number of schools. The program will train someone at each school on how to use the technology.

"We set up the whole program so that teachers can relax," she says.

That idea extends beyond teachers. With a telehealth program in place, Freed says, providers can not only boost care management for students, but be a resource for school staff and even the student's family, helping everyone within the child's orbit to improve their understanding of diabetes and how to help someone living with the chronic condition.

"Type 1 diabetes doesn't end when the school day is over," she says.

And while the program was set up to focus on students living with diabetes, Freed says they'll treat a variety of health issues. One of the long-term goals of the demonstration project, she says, is to prove the feasibility of a telehealth program for addressing almost any health issue in rural and remote schools where access to care is limited.

Avera Health, the sprawling, 300+ site health system based in South Dakota, is supporting the project through its research branch. As of late last year, the program included schools in the Dakotas, Minnesota, Montana, Nebraska, and even Maine, where Avel eCare providers had to learn about the brown-tail moth rash and tick-borne illnesses to treat students, with other states showing interest as well.

"Health systems should pay more attention to these programs," Freed says. "It's a wonderful match for value-based care. Sometimes there's a bit of a disconnect between school system and local health systems, and these programs can bridge that gap."

While some school districts are partnering with health systems for school-based telehealth programs, others turn to telehealth companies like Hazel Health, a San Francisco-based organization launched in 2015 and now working with thousands of schools across the country.

In Los Angeles, city and state organizations are using telehealth to address the dire need for access to behavioral health services in schools. According to the California Master Plan for Kids' Public Health, more than 284,000 school-aged children are dealing with major depression, and two-thirds aren't receiving treatment.

The Los Angeles County Office of Education, partnering with the LA Care Health Plan, Health Net, and the Los Angeles County Department of Mental Health to make free telemental health services available to more than 1.3 million students in kindergarten through grade 12. With $24 million in funding from the health plans and the Department of Health Care Services' Student Behavioral Health Incentive Program, for the next two years, the partnership has contracted with Hazel Health, which expanded its platform to include telemental health services in 2021.

"We continue to see the devastating impact the pandemic has had on our children's mental well-being. This crisis has called us to collective action," Los Angeles County Superintendent of Schools Debra Duardo said in a Los Angeles Daily News story earlier this week. "As a mental health professional, I am keenly aware that partnerships and collaboration across sectors are necessary to meet our children's needs. We must remove barriers to access and continue our efforts to destigmatize help-seeking around mental health. We must also recognize that physical and mental health is crucial to teaching and learning."

Much of the need for behavioral and mental health services has been driven by the pandemic, which disrupted school-based programs and cut off students from familiar healthcare resources. The Centers for Disease Control and Prevention says more than a third of high school students reported mental health issues in 2022, and according to a School Pulse Panel survey used by the US Department of Education's National Center for Education Studies, more than two-thirds of the nation's schools have increased access to mental health services to address that problem.

“I think people should always ask for help,” SaRiya Parker, an 8th-grade student at Benjamin O. Davis Middle School in Compton, told the Los Angeles Daily News. “If you’re suffering in silence it’s like that drowning feeling when you get in the water and can’t get out. Coming to a school psychologist for help is a good way to get out of the water.”