The Utah-based research firm's annual awards recognize 25 programs launched by health systems and payers that address key issues such as data integration and exchange and value-based care.
KLAS Research has unveiled its annual Points of Light awards, highlighting 25 innovative partnerships between healthcare organizations, payers, and vendors that have shown success addressing the nation's biggest healthcare challenges.
Among the projects included in this year's awards is a deviceless remote patient monitoring (RPM) program launched by Illinois-based Carle Health and Health Alliance in a partnership with Lightbeam Health Solutions. The program has shown improved clinical outcomes and reduced monthly costs for a number of patients living at home with hypertension, COPD, and congestive heart failure.
Another project, launched by the Allegheny Health Network and Highmark Health in a partnership with Cedar, consists of a self-pay digital health platform and call center, giving patients real-time access to information including deductible progress, out-of-pocket maximums, and FSA/HAS balances, and a portal through which they can choose a payment plan, pay bills, or seek more information. That program, now being used by one-third of eligible patients, has boosted payments and improved patient engagement and satisfaction.
For each of the profiled programs, KLAS highlights outcomes achieved through collaboration, placing a high value on health systems and payers that work together and with vendors to solve problems. Other key lessons learned included choosing the appropriate technology partners, creating groups and governance structures necessary for success, and using data to drive improved outcomes.
Last year's KLAS Points of Light winners included Vanderbilt University Medical Center, which launched a maternal health bundled payment program with the Metro Nashville Public Schools (MNPS) health plan and Cedar Gate Technologies that helped save more than $400,000 in its first year.
"People don't feel like their health systems are going with them on their journey," CJ Stimson, MD, JD, chief medical officer at VUMC and Vanderbilt University Employee Health Plans and senior vice president of value transformation in VUMC's Office of Population Health, said in a HealthLeaders interview. "So we told them we'll take all the risk."
The study found that California FQHCs were still conducting 20% of primary care visits and 40% of behavioral care visits by telephone or audio-only computer platform.
Federally qualified health centers (FQHCs) in California are still delivering healthcare via the telephone, according to a new study from the RAND Corporation, raising the value of a modality only used since the pandemic to boost access.
The study of 30 FQHCs providing services to 1.3 million underserved residents found that, in August of 2022, audio-only telehealth was used for one out of every five primary care visits and two of every five behavioral healthcare visits.
Federal and state regulators relaxed the rules around telehealth access and coverage during the COVID-19 pandemic to enable more people to access care from their homes and help healthcare organizations reduce the spread of the virus. This included allowing providers to connect with patients by phone for some services.
Telehealth advocates say many underserved populations, especially in rural areas, can only access care by telephone, as they can't afford or don't have easy access to computers or reliable broadband. Critics say the platform isn't good enough for many healthcare services, and that a telehealth connection should at least have an audio-visual connection.
While audio-only telehealth permissions will be scaled back with the end of the public health emergency in May and the two-year grace period included in the Consolidated Appropriations Act of 2023 passed by Congress, RAND researchers found that the platform still has considerable value. Some states, including California, have permanently allowed Medicare coverage for audio-only telehealth for some services, especially behavioral healthcare access.
“It is likely that these safety net clinics continued to deliver audio-only visits in high volume because of their role in improving access to health services,” Lori Uscher-Pines, lead author of the study and a senior policy researcher at the nonprofit research organization, said in a press release issued today. “Our study raises important questions about what kind of role we want audio-only visits playing in the care of disadvantaged populations and the public in general going forward.”
According to the study, which tracked the FQHCs' traffic over roughly two years, primary care visits increased by 8.5% from February 2020 to August 2022, while behavioral health visits jumped 23% during that same time. The proportion of audio-only visits, meanwhile, peaked during the height of the pandemic at 67% of primary care visits and 74% of behavioral care visits, and have since dropped back to 21% and 39%, respectively.
While telehealth use has declined in the wake of the pandemic as patients and providers return to in-person services, the platform still has considerable value in helping underserved populations access care and giving consumers more opportunities to connect with their care providers. Many health systems are looking to balance the two or create a hybrid approach to accessing care.
And while the argument over using a telephone or audio-only channel on a computer will continue, the RAND study indicates it's still a viable avenue for access for those who face barriers accessing care.
“It appears likely that audio only visits in these settings will remain widespread in coming years,” Uscher-Price said in the press release. “More research is needed on the effectiveness of audio-only visits to inform their use in safety net settings.”
The Medical University of South Carolina's chief innovation officer says innovation is part of the health system's culture, and something in which everyone takes part.
Jesse Goodwin sees innovation not as a technology issue, but as a mindset.
"Everyone in the organization has something that doesn't work ideally," she says. "We want them to use creative solutions to address those pain points. We're empowering them to take that next step and come up with innovative solutions."
Goodwin is the chief innovation officer at the Medical University of South Carolina (MUSC), helping to develop and guide innovation strategy for one of only two institutions in the country designated as a National Telehealth Center of Excellence. MUSC is an academic medical center, occupying that unique space between a stand-alone university and a health system, so her efforts and goals are both clinical and educational.
"Innovation is center to the MUSC enterprise," she says. "It's in our mission, vision, and values and the first goal of our strategic plan. Other health systems might play lip service to innovation, but we're all being charged here to be innovative."
"It's not a white-coat thing," she adds. "This is in our culture."
Goodwin, who was vice president of development for the Zucker Institute of Applied Neurosciences and director of the medical device practice of a Boston-based intellectual property consulting firm before taking on the CIO role at MUSC, knows a thing or two about technology. Her biography on the MUSC website notes that she's an engineer by training, and she designed a transcatheter aortic valve replacement device for her senior thesis in college.
Jesse Goodwin, chief innovation officer at the Medical University of South Carolina. Photo courtesy MUSC.
But while technology can, at times, be innovative, innovation isn't always about technology.
"Technology is often not the right route to take," she says. "We're not just looking for new apps [or devices]. We need to work harder to expand the definition."
Goodwin says she wants to separate innovation from technology so that people will think beyond just finding an app or tool to solve a problem. In doing so, she says, they'll take a closer look at workflows and other factors that either contribute to the problem or can be altered to solve it. They'll get a better feel of how innovation can lead to transformation.
"That brings more people into the conversation," she says.
That can also make an answer more complex. In her profile, Goodwin notes that research is a driving force in many healthcare advances, though not the only one. In an industry like healthcare, which is undergoing a transformation of its own to value-based care, the patient experience is taking on a much bigger role. Providers must pay more attention to the patients as a collaborator in healthcare and look at new ideas that include engagement and the use of data supplied from the patient.
Goodwin agrees that healthcare innovation took a leap forward during the pandemic, when healthcare organizations jumped at any opportunity to shift to virtual care, often taking leaps of faith with ideas and technology that would have taken years to plan out and prove. The pendulum is swinging back now, toward a better balance of virtual and in-person care, though the emphasis on consumer preference and opportunities to improve access to care and target social determinants of health remains.
"The opportunities [created by the pandemic] really did give us some new ideas," she says.
This includes new platforms for behavioral health treatment, a key pain point coming out of the pandemic, both in the number of people needing access to care and the shortage of providers offering it. Patient access to the health system's digital front door is also a popular topic, as is patient-friendly reporting (finding ways to integrate the patient voice and patient engagement with the medical record) and precision medicine.
A program of which Goodwin is especially proud is the STEM-Coaching and Resources for Entrepreneurial Women (STEM-CREW) program, established last year in a collaboration with the College of Charleston to boost the number of women entrepreneurs in the medical science field. The program is supported by the $2.4 million grant from the National Institute of General Medical Sciences.
"Studies have shown that women start companies with 50% less money and raise 66% less capital than their male counterparts," Goodwin said in a press release announcing the program's launch. "There are a lot of hypotheses as to why this divide exists, and it includes things like implicit bias as well as the willingness of women to seek funds within their own network of contacts. These are barriers to success for women who have already decided to pursue entrepreneurship. The CREW program hopes to address both through coaching, mentorship, and other programmatic support."
Goodwin says MUSC's culture of innovation will certainly help in this effort.
"Not surprisingly, there a big gender disparity at all stages of the process," she says, noting the MUSC was one of the first in the nation to track the gender representation. "But over the last four or five years, we've seen a strong culture of entrepreneurship taking off. This gives us a chance to flip the switch and really create some new opportunities."
That said, there are challenges. The sluggish economy is playing havoc with many healthcare organizations, forcing them to curb expenses and put their focus on workforce issues. Goodwin says the impact is felt everywhere, from nursing to the IT department. New ideas and platforms need to have a solid business case behind them, with a clear definition of value and a good ROI.
"It puts a lot of attention on the organization's efforts to support innovation," she says. "We don’t have the resources—or the access to resources—that we used to have."
And that's where transformation may be more important than technology. It forces creative minds to find ways to solve problems and improve operations and outcomes without sinking money into new technology.
"Innovation is central to the true MUSC enterprise, and it's never going to go away," Goodwin says. "We actually take it as a goal, just like we do with quality metrics."
HealthLeaders Innovation and Technology Editor Eric Wicklund talks to Geoffrey Boyce, co-founder and CEO of Array Behavioral Care, about the evolution and future of telehealth in the behavioral healthcare space and the impact of proposed DEA rules on the use of telemedicine to prescribe controlled substances.
The Dallas-based Parkland Center for Clinical Innovation saw great success with its Accountable Health Communities (AHC) program, thanks to the participation of community health workers (CHWs).
Community health workers (CHWs) were found to be one of the critical elements that supported the Parkland Center for Clinical Innovation’s (PCCI) successful five-year implementation of the US Centers for Medicare & Medicaid Services' Accountable Health Communities (AHC) model in Dallas County, Texas.
PCCI and its provider partners and community-based organizations supporting the Dallas AHC model offered innovative and highly effective new technologies and methods to help address health-related social needs (including food, housing, transportation, utilities, and interpersonal safety) of Medicare and Medicaid beneficiaries in Dallas County. But the glue to the entire process was the human touch delivered by CHWs who worked with the program participants every day through a process called 'navigation.'
The work itself was not unique to the program. CMS requires AHC awardees to screen and identify high-risk beneficiaries with health-related social needs (HRSNs) and provide them with active navigation services consisting of referrals to aligned CBOs, accompanied by monthly follow-up calls for up to 12 months or until the documented HRSNs are successfully addressed. CMS provided specific methods, goals, and even scripts for this work.
But what we didn’t count on was the impact of our CHWs in delivering compassionate support to those who were not expecting it but were incredibly grateful to receive it.
The Ideal Beneficiary Screening Setting
A key factor in a successful outreach program such as this is to have the 'Ideal Screening Setting.' When we began implementing the AHC program, we thought we could include screening for HRSNs in outpatient clinical site encounters. However, our CHWs and team realized that screening in outpatient clinic waiting areas was not ideal for the beneficiaries, who were waiting to see a physician or financial department advisor. In addition, because we did not have a private space for conducting the screening, there were concerns that others could hear the conversations with the CHWs. As a result, this process yielded a low rate of completed screenings, making it nearly impossible to meet our CMS navigation targets.
We decided to change our approach to conduct screenings in Emergency Departments. While this yielded a slight increase in the number of completed screenings, the numbers were still not sufficient to meet CMS targets. It's no secret that EDs are extremely busy, and CHWs wanted to be respectful of the clinical staff who had other, more pressing priorities. It was also difficult to get participation from individuals who were focused on more immediate health needs or in pain.
With these lessons learned, we shifted to a telephonic post-clinical-visit screening intervention. Our CHWs could screen beneficiaries through a phone call within five days of their inpatient, ER, or outpatient encounter. PCCI’s data scientists helped make this engagement possible by generating daily beneficiary eligibility call lists for the CHWs. The beneficiaries could communicate in the language of their choice, and could even request a call-back if they did not feel comfortable answering the screening questions at the time of the initial call. This process was the 'Ideal Screening Setting,' and it allowed PCCI to not only meet, but ultimately surpass, CMS navigation targets.
What Successful Outreach Looks Like
Once an eligible beneficiary completed the screening and interview, the CHW provided a list of referrals to CBOs best suited to meet the beneficiary’s needs (help with food, rent, or transportation). Referrals for each beneficiary were based on the CHW’s personal knowledge of available local resources.
The outreach didn’t end with one screening or referral. Following a two-week referral follow-up, the CHWs contacted the beneficiary monthly to determine if any additional referrals were needed, as well as to assess the status of the beneficiary’s experience with the resource list and referrals. If a beneficiary was unsuccessful with a specific CBO, the CHW offered additional guidance or a new referral. This proved beneficial, as beneficiaries often reported new needs not identified during the initial screening stage.
The CHWs had to overcome a number of obstacles, especially the pandemic. Many CBOs limited or changed their hours or even closed unexpectedly. Our CHWs found themselves driving by CBOs to check on their availability while updating the program’s network on the CBOs’ status. This speaks to the dedication and passion our team had in making sure the program participants were well cared for and received the most up-to-date and accurate information.
Additionally, with the help of PCCI’S data scientist, they were able to create a daily automated case management report that identified which beneficiaries needed to be prioritized in the CHW’s caseload and weekly workflow. This enabled CHWs on the team to maintain a caseload of about 200-250 beneficiaries at any one time. Because they were consistent with their monthly follow-ups, the CHWs developed a rapport with beneficiaries, making it easier to learn of concerns or additional needs.
Some of the most pressing concerns outside of CMS' five core HRSNs (food, housing, utilities, transportation, and interpersonal safety) are affordable child-care, baby supplies such as formula and diapers, and medical equipment. These additional needs are incorporated into our CBO directory.
The consistency of our outreach made it possible to conclude that it takes, on average, about 93 days or 4 telephone contacts to be able to resolve a need. During the pandemic we also noted that the CHW phone calls with beneficiaries were longer, especially for those who did not have any family or friends to count on or had to isolate because they were at high risk of infection. This truly speaks to the power of human impact and the willingness of the CHW team to go above and beyond for the beneficiaries they served.
Human Touch is Still the Best Human Service
The results of the program speak to its success in very meaningful ways. For example, the results showed that actively navigated individuals saw a greater decrease in ED visits than those in a comparable control cohort, and they also had a statistically significant reduction in average ED utilization, both while actively navigated and in the 12 months after navigation. They also demonstrated a greater likelihood to seek and keep scheduled outpatient visits compared with the control cohort. These results were included in our manuscript in NEJM Catalyst titled "The Dallas Accountable Health Community: Its Impact on Health-Related Social Needs, Care, and Costs."
These results offer our community greater cost savings and lead to a healthier community, especially for those who are considered the most at-risk. In addition, a survey of participants on their perspectives and experiences yielded these comments:
“It helped me out in so many ways with my first baby. As moms we think everything will be easy, but there was so much I didn’t know about that helped me.”
“It made a big difference for me both emotionally and with my physical needs like food and bills. To know Parkland cares about us means so much!”
“It was nice to hear that there was help. I didn't feel alone.”
A highlight from this survey is the value that participants placed on the connection with their CHWs, underscoring the importance of the human touch in improving the health and well-being of those most at-risk. For our team of CHWs, the positive data and cost savings are great, but their pride comes from knowing they have helped to provide meaningful compassion, care, and support to people who needed it the most.
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The Coalition for Health AI (CHAI) includes Stanford, the Mayo Clinic, Vanderbilt, Johns Hopkins, Google, and Microsoft, and is overseen by a number of federal agencies.
A group of healthcare organizations who have joined together to advance AI adoption has released a set of guidelines designed to help providers use the technology responsibly.
“Transparency and trust in AI tools that will be influencing medical decisions is absolutely paramount for patients and clinicians,” Brian Anderson, MD, a co-founder of the coalition and chief digital health physician at MITRE, said in a press release. “The CHAI Blueprint seeks to align health AI standards and reporting to enable patients and clinicians to better evaluate the algorithms that may be contributing to their care.”
The guidelines, which build upon the White House Office of Science and Technology Policy's (OSTP) Blueprint for an AI Bill of Rights and the AI Risk Management Framework (AI RMF 1.0) developed by the US Commerce Department's National Institute of Standards and Technology (NIST), come at a crucial time for the development of AI in healthcare. The technology has been praised as an exciting new tool and criticized as a dangerous trend.
"In a world with increasing adoption of artificial intelligence for healthcare, we need guidelines and guardrails to ensure ethical, unbiased, appropriate use of the technology," John Halamka, MD, MS, president of the Mayo Clinic Platform and a co-founder of the coalition, said in the press release. "Combating algorithmic bias cannot be done by any one organization, but rather by a diverse group. The blueprint will follow a patient-centered approach in collaboration with experienced federal agencies, academia, and industry."
Launched roughly one year ago, CHAI also includes Berkeley, Duke Health, UCSF, Vanderbilt University Medical Center, Change Healthcare, MITRE, and SAS and counts several federal organizations, including the Centers for Medicare & Medicaid Services (CMS), US Food & Drug Admi9nistration (FDA), and Office of the National Coordinator for Health IT (ONC) as observers.
The group is also collaborating with the National Academy of Medicine (NAM) on separate guidelines for the responsible development and adoption of AI in healthcare delivery.
“We have a rare window of opportunity in this early phase of AI development and deployment to act in harmony—honoring, reinforcing, and aligning our efforts nationwide to assure responsible AI," NAM Senior Advisor Laura Adams said in the press release. "The challenge is so formidable and the potential so unprecedented. Nothing less will do."
The Cleveland health system aims to offer the latest in cellular immunotherapies, including chimeric antigen receptor T-cell (CAR-T) and tumor-infiltrating lymphocytes (TIL) cancer therapies, to more patients.
MetroHealth has opened a new facility aimed at making the latest in innovative cancer treatments and therapies available to more patients, including those affected by social drivers of health (SDOH).
The Cleveland-based health system will be offering cellular immunotherapies, including chimeric antigen receptor T-cell (CAR-T) and tumor-infiltrating lymphocytes (TIL) cancer therapies, in its vector and cellular Good Manufacturing Practice (GMP) facility. Officials say they're the first safety-net hospital in the US to make these services available on-site.
“Overcoming social barriers for the communities we serve is part of MetroHealth’s core mission," William Tse, MD, MetroHealth's division director of hematology and oncology, said in a press release. "This new facility furthers that commitment by providing the next generation of cancer treatments to people in need, regardless of financial status.”
“It is crucial that we address social drivers of health for our community – the factors that matter beyond traditional medical care," added Airica Steed, EdD, RN, MBA, FACHE, the health system's president and CEO. "Whether the need is to access transportation for follow-up appointments, healthy food, or other support systems, MetroHealth is committed to changing the way patients receive care. The launch of our vector and cellular facility will match these holistic support offerings with next-generation treatments and clinical trials, providing our community the access they need to enable the best possible outcomes.”
Health system executives noted that CAR-T therapy, which uses T-cells modified in a laboratory to target specific cancer cells, is only accessible to patients of large academic centers or those with the financial means to travel to the health system. MetroHealth will be offering these treatments through its Institute for HOPE, which addresses population affected by SDOH.
The 1,300-square-foot facility will house the MetroHealth Cellular Immunotherapy and Stem Cell Transplantation Program, and was supported by the Cleveland Innovation District, a collaborative partnership that includes the city's five major medical and academic institutions, the state and JobsOhio.
“MetroHealth is different from most transplant hospitals in that we are able to develop and produce our cellular immunotherapies from A to Z in-house, speeding up delivery of innovative treatments, such as CAR-T therapy production, for both patient treatments and clinical trials," Tse said. "As a result, we are better able to address unmet patient needs and bring therapeutic innovations to our community and beyond.”
Allina Health is seeing immediate results with a technology platform that automates the OR scheduling process and helps match surgeons to times and procedures.
Editor's note: This article appears in the June 2023 edition of HealthLeaders magazine.
Experts have often said that the healthcare industry needs to adopt innovative technologies used by the banking and retail industries to become more effective.
At Allina Health, a platform being called the "Open Table for surgery scheduling" is proving that point.
The Minneapolis-based 12-hospital, 90+ clinic network is using an AI-enhanced software platform developed by digital health company Qventus to map out its operating room schedule. The technology integrates with the EHR and automates a block-based process that formerly took up hours of staff time and effort and caused a considerable amount of stress.
"The old process was manual and hadn't really changed in 20 to 30 years," says William Evans, the health system's vice president of surgical services and orthopedics. "It was inefficient, cumbersome, and laborious."
Evans says Allina Health recognized they would need new technology to both improve OR utilization and revenues and make life easier for stressed staff and surgeons. The old process, in which surgeons were responsible for filling up blocks of time and new or visiting surgeons tried to fit in enough procedures to qualify for block scheduling, left too many holes in the OR schedule and gave surgeons and schedulers headaches trying to map out when they could schedule a surgery or grab procedures in need of a surgeon.
Allina Health decided to implement an enterprise-wide, automated scheduling platform, which works along the same lines as a scheduling platform for tables at a restaurant or seats at a theater.
"Allina Health tends to be on the forward edge of [healthcare innovation]," Evans says. "I think we're always finding new ways to use technology. This just seemed like a perfect place."
In a phased roll-out, the health system partnered with Qventus, based in Mountain View, California, to launch the platform for its DaVinci surgical robots at Abbott Northwestern, then expanded the process to include established surgeons who qualify for block scheduling, then to newer and visiting surgeons who hadn't yet qualified for block scheduling. Surgeons are responsible for scheduling their own procedures, he says, and often struggle to balance their time, running the risk of losing out on prime slots in the OR if they can't stay true to their schedule at least 75% of the time.
Evans says it was important to offer this tool on a voluntary basis, rather than mandating that surgeons use it.
"We want them to embrace the technology because it makes their lives better, rather than forcing it on them as a mandate," he says. "Once they see what it can do (including taking only 20 minutes from submitting a request for OR time to approval), they'll accept it and work with it."
According to statistics supplied by the health system and Qventus, Allina Health, which deployed the new platform in mid-2022, saw 3.5 cases added per OR per month in the first four months, including a 36% increase in cases per surgical robot per month. Evans says that success has enabled Allina Health to not only increase robotic surgeries but also add more robots.
On the other side of the ledger, the platform helped to release more than 100 hours of OR block time earlier each month, enabling surgeons to better manage their schedules and allowing the health system to quickly fill up open spots and times left open due to scheduling errors or unforeseen issues. In addition, the platform automatically schedules 2 out of every 3 elective cases, helping to improve a key revenue generator.
According to Evans, the AI technology not only helps surgeons manage their time, but also matches open slots to surgeons based on their typical use patterns and the health system's needs. It also matches surgeons to available surgeries based on their qualifications.
Evans says the health system saw almost immediate benefits with the platform, with surgeons looking to use the technology to plan their schedules during the first phase of roll-out, which was supposed to be limited to robotic surgeries.
"We quickly exceeded our performance goals," he says, noting the platform significantly reduced the workload for schedulers and allowed them to address other administrative tasks that may have been pushed to the back-burner. The health system also saw a reduction in surgeon and staff turnover, he says, and might be used as an incentive to attract new employees.
"There will be some unexpected benefits that we haven't seen yet," he says. "This frees up a lot of time for surgeons and staff and makes their lives better. That's a huge advantage. Automation was the missing piece of the puzzle there."
In this week's episode, HealthLeaders editor Melanie Blackman is joined by Ronda Lehman, PharmD, market president of Mercy Health's Lima Market in Ohio. During the conversation, Ronda shares insights into her career journey, which started in 1995 in one of the system's hospital's pharmacy departments, the initiatives she's excited to lead in the coming months, and shares advice for aspiring healthcare leaders.
Several groups have issued critical reviews of the DEA's proposed revision of rules regarding telemedicine prescriptions of controlled substances. Some say the revision will imperil thousands of patients.
Telehealth and digital health advocates aren't pleased with the US Drug Enforcement Agency's proposed rules for prescribing controlled substances via telemedicine after the expiration of the COVID-19 Public Health Emergency.
The long-awaited proposal, unveiled in February, had been expected to ease the pathway for healthcare providers to use telemedicine to prescribe medications like buprenorphine without needing an in-person examination. But with the agency's 30-day window for public comments expiring, the vast majority of the 20,000+ comments submitted have been negative.
"Leading professional associations, respected think tanks, and experienced clinicians submitted compelling and noteworthy comment letters explaining how the proposed rule will result in limitations on access to care, harm patients in rural and urban areas alike, and likely result in otherwise avoidable overdoses and deaths when patients are denied access to their medically-important medications," several lawyers from Foley & Lardner wrote in the firm's Health Care Law Today blog.
Nathaniel Lacktman, a partner in the firm and chair of its national Telemedicine & Digital Health Industry Team, was among the earliest commenters on the proposed rules.
"The proposed rules are intended to bridge between the DEA’s current PHE waivers and a post-PHE environment," he wrote in a February 27 blog. "In so doing, DEA proposed creating two new limited options for telemedicine prescribing of controlled substances without a prior in-person exam. The options [are] both complex and more restrictive than what has been allowed for the past three years under the PHE waivers. The DEA’s proposal will discontinue the ability for telemedicine prescribing of controlled substances where the patient never has any in-person exam (with the exception of an initial prescription period of no more than 30 days’ supply). Moreover, if the patient requires a Schedule II medication or a Schedule III-V narcotic medication (with the sole exception of buprenorphine for opioid use disorder (OUD) treatment), an initial in-person exam is required before any prescription can be issued."
Lacktman and his colleagues produced a legal guidebook shortly after the proposed rules were unveiled, and submitted a 15-page letter picking apart various aspects of the rules on March 30. Others submitting critical comments (the Foley & Lardner team called it a "tsunami of criticism") include the American Telemedicine Association, the Alliance for Connected Care, and a group composed of members of the Brookings Institution, Harvard Medical School, David Geffen School of Medicine at UCLA, and Harvard T.H. Chan School of Public Health.
Krista Drobac, executive director of the Alliance for Connected Care, said the proposed DEA rules would lead to "immense patient harm," particularly to patients seeking treatment for behavioral health issues. According to the alliance, 65% of all patients living with a substance abuse disorder or overdose diagnosis in 2021 also had a pre-existing mental health condition.
"DEA must find a path to allow the continuation of comprehensive mental health (and substance use disorder--which is often overlapping) treatment to patients through telehealth," she wrote. "While we believe there are many appropriate use-cases for telehealth involving controlled substances, such as palliative care, the vast majority of patients who would be harmed by the rule are relying on telehealth for access to mental healthcare."
The FDA's proposed rules would allow providers to use telemedicine to prescribe 30-day supplies of Schedule III-V non-narcotic controlled medicationsand buprenorphine, the latter specifically for the treatment of opioid abuse disorder, for new patients and without the need for an in-person evaluation. They redefine guidelines that had originally been included in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which 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 DEA.
Dozens of federal and state waivers were enacted during the COVID-19 PHE to improve access to and coverage of telehealth services. Many of those waivers were extended to the end of 2024 by Congress, but others—including the DEA waiver on using telemedicine without an in-person visit—will end with the PHE on May 11.
With that deadline looming, the DEA proposed to amend its rules to allow for more telemedicine use. The response was anything but positive.
While many complained that the 30-day comment period was too short, commenters like Foley & Lardner cited several issues with the proposed rules. Foley & Lardner Partner Nathan Beaver, the author of the letter to the DEA, listed 14 changes that the firm feels should be made, including removing requirements for an in-person exam, creating a special registration process for telemedicine providers as directed by the Ryan Haight Act, grandfathering patients being treated via telemedicine during the PHE, and revising the rules to allow providers to refer patients to medical groups, health systems, and other collaborating practices.
"We believe the proposed rules as written will limit access to legitimate healthcare while not promoting the public health and safety goals of DEA," Beaver wrote. "In this comment letter, we provide reasonable suggestions and solutions that will allow DEA to appropriately address diversion concerns while safeguarding patient access to essential telemedicine services including for the treatment of mental health and substance use disorder."
