| Awaiting DEA Telemedicine Rules as Studies Highlight Telehealth’s Role in Treating Opioid Use Disorder |
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The healthcare community is anxiously awaiting the release of new Drug Enforcement Administration (DEA) regulations for prescribing controlled substances via telemedicine, with time running out before the expiration of pandemic-era flexibilities at the end of 2024. Due to leaks from earlier this year, new regulations are expected to introduce more stringent restrictions (in comparison to the pandemic era flexibilities), including limits on virtual prescribing and mandatory state prescription drug monitoring checks, raising concerns about access to treatment, especially in the context of opioid use disorder (OUD). Last year, the DEA released their first attempt at a post-pandemic telemedicine prescribing controlled substance rule, prompting massive public feedback and forcing them to delay release of a revised rule until now. Since then, the DEA has conducted listening sessions to better understand stakeholder concerns, aiming to develop a rule that better accommodates the diverse needs of all parties involved. However, according to reports, the newly developed (yet to be proposed) rules may also be limiting, with speculation that it could limit providers to issuing no more than half of their prescriptions virtually, and require extensive checks through state prescription drug monitoring programs—posing challenges for telehealth providers, according to a recent Politico article [subscription required].
A recent Axios article points out that at the heart of the issue is balancing the need to maintain access to critical medications, such as those used for treating opioid use disorder and mental health conditions, while minimizing the risk of substances being misused. Testosterone, classified as a Schedule III controlled substance, is among the drugs subject to scrutiny due to its potential for abuse. Over 330 organizations, including prominent health systems and medical associations, wrote a letter to Congress in early September asking for another two-year extension of the pandemic-era policies, arguing that the existing guardrails and remote monitoring technologies can ensure responsible prescribing without compromising access to care. This issue comes to a head as the DEA has recently taken legal action against executives of the telehealth startup Done Health, accusing them of illegitimately prescribing controlled substances, further fueling the debate over how to regulate telemedicine. However, many doctors argue that clinicians should retain discretion over when in-person visits are necessary, especially when existing regulations already ensure responsible use of telehealth.
Concern about the impact of such a rule is mounting, especially in light of recent studies emphasizing the critical role telehealth has played in expanding access to care for patients struggling with OUD, making the pending regulations particularly significant. A recent study published in the Harm Reduction Journal highlights how telehealth has helped mitigate stigma and expanded access to treatment for OUD patients. Patients receiving telehealth-based care reported that virtual appointments reduced their exposure to stigma associated with in-person visits for addiction treatment, particularly in rural areas where access to care is limited. Additionally, other studies, as highlighted in a recent article by The Hill, show that telehealth allowed patients to start and maintain buprenorphine treatment—an essential medication for reducing cravings and preventing opioid overdoses—without increasing overdose risks. Telehealth has proven especially effective for underserved populations, including those with housing instability or transportation barriers. The impending DEA regulations could severely restrict these telehealth benefits, creating new challenges for patients who rely on virtual care. Experts and policymakers, including Senator Mark Warner, have expressed concerns that these rules could jeopardize access to life-saving treatments for some of the most vulnerable patients. Stay tuned to CCHP newsletters for updates on this issue as they transpire. |
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FDA Releases Final Guidance on Decentralized Clinical Trials, Highlighting Telehealth Components |
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The U.S. Food and Drug Administration (FDA) has published a guidance, which finalizes draft guidance made in May 2023, titled “Conducting Clinical Trials With Decentralized Elements,” which provides key recommendations for the integration of decentralized elements into clinical trials for drugs, biological products, and medical devices. This guidance comes at a pivotal time when the healthcare industry is increasingly adopting telehealth and other digital health technologies to enhance trial accessibility and participant convenience. Decentralized clinical trials (DCTs) incorporate trial-related activities that can take place remotely, often using telehealth visits and other virtual tools, allowing participants to engage in clinical research without the need to travel to central trial sites. This approach is particularly beneficial for participants who have limited mobility or face other logistical challenges. Some key decentralized elements covered by the guidance include:
- DCT design, conduct, and oversight;
- conduct of remote clinical trial visits and activities including the use of local healthcare providers (HCPs);
- use of digital health technologies in DCTs;
- the roles of sponsors and investigators in DCTs;
- informed consent and institutional review board oversight of DCTs;
- types of investigational products appropriate for study in DCTs;
- packaging and shipping of investigational products in DCTs;
- processes and procedures to ensure participant safety; and
- use of software in DCTs.
While the guidance is final, the FDA is accepting comments from the public and stakeholders. Those interested in learning more or providing feedback, can visit the FDA DCT guidance for different ways to provide comments. |
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NIHCM Highlights the Role of AI in Transforming Health Care
In a recent newsletter, the National Institute for Health Care Management (NIHCM) explored the expanding role of artificial intelligence (AI) in health care, emphasizing its potential to transform patient care. AI adoption is growing rapidly, with medical scribe technology increasingly being used to assist doctors with administrative tasks. Many health care leaders are optimistic about AI, considering it one of the most exciting emerging technologies in the industry. A recent survey featured in the NIHCM newsletter revealed that most Americans are comfortable with AI in health care, with 75% believing it can reduce human error and 70% feeling comfortable with AI taking notes during an appointment.
The NIHCM newsletter also examined the issue of health equity, pointing out how AI could help address disparities by reducing human biases. However, an investigative series by STAT raised concerns about the continued use of race-based algorithms, which can contribute to underdiagnosis and harm Black patients. Despite these challenges, there is hope that AI, with proper oversight and regulation, can improve health care delivery, particularly for underserved populations. NIHCM continues to focus on this evolving landscape, offering webinars and resources to educate stakeholders on AI’s potential in health care. To learn more, see NIHCM’s newsletter, and review their list of resources and initiatives related to AI. |
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Latest Policy Developments in CCHP’s Telehealth Policy Finder and Policy Trends Map
CCHP’s Telehealth Policy Finder look-up tool and Policy Trend Maps were updated throughout the past month based on the latest information from our ongoing state telehealth policy tracking. The latest states to be updated include Michigan, Missouri, Pennsylvania, Texas and Virgin Islands.
Over the past month, multiple states made changes to their telehealth policies in an array of policy areas, including their Medicaid programs, professional regulations, and cross-state licensing. Highlighted changes from this group of states include:
- MICHIGAN: Passed HB 4579 which amended the state’s telehealth private payer law to specify that an insurer shall not require face-to-face contact between a health care professional and a patient for services appropriately provided through telemedicine, as determined by the insurer. It clarifies that telemedicine services must be provided by a health care professional who is licensed, registered, or otherwise authorized to engage in his or her health care profession in the state where the patient is located. The law now further requires that if a service is provided through telemedicine, the insurer shall provide at least the same coverage for that service as if the service involved face-to-face contact between the health care professional and the patient. Telemedicine is defined to encompass electronic media that links patients with health care professionals in different locations. To be considered telemedicine under this section, the health care professional must be able to examine the patient via a health insurance portability and accountability act (HIPAA) compliant, secure interactive audio or video, or both, telecommunications system, or through the use of store and forward online messaging.
- MISSOURI: Missouri Medicaid updated their guidance for Behavioral Health Integration Services. It now allows for reimbursement of interprofessional consultations (including for psychiatrists and advance practice psychiatric nurses) as long as certain requirements are met. For example, the interprofessional consultation must be for the direct benefit of the participant, the treating/requesting physician and the consultant must both be enrolled in Missouri Healthnet Division (MHD) and the consultant should not have seen the patient in a face to face (or telehealth) encounter within the last 14 days. Missouri Medicaid also issued an update in August announcing that they will expand continuous glucose monitors to participants currently diagnosed with Gestational Diabetes.
- PENNSYLVANIA: Passed a new law that requires a health insurance policy to provide coverage for medically necessary health care services provided through telemedicine and delivered by a participating network provider who provides a covered health care service through telemedicine consistent with the insurer’s medical policies. A health insurance policy may not exclude a health care service from coverage solely because the health care service is provided through telemedicine. The insurer must pay or reimburse a participating network provider for covered health care services delivered through telemedicine in accordance with the terms and conditions of the contract as negotiated between the insurer and the participating network provider. Payment or reimbursement may not be conditioned upon the use of an exclusive or proprietary telemedicine technology or vendor.
- TEXAS: TX Medicaid updated their telemonitoring benefit, effective September 1, 2024. Specifically, TX Medicaid guidelines now indicate that in addition to physicians, providers who may request home telemonitoring and sign prior authorization forms will include nurse practitioners, clinical nurse specialists, and physician assistants. Additionally, it requires home telemonitoring providers to establish a plan of care with outcome measures based on the physician’s or requesting provider’s order for each client. FQHC and RHC providers may also be reimbursed separately for the provision of home telemonitoring services if the services follow all requirements and guidelines. The update also made modifications to prior authorization requirements for clients of any age who have diabetes or hypertension. See the telemonitoring update for more details on the requirements.
Given the nuanced and varied approaches states are taking with their telehealth policies, please reference CCHP’s telehealth Policy Finder to link to additional details and access each states’ policies in their entirety. |
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HHS Provides Telehealth Resources for Substance Use Disorder and Behavioral Health
The U.S. Department of Health and Human Services (HHS) offers a wide range of telehealth resources aimed at improving access to care for individuals with substance use disorder (SUD) and behavioral health needs. These tools are designed to help both patients and providers navigate telehealth solutions for better care delivery. Some key resources include:
- Guide to Telehealth for Substance Use Disorder (SUD) for Providers - Aimed at healthcare providers, this guide offers best practices for using telehealth to support patients with SUD. It includes strategies for implementing virtual care effectively and outlines key considerations for prescribing medications remotely.
- How Can I Use Telehealth for Substance Use Disorder? - This resource provides practical information for patients on how to access telehealth services for SUD treatment. It explains how telehealth can help connect patients to treatment programs and medications remotely, making it easier to manage recovery. Examples of the questions it answers include:
- What is telehealth for substance use disorder?
- What are the benefits of using telehealth?
- How can telehealth services support people with a substance use disorder?
- What types of providers can I see using telehealth?
- How do I prepare for a telehealth appointment?
- Using Technology to Increase Behavioral Health Support for New Parents - This resource shares community stories highlighting how technology and telehealth can be leveraged to support the mental and behavioral health of new parents, providing an innovative approach to extending care to those in need.
These HHS resources are part of an ongoing effort to expand access to essential telehealth services, offering support to those managing substance use disorders and behavioral health challenges across the country. Examples of additional topics available include home-based, hybrid health care in rural communities, virtual case management services for people with HIV, and expanding access to telehealth on an island. To explore the complete set of resources, visit HHS’ telehealth website. |
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What’s New at CCHP this Month?
CCHP is continually working to create helpful informational content to keep those interested in telehealth and related policies up to date via our policy finder, informational factsheets, webinars, reports and email blasts. As you may already be aware, CCHP regularly distributes a single topic specific email every Tuesday titled “Telehealth Tuesdays”. If you are not yet on our distribution list to receive these emails, and would like to be added, you can do so by registering on the CCHP website.
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Quick links to recently curated and featured insightful topics in our Telehealth Tuesday email blasts:
OCTOBER 1, 2024: New Health Affairs Study Examines which Providers are Utilizing Telehealth the Most covering a Health Affairs study where researchers found that female physicians, primary care physicians (PCP), psychiatrists and physicians in nonrural practices use telehealth more and will likely be most impacted by changes to the current telehealth policy environment for Medicare.
SEPTEMBER 24, 2024: Telehealth Waiver Bill Moves Forward covering the mark up and passage out of the House Energy and Commerce Committee of HR 7623, the Telehealth Modernization Act of 2024. The most significant part of HR 7623 that readers may be interested in is that it extends the Medicare telehealth waivers an additional two years.
SEPTEMBER 17, 2024: HHS Resources Highlight Telehealth Access for Older Adults covering a recent bulletin from the Health Resources and Services Administration (HRSA) Office for the Advancement of Telehealth (OAT) highlighting helpful resources for older adults using telehealth in recognition of September being Healthy Aging Month. Developed by the Department of Health and Human Services (HHS), the resources include a best practice guide addressing telehealth accessibility for older patients, as well as a website focusing on telehealth considerations for older adults.
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In addition to our featured topics in CCHP’s Telehealth Tuesday emails we have also released the following valuable resources:
- CCHP conducted a webinar on October 3, 2024, which is now available for viewing, covering two pivotal cases—MacDonald et al v. Sabando (New Jersey, December 2023) and McBride et al v. Hawkins (California, May 2024)—that challenge the constitutionality of requiring providers licensed in one state to obtain a separate license for telehealth interactions with patients in another state. The session explored the impact of existing licensure laws, the potential implications if these cases succeed, and the broader consequences for telehealth regulations.
- Last month, CCHP released its 2024 Medicare Fee-for-Service Billing Guide, updated to reflect recent telehealth policy changes from the Centers for Medicare and Medicaid Services (CMS). This edition focuses on billing under the temporarily extended Medicare telehealth policies, with notes on permanent policies where they differ. The guide has been reorganized for easier navigation and includes billing examples to help clarify both simple and complex scenarios.
Also, join the California Telehealth Policy Coalition, which is convened by CCHP, for our annual legislative briefing on October 10, 2024 to review policy developments over the last year and discuss remaining gaps and opportunities for advancing access to telehealth in California. During this briefing, a panel of experts and stakeholders will discuss topics including asynchronous telehealth policies, licensure, broadband and artificial intelligence (AI). |
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California Telehealth Policy Coalition 2024 Legislative Briefing: Telehealth Developments and Opportunities
THURSDAY, OCTOBER 10, 2024 | 1:00 PM - 2:30 PM PT
SPEAKERS WILL INCLUDE:
- Paul Glassman, DDS, Professor and Associate Dean for Research and Community Engagement, California Northstate University
- Mike Kurliand, Vice President of Clinical Quality and Integration, MedWand
- Shirley Lam, Assistant Director of Policy, Insure the Uninsured Project
- Lisa Matsubara, General Counsel & Vice President of Policy, Planned Parenthood Affiliates of California
- Natalie Pita, Office of California Assemblymember Mia Bonta
This webinar is free and open to the public.
REGISTER HERE
The California Telehealth Policy Coalition is made up of over 170 statewide and national organizations and individuals interested in advancing telehealth policy in the state of California. The Center for Connected Health Policy founded, and acts as, the convener for, the Coalition. THANK YOU TO OUR SPONSORS:   |
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FEDERAL LEGISLATION
Telehealth Modernization Act of 2024
HR 7623 (Rep. Carter R-GA) - Extends the Medicare telehealth waivers an additional two years (until December 31, 2026). The permanent telehealth Medicare policies this will impact include continuing to allow telehealth to take place regardless of location (both geographic and type of site); allowing the larger list of providers to continue to be eligible to provide services via telehealth and be reimbursed by Medicare, including federally qualified health centers (FQHCs) and rural health clinics (RHCs), occupational and physical therapists, and continuing coverage of audio-only services. The prior in-person visit requirements for mental health visits that do not meet the geographic requirement or exceptions to it will also continue to be delayed. The bill will also require modifiers to be used in certain instances when services are delivered via telehealth. The Acute Hospital Care at Home waiver flexibilities will also be extended but for an additional five years, ending in 2029. See the complete bill text for more information. (Status: 9/18/24 – Ordered to be Reported (Amended) by the Yeas and Nays: 41 - 0. Action By: Committee on Energy and Commerce)
Health Equity and Accountability Act of 2024
HR 9161 (Rep. Lee D-CA)/S 4773 (Sen. Hirono D-HI) - Requires HHS to encourage and facilitate the adoption of provisions allowing for multistate practitioner practice cross state lines. It also requires Medicaid coverage of dental and oral health services for adults, defines telehealth for alternative dental health care providers and specifies that services can be provided via telehealth in the demonstration program. The bill also requires a GAO Report on state Medicaid programs use of telehealth to increase access to maternity care and for HHS to issue and disseminate guidance to states to clarify strategies to overcome existing barriers and increase access to telehealth under the Medicaid program, and establishes Telehealth and Rural Access Pilot Projects under the Secretary of Veterans Affairs in cooperation with the Secretary of Defense. Finally, the bill would eliminate the rural geographic requirement and expand eligible originating sites for telehealth in Medicare. (Status: HR 9161 - 9/17/24 – Referred to the Subcommittee on Health under the House Committee on Veterans’ Affairs/S 4773 – 7/25/24 - Read twice and referred to the Senate Committee on Finance)
Right to IVF
S 4445 (Sen. Duckworth D-IL) – Stipulates that an individual has a statutory right under this title, without prohibition, limitation, interference, or impediment, to the extent that such prohibition, limitation, interference, or impediment in any way or degree obstructs, delays, or affects commerce over which the Federal Government has jurisdiction to receive fertility treatment from a health care provider. This would include limits on a health care provider’s ability to provide, or a patient’s ability to receive, fertility treatment via telemedicine, in accordance with widely accepted and evidence-based medical standards of care among other policies. (Status: 9/17/24 – Upon reconsideration, cloture on the motion to proceed to the measure not invoked in Senate by Yea-Nay Vote. 51 - 44)
Protections for Individuals with respect to Algorithms [Official title not yet available.]
S 5152 (Sen. Markey D-MA) - Establishes protections for individual rights with respect to computational algorithms, and for other purposes. [Based on bill description. Full text not yet available.] (Status: 9/24/24 – Read twice and referred to the Committee on Commerce, Science, and Transportation)
Strengthening Security Standards for Health Information [Official title not yet available.]
S 5218 (Sen. Wyden D-OR) - Amend titles XI and XVIII of the Social Security Act to strengthen, increase oversight of, and compliance with, security standards for health information, and for other purposes. [Based on bill description. Full text not yet available.] (Status: 9/25/24 – Read twice and referred to the Committee on Finance)
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STATE LEGISLATION
ALASKA
SB 91 – Allows a member of a physician's multidisciplinary care team to provide a health care service through telehealth to a patient located in Alaska if the health care service, as provided by the multidisciplinary care team, is not reasonably available within Alaska. The privilege to practice under the section extends only to certain situations, such as follow up care provided by a physician part of the multidisciplinary care team regarding a suspected or diagnosed life-threatening condition. (Status: 10/9/24 – Will become law without Governor’s signature)
DELAWARE
SB 331 – Provides that out-of-state practitioners who wish to prescribe controlled substances in Delaware pursuant to a practice privilege, interstate compact license, telehealth registration, or military registration, must obtain a Delaware controlled substance registration. This Act will ensure that these out-of-state practitioners are subject to Delaware regulation with respect to prescribing controlled substances to Delaware patients. (Status: 8/29/24 – Signed by Governor)
DISTRICT OF COLUMBIA
B 25-0287 – Authorizes the Mayor to execute the Counseling Compact in the District of Columbia for the purpose of increasing access to licensed professional counseling, establish requirements for states to conduct and report adverse actions and the consequences for licensed professional counselors receiving adverse action, among other provisions. (Status: 9/17/24 – First reading)
MISSOURI
HB 2824 – Modifies the definition of telehealth or telemedicine to include audio visual and audio-only technologies. It also specifies that health care providers shall not be limited in their choice of electronic platforms used to deliver telehealth or telemedicine, provided that all services delivered are in accordance with HIPAA. (Status: 5/16/24 – Dropped from Calendar - Pursuant to House Rules)
NEW HAMPSHIRE
HB 1571 – Requires insurers and Medicaid provide coverage of equipment used for continuous and traditional blood glucose monitors and the necessary supplies for any person with diabetes. (Status: 9/19/24 – In a Subcommittee Work Session on 9/24/24)
NEW JERSEY
S 2988 – Extends the requirement that heath benefit plans in New Jersey provide coverage and payment for health care services delivered to a person through telemedicine or telehealth at a provider reimbursement rate that equals the provider reimbursement rate that is applicable when the services are delivered through in person contact and consultation, to Dec. 31, 2025 (it is currently set to expire December 31, 2024). (Status: 9/19/24 – Transferred to Senate Health, Human Services and Senior Citizens Committee) |
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