With the onset of COVID-19, monumental changes in healthcare ensued across the industry and within telehealth, specifically in telehealth delivery. In response to the declared national and state-level states of emergency declared, regulatory bodies provided relief for providers in many forms, in part by suspending existing constraints on telehealth practice, patient information privacy enforcement, and provider licensing requirements.
These changes provided much relief to healthcare providers adapting to the chaotic COVID-19 environment; however, as states of emergency are lifted across the United States, states are determining whether to make these practice modifications permanent or to roll them back to pre-COVID-19 operations. In states now accustomed to operating under these often-favorable changes, such rollbacks may be detrimental; thus many states have determined to keep beneficial aspects of these changes, which often brought meaningful updates to telehealth practice. This article examines some of the changes across the United States — what is changing, what will remain, and how these decisions affect practitioners on a state-by-state basis.
Regulatory and Legal Actions Taken to Facilitate Telehealth Use in Response to the COVID-19 State of Emergency Declarations
President Trump’s declaration of COVID-19 as a national emergency1 cultivated the perfect environment for explosive telehealth growth, as state lockdowns and social distancing requirements necessitated alternative treatment methods. In support, Congress enacted legislation to expand telehealth, treat patients in isolation, and equip the healthcare workforce with tools to promote socially-distanced care.2 These telehealth benefits extended to rural healthcare providers; on March 6, 2020, Congress passed a house bill to remove the rural and site limitations related to Medicare reimbursement for telehealth coverage,3 allowing the provision of telehealth services regardless of the Medicare enrollee’s geographical location or type of site (opening up the home as a potential originating site). Furthermore, the Department of Health and Human Services (HHS) and, consequently, many private insurance companies waived cost-sharing requirements for service receipt, increasing telehealth appeal among patients.4 However, these changes were only the beginning, with many more implemented at the federal and state level.
Medicare and Medicaid Changes
The Centers for Medicare & Medicaid Services (CMS) and HHS’ Office of Inspector General (OIG) promulgated significant changes intended to facilitate telehealth care by removing barriers to telehealth technology use, including removing restrictions on telehealth use in certain hospital and clinical settings; expanding the list of modalities, clinical services available, and providers able to bill for telehealth;5 requiring full telehealth payment parity; waiving certain face-to-face visit and hands-on care requirements;6 and removing frequency limitations on telehealth visits.7
Cross-State Medical Practice, Reimbursement, and Provider Licensing
Due to COVID-19, Medicare expanded the list of services billable under telehealth as well as the modalities by which telehealth could be provided;8 additionally, it allowed for cross-state services.9 CMS also designated Federally Qualified Health Centers and Rural Health Clinics as eligible telehealth providers,10 and stated that telehealth services were to be reimbursed at the same rate as in-person visits.
In response to federal actions, states quickly followed suit in removing restrictions on telehealth, with 47 states waiving in-state licensure requirements for telehealth practice.11 States also facilitated provider enrollment in state healthcare programs through Medicaid waivers, and private payors began to implement telehealth parity, ensuring telehealth services received reimbursement at the same rate as in-person visits.12
HIPAA Discretionary Enforcement
During the pandemic, the Office for Civil Rights (OCR) issued a notice stating that, with some exceptions,13 OCR would exercise its enforcement discretion not to penalize organizations or individuals for Health Insurance Portability and Accountability Act (HIPAA) violations related to the good faith provision of telehealth services over non-public-facing, end-to-end encrypted technologies such as Zoom or Skype, assuming providers still continued to take basic precautions to protect patient privacy.14
In response to the growing need for purely telehealth services, the Drug Enforcement Administration (DEA) permitted providers to prescribe controlled substances (except buprenorphine for maintenance or detoxification treatment)15 without an in-person visit16 by allowing for a patient evaluation through a real-time, two-way, audio-visual communications device.17
To allow providers to more freely test new products or devices that could potentially combat COVID-19 but which had not yet been approved by the Food and Drug Administration, HHS expanded liability immunity18 to a number of individuals and entities, including those that manufacture, distribute, administer, prescribe, or use “Covered Countermeasures”19 — approved efforts, products, or devices to be utilized in the efforts to combat COVID-19.20
Stark and Anti-Kickback Changes
Although commercial reasonableness and fair market value rules still applied to telehealth consults, the OIG elected to waive enforcement of certain aspects of Stark and Anti-Kickback regulatory requirements to enable more effective remote care options for providers. Some of the newly-waived requirements allowed for property or equipment rental to providers above or below fair market value, a broader scope of rental arrangements available for treating COVID-19 patients, and the provision of telehealth services and equipment to physicians at below-fair-market-value rates.21 Further, the OIG opted to exercise its enforcement discretion under the Anti-Kickback Statute not to pursue administrative sanctions for certain actions that are normally prohibited.22
What is Changing, and What Will Remain the Same
As the COVID-19 pandemic continued and changed, states began to either allow their telehealth waivers and suspended regulatory restrictions to expire, or began to implement these beneficial changes permanently. Though these changes may simply appear to be a return to the status quo, the implications are much bigger, since many states have grown accustomed to practicing under these new leniencies. Further, as some states continue to implement these changes on a more permanent basis while others return to pre-COVID-19 practices, the tension between these states is heightened as practice operations and regulatory structures grow increasingly diverse.
Changes at the Federal Level Becoming Permanent
Following the pandemic, CMS has opted to ensure the continuance of a number of positive changes to telehealth operations and policies. CMS expanded the list of services permanently available to patients via telehealth, including group psychotherapy, cognitive assessment and care planning, psychological and neuropsychological testing, and domiciliary, rest home, or custodial care services for certain patients.23 Although relatively few of the numerous changes to telehealth practice have been made permanent with certainty, CMS continues to evaluate potential changes, and has also extended a number of telehealth practice leniencies through the end of December 2021.24
States Returning to Pre-COVID-19 Status
Currently, 29 states have rescinded their states of emergency and/or their associated telehealth waivers or have allowed them to expire. Among those states were Alabama,25 Alaska,26 Connecticut, Florida,27 Maryland,28 Massachusetts,29 Michigan,30 Minnesota,31 Montana,32 Nebraska,33 New Jersey,34 North Dakota,35 Oklahoma,36 Oregon,37 Rhode Island,38 South Carolina,39 South Dakota,40 Virginia,41 and Wisconsin.42 Mississippi43 is scheduled to lift its declaration of public health emergency soon and has not yet indicated intent to renew.
Typically, when a state’s waivers are rescinded, this means that the practitioners who began practicing in the state via telemedicine during the state of emergency now must apply for full licensure in the state. However, some states, such as Alaska, have begun to address this issue by allowing for extended provisional licensing to practice in the state, even after the state of emergency has been lifted.44 Some states have simply extended provisional licensure for a defined, or even indefinite, time period; others have taken advantage of the pandemic situation to make these changes permanent. One such state is Arizona, which signed HB 2454 on June 5, 2021, allowing for practitioners in other states to practice telemedicine in Arizona following a simple application to practice.45 Ideally, the United States will continue to see such changes extending, at minimum, provisional licensure for providers that facilitates cross-state telehealth practice and ensures continuity of care for patients post-pandemic.
States Incorporating Telehealth Waiver Changes Moving Forward
There are a number of states that have opted to include changes from their waiver programs into their prospective telehealth programs. For example:
● Arizona permanently incorporated much of its telehealth waivers into law through H.B. 2454;46
● Colorado passed SB 20-212, which expands access to telehealth;47
● Delaware48 and Hawaii49 have both passed legislation permitting patients to attend initial physicians’ appointments via telehealth (rather than requiring in-person visits);
● Idaho’s governor issued an executive order making the COVID-19 telehealth expansion provisions permanent;50
● Nebraska,51 New York,52 and Oklahoma53 have expressly permitted audio-only telehealth;
● New Hampshire established phone-based telehealth care and payment parity;54 and
● West Virginia passed a law allowing physicians to become interstate telehealth practitioners.55
The most commonly-made changes tend to be those defining what telehealth use looks like. For example, a number of states have begun to update their telehealth laws by simply including audio-only, asynchronous, or remote patient monitoring interactions in the definition of telehealth. Another accepted change is state medical boards permitting the cross-state licensure of providers for telehealth services. This second issue is vital for states to continue to address, as cross-state licensure remains one of the biggest barriers to efficient, effective telehealth practice — particularly in areas of provider shortages.
States Continuing Declarations of Public Health Emergencies and/or Waivers
While many states have opted to end their declared public health emergencies, a number of states have continued them in 30-day periods or even until the pandemic ends. These states include California,56 Connecticut,57 Georgia,58 Illinois,59 Indiana,60 Iowa,61 Kentucky (which has lifted all COVID-19 restrictions, though its state of emergency remains in place),62 Louisiana,63 Missouri,64 Nevada,65 New Mexico,66 North Carolina,67 North Dakota,68 Pennsylvania,69 Tennessee,70 Texas,71 Utah,72 Vermont,73 Washington,74 Washington, D.C. (which extended the Public Emergency but rescinded the Public Health Emergency, retaining certain provisions of mayoral emergency authority),75 and Wyoming.76
In the upcoming future, as telehealth continues to develop, particularly in those states retaining changes brought about by their telehealth waivers, there will likely be a heightened level of conflict between telehealth-waivered states and those who have returned to the pre-COVID-19 status quo. For example, during the pandemic, providers flocked to meet the needs of a surge of patients seeking care, establishing cross-state provider-patient relationships. Now, those same providers must often apply for full licensure in these same states in order to continue treating their patients. This affects both healthcare organizations and patients in states facing provider shortages, and states must now determine whether to respond through provisional licensing, joining an expedited licensure group such as an interstate compact, or creating their own method of expedited licensure for practitioners already practicing in the state. Further frustration will likely arise through the increasingly varied definitions of telehealth (and which services are reimbursable), as providers who traditionally provide certain modalities of telehealth services may need to adapt more quickly to other states’ changing requirements, increasing the total costs of care and compliance.
Broader Implications of Maintaining or Rolling Back Legal Changes in Response to the End of States of Emergency
While there was much hope during the height of the pandemic that the state of emergency declarations and subsequent telehealth waivers would open the door for significant telehealth advancements across the United States, this has not proven to be the case across all states. Some states have elected to retain much of the beneficial changes to telehealth, bringing significant expansion and updates to this healthcare sector. However, other states have simply rescinded their states of emergency without having made the changes to telehealth law permanent, instead opting to later revisit these laws and permanently incorporate them bit by bit through the traditional legislative process.
According to a report by the Minnesota Department of Human Services, telehealth demand rose by over 2,600 percent between March through June of 2020 when compared to the same period in 2019.77 The popularity of and demand for telehealth services are at an all-time high, with demand expected to increase by 28 percent through 2026.78 The data are clear — telehealth is likely here to stay, and the telehealth waivers provided by the states during the pandemic served a vital role not only in providing the opportunity for growth, but in bringing the laws up to speed with technological capabilities and service demand. Although some states have recognized this growth and the increasing need for technologically-driven remote care solutions, not all have adapted to the new post-pandemic world, leaving questions about how to move forward in this area. How easy will it be, really, to roll back these arguably inevitable changes once they’ve been permitted? How will states that have completely rescinded their public health emergencies adapt when other states around them have determined to advance in telehealth technology, drawing healthcare business and patients across state borders to provide and receive care? Is it so easy to recapture the proverbial cat once it has been let out of the bag?
While the federal and state governments, as well as private payors, have made significant strides toward progressing telehealth service development, each of the individual states has arrived at a crossroads in the pandemic where they must decide how to proceed. While many states have begun to simply rescind their declarations of states of emergency, consequently rolling back progress on telehealth care provision, other states have determined to leverage these pandemic developments to move forward with telehealth in accordance with technological developments, legal and regulatory changes at the federal level, and the newfound demand for remote services. With so much emphasis on and movement toward telehealth services, and with an unprecedented opportunity to proceed more quickly than permitted previously due to legal and regulatory constraints, states mustn't waste this opportunity to advance. Once the gains are accomplished, they will be much harder to recapture if the states allow their legal and regulatory requirements for telehealth to sink back to the pre-pandemic status quo. Now is the time for each state to envision its desires for its telehealth care future — and to determine that its next steps will move forward in accomplishing this vision.
- Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak – The White House (archives.gov)
- H.R.6074 – Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020.
- HHS OIG Policy Statement on Practitioners That Reduce, Waive Amounts Owed by Beneficiaries for Telehealth Services During the COVID-19 Outbreak; see also Cost-sharing waivers and premium relief by private plans in response to COVID-19 - Peterson-KFF Health System Tracker
- CMS Finalizes Meaningful Expansions of Medicare Telehealth Service Coverage Through 2021 - Health Management Associates
- https://www.ama-assn.org/delivering-care/public-health/cares-act-ama-covid-19-pandemic-telehealth-fact-sheet; see also https://www.uhcprovider.com/en/resource-library/news/Novel-Coronavirus-COVID-19/covid19-telehealth-services.html
- https://www.hhs.gov/about/news/2020/03/20/ocr-issues-guidance-on-telehealth-remote-communications-following-its-notification-of-enforcement-discretion.html; see also https://www.hhs.gov/sites/default/files/telehealth-faqs-508.pdf
- Under the PREP Act, a “Covered Countermeasure” is considered a “qualified pandemic or epidemic product” or a “security countermeasure,” or a drug, biological product, or device authorized for emergency use. See Federal Register: Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19
- CMS makes some telehealth services permanent after COVID-19 (healio.com)
- https://www.nj.gov/governor/news/news/562021/20210604b.shtml#:~:text=This%20authority% 20lasts%20until%20January,normalcy%2C%E2%80%9D%20said%20Governor%20Murphy.
About the Authors
Anjali Dooley, Esq., MBA is the CEO & Founder of The Innovators Law Firm, LLC. In her past roles she has acted as the General Counsel of Forefront Telecare, Inc., a behavioral health telemedicine company, In Alameda County. CA. She has a boutique national and international telemedicine and healthcare advisory practice. She is an entrepreneur and business leader, with extensive experience in rural healthcare, startups, emerging healthcare technologies, telemedicine, and business law. In her private law practice, her focus is on the representation of start-up businesses in financing and business development matters and on healthcare regulatory compliance. Previously, she has served as both a Special Prosecutor and Public Defender for the State of Missouri. Ms. Dooley is a leader within the American Bar Association Health Law Section, serving as Vice-Chair of the Section’s eHealth, Privacy, and Security Interest Group (2016-2019) and 2019-2021 as Vice Chair of Membership. She is a leader in the Missouri Bar as Chair of the Technology & Innovation Committee (2020-2022). Her longstanding interest in rural health has led her to serve on various policy and advisory committees for the National Association of Rural Health Clinics. She also served as an Adjunct Professor and Coleman Fellow at Saint Louis University’s MBA Program in Entrepreneurship, which is ranked 12th nationally. She is a legal analyst/expert for local and national news outlets, magazines, and bar associations. She received her law degree from the University of Missouri-Kansas City School of Law, her MBA from the DePaul University-Charles H. Kellstadt Graduate School of Business, and her BA in Economics from the University of Illinois at Champaign-Urbana. She may be reached at firstname.lastname@example.org.
Erin Grant, Esq., MHA serves as Associate Counsel at The Innovators Law Firm, LLC, where she assists healthcare startups in organizational compliance, development, and growth across states. She has a broad range of experience in healthcare, where she has worked in medical malpractice as well as in administrative roles with an emphasis on value-based care arrangements. In 2018-2019, she completed an administrative fellowship with Memorial Health System in Springfield, Illinois, later joining the organization as Value-Based Agreement Coordinator. She has contributed to a number of national publications on topics related to telemedicine, Stark and anti-kickback issues, pharmaceuticals and rural healthcare reimbursement, as well as informed consent in clinical trials. Ms. Grant received her law degree with a Concentration in Health Law as well as her Master’s in Health Administration from Saint Louis University. She may be reached at email@example.com.