As we enter the third year of the pandemic, life with COVID-19 has become the new "normal" for many Americans. While debate can be had about when a pandemic ends or becomes endemic, there is no dispute that more and more Americans feel COVID-19 is no longer a national crisis1 and that the nation currently faces larger problems.2 This shift in public opinion has implications for the declaration of a Public Health Emergency by the Department of Health and Human Services (HHS), upon which many of the telehealth expansions of the pandemic are dependent. While the Public Health Emergency is likely to continue for the remainder of 2022,3 its eventual end will necessitate an examination of the utility of the government's telehealth waivers and their impact on the delivery of health care. Early pandemic data suggests that telehealth's rapid adoption increased the accessibility of health services-particularly for susceptible population groups-but that inequities exist in its delivery. Further, concern regarding the potential for fraud and abuse in the delivery of telehealth services remains a focus of the federal government and its enforcers. Finally, while permanent federal legislation expanding the scope of telehealth services and reimbursement remains to be seen, a large bipartisan push to expand the services permanently appears likely in late 2023 or early 2024.
Explosive Growth
At the beginning of the pandemic, stay-at-home orders and social distancing required that the delivery of health care be changed overnight. With the declaration of a Public Health Emergency and passage of the Coronavirus Preparedness and Response Supplemental Appropriations Act4 and the Coronavirus Aid, Relief and Economic Security Act,5 the Centers for Medicare & Medicaid Services (CMS) was granted the ability to waive6 certain requirements for telehealth services. Before the pandemic, telemedicine7 was limited to certain services which could only be provided by specific practitioners8 to rural patients at "originating sites."9 These requirements were quickly waived to allow for the provision of telemedicine services to urban and suburban communities, including telemedicine by practitioners previously barred from providing telemedicine services.10 Licensing requirements for out-of-state practitioners were also waived11 and certain telehealth services were allowed to be provided via "audio-only," including office visits and behavioral health services.12 This superseded the requirement that telehealth services be furnished via audio and video equipment, permitting two-way, real-time interactive communication between the patient and practitioner. 13
Following these actions, the use of telehealth skyrocketed. From the period of March 1, 2020 to February 28, 2021, approximately two in five Medicare beneficiaries utilized telehealth14 services, a rate 88 times that of the year prior to the pandemic.15 The use of telehealth remained heightened into early 2021, when in-person office visits had resumed for most providers.16 During this first year, Medicare beneficiaries received over 54.5 million office visits via telehealth and 34 million instances of virtual care services.17 Telehealth was frequently used among beneficiaries for behavioral health services and nursing home visits, totaling 14.1 million and 3.3 million services, respectively.18
Another study utilizing the Census Bureau's Household Pulse Survey from April to October 2021 found a 23.1% use of telehealth services, with nearly one in four adults polled reporting an appointment with a healthcare professional by video or phone in the previous four weeks.19 The highest rates of telehealth utilization were among those with Medicaid (29.3%) and Medicare (27.4%), Black individuals (26.8%), and those earning less than $25,000 (26.7%).20 However, video telehealth services were most likely to be utilized by young adults, those earning at least $100,000 a year, those with private health insurance and White individuals.21 The study found that video services required a "more complex setup, video-enabled devices, and broadband internet access," which could present barriers for older adults, lower income households and those with limited English proficiency.22 There was also a strong correlation between video telehealth visits and one's education.23
This data shows that the adoption of telehealth has been consistent across demographics and has been particularly beneficial at reaching at-risk population groups. Further, telehealth can be utilized to address the nation's mental health crisis24 through increased accessibility to behavioral and mental health services with reduced stigmatization. However, work remains to be done concerning an equitable distribution of video telehealth services among population groups.
Efforts to Sustain Expansion
With Medicare's telehealth waivers dependent upon the existence of a Public Health Emergency, legislative efforts are necessary to ensure the benefits of telehealth are maintained. Congress appears to be taking a measured approach to any permanent changes to telehealth flexibilities, and while no laws solidifying the expansions have been passed, measures have been taken to ensure providers do not experience a "telehealth cliff."
Recently, Congress passed the "Consolidated Appropriations Act of 2022,"25 which included "Telehealth Flexibility Extensions" to continue the telehealth extensions of the pandemic for a period of 151 days past the end of the Public Health Emergency. These extensions include flexibilities removing geographic requirements for the delivery of telehealth, continuing the expansion of practitioners eligible to provide telehealth services, extending telehealth services for federally qualified health centers and rural health clinics not located at the same location as the beneficiary, removing in-person requirements for mental health services, allowing audio-only telehealth services and the use of telehealth to conduct face-to-face encounter for recertification of hospice care.26
The legislation further directed the Medicare Payment Advisory Commission to "conduct a study on the expansions of telehealth service . . . as a result of the COVID-19 public health emergency," with the report due to Congress no later than June 15, 2023.27 The Secretary of HHS was also directed to begin publishing data on a quarterly basis regarding telemedicine utilization, and the Office of the Inspector General (OIG) was directed to also submit a report to Congress by June 15, 2023, on program integrity risks associated with telehealth services.28 These actions evidence Congress' intent to provide a permanent, workable solution to telehealth expansion prior to the removal of the waivers at the end of the Public Health Emergency, though this could be delayed until after the summer of 2023.
This legislation follows support by 336 health care and other interested organizations who urged Congress to extend the telehealth waivers until 2024, after which it could take up "permanent, evidence-based telehealth legislation" to "effectively modernize U.S. health care delivery."29 They cited data demonstrating overwhelming public support for increased access to telehealth services.30 CMS itself-while unable to amend statutory telemedicine requirements-has already broadened its telehealth coverage outside of the waivers by expanding its definition of "telecommunications" to include audio-only communications technology when used for telehealth for the diagnosis, evaluation or treatment of mental health disorders.31 CMS has further agreed to finalize services added to the Medicare telehealth services list through Dec. 31, 2023, to allow for additional time to evaluate whether such services should be added permanently.32
The extensions of the Consolidated Appropriations Act of 2022 along with a groundswell of support for expanded telehealth by invested stakeholders and CMS suggest many telehealth waivers will be made permanent in the post-pandemic world. However, these decisions will not be made in haste, and permanent change is unlikely until CMS and the OIG have provided comment regarding the effect of the telehealth expansions on both the delivery of health care and health care fraud.
Concern over Fraud and Abuse
Fraud in telehealth has garnered attention throughout the pandemic, with telehealth flexibilities increasingly being exploited in large-scale fraud schemes. In May 2021, the first enforcement action by the Department of Justice (DOJ) specifically relating to Medicare's telehealth expansions was aimed at telemedicine executives, physicians, marketers and medical business owners.33 As with other recent telemedicine schemes, providers performed a telemedicine "consultation" and prescribed a certain service or product in exchange for an illegal kickback.34 However, this enforcement action differed from other recent DOJ enforcement actions in that some telemedicine visits were billed in addition to being used to prescribe or order unnecessary health care items and services.35
This trend continued into September 2021 when the DOJ charged 138 defendants-including 42 doctors, nurses and other licensed medical professionals-for participation in health care fraud schemes totaling $1.4 billion in losses, with $1.1 billion involving telemedicine.36 Court documents show that telemedicine executives paid practitioners to order unnecessary durable medical equipment, genetic testing and pain medications, often without any patient interaction or with only a brief telephone conversation with a patient the practitioner never met.37 Again, the DOJ noted that "[i]n some instances, medical professionals billed Medicare for sham telehealth consultations that did not occur as represented."38
However, telemedicine's use in such schemes often remains a means to an end rather than the source of fraud itself-the telehealth visits are frequently not billed and are used solely to try to legitimize ordering otherwise unnecessary and expensive medical services. This differs from individualized practitioner fraud involving up-coding, misrepresenting telehealth services provided and billing for telehealth services not actually rendered.39 In an attempt to differentiate between the two, Christi Grimm, Principal Deputy Inspector General of the OIG, issued a statement addressing both "telefraud" and "telehealth" schemes.40 Grimm noted the importance of distinguishing between telefraud schemes, which "inappropriately leverage[] the reach of telemarketing schemes in combination with unscrupulous doctors conducting sham remote visits," and "the evolution of scams that may relate to telehealth."41 This distinction is important for proponents of telehealth, as "telefraud schemes" involving illegal kickbacks existed prior to the increased use of telehealth and are unlikely to be indicative of telehealth fraud occurring in existing practitioner-patient relationships. In order to protect honest practitioners from involvement in such schemes, the OIG issued a "Special Fraud Alert" describing suspect characteristics of arrangements with telemedicine companies.42
While the use of telehealth frequently makes headlines in fraud cases, data concerning individualized fraud by practitioners remains sparse. The OIG has several "Active Work Plan Items"43 to study, address and audit the use of telehealth during the pandemic which are expected to be issued in 2022. These studies, along with the OIG's June 15, 2023, report on program integrity risks associated with telehealth, will have a heavy influence on which telehealth expansions will outlive the Public Health Emergency.
The Post-Pandemic Future of Telehealth
The use of telehealth during the pandemic has undoubtedly increased access to care, particularly among at-risk population groups. Its use will continue to grow post-pandemic, and concerted efforts will be made to ensure a more equitable distribution of video telehealth services. Federal legislation codifying current telehealth expansions dependent upon the Public Health Emergency can be expected following the summer of 2023, and the Secretary of HHS will likely continue to extend the Public Health Emergency until this time. Finally, while telehealth's use in "telefraud" schemes will continue to make headlines, data regarding individualized fraud will be used to determine what additional safeguards are needed to prevent everyday telehealth fraud, and many of the present-day concerns regarding telehealth will quickly become a thing of the past.
Footnotes
1. Axios/Ipsos poll: Most Americans say COVID is no longer a crisis, (April 12, 2022) https://www.axios.com/2022/04/12/axios-ipsos-poll-most-americans-say-covid-is-no-longer-a-crisis. Less than 1 in 10 Americans now consider COVID-19 a crisis, though the vast majority still consider it a problem, albeit manageable.
2. By a wide margin, Americans view inflation as the top problem facing the country today, (May 12, 2022) https://www.pewresearch.org/fact-tank/2022/05/12/by-a-wide-margin-americans-view-inflation-as-the-top-problem-facing-the-country-today/. Only 19% of U.S. adults still view COVID-19 as a "very big problem," placing it behind inflation, the affordability of health care, violent crime, gun violence, the federal budget deficit, climate change, the quality of public K-12 schools, illegal immigration, racism, conditions of roads, bridges, and other infrastructure, and unemployment in the category. Id.
3. Secretary of the Department of Health and Human Services ("HHS") renewed the determination of a Public Health Emergency for an additional 90-day period on April 16, 2022. Renewal of Determination That a Public Health Emergency Exists, (April 16, 2022), https://aspr.hhs.gov/legal/PHE/Pages/COVID19-12Apr2022.aspx. It has also been reported that an additional extension will be made beyond the present mid-July deadline. US Set to Extend Covid-19 Public Health Emergency Past July, (May 16, 2022), https://www.bloomberg.com/news/articles/2022-05-16/us-set-to-extend-covid-19-public-health-emergency-past-july (reporting that the declaration of a PHE will be extended beyond mid-July "according to a person familiar with the matter, who asked not to be identified because the details aren't public.").
4. H.R. 6074, 116th Cong. § 102 (2020).
5. H.R. 748, 116th Cong. § 3703 (2020).
6. See 42 U.S.C. § 1320b-5(b)(8) (giving the Secretary of HHS the authority to waive requirements during national emergencies).
7. Telemedicine is considered a form of telehealth. See National Survey Trends in Telehealth Use in 2021: Disparities in Utilization and Audio vs. Video Services, at 1-2, Office of Health Policy of Assistant Secretary for Planning and Evaluation of DHHS, (Feb. 1, 2022), https://aspe.hhs.gov/sites/default/files/documents/ 4e1853c0b4885112b2994680a58af9ed/telehealth-hps-ib.pdf ("Telehealth is comprised of two forms: 1) two-way, synchronous, interactive client-provider communication through audio and video equipment (sometimes referred to as telemedicine), and 2) asynchronous client-provider interactions using various forms of technology (e.g., web-based client portals, e-mail messages, text messages, mobile applications, symptom management tracking, sensors, peripherals, client education modules, or electronic medical record data).").
8. U.S.C. § 1395m(m)(1); 42 U.S.C. § 1395u(b)(18)(C).
9. U.S.C. § 1395m(m)(4)(C).
10. Covid-19 Emergency Declaration Blanket Waivers for Health Care Providers, (Dec. 1, 2020), at 1, 38, https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf. These included physical therapists, occupational therapists, speech language pathologists, among others.
11. Id. at 2.
12. Id. at 1; Telehealth was Critical for Providing Services to Medicare Beneficiaries During the First Year of the COVID-19 Pandemic, OEI-02-20-00520, at 3 (March 15, 2022), https://oig.hhs.gov/oei/reports/OEI-02-20-00520.pdf.
13. 42 U.S.C. 1395m(m)(1); 42 C.F.R. 410.78(a)(3) ("Interactive telecommunications system means multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.").
14. Telehealth was Critical for Providing Services to Medicare Beneficiaries During the First Year of the COVID-19 Pandemic, OEI-02-20-00520, at 12 (March 15, 2022), https://oig.hhs.gov/oei/reports/OEI-02-20-00520.pdf. For purposes of the study, the OIG included virtual care services, or "Communication Technology-Based Services" as part of its study. These include virtual check-ins, e-visits, remote patient monitoring, and telephone calls with a provider to discuss a beneficiary's medical condition. Id.
15. Id. at 1.
16. Id. at 2. The OIG found that Medicare beneficiaries' use of telehealth for behavioral health services was a larger share than that for office visits-43% versus 13%, respectively. Behavioral health services include individual therapy, group therapy, and substance use disorder treatment, among others. Id. at 8.
17. Id. at 8. Virtual care services may only be provided remotely, unlike office visits which may take place in-person.
18. Id. at 8-9.
19. National Survey Trends in Telehealth Use in 2021: Disparities in Utilization and Audio vs. Video Services, at 1, 3, Office of Health Policy of Assistant Secretary for Planning and Evaluation of DHHS (Feb. 1, 2022) https://aspe.hhs.gov/sites/default/files/documents/4e1853c0b4885112b2994680a58af9ed/telehealth-hps-ib.pdf.
20. Id. at 1.
21. Id. Video telehealth for White individuals was 61.9%, followed by Black individuals at 53.6%, Asian at 51.3%, and Latinos at 50.7%. Of note, the lowest utilization of telehealth amongst subgroups occurred among adults over age 65 at 43.5% and persons without a high school diploma at 38.1%. Id.
22. Id. at 9.
23. Id. at 5.
24. See FACT SHEET: President Biden to Announce Strategy to Address Our National Mental Health Crisis, As Part of Unity Agenda in his Frist State of the Union, The White House Briefing Room, (March 1, 2022), https://www.whitehouse.gov/briefing-room/statements-releases/2022/03/01/fact-sheet-president-biden-to-announce-strategy-to-address-our-national-mental-health-crisis-as-part-of-unity-agenda-in-his-first-state-of-the-union/.
25. H.R. 2471, 117th Cong. §§ 301-09 (2022).
26. H.R. 2471, 117th Cong. §§ 301-06 (2022).
27. H.R. 2471, 117th Cong. §§ 308(a)(1)-(2) (2022).
28. H.R. 2471, 117th Cong. §§ 308(b)-(c) (2022). The OIG report must include "recommendations to prevent waste, fraud, and abuse under the Medicare program as appropriate." Id.
29. Letter to Senators Charles Schumer and Mitch McConnell and Representatives Nancy Pelosi and Kevin McCarthy Re: Establishing a Pathway for Comprehensive Telehealth Reform, at 1-2 (January 31, 2022), https://www.americantelemed.org/wp-content/uploads/2022/01/Telehealth-Pathway-to-Reform-Letter-to-Congress-w-signers-FIN-v2.pdf
30. Id. at 2.
31. 42 C.F.R. § 410.78(a)(3); Calendar Year (CY) 2022 Medicare Physician Fee Schedule Final Rule, CMS (Nov. 2, 2021), https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2022-medicare-physician-fee-schedule-final-rule. Notably, this definition is only applicable when the patient is not capable of or doesn't consent to the use of video technology.
32. Id.
33. DOJ Announces Coordinated Law Enforcement Action to Combat Health Care Fraud Related to COVID-19, (May 26, 2021), https://www.justice.gov/opa/pr/doj-announces-coordinated-law-enforcement-action-combat-health-care-fraud-related-covid-19 ("[P]ursuant to the COVID-19 emergency declaration, telehealth regulations and rules were broadened so that Medicare beneficiaries could receive a wider range of services from their doctors without having to travel to a medical facility. The cases announced today include first in the nation charges for allegedly exploiting these expanded policies by submitting false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.").
34. Id. In a Southern District of Florida case, a Texas company allegedly exploited temporary waivers of telehealth restrictions by offering telehealth providers access to Medicare beneficiaries for whom they could bill for telehealth consultation. In exchange, the providers referred the beneficiaries to the Texas company's laboratories for unnecessary genetic testing.
35. See id.
36. National Health Care Fraud Enforcement Action Results in Charges Involving over $1.4 Billion in Alleged Losses, (Sept. 17, 2021), https://www.justice.gov/opa/pr/national-health-care-fraud-enforcement-action-results-charges-involving-over-14-billion.
37. Id.
38. Id.
39. Fraud Emerges as Telehealth Surges, ABA's White Collar Crime Committee Newsletter, Winter/Spring 2021, at 2, https://www.americanbar.org/content/dam/aba/publications/criminaljustice/2021/telehealth_fraud.pdf. Up-coding involves misstating the time and complexity of the telehealth service provided in order to receive a greater reimbursement.
40. Principal Deputy Inspector General Grimm on Telehealth, (Feb. 26, 2021), https://oig.hhs.gov/coronavirus/letter-grimm-02262021.asp.
41. Id.
42. Special Fraud Alert: OIG Alerts Practitioners to Exercise Caution When Entering Into Arrangements with Purported Telemedicine Companies, (July 20, 2022), https://oig.hhs.gov/documents/root/1045/sfa-telefraud.pdf. The "suspect characteristics" of fraudulent telemedicine arrangements include the following: 1) the purported patients for whom the practitioner orders or prescribes items or services are identified or recruited by the telemedicine company, a telemarketing company, sales agent, recruiter, call center, health fair, and/or through internet, television, or social media advertising for free or low out-of-pocket cost items or services; 2) the practitioner does not have sufficient contact with or information from the purported patient to meaningfully assess medical necessity; 3) the telemedicine company compensates the practitioner based on the volume of items or services ordered or prescribed, which may be characterized as compensation based on the number of purported medical records reviewed; 4) the telemedicine company only furnishes items and services to federal health care program beneficiaries and does not accept insurance from any other payor; 5) the telemedicine company claims to only furnish items and services to individuals who are not federal health care program beneficiaries but may in fact bill federal health care programs; and 6) the telemedicine company only furnishes one product or a single class of products (e.g., durable medical equipment, genetic testing, diabetic supplies, or various prescription creams), potentially restricting the practitioner's treating options to a predetermined course of treatment.
43. Active Work Plan Items, OIG (last accessed June 29, 2022), https://oig.hhs.gov/reports-and-publications/workplan/active-item-table.asp#example=ftelehealth.
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