chevron-down Created with Sketch Beta.
June 01, 2021

Medicare's Expanded Telemedicine Horizon

By Nathaniel A. Gardner, JD/MHA, Saint Louis University (2020), St. Louis, MO

Introduction

On January 31, 2020, Alex Azar, Secretary of the U.S. Department of Health and Human Services (HHS), declared a Public Health Emergency (PHE) for the 2019 Novel Coronavirus (COVID-19).1 In response, telemedicine became more readily available through a variety of deregulatory legal mechanisms, chiefly statutory and regulatory waivers. The Centers for Medicare & Medicaid Services (CMS) has taken the stance that telemedicine visits are preferable to in-person appointments during the PHE due to the risk of COVID-19 exposure for patients and providers alike.2

This article provides a brief history of the adoption of telemedicine in the United States, expounds on the benefits of telemedicine delivery, narrates telemedicine’s expansion during the pandemic while analyzing the modifications that made such expansion possible, and makes recommendations as to which modifications should remain at the eventual end of the PHE. The recommendations will focus on Medicare Part B’s coverage of and reimbursement for telemedicine. These recommendations have far-reaching implications, as commercial health insurers tend to follow the coverage and payment trends of Medicare.3

Background

Telemedicine is:

The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.4

Telemedicine is a subset of telehealth.5 The broader telehealth encompasses healthcare technologies “used to provide care and services at-a-distance.”6 The principal difference is that telemedicine involves the direct delivery of clinical services from a provider to a patient.7

Telehealth includes health-related services closely or tangentially related to clinical healthcare, such as mobile apps for diet tracking, remote monitoring devices that track a patient’s heart rate, patient portals, or vaccination email reminders.8 The three modalities of telehealth are synchronous, asynchronous, and remote patient monitoring.9 The best example of synchronous telehealth would be a real-time telemedicine visit through a video call between a patient and his or her primary care physician. With asynchronous telehealth, the user’s health or health-related data is collected, transmitted, and then “interpreted or responded to later.”10 An example would be a patient portal where patients may send to and receive messages from their therapist. Remote patient monitoring involves technologies that collect and send a patient’s health data, such as vital signs, to a remotely located provider.11 The remotely monitored patient may be in a clinical setting or at home.12

Telemedicine became increasingly crucial during the COVID-19 pandemic. COVID-19 is a respiratory virus that can spread through the air, through close contact with infected individuals, or through contact with contaminated surfaces.13 As of early March 2021, COVID-19 had caused over half a million deaths in the United States alone14 and wreaked havoc on the economy.15 The telemedicine modality, allowing completely contactless healthcare delivery, could not be a better solution to both ongoing and COVID-related health needs during the PHE.

CMS, a federal agency nestled within HHS, administers and provides oversight of Medicare and Medicaid – the nation’s two largest health insurance programs.16 Beginning in March 2020, CMS employed its statutory authority to waive certain statutory and regulatory requirements with the aim of making telemedicine more accessible, particularly in the Medicare program.17 Following the implementation of these waivers, telemedicine adoption by healthcare providers and utilization by patients has skyrocketed. In February 2020, only 0.1 percent of Medicare primary care visits were conducted via telemedicine, but in April 2020 – once waivers were in effect – 43.5 percent of those visits were conducted through telemedicine.18 Patients have expressed high levels of satisfaction with telemedicine,19 and the expansion of payment coverage and utilization during the PHE has not been limited to government insurance programs.20

The Benefits of Telemedicine

Telehealth and telemedicine are the healthcare facilities of the future. They are revolutionizing the delivery of medical and behavioral healthcare through an exponential expansion of where patients can be treated, which patients can be treated, and the number and scope of providers available to deliver healthcare. Organizations such as the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) are supportive of their adoption and expansion.21 Telemedicine’s chief asset is the capacity to channel health-related services and resources without requiring patients – who may be weak, sick, or even contagious – to leave their homes.

Starting in the 1990s, efforts to improve America’s healthcare system have fundamentally focused on three problem areas: cost, quality, and access.22 Use of the telemedicine modality of care over in-person visits, in many circumstances, furthers the goal of simultaneously improving all three areas.23 The U.S. healthcare system is notorious for having uncontained costs, despite countless attempts by legislators and healthcare leaders to reduce such costs.24 Considering that telemedicine has proven, in several studies involving real-world application, to significantly reduce healthcare delivery costs, why would CMS not consider expanding the availability of telemedicine visits in its cost-constrained programs?25

The direct consumer price of a non-urgent telemedicine appointment is typically less than half of what an in-person visit would cost the same patient.26 Provider costs can plummet, too.  For instance, a healthcare system implemented an initiative to divert non-emergent patients to its telemedicine platform instead of its emergency rooms.27 The health system offered on-demand telemedicine visits for $49. Financial analyses revealed that each successful diversion of an emergency room visit to the telemedicine platform saved the system, on average, between $309 and $1,546.28 But telemedicine visits not only reduce the direct consumer and healthcare provider costs of healthcare; they also significantly reduce indirect costs of medical care for patients. Those indirect costs include travel, lost wages, and family expenses, with savings being most meaningful for low-income and rural patients.29

Cost reduction is not the only benefit of telemedicine delivery – access and quality, too, are improved. CMS reports that telehealth and telemedicine have increased access to care, improved the management of chronic health conditions, and facilitated infection control measures.30 During the PHE, some physicians have voiced skepticism about the quality of care they can provide through telemedicine.31 Yet, studies show that many types of healthcare provided through telemedicine result in outcomes that are similar to, or better than, in-person care.32 Studies have shown that telemedicine improves healthcare outcomes for behavioral health conditions, childhood asthma, diabetes, digestive diseases, cancer, and chronic conditions.33 Telemedicine’s positive impact on quality of care is particularly significant in rural and medically underserved areas, which tend to experience health professional and specialist physician shortages.34 Likewise, telemedicine makes quality healthcare more accessible for all Americans, but especially for those living in rural and other medically underserved areas.35 Still, telemedicine is not a magic pill to improving the provision of high quality, safe healthcare – quite a few medical services simply cannot be delivered through this means, or not as effectively.36 As discussed below, telemedicine is also subject to various regulatory and reimbursement restrictions that are above and beyond the requirements for in-person care.

Pre-Pandemic Telemedicine Landscape

History of Telemedicine

The Institute of Medicine’s 2001 landmark study report, Crossing the Quality Chasm, recognized that “information technology must play a central role in the redesign of the healthcare system if a substantial improvement in quality is to be achieved.”37 Since 2001, healthcare information technology has experienced a revolution – particularly with regard to interconnectivity and information sharing – and the use of telemedicine as a tool to deliver better, less costly, and more accessible healthcare has been an important part of that.38

Telemedicine is not a new concept. Some forms of telemedicine have been employed in the United States for over 60 years.39 Starting in the late 1950s, the Nebraska Psychiatric Institute and Norfolk State Hospital used a closed-circuit television connection for psychiatric consultations.40 Teleradiology services, where medical imaging is outsourced to remotely located radiologists, have also been in use since the 1950s.41 The 1990s are considered the “development years” for telemedicine.42 In the 1990s, video call platforms became more affordable for providers, and both state and federal laws were passed to support health insurance coverage for telemedicine.43

By 2010, federal healthcare programs had increasingly turned to telemedicine. Large studies by the Veterans Health Administration (VHA) had demonstrated the effectiveness of telemedicine in chronic disease management.44 In 2015, over 700,000 veterans received care from the VHA through telemedicine or telehealth modalities.45 Medicaid, with its affinity for innovative healthcare delivery,46 helped set a trend towards insurance payment for telemedicine visits. By 2016, Medicaid programs in 48 states and Washington D.C. provided payment coverage for telemedicine visits.47 The telemedicine market is projected to grow to over $194 billion by 2023, which is nearly four times the market’s 2019 value.48 Telemedicine companies, or businesses that do nothing but provide telemedicine, are becoming popular.49

While telemedicine generally has been increasing in capability and adoption for decades,50 consumer-centric telemedicine did not come onto the scene until the later 2010s. This is due partly to the rapid advancement of internet-connected mobile devices and related mobile applications. This is also due to increasing consumer expectations, generally, and the “On-Demand Economy.”51 Consumers have come to expect online engagement and digestible, actionable information from retailers and service providers at the tap of an app. Patients are coming to expect this sort of interconnectivity and breadth of information from their healthcare providers.52

Pre-Pandemic Legal Hurdles to Telemedicine

Medicare is a national, federal health insurance program that primarily covers Americans who are 65 and older and those with long-term disabilities.53 Medicare is comprised of four parts: Part A (inpatient care), Part B (outpatient care), Part C (Parts A and B delivered through a managed care plan), and Part D (prescription drugs).54 Medicare Parts B and C provide payment coverage for Medicare telemedicine visits.55 Medicaid is America’s safety-net insurer; the program’s focus encompasses low-income individuals and families. Medicaid is a joint state-federal program, and it varies greatly by state. Each state chooses what benefits will be covered and who qualifies for the program.56 Medicare and Medicaid have both been instrumental in leading the way for the adoption of and payment coverage for telemedicine.57

This article focuses primarily on telemedicine coverage under Medicare Part B, which is subject to Section 1834(m) of the Social Security Act in covering telemedicine care.58 These statutory requirements originated in the Balanced Budget Act of 1997. Section 1834(m) has been significantly amended and expanded since first implemented in 2001.59  For example, a recent 2019 regulation added Medicare coverage for remote patient monitoring and virtual check-ins for patients who have an established relationship with their provider.60 However, Medicare Part B coverage for telemedicine, prior to the PHE, remained limited in scope, and the arguably narrow statutory and regulatory language limited the growth of telemedicine in Medicare.61 For instance, significantly lower payment rates for telemedicine visits as compared to in-person visits were a major hurdle to expansion.62

Waiver Authority

A waiver is a legal mechanism that may be used to set aside and/or modify statutory requirements and the mandates of underlying regulations. Waivers derive their power from statutes, and the language of the waiver statute determines which legal requirements can be altered.63 These powerful tools are commonplace in the Medicaid program, but are extraordinary elsewhere.64 The types of waivers used during the COVID-19 pandemic include blanket waivers (Section 1135 waivers), individual entity waivers, Medicaid State Plan Amendments (tied to 1135 waivers), and “Public Health Emergency” Section 1115 Medicaid waivers.65 This article will focus on Section 1135 blanket waivers, which modify requirements of the Medicare statute and underlying regulations.66

Section 1135 waivers are so named for their codification at Section 1135 of the Social Security Act.67 Section 1135 waivers are a type of “blanket” waiver that apply to all regulated entities; in the instant case, Medicare providers are the regulated entities.68 The purpose of these waivers is to give HHS, the federal agency charged with oversight of healthcare on the federal level, discretion during a declared emergency. This discretion granted under Section 1135 permits HHS to relax select requirements of the Medicare and Medicaid programs “to assure an adequate availability of healthcare services.”69 Under Section 1135 of the Social Security Act, the Secretary of HHS (Secretary) has authority to temporarily waive certain enumerated requirements of the Medicare statute and regulations, including Conditions of Participation and particularly “the requirements [for Medicare telemedicine under] section 1834(m)” of the Social Security Act.70 The Secretary may waive or modify these requirements while a PHE has been declared.71 These blanket waivers can have a retroactive effect, and the Secretary must renew the waiver every 60 days if the emergency continues and extension is desired.72

CMS took full advantage of this discretionary waiver authority during the COVID-19 pandemic to best serve its beneficiaries, and central to this was the modification of Medicare’s limitations on telemedicine.73 On January 31, 2020, the Secretary of HHS declared a PHE.74 Then, on March 13, 2020, then-President Trump issued a declaration of national PHE under the Robert T. Stafford Disaster Relief and Emergency Assistance Act.75 Under Section 1135 of the Social Security Act, the issuance of these declarations gave CMS the authority to grant the blanket waivers described herein and to maintain them during the duration of the PHE.76

While these waivers are advantageous to patients, they have been a nightmare for healthcare attorneys and compliance professionals. During the first months of the pandemic, hospital compliance teams struggled to keep up with the patchwork of waivers and to support providers in transitioning to telemedicine delivery while minimizing liability.77

Medicare Telemedicine Coverage: Modifications of Pandemic Proportion

Section 1135 Waiver Modifications

Eligible Practitioners Waiver

CMS utilized its waiver authority to expand the range of medical practitioners who may provide telemedicine services in the Medicare program. Under the Medicare Act, the only providers eligible to be reimbursed for telemedicine include medical doctors, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists,78 clinical social workers, clinical psychologists, and registered dietitians.79 CMS’ waiver expanded the list to include all providers “eligible to bill Medicare for their professional services.”80 Occupational and physical therapists are a few of the provider types that may now be reimbursed for telemedicine services during the PHE.81

Waivers Regarding Locations Eligible for Telemedicine Visits

Traditionally, Medicare would only pay for telemedicine services when the patient was located in a “rural” or “health professional shortage” area.82 Under its waiver authority, CMS made it possible to provide telemedicine services to Medicare beneficiaries located in any area of the United States.83 The Medicare statute has an additional requirement regarding the location, or “originating site” where the patient receives treatment. According to statutory originating site requirements, a Medicare beneficiary receiving telemedicine services must be located in a medical office or hospital setting.84 Again, using its Section 1135 waiver authority, CMS empowered patients to receive care in their homes, or almost anywhere, during the PHE.85

Payment Rate Parity Waiver

Before the PHE, telemedicine visits were reimbursed by Medicare at a meaningfully lower rate than the same in-person medical care.86 During the pandemic, CMS used its Section 1135 waiver authority to enable Medicare providers to receive the same payment rate for services delivered through telemedicine as for in-person visits.87 This applies to all visits that Medicare covers through telemedicine during the PHE. However, CMS clarified through an April 6, 2020 interim final rule (IFR) that for telehealth services rendered to patients in their homes, providers may not bill for a facility fee.88 The IFR also instructs Medicare providers to use a CPT code modifier, modifier 95, when they bill for telemedicine services during the PHE.89

Audio Only Delivery Waiver

Medicare typically requires that telemedicine services be provided through channels that include both audio and video technologies.90 The blanket waiver allows Medicare payment coverage for telephone evaluation and management visits and behavioral health services by telephone.91 Medicare’s exclusion of audio only delivery was waived through authority granted by the Coronavirus Preparedness and Response Supplemental Appropriations Act.92 Moreover, CMS clarified that during the PHE, “telecommunications system” will include a mobile device or smartphone.93 This was necessary due to restrictive regulatory language, which provides that “[t]elephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system.”94

Provider Licensure Blanket Waiver

State licensure requirements for physicians and other healthcare providers have served as another barrier to telemedicine delivery. Physicians are required to hold a license in each state where they practice.95 This is despite the fact that standards for physician training are determined at a national level.96 However, the Secretary of HHS waived this requirement for the duration of the PHE by permitting physicians to practice across state lines. There are two caveats. The first is that the provider must “have an equivalent license from another State” and not be barred from practicing medicine in any state.97 The second is that providers are also subject to state licensure requirements, which may be above and beyond Medicare program requirements. As of March 2021, 44 states and Washington D.C. had made legal changes to either waive their in-state licensure requirements or make it easier for physicians to obtain licensure, typically on an “emergency” or temporary basis.98

Stark Law Waiver

The Physician Self-Referral Law, also known as the Stark Law, is a federal fraud and abuse law that essentially prohibits referrals from physicians to hospitals or other specified entities when there is a financial relationship between a physician, or an immediate family member of that physician, and the entity.99  The law has several “exceptions” that make such referrals lawful even when such a financial relationship exists. The Stark Law attempts to ensure that healthcare is provided based on medical necessity, not physician financial interests, and it applies to “designated health services” provided in the Medicare and Medicaid programs.100

HHS used Section 1135 Waiver authority to ease the Stark Law’s restrictions on and requirements for physician remuneration and referrals by relaxing requirements of various Stark law exceptions in order to ensure the availability of physicians during the PHE.101 The waiver applies only when a physician is engaged in services related to “COVID-19 Purposes.”102 Although the waiver makes it easier for a referral arrangement involving a physician to comply with the Stark Law, a finding of fraud or abuse by the government is not precluded despite coverage by the waiver.103

Other Legal Changes Expanding Telemedicine

Elimination of the Pre-Existing Doctor-Patient Relationship Requirement

The CARES Act amended Section 1135 of the Social Security Act to make telemedicine more accessible to Medicare beneficiaries.104 The amendment eliminates the requirement that the provider have a prior established relationship with the patient in order for the patient to be eligible for a telemedicine appointment. Before the amendment, the provider105 had to have treated the patient within the past three years as a prerequisite for coverage of a Medicare telemedicine visit during a PHE.106 With the amendment, it is permissible to create a doctor-patient relationship through an approved video call platform, as discussed immediately below.

HIPAA Enforcement Discretion

The only devices and applications that could be used for telemedicine visits prior to the PHE were not ordinarily accessible outside of medical settings.107 This is due to the strenuous regulations under the Health Insurance Portability and Accountability Act (HIPAA) that seek to protect the privacy and confidentiality of patient protected health information. Following CMS’ trend of making telemedicine more accessible during the PHE, HHS’ Office for Civil Rights (OCR), which enforces HIPAA, issued a “Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency” (Notice) in March 2020.108

In the Notice, OCR explained that it will not enforce violations of the “HIPAA Privacy, Security, and Breach Notification Rules that occur in the good faith provision” of telemedicine during the PHE.109 The Notice also clarified that popular “non-public facing” communication products, like Skype or Zoom, are acceptable to use for telemedicine, but “public facing” platforms such as Facebook Live, Twitch, or TikTok may not be used.110 OCR did encourage providers to use “all available encryption and privacy modes” and to notify patients that applications may pose privacy risks.111 Arguably, none of the COVID-19 regulatory waivers would have been meaningful without this OCR Notice of enforcement discretion, as many providers likely would have been hesitant to conduct telemedicine appointments at the risk of violating HIPAA.112

Prescribing of Controlled Substances

Under the Ryan Haight Act of 2008, in order to prescribe a controlled substance through telemedicine, a healthcare provider must conduct at least one in-person evaluation of the patient.113 HHS, acting under an exception to this Act,114 has permitted Drug Enforcement Administration (DEA)-registered providers to prescribe controlled substances through telemedicine during the PHE – even if no in-person visit has occurred – if three conditions are met. Those conditions are: (1) the prescription is issued for a legitimate medical purpose by a provider acting in the usual course of his/her professional practice; (2) the telemedicine visit is conducted using an audio-visual, real-time, two-way interactive communication system; and (3) the provider is acting in accordance with applicable federal and state laws.115

Expansion of Reimbursable Medicare Telemedicine Services

CMS has issued multiple regulations and guidance documents expanding the number of outpatient telemedicine visits eligible for Medicare reimbursement under Part B during the PHE. On March 30, 2020, CMS issued an IFR to “facilitate the use of telecommunications technology as a safe substitute for in-person services.”116 Through the March 30 IFR, CMS added more than 80 services that Medicare would pay for when delivered through telemedicine that were previously covered only as in-person visits. CMS also waived frequency restrictions on those visits during the PHE.117 A separate IFR was issued on April 30, 2020, which streamlined CMS’ process for adding or subtracting services from the “Medicare Telehealth List.”118 The April 30 IFR empowered CMS to use subregulatory guidance during the PHE to modify the list of telemedicine services eligible for payment coverage. This is a departure from the typical procedure requiring formal agency rulemaking to modify the Medicare Telehealth List.119 On October 14, 2020, CMS used this expedited process for the first time to add 11 new telemedicine services, bringing the total number of telemedicine services added during the PHE to 144.120

CMS released its 2021 Physician Fee Schedule Final Rule in December 2020.121 That Rule created a new, albeit temporary, “Category 3” of telemedicine services that will be reimbursable beyond the end of the PHE. This category will include 63 of the services added during the pandemic, and these services will be reimbursable through the end of the calendar year in which the PHE ultimately ends.122 However, the crux is that when the PHE ends, the Section 1135 waivers and other interim measures that expanded the reimbursement for telemedicine, the settings permissible, and much more, as discussed above, will evaporate and these services will not reach as many patients. Ultimately, these services will also have to meet established regulatory requirements for being added to the Medicare Telehealth List in order to become permanently available services.123 Additionally, the Physician Fee Schedule Final Rule did specify nine telemedicine services that have been added to the Medicare Telehealth List permanently, including group psychotherapy, home visits for established patients, and psychological testing.124

Recommendations to Expand Medicare Telemedicine Beyond the COVID-19 Pandemic

The adoption of telemedicine by healthcare providers increased exponentially during the PHE, primarily due to CMS’ use of its statutory authority to waive burdensome statutory and regulatory requirements for the delivery of telemedicine in Medicare Part B. Patients and providers, both before and during the pandemic, have been highly satisfied with care delivered through telemedicine.125 Some of the changes made during the PHE should be expanded permanently; such changes would have far-reaching implications for the way healthcare is delivered in the United States, especially with regard to patient access to quality, timely care.

Modifications That Should Be Extended Beyond the PHE 

Providers Eligible to Deliver Telemedicine

Lamar Alexander, Chair of the Senate Committee on Health, Education, Labor, and Pensions, announced in June 2020 that retaining the expanded scope of telemedicine services available was, in his view, one of the two most important policy changes that should be made permanent.126 Preserving the scope of available telemedicine services has two components, permanently expanding: (1) the kinds of providers who can deliver care, and (2) the telemedicine services payable under Medicare Part B. The provider types given the greenlight to bill Medicare during the PHE include physical therapists, occupational therapists, and speech language pathologists.127 The limitation on provider types is statutory and codified at 42 U.S.C. § 1395u(b)(18)(C). Congress should legislate to modify this list to include these three provider types. This change would bring CMS’ telemedicine policies in line with the WHO’s definition of telemedicine, which includes the “delivery of health care services . . . by all health care professionals.128

Services Reimbursable Under the Medicare Telehealth List

Even if Congress moves to expand the kinds of practitioners who can provide Medicare telemedicine services, the change is null if CMS does not make those services payable. These healthcare services were made payable by Medicare (e.g., added to Part B’s Medicare Telehealth List) during the PHE through the expansion of services under the various CMS IFRs, as discussed above. Being able to receive these services at home is valuable to Medicare beneficiaries, who tend to be elderly or disabled. Broadening the scope of telemedicine services available to Medicare Part B beneficiaries would also be consistent with CMS’ 2019 regulatory expansion of telemedicine coverage in Medicare Part C.129

At the end of the pandemic, CMS should seriously consider making permanent all of the services it added to the Medicare Telehealth List for the duration of the PHE. Existing Medicare requirements and controls ensure that telemedicine services are only delivered and paid for under circumstances that make such services medically necessary – as all Medicare Part B services must be either medically necessary or for preventive purposes in order to be covered.130 To so expand the Medicare Telehealth List, CMS would use its process for revising the list of telemedicine services it covers, a process specified in a 2003 Final Rule.131 The process involves CMS’ annual review of public requests, or agency initiatives, for additions or subtractions from the Medicare Telehealth List.132 In making decisions as to this list, CMS considers the service’s “clinical benefit” and may categorize the service as “Category 1” (service similar to those on the current Telehealth list) or “Category 2” (service not similar to those on the list).133 As discussed above, CMS recently added a “Category 3” for temporary approved telemedicine services through the 2021 Medicare Physician Fee Schedule Final Rule.

Sites Where Telemedicine Can Be Delivered Under Medicare Part B

The third, and arguably most important recommendation, involves which patients (or sites of care) can receive telemedicine. Even if the numbers of services and providers are expanded, the change is much less meaningful if the only patients who can access such care are rural patients or those in an institution.134 Thus, limitations on where patients can receive telemedicine should be removed – those being the Medicare statute’s “originating site” and “rural” setting requirements – which changes could only be accomplished through a legislative act of Congress.135 Rick Boucher, former Chair of the House Energy and Commerce Committee’s Subcommittee on Communications and the Internet, stated that these requirements were adopted “at a time when broadband networks were not as fast and reliable as they are today. With network connectivity limited and high-quality video generally only available over connections in institutional settings, it’s perhaps understandable that regulations restricted the places where telemedicine services could be offered.136 However, things have changed; most Americans in 2020 have internet connectivity and mobile devices or computers that can aptly support telemedicine visits.137

HIPAA Privacy Requirements

Implementation of the above recommendations would be less significant if HIPAA rules remain in their pre-pandemic state following the PHE. The telemedicine platforms (e.g., mobile device applications) used by many providers and patients for telemedicine visits, such as Skype or Zoom, are not currently HIPAA compliant.138 Following the pandemic, OCR should modify its HIPAA regulations in order to permit the “non-public facing” platforms it recognized during the pandemic to be used for telemedicine visits.139 OCR could, by regulation, create an approval pathway for telemedicine platforms that is practical and considers the privacy and security capabilities of platforms lawfully used during the PHE. This approval system should be accompanied by ongoing auditing and monitoring by OCR for approved telemedicine platforms.140 Applications cleared through that pathway should be publicized on OCR’s website,  which would create confidence in both patients and providers.

Barriers to Recommended Modifications

There exist two major barriers to the permanent broadening of telemedicine in Medicare Part B: money and fraud. As discussed above, for the duration of the PHE, the payment rate for telemedicine services is the same as if the same service were provided in a healthcare facility. Most will agree that providing telemedicine services is typically less costly than providing in-person healthcare, but the point of contention is to what extent. If telemedicine is expanded as recommended by this article, Medicare payment rules will need to be adjusted, and in a way that is fair to the various provider and episode of care types. The downward adjustments to Part B telemedicine payment rates should be reasonable enough that providers are willing to continue providing the services, but also weighty enough that the already challenged Medicare budget remains sound.

Fraud relating to the use of telemedicine is likewise a major concern, particularly in light of the expansion of telemedicine. The U.S. Department of Justice reported that more than $4.5 billion in false and fraudulent healthcare payment claims related to telemedicine were submitted in 2020.141 Nonetheless, targeted enforcement mechanisms such as audits to detect telemedicine fraud have already been implemented.142

Conclusion

Medicare beneficiaries, many of whom are elderly, disabled, or members of vulnerable populations, benefit from being able to receive healthcare without having to travel to their provider’s office – and Congress is beginning to acknowledge this.143 The COVID-19 pandemic has greatly expanded patients’ ability to be treated via telemedicine, and it would be worthwhile to retain some of these changes once the PHE has ended. Adoption of the recommendations contained in this article would make healthcare more accessible to the Medicare population – and likely influence commercial healthcare insurance companies to expand their telemedicine offerings. Telemedicine is the future of healthcare, and now is the time for Medicare to take the lead in permanently expanding this modality of care in its Part B Program.
 

Ana Santos Rutschman, S.J.D. (Assistant Professor, SLU Law) advised this paper through the Emerging Health Technologies Seminar course. I would like to thank Professor Rutschman for her endless support and encouragement throughout my law school journey. I encourage any student or practitioner considering a career in health law to contact St. Louis University School of Law.  

  1. HHS, Secretary Azar Declares Public Health Emergency for United States for 2019 Novel Coronavirus (Jan. 31, 2020), https://www.hhs.gov/about/news/2020/01/31/secretary-azar-declares-public-health-emergency-us-2019-novel-coronavirus.html#:~:text=Health%20and%20Human%20Services%20Secretary,responding%20to%202019%20novel%20coronavirus.
  2. 85 Fed. Reg. 19230, 19234 (Apr. 6, 2020).
  3. See, e.g., Gruessner, V., Private Payers Follow CMS Lead, Adopt Value-Based Care Payment, Health Payer Intelligence (Oct. 17, 2016), https://healthpayerintelligence.com/news/private-payers-follow-cms-lead-adopt-value-based-care-payment.
  4. World Health Organization, Telemedicine: Opportunities and Developments in Member States: Global Observatory for eHealth 9 (Volume 2, 2010).
  5. The terms are commonly misused by prominent organizations and in the literature – for example, even on CMS’s website: CMS, List of Telehealth Services, https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes (last visited Mar. 6, 2021).
  6. American Academy of Family Physicians, What’s the Difference Between Telemedicine and Telehealth?, https://www.aafp.org/news/media-center/kits/telemedicine-and-telehealth.html.
  7. Id.
  8. CDC, Using Telehealth to Expand Access to Essential Health Services During the COVID-19 Pandemic (June 10, 2020), https://www.cdc.gov/coronavirus/2019-ncov/hcp/telehealth.html; Mayo Clinic, Telehealth: Technology Meets Health Care (May 15, 2020), https://www.mayoclinic.org/healthy-lifestyle/consumer-health/in-depth/telehealth/art-20044878.
  9. CDC, supra n. 8.
  10. Id.
  11. Id.
  12. TeleICU services are an example of remote patient monitoring that allow hospitals to increase patient safety through better monitoring and empowering clinicians to attend to the most urgent matters. For instance, Mercy Virtual, whose facility and telehealth providers are located in St. Louis, Missouri, monitors nearly 500 ICU beds. Mercy Virtual, Smart Monitoring for Safer Care, https://www.mercyvirtual.net/safe-watch/.
  13. CDC, How to Protect Yourself and Others (Nov. 4, 2020), https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html.
  14. CDC, CDC COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days (last visited Mar. 6, 2021).
  15. See generally, e.g., Auger, K., et al., Association Between Statewide School Closure and COVID-19 Incidence and Mortality in the US, 324 JAMA 859 (July 2020).
  16. CMS, CMS Roadmaps Overview (2016), https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/qualityinitiativesgeninfo/downloads/roadmapoverview_oea_1-16.pdf.
  17. CMS, Medicare Telemedicine Health Care Provider Fact Sheet (Mar. 17, 2020), https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet.
  18. HHS Assistant Secretary for Planning and Evaluation, Medicare Beneficiary Use of Telehealth Visits: Early Data from the Start of the Covid-19 Pandemic (July 28, 2020), https://aspe.hhs.gov/system/files/pdf/263866/HP_IssueBrief_MedicareTelehealth_final7.29.20.pdf.
  19. J.D. Power, Telehealth: Best Consumer Healthcare Experience You’ve Never Tried, Says J.D. Power Study (Oct. 28, 2019), https://www.jdpower.com/business/press-releases/2019-us-telehealth-satisfaction-study.
  20. Hudman, J., et al., How Private Insurers Are Using Telehealth to Respond to the Pandemic, Health System Tracker (Aug. 6, 2020), https://www.healthsystemtracker.org/brief/how-private-insurers-are-using-telehealth-to-respond-to-the-pandemic/. Similar upward trends have been seen for patients with private health insurance. Id.
  21. See generally World Health Organization, supra n. 4; CDC, supra n. 8.
  22. See generally Kissick, W., Medicine's Dilemmas: Infinite Needs Versus Finite Resources (Yale University Press, 1st ed., 1994).
  23. See American Hospital Association, Telehealth: Helping Hospitals Deliver Cost-Effective Care 2 (2016), https://www.aha.org/system/files/content/16/16telehealthissuebrief.pdf.
  24. Peter G. Peterson Foundation, Why Are Americans Paying More for Healthcare? (Apr. 20, 2020), https://www.pgpf.org/blog/2020/04/why-are-americans-paying-more-for-healthcare#:~:text=The%20United%20States%20has%20one,to%20about%20%2411%2C000%20per%20person.
  25. Iafolla, T., Research Review: Does Telehealth Really Save on Costs?, eVisit (Apr. 26, 2016), https://blog.evisit.com/virtual-care-blog/research-review-does-telehealth-really-save-on-costs.
  26. Beck, M., How Telemedicine Is Transforming Health Care, The Wall Street Journal (June 26, 2016), https://www.wsj.com/articles/how-telemedicine-is-transforming-health-care-1466993402.
  27. Nord, G., et al., On-Demand Synchronous Audio Video Telemedicine Visits Are Cost Effective, 37 Am. J Emergency Med. 890, 892 (2019).
  28. Id.
  29. Bynum, A., et al., The Impact of Telemedicine on Patients' Cost Savings: Some Preliminary Findings, 9 Telemedicine & e-Health (December 2003); Schadelbauer, R., The Rural Broadband Association, Anticipating Economic Returns of Rural Telehealth (March 2017).
  30. See CDC, supra n. 8.
  31. Landi, H., In Rush to Embrace Telehealth, Many Physicians Still Have Concerns About Quality of Care, Survey Finds, Fierce Healthcare (Sept. 10, 2020), https://www.fiercehealthcare.com/practices/rush-to-embrace-telehealth-many-physicians-still-have-concerns-about-quality-care-survey.
  32. See generally Wechsler, L., et al., Telemedicine Quality and Outcomes in Stroke: A Scientific Statement for Healthcare Professionals from the American Heart Association/American Stroke Association, 48 Stroke e3 (January 2017); Wheel Health Team, The Most Important Telemedicine Clinical Outcomes Research You Should Know (May 8, 2019), https://www.wheel.com/blog/telemedicine-clinical-outcomes-you-should-know. But see Pines, L.U., et al., Access and Quality of Care in Direct-to-Consumer Telemedicine, 22 Telemedicine J. & E-Health 282, 282–86 (April 2016) (finding that a telemedicine company provided poorer quality care in some cases).
  33. Wheel Health Team, supra n. 32.
  34. See Dixon, B.E., et al., Agency for Healthcare Research and Quality, Using Telehealth to Improve Quality and Safety: Findings from the AHRQ Portfolio 1 (2008); Dharmar, M., et al., Impact of Critical Care Telemedicine Consultations on Children in Rural Emergency Departments, 41 Critical Care Med. 2388 (2013).
  35. Enlund, S., Increasing Access to Health Care Through Telehealth, National Conference of State Legislatures (May 30, 2019), https://www.ncsl.org/research/health/increasing-access-to-health-care-through-telehealth.aspx.
  36. Rosenthal, E., Telemedicine Is a Tool — Not a Replacement for Your Doctor’s Touch, Kaiser Health News (May 6, 2021), https://khn.org/news/article/telemedicine-is-a-tool-not-a-replacement-for-your-doctors-touch/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsmi=125810358&_hsenc=p2ANqtz--QavzPdmwVpJcWY8TrceJwtdpOVwXAenw_vJh1mI9Ff-1sEHoaHHttUSXoWm4rtWl4F3mgv4bqoP_6aes-roBiz7u2RQ&utm_content=125810358&utm_source=hs_email. The major limitations of telemedicine visits are the limited ability to accurately record vital signs and the common failure of patients to have in their possession diagnostic equipment. Jin, M., et al., Telemedicine: Current Impact on the Future, 12 Cureus e9891 (August 2020).
  37. Institute of Medicine, Crossing the Quality Chasm 16 (2001).
  38. See Becker’s Hospital Review, 10 Biggest Technological Advancements for Healthcare in the Last Decade (Sept. 17, 2015), https://www.beckershospitalreview.com/healthcare-information-technology/10-biggest-technological-advancements-for-healthcare-in-the-last-decade.html.
  39. See Bashshur, R. & Shannon, G., History of Telemedicine: Evolution, Context, and Transformation (Mary Ann Liebert, Inc., 2009).
  40. Nesbitt, T., The Evolution of Telehealth: Where Have We Been and Where Are We Going? 11–15 (Nov. 20, 2012), https://www.ncbi.nlm.nih.gov/books/NBK207141/.
  41. Id.
  42. Nesbitt, T. & Katz-Bell, J., History of Telehealth. In: Understanding Telehealth (McGraw-Hill 2018), https://accessmedicine.mhmedical.com/content.aspx?bookid=2217&sectionid=187794434.
  43. Id.
  44. Id.
  45. Id.
  46. See, e.g., Rosenbaum, S., A Program for All Seasons, 13 Saint Louis U. J. Health L. & Pol’y 5, 15 (2019) (explaining how Medicaid is designed to adapt to the evolving healthcare needs of Americans, and that the program “anchor[s] health services where they are needed”). Medicaid and telemedicine are discussed in further detail below.
  47. Nesbitt & Katz-Bell, supra n. 42.
  48. The Business Research Company, COVID-19 Is Behind the Remarkable Telemedicine Market Growth Rate of 40% Through 2023, GlobeNewswire (Nov. 19, 2020), https://www.globenewswire.com/news-release/2020/11/19/2130291/0/en/COVID-19-Is-Behind-The-Remarkable-Telemedicine-Market-Growth-Rate-Of-40-Through-2023.html#:~:text=The%20global%20telemedicine%20market%20size,a%20remarkable%20rate%20of%2040.4%25.
  49. Alpert, G., Telemedicine Companies, Investopedia (Mar. 24, 2020), https://www.investopedia.com/articles/insights/120316/top-5-companies-telemedicine.asp.
  50. See Nesbitt & Katz-Bell, supra n. 42. A contemporary search of PubMed for peer reviewed papers published between 2016 and 2021 including keywords “telehealth” or “telemedicine” produced over 21,200 results. PubMed, https://pubmed.ncbi.nlm.nih.gov/?term=%22telehealth%22+or+%22telemedicine%22&filter=years.2016-2021 (last visited Apr. 27, 2021).
  51. Bobinet, K. & Petito, J., Designing The Consumer-Centered Telehealth & eVisit Experience, The Office of National Coordinator for Health Information Technology – U.S. Department of Health & Human Services (2015), https://www.healthit.gov/sites/default/files/DesigningConsumerCenteredTelehealtheVisit-ONC-WHITEPAPER-2015V2edits.pdf.
  52. Faig, C. & Hall, R., US Consumers and Physicians Agree that Stakeholders Must Deliver Convenience and Personalization to Customers in the Next Wave of Health, EY (June 3, 2019), https://www.ey.com/en_us/future-health/is-your-health-strategy-keeping-pace-with-consumer-expectations-or-shaping-them.
  53. HHS, Who is Eligible for Medicare? (Sept. 11, 2014), https://www.hhs.gov/answers/medicare-and-medicaid/who-is-elibible-for-medicare/index.html#:~:text=Generally%2C%20Medicare%20is%20available%20for,Part%20B%20(Medicare%20Insurance).
  54. Kaiser Family Foundation, An Overview of Medicare (February 2019), http://files.kff.org/attachment/issue-brief-an-overview-of-medicare.
  55. See CMS, List of Telehealth Services, https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes, 42 C.F.R. § 422.135 (2020); Minemyer, P., CMS Finalizes Plan to Allow Medicare Advantage Plans to Expand Telehealth Benefits, Fierce Healthcare (May 2020), https://www.fiercehealthcare.com/payer/cms-finalizes-plan-to-allow-medicare-advantage-plans-to-expand-telehealth-benefits.
  56. Kaiser Family Foundation, Medicaid: A Primer (March 2013), https://www.kff.org/wp-content/uploads/2010/06/7334-05.pdf.
  57. See, e.g., Nesbitt & Katz-Bell, supra n. 42.
  58. 42 U.S.C. § 1395m (2020). The ability of Medicare Part C – or Medicare managed care – plans to cover telemedicine was greatly expanded in 2019, and the relevant regulation clarifies that these plans do not have to comply with Section 1834(m) if they decide to provide coverage for telemedicine visits. Due to Part C plans’ exemption from the Part B rules, Part C plans’ flexibility is significant and will not be further discussed herein. 84 Fed. Reg. 15680, 15829 (Apr. 16, 2019); 42 C.F.R. § 422.135 (2020).
  59. WestLaw, Telehealth Bridged Many Medicare Primary Care Services this Year, But What's Next, Medicare & Medicaid Guide 65454 (2020) (citing Medicare Payment Commission, Report to the Congress: Medicare and the Health Care Delivery System 235–36 (June 2016)).
  60. See 83 Fed. Reg. 59452, 59683–84 (Nov. 23, 2018). 
  61. See, e.g., 42 U.S.C. § 1395m(m) (2020); Lee, N.T., et al., Removing Regulatory Barriers to Telehealth Before and After COVID-19, Brookings Institution (May 6, 2020), https://www.brookings.edu/research/removing-regulatory-barriers-to-telehealth-before-and-after-covid-19/.
  62. Advisory Board, Should Medicare rates for telehealth be the same as in-person care? (Apr. 20, 2021), https://www.advisory.com/en/daily-briefing/2021/04/20/telehealth-rates; Boucher, R., Insight: Telemedicine Rules Should Be Permanently Eased, Bloomberg (May 13, 2020), https://news.bloomberglaw.com/health-law-and-business/insight-telemedicine-rules-should-be-permanently-eased.
  63. 42 U.S.C. § 1320b-5 (2020).
  64. Mitchell, F.H. & Mitchell, C.C., Health Law After COVID-19: Part 5. State-specific Medicaid Waivers can Support Expedited Business Planning by Enterprises, 28 No. 05 Westlaw Journal Health Law 02 (2020). Examples of Medicaid program waivers include Section 1115 waivers that permit state demonstration projects for innovative healthcare delivery and payment and 1915(c) waivers that allow for the expansion of home and community-based services for seniors and people with disabilities. Demonstration projects are commonly used to set aside statutory requirements in order to deliver care in innovative ways. For further reading on Section 1115 and 1915(c) waivers, see, e.g., American Academy of Family Physicians, Section 1115 Demonstration Waivers (2019), https://www.aafp.org/dam/AAFP/documents/advocacy/coverage/medicaid/BKG-Section1115Waivers.pdf; Wang, Y., Understanding Home and Community-Based Long-Term Services and Supports An Evaluation of Medicaid's Balancing Incentive Program, RAND (2019), https://www.rand.org/content/dam/rand/pubs/rgs_dissertations/RGSD400/RGSD426/RAND_RGSD426.pdf.
  65. Schneider, A., COVID-19 Medicaid Waiver Soup Explained, Georgetown U. Health Pol’y Inst. (Apr. 23, 2020), https://ccf.georgetown.edu/2020/04/23/covid-19-medicaid-waiver-soup-explained/; Popa, A.M., The Role of Compliance in Creating Flexible Hospital Operations During the Covid-19 Nationwide Emergency, 22 No. 3 J. Health Care Compliance 17, 18 (2020). For further reading on State Plan Amendments, see, e.g., Gardner, A., Approved Disaster Relief SPAs Reduce Burdens on Beneficiaries, Georgetown U. Health Pol’y Inst. (Apr. 15, 2020), https://ccf.georgetown.edu/2020/04/15/approved-disaster-relief-spas-reduce-burdens-on-beneficiaries/.
  66. For an updated listing of COVID-19 waivers, see CMS, Coronavirus Waivers & Flexibilities, https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.
  67. 42 U.S.C. § 1320b-5 (2020).
  68. Popa, supra n. 65, at 18.
  69. Mitchell & Mitchell, supra n. 64.
  70. 42 U.S.C. § 1320b-5(b) (2020).
  71. 42 U.S.C. § 1320b-5(g) (2020).
  72. 42 U.S.C. § 1320b-5(e) (2020).
  73. 42 U.S.C. § 1395m(m) (2020).
  74. CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers 36 (Sept. 29, 2020), https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf.
  75. Id.
  76. Id.; 42 U.S.C. § 1320b-5 (2020).
  77. Brown, C., Relaxed Regulations Bring Compliance Challenges, Attorneys Say, Bloomberg (Apr. 7, 2020), https://news.bloomberglaw.com/health-law-and-business/relaxed-regulations-bring-compliance-challenges-attorneys-say.
  78. Certified registered nurse anesthetists are advanced practice registered nurses who have been credentialed to provide certain anesthesia services. American Association of Nurse Anesthetists, Certified Registered Nurse Anesthetists Fact Sheet (Feb. 1, 2021), https://www.aana.com/membership/become-a-crna/crna-fact-sheet.
  79. 42 U.S.C. § 1395m(m)(4)(E) & 1395u(b)(18)(C) (2020).
  80. CMS, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers 1 (Apr. 8, 2021), https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf.
  81. Id.
  82. 42 U.S.C. § 1395m(m)(4)(C)(i) (2020); 42 C.F.R. § 410.78(b)(4) (2020).
  83. CMS, supra n. 17.
  84. 42 U.S.C. § 1395m(m)(4)(C)(ii) (2020); 42 C.F.R. § 410.78(b)(3) (2020).
  85. This change was made through the Coronavirus Preparedness and Response Supplemental Appropriations Act, P.L. 116–123 § 102(a), 134 STAT. 156 (Mar. 6, 2020). CMS, supra n. 17. State licensure laws for physicians may still place limits on the patient’s location, but only if the provider and physician(s) are located in separate states.
  86. Boucher, supra n. 62.
  87. CMS, supra n. 17.
  88. Coronavirus Preparedness and Response Supplemental Appropriations Act, P.L. 116–123 § 102(a), 134 STAT. 156 (Mar. 6, 2020); 42 U.S.C. § 1395m(m)(4)(C)(ii) (2020). Such a fee may be used if the originating site (site where the patient receives care) is a physician’s office, hospital, or most other types of medical settings. 85 Fed. Reg. 19230, 19233 (Apr. 6, 2020).
  89. 85 Fed. Reg. 19230, 19233 (Apr. 6, 2020).
  90. 42 U.S.C. § 1395m(m)(1) (2020); 42 C.F.R. § 410.78(a)(3) (2020).
  91. CMS, supra n. 80, at 1. For the list of services that can be furnished by telephone, see https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.
  92. Coronavirus Preparedness and Response Supplemental Appropriations Act, P.L. 116–123 § 102(a), 134 STAT. 156 (Mar. 6, 2020).
  93. 85 Fed. Reg. 19230, 19243 (Apr. 6, 2020); 42 C.F.R. § 410.78(a)(3)(i) (2020).
  94. 42 C.F.R. § 410.78(a)(3) (2020) (emphasis added).
  95. 42 C.F.R. § 410.78(b)(1) (2020).
  96. Nelson, K., “To Infinity and Beyond”: A Limitless Approach to Telemedicine Beyond State Borders, 85 Brook. L. Rev. 1017, 1018.
  97. Public Health Emergency, Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (Mar. 13, 2020), https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
  98. Federation of State Medical Boards, U.S. States and Territories Modifying Licensure Requirements for Physicians in Response to COVID-19 (Mar. 16, 2021), https://www.fsmb.org/siteassets/advocacy/pdf/state-emergency-declarations-licensures-requirementscovid-19.pdf.
  99. 42 U.S.C. § 1395nn (2020).
  100.   Id.
  101. The Stark Law, codified at 42 U.S.C. § 1395nn, is Section 1877 of the Social Security Act. Thus, these waivers are referred to as 1877(g) waivers.
  102.  Public Health Emergency, Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (Mar. 13, 2020), https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.; CMS, Blanket Waivers of Section 1877(g) of the Social Security Act Due to Declaration of COVID-19 Outbreak in the United States as a National Emergency (Mar. 1, 2020), https://www.cms.gov/files/document/covid-19-blanket-waivers-section-1877g.pdf. COVID-19 purposes include: “Diagnosis or medically necessary treatment of COVID-19 for any patient or individual, whether or not the patient or individual is diagnosed with a confirmed case of COVID-19; Securing the services of physicians and other health care practitioners and professionals to furnish medically necessary patient care services, including services not related to the diagnosis and treatment of COVID-19, in response to the COVID-19 outbreak in the United States; Ensuring the ability of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States; Expanding the capacity of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States; Shifting the diagnosis and care of patients to appropriate alternative settings due to the COVID-19 outbreak in the United States; or Addressing medical practice or business interruption due to the COVID-19 outbreak in the United States in order to maintain the availability of medical care and related services for patients and the community.” Id.
  103.  CMS, supra n. 102. For further reading on Stark waivers, see, e.g., Jenkins, M., The Time Is Now for a Blanket Stark Law Waiver, Law 360 (Mar. 23, 2020), https://www.law360.com/articles/1255516/the-time-is-now-for-a-blanket-stark-law-waiver.
  104.  CARES Act, P.L. 116–136 § 3703, 134 STAT. 416 (Mar. 27, 2020); 42 U.S.C. § 1320b-5 (2020).
  105.  Or another provider in the same medical practice. 42 U.S.C. § 1320b-5(g)(3)(B) (2019).
  106.   See supra, CARES Act, N. 104.
  107. See Boucher, supra n. 62.
  108.  HHS, Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (last updated Mar. 30, 2020), https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html. For the HIPAA rules, see 45 C.F.R. Parts 160 & 164.
  109.  HHS Office for Civil Rights, FAQs on Telehealth and HIPAA During the COVID-19 Nationwide Public Health Emergency, https://www.hhs.gov/sites/default/files/telehealth-faqs-508.pdf.
  110. Id.
  111. Id.
  112. For further reading on sizable consequences for HIPAA violations, see, e.g., HIPAA Journal, What Are the Penalties for HIPAA Violations (June 24, 2015), https://www.hipaajournal.com/what-are-the-penalties-for-hipaa-violations-7096/.
  113. 21 U.S.C. § 829(e).
  114. 21 U.S.C. § 802(54)(D).
  115. U.S. DEA Diversion Control Unit, COVID-19 Information Page (last visited Mar. 27, 2021), https://deadiversion.usdoj.gov/coronavirus.html.
  116. 85 Fed. Reg. 19230, 19232 (Apr. 6, 2020).
  117. Id.
  118. 85 Fed. Reg.  27550, 27602 (May 8, 2020).
  119. 42 C.F.R. § 410.78(f) (2020).
  120.  CMS, Trump Administration Drives Telehealth Services in Medicaid and Medicare (Oct. 14, 2020), https://www.cms.gov/newsroom/press-releases/trump-administration-drives-telehealth-services-medicaid-and-medicare. The up-to-date Medicare Telehealth List can be found at: https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.
  121. 85 Fed. Reg. 84472 et seq. (Dec. 28, 2020).
  122. 85 Fed. Reg.  84472, 84507–17 (Dec. 28, 2020).
  123. That is, they must be deemed, after clinical evaluation, either a “Category 1” service, (service similar to those on the current Medicare Telehealth list) or a “Category 2” (service not similar to those on the list). 85 Fed. Reg.  19230, 19233–34 (Apr. 6, 2020); 67 Fed. Reg. 79966, 79988 (Dec. 31, 2002). 85 Fed. Reg. 84472, 84507 (Dec. 28, 2020).
  124. 85 Fed. Reg.  84472, 85003 (Dec. 28, 2020).
  125. Looney, K. & Huffman, M., That Was Then and This Is Now—How the COVID-19 Crisis Changed Telehealth Services: Are the Changes Here to Stay?, AHLA (Sept. 1, 2020) (citing Telehealth: Best Consumer Healthcare Experience You’ve Never Tried, Says J.D. Power Study, J.D. Power (Oct. 28, 2019), https://www.jdpower.com/business/press-releases/2019-us-telehealth-satisfaction-study).
  126. Alexander, L., Alexander: Make the Two Most Important COVID-19 Telehealth Policy Changes Permanent (June 17, 2020), https://www.alexander.senate.gov/public/index.cfm/2020/6/alexander-make-the-two-most-important-covid-19-telehealth-policy-changes-permanent (the other permanent change Alexander recommended is making telemedicine services reimbursable regardless of where the patient is located).
  127. CMS, supra n. 17.
  128. World Health Organization, supra n. 4, at 9 (emphasis added).
  129.  84 Fed. Reg. 15680, 15829 (Apr. 16, 2019); 42 C.F.R. § 422.135 (2020).
  130.  Medicare, What Part B Covers, https://www.medicare.gov/what-medicare-covers/what-part-b-covers.
  131. Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2003 and Inclusion of Registered Nurses in the Personnel Provision of the Critical Access Hospital Emergency Services Requirement for Frontier Areas and Remote Locations, 67 Fed. Reg. 79966, 79988 (Dec. 31, 2002); 42 U.S.C. 1395m(m)(4)(F)(ii) (2020); 85 Fed. Reg. 19230, 19233 (Apr. 6, 2020). For further information on the regulatory process of adding telemedicine services to the list, see CMS, CMS Criteria for Submitted Requests, https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Criteria.
  132. 85 Fed. Reg. 19230, 19233–34 (Apr. 6, 2020); 67 Fed. Reg. 79966, 79988 (Dec. 31, 2002).
  133. Id.
  134. Morse, S., Congressional Action Is Needed for Telehealth Not to Return to a Rural Benefit, Seema Verma Says (Dec. 1, 2020), https://www.healthcarefinancenews.com/news/congressional-action-needed-telehealth-not-return-rural-benefit-cms-administrator-seema-verma.
  135. 42 U.S.C. § 1395m(m)(4)(C)(ii) (2020); 42 C.F.R. § 410.78(b)(3) (2020); 42 U.S.C. § 1395m(m)(4)(C)(i) (2020); 42 C.F.R. § 410.78(b)(4) (2020).
  136. Boucher, supra n. 62 (emphasis added).   
  137. See Lee, et al., supra n. 61. There are also multiple initiatives at the state and federal levels to expand broadband access for Americans, e.g., id.; Stauffer, A., et al., How States Are Expanding Broadband Access, The Pew Charitable Trusts (February 2020), https://www.pewtrusts.org/-/media/assets/2020/03/broadband_report0320_final.pdf. At the federal level, the Federal Communications Commission has provided hundreds of millions of dollars to healthcare providers during the PHE to increase their access to broadband and the devices and information necessary to provide telemedicine visits. Federal Communications Commission, Connecting Americans to Health Care, https://www.fcc.gov/connecting-americans-health-care (last visited May 9, 2021).
  138. Shachar, C., et al., Implications for Telehealth in a Postpandemic Future: Regulatory and Privacy Issues, 323 JAMA 2375, 2375 (June 2020) (arguing that once the PHE has ended, “clinicians may be challenged in finding telehealth technology partners willing to sign business associate agreements given the prepandemic requirements for security and privacy”).
  139. HHS, supra n. 108.
  140.  See Shachar, et al., supra n. 138.
  141. DOJ, National Health Care Fraud and Opioid Takedown Results in Charges Against 345 Defendants Responsible for More than $6 Billion in Alleged Fraud Losses (Sept. 30, 2020), https://www.justice.gov/opa/pr/national-health-care-fraud-and-opioid-takedown-results-charges-against-345-defendants.
  142. Sullivan, T., HHS OIG Announces Audits for Telehealth and Medicare Part B (Feb. 28, 2021), https://www.policymed.com/2021/03/hhs-oig-announces-audits-for-telehealth-and-medicare-part-b.html.
  143. Committee on Energy and Commerce: Opening Statement as Prepared for Delivery of Subcommittee Chairwoman Anna G. Eshoo Hearing on “The Future of Telehealth: How COVID-19 is Changing the Delivery of Virtual Care” (Mar. 2, 2021), https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/2021.3.2.%20Eshoo%20Opening%20Statement.HE_.pdf.

About the Author

Nathan Gardner dreamed of practicing health law from the age of seventeen when he happened to fall into a health law track at a local university summer camp in northeast Louisiana. During college at Louisiana Tech University, he experienced a failed surgery and the healthcare system’s utter lack of coordination. Inspired by that experience, Mr. Gardner strives to promote high quality, accessible healthcare through his practice. He attended Saint Louis University, where he concurrently obtained a Juris Doctor degree with a health law concentration and a Master of Health Administration. He is an associate at the law firm of Carlton Fields, in Tampa, Florida where he practices in the transactional and regulatory healthcare space.  He may be reached at [email protected].