On March 11, 2020 the World Health Organization (WHO) declared the new coronavirus a pandemic.1 At a national level, countries have initiated or strengthened their protective measures to contain the COVID-19 disease outbreak. The health systems of most countries were not prepared to deal with the results of a pandemic. People were also not ready for such an abrupt change of lifestyle, including determinations of social distancing and social isolation.
The current situation brought to light the most complex and wide-ranging legal discussions regarding healthcare delivery, and has encouraged government authorities to soften many regulatory requirements regarding the provision of healthcare services. Countries such as the United States and Brazil saw it as a way to invest in alternative methods of offering healthcare services without the need for people to leave their homes.
In this scenario, the importance of digital health is growing significantly. Its impacts adapt to different social and economic realities in different countries, such as the United States and Brazil. Although the structures of their healthcare systems are very different, both countries have issued new rules or amended existing legislation that somehow encourage the use of telehealth2 to combat the spread of COVID-19.
This article will provide an overview of the American and Brazilian healthcare systems and the ways they have expanded telehealth in light of the pandemic. Despite having very different healthcare systems, both countries have been adopting this similar solution in the fight against COVID-19.
The American and Brazilian Healthcare Systems
The United States
The United States does not provide universal healthcare coverage to its citizens, residents or visitors. Individuals may have access to healthcare through public insurance, private insurance and/or direct out of pocket expenses.
The United States Department of Health and Human Services (HHS) administers the nation’s major healthcare programs (i.e., public insurances), including Medicare, Medicaid and the Children’s Health Insurance Program (CHIP). In 2018 public coverage encompassed 34.4 percent of the population.3
Medicare is a federal health insurance program for people who are 65 or older, certain younger people with disabilities and people with permanent kidney failure requiring dialysis or a transplant. Medicare has different parts for the coverage of specific services, as follows: hospital insurance (Medicare part A); medical insurance (Medicare part B); prescription drug coverage (Medicare part D); and an “all in one” alternative (Medicare Advantage, also known as part C).4
The Medicaid program provides insurance coverage to certain low-income adults, children and pregnant women, elderly adults, and people with disabilities that meet certain eligibility requirements. Within certain general federal parameters, each state has the flexibility to determine covered populations, covered services, healthcare delivery models, and reimbursement structures.5
The CHIP program provides low-cost health coverage to children, and sometimes pregnant women, in families that earn too much money to qualify for Medicaid but not enough to buy private insurance. Like Medicaid, CHIP is administered by states, according to federal requirements and funded jointly by states and the federal government.
Private insurance plays a significant role in the American healthcare system. According to U.S. census data from 2018, private health insurance continued to be more prevalent than public coverage, covering 67.3 percent of the population.6 For the same year, of the subtypes of private health insurance coverage, employer-based insurance was the most common.7 The states are the primary regulators of private health insurance, but some forms of private insurance are governed by federal law, such as the Employee Retirement Income Security Act (ERISA).8
It is noteworthy to mention that the health industry is highly regulated in the United States. Just a few of the federal laws regulating healthcare include the Patient Protection and Affordable Care Act (PPACA),9 Medicare Access and CHIP Reauthorization Act,10 and Health Insurance Portability and Accountability Act (HIPAA).11 There are also a vast range of regulatory requirements which are normally defined by the states for the healthcare service providers to be able to develop their activities, including the obtaining of a license or permit.
Unlike the United States, in Brazil the right to health is standardized as a fundamental right by the Brazilian Federal Constitution.12 Thus, the Brazilian federal government has the power to establish social and economic policies and rules to regulate not only public health assistance activities, but also the private healthcare system and the provision of medical services. At a federal level, the Ministry of Health is the government body responsible for organizing public plans and policies for matters related to health.
Since 1988, when the current Brazilian Federal Constitution was enacted, the country has one of the largest public health systems in the world, known as the Universal Health System (in Portuguese: Sistema Único de Saúde - SUS).13 SUS is regulated by federal government bodies and state and municipal public agencies (including governmental authorities and foundations maintained by the government). SUS is full, universal and free for the Brazilian population. It provides all types of healthcare assistance, from outpatient care to organ transplantation, including drug supply.
As in the United States, the Brazilian population counts on private healthcare insurance as well. However, the reason for doing so is different. Since the United States does not provide universal health coverage for its population, if an individual is not enrolled in public health insurance (for which the eligibility is limited), there are only two alternatives: purchasing private insurance or bearing the risk of not having any insurance. On the other hand, in Brazil, although SUS is a well-intentioned program, it is a challenge to apply theory in practice. The lack of resources that exists in the country makes it harder for SUS to provide all of the healthcare services which are guaranteed by the legislation.
Therefore, even though the Brazilian government provides free healthcare access for everyone, at the end of 2019 24.1 percent of the Brazilian population counted on a private healthcare plan instead of being enrolled with SUS, according to public data from the National Private Health Insurance and Plans Agency (in Portuguese: Agência Nacional de Saúde Suplementar – ANS).14
ANS is a regulatory agency in charge of regulating, monitoring and overseeing health maintenance organizations (HMOs) and health insurance companies, as well as their relationship with healthcare providers and consumers.15 In addition, HMOs, health insurance companies and healthcare service providers (including healthcare establishments and healthcare professionals) are normally regulated by other governmental authorities, such as the National Health Surveillance Agency (in Portuguese: Agência Nacional de Saúde Suplementar (ANVISA),16 the Professional Council of Medicine (in Portuguese: Conselho Federal de Medicina (CFM),17 and local authorities.
New Regulatory Highlights Regarding Telehealth
HHS declared a public health emergency in the United States on January 31, 2020, under Section 319 of the Public Health Service Act (42 U.S.C. § 247d), in response to COVID-19.18 On March 13, 2020 President Donald Trump proclaimed that the COVID-19 outbreak in the United States constitutes a national emergency. One of the provisions encompassed under the national emergency declaration is that HHS may exercise the authority under Section 1135 of the Social Security Act (SSA) to temporarily waive or modify certain requirements of Medicare, Medicaid, CHIP and HIPAA throughout the duration of the declared public health emergency.19
The American federal government also adopted quarantine and isolation measures on the grounds of the Commerce Clause of the U.S. Constitution.20 To enforce isolation and quarantine within their borders, several states and local authorities have enacted so called “stay-at-home orders.”21
On February 3, 2020 the Brazilian Ministry of Health issued Ordinance No. 188/2020 declaring the effects of COVID-19 as a national public health emergency.22 A few days later, Brazilian President Jair Bolsonaro enacted Law No. 13,979/2020, which provides for measures to address the public health emergency of international importance due to the coronavirus outbreak, including the possibility of adoption of isolation and quarantine.23 Therefore, several states, including São Paulo, imposed a quarantine and determined that people should stay home.24
Since isolation has been adopted in both countries as a vehicle to contain the spread of the virus, investing in an alternative so that people can continue to devote themselves to their health without leaving home is essential. Telehealth plays a significant role in the accomplishment of the isolation measures concomitantly with the continuous delivery of healthcare services.
The United States
Prior to the coronavirus outbreak, telehealth was somewhat familiar in the United States, though not common in practice due to the heavy regulations and restrictions on reimbursement and platforms which could be used.25
As mentioned above, Section 1135 of the SSA authorizes the HHS secretary to temporarily modify or waive certain Medicare, Medicaid, CHIP, and HIPAA requirements.26 The purpose of the 1135 waiver is to ensure that enough healthcare services are available to meet the needs of individuals enrolled in public healthcare programs in an emergency.27 As result of this prerogative, the Centers for Medicare & Medicaid Services (CMS) issued several blanket waivers to expand the use of telehealth.28
On March 17, 2020, CMS announced that it will relax telehealth restrictions on Medicare. Treatment was extended to patients’ homes, and telehealth is no longer limited to patients in remote areas. Prior to this waiver, Medicare could only pay for telehealth when the person receiving the service was in a designated rural area and when he/she left home and went to a clinic, hospital, or certain other types of medical facilities for the service. By relaxing the restrictions, CMS allowed program funds to be spent on telehealth services to broaden the number of patients who can be treated and reduce the need for sick patients to travel for treatment to or within major population centers.29
According to the Medicare Telemedicine Health Care Provider Fact Sheet issued by CMS,30 which is effective for services starting March 6, 2020 and for the duration of the COVID-19 emergency, physicians might render telehealth services from their home while continuing to bill using the address on their Medicare enrollment form without having to report their home address.
HHS’ Office of Inspector General (OIG) is providing flexibility for healthcare providers to reduce or waive cost-sharing for telehealth visits paid by federal healthcare programs.31 Usually the Medicare coinsurance and deductible would apply to telehealth services. In addition, according to the policy of enforcement discretion announced by HHS, to the extent the 1135 waiver requires an established relationship, HHS will not conduct audits to ensure that such a prior relationship existed for claims submitted during this public health emergency.32 In addition, HHS announced that it will waive potential penalties for unintentional and good faith violations of HIPAA to encourage healthcare providers to use telehealth services to treat potentially sick patients.33
In addition, CMS is temporarily waiving requirements that licensed, out-of-state practitioners be licensed in the state where they are providing services when specific conditions are met, including for consultation via telehealth. However, the specific state also would have to waive its licensure requirements, either individually or categorically, for the type of practice for which the physician or non-physician practitioner is licensed in his/her home state.34 For instance, California,35 Florida,36 Louisiana,37 and Washington38 have waived certain healthcare provider licensing requirements or delegated this authority to the applicable regulatory agencies.
On March 27, 2020 the Coronavirus Aid, Relief, and Economic Security (CARES) Act39 was enacted into law, providing, among other things, $200 million to the Federal Communications Commission (FCC) to support healthcare providers in the fight against the ongoing pandemic. On April 2, 2020, the FCC launched two programs to support healthcare providers in expanding telehealth and virtual care to patients, the Telehealth Program and the Connected Care Pilot Program. The former will provide funding to help healthcare providers provide connected care services to patients at their homes or mobile locations in response to the pandemic. The Connected Care Pilot Program aims to provide financial support to help defray healthcare providers’ costs of providing connected care services and to help assess how the Universal Service Fund (USF)40 can be used in the long term to support telehealth.41
States have also taken steps to increase access to telehealth. For example, New York Governor Anthony Cuomo issued Insurance Circular Letter No. 6/2020 (Letter) with the purpose of reminding insurers authorized in the state, such as article 43 corporations, HMOs and municipal cooperative health benefit plans (Issuers) of coverage requirements for telehealth services.42 According to the Letter, Insurance Law §§ 3217-h and 4306-g and Public Health Law § 4406-g forbid issuers from excluding a service that is otherwise covered under a health insurance policy or contract because the method for delivery of the service is telehealth. In addition, the Letter states that the use of telehealth is essential to reduce the spread of COVID-19 and to ensure access to covered services. Lastly, according to the content of the Letter, Issuers and prepaid health services plans should ensure that telephonic and video modalities are covered for telehealth when medically appropriate for the provision of services covered under a policy or contract, including Medicaid coverage.
The regulation from CFM currently in force allows the exercise of telehealth only in situations of urgency and emergency.43 Thus, before the crisis, it was possible to say that telehealth in Brazil was not familiar to the population and even more restricted than in the United States. However, as a way of combating the coronavirus outbreak, Federal Law No. 13,989/2020 was enacted by the Brazilian National Congress in mid-April to regulate the use of telehealth during the crisis caused by the pandemic.44
The law determines that the healthcare service provided via telehealth shall follow the usual normative and ethical standards of in-person care, including in relation to financial compensation for the provision of the service. In addition, it states that public authorities should not fund or pay for such services when they are not directly provided in connection with SUS.
Therefore, on an exceptional basis and as long as the pandemic lasts, CFM recognized the possible use of telehealth. The physician is required to inform the patient of all limitations on the use of telehealth, including the impossibility of performing a physical examination during the consultation.45
In addition to the law mentioned above, ANS recognized by means of a technical notice telehealth as a modality of medical consultation.46 Since medical consultation was already listed among the mandatory services/procedures in the agency’s list, ANS did not need to issue a new regulation to directly include telehealth in the list. Thus, private health insurances are supposed to cover consultations via telehealth at least so long as the pandemic scenario lasts.
Furthermore, to help healthcare providers to develop their services via telehealth, other resolutions have been enacted by the Ministry of Health and other federal authorities, such as one which determines the requirements for digital medical prescription.47
Preliminary Effects of the Relaxation of Restrictions
Across the globe, people are turning to telehealth, remote work, online learning and other digital resources to enable social distancing measures. Considering: (1) the large size of both Brazil and the United States; and (2) the fact that Brazil and the United States are among the 10 most populated countries in the world, providing healthcare services without the need of physical presence has been an important tool to slow the spread of coronavirus.
The regulatory and legal flexibilities granted by both the United States and Brazil significantly increased the use of telehealth to provide and receive healthcare services during the COVID-19 crisis. For example, in the United States, from March 14 to April 1, daily telehealth claims for upper respiratory infections using ICD-10 diagnosis codes from private insurance increased nearly 12 times from the daily average over the previous month. 48 Also, according to the same report, telehealth’s recent growth coincides with a significant reduction in urgent care and hospital outpatient services utilization since March. In Brazil, companies offering telehealth services are constantly growing.49 In addition, due to the large size of both countries, telehealth plays an important role providing health services to populations in more remote areas.
The American and Brazilian governments have chosen to grant regulatory flexibility to encourage the use of telehealth to combat the public health crisis. While in the United States telehealth was already somewhat familiar and the most significant barriers were regarding regulatory issues and operation procedures (reimbursements, platforms, etc.), in Brazil telehealth was barely used before the pandemic and, for example, forbidden by CFM unless the situation was characterized as urgency or emergency. Furthermore, since the United States and Brazil have completely different healthcare systems and social economic realities, it is expected that the evolution of telehealth will be different in each country.
For healthcare service providers, HMOs, insurance companies, beneficiaries/policyholders, and patients it is important to keep monitoring the regulatory changes while the emergency scenario persists. It is also relevant to reflect about the post crisis period and the impacts that a pandemic experience will leave on the society and legal systems. The impact that the use of technology as an auxiliary source in the provision of health services has generated in society is evident. In this regard, the question that remains is if governments will keep encouraging the use of telehealth on a permanent basis.
- While “telehealth” and ‘telemedicine” generally have two separate and distinct meanings and implications, the term telehealth will be used for the purposes of this article.
- ERISA is a federal law that sets minimum standards for most voluntarily established retirement and health plans in private industry to provide protection for individuals in these plans. See https://www.congress.gov/bill/93rd-congress/house-bill/2 and https://www.dol.gov/general/topic/health-plans/erisa.
- Brazilian Federal Constitution - http://www.planalto.gov.br/ccivil_03/constituicao/constituicao.htm - PT language only.
- SUS was created from the 1988 Brazilian Federal Constitution, which determined access to healthcare for everyone. See https://www.saude.gov.br/sistema-unico-de-saude/sistema-unico-de-saude - PT language only.
- https://www.ans.gov.br/perfil-do-setor/dados-gerais - PT language only.
- Competence of ANS - Federal Law - http://www.planalto.gov.br/ccivil_03/leis/l9656.htm - PT language only.
- ANVISA’s purpose is to promote the health protection of the population, through the sanitary control of the production and commercialization of products and services submitted to sanitary surveillance, including environments, processes, inputs and related technologies, as well as the control of ports, airports and borders. See http://www.planalto.gov.br/ccivil_03/leis/l9782.htm - PT language only.
- CFM has attributions of inspection and regulation of the medical practice. The Council defends, primarily, the interests of the medical professionals. - http://portal.cfm.org.br/index.php?option=com_content&view=article&id=20671&Itemid=23 - PT language only.
- https://www.cdc.gov/quarantine/aboutlawsregulationsquarantineisolation.html and https://edition.cnn.com/2020/03/23/us/coronavirus-which-states-stay-at-home-order-trnd/index.html.
- http://www.in.gov.br/en/web/dou/-/portaria-n-188-de-3-de-fevereiro-de-2020-241408388 - PT language only.
- http://www.in.gov.br/en/web/dou/-/lei-n-13.979-de-6-de-fevereiro-de-2020-242078735 - PT language only.
- https://www.al.sp.gov.br/repositorio/legislacao/decreto/2020/decreto-64881-22.03.2020.html - as well further modifications - PT language only.
- https://www.brookings.edu/research/removing-regulatory-barriers-to-telehealth-before-and-after-COVID-19/, https://www.whitehouse.gov/articles/deregulation-sparks-dramatic-telehealth-increase-COVID-19-response/ and https://www.usnews.com/news/healthiest-communities/articles/2020-05-07/telehealth-a-boost-for-rural-america-during-coronavirus-pandemic.
- https://www.gov.ca.gov/wp-content/uploads/2020/03/3.4.20-Coronavirus-SOE-Proclamation.pdf and https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-COVID-19-outbreak/.
- https://www.fcc.gov/document/fcc-fights-COVID-19-200m-adopts-long-term-connected-care-study; https://www.fcc.gov/fcc-approves-emergency-COVID-19-telehealth-and-connected-care-pilot-programs and https://www.fcc.gov/COVID-19-telehealth-program.
- https://sistemas.cfm.org.br/normas/visualizar/resolucoes/BR/2002/1643 and https://sistemas.cfm.org.br/normas/visualizar/resolucoes/BR/2018/2217 - PT language only.
- http://www.in.gov.br/en/web/dou/-/lei-n-13.989-de-15-de-abril-de-2020-252726328 - PT language only.
- http://portal.cfm.org.br/images/PDF/2020_oficio_telemedicina.pdf - PT language only.
- http://www.ans.gov.br/images/stories/noticias/pdf/Nota_Técnica_3.pdf and www.ans.gov.br/images/stories/noticias/pdf/NOTA_TÉCNICA_7_DIPRO.pdf - PT language only.
- http://www.in.gov.br/en/web/dou/-/resolucao-n-170-de-23-de-abril-de-2020-253759543 and http://www.in.gov.br/en/web/dou/-/portaria-n-467-de-20-de-marco-de-2020-249312996 - PT language only.
- https://cryptoid.com.br/identidade-digital-destaques/empresa-de-telemedicina-aumentou-em-10-vezes-o-numero-de-atendimentos-desde-o-inicio-da-pandemia/- PT language only.
About the Authors
Ana Cândida Sammarco is admitted to practice law in São Paulo/Brazil. She is the partner head of Mattos Filho Advogados’ Life Science & Healthcare practice. She holds an LL.M. degree from Miami University, has extension courses in Business Negotiation from Harvard Law School and in Business Law from Escola de Formação da Sociedade Brasileira de Direito Público in Brazil. Ms. Sammarco was recommended by Who’s Who Legal: Healthcare (2020). She can be reached at [email protected].
Caroline Aguiar is admitted to practice law in the State of New York/United States and in São Paulo/Brazil. She is an associate at Mattos Filho Advogados and is part of the Life Sciences and Healthcare practice. Ms. Aguiar holds an LL.M. degree from the University of Chicago. She may be reached at [email protected].
Victoria Henriques is admitted to practice law in Rio de Janeiro/Brazil. She is an associate at Mattos Filho Advogados and is part of the Life Sciences and Healthcare practice. Ms. Henriques is pursuing a post-graduation certificate in Health Law at the State University of Rio de Janeiro in Brazil. She may be reached at [email protected].