This article was originally published in the American Bar Association Health Law Section’s The Health Lawyer August 2020 edition, which you can view by clicking here.
COVID-19 has been catastrophic in terms of loss of lives and impact on the U.S. economy. The entry of COVID-19 into the United States has been nothing short of a dawning of a new age for telehealth, however. Before the highly contagious, easily transmitted COVID-19 virus came to U.S. shores in early to mid-winter, telehealth had been gaining traction in mainstream medicine, but the practice still had a long way to go before being adopted and utilized ubiquitously. Several barriers to entry existed that counseled away from providers actively pursuing adoption of telehealth. For example, coverage for telehealth services was limited, and the process for obtaining required licenses for treating patients across state lines was burdensome. Integrating telehealth into the practice of healthcare required an attitude shift that COVID-19 forced upon providers and patients alike. Historically, patients objected to the notion that their ailments could be treated via remote means, and physicians remained reluctant to adopt the technology required to practice clinical care virtually. COVID-19 forced a number of important changes upon telehealth practice, which are addressed methodically below, but many of these changes are temporary in nature. Whether and to what extent some of the COVID-19-inspired changes remain as the world adjusts to the new normal is an open question, but worthy of consideration.
I. Licensure
A fundamental principle underlying the delivery of healthcare is that the provider must be appropriately licensed, which typically means being licensed in the state in which a patient in located. A clinician hoping to provide care across multiple state lines generally must be licensed in the corresponding states in which he or she hopes to provide care. Obtaining licensure in multiple states is both costly and time consuming. For qualifying physicians, there does exist an expedited pathway for licensure, the Interstate Medical Licensure Compact (IMLC), provided a given state is a member of the IMLC.[1] The IMLC is an agreement among participating U.S. states to work together to streamline licensing for physicians who want to practice in multiple states. Currently, the IMLC includes 29 states, the District of Columbia, and Guam. Physicians wanting to practice in states that are not members of the IMLC must navigate the draconian and often lengthy licensure process instituted by the state medical board.[2]
In advance of the telehealth exceptions enacted in response to COVID-19, there existed and continue to exist exceptions to this basic truth that a provider must be licensed in the state in which a patient is located, but the exceptions are limited. For example, in Virginia, under Va. Code Ann. § 54.1-2901(A), the requirement that a physician be licensed in the state of Virginia before providing clinical services to a patient located in Virginia does not apply to the rendering of medical advice or information through telecommunications from a physician licensed to practice medicine in Virginia or an adjoining state, or from a licensed nurse practitioner, to emergency medical personnel acting in an emergency situation. Effective July 1, 2020, the newly enacted Virginia H.B. 1701 mandates a determination of the feasibility of a “Medical Excellence Zone Program” and requires the Department of Health Professions (which includes physicians) to pursue reciprocal agreements with states contiguous with the Commonwealth for licensure for certain primary care practitioners under the Board of Medicine.[3]
Many states have enacted a peer-to-peer licensure exception that allows providers not licensed in the state in which the patient is located to consult with a physician who is licensed in the state in which the patient is located and is treating that patient. For example, under Mich. Comp. Laws Ann. § 333.16171(e), an individual who resides in another state or country and is authorized to practice a health profession, e.g., a provider licensed under Article 15 of the Michigan Public Health Code such as physicians, dentists and nurses in that state or country who, in an exceptional circumstance, may be called in for consultation or treatment by a health professional in Michigan.
Licensure has long been considered a barrier to entry for healthcare providers hoping to practice their craft across state lines via telehealth, and, despite cries from industry for an efficient licensure process in all states, states have been historically slow to adopt a seamless process . . . until COVID-19. The acute need for healthcare professionals in states experiencing a spike in COVID-19 cases led state governors to issue temporary waivers of professional licensure for out-of-state telehealth providers and telehealth standards of practice in response to COVID-19. For example, on March 23, 2020, the Connecticut Department of Public Health suspended licensure requirements for medical services, medicine and surgery, physical therapists, nursing, nurse’s aides, respiratory care practitioners, psychologists, marital and family therapists, clinical social workers and master social workers, professional counselors, emergency medical services personnel, and pharmacists to allow persons who are appropriately licensed, certified or registered in another state or territory of the United States or the District of Columbia, to render temporary assistance in Connecticut within the scope of the profession for which a provider is licensed, certified or registered.[4] On April 22, 2020, the Governor of Connecticut issued Executive Order No.7DD suspending the licensure requirements found at Connecticut statute section 19a-906 for Medicaid enrolled providers.[5] Under existing law, the Connecticut Department of Health is permitted to establish a procedure to process out-of-state licensure applications without examination.[6] The Department of Public Health’s Order was broader than the Governor’s Executive Order No. 7G and was not limited to Medicaid providers as was the Governor’s Executive Order.[7] On July 14, 2020, the Governor signed Executive Order No. 7HHH and authorized the Commissioner of Public Health to temporarily suspend, for the duration of the public health and civil preparedness emergency, the requirements for licensure, certification, or registration for a broad swath of providers such as physicians, nurses, and physical therapists.[8] The Department of Public Health obliged by issuing an Order to allow the same broad swath of providers who are appropriately licensed, certified or registered in another state or territory of the United States or the District of Columbia, to render temporary assistance in Connecticut within the scope of the profession for which a provider is licensed, certified or registered.[9]
As the Connecticut order demonstrates, state licensure waivers are temporary, and, unless made permanent, will expire. Although many are hopeful that the waiver regime in place during COVID-19 will continue past the instant public health crisis, it is not intuitive that states will take a permissive approach to licensure when the need for healthcare providers subsides.
When the President of the United States declares a major disaster under the Stafford Act or an emergency under the National Emergencies Act and the Health and Human Services (HHS) Secretary declares a public health emergency under Section 319 of the Public Health Service Act, the Secretary is authorized to take certain actions in addition to his or her regular authorities under section 1135 of the Social Security Act. On March 13, 2020, the President of the United States issued a proclamation that the COVID-19 outbreak in the United States constitutes a national emergency by the authorities vested in him by the Constitution and the laws of the United States, including sections 201 and 301 of the National Emergencies Act (50 U.S.C. 1601 et seq.), and consistent with section 1135 of the Social Security Act. On March 13, 2020, pursuant to section 1135(b) of the Act, the Secretary of the United States Department of Health and Human Services waived or modified certain requirements of titles XVIII, XIX, and XXI of the Act as a result of the consequences of the 2019 Novel Coronavirus pandemic.
Following the emergency declarations issued by HHS and by President Trump, the Centers for Medicare & Medicaid Services (CMS), utilizing its 1135 wavier authority, waived the requirement that healthcare providers be licensed in the state in which they are providing services, provided that they have equivalent licensing in another state (and are not affirmatively barred from practice in that state).[10] Although the federal medical licensure waiver allows authorized healthcare providers to render services outside their states of Medicare enrollment, the waiver is limited in scope to conditions of participation and payment for federal healthcare programs such as Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP). The waiver applies to Medicare and Medicaid patients.[11] The 1135 waiver authority applies only to federal requirements and does not apply to state requirements for licensure, which is the province of the states.
II. Reimbursement
In advance of COVID-19, telehealth reimbursement was often limited regardless of payor-type. For example, many states lacked payment parity laws, which are laws mandating that insurers in a given state cover telehealth services and do so at the same rate as in-office visits.[12] For example, as of December 2019, neither Alabama nor Idaho had enacted a telehealth coverage law.[13] States such as Massachusetts addressed this gap in coverage almost immediately upon the surge in COVID-19 cases in Massachusetts. The Massachusetts Governor issued an order requiring the state’s Group Insurance Commission (GIC), all Commercial Health Insurers, Blue Cross and Blue Shield of Massachusetts, Inc., and Health Maintenance Organizations (Carriers) regulated by the Division of lnsurance (Division) to allow all in-network providers to deliver clinically appropriate, medically necessary covered services to members via telehealth and mandating reimbursement for such services.[14]
State payment parity orders, like licensure waiver orders, are limited to the timeframe contemplated by the specific order. However, unlike licensure, a number of states have already begun legislative attempts to make payment parity permanent. For example, the Massachusetts senate unanimously passed a bill that addressed coverage offered by the group insurance commission (GIC) to an active or retired employee of the Commonwealth insured under the GIC, and requires the GIC to provide coverage for healthcare services via telehealth by a contracted healthcare provider and for the CIG to cover services delivered via telehealth to the same extent as if they were provided via in-person consultation of delivery.[15] New Hampshire is another example of a state that is making permanent telehealth advances by passing emergency measures to deal with COVID-19, including payment parity. On July 23, 2020, the New Hampshire Governor signed into law H.B. 1623, which, inter alia, mandates that the state’s Medicaid program provide coverage and reimbursement for healthcare services provided through telehealth on the same basis as the Medicaid program provides coverage and reimbursement for healthcare services provided in person.[16] Additionally, the law requires that an insurer offering a health plan in New Hampshire provide coverage and reimbursement for healthcare services provided through telehealth on the same basis as the insurer provides coverage and reimbursement for healthcare services provided in person.[17]
States are not the only place one can observe movement toward payment parity. Capitalizing on the regulatory flexibilities granted under the President’s emergency declaration, CMS, on a temporary and emergency basis under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act, enabled Medicare to reimburse telehealth services under the Physician Fee Schedule at the same amount as in-person service.[18]
Because being paid for one’s time and effort is a reasonable and often necessary precondition for healthcare providers adopting telehealth, payment parity efforts have been instrumental in the increased use of telehealth observed during the pandemic. There has been ongoing discussion regarding CMS making Medicare payment parity permanent,[19] but no such legislation has been passed to date.
III. Medicare Geographic Areas, Covered Services, and Modalities Expansions
Under the Coronavirus Preparedness and Response Supplemental Appropriations Act, as signed into law by President Trump on March 6, 2020, and the Section 1135 waiver authority, CMS broadened access to Medicare telehealth by removing geographic and “originating site” restrictions. An originating site refers to the location of the Medicare patient at the time the service being furnished via a telecommunications system occurs. In advance of CMS enacting certain flexibilities, a Medicare beneficiary receiving telehealth services had to live in a qualifying rural area and had to travel to a local, qualifying physician’s office or other authorized healthcare facility to get telehealth services from a specified distant site practitioner in a remote location.[20] Beneficiaries generally could not get telehealth services in their home.
Effective March 6, 2020, healthcare providers eligible to furnish Medicare telehealth services during the public health emergency, including physicians and certain non-physician practitioners such as nurse practitioners, physician assistants and certified nurse midwives, may provide covered telehealth services to patients outside of rural areas, including treating patients in their homes.[21] CMS also expanded the universe of available telehealth services by adding over 80 additional covered services to the list of telehealth services.[22] The result has been the rapid expansion of telehealth. Originating site restrictions have limited the accessibility of telehealth in rural areas, as people may not be willing to leave home for medical care. Urban Medicare beneficiaries have been longing for access to telehealth, and CMS’ response to COVID-19 resulted in opening the door to telehealth for this population, as well.
Importantly, under the CARES Act, CMS waived the pre-COVID requirement that interactive telecommunications systems be used to furnish telehealth services, to the extent they require use of video technology, for certain services.[23] This waiver allows the use of audio-only equipment, a/k/a telephones, to furnish services described by the codes for audio only telephone evaluation and management services, and behavioral health counseling and educational services. The adoption of telephones as an acceptable modality for telehealth has been instrumental for the elderly population, some of whom do not have access to real-time audio-visual equipment. Healthcare providers should note, however, that unless provided otherwise, other services included on the Medicare telehealth services list must be furnished using, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site.[24]
Whether CMS will keep these important flexibilities in place following the public health emergency is yet unknown. However, telehealth has been successfully adopted by people in all geographic areas for a myriad of services. Turning back the flexibilities that have resulted in easier access to care will undoubtedly be met with incredible resistance from healthcare providers and beneficiaries alike.
IV. HIPAA Compliance
In advance of COVID-19, telehealth healthcare providers were subject to enforcement for failing to comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA),[25] as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, as incorporated in the American Recovery and Reinvestment Act of 2009 (ARRA),[26] and its implementing regulations. This meant that healthcare providers were required to utilize HIPAA compliant platforms for telehealth consultations, which typically included subscribing to such a service provided by a third party.
On March 17, 2020 the Health and Human Services Department’s Office for Civil Rights (OCR), the department enforcing certain regulations issued under HIPAA, published a Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency. The notice addressed HIPAA and its implementing regulations, which regulate how health information is conveyed and shared from a healthcare provider to other parties, and stated that OCR is exercising enforcement discretion to not impose penalties for noncompliance with the HIPAA rules in connection with the good faith provision of telehealth using such non-public facing audio or video communication products during the COVID-19 nationwide public health emergency.[27] Specifically, OCR noted that covered healthcare providers may use popular applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, to provide telehealth without risk that OCR might seek to impose a penalty for noncompliance with the HIPAA rules related to the good faith provision of telehealth during the COVID-19 nationwide public health emergency. OCR encouraged healthcare providers to notify patients that these third-party applications potentially introduce privacy risks, and healthcare providers should enable all available encryption and privacy modes when using such applications.[28]
Because so many people have smart phones, allowing use of existing popular applications that are well known to smartphone users was an easy way to roll out telehealth quickly. Healthcare providers were not left researching and executing agreements with HIPAA compliance platform providers. Additionally, beneficiaries were not, in most cases, asked to learn the protocols associated with a new smartphone application. This approach makes sense when use of telehealth is critical, as has been true while COVID-19 numbers continue to rise. However, people have a general expectation of privacy and data security where healthcare is concerned. At some point it will likely make sense to transition back to use of HIPAA compliant platforms for delivery of healthcare via telehealth.
V. Post-COVID Telemedicine Landscape
Although it is impossible to know exactly what standards and practices will become permanent when COVID-19 is controlled, there is at least one indicator of what can be expected in the near future. On August 3, 2020, CMS issued the advance copy of its proposed 2021 Physician Fee Schedule rule (PFS), which contains new telehealth services covered under Medicare.[29] Importantly, the PFS proposes removing frequency limitations for facility inpatient-type telehealth services and allowing physicians to fulfill direct supervision requirements while remote, provided the physician is immediately available to engage via audio-video technology, which will undoubtedly increase physician leverage and virtual oversight.[30] Additionally, CMS proposed nine new telehealth codes to the list of coverable telehealth services, e.g., Group Psychotherapy (90853) and Neurobehavioral Status Exam (96121).[31] The Physician Fee Schedule may be a bellwether for which telehealth adjustments made during the height of the COVID-19 pandemic will become permanent.
VI. Conclusion
Telehealth has enjoyed the spotlight amidst a public health emergency. Providing care via this format was an obvious shift for conditions amenable to treatment via telehealth when person-to-person contact should be minimized for public health safety. People have generally reacted quite well to telehealth. Importantly, widespread use of telehealth during this pandemic will provide much needed information and data about telehealth use, which will be useful as legislators confront returning to life when the COVID-19 threat subsides. It seems unlikely that the healthcare industry will ever return to a world where telehealth is the exception.
[1] Interstate Medical Licensure Compact, available at https://www.imlcc.org/.
[2] Exceptions to the general principle that a physician must be licensed in the state in which a patient is located exist, e.g., peer-to-peer consultations and bordering state exceptions where applicable. See, e.g., Ariz. Rev. Stat. Ann. § 32-1421.
[3] See the full version of the bill as passed: http://lis.virginia.gov/cgi-bin/legp604.exe?201+ful+HB1701ER.
[4] See Department of Public Health Order (May 15, 2020), available at https://portal.ct.gov/-/media/Coronavirus/20200515-Order-temporarily-suspending-the-requirements.pdf.
[5] Executive Order No.7DD, Protection Of Public Health And Safety During Covid-19 Pandemic And Response – Expansion Of Healthcare Workforce (Apr. 22, 2020), available at https://portal.ct.gov/-/media/Office-of-the-Governor/Executive-Orders/Lamont-Executive-Orders/Executive-Order-No-7DD.pdf.
[6] See Conn. Gen. Stat. § 20-12.
[7] Department of Public Health Order (May 15, 2020), available at https://portal.ct.gov/-/media/Coronavirus/20200515-DPH-Order-extending-the-temporary-suspension-of-the-requirements.pdf.
[8] See Executive Order No. 7HHH (July 14, 2020), available at https://portal.ct.gov/-/media/Office-of-the-Governor/Executive-Orders/Lamont-Executive-Orders/Executive-Order-No-7HHH.pdf.
[9] See Department of Public Health Order (July 14, 2020), available at https://portal.ct.gov/-/media/Coronavirus/20200714-DPH-order-on-out-of-state-practitioners-for-duration-of-pandemic.pdf.
[10] Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (Mar. 13, 2020), available at https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx<span>; CMS, COVID-19 Emergency Declaration Health Care Providers Fact Sheet, available at https://www.cms.gov/files/document/covid19-emergency-declaration-health-care-providers-fact-sheet.pdf.
[11] Id.
[12] See 50-state Survey of Telehealth Commercial Payer Statutes (Dec. 2019), available at https://www.foley.com/-/media/files/insights/health-care-law-today/19mc21487-50state-survey-of-telehealth-commercial.pdf.
[13] Id.
[14] Order Expanding Access to Telehealth Services and to Protect Health Care Providers (Mar. 15, 2020), available at https://www.mass.gov/doc/march-15-2020-telehealth-order/download.
[15] See An Act Putting Patients First, Bill S.2796 191st Sess. (Ma. 2020), available at https://malegislature.gov/Bills/191/S2796.
[16] See An Act Relative to Telehealth, H.B. 1623-FN 2020 Sess. (N.H. 2020), available at http://gencourt.state.nh.us/bill_status/billText.aspx?sy=2020&id=1180&txtFormat=html.
[17] Id.
[18] CMS, Medicare Telehealth Frequently Asked Questions (FAQs) (Mar. 17, 2020), available at https://www.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf.
[19] See, e.g., American College of Physicians, Letter to Seema Verma Re: ACP Recommendations for Maintaining Certain Telehealth Policies and Waivers after the Public Health Emergency (June 4, 2020), available at https://www.acponline.org/acp_policy/letters/acp_letter_to_cms_regarding_extending_telehealth_policy_changes_after_the_phe_june_2020.pdf.
[20] MLN Booklet, Telehealth Services, available at https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/telehealthsrvcsfctsht.pdf.
[21] Medicare Telehealth Frequently Asked Questions (FAQs), supra note 14.
[22] CMS, List of Telehealth Services, available at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.
[23] See 42 CFR § 410.78(a)(3).
[24] CMS, Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19, available at https://www.cms.gov/files/document/covid-19-physicians-and-practitioners.pdf.
[25] The Health Insurance Portability and Accountability Act of 1996 (HIPAA) P.L. No. 104-191, 110 Stat. 1938 (1996).
[26] The American Recovery and Reinvestment Act of 2009 (ARRA), P.L. No, 111-5, 123 Stat. 115 (2009).
[27] Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency, available a: https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html.
[28] Id.
[29] Department Of Health and Human Services, Centers for Medicare & Medicaid Services, Medicare Program; CY 2021 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies (Aug. 3, 2020), available at https://www.cms.gov/files/document/cms-1734-p-pdf.pdf.
[30] Id.
[31] Id.