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On March 30, 2020, the US Centers for Medicare & Medicaid Services (CMS) released an interim final rule that capped off a dizzying month of temporarily loosening regulations to give health care professionals maximum flexibility in responding to the coronavirus disease 2019 (COVID-19) pandemic.1 A primary goal of this regulatory flexibility, enabled by the President’s declaration of a national emergency and the declaration of the Secretary of the Department of Health and Human Services (HHS) of a public health emergency, is the promotion of virtual medicine by expanding coverage for telehealth services to Medicare beneficiaries. Telehealth may facilitate US citizens’ access to essential health benefits while respecting physical distancing, an essential disease spread mitigation strategy for COVID-19.2 With a vulnerable patient population, these changes have already had a widespread effect on the delivery of oncology services during the pandemic and may yet have unforeseen effects.3 We herein review the changes and consider their effects on quality of care.
Telemedicine in the Time of COVID-19
There were 3 primary federal stimulus packages addressing the COVID-19 pandemic enacted in March 2020: (1) the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSA), (2) the Families First Coronavirus Response (FFCR) Act, and (3) the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CPRSA was an $8.3 billion emergency funding bill that included $500 million to expand Medicare telehealth coverage during emergencies. The FFCR Act was a relief package focused on expanding COVID-19 testing, supporting Medicaid, and enhancing unemployment benefits. It included a technical change to the CPRSA to further expand Medicare beneficiaries’ telehealth access. The CARES Act was a sweeping $2.2 trillion economic stimulus package that provided a variety of direct economic support measures. It further expanded coverage and loosened the definitions of Medicare telehealth services.
In addition, CMS issued clarifications further detailing the regulatory waivers and rules.2,4 These clarifications, in concert with the emergency declarations and stimulus packages, effectively unshackled telemedicine, resulting in its rapid adoption through the following features.
The CMS previously covered telehealth only when a patient was receiving care at a facility in a nonurban area or an area with a health professional shortage. Lifting this restriction during emergency circumstances (the COVID-19 pandemic) has effectively permitted the delivery of telehealth services directly to a patient’s home or elsewhere.
Medicare previously required that telehealth recipients have a prior established relationship with a particular health care professional; however, during the public health emergency, CMS agreed to a state of nonenforcement. This has effectively enabled patients to be cared for by new physicians remotely (eg, new patient consultations).
The CMS expanded telehealth coverage to more than 80 additional services.4 This effectively allowed the primary face-to-face patient–oncologist encounters (consultations, follow-ups, and, for radiation oncologists, on-treatment visits) to be conducted entirely virtually.
Privacy regulations, such as the Health Insurance Portability and Accountability Act (HIPAA), restrict the remote communication technologies allowable for telehealth. During the COVID-19 public health emergency, the HHS will exercise enforcement discretion and not impose penalties for noncompliance with HIPAA regulatory requirements during the good-faith provision of telehealth. Effectively, this allowed health care professionals to use widely available remote audiovisual communication platforms (eg, Zoom Video Communications) for patient appointments. Audio-only communication is now allowable in certain instances, with CMS acknowledging that audio and video may not always be available.
The CMS sets physician supervision requirements for specific covered services as a condition for payment. For example, certain oncology services provided in the physician office setting may require direct supervision, meaning the physician must be “immediately available to furnish assistance and direction” during the service delivery.5 During this crisis, CMS is allowing real-time audiovisual technology to satisfy the direct supervision requirement. It has also loosened the supervision requirements for diagnostic services, such as image-guided radiation therapy. Effectively, this permits remote supervision of many oncology services.
Eligible Health Care Professionals
The CMS has loosened the resident physician supervision requirements for services rendered, such that they can be satisfied through direct supervision with interactive telecommunications technology. Additionally, CMS allows supervision requirements to be met when the resident physician is furnishing telehealth services while the teaching physician is also practicing direct supervision of the service via interactive telecommunications technology. Effectively, this virtual supervision of resident physicians, when the service is being delivered in person or via telehealth, increases latitude for resident physicians in the delivery of care during COVID-19.
The CMS clarifications specifically state that telehealth services paid under the Physician Fee Schedule will be the same amount as in-person services.2
Limitations of Loosened Telemedicine Rules
A caveat to these expansions is that they apply to Medicare beneficiaries—a federal domain. Many barriers to widespread adoption of telemedicine before the COVID-19 pandemic, such as credentialing and commercial payers’ and Medicaid reimbursement, are typically regulated by individual states, which have their own payment policies.6 However, many private payers (eg, some Blue Cross Blue Shield companies) have also announced expanded coverage of services during the public health emergency; this remains in flux.
Quality of Care
The foremost concern during the rapid adoption of telemedicine is maintaining the safety and quality of care. The care delivery regulations (eg, supervision requirements5) that existed before the COVID-19 pandemic were in place for good reason—to safeguard patients and health care professionals. Professionals will need to balance physical distancing with telehealth-appropriate services; clearly, there will always be some medical encounters for which physical presence is irreplaceable. Considerations include how to best account for objective patient assessments (eg, patient-reported outcomes, physical examinations, laboratory tests, imaging, and endoscopy), monitor for any fraud or abuse, and maintain patient and physician satisfaction. Monitoring quality metrics will help quantify the effect of telehealth on quality of care. Specific examples include rates of emergency department visits, hospitalizations, and adverse events; delays in treatment initiation; and rates of adjuvant therapy receipt.
These issues create demand for quality care investigations. Despite CMS’s facilitating measures, implementation barriers remain, such as device operability (eg, hardware and software for patients and health care professionals) and human factors (eg, physician and patient comfort), to name a few.7 Although telehealth may enable access to care, the technical requirements risk perpetuating disparities. Understanding adoption rates of such at-risk groups as US citizens who are poor, elderly, or live in rural areas will be important. Health services research regarding national practice patterns will reveal valuable information about the extent and rapidity of telehealth adoption and about regional variations in service, as well as about the subspecialties and patient encounters for which it is most effective. Just as this environment creates new research opportunities, it also introduces major hurdles, particularly for clinical trials and their frequent requirements for in-person visits. Early survey results show that the COVID-19 pandemic has significantly disrupted the conduct of clinical trials (eg, enrollment; protocol adherence; and patient, physician, and supportive staff and services engagement).8 Telehealth has emerged as an essential facilitator in keeping trials operational and may provide an opportunity to ultimately improve the clinical trial system, for example, by requiring fewer in-person visits and their associated burdens.
The COVID-19 pandemic has resulted in the rapid temporary deregulation of telehealth services. Specifics include lifting geographical restrictions; broadening patient, health care professional, and services eligibility; relaxing supervision requirements; and preserving reimbursement. The pandemic is likely to leave a permanent mark on society, and it is plausible that it will catalyze new models of care, including telehealth. With physical distancing mandates being extended, there will be significant time to operationalize opportunistic care models, some of which may not easily be undone as health care professionals and patients adapt and recalibrate expectations of care. How telehealth affects the safety and quality of care, and how the regulatory landscape will look when the COVID-19 public health emergency is behind us, remain open questions that deserve continued observation.
Corresponding Author: Trevor J. Royce, MD, MS, MPH, Department of Radiation Oncology, University of North Carolina at Chapel Hill, 101 Manning Dr, CB 7512, Chapel Hill, NC 27599 (email@example.com).
Published Online: July 16, 2020. doi:10.1001/jamaoncol.2020.2684
Conflict of Interest Disclosures: Dr Sanoff reports grants from Bayer. No other disclosures were reported.
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Royce TJ, Sanoff HK, Rewari A. Telemedicine for Cancer Care in the Time of COVID-19. JAMA Oncol. Published online July 16, 2020. doi:10.1001/jamaoncol.2020.2684
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