Telemedicine in the time of COVID-19: Considerations for Cancer Care in the United States

On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) released an Interim Final Rule that capped off a dizzying month of temporarily loosening regulations in order to give providers maximum flexibility in responding to the 2019 Novel Coronavirus pandemic (COVID-19). A primary goal of this regulatory flexibility, enabled by the President’s national emergency declaration and the Secretary of the Department of Health and Human Services’ (HHS) declaration of a public health emergency, includes the promotion of virtual medicine by expanding coverage for telehealth services to Medicare beneficiaries. Telehealth may facilitate Americans’ access to essential health benefits while respecting physical distancing, an essential public health spread-mitigation strategy for COVID-19.¹ With a vulnerable patient population, these changes have potentially widespread impact on the delivery of oncology services during the pandemic and beyond.² We herein review the changes and consider their impact on the quality of care.

Telemedicine in the time of COVID-19

There were three primary federal stimulus packages addressing COVID-19 enacted in March: 1) Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSA), 2) Families First Coronavirus Response Act (FFCR), and 3) Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CPRSA is an $8.3 billion emergency funding bill that included $500 million to expand Medicare telehealth coverage during emergencies. The FFCR 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 provides a variety of direct economic support measures. It further expanded coverage and loosened definitions of Medicare telehealth services.

CMS issued additional clarifications further detailing the regulatory waivers and rules.^1,3 These clarifications, in concert with the emergency declarations and stimulus packages, effectively unshackled telemedicine, resulting in its rapid adoption through the following features:

• Geographic restrictions. CMS previously covered telehealth only when receiving care at a facility in a non-urban or health professional shortage area. Lifting this restriction during emergency circumstances (e.g. COVID-19) effectively permitted the delivery of telehealth services directly to patient’s home or elsewhere.

• Eligible patients. Medicare previously required that telehealth recipients have a prior established relationship with a particular provider, however, during the public health emergency CMS agreed to a state of non-enforcement. This effectively enabled new patients to be cared for by new providers remotely (e.g. new patient consultations).

• Eligible services. CMS expanded telehealth coverage to over 80 additional services.³ This effectively allowed the primary face-to-face patient-oncologist encounters (consultations, follow-ups, and for radiation oncologists, on-treatment visits), to all be conducted virtually.

• Delivery platforms. Privacy regulations such as the Health Insurance Portability and Accountability Act (HIPAA) restrict the remote communication technologies allowable for telehealth. During the public health emergency, the HHS will exercise enforcement discretion and not impose penalties for noncompliance with the HIPAA regulatory requirements during the good faith provision of telehealth. Effectively, this gave providers access to widely-available remote audiovisual communication platforms (e.g. Zoom). Audio-only communication is now allowable in certain instances, with CMS acknowledging that audio and video may not always be available.

• Supervision requirements. 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.⁴ CMS is allowing real-time audiovisual technology to satisfy the direct supervision requirement. CMS loosened the supervision requirements also for diagnostic services, such as image guided radiation therapy. Effectively, this permits remote supervision of many oncology services.

• Eligible providers. 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 practicing direct supervision of the service also 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.

• Reimbursement. The CMS clarifications specifically state that telehealth services paid under the Physician Fee Schedule will be the same amount as in-person services.¹

A caveat to these expansions is that they apply to Medicare beneficiaries – a federal domain. Many barriers to widespread adoption of telemedicine pre-COVID – credentialing, commercial payers’ and Medicaid reimbursement – are typically regulated by individual states, who have their own payment policies.⁵ However, many private payers (e.g. some Blue Cross Blue Shield companies) have also announced expanded coverage of services under the public health emergency; this remains in flux.

Quality

The foremost concern during the rapid adoption of telemedicine, is maintaining the safety and quality of care. Presumably, the pre-COVID care delivery regulations (e.g. supervision requirements⁴) were in place for good reason - to safeguard patients and providers. Providers will need to balance physical distancing with telehealth-appropriate services; clearly, there will always be some encounters where physical presence is irreplaceable. Considerations include how to best account for the objective patient assessments (e.g. patient reported outcomes, physical exams, laboratory tests, imaging, and endoscopy), monitoring for any fraud/abuse, and maintaining patient and physician satisfaction. Monitoring quality metrics will help quantify the impact; specific examples include rates of emergency room 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’ facilitating measures, implementation barriers remain, such as device operability (e.g. hardware and software for patients and providers) and human factors (e.g. physician and patient comfort), to name a few.⁶ Though telehealth may enable care access, the technical requirements risk perpetuating disparities. Understanding adoption rates of at-risk groups will be important, such poor, rural, or elderly Americans. Health services research regarding national practice patterns on the extent and rapidity of telehealth adoption, regional variations, and for which subspecialties and patient encounters will be revealing. 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 the pandemic has significantly disrupted conducting clinical trials (e.g. enrollment; protocol adherence; patient, provider, and supportive staff and services engagement). 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 allowing fewer in-person visits and their associated burdens.⁷

Conclusions

The COVID-19 pandemic has resulted in the rapid temporary deregulation of telehealth services. Specifics include lifting geographical restrictions, broadening patient, provider, and services eligibility, relaxing supervision requirements, and preserving reimbursement. The pandemic is likely to leave a permanent mark on society, and it is plausible it catalyzes 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 be easily undone as providers and patients adapt and recalibrate expectations of care. How telehealth impacts the safety and quality of care, and how the regulatory landscape looks when the COVID-19 public health emergency is behind us, remain open questions that deserve continued observation.