Reimagining Home-Based Cancer Care: Key Legal and Regulatory Considerations

Turbocharged during the COVID-19 pandemic, evolving technology, enhanced reimbursement modalities and increased regulatory flexibility are creating new opportunities to offer acute-level oncology care to patients in their own homes. For hospitals and providers looking to expand their programs into the home and reimagine patient care, these are the key legal and regulatory things to know in September 2024. This topic was discussed on the panel “The Virtual Cancer Clinic: Extending Care to the Home and Reimaging the Patient Experience” at the September 2024 Cancer Care Business Exchange.

Reimbursement Models for Home-based Care Require Regular Attention

Commercial payors were slower than governmental payors to appreciate the benefits of moving care from facility to home-based and virtual settings. But negotiation of new payor contracts that incorporate these new modalities remains critical in the oncology space as considerable patient volume remains in the commercial/employer-sponsored environments. Partnering between payors and providers to help patients receive medically appropriate care in the safer and more comfortable home-based setting is essential. The critical issue is whether these settings are, in fact, less costly and, therefore merit lower reimbursement. Over time, this may come to be true, but we remain in a transitional period.

In the commercial payor environment, since 2019, the legal landscape for telehealth insurance coverage and reimbursement has significantly expanded, making access to medical care easier for many people. In the governmental environment, both Medicare and various state Medicaid programs ramped-up reimbursement for new modalities, including hospital level care at home, during the pandemic. Medicare coverage for hospital at home is set to sunset at the end of 2024, but there is considerable bi-partisan support for further extensions, likely another five years. Providers need to stay vigilant on these payment streams as they invest in technology, staffing and patient-awareness.

Licensure Rules and Practice Standards Need to be Carefully Analyzed

Prior to setting up a cancer care at home program, provider models and state-specific requirements should be analyzed carefully. Depending on how a program is structured (freestanding vs. facility-based) there are often entirely different regulatory structures at play. If a program is hospital-based, both the Federal Conditions of Participation and related accreditation standards as well as state health care licensure rules must be met or waived. A carefully structured facility-based program may need rely on waivers such as the Federal Acute Care Hospital at Home Program (for Medicare Conditions of Participation associated with inpatient services) and state health facility licensure requirements. True freestanding (medical practice) delivery models will have lower regulatory oversight, but likely lower reimbursement to cover the overhead of the programs. Licensure requirements will depend on the types of practitioners who will be providing the services, generally including at least physicians, APPs, nurses, mobile integrated health (paramedic) services, and medical assistants. A comprehensive program would also be expected to offer diagnostics (e.g., electrocardiograms, echocardiograms, x-rays); treatments like O2 therapy, IV fluids, intravenous antibiotics; therapies including respiratory, OT, PT; skilled nursing services; pharmacy; and supportive services such as delivery, transport and durable medical equipment. The state may have a telehealth registry requirement that will need to be complied with. As a general rule, the patient’s location at the time of the consult is central to the determination of which state’s laws/rules (e.g., physician licensure requirements and telehealth practice standards) apply to a telehealth consult. (There are a few standard exceptions, such as those allowing peer-to-peer consults and provisions supporting follow-up care.) If the patient population crosses the state border, or includes many snowbirds in the mix, then those state laws will need to be reviewed.

Design Your Virtual Support with All Telehealth Requirements in Mind

An appropriately licensed and credentialed team, as discussed above, and HIPAA compliant integrated audio/video telehealth platforms are key to offering telehealth in support of patients in their homes. State law typically defines the minimum required modality that will be needed to create a patient-physician relationship, and there may be different modality requirements for establishing a valid physician-patient relationship and practicing telehealth after that relationship has been established (i.e., for established patients). As of this writing, approximately nine states expressly ban asynchronous (i.e., interactions not occurring in real-time) telehealth visits, instead requiring the use of a synchronous modality (i.e., interactions that occur utilizing audio and/or video). If using (and relying on) asynchronous-only modalities to evaluate and/or treat patients, some states may require the clinician to not only rely on a patient’s self-evaluation (e.g., via a medical questionnaire), but also review clinically-relevant, extrinsic medical information (e.g., reliable lab results, prior medical records, images, diagnostic peripherals) to inform the clinician’s diagnosis and treatment recommendations. Such medical information should be made a part of the medical record. In addition, it is best practice to establish internal protocols to detect and prevent fraudulent and abusive activity through the use of telemedicine services, including patient fraudulent activity such as creating multiple user accounts for the same IP address. Regardless of whether the applicable state law permits the use of telehealth, the clinician must always make an independent professional determination of whether the standard of care can be met utilizing telehealth for the patient’s particular use case. 

Obtain Appropriate Patient Authorization

An informed patient authorization will describe the process, care team, and include any telehealth and virtual care-related considerations. Both federal and state laws establish requirements for privacy and security. In general, federal laws should be viewed as a minimum standard, as states can place additional safeguards above and beyond (but cannot deviate from) federal requirements. As of this writing, more than half of the states have adopted some version of telehealth patient informed consent requirements. Many also have patient identity verification or special patient disclosure requirements. Specific patient authorization criteria also applies if genetic information will be collected; if the patient is a minor; and if substance abuse or mental health information are involved (which may be the case in an interdisciplinary care model). As a general matter, community oncologists using telehealth to support home programs will generally need a privacy policy that governs the collection, use and sharing of information collected, stored, and shared by the provider through the online platform, and a separate notice of privacy practices that covers the collection, use and sharing of protected health information. 

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Reimbursement and regulatory trends are expected to continue to evolve in ways that will support greater delivery of oncology care to patients in their homes. Nevertheless, hospitals and oncology groups looking to offer such services should carefully vet state law and build their programs with appropriate consideration of their patient populations.

Foley is monitoring this evolving legal and business landscape related to home-based care closely across multiple sectors, including health care and life sciences, with a team of Foley attorneys poised to assist. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group and Health Care & Life Sciences Sector with any questions.