Telehealth and telemedicine are rapidly growing methods of providing patient care by way of electronic communication. Telehealth allows clinicians to connect with patients in a non face-to-face encounter via a technology platform, obviating the need for patients to leave their home and travel to a healthcare facility or provider’s office. Each arrangement presents its own particular challenges and must be structured to ensure compliance with the myriad of diverse laws and regulations including, but not limited to, the False Claims Act, Anti-Kickback Statute, Stark Law, Health Insurance Portability and Accountability Act (HIPAA), Patient Choice laws, state insurance laws, and state professional board regulations which enumerate the requirements for engaging in the practice of medicine.
What are Some of the Benefits of Telehealth?
Telehealth provides a variety of benefits to both patients and providers, generally allowing greater access to healthcare for patients. Engaging in remote healthcare allows healthcare providers to retain existing patients, reach new ones, and grow their businesses by offering health care services via videoconference or store and forward rather than requiring patients to travel to an office or hospital. While telehealth may present significant opportunity for every party to a telehealth transaction, each party must evaluate the risk of the model, including the treating provider, technology company, and any ancillary provider in receipt of orders or prescriptions derived from telehealth encounters, such as a pharmacy or laboratory.
Scope of Practice
Improving patients’ access to care can eliminate many unnecessary emergency or urgent care visits and enhance patients’ interaction and loyalty to a particular physician or practice. By utilizing telemedicine technology, solo practitioners are able to provide greater continuity of care to their patients, which results in increased patient outcomes and reduced overall cost. Additionally, primary care physicians can more effectively triage their patients, having full knowledge of the patients’ conditions, in order to recommend appropriate follow up and avoid unnecessary in-person encounters. Telehealth also has the promise of increasing patient compliance with drug regimens and other treatment modalities resulting from regular encounters with, and evaluations by, the patient’s healthcare team.
Rural Health Facilities
Telemedicine can significantly increase the level and scope of services provided at rural health facilities. Patients seeking care in rural areas can be connected remotely to specialists for convenient and efficient consultations that may otherwise be inaccessible. Pursuant to Medicare reimbursement guidelines, beneficiaries must be located at a “designated originating site,” which includes rural health clinics, in order to qualify for a reimbursable encounter. Rural health facilities can take advantage of this billable service in order to expand specialized services offered to patients.
Urgent Care Centers
Many patients seek medical care at urgent care centers as an alternative to hospital emergency department visits or for purposes of convenience. Urgent care centers that make telehealth available to patients are able to reduce operating expenses and potentially treat a greater number of patients. By implementing telehealth modalities, these centers can reduce wait times and more efficiently triage patients who may require additional or alternative care. However, like all other providers, physicians practicing in urgent care centers should be aware of the applicable standards of care and thoroughly review their professional liability insurance policies. In the event that a virtual patient visit does not result in a billable encounter, clinicians remain responsible for the any medical advice provided.
Mental Health providers will find significant opportunity by expanding their practices to include telehealth. Telemental health not only increases the potential to lower a provider’s operating expenses, but clinicians can be more easily accessible to patients in crisis. Often, care provided by these practitioners does not require physical presence in order to effectively treat a patient’s condition. Therefore, mental healthcare providers can provide a comprehensive scope of services through virtual encounters and comply with the applicable standard of care. While all providers must review any software and third-party platforms to ensure compliance with the requirements of HIPAA, mental health providers should consider the sensitive protected health information in their possession, which may subject them to greater scrutiny.
Marketing agents that leverage the services of telehealth platforms in order to assist patients in obtaining particular items or services must ensure that their business relationships with these companies do not implicate or violate the Anti-Kickback Statute, HIPAA, or state fee splitting and patient steering prohibitions. Marketing agents must perform proper due diligence for any telehealth company with whom the marketer seeks to do business. An improper arrangement between a telehealth company and a treating provider can frequently interfere with the validity of a practitioner-patient relationship, and subsequently invalidate any resulting order that may be issued pursuant to the telemedicine encounter. Additionally, providers who perform encounters on telehealth platforms that do not comply with state laws regarding the modality of the encounter likewise may result in invalid orders. Due diligence of the telehealth company and its business model is always necessary.
In many ways, healthcare technology companies’ developments are charting the course for virtual healthcare legislation. Functionalities that were not possible ten years ago are now in their third and fourth iterations. As a result, telehealth platforms and software products have the capability of being comprehensive and sophisticated in order to support the needs of practitioners who will use the technology. However, technology companies that build virtual platforms, software, and other services for providers engaged in telehealth must ensure that their technology comports with applicable federal and state patient privacy laws. Moreover, these companies must evaluate and properly structure their relationships with their respective clients, such as the health care providers utilizing their services. Regulatory analyses are particularly pertinent in circumstances wherein technology companies do more than offer stand-alone technology products. For example, if a technology company also offers a marketing services that drives patients to the users of its platform, the arrangement must be evaluated for compliance with the Anti-Kickback Statute, patient steering laws, and professional fee splitting prohibitions.
Regulators, insurers, and PBMs continue to scrutinize telehealth arrangements for compliance with law and reimbursement requirements. Telehealth stakeholders must comply with federal and state laws including, but not limited to, the False Claims Act, Anti-Kickback Statute, Stark law, state and federal Patient Choice laws, state insurance laws, state professional board regulations, and HIPAA.
An appropriate analysis must be performed with respect to each transaction in a telehealth model. This includes evaluating the relationships between ancillary providers and marketing companies, marketing companies and technology companies, technology companies and providers, providers and patients, and patients and ancillary provider(s). Each link in this chain, and any other link that may exist, creates risk in the model that may directly affect every other party involved.
Frier Levitt has vast experience in developing appropriate corporate structures, strategizing compliant telehealth relationships, conducting compliance reviews for various stakeholders, as well as drafting and negotiating the contracts necessary to effectuate telehealth arrangements. Frier Levitt has performed these services on behalf of technology companies, physicians, mid-level practitioners, pharmacies, and marketers.
Ready To Set Up a Telemedicine Program?
Frier Levitt has developed, restructured, and reviewed a wide array of diverse telehealth business models. Each arrangement presents its own challenges and must be structured to ensure compliance with the various laws and regulations discussed above. If you or your company is considering engaging in telehealth, Frier Levitt can comprehensively vet and recommend modification to your proposed arrangement. Contact us today.