Telemedicine or telehealth, which refers to providing care via electronic communication when patients and providers are in separate locations, has been available for decades. However, the COVID-19 pandemic has accelerated the adoption of telehealth due to the urgent need to deliver care in new ways. Before the pandemic, telehealth faced challenges such as limited reimbursement, cross-border licensure requirements, and access to technology. The pandemic prompted increased flexibility in reimbursement and explosive growth in telehealth services. Eventually, these terms may become commonplace in healthcare and simply be referred to as “healthcare.” However, for now, compliance considerations must be taken into account as telehealth is subject to various state and federal healthcare regulations.
1. Ensure the Privacy and Security of Data Remains Intact
During the COVID-19 pandemic, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) temporarily waived certain data security requirements under the Health Insurance Portability and Accountability Act (HIPAA). This allowed providers to use HIPAA-compliant communication platforms without a HIPAA business associate agreement. However, OCR’s decision to relax HIPAA requirements expired on May 11, 2023, with a 90-day grace period. As a result, after midnight on Aug. 9, 2023, telehealth providers will no longer be able to rely on that enforcement discretion if their telehealth platform fails to meet HIPAA standards.
2. Ensure Compliance with State Licensure Laws: Do you know the Whereabouts of Your Patient?
While human physiology remains the same across state lines, licensure requirements may differ. Telehealth practitioners who cater to patients in other states or countries should be familiar with licensure laws in the jurisdictions where their patients are located. In most states, practitioners must be licensed in the state where the patient is located at the time telehealth services are provided. Practitioners serving patients in multiple states may need to hold licenses in those states. Although some states offer limited licenses, many require full licensure. Telehealth practitioners should comply with state licensing laws and be aware that some state licensure restrictions were relaxed during the COVID-19 PHE, but with the end of the PHE on May 11, 2023, licensure restrictions have returned or are in the process of tightening once again.
3. Give Proper Consideration to the Corporate Structure
Several states prohibit the corporate practice of medicine, which affects the structure of telehealth platforms. As the platform is typically a lay entity, it is not allowed to directly employ or contract with practitioners to provide professional telehealth services in these states. Therefore, compliance with corporate practice of medicine laws must be taken into account, including affiliation with a physician practice or a friendly physician entity to provide professional medical services in states that prohibit the corporate practice of medicine.
4. Be Cautious About Engaging in Precarious Compensation Arrangements
Compensation arrangements in telehealth may pose risks under state or federal law. If a telehealth app or online platform receives a percentage of a practitioner’s professional fee as compensation, or if the compensation arrangement is not at fair market value, it could violate state and federal fraud and abuse laws that prohibit kickbacks or fee splitting. The HHS Office of Inspector General (OIG) Special Fraud Alert issued on July 20, 2022, provides information on potential fraud and abuse concerns in telehealth arrangements. This alert discusses how certain telemedicine companies pay kickbacks to practitioners to further fraudulent schemes. The HHS Office of Inspector General (OIG) has identified several suspect characteristics of telehealth arrangements that could violate state and federal fraud and abuse laws. These characteristics include:
• Offering free or low-cost services or products to recruit patients
• Limited contact between the practitioner and the patient, which could involve audio-only technology even if it’s not preferred by the practitioner or patient
• Providing compensation to the prescriber based on the volume of items or services prescribed
• Focusing on only one product or class of products, which could limit the prescribing practitioner’s treatment options.
It’s important to consider state laws and regulations that prohibit fee splitting and kickbacks in the states where the practitioner offers telehealth services.
5. Give Careful thought to Obtaining Informed Consent
Patients must provide consent for the treatment they receive, and to give informed consent, they need to understand the potential risks associated with a particular course of treatment. If telehealth care poses risks, patients must understand the potential limitations and challenges of receiving care through telehealth technology. In some states, patients are required to give consent specifically for telehealth care in addition to general informed consent requirements.
6. Keep Current with Prescribing Regulations.
During the PHE, requirements for prescribing controlled substances were relaxed, and the DEA and Substance Abuse and Mental Health Services Administration have extended these flexibilities until Nov. 11, 2023, with further extensions possible in certain circumstances. On March 1, 2023, the DEA proposed rules related to telehealth prescribing that may bring additional changes. It’s important to consider state law restrictions when prescribing controlled substances via telehealth, as well as state and federal laws governing the prescribing of legend drugs via telehealth.
7. Assess Changing Standards of Care.
In the past, the idea of doctors practicing solely through audio and video feeds, without an in-person examination, was considered science fiction. Nowadays, it’s a common practice for many healthcare needs and ailments. However, standards of care for physicians can vary from community to community. Telehealth practitioners must ensure that the telehealth environment provides adequate information to make an accurate diagnosis. Additionally, each state has its own laws and regulations governing telehealth, including technological requirements, such as whether two-way video is necessary or if store-and-forward technology is sufficient. It’s crucial to understand and comply with telehealth requirements in each state where a patient is located.
8. Don’t Forget to Keep a Record
Even when providing care to patients via telehealth, physicians and other practitioners must maintain medical records in compliance with their specific licensure requirements. Accurate recordkeeping is crucial to justify the care provided, comply with relevant laws, and support the reimbursement received.
9. The ERA of Payment for Telehealth Services May be Coming to a Close.
For many years, the lack of reimbursement for telehealth hindered its growth. However, during the PHE, payers were willing to cover telemedicine care. If health plans and insurers see costs increase due to the increased accessibility of care offered by telehealth, they may begin to limit reimbursement under certain circumstances or restrict payment by imposing more demanding requirements for billing and collecting for telehealth.
10. Keep Up-to-Date with Legal Advancements
The future of telehealth is unpredictable, but it’s certain that it will continue to evolve. Laws and regulations often lag behind technological advancements. Telehealth practitioners must stay up-to-date with regulatory requirements at the federal level and in all states where they offer telehealth services. They should also have comprehensive policies and procedures in place to ensure compliance with regulations.