Telehealth has grown from a supplemental service to a core component of healthcare delivery. Since 2020, the explosive growth of telehealth has been accompanied by an increasingly complex framework of state and federal policies.

Advisory areas include:

• Cross-State Licensure: Understanding licensure requirements for cross-state practice and the role of licensure compacts.

• Prescribing Standards: Translating how the Ryan Haight Act, Drug Enforcement Administration (DEA) rulemaking, and state laws regulate prescribing medication via telehealth.

• Reimbursement: Navigating Medicare, Medicaid, and private payer requirements for telehealth payment.

• Audio-Only, Asynchronous, & Modality-Specific Rules: Guiding the use of telehealth modalities that carry unique regulatory requirements, particularly concerning the establishment of a patient-clinician relationship.

• Post Public Health Emergency (PHE) Strategy: Planning around the temporary nature of COVID-19 era waivers to ensure continuity of care and operations.

The current legal landscape of artificial intelligence (AI) and machine learning (ML) tools is highly fragmented, creating legal risks for the implementation of these tools in healthcare settings.

VC-PA’s strategic guidance on AI/ML includes:

• AI Governance & Risk Management Strategy: Understanding and building the components of an effective governance strategy.

• Reimbursement Opportunities: Identifying new opportunities to optimize revenue from AI/ML investments.

• State / Federal Policy Changes: Providing real-time intelligence affecting your organization’s compliance strategy.

• Liability and Accountability Frameworks: Tracking legal developments in AI’s role in medical malpractice and other litigation.

• Scope of Practice: Defining where the law says AI can or cannot make clinical decisions.

• Transparency and Disclosure: Identifying when and how the use of AI in healthcare settings must be disclosed.

Consumer wearable devices are popular among patients looking for greater insight into their health. These devices introduce unique challenges when integrated with patient care plans:

• FDA Regulatory Strategy: Differentiating the FDA’s regulation of “general wellness” products with the increased scrutiny of medical devices.

• Reimbusement: Understanding how to leverage new reimbursement models, such as CMS’ ACCESS model, promoting health device use.

• Data Privacy & Security: Managing how patient health data is generated, stored, and used from consumer wearables.

In today’s virtual care environment, a robust health information technology (IT) program is a necessity for operational efficiency and legal compliance.

• Information Blocking: Understanding how information blocking enforcement can create legal risks for practices.

• Interoperability Standards: Advising on participation in the Trusted Exchange Framework and Common Agreement (TEFCA) and other federal intiatives promoting interoperability.

• HIPAA Compliance Updates: Understanding how new federal regulations affect compliance obligations for health information.

• Cybersecurity: Tracking threats targeting healthcare organizations and health data.

Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM) are effective tools for chronic disease management and rehabilitative care.

Our strategic RPM/RTM advising includes:

• Reimbursement Strategy: Ensuring that your RPM/RTM investments are sustainable and providing demonstrable return on investment.

• OIG Audit Risk Mitigation: Identifying billing patterns that may put your organization at risk of False Claims Act (FCA) investigation.

• Device Management: Implementing your organization’s model for managing RPM/RTM devices from purchase to patient use.

• Workflow Design: Implementing RPM/RTM tools within your organization’s existing workflow.