Once developed primarily to reach patients in remote locations, telemedicine has quickly transformed into a complex integrated service offering greater options for patient care in our technologically-savvy, fast-paced modern world. Telemedicine has the power not only to break down geographical barriers to care access but to make the entire healthcare delivery model more convenient to all patients. However, integrating a new technology-based service in an established field that has traditionally required personal interaction, especially in a heavily regulated industry, can present significant challenges. As with most innovations, the marketplace is far ahead of the law, causing legal and policy issues and concerns. Hospitals, healthcare providers, and vendors need proactive legal counsel that can warn clients about potential pitfalls while ensuring regulatory compliance and reliable reimbursements in this burgeoning new field.
Legal counsel must work closely with clients to navigate the patchwork of state and federal laws that are constantly evolving in the effort to bring new practices and products to market. Likewise, telemedicine providers must ensure that practices and products are reimbursable by private and government payors alike. How much and which telemedicine services private payors pay for varies widely by state.
In addition to reimbursement issues, telemedicine also implicates licensing issues. Offering services across state-lines raises a particular challenge given the different licensing requirements that are set up by each state individually. Either the doctor must be licensed in the state where the patient is located or in a state that has a cross-state licensing arrangement with the patient’s state. Corporate practice of medicine, state board ethics and discipline procedures, scope of practice, and credentialing are all implicated in new ways by the cross-state practice of telemedicine.
Synchronous telemedicine (real-time patient consultations) demands sophisticated protocols, secure technological resources, and experienced legal counsel regarding cybersecurity issues and legal requirements involved in storing and moving patient information. Like all technology in the healthcare space, telemedicine solutions need to be HIPAA compliant to protect patient privacy. Technology used for telemedicine services needs to ensure high-level security and prevent any breaches of patient personal health data.
In addition to the issues unique to telemedicine’s changing legal landscape, providers, developers, and vendors must also consider legal and regulatory issues that affect all healthcare providers including fraud and abuse, Stark and anti-kickback laws, licensing, professional ethics and discipline, staffing and credentialing issues, and malpractice liability.
Jackson Walker has the experience necessary to navigate the many legal challenges affecting telemedicine so as to minimize risk and maximize business growth for our clients. With the one of the largest Healthcare practice groups in the state of Texas and a cutting edge Cybersecurity practice group, our attorneys are at the forefront of the legal and regulatory issues affecting telemedicine. We assist with telemedicine program assessment, development, and implementation and advise telemedicine providers and related vendors of all kinds, both within Texas and around the country. From guidance on launching a telemedicine platform to advice regarding internet prescribing, our attorneys offer clients the insight, experience, and skill that will help them make the most of this new business innovation.
- Provided guidance to hospital system clients about reimbursement for telemedicine services from Medicare, Medicaid and third party insurers.
- Act as general counsel for asynchronous telemedicine provider offering advice on the emerging field of telemedicine law, corporate structuring, general corporate work, contract review and drafting, healthcare regulatory advice, review of advertisements from a regulatory standpoint, and assistance with due diligence in fundraising initiatives. Advise on licensing issues and the Corporate Practice of Medicine and provide guidance regarding HIPAA regulations.
- Advised hospitals about the barriers to implementation of a telemedicine program.
- Assisted hospital system is setting up telemedicine network.
- Work with large telemedicine provider providing specialty services to hospitals.
- Compliance with federal and state laws affecting the practice of telemedicine
- Considerations regarding corporate structures for telemedicine providers and vendors
- Strategies to ensure third-party reimbursement from government and private payors
- Drafting and negotiation of contracts between providers, payors, and technology companies
- Compliance with fraud and abuse laws including those prohibiting self-referral (Stark) and kickbacks
- Advice regarding the changing telemedicine regulatory landscape and its impact on client operations
- Online prescription counsel and guidance
- Counsel regarding the corporate practice of medicine, fee-splitting, and advertising issues which often apply to telemedicine ventures
- Guidance regarding privacy and security requirements, including breach responses, under HIPAA, HITECH, and state laws
- Licensing issues, including state-by-state telemedicine requirements for diagnosis, treatment, and/or prescription
- Guidance in connection with mobile apps and online health programs
- Development and implementation of procedures and protocols to ensure compliance with HIPAA and other patient privacy concerns and regulations
- Advice on cybersecurity and other data storage and maintenance concerns