By Stephanie T. Eckerle and Stacy Walton Long
Health care providers regularly engage in the practice of telemedicine within Indiana and elsewhere. Although the practice of telemedicine has existed for many years, the statutory and regulatory requirements, technology, and best practices are constantly evolving. Attorneys advising health care providers on telemedicine matters should be aware of several key factors in that evolutionary process.
Indiana statutory requirements for prescribers. The practice of telemedicine is not new to Indiana. In 2015, the Indiana Medical Licensing Board initiated the Telehealth Pilot Program. Indiana’s current telehealth law is now found at Indiana Code § 25-1-9.5, et seq. There are several key requirements that all health care attorneys should understand. First, the law applies to “prescribers,” which includes physicians, physician assistants and nurse practitioners licensed in Indiana. If the licensed prescriber is located out of state while providing telemedicine services to patients in Indiana, the prescriber and their employer must file telemedicine certifications with the Indiana Professional Licensing Agency. Second, telemedicine services must be provided via secure videoconferencing, interactive audio-using store-and-forward technology, or remote patient monitoring. An email or telephone call does not qualify as telemedicine. Third, a provider-patient relationship must be established prior to issuing a prescription. Indiana law specifically requires prescribers to take eight steps to establish that relationship, which includes obtaining the informed consent of the patient, obtaining the medical history of the patient, issuing proper instructions for follow-up care, creating certain medical records, and providing a telemedicine summary to the patient.
Prescribing controlled substances via telemedicine. Prescribing a controlled substance via telemedicine is restricted under state and federal law. Under Indiana law, a prescriber cannot prescribe opioids via telemedicine unless such are being used to treat opioid dependence. Furthermore, a prescriber can only prescribe controlled substances via telemedicine if the following conditions are met: (1) the prescriber maintains an Indiana Controlled Substance Registration (CSR); (2) the prescriber meets the requirements of certain federal laws; (3) the patient has been examined by a licensed Indiana health care provider who has established a treatment plan to assist in the diagnosis of the patient; (4) the prescriber has reviewed and approved the treatment plan and is prescribing pursuant to the treatment plan, and; (5) the prescriber complies with the requirements of INSPECT. One of the key requirements under Indiana law is that the patient has been examined by a “licensed Indiana health care provider” who has established a “treatment plan.” The term “licensed Indiana health care provider” is not defined; however, it is critical that the “licensed Indiana health care provider” is acting within their scope of practice. Additionally, “treatment plan” is not defined.
All prescribers practicing telemedicine must also ensure compliance with The Ryan Haight Act, which amended the Controlled Substances Act in 2009. The Ryan Haight Act was implemented to address the issue of internet sites selling controlled substances, particularly hydrocodone, for illegitimate, non-medical reasons. The Ryan Haight Act, however, has had the likely unintended consequence of impacting a prescriber’s ability to provide legitimate telemedicine services. The Ryan Haight Act requires that before prescribing a controlled substance, a provider must either conduct at least one in-person medical evaluation or must meet the definition of a “covering practitioner,” unless the practitioner is engaging in the “practice of telemedicine.” The definition of telemedicine in the Controlled Substances Act is narrow and does not take into account many modern telemedicine arrangements. For example, The Ryan Haight Act generally does not allow the practitioner to prescribe a controlled substance to a patient the prescriber has never examined in person if that patient is at home or work during the telemedicine encounter.
Reimbursement considerations. If a provider intends to seek reimbursement from Medicare, Medicaid or private payers for telemedicine services, the provider should understand any specific requirements imposed by that third-party payer. For example, the 2017 House Enrolled Act 1337 (HEA 1337) updated Indiana’s Medicaid reimbursement requirements, which were effective June 27, 2018. HEA 1337 removed the 20-mile restriction on telemedicine services (which previously did not apply to federally qualified health centers, rural health centers, community mental health centers and critical access hospitals). Further, under Indiana Medicaid, the patient must be at an originating site with an attendant to connect the patient to the provider at the distant site. The practitioner at the distant site must determine if it is medically necessary for that attendant to be a provider and must document the need for the provider’s presence. Separate reimbursement for a provider at the originating site is payable only if that provider’s presence is medically necessary. Furthermore, the telemedicine services may be rendered in an outpatient, inpatient or office setting. Lastly, certain services and providers will not be reimbursed for telemedicine by Indiana Medicaid, including ambulatory surgical centers, outpatient surgical services, chiropractic services and podiatric services (for a complete exclusion list see 405 Ind. Admin. Code 5-38-4(5)).
Telemedicine policies and procedures. Once health care providers understand the legal framework they are operating under when providing telemedicine, the providers should consider creating telemedicine policies and procedures. These policies should go beyond the regulatory necessities and address other operational and policy considerations. As a baseline, health care providers should consider specific factors relative to their respective specialty or facility. For example, the telemedicine policies of a community mental health center should be dramatically different from those of an intensive care unit. Other considerations that may be relevant to policies and procedures are: (1) what type of telemedicine software and hardware will be utilized; (2) whether the organization has emergency management protocols for telemedicine services, (3) whether the organization has the proper privacy and security protections in place for telemedicine services and whether they are aligned with HIPAA policies and procedures; (4) whether the telemedicine platform integrates with the EMR, (5) how informed consent is handled, especially with regard to minors, and; (6) whether providers intend to treat patients outside of Indiana, and what the associated legal framework is. All these issues and others should be considered when a provider or health care organization plans to implement the practice of telemedicine.•
• Stephanie T. Eckerle and Stacy Walton Long are partners at Krieg DeVault LLP. Opinions expressed are those of the authors.