With the onset of the pandemic, the Centers for Medicare and Medicaid Services (CMS) implemented waiver authority under section 1135 of the Social Security Act to relax requirements of section 1834(m)(1) of the Act and 42 CFR § 410.78 for use of interactive telecommunications systems to provide telemedicine services. This permitted organizations to provide health services to patients remotely to limit the risk of the spread of COVID-19. Now that the pandemic is tentatively set to end in May of this year, the Consolidated Appropriations Act of 2023 provides for an extension for some of these flexibilities through December 31, 2024.
Telemedicine has increased the ability of clinicians to reach their patients, reduce overhead costs, and has demonstrated a capability to provide health services during an emergency management event. Even with the 3 years of the pandemic behind us, how well is your telemedicine program aligned with regulations? What measures are you using to ensure that your patients are provided safe care through this medium? How are you ensuring that you have optimized functionality and the patient care experience?
Regulations for Telemedicine
Unfortunately, there is no single source for federal telemedicine regulations. Regulations and standards are established by state-specific regulatory institutions that establish standards for in-person clinical treatment. These state-run regulatory boards must operate in accordance with federal telemedicine regulations, including the Health Insurance Portability and Accountability Act (HIPAA) and rules from the Centers for Medicare and Medicaid Services (CMS) governing reimbursement for federal programs. However, there are resources available that can link organizations to their state specific requirements and Federal guidance as well. Organizational Telemedicine program leaders should ensure they are reviewing these requirements and adjusting their programs for compliance.
The Federation of State Medical Boards (FSMB) has published an updated, state-specific summary of telemedicine policies to help organizations determine the requirements they are governed by. You can find it at this link: https://www.fsmb.org/siteassets/advocacy/pdf/states-waiving-licensure-requirements-for-telehealth-in-response-to-covid-19.pdf.
The Center for Connected Health Policy (CCHP) has provided guidance on Federal and state-by-state laws and reimbursement policies, as well as legislation and regulations proposed and under consideration. Since 2012, they have been recognized as a Federally designated National Telehealth Policy Resource Center. You can access their website here: https://www.cchpca.org/
CMS provides some great resources for telemedicine including the Telemedicine for Providers Toolkit that can help organizations to ensure their alignment with regulations and optimization of patient safety practices. (https://www.cms.gov/files/document/telemedicine-toolkit-providers.pdf)
In general, state telemedicine laws are designed to address several critical focus areas:
- Licensure: Requirements for healthcare provider licensure varies between states. Cross-state licensing is a topic gaining legislative attention. In many cases, the provider must currently adhere to licensing requirements in the state in which the patient is located during the encounter. Some states allow cross-border delivery of healthcare services in other states in limited situations, and others ban it completely. Organizations should ensure they are reviewing their state requirements and how that applies to their telemedicine services, especially if the provider is home-based in another state.
- Clinician-patient relationship: Each state may define the clinician-patient relationship differently. Ensure that you review your state requirements and abide by their stipulations. This could include requiring an in-person visit prior to starting a telemedicine service with a patient.
- Online prescribing: A number of states have strict requirements for prescribing medication online. These may include requirements for an in-person visit before certain types of medication can be prescribed. Review your state policies and engage both your provider and pharmacy staff. Ensure that you have a means for pharmacy staff to screen potential ordering violations. Educate your provider staff on any limitations. If possible, place hard stops in electronic medication ordering systems to provide a safety stop.
- Informed consent: Healthcare providers must look closely at their state’s regulations to determine whether written informed consent is needed before conducting telemedicine services. Specific informed consent laws may vary by state. However, some important considerations include that you explain to the patient what they can expect from the telehealth visit and what their rights are. Ensure that patients understand their responsibilities during online counseling or other telebehavioral health visits. This might mean specific steps like wearing headphones and finding a place to be alone during the visit to ensure privacy on their end. Patients should give consent if anyone is observing the visit. Ensure the informed consent and other compliance documentation has been received and/or is documented during check-in, including verbal consent.
Telemedicine Program Considerations
There are other key considerations for your telemedicine services to ensure alignment with other regulatory requirements and the safe and efficient delivery of services. Some questions and topics to review with your telemedicine service coordinators include:
- Is your service HIPAA compliant? Have your Privacy Officer review all of your telemedicine services for privacy protection. This includes audio only services. The US Department of Health and Human Services has some great resources at this link to provide guidance including links to risk assessment tools. https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/hipaa-audio-telehealth/index.html
- Do you need a contract with the telemedicine service? Unless your organization is providing the service, you probably do. Has your contract management services and legal resources reviewed the contract? Ensure there are provisions included that address patient safety and privacy. Most accrediting organizations require that you evaluate all contracted health care services. Have you developed performance metrics and incorporated them into the contract? Are these metrics evaluated periodically and used in determining if the contract is meeting your organization’s needs and those of the patient?
- Does it integrate into my electronic health record (EMR)? Seamless integration with your organization’s EMR supports transparency and communication to the healthcare team, the patient and a means to data mine for performance metrics. Does this include online prescribing? If there is integration with the EMR, have cybersecurity concerns been addressed with continuous monitoring for possible breaches?
- Will it be easy for my patients to use? It’s imperative that the telemedicine platform your organization chose is easy to use by your patient population. This includes ease of access, navigation, reference, and interactivity. Ensure you have researched any third-party product or service for satisfaction of current and previous clients. Does the platform provide access to patients under the American with Disabilities Act? Ask if your patients need assistive devices to participate in virtual visits. Engage with your patient advisory team to review and provide recommendations. What provisions have you set in place in the event a patient is unable to use the platform? Check out the link on telemedicine and accessibility from the US Office of Justice (Civil Rights Division): https://www.ada.gov/topics/telehealth/
- Can staff or patients schedule visits through the platform? The ability of staff and patients to schedule visits via the platform provides a means to integrate additional features that can make it more useful and familiar to your staff and patients. Additionally, consider the ability of staff and patients to modify or cancel appointments through the platform. This could provide a valuable feature but could be chaotic without ground rules to avoid scheduling conflicts.
- Will my patients need to download an application to have a telemedicine visit? If patients are required to download an application, is time allotted prior to the visit to ensure this is done? Is there technical support available to guide the patient through this process? If the visit is via smartphone, have compatibility issues with Android vs iPhone been considered? Ensure that cybersecurity with the patient’s computer and/or smartphone have been explored.
- Will the telemedicine contract limit the number of users? Ensure that you thoroughly review the contract for site license limitations and consider if there are provisions to support expansion of services. If staff and patients embrace the technology with more deciding to adopt the new technology, you may exceed user licenses. These considerations should be part of your telemedicine strategic plan.
- Does the platform allow for additional providers to participate at the same time? You may wish to bring in additional providers or specialists for consultation during a virtual visit. How is this done? Can the technology support it and do staff know how to “conference call”? Ensure you have clear directions for providers on how to bring in additional healthcare participants and have IT support available.
- How are you addressing healthcare inequities with the use of telemedicine technology? Ensuring that your patients are able to use this service includes understanding the nuances of your customer. Not all may be savvy with the technology. In some cases you may need to provide an alternative that provides the same access and convenience as those who are skilled in using telemedicine. How are you addressing language barriers? Are you ensuring that written directions and materials are provided in multiple languages of your patient population? Use images and words for patients with low literacy. Use inclusive terms on patient forms including language and pronoun preferences (this should align with your organization’s policies).
- Measure patient satisfaction with the use of telemedicine services and implement improvements to address opportunities. Understanding how your patients feel about using the technology will help them feel more comfortable with future visits and provide you with information on vulnerabilities to ensure patients are not left behind.
It is expected that telemedicine will continue to evolve as a viable means for patients to access healthcare. The pandemic has proved that it can serve as an excellent entry portal for patients to access care. Additional changes in regulations and guidance should be expected. Organizations should ensure they are periodically reviewing their state requirements and include telemedicine services as a focus for regulatory rounding.
To learn more about regulatory considerations for telemedicine contact the C&A team at 704-573-4535 or email us at email@example.com.