Healthcare providers must address these other policy, legal and regulatory issues when providing healthcare via telehealth during a pandemic:
Consent
Healthcare providers furnishing telehealth services must have procedures in place to comply with varying payer rules and federal and state laws and regulations regarding patient consent and documentation in the record. During the COVID-19 PHE, CMS allows consent at the same time that the CTBS service is being furnished. For RPM, CMS allows beneficiary consent to be obtained by auxiliary staff in addition to the billing clinician. These policies should be made permanent.
Source:
Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19
Supervision
Current rules allow general supervision to be performed virtually while direct supervision requires the supervising clinician be on site with the billing clinician when the service is provided. Physician supervision requirements have traditionally been a barrier to the delivery of telehealth services. During the COVID-19 pandemic, CMS allows virtual direct supervision of incident-to and diagnostic services to be done through telehealth using real-time, audio-video technologies. These policies should be made permanent.
Sources:
Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19
Hospital Telehealth Credentialing / Privileging
CMS and the Joint Commission require hospitals to have a credentialing and privileging process in place for providers furnishing services to the hospital via telehealth. Federal regulations allow “credentialing by proxy” that allows the originating site hospital to rely on the privileging and credentialing decisions made by the distant site hospital or entity furnishing the telehealth services, provided certain requirements are met. The privileging process which involves verifying licenses and qualifications creates a barrier for telehealth providers who must go through the process at every healthcare organization for which they plan to provide services. CMS requires participating hospitals to maintain a “comprehensive emergency preparedness program” under its Conditions of Participation to address “…the use of volunteers in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.” Hospitals that are accredited by the Joint Commission can refer to the Commission’s standards for issuing temporary and disaster privileges, both of which should be addressed in accordance with the medical staff bylaws. Hospitals must also follow The Joint Commission, federal and state requirements for focused professional practice evaluation/ongoing professional practice evaluation (FPPE/OPPE) peer review processes, in accordance with the medical staff bylaws.
Sources:
Federal Code Governing Body Conditions of Participation
Federal Code Medical Staff Conditions of Participation
Accreditation Association for Ambulatory Health Care (AAAHC)
Telehealth Malpractice Insurance
Many insurers provide malpractice coverage for providers furnishing telehealth services to their patients, however, some plans expressly deny coverage. Since malpractice insurance is regulated at the state level, barriers exist for providers with multi-state telehealth practices. Providers should confirm with their carriers that their current malpractice insurance covers services provided via telehealth and if the provider is practicing across state lines, that their coverage extends into the other state(s). Malpractice coverage should not exclude services provided via telehealth.
Source:
Center for Connected Health Policy
Crisis SOPs
Healthcare providers must comply with applicable state and federal laws and regulations, as well as, CMS Conditions for Participation that require a comprehensive emergency preparedness program and Joint Commission requirements, as applicable. Healthcare providers should develop crisis standard operating procedures (SOPs) for the use of telehealth to prepare for any pandemic. Guidelines for clinical practice, training and data collection for telehealth applications should be included.
Source:
Federal Code Governing Body Conditions of Participation
Federal Code Medical Staff Conditions of Participation
Fraud and Abuse
Telehealth arrangements involving federal healthcare program dollars must comply with applicable federal fraud and abuse laws such as the Anti-kickback and Stark laws. State-level fraud and abuse laws must also be followed. During the COVID-19 PHE, CMS issued blanket waivers of certain provisions in the Stark law regulations regarding remuneration and referrals related to COVID-19. Some states also took action during the pandemic. Policies that remove barriers to innovation and use of telehealth technologies should remain in place.
Source:
Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19
Medical Devices (FDA)
FDA regulates food, drugs, medical devices (i.e. includes definitions for both hardware and software), biologics and a host of other products. During the COVID-19 PHE, FDA has supported development of medical countermeasures and provided regulatory advice, guidance, and technical assistance to advance the development and availability of vaccines, therapies, diagnostic tests and other medical devices for use in diagnosing, treating, and preventing the coronavirus. FDA has also issued emergency use authorizations (EUA) to provide more timely access to critical medical products. Providers must stay apprised of any related federal and state regulatory changes during the PHE. For example, during the COVID-19 PHE, CMS requires any device used for RPM to meet the FDA’s definition of a medical device. Policies that remove barriers to innovation and use of telehealth technologies should remain in place.
Sources:
Connectivity
Telehealth requires adequate telecommunications infrastructure over which remote services can be delivered to patients. Video-based services, store and forward services, and other mobile technologies require a range of bandwidths to transfer healthcare data for different applications. Adequate IT / broadband is also needed for distance education, teleworking, and other online services. As people sheltered in place during the COVID-19 crisis, it placed more reliance on technology in the home. Lack of affordable technology and broadband connectivity for many low-income families, seniors and residents living in rural areas was exacerbated during this crisis and brought to light digital inequities that have always existed. Implementing a national IT / broadband infrastructure to close the digital divide is necessary for preparedness and emergency response in the next pandemic. Providing funding support for providers to build telehealth and telecommunications infrastructure will help create provider incentives to adopt and expand healthcare service delivery via telehealth. Eliminating cost-sharing requirements (e.g. co-payments) or offering other financial incentives to patients could help encourage use of telehealth and enable access to care for vulnerable and at-risk populations during or before a pandemic.
Sources:
Transportation
The transportation and logistics industry performs vital services in today’s modern globalized, interconnected world. The COVID-19 PHE demonstrated the need for creative solutions to address transportation / distribution of supplies (e.g. drones to deliver medications regulated by the FAA) and healthcare delivery outside the hospital walls (e.g. via telehealth or wherever the patient is located). Providers need to be aware of relevant federal, state and local requirements or regulatory changes issued during a pandemic. Pandemic preparedness requires a coordinated effort involving government, private sector, and other stakeholders. Telemedicine eliminates the need for patient transportation and, in many cases, provider transportation as well (e.g., policies allowing EMS personnel to provide healthcare at the patient’s home or via telehealth would help divert patients from being transported to the hospital ED and spread of the virus (e.g. CMS Emergency Triage, Treat and Transport model, ET3.).
Sources:
Surveillance / Reporting
Public health surveillance and reporting are essential tools for decisionmakers to lead and manage effectively in a pandemic. However, inadequate funding for resources and critical infrastructure at both federal and state levels, a lack of standardized data collection methodologies, politicization of public health, and other challenges have hindered public health’s response during the COVID-19 pandemic. Changes are needed to strengthen the nation’s public health surveillance and reporting functions to protect and improve public health during any pandemic. Standards, systems and infrastructure for electronic collection, reporting, and data sharing are critical in an effective pandemic response.
Sources:
CDC Public Health Professionals Gateway
Public Health Accreditation Board (PHAB)
Accreditation Association for Ambulatory Health Care (AAAHC)
Recommendations for Other Policy Considerations
- Providers
- Industry to create standardized terminology, evidence-based practice guidelines for use cases/modalities to ensure quality care/patient safety during a pandemic.
- Stay apprised of federal, state and local policy changes during a pandemic.
- Keep team informed/trained to stay compliant.
- Integrate telehealth into day-to-day delivery of care.
- Policymakers
- Remove barriers/restrictions placed on telehealth to incentivize adoption, improve access to care and preparedness for future pandemics.
- Remove administrative barriers/streamline credentialing and enrollment procedures.
- Crisis SOPS
- Make the implementation of telehealth capabilities a required element of hospital emergency preparedness programs.
- Provide opportunities for funding telehealth infrastructure.
- Connectivity
- Establish national pandemic response preparedness effort to implement telecommunications infrastructure for remote healthcare delivery/telehealth, remote work (teleworking) and remote education (remote classrooms).
- Upgrade the nations IT and broadband infrastructure which has remained unresolved for decades.
- Solve access inequity and the digital divide.
- Stimulate the economy and economic capabilities of the country.
- Create jobs in building out this infrastructure.
- Significantly improves national preparedness and flexibility for the next pandemic.
- Transportation
- Establish policies that remove barriers to healthcare via telemedicine.
- Allow EMS personnel to provide emergency healthcare services at the patient’s home or via telehealth instead of bringing the patient to the hospital ED.
- Surveillance/Reporting
- Increase funding for public health at the federal, state and local levels as a sustainable function across the nation.
- Fund and implement critical infrastructure to modernize systems, technologies for the collection/reporting of public health data.
- Set national data collection standards.
- Expand data collection beyond the ED to modern care entry points (urgent care, convenience clinics, online on-demand telehealth, etc.)
- Depoliticize the role of public health agencies, information disseminated, etc.
- Establish meeting rules to reduce public health meeting disruption and to address threats against public health officials.