On January 31, 2020, the Secretary of the Department of Health and Human Services issued a public health emergency as a result of COVID-19. The emergency declaration requires public health professionals, first responders, and public officials to work together to minimize death while preventing illnesses. The declarations provided the government with the flexibility to waive or modify standard requirements as it relates to both public and private insurance, service providers, and authorizations including telehealth. Telehealth provided access to healthcare to those who face barriers as well as flexibility in being able to manage care while reducing the spread of COVID-19 along with other infectious diseases. There remained uncertainty regarding the freedom to prescribe controlled substances via telemedicine with the Biden administration set to end the public health emergency on May 11, 2023. However, on February 24, 2023, the Drug Enforcement Administration (DEA) released a proposed rule that aims to permanently extend controlled substance prescribing flexibilities.
During the COVID-19 pandemic, the federal government and the Drug Enforcement Agency (DEA) temporarily lifted the Ryan Haight Act’s mandate that imposes federal prohibition on online prescribing of controlled substances. The DEA waived its in-person medical examination requirement and set forth different criteria for controlled substances. For as long as the duration of the public health emergency (which was extended through January of 2023 this month), a patient can receive a controlled substance prescription without an in-person examination if the communication was conducted in a two-way, audio-visual, and real-time interactive communication. Covid highlighted the increased use of telehealth and digital health platforms. However, as telehealth surged, public policy has failed to move at the same speed.
The COVID-19 pandemic has fundamentally changed many aspects of healthcare delivery. Most notably, the pandemic increased the demand for digital health services. Telemedicine saw ten years’ worth of expansion in one year, but it was not the only digital health service that exploded as a result of the pandemic. Telehealth has evolved from merely meeting with a provider via a video conference to include more sophisticated technologies. Remote Patient Monitoring (“RPM”) allows for providers to collect patient data without the patient having to go to a healthcare facility for monitoring. RPM can improve the quality of healthcare delivery by more closely monitoring a patient while also reducing patient volumes within a healthcare setting. In addition, because RPM allows patients to get more care at home, it can largely reduce costs to the patient and the payor while increasing access. Despite the many benefits associated with RPM, there are considerable risks and compliance issues.
The Coalition to Protect Telehealth and State Representative Deb Conroy of the Illinois 46th House District have introduced legislation that would permanently expand access to telehealth services for Illinoisans. The legislation also details provisions that promote telehealth payment rate partity between telehealth services and in-person care. In a direct response to the COVID-19 pandemic, telehealth providers have been granted temporary waivers to align their payment rates with those prescribed for traditional care in health care facilities. These waivers have served as stabilizing financial mechanisms for many practitioners experiencing revenue loss due to the restrictions on elective procedures and non-emergency care. The proposed legislation would give patients more freedom to utilize telehealth services by removing the patient responsibilities to demonstrate hardship or access issues.
The Health Insurance Portability and Accountability Act – enacted in 1996 by the U.S. Congress and signed by then-President Bill Clinton – has long served to maintain the standards of electronic health records and patient privacy, among many other provisions. Violating HIPAA can result in both criminal prosecution as well as steep civil penalties. As the healthcare industry transitioned from the use of paper records to storing patient data on electronic health records over the last two decades, health organizations have learned to adapt to HIPAA compliance, with many increasing their compliance programs by hiring full-time compliance officers, designating an individual as the compliance manager, and/or appointing a compliance committee within the organization.
With COVID-19 rapidly spreading, telehealth services have been seeing an explosion of demand. On March 17, 2020, President Trump announced during a White House press briefing an unprecedented expansion of telehealth services for the 62 million Medicare beneficiaries who are amongst the most vulnerable to the disease. The Department of Health and Human Services (“HHS”) and Centers for Medicare and Medicaid Services (“CMS”) have since vowed to work with the administration by temporarily relaxing certain HIPAA, altering licensure, cost-sharing, and auditing requirements. As the number of patients increases, compliance and privacy risks associated with telehealth also surge.
COVID-19 has rapidly changed the healthcare field unlike anything has before. With the continued spread, healthcare providers have started to adopt telehealth as a way to access patients and continue to provide quality care, without breaking their self-isolation. One avenue that has long been closed off for physicians has been online prescribing, but COVID-19 appears to be changing even that.
Telehealth allows for the delivery and facilitation of medical services through technology. It is rapidly evolving as the tech industry grows. Ten years after the passage of the Ryan Haight Act, the Drug Enforcement Agency (DEA) has still not taken any action to assist physicians in their usage of telehealth. Recently, Congress finally stepped in and passed a bill that requires the DEA to take action within the next year. But, the question still remains whether the DEA will finally act, or continue their history of avoidance?
In April 2013, members of the Federation of State Medical Boards (FSMB) and the Council of State Governments (CSG) embarked on a venture to create the Interstate Medical Licensure Compact (the Compact or IMLC), a voluntary, expedited pathway to licensure for qualified physicians who wish to practice medicine in multiple states. On April 20, 2017, the Interstate Medical Licensure Compact Commission, (IMLCC) issued its first Interstate Medical License to a Wisconsin physician who applied to practice in Colorado, setting a groundbreaking precedent in medical licensure portability. While the IMLC is a great first step toward increasing access to healthcare by expanding licensure portability, this initiative faces multiple regulatory hurdles.