In December of 2019, people in the U.S. prepared for the holidays, making arrangements for meals, family get-togethers and the kids being home all day during the school break. Little did we know just how quickly life as we know it would change.
On the other side of the world, an unidentified form of pneumonia began to spread in Wuhan, China. A large percentage of the people who became infected died from the disease. Though scientists took note and got to work identifying and attempting to understand the source of the illness, most of the world’s population saw the event as little more than a curiosity and an unfortunate event that had little to do with their daily lives.
Then it started spreading to other countries.
Scientists identified the coronavirus, naming it SARS CoV-19, which causes the illness known as COVID-19.
By January 15th, 2020, the first confirmed case in the U.S. occurred in Washington state. By March 11th, the World Health Organization declared the coronavirus a global pandemic. On March 19th, California issued the country’s first stay-at-home order.
The regulatory landscape began to shift simultaneously, opening the door for widespread access to telemedicine services. Since then, telemedicine use has increased dramatically.
Telemedicine Access
Prior to the pandemic, offering telemedicine services was not always easy. The regulatory landscape was hard to navigate: providers had to sort through different federal and state regulations, physician licensing concerns, parity laws, private insurance rules, and Medicare and Medicaid regulations.
Despite these hurdles, telemedicine was already on the rise. A study on telemedicine use by rural Medicare participants found that the use of telehealth increased by 25% over the 9-year period from 2004 to 2013.
The coronavirus made it necessary for healthcare facilities to reconsider how they safely triage, evaluate and care for patients, both with and without COVID. Treating patients who have the virus exposed healthcare workers, putting them at greater risk of contracting the virus themselves. Treating non-COVID cases posed a threat to patients who would have to visit a facility where coronavirus patients were being treated. Furthermore, the general population grew increasingly reluctant to visit a doctor or go to the hospital, even in an emergency, out of fear they could become sick with the coronavirus.
Between January and March of 2020, the number of people who used telemedicine services increased by 50% over the same time period in 2019. It quickly became clear that telemedicine services offered a means of providing patient care safely and effectively, but regulations would have to change to remove barriers to access.
On March 17th, 2020, the Centers for Medicare & Medicaid Services (CMS) established temporary changes to telemedicine laws to reduce exposure to the virus in the elderly population, beginning a move to make healthcare more accessible for everyone during the pandemic.
Changes to Medicare and Medicaid Policies
When COVID-19 landed in the U.S., it hit nursing homes and the elderly harder than other populations. It appeared that people over the age of 65 were more vulnerable to contracting and dying from the illness. They’re also the people who require some of the most regular medical attention.
One of the first steps to continue to provide for the healthcare needs of this vulnerable population was to relax the policies that govern Medicare and Medicaid. This initial measure potentially impacted more than the elderly, as a total of 34% of the U.S. population is part of one of these two healthcare systems.
These initial regulatory changes made it easier for anyone with Medicare or Medicaid to access telemedicine services.
Waivers for Telemedicine
CMS announced that it would implement several waivers and flexibilities for telemedicine that would last for the duration of the pandemic. These changes impact:
- Location of services: Healthcare providers can offer telemedicine services to Medicare and Medicaid patients regardless of whether they live inside or outside of the rural regions already approved for telemedicine. Providers will be paid for virtual services conducted in lieu of face-to-face services.
- Practice across state lines: The waiver for providing services in a patient’s home extends to those who live across state lines. Providers could now deliver healthcare using technology to people who reside in a different state. However, there are still limitations imposed at the state level, primarily concerning licensing requirements.
- Physician–patient relationships: Healthcare providers can offer telehealth and other services to existing and new patients.
- Services covered: CMS expanded the types of services that can be delivered using communication technologies ranging from audio-visual platforms (such as FaceTime, Zoom and Skype) to the telephone.
- Provider eligibility: There are no special requirements for provider eligibility beyond that the provider is eligible to bill for Medicare services.
- Supervision of services: Healthcare provider supervision of services is expanded to allow for virtual supervision.
These policy changes relieve the burden for providers and patients during a time when stress surrounding health and care are especially high.
Waivers for Federal Cost-Sharing Programs
The federal government requires healthcare providers to collect cost-sharing obligations — such as deductibles and coinsurance — from Medicare and Medicaid beneficiaries. Failure to do so usually results in fines and sanctions. For the duration of the pandemic, the federal Office of Inspector General waived this requirement for telemedicine services. If physicians or other healthcare providers reduce or waive deductibles and coinsurance payments for Medicare and Medicaid beneficiaries, they will not be fined or sanctioned.
Other Medicare Telemedicine Policy Changes
In addition to the above changes in telemedicine laws, CMS implemented flexibility measures aimed specifically at Medicare rules. These changes affect:
- Home dialysis for end-stage renal disease patients: Before the pandemic, Medicare patients who received dialysis at home and obtained telemedicine services had to make a once-a-month in-person visit for the first three months of dialysis and once every third month after the initial three-month period. This requirement was been waived. Physicians no longer have to require face-to-face visits, but patients can still choose them.
- Nursing home patients: Medicare beneficiaries who reside in a nursing home are no longer required to see a healthcare provider in person. They can instead opt for telemedicine services.
- Hospice patients: For the duration of the pandemic, hospice physicians and nurse practitioners can use telehealth to assess hospice patients for continued eligibility rather than requiring in-person visits at the patient’s home.
- Frequency limitations: Medicare patients are typically limited in the number of subsequent in-person visits and skilled nursing facility visits to every three days for the first and once a month for the second. Critical care consults were limited to once per day. These limitations have all been removed during COVID-19.
- Stark Laws: For the duration of the pandemic, physicians can offer one another financial support, and healthcare facilities can rent equipment or obtain physician services at prices above or below fair market value. The goal of this waiver is to facilitate continuity of care and healthcare operations more easily.
- Originating site fees: When patients receive telemedicine services during the pandemic, the hospital can still charge an originating site fee.
- Therapy and education service: Hospitals may allow their counselors and therapists to use telecommunications technology to provide behavioral health therapies and education services, including partial hospitalizations, to patients in their homes.
- Opioid treatment programs: When patients in opioid treatment programs do not have access to live video, therapists and counselors can deliver services via the telephone.
Medicare recipients who require specialized services now have broadened access to these services using telemedicine to supplement or replace in-person services.
Changes to Drug Enforcement Agency Policy
The DEA’s job is to enforce laws and regulations governing the dissemination and use of controlled substances. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was enacted to regulate prescriptions obtained online. One component of the Act requires physicians to conduct an in-person medical evaluation before issuing a prescription for a controlled substance. Once the initial exam occurs, doctors must perform face-to-face exams at least once every two years while the patient is still taking the medication.
When the pandemic was declared a national emergency, the DEA established an exception to the Ryan Haight Act for the in-person evaluation requirement for controlled substances. For the duration of the emergency, physicians providing telehealth services can forgo the in-person evaluation requirements. Some caveats must be met. Physicians can only issue a prescription for a legitimate medical condition and only in the course of their standard practices. Telemedicine services have to be conducted via audio-visual technology and in real-time, with both the patient and the physician participating. The doctor must also still follow federal and state laws.
Changes to the Health Insurance Portability and Accountability Act of 1996
HIPAA is a federal law that was enacted to protect patients’ sensitive information. The Act made it illegal to disclose the information without the patient’s consent. With the rise of computer technology, healthcare providers must follow security measures for protecting data stored or transmitted digitally. Cybercrimes in the healthcare industry have risen sharply in the past several years, creating a HIPAA challenge for healthcare providers. This has obvious implications for telemedicine.
With the onset of the global pandemic and the moves to increase access to telemedicine, HIPAA was relaxed for telehealth providers. The changes allowed providers to utilize communication technologies that are widely available to deliver their services. The flexibility enabled a rapid expansion of services and relieved practitioners of liability as long as they followed newly established technology guidelines.
Considerations for App Technology
To improve access, physicians can now use widely accessible applications to provide telemedicine services without fear of HIPAA repercussions, including civil rights lawsuits. However, applications such as Facebook Live and Twitch, which are public-facing, are disallowed. Video chat app including Zoom, Skype, Apple FaceTime, Google Hangouts Video and Facebook Messenger video chat, are permissible. Text messaging is another avenue open to telehealth providers, using text apps such as iMessage, Google Hangouts, Jabber, Signal, WhatsApp and Facebook Messenger.
Considerations for Communication Technologies
In addition to apps, a wide array of stand-alone communication technologies is available to telemedicine service providers. These tools offer additional privacy protections that are not provided in most applications. However, under the new allowances, providers have to select technologies from HIPAA-compliant vendors who agree to enter into a HIPAA business associate agreement.
Though not confirmed by the Department of U.S. Health and Human Services, several vendors have indicated that they are compliant and willing to enter into a business agreement. A few communication technologies companies have created platforms specifically for the healthcare industry, including Zoom for Healthcare and Spruce Healthcare Messenger.
Telemedicine Modalities
Telemedicine is a term that covers a broad range of service delivery methods. Still, all utilize communication technologies that remove the need for in-person visits when providing primary, chronic, acute and specialty care. With the current easing of regulations, telehealth providers can more easily treat noncritical COVID-19 patients and non-COVID patients.
Synchronous Delivery
When most people think of a doctor’s visit, they think of a real-time exchange between a patient and the physician. This is synchronous service delivery. In telemedicine, instead of an in-person meeting with the provider, the patient engages in real-time exchanges with their doctor using one of the apps or technologies mentioned on their phone, tablet or computer. Telephone calls fall into this category as well.
Asynchronous Delivery
This delivery modality does not happen in real-time. Instead, data, images and messages are added to a system at one point in time and then picked up at a later time for analysis or diagnosis before a response is sent. Often, these occur through service portals that offer a secure means of data transmission.
Remote Patient Monitoring
In this instance, patients are usually connected to devices that measure their clinical stats. These data are transmitted to the patient’s doctor, which can occur in real-time or not.
Telemedicine Benefits During the Pandemic
As scientists began to understand the coronavirus better, the CDC implemented guidelines to reduce the spread of the virus and alleviate the pressure on the healthcare system. These guidelines included social distancing measures. Telemedicine increases the ability of the healthcare industry to follow social distancing protocols. It also frees up medical staff and medical equipment — both of which have been in short supply during the pandemic — to care for critical patients and increases access to medical services for those who would be otherwise reluctant to visit their doctor in person. Further, telehealth is beneficial for preserving the doctor–patient relationship when patients are unable to access in-person care.
Potential Telemedicine Limitations
Even with the relaxing of guidelines during the pandemic, there are still some potential limitations to telehealth service delivery. One of the biggest regulatory hurdles practitioners must still overcome is the state licensing requirements for telemedicine and cross-border access. There are also occasions when an in-person visit is a better option.
The original intent of the changes to Medicare and Medicaid rules was to protect the elderly, yet this is one segment of the population that may potentially have a more difficult time utilizing some of the technology available for telemedicine, due to either lack of access, lack of skills, or distrust of the virtual forum in healthcare.
Seniors aren’t the only ones who could face these challenges. Audio-visual technologies require sufficient internet connectivity. Those who do not have reliable access may be unable to connect, or they may experience high levels of frustration during the exchange when there is a poor connection. Some people may also find it difficult to discuss sensitive topics via video chat, text messaging, or phone.
Telemedicine Policies Beyond the Pandemic
Thus far, all of the regulatory changes are temporary measures that the government implemented to improve healthcare services during this global crisis. Though vaccinations are well underway, the coronavirus could be with us for a long time. Already, scientists have identified numerous variants that are potentially concerning.
There is still uncertainty about how well the vaccines will hold up against emerging variants. Furthermore, the vaccines were all initially authorized for emergency use, and their long-term effectiveness is unknown. There is a good possibility that the world could face resurgences in the future, either because vaccine effectiveness wanes or because of a rise in vaccine-resistant variants.
Though there have been no moves to make any of the changes to telemedicine laws permanent, it’s unlikely that telemedicine will return to a pre-pandemic state once the pandemic subsides. Technology improvements are likely to continue, and providers and patients will become more accustomed to remote healthcare services. Telemedicine is a valuable service that fills a need beyond the current crisis. We’re bound to see future regulatory measures that permanently increase access to telemedicine services and make it easier for healthcare providers to offer them.
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