COVID-19 Pandemic: CMS Waivers to Streamline Operations, How Telemedicine Can Be Used in Patient Care and Free Offers

Pat Stricker, RN, MEd
Former SVP, Clinical Services
TCS Healthcare Technologies

Overview of COVID-19 and Statistics
One thing I think we can all agree on is that the pandemic of the novel coronavirus (COVID-19) has totally shocked and overwhelmed the world. It has changed our healthcare system and rocked our world. Due to the need for social distancing, our entire country, and others as well, have some form of lockdown, requiring all non-essential businesses to close. While most healthcare offices and organizations are still open, many of them are functioning in different roles. It seems unthinkable that in today’s world, with all our expertise, advanced technology, data analytics, and scientific knowledge, we could be caught off-guard by this virus so quickly and dramatically.  

The first case of COVID-19 was reported in Wuhan, China in late December. However it is now thought that the first case was actually traced back to November 17. On December 31, China informed the World Health Organization (WHO) about a cluster of “41 patients with a mysterious pneumonia.” The first confirmed case outside of China was reported in Thailand on January 13 and the first case in the United States (U.S.) was reported on January 20, and the number of cases had increased to 9,976 in 21 countries. WHO declared a global public-health emergency.

As of April 15, 2020, according to the Johns Hopkins Corona Resource Center, there are 1,982,939 confirmed cases in 185 countries, accounting for 126,761 deaths. The United States leads all other countries in the number of confirmed cases (609,516) and the number of deaths (26,057). The country with the second highest number of confirmed cases is Spain at 174,060, which is only about 29% of the U.S. total.  Italy has the second highest number of confirmed deaths at 21,067, which is about 20% less than the U.S. The state of New York accounts for almost 1/3 of the confirmed cases within the 50 states and about 41% of the total U.S. deaths (10,842). These numbers are astounding, and unfortunately the pandemic is still in its early stages.   

Background and Proactive Preparation
The healthcare systems in the hardest hit countries are being totally overwhelmed with the number of patients presenting to the emergency departments (EDs) with respiratory distress. Many of them, especially the elderly or patients with other co-morbid diseases, deteriorate quickly into severe distress that requires ventilator care. Studies have shown that between 45% and 66% of COVID-19 patients placed on a ventilator have died. This is higher than the normal rate of about 35% for patients placed on a ventilator for pneumonia.

The number of critical patients and the death rates are not only overwhelming the staff, but they are creating a severe shortage of ICU beds and ventilators. Here in the U.S., the states have had a very difficult time trying to proactively assure that they will be enough available ICU beds and ventilators when they are needed. Obtaining enough test kits, swabs, and personal protective equipment (gowns, masks, gloves, and face shields) has also been very a frustrating experience due to the overwhelming number of cases.   

The hospitals have stopped all non-essential inpatient and outpatient surgeries to free up beds, ensure adequate staffing to care for the COVID-19 patients, and to use the extra gowns, masks, and gloves for use with COVID-19 patients. Temporary “field hospitals” have been set up in arenas, conference centers, football stadiums, etc. to provide extra beds. Personnel have been shifted from areas that were closed down or downsized to triage and testing areas or other functions within the healthcare system. Calls from the “worried well” are overwhelming physician offices, clinics, health plans, mental health agencies, and numerous other agencies, and those who answer do not have accurate, approved protocols or patient information to provide to them because the crisis is moving so quickly.

CMS’ Extensive Blanket Waivers
In order to meet the demand for all the needs listed above, as well as others not listed, the Centers for Medicare & Medicare Services (CMS) quickly issued a COVID-19 Emergency Declaration that defined blanket waivers for healthcare providers. The waivers are unprecedented and were intended to allow aggressive changes to be made quickly to manage the COVID-19 crisis. The 26 page Emergency Declaration document explains in detail each of the numerous changes that were made to: programs, processes, rules, regulations, licensing, billing processes, paperwork and medical records, patient rights, information sharing, reporting requirements, verbal orders, utilization review, quality assurance, hospital capacity, discharge planning, physician and nursing services, physician supervision of NPs, mental health, rehabilitation, respiratory care, long-term and skilled nursing care, home health, staffing, roles and responsibilities, hospice, ESRD, dialysis, provider enrollment, telemedicine and many other areas. (Some of these are described in more detail in the next paragraph.) These changes relaxed rules and regulations to: make it easier for staff to work in different roles; allow hospitals to care for patients in different environments outside the walls of the hospitals; revise policies, regulations and processes to streamline the processes; and revise licensing changes to allow healthcare professionals to travel to other cities and states to help during the pandemic. The temporary changes are retroactive to March 1 and are effective through the end of the emergency declaration. The waivers also allow for services to be billed.   

On March 30, 2020, CMS issued additional temporary, regulatory changes to ensure healthcare organizations, hospitals, and providers have the ability to manage the predicted, unprecedented surge of COVID-19 patients. These are some examples of the more significant temporary CMS rule changes affecting patient care during the COVID-19 emergency:  

1. Increase Hospital Capacity: Allows hospitals to increase their bed count without incurring penalties and expand bed capacity by creating additional COVID-19 treatment sites. Patients can be transferred to other facilities outside the actual hospital, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels and dormitories, hospital ships, FEMA-constructed temporary facilities, etc.

• Ambulatory surgery centers (ASCs) are allowed to provide cancer procedures, trauma and other essential surgeries that are typically performed in hospitals. They can contract with local health systems to provide hospital services or bill as hospitals during the emergency.
• Dialysis facilities can create special facilities to just care for COVID-19 patients, because they are immunocompromised and at high-risk for developing complications, if infected with the COVID-19 virus.
• Ambulances can now transport patients to physician's offices, urgent care facilities, ambulatory surgery centers, ESRD or dialysis centers, federally qualified health centers and mental health centers. 

2. Rapidly Expand the Healthcare Workforce: Front-line healthcare workers need to be recruited, retained and cared for. They are facing unbelievable challenges each day in caring for large numbers of critically ill patients and also worrying about whether they or their families will contract COVID-19. 

• Hospitals can provide benefits to their staffs who provide patient care, such as: free daily meals, child care services, and laundry services for personal clothing.
• Medical residents can provide more services, and supervision can be by audio and video means, if not able to be present.
• Physician assistants, nurse practitioners, and other healthcare professionals can now perform specific services without a direct physician's order.
• Verbal orders, rather than written orders, can be given so physicians can focus more on taking care of patients.
• Bi-weekly onsite visits by a nurse for home health and hospice care and for a nurse or professional to evaluate the care provided by aides is consistent with the care plan are no longer required, as that may not be physically possible during the crisis.
• Local private practice physicians, who have closed their non-essential practices during the pandemic, can enroll in Medicare temporarily so they can work as employees.

3. Put Patients Over Paperwork: Paperwork requirements are being eliminated temporarily to allow clinicians to spend more time with patients.

• Medicare patients will be allowed more access to respiratory devices and equipment (non-invasive ventilators, multi-function ventilators, respiratory assist devices, and continuous positive airway pressure devices). Respiratory-related devices and equipment will be covered, if determined to be medically necessary by a clinician.
• Written policies of processes and visitation of patients in COVID-19 isolation are not required. 
• Hospitals will be allowed more time to provide patients a copy of their medical record.
• CMS will continue oversight activities, but will: stop requesting additional information from providers, healthcare facilities, Medicare Advantage and Part D prescription drug plans, and States; reprioritize scheduled Medicare program audits to allow more time to focus on patient care; and modify the 2021 and 2022 Part C and D Star ratings due to the expected disruption to data collection and scores by the pandemic.

4. Promote Telehealth: CMS is expanding access to Medicare telehealth services to save complex remote evaluations and monitoring, using audio and visual capabilities, for acute conditions, ED visits, and COVID-19 patients.

• 80 additional telehealth services provided by a telehealth clinician have been added, including ED visits and initial nursing facility and discharge visits.
• Telehealth will serve as a face-to-face requirement for patients in inpatient rehabilitation facilities, assisted living facilities, hospice and home care.
• Physicians can now evaluate patients using audio-only telephones, as well as those with interactive applications with audio and visual capabilities.
• Home health and hospice providers can provide more telehealth services, if they are part of the care plan and do not replace needed in-person visits. 
• A patient will be considered “homebound” and will qualify for Medicare’s Home Health Benefit, if a physician determines they need skilled services, but cannot leave home because of a medical issue or has a suspected/confirmed COVID-19 diagnosis.
• Physicians can now provide virtual check-in services (brief check-ins with patients) to both new and established patients by audio or video device.
• Clinicians can provide remote patient monitoring services for patients with a chronic condition or a COVID-19 diagnosis, such as monitoring a patient’s oxygen saturation level using pulse oximetry.

Telemedicine Programs for Routine, Non-Urgent Patients
One of the main areas with many significant changes was telemedicine. Telehealth and telemedicine refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health. Telemedicine has been slowly increasing in popularity over the past few years, but there were only minimum services available and regulations were restrictive. Now with COVID-19, telemedicine has been changed to increase access to telehealth services, so patients can receive more services without having to travel to a healthcare facility. This will help to contain the community spread of the virus and reduce the chance of exposure for the patient. Physicians and other healthcare workers will also be protected from contracting or transmitting the virus because there is no physical contact. Another big advantage of telemedicine is that it is a quicker, more efficient, and more cost-effective way to handle large numbers of people that would normally be flocking to urgent care and emergency departments.

Telehealth services will be able to off-load some of the increased call volume being experienced by the physician’s offices, clinics, health plans, mental health agencies, home health services, etc. The volume of calls at these sites has increased immensely with people who have symptoms and need to be evaluated. The calls are also from people who are afraid of the virus and have a lot of questions. Having these calls taken by a telemedicine service or a nurse line, will allow the staff working with the patients to spend more time focusing on them.    

With the relaxed telemedicine restrictions and remote visits, telemedicine will be able to be more innovative, efficient, and provide more meaningful services. Patients will be able to continue to get routine care for illness and follow-up visits, without getting lost in the chaos caused by the pandemic. Vulnerable patients will even be able to receive care in their homes.

The three types of virtual services physicians and other professionals can provide are explained by CMS in these two documents: General Provider Telehealth and Telemedicine Tool Kit that explains the changes, which became effective March 6, 2020, in detail, and the Medicare Telemedicine Health Care Provider Fact Sheet.

• Telehealth visits and time on phone to triage medical issues
• Virtual check-ins for those who may have more symptoms. Allows provider to offer recommendations or take necessary precautions if they need to be seen in the office.
• E-visits allow patient to talk to their doctor using an online patient portal without going to the doctor’s office. They can be used for the treatment of COVID-19 from anywhere, including places of residence, such as homes, nursing homes, and assisted living facilities.

The Tool Kit contains links to sources of information for telemedicine and information that is helpful in establishing a new telemedicine program. The Fact Sheet describes each of the services in detail, including relevant codes, and provides key takeaways for each service. 

There are more than 50 U.S. health systems that already have operational telemedicine programs, while other organizations out-source those services to for-profit companies. It was easier for those types of organizations to start handling the increased COVID-19 call volumes. For organizations that did not have telemedicine programs, it took time to get them set up, e.g., obtaining and setting up audio-visual equipment, hiring and training staff, developing policies and procedures, setting up medical coding and billing rules, etc.

Before the pandemic, 1 in 10 patients in the U.S. used telemedicine services. However, telemedicine programs saw dramatic increases in call volumes in the first two weeks of March after COVID-19 was announced. Most programs reported at least a 10 – 20 fold growth in calls, with 2/3 of the calls related to COVID-19. One medical university had an increase from 40 calls per day to 120 calls by noon. Another program said they increased physician staffing from 6 – 60, but still had to schedule several days out in order to handle all the calls.

Programs are struggling trying to find physicians to take the calls. Some are asking physicians who closed their non-essential offices to work temporarily for them or asking PCPs to reduce their non-essential office visits and perform telemedicine visits. Others are using quarantined physicians, taking calls from their home or trying to get physicians from other cities or states to help, since they can be set up remotely and the licensing requirements now temporarily allow physicians to practice in other states. Some programs are adding nurses (or quarantined nurses working from home) to pre-screen patients using standardized protocols to reduce the time needed on each call for the physicians evaluation.

Staffing is only one of their challenges. Others include: training numerous physicians to deliver virtual care is time-consuming (it’s different than assessing patients face-to-face); training physicians on the process; documentation and use of the audio-visual equipment; working out billing issues; assuring that the internet bandwidth is sufficient for large call volumes; and keeping the information about COVID-19 up to date for the staff, since it is changing so rapidly.

Some telemedicine programs are caring for hospitalized patients as well, helping to lessen the need for hospital staff. With the right physical set up physicians and nurses can remotely monitor 60-100 patients in ICUs in multiple hospitals. Of course, staff still needs to be present in the ICU, but fewer would be needed. Other programs are evaluating patients remotely and directly admitting them to a hospital bed, bypassing the ED and lessening the ED workload, thereby reducing the risk of exposure and virus spread to patients and healthcare personnel.

Telemedicine seems to be the perfect type of program for handling the COVID-19 pandemic. It is patient-centered, available 24 hours a day, amenable to self-quarantine, is able to use smart phone or web-enable computers that patients have, is time-efficient and cost-effective, and it protects patients, clinicians and the community from exposure to and spread of the virus.

The previous outbreak of H1N1 gave us some insight into how a telemedicine program would work, although that was before the programs were as advanced as they are now.

Advantages of a Telemedicine Program

• CMS can quickly issue waivers to temporarily remove restrictive regulations.
• The necessary processes and procedures for training, staffing and workflow can be developed and implemented fairly quickly.
• The care delivery is set up to protect the patient and providers and limit the risk of exposure or spread of the virus. There is no direct contact.
• Most non-urgent and a few urgent conditions can be effectively managed remotely without compromising the patient’s health or the quality of care. And all of these cases mean that EDs have less non-urgent patients, giving them more time to focus on COVID-19 patients.
• The required electronic devices (smartphone and computer) and online connectivity are usually readily available for the patient and physician.
• Telemedicine is a time-efficient, cost-effective, and safe care delivery system.
• Telemedicine allows the management of large, high volume care visits with less staff than person-to-person care.

Lessons Learned for the Future:

• Clinicians must follow normal processes, protocols, documentation and follow-up procedures and report any adverse events.
• Quality of care should be the same in telemedicine as it is in person-to-person care. Nothing should jeopardize the care process or patient safety.
• Unnecessary administrative functions should be removed from the care process and delegated to others, whenever possible.
• Having a standardized and up-to-date telephone script for H1N1 across all primary care practices was a benefit, but difficult to quantify.
• Pre-screening by nurses trained in telephone triage, using standardized, evidence-based protocols, would be a good addition to the process, especially during really busy times, because it would allow physicians to handle more calls.

Telemedicine is definitely a program that will become very popular in the future. I’m surprised it has taken so long, but I think after this experience, it will begin to flourish. It’s about time!  

Extra - Free Offers:
While researching this article I found the following items that are available free, so I thought I would mention them here for those of you who may be interested.

• Free Telemedicine Newsletter
  For those with a current telemedicine program or those planning on implementing one, you might want to review and sign up for Briefings in Telemedicine, a weekly newsletter that provides important updates, protocols, and specific examples to help hospital leaders and healthcare providers develop or expand their own telehealth programs.
• 2 Free Standardized, Evidence-based COVID-19 Protocols: Exposure and Diagnosed/Suspected with ClearTriage Software
  In the telemedicine portions of this article, standardized, evidence-based protocols and nurse screening were mentioned. As a former telephone triage nurse manager and program director, I totally understand the importance of using these types of protocols (algorithms) when assessing a patient. It provides guidance and standardization for the nurse so nothing is overlooked.
  
  For organizations who are receiving high call volume from people who are afraid they may have symptoms or just have questions about COVID-19, I’m sure that has to be difficult. I know how difficult and time-consuming it is to write protocols and the additional care advice and educational information that are included in them. And I can’t even imagine how organizations on the front line, receiving high call volumes, are even able to have the time to develop a thorough, detailed COVID-19 protocol at this time. Just keeping it up-to-date as things change so rapidly would be almost impossible. Yet you have to have this type of document for the nurses taking those calls. How do you do that?
  
  I think I found a solution for any group or organization that needs COVID-19 assessment protocols, care advice, patient education material, and online software that makes using and documenting the assessment really easy. And they are free!
  
  Dr. Barton Schmitt and Dr. David Thompson, authors of the “gold standard” nurse telephone triage protocols, and ClearTriage, the leading online software for the Schmitt-Thompson protocols, are jointly offering a 2 free COVID-19 protocols with the ClearTriage online software to any hotline, telephone triage program, doctors’ office, clinic, health plan, or any other organization that handles COVID-19 calls.  
  
  These protocols were developed by Drs. Schmitt and Thompson in close cooperation with the Centers for Disease Control and Prevention (CDC) and other infectious disease experts. They were released as part of the complete Schmitt-Thompson Nurse Triage Protocols on Feb. 7, 2020, and have been updated five times since then, due to the rapidly changing pandemic. 

There are two free COVID-19 protocols available in both pediatric and adult versions:

• COVID-19 Exposure: Used to assess patients based on travel to a high risk area or close contact with a person diagnosed with or suspected to have COVID-19.
• COVID-19 Diagnosed or Suspected: Used to screen in areas of high community transmission where all fevers and coughs are handled as if COVID-19 positive.

The free protocols are provided in three different formats:

• COVID-19-Only Protocols available with the online ClearTriage software: This option is intended for any program handling COVID-19 related calls. The protocols and educational information are very detailed, but very easy to use. There is no setup or installation needed. Simply register, log in to the software, and start your assessment. Once the assessment is completed, the recommended referral is discussed, and the patient care advice and educational information is reviewed, you simply click a button, which makes a copy of the transaction and then paste it into the organization’s EHR or other documentation system. The software also allows the user to send CDC handouts to the patient by email or text. Click here to learn more about this option and to try out the protocols and software.  
• PDFs: The protocols are also available as PDFs. These can be used without a software system, but the transaction needs to be documented in the organization’s EHR or other documentation system, so it does take more time and effort for each call. 
• The COVID-19 Protocols as part of the complete Nurse Triage Protocols with the ClearTriage Software: This option contains the two protocols that is included in the complete Schmitt-Thompson Nurse Triage Protocols with the ClearTriage online software. The software allows the user to customize the protocols, review usage reports, or choose different documentation options. It is intended for organizations that take symptom-based calls and need a complete triage system. This option, with the use of all protocols and ClearTriage software, is offered as a free 30-day trial.  

The ClearTriage website contains self-help training materials that organizations can use: A User’s Guide, protocol indexes, and software instructions. They also offer a Clinical Newsletter, a Blog with tips for using the protocols and software, Customer Interviews, and Frequently Asked Questions. ClearTriage also offers periodic webinars. 

I know this may sound like an advertisement, but that’s not what it’s meant to be. These protocols are a needed part of our healthcare system right now and there is no need for every organization to develop their own. These are quality protocols and software developed by professionals in the triage area. And they are offering them free. So why would anyone want to spend time and effort developing them? Check them out and decide for yourself.

The opinions expressed in this editorial are solely the author's own and do not reflect the views of the Case Management Society of America.