Medicine’s New Virtual Reality

Decreasing Risk

Because of the nature of hematologic diseases, hematology practices care for patients who are immunocompromised or are receiving drugs that can cause immunosuppression. Data that emerged at the beginning of the COVID-19 outbreak in China suggested that patients with cancer, including hematologic malignancies, may be at increased risk for worse outcomes from SARS-CoV-2 infection. One early retrospective study showed that, in 28 patients with cancer who were infected with COVID-19, the mortality rate was 29%.¹ Patients who had received antitumor treatment within 14 days of infection had a 4-times higher risk of experiencing death, intubation, or another severe complication, compared with the non-cancer population.

While acknowledging that patients with some hematologic conditions may have an increased risk of contracting COVID-19 or experiencing severe complications, many hematology/oncology specialists have also cautioned that deferring necessary medical services may put patients at an even greater risk for adverse outcomes. That has made decisions about when and how to treat patients difficult and challenging.

Angela Dispenzieri, MD, Chair of Research in the Hematology Division at Mayo Clinic in Rochester, Minnesota, mostly cares for patients with multiple myeloma, amyloidosis, and rare plasma cell disorders such as POEMS syndrome. Some of her patients travel hundreds or even thousands of miles for the expertise offered at her center.

"Over the past year, there had been some discussion at our center about doing more video encounters for patients, but it hadn't really moved into hematology yet," Dr. Dispenzieri said. "We did some video consultations between physicians, but telehealth for patient interactions was in its infancy."

Minnesota began "sheltering in place" in late March. At that time, Dr. Dispenzieri's practice converted all regular visits to telephone visits, then slowly expanded video capabilities.

"Now, almost all my visits, save maybe 10% of them, have been virtual visits as opposed to face-to-face," she said.

The transition to virtual visits was easiest for patients whose disease had been in a steady state or remission for an extended period, Dr. Dispenzieri said. Many patients with plasma cell disorders undergo frequent blood work and urine studies, which can be done at local collection sites or via mail-in kits. That means the patient may still have to "touch" a health care facility, but will not necessarily have the same number of interactions with other people that would occur if they were traveling to Mayo Clinic by plane, staying in a hotel in Rochester, and eating in restaurants.

Patients who are receiving maintenance therapy or who have started a new oral regimen also can be monitored at home, she added.

"You can easily talk to these types of patients over video to assess symptom burden or shortness of breath," Dr. Dispenzieri said. "These virtual visits can then be converted into face-to-face visits if my antennae go up and I have concerns for the patient."

Jean M. Connors, MD, of Brigham and Women's Hospital and Dana-Farber Cancer Institute in Boston, specializes in classical hematology. For her patients who are taking chronic medications that require monitoring such as warfarin or hydroxyurea, a trip to Brigham and Women's can sometimes be avoided by having lab work completed elsewhere closer to the patient's home, and results then discussed via phone or video.

Brigham and Women's Hospital started a virtual medicine program in 2016, Dr. Connors said, but after about 3 years of use, only 11% of attending physicians had adopted it. "Now, 100% of hematology physicians at our institution are doing some form of virtual medicine," she noted.

Making Virtual Visits a Reality

Cleveland Clinic's Matthew Faiman, MD, MBA, directs the center's Express Care Online program, which allows patients to schedule on-demand virtual visits for non-emergency concerns. (Editor's note: Dr. Faiman is married to ASH Clinical News Associate Editor Beth Faiman, CNP, PhD.) Despite being accustomed to seeing patients online, the COVID-19 pandemic forced him to rethink everything about telemedicine.

"Practically overnight, we needed to be more thoughtful about social distancing and had to reschedule brick-and-mortar visits," Dr. Faiman said. "Prior to the pandemic, on a monthly basis, we had maybe 5,000 digital health encounters. In the last 30 days, we have had more than 60,000 digital health encounters – nearly a 15-fold increase in volume and traffic."

Meeting the demand of this increase meant a lot of sleepless nights and a lot of coffee, Dr. Faiman told ASH Clinical News.

"We had an ‘all hands on deck' approach early on, creating some guidelines for telehealth visits and getting legal advice to make sure we were scaling this up thoughtfully," Dr. Faiman said.

In the past, limitations put in place by the Centers for Medicare and Medicaid Services (CMS) were a major hurdle for telehealth. In its response to the COVID-19 outbreak, the agency broadened access to telehealth services so that beneficiaries could receive a wider range of services without having to travel to a health care facility.² Now, doctors, nurse practitioners, clinical psychologists, and licensed social workers can offer telehealth services and be reimbursed for their work.

The U.S. Department of Health and Human Services (HHS) Office of Inspector General also is offering flexibility for health-care providers to reduce or waive cost-sharing for telehealth visits paid by federal health care. Prior to this, Medicare would only pay for telehealth on a limited basis.

The American Society of Hematology (ASH) has advocated for the government to further expand Medicare telehealth benefits. For example, early in the pandemic, ASH advocated reimbursing for audio-only telehealth visits for office and outpatient evaluation and management services codes at a rate equivalent to in-person visits. The Society also signed on to two separate letters by the American College of Physicians and by the Cognitive Care Alliance requesting the Trump administration take action to allow physicians to conduct audio-only visits and bill at the same rate as in-office visits. ASH expressed concern that reimbursement for audio-only Current Procedural Terminology (CPT) codes was low and "does not adequately represent the services provided by hematologists and many other subspecialty providers."³

ASH appreciated that CMS announced reimbursement for the audio-only telehealth services in March but was even more pleased when the agency increased the reimbursement for these codes in April to align payment with the comparable in-person visits. ASH is still advocating for the government to further expand telehealth benefits, as physicians are still unable to bill the highest level code for office/outpatient in-person visits via audio-only telehealth, and physicians are still struggling with time spent attempting to get patients on video – time they are unable to bill for.

Still, CMS' decision to relax telemedicine reimbursement rules introduced many opportunities for recalibrating patient encounters, according to Dr. Faiman. At Cleveland Clinic, he worked with an IT team and a clinical team to quickly develop reference guides and videos to train providers to use telehealth.

"This guidance needed to include many technical details as well, like how to bill telephone encounters because CMS is now using CPT codes that we didn't have before," Dr. Faiman explained. "It also included instructions on many other things, like how to do hospital inpatient rounding virtually."

Telemedicine and Privacy: HIPAA Rules Relaxed

Ensuring patient privacy was another concern raised with the shift to telehealth. Dr. Faiman said that Cleveland Clinic uses the American Well telehealth platform and has used a video platform embedded in its electronic medical record (EMR) platform, but at the beginning of the pandemic, many commonly used EMR platforms such as Epic did not have integrated videoconferencing. Also, videoconferencing platforms used for general business purposes were not considered compliant with the Health Insurance Portability and Accountability Act (HIPAA).

In March, the HHS Office for Civil Rights announced it would temporarily waive penalties for HIPAA violations to allow broad use of videoconferencing platforms. The agency reported that it will "exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered health care providers in connection with the good-faith provision of telehealth during the COVID-19 nationwide public health emergency."⁴

As a result, when physicians are having issues with telehealth platforms – like when traffic overwhelms the system – they are now able to use platforms like FaceTime or Doximity, Dr. Faiman said. It is unclear how long this will remain feasible.

Figuring Out Logistics

It wasn't just physicians who were slow to adopt telehealth options, said Dr. Connors. Before the pandemic, many of her patients were not very interested in virtual visits either.

"In 2016, when the program started, I talked to several long-standing patients who I thought were tech-savvy and might be open to virtual visits," Dr. Connors recalled. "None wanted to do it."

However, in early February 2020, a fractured knee from a skiing accident forced Dr. Connors to begin scheduling virtual visits with some of her patients, just ahead of the COVID-19 pandemic. To participate in a virtual visit, patients had to sign consent forms and work with a virtual care IT team over the phone to check that they knew how to launch the telehealth program, which was embedded in the EMR system.

"It took a lot of time to get it up and running," said Dr. Connors, who underwent training along with her staff. "Three groups were involved − the scheduling admin, the Brigham virtual care team, and me."

Now, amid the pandemic, anyone who had previously gone through training on the EMR platform can use it for telehealth. Everyone else, she said, sees patients over other videoconferencing platforms like Zoom.

Conduct During Virtual Visits

Ms. Florendo said providers at Mount Sinai received a multipage document with step-by-step instructions, complete with pictures, for how to conduct virtual visits using its EMR platform.

"Conducting these visits requires a smartphone, tablet, or a laptop, and luckily most of our providers are provided a smartphone, so they already had the tools," she said. "If someone didn't have the equipment, they would be provided with it."

The guideline also detailed some specifics, like how to position the smartphone or tablet to try to mimic the angle and feel of an in-office visit, how providers should dress (professionally), and how to document the visit.

"They wanted to us to dress however we normally would for in-person visits," Ms. Florendo said. "If we normally had on a lab coat or had a stethoscope around our neck, that is what we should do on the video visit."

Dr. Dispenzieri starts her virtual visits in a similar manner to in-office visits, greeting the patient and going through their medications and history.

"I ask how they are doing, review their symptoms, and go through a checklist of issues to make sure I'm covering everything," Dr. Dispenzieri said. "The major difference is that I am not touching and listening to parts of their body, but much of the interaction is similar."
Video visits, she has found, are more helpful than telephone visits because they allow her to read her patients' faces and reactions.

"We also rely heavily on spouses or family members and their nonverbal signals during appointments," Dr. Dispenzieri said. "Sometimes these nonverbal cues are just as important as putting a stethoscope to someone's chest in finding out what is really going on."

Ms. Florendo said that, in some cases, if a patient has access to a thermometer or a blood pressure cuff, she may ask them to take their vital signs so that they can be recorded.

Billing for Telehealth

While the logistics of a virtual visit are now straightforward for most practitioners, the billing details are more complicated. Ms. Florendo noted that Mount Sinai's training guideline also included three pages of billing information and questions.

"When we were first doing telehealth, it was mandated that we use it only for patients who lived in New York because of billing issues with out-of-state patients, even those who lived just a few miles away in New Jersey or Connecticut," she said. "Once COVID-19 started to affect a wider range of services and areas, that changed."

Patients also have questions about billing, she added. In Mount Sinai's system, patients were asked to pay their co-pay before logging on for a virtual visit. Patients were billed in the same manner as for a regular office visit, she explained, which resulted in a wide variety of co-payments depending on the patient's specific insurance policy. As the pandemic continued and telehealth services increased, Mount Sinai added a notation to the guideline: If patients were unable to figure out what the cost of the visit should be, or they were waiting to hear back from their insurance provider, virtual visits would be assigned a flat $75 doctors' fee.

"We do ask patients for a credit card when they check in," Ms. Florendo said. "One caveat is that if they said they were scheduling an appointment for COVID-19–related issues rather than myeloma, the charges would be reversed and the patient would not be billed for that visit."

Even though parity has been reached for provider telehealth services and in-person visits, institutions can't collect a facility fee for telehealth, and such fees represent a substantial portion of many medical bills. Many health systems have experienced huge financial losses during the pandemic due to deferral of elective procedures, and some experts and health system leaders have expressed concern that the loss of facility fees will contribute to continued poor financial performance at health institutions and hospitals in the months to come.

Coming On-site

Regardless of how much effort institutions put into expanding their telehealth capabilities or how many patients are able to delay treatment, it is inevitable that some patients will have to come in for face-to-face appointments.

For example, some of Dr. Connors' hematology patients cannot be seen with virtual visits because they rely on blood cell transfusions. "For patients with beta thalassemia who are reliant on transfusion or patients dependent on injectable growth factor support for a variety of conditions, we have to prioritize getting them in and out of the clinic as quickly and safely as possible," Dr. Connors said.

At Brigham and Women's and Dana-Farber, patients requiring an on-site visit go through both telephone and in-person screening, she said. First, patients get a phone call the day before their appointment to assess for typical symptoms of COVID-19 (such as fever, cough, chills, or gastrointestinal upset). Then, they are screened again upon their arrival.

"If they are clear, they go to the next step in the visit. If they appear symptomatic, they are put onto a separate pathway," Dr. Connors explained. "In addition, all health-care providers and patients have to wear a mask to come through the door, and staff have to affirm every day that they are free of symptoms."

Mount Sinai has similar processes in place, Ms. Florendo said. Everyone coming to the hospital is now funneled through one of two main entrances where they are screened for COVID-19 symptoms. An area of the hospital is sectioned off for oncology staff and patients who are free of symptoms.

Any oncology patient who displays symptoms when they present to the hospital is sent for testing.

"In the beginning, test results would take 24 to 48 hours. More recently, polymerase chain reaction (PCR)­–based testing results can come back as quickly as 6 hours," she said. "We are now working on a test that would get results even faster to make sure oncology patients are testing negative before we allow them in for treatment."

Rethinking Clinical Trials

The COVID-19 outbreak has also disrupted the clinical research enterprise, with a recent survey showing that, just a few weeks into the pandemic, 60% of research programs reported halting screening or enrollment for certain clinical trials.⁵ In addition, more than two-thirds of respondents reported using virtual visits to replace clinical trial visits, and, on the whole, respondents reported a decline in patients' willingness or ability to come to the site.

"I'm sure it is different at different sites, but at Mount Sinai we had to stop enrollment for all trials for multiple myeloma," Ms. Florendo said. For participants in existing clinical trials, she explained, the team tried to obtain sponsor approval to adjust treatment if a patient was doing well, through skipping doses, moving to an oral agent, or administering smaller doses. "We perform our regular on-site visits over the phone to capture adverse events," she added. "It has required a great deal of communication with sponsors about missed visits or missed samples."

Dr. Connors said that many of the trials she is involved with had to shut down. For trials with patients already enrolled, she is continuing to monitor participants, but there is no new enrollment.

Staying Power

For any program still struggling to adapt to telehealth visits, ASH has listed some best practices regarding telehealth on its COVID-19 Resources website. ASH also hosted an online webinar on telehealth during COVID-19 in April, which offers insight and information on navigating these challenging times; it can be viewed here.

These resources may be helpful in the future as well, as some providers hope that the advances made in telehealth will continue after the COVID-19 pandemic has passed.

"It has been good to see how all of this works, and that it can be done – especially for someone like me who treats patients with rare diseases," Dr. Dispenzieri said. "The ability to talk to the patient and review labs or studies and not have to lay hands on them is a great opportunity. This is particularly true for elderly patients or those who would have to take time off from work to travel hundreds of miles to see me."

Going forward, Dr. Connors said, she hopes that health-care facilities can continue to apply some of the best practices that have been adapted during COVID-19.

As Dr. Faiman remarked about telemedicine, "The cat is out of the bag." Consumers, he believes will "vote with their feet" and demand that telemedicine remain.

"It is likely that many restrictions that have been loosened up will be tightened back up a bit," Dr. Faiman said. "Commercial payers have put a bit of a finite timeline on this, but I predict that CMS will evolve from where they were before the pandemic."

He hopes that the COVID-19 outbreak will be the first step toward improvements in telehealth coverage, parity, and payment that would have otherwise taken years to accomplish. —By Leah Lawrence