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MARCH 27, 2020 -- The test-driven world of cardiovascular medicine is rapidly shifting to remote hands-off telemedicine to keep patients and their physicians safe during the COVID-19 pandemic.
During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital in Boston, said they've gone from seeing 400 patients a day in their clinic to less than 40 and are trying to push that number even lower and use virtual care as much as possible.
"The reason is we are having to send home physicians who are exposed and it's cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you're going to need to call them in in the next couple of weeks," she said. "And our [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that's a mask that can be used by someone performing CPR in an ICU."
The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Bhatt, who co-authored the American College of Cardiology's (ACC) recent guidance on establishing telehealth in the cardiology clinic.
"We find that sending people tip sheets and PowerPoints in addition to everything that is happening...is too much," Bhatt observed. "So actually holding your friend's hand and walking them through it once you've learned how to do it has been really great in terms of adoption. Otherwise everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan."
During the same March 20 webinar, David Konur, FACHE, chief executive officer, Cardiovascular Institute of the South, Houma, Louisiana, said they began doing tele-cardiology over 5 years ago and now do about 30,000 "patient touches" a month with 24/7 access.
"This is certainly an unprecedented time," he said. "COVID-19 is shining a very bright light on the barriers that exist in healthcare, as well as the friction that exists to accessing care for all of our patients."
A new US Food and Drug Administration (FDA) policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic.
The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.
As such, the FDA "does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared non-invasive remote monitoring devices that are used to support patient monitoring."
Modifications could include: the addition of monitoring statements for patients with COVID-19 or co-existing conditions such as hypertension and heartfailure; a change to the indications or claims related to home use of devices previously cleared only for use in healthcare settings; and changes to hardware or software to increase remote monitoring capability.
The approved devices listed in the guidance are: clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.
The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the US Department of Health & Human Services (HHS) said it would not penalize healthcare providers for using non-HIPAA compliant third-party apps like Skype or Google Hangouts video.
The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.
"All these mandates have come in a time of desperation where we're doing the best that we can to provide for patients and keep them safe," Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women's Cardiovascular Center, Lenox Hill Hospital, New York City, told theheart.org | Medscape Cardiology. "Realistically, the whole digital realm has a lot of promise for our patients."
She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as healthcare providers.
"In times of need, the most promising technologies we have, have to come to the forefront," Gianos said. "So using the data from the home — whether they have a blood pressure cuff or something that tracks their heart rate or their weight — when we don't otherwise have data, is of great value."
Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, Colorado, said "in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn't surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach."
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.
The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Freeman, who co-authored the telehealth guidance and also serves on the ACC's Innovation Leadership Council.
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat "vaguely worded," Freeman noted, but highlights the ability of existing technology to provide essential patient data from home.
"I think as we add adjuncts to the things we're used to in the normal face-to-face visit, it's going to make the face-to-face visit less required," he said.
Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS's decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines is also being viewed cautiously until tested legally, Freeman observed.
"If there's one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that's readily available to folks," he said.
Earlier today, the American Heart Association (AHA) announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9 to 12 months and focus on how this novel coronavirus impacts heart and brain health.
Additional funding will also be made available to the AHA's new Center for Health Technology & Innovation's Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.
The rapid response grant is an "unprecedented but logical move for the organization in these extraordinary times," AHA president Bob Harrington, MD, chair of medicine at Stanford University, California, said in a statement. "We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel-ready with the laboratories, tools and data resources to immediately begin work on addressing this emergent issue."
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