The emergence of the new variety of coronavirus has had a massive effect on medical care across the globe, which has boosted telehealth coverage while suppressing non-emergency procedures. Several medical societies have published guidelines for procedures during the COVID-19 outbreak, however, which in the aggregate suggest that many procedures will be significantly delayed.
Medicare coverage of telehealth has expanded significantly in response to the pandemic, but the CMS and the FDA are not the only federal agencies that have responded to the crisis. The Federal Communications Commission has been provided with a $200 million telehealth bolus that should boost sales of related devices and equipment, a move that follows by less than a year a $100 million telehealth program that was the subject of a July 2019 final rule.
Capital equipment purchases also taking a hit
Analysts with several investor firms had advised in March that a number of elective procedures have been delayed, although the term “elective” is not widely defined in a single manner. Some hospitals had reduced surgical volumes by as much as 50% by mid-March, a reduction that has hit catheterization lab procedures as well as those taking place in conventional operating rooms. However, at least one analyst group, the team led by Ryan Zimmer at BTIG Research, believe that purchases of capital equipment may slow as well. Volumes for equipment with price tags in excess of $1 million, such as high-end imaging systems, may not recover immediately upon the cessation of the state of emergency.
Speaking on behalf of the American Academy of Orthopedic Surgeons was Alan Hilibrand of the Rothman Orthopedic Institute in Philadelphia, who told BioWorld that the impact on volumes has varied significantly by location. “Essentially, in places where there is a surge, they really have become very strict” about non-essential surgical procedures, although Hilibrand noted that some frameworks for prioritizing ER procedures rely on a three-tier approach. A March 31 AAOS guideline states that elective surgery is defined as a procedure that can be delayed without significant harm to the patient or on the eventual outcome.
There is a category for urgent/somewhat elective surgeries – which addresses procedures for repair of ligaments in the lower limbs – as well as for urgent-only procedures. This latter category is for procedures needed to address conditions that would incur significant patient impairment if unaddressed. Among the items in this group are fractures of the pelvis and femur, and this framework is to be applied to the conditions declared by hospital administrators. The American College of Surgeons also has a set of guidelines, which Hilibrand said run largely parallel to the AAOS framework.
Patients avoiding hospitals, other clinical settings
The volume of orthopedic surgeries “has not gone to zero, nor do I think it will, but I think in the next three weeks it will get very light,” Hililbrand said. He said some of the less pressing surgeries won’t necessarily hamper patient outcomes, but he also indicated that some patients might remain wary of hospitals and outpatient surgical centers even after this first wave of COVID-19 has demonstrably passed.
When asked whether patient overreaction could ultimately harm outcomes for patients over time, Hilibrand said, “I think that is possible,” inasmuch as the procedure may become both more complex and incur a higher risk due to a degradation in the patient’s condition.
Hilibrand said his practice undertakes a weekly director’s conference call, explaining that the tone of the call is different every week, thanks to the rapidly shifting landscape of COVID-19 prevalence and the reaction by hospitals and other clinics. He said the board is no longer trying to predict when normalcy will resume, adding, “they see the surge coming, and they really don’t want to have people thinking past how we’re going to get through this.” Hilibrand said there is also some fear that there will be a rebound of the SARS-CoV-2 pathogen prior to the upcoming flu season if social distancing guidelines prove insufficient to suppress the spread.
Multiple guidelines, but same principles
Sahil Parikh, director of endovascular services at Columbia University Irving Medical Center, told BioWorld, that not only do the medical societies have guidelines, but so also do some medical centers and systems. Parikh, who is also a member of the peripheral vascular disease council at the American College of Cardiology, said the underlying principles for these guidelines are essentially the same. He also noted that utilization of paclitaxel-bearing devices had been trending up in the months before the COVID-19 pandemic sent hospital volumes into a tailspin.
Following the FDA advisory regarding paclitaxel in devices for the peripheral vasculature, volumes of such devices had dropped significantly, and Parikh said this was followed by a noticeable increase in target lesion revascularization “consistent with what you would expect” from previous data. He said patients whose peripheral vascular disease does not seem to present an imminent threat to life or limb are being deferred, at least for the time being. When it comes to heart disease, there are some difficult decisions to make, and Parikh said this might extend to treating a single vessel in the coronary arteries via percutaneous coronary intervention, an approach that discharges the patient as quickly as possible without neglecting an urgent problem.
Hospital sterilization of devices is also affected, although Parikh noted that an autoclave is pretty effective in dealing with the SARS-CoV-2 virus. There are also some issues with regard to operating room and cath lab operations, given that many such rooms are provided with positive air pressure. The problem is that positive pressure would discharge any SARS-CoV-2 viruses into the surrounding areas in a hospital or outpatient surgical center, and thus the source of air pressure has to be flipped to negative pressure.
Some, but not all, of these systems are bidirectional, but there are of course some concerns about equipment contamination. These considerations have led some clinical sites to designate COVID-only operating rooms. However, hospitals are starting to make use of ultraviolet light to blast the virus after procedures.
Perhaps predictably, non-device therapies may see an uptick. Doctors are prescribing a range of conservative therapies, such as drugs, although there will also be some emphasis on prodding patients to undertake or cease activities in an effort to tamp down on bad outcomes. “In general, if it’s better to have a procedure than a medication and there are poor alternatives, those patients will be treated. But the bar for entry is much higher than ever,” Parikh said. He confirmed that patients are aware of the risks, and that one of the consequences will be a reduction in overall care in addition to greater utilization of non-device therapy. This will mean that some patients will miss a window of opportunity for treatment, ending up in damage or death. He said early indicators of this phenomenon are starting to show up. “This may be just the tip of the iceberg, and we’re to see the totality of what’s going on” only after some months have passed.