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More Medical Innovation, Less Regulation

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More Medical Innovation, Less Regulation

Four practicing emergency physicians describe some practical fixes to make treating Covid-19 patients safer and more effective. April 9, 2020
Covid-19
Health Care

You have heard the pleas of the Covid-19 frontline health-care workers to “#GetMePPE.” The need for personal protective equipment is dire. Italy’s experience has shown that hospitals may be engines for spread, with health-care workers becoming infected (and dying) at alarmingly high rates.

The SARS-CoV-2 virus—the technical name for the novel coronavirus—has several qualities that magnify the importance of appropriate PPE. Covid-19 causes a wide array of clinical symptoms and can be spread by patients who are minimally symptomatic. Indeed, patients may be most infectious before symptoms become apparent. If patients are not symptomatic, there is no way to screen them based on symptoms. Even patients with dangerously low blood-oxygen levels are arriving at hospitals with seemingly unrelated complaints and without overt signs of distress. Despite rapid evolution of the triaging process for Covid-19—through which patients are initially assessed to identify their risk of infection—we now believe that it is impossible to distinguish rapidly between low-risk and high-risk patients, thus disabling the no-risk triage pathway. We must assume that every patient is infected, and thus must use some level of PPE for every patient whom we see.

The challenges that health-care workers face are compounded by a dearth of testing and inability to test patients rapidly. And the accuracy of current testing protocols is disappointing, with a false-negative rate of 30 percent to 40 percent. However, testing remains critical to protecting staff and patients in hospitals, the hottest of infection zones. As health-care workers, we must doff PPE when we leave the room of a suspected patient and don new, clean PPE before entering the room of another. Doing so ensures that staff don’t become vectors of infection. (Doffing itself is the procedure that puts workers at highest risk of self-contamination. Studies have shown self-contamination in more than 40 percent of doffing episodes.) In dedicated Covid hospital units, where all patients are known to be infected, workers can wear much of the same PPE from room to room without fear of causing a new Covid infection. (Fewer doffing episodes means decreased self-contamination risk.) If, through widespread testing, we had a sense of the rate of infection throughout a community, we could make clinical judgements about the pretest probability that a patient is infected, and his need for isolation. But since we are currently operating in a state of community spread, we must assume the worst in each case.

One of the biggest hurdles to controlling hospital hotspots has been the risk-averse culture of medicine that has developed in response to the Centers for Medicare and Medicaid Services (CMS) regulations and to the “quality incentives,” billing rules, and fines imposed by the government and regulatory agencies. Predictably, the prevailing “business as usual” culture of the health-care system places high value on patient satisfaction—based on surveys, rather than outcomes—and regulatory compliance, and has become a barrier to implementing changes that are best for patients and for public health.

We can solve many of our problems with rapid, innovative changes to our usual practices, significant reorganization, and implementation of commonplace technology. For example, the use of telehealth within hospitals can decrease both health-care-worker risk and PPE use. All entry into the patient’s room can be coordinated and consolidated. We estimate that for a “Covid rule-out” patient, using a combination of video intercom and changes to processes, we can decrease the number of N95 respirators used from nine to one, or even zero. Implementing these changes for inpatients can yield similar results.

Regulatory barriers to implementation have slowed these and other common-sense efforts. In addition to a lack of resources to purchase devices and get them working, hospitals and IT departments have been fearful of violating HIPAA patient privacy provisions with technology that has not been fully vetted. Billers worry that they will be prosecuted for Medicare fraud for violating technical definitions of telehealth. Physicians worry about violating EMTALA, a federal law regarding the stabilization of any patient entering an emergency room and incurring personal fines of more than $100,000 per violation.

Physician, hospital, and specialty groups have worked with CMS to break down these barriers. In response, CMS has made thoughtful revisions to telehealth regulations and relaxed HIPAA rules to expedite implementation. Private insurance should follow suit with pay parity between physical and video visits, and lift requirements for redundant exams that are required for billing but require more “face to face” encounters. We are now able to “see” patients remotely in the emergency department, in a tent, and perform follow-up visits in ways previously unavailable. By virtually connecting a clinician and patient, we can preserve PPE, reduce high-risk contact points, and engage patients after they’ve left the brick-and-mortar hospital. Doing so will reduce infectious spread within hospitals and our communities.

The risk-averse mindset and faith that established practices should remain in place until a surge will lead to excess mortality. The enemy is here already. The time to implement novel solutions and crisis standards of care to protect our health-care workers and patients is now. We don’t yet know how to treat Covid-19; containment is the most effective medicine we currently have. Lifting regulatory, malpractice, and billing barriers swiftly will save lives.

Photo: GizemBDR/iStock

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