COVID-19 and the Changing Compliance Landscape in Healthcare

The COVID-19 pandemic brought about several shifts in healthcare compliance standards, and there's a good chance it will speed up future related changes. Here's a look at some of the examples relevant to providers, medicine or device manufacturing companies and patients.

The Centers for Medicare and Medicaid Services (CMS) used the coronavirus pandemic to justify providing blanket waivers for the medical industry. These waivers make it easier to provide care without encountering so much regulatory red tape. Obtaining one outside of emergencies requires filling out paperwork and waiting days for approval. 

The tricky thing regarding these so-named 1135 waivers is that they come with a unique set of parameters. The goal is to streamline care, but that does not mean providers have absolute freedom. There are several things the blanket waivers do not permit, including getting reimbursed for services not covered or making someone eligible for Medicare if they do not ordinarily qualify. 

People in the medical industry must be careful to understand the specifics of these waivers and COVID-19 healthcare compliance. They may otherwise make costly errors. Another crucial thing to know is that these blanket waivers will not last forever. They end when the country's state of emergency does, or no later than 60 days from the waiver's publication date. The exception is if the Health and Human Services secretary chooses to extend the permission for up to 60 days. 

The Food and Drug Administration (FDA) also issued content relevant to medical companies working on coronavirus testing options. The FDA recognized the severe health threat posed and the desire for the United States to increase its testing capacity as soon as possible. Thus, the agency released a document advising the respective enterprises on how to bring their offerings to the market faster. There are currently more than 85 commercial COVID-19 test kits.

The FDA's guidance only remains in effect for the duration of the United States' health emergency. Challenges may result if the FDA's change becomes irrelevant when a company is still working on a test kit. In that case, they may have started working on the project while abiding with one set of guidelines, then find they are different once completing the product. 

The FDA recently approved a process that allows a person to collect a sample at home and send it to an authorized testing facility. It applies to multiple tests and laboratories and could be ideal if someone who cannot easily get to a testing facility because of a challenge such as a lack of transportation. If this approach works well, more companies may start developing home-based test kits for other ailments.

That could be both positive and negative for medical providers. If people rely on home testing kits to get suspicious symptoms professionally checked instead of waiting until a problem becomes too bothersome, it's a good thing. However, some people may view home testing kits as ways to avoid doctor visits that they need. That could mean their conditions exacerbate to the point that successful treatments are less likely. 

Medical facility directors are familiar with preparing for regulatory audits. They may follow checklists or hold workshops for employees that keep them abreast of what regulations require. Scientists don't know how long the coronavirus will threaten global society, but many agree it will remain a risk for the foreseeable future. 

One of the effects impacting COVID-19 and healthcare compliance, then, may be that audits occur differently. For example, auditors can apply social distancing to their processes by using remote communications platforms in place of in-person visits. Another helpful adjustment is to complete some audit-related tasks — such as reviewing paperwork about operating procedures — off-site. If an auditor must spend time face-to-face, it's less than during the typical process. 

The potential for remotely conducted audits means the people on the receiving end of those inspections may need to get acquainted with new procedures and tech tools. They should also not wait until a few days before a scheduled audit to learn about what's new. Doing it well in advance of an appointment reduces the chances of things going wrong and preventable stress. 

The CMS relaxed telemedicine reimbursement restrictions due to the coronavirus. That action spurred a boom in the telemedicine sector, particularly as many providers started using such services for the first time or ramped up their usage. Patients could get the care they need without traveling to physical facilities and possibly putting others at risk of coronavirus infections. 

However, CMS only agreed to make telemedicine reimbursements easier to acquire throughout the public health emergency that COVID-19 caused. Some analysts think the experiences of those using telemedicine services now could make the changes long-term. Some state governments also eased the requirement of physicians to hold licenses for every state in which they practice. This adjustment boosts the United States' capacity for care during the pandemic. 

Another recent shift to better equip nations for the coronavirus involves permitting medical students to work on the front lines faster. In countries like Ireland and Italy, regulators gave students chances to contribute to the medical field sooner. Universities elsewhere enabled learners to get their degrees early.

Health workers requiring physician supervision when performing certain procedures can also do those tasks without oversight. That's due to the CMS waivers discussed earlier, but the temporary reduction in restrictions could have long-term effects. The experience gained could make providers even more valuable in their efforts to provide timely care.

It's too early to say whether the examples here may persist longer than planned. However, such time-based measures could have ripple effects by encouraging regulators to expedite or otherwise revisit regulations to benefit patients and providers alike.

Kayla Matthews is a MedTech journalist and writer. Her work has also been featured on Medical Economics, HIT Consultant, HealthIT Outcomes and Health IT Answers. To read more from Kayla, please visit her blog here.