COVID Waivers: Preparing for the End

By Matt Fisher, General Counsel, Carium
Twitter: @matt_r_fisher
Twitter: @cariumcares
Host of Healthcare de Jure#HCdeJure

How many people remember how healthcare fully operated prior to the onset of the COVID-19 driven pandemic? The question is only somewhat facetious as the delivery of care and running of organizations along with so many other components of the healthcare industry have changed to a large degree. Telehealth is an obvious area that expanded, but relationships and compliance have been impacted too.

Public Health Emergency Declaration

Back in March 2020 when COVID emerged and disrupted the world, the United States declared a public health emergency (PHE). The PHE was also noticed by the Department of Health and Human Services (HHS). The HHS PHE opened the door for the Secretary of HHS (through all of the subagencies and offices) to issue waivers or notices of non-enforcement of many regulations impacting the healthcare industry. The changes will broadly be referenced as waivers, even though from a technical legal standpoint not all waive an obligation or requirement.

A quick, non-comprehensive review of the waivers will give a bit of a reminder of just how many changes occurred. HIPAA experienced enforcement discretion to enable the rollout of telehealth tools that may not meet all HIPAA privacy or security protections. While not ever tool was given a free pass (think public facing interactive tools like Facebook Live), a whole host of tools were enabled, which ignored that so many easy to acquire compliant tools were available. While healthcare organizations are moving to mature the telehealth and virtual care offerings, it is not clearly known what posture has been adopted by all organizations. There are likely a large number of organizations still relying on free tools that don’t take the effort to meet HIPAA requirements.

Foregoing cost sharing requirements, such as copays or coinsurances, is another change that swept across the healthcare landscape. While many commercial insurance plans already stopped the cost sharing waivers, Medicare still arguably lets waivers occur without needing to go through a financial hardship or other analysis. Some waivers were more clearly enacted by emergency legislation to address cost sharing related to COVID-19 care, but guidance form the Office of the Inspector General also broadly addresses cost sharing for Medicare. Normally cost sharing waivers should only occur on a limited basis and after conducting a financial hardship assessment. Those requirements were thrown out the window as a result of the COVID-19 impact and lack of cost sharing has let enabled certain services to thrive. Those certain services include a number of virtual care services that are driving better patient outcomes, but will come with a monthly patient financial responsibility that could impact ongoing participation.

Reimbursement coding also experienced a constantly changing environment early in the pandemic. While the pace of changes slowed down after a few months, a number of modifiers and new codes to reflect newly adopted services. Workflows have been adjusted and systems changed to ensure that appropriate codes and supplements are included. Going back to scrub all of those changes out will be another issue to pile on top of already busy operations.

New arrangements connected to delivery of COVID-19 services, or potentially more expansive deals, benefited from the waiver of fraud and abuse regulatory requirements. The fraud and abuse regulations are very technical, detailed, and full of traps. Not having to keep those front and center while arrangements were often established on the fly means that a whole host of contracts likely need to be rewritten or potentially terminated altogether. Reviewing and confirming compliance of all of the impacted contracts could result in potential disruption of services or the ending of certain beneficial relationships.

Where Can be Done?

Even with the PHE remaining in place, the current waning of pressing COVID issues offers an opportunity to get in front of any formal termination of the PHE. Competing concerns will always be grabbing attention, but refreshing memories as to the full scope of changes from the PHE and comparing to action taken to permanently encode changes is necessary. If an organization does not remember what modifications to procedures were put into place because of the PHE, unwinding where necessary becomes impossible. A collective effort will be necessary to tease apart all of the interconnected threads related to PHE changes.

At the same time, assessing what changes should still be permanently encoded will also help. Full relaxation of regulatory requirements is clearly not a realistic possibility or even preferred outcome, but some of the changes do need to stay. Assessing impact and developing evidence as to the good and bad of all changes can appropriately inform future action.

The current key though is to get prepared now. Waiting until the PHE expires from non-renewal will unnecessarily stress operations, which means individuals across all organizations. A proactive approach (which mirrors the trend for delivery of care) will set organizations up to continue succeeding and delivering care, which is the real goal.

The End of the PHE?

The PHE was last renewed in January 2022 and would currently expire in April. That time will be here before anyone knows it or is really ready for it. Get going now to avoid an unpleasant surprise.

This article was originally published on The Pulse blog and is republished here with permission.