HHS has given states, providers and payers extraordinary leeway to respond to the COVID-19 outbreak. But unwinding flexibilities—some of which have been long sought after by key industry stakeholders—will prove challenging, confusing and time-consuming.
How and when the new regulatory flexibilities will end depends on what powers HHS used to establish them. For instance, far-reaching Section 1135 waivers of Medicare requirements will, depending on the waiver type, end with the president's national emergency, HHS' public health emergency or within a time frame established in the waiver, said Sandra DiVarco, partner at McDermott Will & Emery.
Congress tied many provisions of its relief packages to HHS' emergency declaration, so stakeholders will need to pay close attention to legislative language to understand how they're affected, said Tom Leary, vice president of government relations for the Healthcare Information and Management Systems Society.
"It is possible that HHS and CMS will take action to pull back on certain relief measures once the COVID-19 pandemic begins to subside," DiVarco said. Gradually phasing out changes like temporary Stark Law relief could ease the transition back to normal life because hospitals wouldn't have to worry about falling out of compliance.
The CMS will likely give hospitals and other providers time to wind down arrangements stemming from temporary relief measures like the so-called Hospitals Without Walls initiative, which allows for easier transfer of patients to nonacute settings and lets physician-owned hospitals boost bed capacity.
In addition to the regulatory relief and flexibilities afforded by the emergency declarations, HHS is taking advantage of its conventional rulemaking and enforcement powers to help the industry respond to the pandemic. For example, the Office for Civil Rights temporarily eased HIPAA requirements so providers could deliver telehealth services to their patients using non-public-facing smartphone apps like FaceTime or Skype.
"Ordinarily, that would be a big problem, but the agency has said they will choose not to enforce those HIPAA requirements in order to serve the broader public health goals," said Nick Diamond, a consultant with Avalere Health.