The Public Health Emergency is Ending Soon – What are the Compliance Implications?

At the end of January 2023, the White House announced it intends to end the public health emergency (PHE) declaration on May 11, 2023.

Even though many Americans have been living life at a somewhat normal level for many months now, the official PHE declaration has continued since the declaration in early 2020. For compliance professionals, many pre-PHE requirements that were loosened during the PHE will come to an end.

In layman’s terms, ‘we got to get the horses back in the barn.’ Meaning, some of those loosened compliance rules will likely need to be tightened back up.

Before we jump in, we have to add a quick disclaimer: the government can change its mind, so staying up to date on the most current announcements is essential.

In the absence of any future announcements, below are some examples of PHE waivers that are likely to come to an end in tandem with the PHE, so compliance programs should plan accordingly.

Emergency Medical Treatment and Active Labor Act (EMTALA)

CMS has been partially waiving the enforcement of certain provisions of EMTALA. The PHE waiver has allowed hospitals, psychiatric hospitals, and critical access hospitals to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19, while remaining consistent with the state emergency preparedness or pandemic plan. This waiver will terminate at the end of the PHE.

Stark Law

During the PHE, the Centers for Medicare & Medicaid Services (CMS) issued blanket waivers of certain Stark Law provisions. These blanket waivers applied to financial relationships and referrals related to the COVID-19 emergency. The remuneration and referrals described in the blanket waivers had to be solely related to COVID-19 purposes, as defined in the blanket waiver document.

CMS permitted certain referrals and the submission of related claims that would otherwise violate the Stark Law, if all requirements of the waivers were met. When the PHE ends, the waivers will terminate, and physicians and entities must immediately comply with all provisions of the Stark Law.

Physician Supervision

CMS modified Medicare physician supervision requirements related to the regulatory definition of direct supervision, which requires the supervising physician or practitioner to be “immediately available” to furnish assistance and direction during the service and to include “virtual presence” of the supervising clinician with real-time audio and video technology. This flexibility is currently set to return to pre-PHE rules at the end of the calendar year that the PHE ends.

Non-Physician Practitioners

On an interim basis during the PHE, Medicare created flexibility to allow nurse practitioners, clinical nurse specialists, certified nurse-midwives, and physician assistants to supervise diagnostic tests as authorized under state law and licensure. These practitioners continued their required statutory relationships with supervising or collaborating physicians.

National and Local Coverage Determinations

In some circumstances, national coverage determinations and local coverage determinations may have required a specific practitioner type or physician specialty to furnish or supervise a service. During the PHE, the Chief Medical Officer (or equivalent) of a hospital or facility had the authority to make those staffing decisions. This waiver ends upon the conclusion of the PHE.

Telehealth

Not everything will go precisely back to pre-PHE standards when the PHE ends.

Pre-PHE, telehealth services had very specific requirements that needed to be met before they would be considered reimbursable by Medicare.

During the PHE, some of these requirements loosened up. For example, according to the Kaiser Family Foundation, the following major changes were made to Medicare coverage of telehealth during the PHE:

• Medicare beneficiaries in any geographic area could receive telehealth services, rather than beneficiaries living in rural areas only
• Beneficiaries could remain in their homes for telehealth visits reimbursed by Medicare, rather than traveling to a health care facility
• Telehealth visits could be delivered via smartphone in lieu of equipment with both audio and video capability
• An expanded list of the types of Medicare-covered services could be provided via telehealth

Originally, all these telehealth services changes were set to expire 151 days after the end of the PHE.  But, in the case of telehealth services, the Consolidated Appropriations Act of 2023 has extended these flexibilities through December 31, 2024.  And many feel that Congress will likely take up the issue before that 2024 deadline.  These are just a few of many, many loosened regulations that compliance professionals need to consider. They should work with staff and key stakeholders to make sure individuals understand that certain flexibilities many have become accustomed to over the last two to three years will be going away soon.

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