Understanding the Public Health Emergency’s Impact on Health Care
The COVID- 19 Public Health Emergency (PHE), declared on January 31, 2020, under Section 319 of the Public Health Service (PHS) Act, expired on May 11, 2023. In addressing COVID- 19, the Secretary of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) afforded temporary modifications and waived certain requirements relating to health laws and regulations such as Medicare/Medicaid, HIPAA, Stark Law, and EMTALA. These included 1135 waivers, federal and state-level flexibilities, and temporary enrollments. For example, there were relaxed conditions of participation, preapproval requirements, and state-specific licensing requirements for healthcare professionals.
When there's an emergency, sections 1135 or 1812(f) of the Social Security Act (SSA) allow CMS to issue waivers. These waivers and flexibilities come into play during emergencies, allowing CMS to support beneficiaries' care access. During the PHE, healthcare providers were granted considerable leeway to streamline service delivery and ensure continued access to care. While congressional action has made some of these waivers and flexibilities permanent or extended their validity, others have expired as they were intended for immediate pandemic response rather than to permanently supersede standard rules. In fact, as of May 11, 2023, most of the blanket waivers have expired (i.e., 1135 waivers that providers were not required to apply for individually).
What does this mean? Importantly, health care entities must review their operations to address any reliance on such waivers and flexibilities issued by HHS, CMS, States, and others. Additionally, policies and procedures must be reviewed and modified accordingly to ensure compliance with the unwinding thereof.
This Article highlights key points associated with forming and carrying out unwinding plans by health care entities relating to the Emergency Medical Treatment and Labor Act (EMTALA) and the Stark Law blanket waivers.
EMTALA Blanket Waivers 101
CMS issued only two EMTALA blanket waivers that lifted potential sanctions for hospitals operating under the Act for (1) directing or relocating individuals to another location to receive medical screening examinations in accordance with a proper state emergency preparedness plan; or (2) transferring individuals not yet stabilized if necessary due to the declared COVID- 19 federal public health emergency. These waivers served as a crucial tool for participating hospitals, including critical access hospitals with dedicated emergency departments (EDs), in their fight against COVID- 19. They allowed these institutions to manage the spread of the virus more effectively, by providing increased flexibility in patient handling. The EMTALA waivers, activated on March 15, 2020, had retroactive effect from March 1, 2020, and applied nationwide until the expiration of the PHE. The EMTALA waivers applied to participating hospitals if the following criteria were met:
1) Hospitals couldn't discriminate based on an individual’s source of payment or ability to pay;
2) The hospital had to activate its disaster protocol; and
3) The state had to activate an emergency preparedness or pandemic preparedness plan, with any redirection of individuals for a medical screening examination being consistent with this plan.
Reshaping Operations: The EMTALA Waiver Fallout
Given that we have transitioned out of the PHE, it's vital for hospitals to carefully consider the potential impact of unwinding EMTALA waivers and adapt accordingly. Here are some key considerations:
Off-site Patient Screening Locations: Hospitals should identify any off-site patient screening locations currently in use due to the EMTALA waivers. With the end of the PHE, it is necessary to phase out the use of these off-site locations and transition back to standard screening processes within the hospital premises.
Emergency Department Processes/Practices: Hospitals should assess their emergency department (ED) processes and practices that depend on EMTALA waivers. For example, the use of hallway beds or specific procedures for screening mental health patients may need to be revisited and adjusted in line with standard regulations. Also, it’s prudent to prospectively address any potential downstream consequences on non-emergency department operations resulting from the overcrowding of the EDs.
Staff Re-education: There's a crucial need to re-educate all ED staff, including registration, nursing, and physician staff, about the termination of EMTALA flexibilities. This will involve communicating the changes clearly and providing appropriate training where necessary to ensure all staff members understand their responsibilities under the standard EMTALA regulations.
Emergency Medical Services Providers Notification: As changes occur in the screening locations due to the unwinding of waivers, hospitals must notify Emergency Medical Services (EMS) providers. Clear and timely communication will ensure EMS teams are aware of any changes in patient intake procedures or locations, thereby ensuring a smooth transition back to normal operations. For example, EMS providers should be notified that patients will no longer be showing up at off-site patient screening locations.
These steps will help hospitals navigate the unwinding of EMTALA waivers in an organized and efficient manner, minimizing potential disruptions to patient care.
Stark Law Blanket Waivers 101
The Physician Self-Referral Law, known as the Stark Law, prohibits physicians from making referrals for designated health services payable by Medicare or Medicaid to entities with which they, or their immediate family, have a financial relationship unless an exception applies.
In response to the COVID- 19 emergency, CMS issued blanket waivers to certain Stark Law provisions on March 30, 2020. These waivers lifted potential sanctions for the purpose of COVID- 19 relating to specific transactions that are usually prohibited. However, with the end of the PHE, many of these have expired, necessitating timely compliance with standard Stark Law provisions. Some key blanket waivers and flexibilities under Stark Law include:
Fair Market Value Adjustments: Physicians could receive payments that exceeded the standard Fair Market Value (FMV) for their services in the context of the pandemic.
Financial Support: Providers could financially support each other to maintain healthcare operations. A physician owning a hospital could, for example, provide a no-interest personal loan to the hospital.
Non-Monetary Compensation Exceeding Annual Limits to Medical Staff: Hospitals could offer benefits like meals, laundry service, or childcare to their medical staff during their hospital duty.
Temporary Increase in Resources: Physician-owned hospitals could temporarily increase their licensed beds, operating rooms, and procedure rooms, addressing patient surges during the pandemic.
Home Services: Group practices could provide medically necessary services at a patient's home more flexibly. For instance, any physician in the group could order services provided by a nurse or technician at the patient's home.
Use of Mobile Facilities: Group practices could provide medically necessary services like MRIs or lab services from temporary locations, such as mobile vans in parking lots.
Discounted Space or Equipment Rental: Space or equipment could be rented out at rates below FMV to support healthcare providers' response to COVID- 19.
Considering the PHE has ended, all of these waivers and flexibilities need to be reviewed and potentially unwound to ensure continued compliance.
Reshaping Operations: The Stark Law Waiver Fallout
The COVID- 19 pandemic necessitated the temporary waiver of several Stark Law requirements relating to physician arrangements, all intended to provide flexibility and facilitate a robust response to the crisis. But, as we've transitioned out of the public health emergency, healthcare providers must revert these arrangements to pre-PHE compliance levels unless there is an extension or change in the law. If your organization is still operating under these or other waivers, begin modifying these arrangements to comply with pre-PHE Stark Law rules.
Despite the expiration of most waivers, certain flexibilities under the Stark Law will remain due to changes in the law during the PHE. These include, for example, the wellness exception, which allows for the provision of certain items or services that improve a provider’s health. Other exceptions include limited remuneration to physicians and value-based arrangements. So, if your operations rely on any of these exceptions, your related operations will remain compliant. Otherwise, you will need to determine whether there is an extension that relates to any such waivers and flexibilities your organization has been relying on. This requires continued monitoring and due diligence on your part.
Charting the Course: Reaching Alignment with the Post-PHE Landscape
As we navigate the post-PHE era, there are vital steps healthcare providers must undertake to ensure a smooth transition. Embarking on this process is akin to separating your clean laundry from the dirty. By focusing on areas of your operations that have depended on PHE waivers and flexibilities, you can determine whether these practices are still compliant with current laws and regulations. This evaluation must consider any permanent changes in the law that were enacted during the PHE.
For operations found to be compliant, you can continue on the same path, armed with the assurance of conformity to legal requirements. However, for practices that will not meet the post-PHE regulatory framework, necessary changes must be made. This might involve minor adjustments or, in some instances, a complete discontinuation of the operation. Take a close look at the following steps and act sooner than later:
Stay Updated: First and foremost, keep a keen eye on guidance from various entities - Congress, state agencies, accrediting bodies, and federal regulatory agencies like HHS, CMS, Office for Civil Rights (OCR), Office of Inspector General (OIG), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA). The landscape is continually evolving, and some flexibilities may continue to extend into the future if they have not already.
Conduct an Inventory: Next, you need to identify all the waivers, flexibilities, and temporary licenses you've utilized during the pandemic. This step involves a comprehensive inventory, mapping out all adjustments made to your operations in response to COVID- 19.
Educate Your Staff: Your team must be kept in the loop about these changes. Transparent communication and education regarding the "unwinding" process are crucial to ensure ongoing compliance.
Your Document Compliance: Review and ensure your internal documentation reflects the changes made during the PHE and is updated accordingly as waivers are expired. For any flexibilities you've leveraged, even on a one-off basis, ensure they're properly documented. Be prepared for audits–solid, clear documentation is your best friend.
Keep in mind that this Article focuses on EMTALA and Stark Law blanket waivers. Many healthcare providers have also taken advantage of individual waivers and other flexibilities. These, too, must be included in your post-pandemic compliance checklist. As we navigate this uncharted territory, maintaining a proactive, thorough, and informed approach is the key to successful adaptation. If you have any questions or need assistance with ensuring compliance with the demands of the end of the PHE, please feel free to reach out to your preferred health care lawyer. I’m here to help.
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