Getting Back to Regulatory Readiness

COVID-19 interrupted many organizations’ daily operations – including, most likely, a reduced or suspended cadence of regulatory readiness planning.

Any regulatory readiness that’s been on pause, however, will need to pick up quickly. The Joint Commission announced it will begin resuming regular surveys and reviews this month.

Healthcare leaders need to ensure that their plans to resume routine operations, including reopening services that were closed or significantly reduced, take into account strategies to reinstitute regulatory compliance activities and waiver reversal. Failure to do so could risk the loss of Medicare and third-party payer reimbursements.

The Centers for Medicare & Medicaid Services (CMS) granted regulatory flexibility via waivers during the pandemic – many of which Premier believes should be extended.

Most U.S. healthcare providers participate in the Medicare program, and are accountable for implementing and maintaining a non-negotiable and foundational set of quality and patient safety standards, part of the Medicare conditions of participation. An emergency can prompt CMS to temporarily modify or waive certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP) or Health Insurance Portability and Accountability Act (HIPAA) requirements, called 1135 waivers.

Early in the pandemic, CMS did just that. Under Section 1135 of the Social Security Act, CMS activated more than 35 individual waivers for various Medicare and Medicaid requirements to give healthcare providers more flexibility in responding to the pandemic. These waivers were made effective retroactively to March 1, 2020, and allowed hospitals to suspend compliance with certain reporting requirements and bedside documentation requirements to ensure maximum focus and flexibility in caring for the COVID-19 patient. In addition, CMS and accrediting organizations ceased almost all survey activities.

CMS has indicated the waivers will end no later than the termination of the public health emergency. Premier has advocated that 24 of the regulatory waivers be made permanent as the pandemic subsides. Earlier this month, we provided a list to the Department of Health and Human Services and Congress that includes recommendations to make permanent waivers around telehealth policies, the Emergency Medical Treatment and Labor Act (EMTALA) and process roles.

Expectations with reverting back to routine operations – and unwinding activities taken under the guise of the waivers – can be complex.

With more than 35 potential waivers activated by CMS during the pandemic, providers now must identify the waivers they sanctioned and resolve the waiver status – potentially a heavy lift as organizations navigate a new normal.

As providers aim to understand their current state relative to the 1135 waivers and their associated risks, priorities will include:

Identify a team to review which waivers were sanctioned, by whom and the plan to return to normal operations. Decisions on sanctioning COVID-19 waivers may have been made at various levels in the organization, including the emergency command center, so it will be important for this team to catalogue when and by whom these decisions made.

Document decision-making for waivers the organization claimed. When an organization reverts back to pre-COVID-19 processes associated with the CMS 1135 waivers, it will be critical to retain the documentation to claim specific waivers, the timing of the return to routine operations and verification of subsequent regulatory compliance, as these activities will likely fall under the scrutiny of regulatory surveyors in the next 12-18 months.

• For some of the waivers, there is catch up work that must be completed with appropriate documentation within a certain time frame (e.g., provider credentialing and privileging decisions). For other waivers, the healthcare organization must simply return to compliance with the temporarily waived requirement once routine operations are resumed.
• Careful documentation should include dates the decisions were made, leaders involved in making those decisions, and the timeframe in which the organization discontinued emergency operations and began to return to normal operations. A good starting point will be the incident command center, which should be able to help review records to validate the waivers sanctioned and the timeframes.
• The incident command center itself will also fall within the purview of surveyors. Providers will need to record key timeframes including the date the incident command center was activated, when the organization began treating COVID-19 patients, the date the incident command center ceased operation and when the organization was no longer treating COVID-19 patients.

During accreditation surveys, especially in the next year, surveyors will want to verify the return to full compliance. Of note, neither The Joint Commission nor Det Norske Veritas surveys will include documentation and medical record review during this declared timeframe.

Evaluate emergency management plans. COVID-19 has likely provided the most practical test of the effectiveness of your emergency operations plan! Likely, leaders who have not been active participants in the command center before spent significant time learning and enacting the incident command process.

Accrediting organizations have specific expectations for documentation of the evaluation of emergency management plans. Organizations should work through their emergency management and preparedness structure to capture the opportunities for improvement that were identified during the COVID-19 experience and update their emergency management plans accordingly.

All regulatory bodies require evaluation of the implementation of emergency management activities should be thorough, with input from a representative group of participants at all levels, including some who were engaged for the first time. The emergency management team should take advantage of this opportunity to update and improve the emergency operations plan by incorporating improvement ideas and best practices that surfaced while COVID-19 put the plan to the test.

Reduce the risk of non-compliance post-pandemic.

Healthcare providers are beginning to return to pre-COVID-19 operations with a new definition for routine operations. As they wade through the post-pandemic realities – from increased telehealth utilization to rapid-cycle margin improvement – regulatory readiness must also be a part of their resumption plans.

Identifying which waivers were claimed, and the timeframe to revert to pre-COVID-19 waiver status, can be a rigorous undertaking. Competing priorities post-crisis may create internal bandwidth issues in managing this labor-intensive process.

Contact us to learn how Premier’s experts can help with every step, from evaluation and documentation of COVID-19 waivers to creating a game plan that quickly gets your organization back to regulatory and accreditation readiness.