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Medicare Conditions of Participation COVID-19 Waivers—Managing and Implementing the Waivers in Accordance with Accreditation Standards and Expectations

This Bulletin is brought to you by AHLA’s Hospitals and Health Systems Practice Group.
  • August 03, 2020
  • Brett D. McNeal , Lexington Medical Center

As the coronavirus pandemic dominated the news in 2020, the Centers for Medicare & Medicaid Services (CMS) recognized early on the unique challenges that COVID-19 posed to health care providers, particularly hospitals, not just from a delivery of care perspective, but as to their ability to meet the needs of the communities they serve while staying within existing statutory and regulatory guardrails. This article focuses on waivers of Medicare Conditions of Participation (CoPs),[1] a core set of patient health and safety requirements that often represent congressional prerogatives and/or the informed judgment of public health and other policy experts. Many of the CoPs were established long ago and adapted for circumstances wildly different from those confronting the nation’s hospitals today. During normal operations, hospitals generally are able to maintain their compliance with these commitments. Because COVID-19 impressed a different reality on hospitals, Department of Health and Human Services Secretary Alex Azar authorized CMS Section 1135 Blanket Waivers of certain federal requirements and made their application retroactive to March 1, 2020.[2] The initial set of blanket waivers, which applied to many CoPs, suspended enforcement of those regulations CMS viewed as the most immediate obstacles for hospitals during the pendency of the COVID-19 pandemic.[3] CMS has since issued additional waivers that apply during the public health emergency.

CMS must supervise the nation’s Medicare-participating hospitals to ensure they are complying with the CoPs, which the agency largely does through accreditation agencies.[4] While the interplay between CMS, accreditation agencies, and the hospitals governed by the Medicare CoPs is well established, the COVID-19 pandemic has upended the normal standards and expectations of this dynamic.

Similar to CMS, the accreditation industry recognized the challenges posed by COVID-19 and responded by reorienting regular processes, including helping member-clients adapt to and synthesize the 1135 waivers into their operations. For example, on April 8, 2020, The Joint Commission released a webinar discussing the 1135 waivers.[5] The presenters provided a general overview of the waivers’ legal foundation and application and offered a more in-depth discussion of several waivers that were particularly relevant to hospital clients. One of the presenters stated that The Joint Commission expected hospitals would perform an assessment to determine if a particular waiver was needed in the first place but didn’t provide additional detail or context on what that process would entail.

DNV GL Healthcare sent out an advisory notice on April 16, 2020 to provide guidance on implementing the 1135 waivers explicitly stating that its member hospitals must first assess the need for a waiver before starting to use a particular one.[6] DNV did concede that a hospital had discretion to determine how to conduct the assessment, so long as it was based on objective evidence and applicable risk.

One approach for conducting these assessments is for the hospital’s operational leadership to establish a steering committee—or, if the hospital has one, assign responsibility to its survey-readiness team. The compliance committee also could be tasked with reviewing the 1135 waivers and working directly with those who have director-level management responsibilities over the parts of the hospital that intersect with a particular waiver to determine whether COVID-19 posed a risk to that area of operations.

The lack of specific knowledge about COVID-19 is a challenge for hospitals trying to evaluate risk. Hospitals can look to available resources from the federal government, state and local public health authorities, and its own practices and track record in dealing with infectious agents generally. Another good place to start is with the hospital’s medical staff, tapping into the specialized training and skill of the clinicians who play an active role in improving the quality of care provided to patients and who are already familiar with the hospital’s structure and operations. Another data point for hospitals to consider as it evaluates risk is other hospitals in the community, particularly in assessing the ability of the hospital to deal with COVID-19 without needing the relief the waivers offer.

It is important to emphasize that each hospital’s analysis will depend on its specific circumstances, including its financial status, the skills and competencies of its existing workforce, and its supplies and equipment, as well as its ability to be nimble and make changes to workflows and, perhaps most importantly, the hospital’s culture. If a hospital doesn’t believe a risk can be safely and effectively addressed, the waiver is almost assuredly the appropriate option, and the hospital most likely will have satisfied the assessment that DNV requires.

As an alternative to a steering or other hospital committee, another approach to the assessment could involve appointing a single individual such as the hospital’s chief executive or chief of staff who can leverage and mobilize department chairs and section chiefs. Under this approach, the appointed individual could go—in varying degrees of formality—directly to these chairs and chiefs with instructions for assessing and debating, from the vantage point of their specialty designations and practice areas, the specific risks posed by COVID-19 at the hospital. The chairs and chiefs could report back on these discussions which, ideally, would be documented in meeting minutes or some other narrative. For example, the appointee might ask the pediatrics chair how its membership feels about the hospital’s policies on verbal orders and whether those pose an obstacle to care and treatment of COVID-19 pediatric patients. An adult medicine department chief may be brought in to have her department consider whether strict adherence to the discharge planning rules might keep patients—COVID-19 patients and non-COVID-19 patients alike—in the hospital longer and thereby increase their chance of catching the virus.

A less formal, though probably more efficient, way to accomplish these discussions may be to gather the chairs and chiefs and ask them for their opinions. Either scenario can help hospitals capitalize on their existing infrastructure that has been operationalized by physicians and other stakeholders. Under this approach, the measured judgment of these stakeholders can help inform the appointee’s final assessment.

Given the unprecedented nature of the COVID-19 pandemic, a hybrid, and potentially more realistic, approach, may be to have the appointee deliver only an initial assessment or recommendation to the hospital’s governing body. After reviewing the initial recommendation, the governing body could adopt the assessment, in part or in full; express its disagreement; or ask for additional information.

In addition to the assessment, DNV also wanted documentation from the hospital of its deliberations. Though short on specifics, DNV did say that, just as hospitals have flexibility in conducting the assessment, they also have flexibility in how to document it. Without specific examples or general guidance in DNV’s advisory notice, a hospital using the steering committee approach could formalize certain requirements, including a basic charter setting out the committee’s duties, responsibilities, and membership, with a schedule of meetings to ensure that progress is being made and roadblocks or obstacles are timely resolved. Meeting minutes should be taken, with action item(s) and deadlines for their completion. The minutes should clearly lay out the steps the hospital took for all phases of the assessment.

There are certainly other, less cumbersome ways to document the assessment. For example, by using an already established committee or other interdisciplinary group of staff that meets regularly, documenting the assessment may be as simple as placing the item on the committee’s or group’s agenda and recording the material elements of the assessment in meeting minutes. Simpler still might be drafting and circulating a memorandum to affected staff that lays out the hospital’s approach in step-wise fashion for doing the assessment, which would later be supplemented with the hospital’s judgment on, among other things, the COVID-19 impact and the relative need or desirability of the waivers.

As the COVID-19 crisis persists, the nation’s hospitals continue their efforts to meet the unique challenges posed by the virus. The waivers have altered the regulatory landscape allowing hospitals to have almost a singular focus on the pandemic. Accreditation bodies also have recognized the unprecedented nature of the pandemic and have adapted their expectations accordingly. While everyone is hopeful that either—or both—a reliable therapeutic option or a vaccine is developed in the short term, hospitals will continue doing their part to deal with COVID-19, ideally aided and comforted by CMS’ 1135 waivers and by additional flexibilities from the accreditation community. 

Brett McNeal is Associate General Counsel at Lexington Medical Center, which is located in West Columbia, SC. Brett is a health care regulatory attorney with significant experience representing hospitals across a range of matters, including the fraud, waste, and abuse, HIPAA, and Medicare and Medicaid program requirements. Brett holds undergraduate and law degrees from the University of Minnesota.

 


[1] 42 U.S.C. § 1395x(e); 42 C.F.R. § 482.1 et seq.

[2] Alex M. Azar, Waiver or Modification of Requirements Under Section 1135 of the Social Security Act, https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.

[3] Centers for Medicare & Medicaid Services, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers.

[4] 42 U.S.C. § 1395bb.

[6] DNV GL Healthcare USA, Inc., Advisory Notice No. 2020-HC10, DNV GL Healthcare Guidance to Implementing the CMS 1135 Blanket Waivers.