AHA Expresses Concern with Lack of Clear And Actionable Guidance on Environmental Risk Mitigation

The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue SW, Room 445–G
Washington, DC 20201

Dear Administrator Brooks-LaSure:

On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, the American Society for Health Care Engineering and American Society for Health Care Risk Management, our clinician partners and, especially, the 105 psychiatric hospitals and 846 hospitals with dedicated behavioral health beds, the American Hospital Association (AHA) expresses its concern with the ongoing lack of clear and actionable guidance on environmental risk mitigation in facilities that provide psychiatric services. We again urge the Centers for Medicare & Medicaid Services’ (CMS) to issue the guidance these providers need in order to ensure compliance with federal laws and regulations.

Hospitals and health systems are committed to the safety of our patients and take precautions to minimize the risk that anyone intending self-harm can succeed. CMS issued draft guidance on ligature risk on April 19, 2019; this guidance sought to clarify existing interpretive guidelines to provide details on requirements for abating risk for patient harm within psychiatric facilities. Unfortunately, this draft guidance failed to address a number of concerns and areas of confusion for our members. Further, the draft guidance was never finalized. As such, these providers have been waiting for four years for clear instructions on what is expected of them by CMS surveyors. Meanwhile, hospitals have continued to be surveyed against the existing unclear and arbitrary guidance.

This lack of clarity has had negative consequences for patients. Facilities have sometimes been compelled by CMS surveyors to take otherwise usable psychiatric beds temporarily offline to make changes they were not aware were needed, thereby worsening wait times for inpatient psychiatric care. Some facilities also have spent millions of dollars making facility changes asked for by CMS surveyors but with no guarantee these changes align with requirements that CMS could require in the near future. Wasteful spending driven by regulatory uncertainty hinders hospitals’ efforts to maintain access to inpatient behavioral health care. This is especially worrisome at a time when both behavioral health care access and hospital finances are severely constrained.

Hospitals need clear, specific and timely information about the standards they are required to meet, as well as the oversight process for compliance with those standards. We urge CMS to issue interpretive guidance immediately laying out the risk mitigation steps hospitals are expected to take, or, alternatively, issue guidance to surveyors that clearly permits hospitals and their staffs to use their own best judgement in determining what mitigation steps to take.

Background

Psychiatric facilities and units in general acute care hospitals are subject to unique structural requirements in the Conditions of Participation due to the vulnerability of the patients they serve; specifically, psychiatric facilities and units must meet standards involving patient harm risk abatement. By statute and per the Code of Federal Regulations, psychiatric facilities and units participating in Medicare are required to uphold a patient’s right to receive care in a safe setting. In part, CMS has interpreted this to mean that facilities should take steps to mitigate opportunities for patient self-harm. These requirements result in an estimated $1.7 billion in compliance costs annually to inpatient psychiatric facilities alone.^1,2

In December 2017, CMS issued interim guidance regarding general definitions for ligature “resistant” or ligature “free” environments, timeframes for corrections of ligature risk deficiencies, and qualifications for waivers from this Condition of Participation.³

While CMS originally announced that this guidance would be reviewed by a CMS psychiatric task force, the task force did not convene as planned in July 2018 because the agency determined that “the proposed psychiatric task force to address environmental risks is not the most appropriate vehicle.”⁴ Instead, CMS announced it would incorporate outcomes of The Joint Commission’s Suicide Panel into its interpretive guidance; in the interim, the agency noted that state survey agencies and accrediting organizations “may use their judgment” in determining whether facilities were in compliance.

This lack of clarity in how surveyors were to evaluate compliance led to multiple reports by facilities of citations by surveyors that would require expensive environmental updates to remediate. AHA reported these concerns to CMS and, in April 2019, CMS issued a draft update to its guidance for comment. The updated guidance if finalized, would have clarified the definition of risk, differentiated requirements for locked versus unlocked psychiatric units, provided processes to request extensions for corrections, set new requirements for education and training, and changed survey procedures.⁵ Although AHA and others submitted comments on this guidance by the June 19, 2019 deadline, it was never finalized.

New Issues

While waiting for updates on ligature risk guidance, AHA brought a new issue to CMS’ attention: the use of medical beds in psychiatric units. While The Joint Commission allows the use of medical beds in psychiatric units (along with appropriate risk mitigation procedures),⁶ AHA members surveyed by CMS surveyors are told that the agency does not allow them under any circumstances and instead mandates the use of behavioral health-specific platform beds. Members have reported that surveyors have even prohibited them from admitting psychiatric patients to an available medical bed. This has resulted in some facilities having to replace medical beds (sometimes dozens of them) with platform beds and/or take otherwise usable beds offline; patients with medical needs being excluded from psychiatric facilities; psychiatric patients waiting for a free platform bed in a medical unit, but in the meantime laying in a medical bed; patients with medical issues and suicidal ideation being put in platform bed, thereby being at greater at risk for falls and aspiration; and patients waiting long periods of time without a bed (in a chair or even on the floor) in the ED for placement in a non-medical bed.

Hospitals and health systems have reported other consequences of a result of conflicting guidance from surveyors. For example, some purchased behavioral health-specific beds at significant cost, only to be told by surveyors that the beds are not compliant. Members have also reported citations on beds that were deemed in compliance on a previous survey without any change in policy or guidance. These mixed messages add substantial cost to the health care system. A bed sold by a major manufacturer that is touted to be in compliance with “the FDA’s monitored Entrapment Zones 1 – 4” retails for $3,336, plus a $928 mattress.⁷ According to the most recent National Mental Health Services Survey, the average psychiatric facility has 56 beds designated for mental health treatment.⁸ That means that it would cost the average facility $238,784 to replace all of their beds with products that may not be necessary to serve the needs of their patients or meet regulatory requirements. According to the Medicare Payment Advisory Commission (MedPAC)’s most recent analysis, the average margin across all inpatient psychiatric facilities is -2.4%, with not-for-profit hospital-based facilities seeing an average margin of -18.5%.⁹ Funds that could be spent on hiring additional staff, such as additional psychiatry-specialized nurse practitioners, are instead going to potentially unnecessary or wasteful equipment purchases. The unnecessary costs that these facilities have incurred as a result of unclear guidance on how to comply with risk abatement requirements are a substantial threat to access, as facilities may be forced to close beds rather than replace them in order to maintain operations.

Next Steps

Issuing subregulatory guidance that is not only based on clinical evidence, but also practicable, clear and meaningful to providers and patients is never easy. The issues of ligature risk and environmental risk abatement in psychiatric units and facilities is particularly sensitive. Our member hospitals seek to prevent every preventable death in our hospitals, and data show that across all hospitals, the annual incidence of suicide within a hospital facility is extremely low (between 31-51 psychiatric inpatients per year, far fewer than the 1,500 per year figure that is commonly cited, or 3.2 per 100,000 psychiatric inpatient admissions).^10,11 Still, any suicide is one too many.

At the same time, behavioral health needs have increased. Barriers to access to care, including a lack of available beds when needed, exist across the nation. When behavioral health facilities must expend resources to determine how to comply with nebulous standards not backed by evidence, they have fewer resources to dedicate to needed patient care.

Given the considerable impact on patient access to care, as well as wasteful costs to the system, we request that the agency immediately issue the interpretive guidance, ensuring that it provides clarity on the following topics:

• Types of fixtures, beds and supplies considered in compliance;
• Differences in ligature risk abatement requirements between locked and unlocked psychiatric units, including specifically what constitutes a “locked unit;”
• Requirements for dedicated psychiatric beds in emergency departments;
• Examples of appropriate patient assessments beyond that used by the Department of Veterans Affairs;
• CMS’ intent relating to a staff “immediately available to intervene” when using 1:1 video monitoring for at-risk patients;
•  Processes for hospitals approved for a ligature-risk extension request, unannounced surveys and Immediate Jeopardy designations;
• Education and training requirements for contracted employees and short-term employees; and
• Updates to survey procedures and CMS’s surveyor training processes.

If that is not possible, then we ask that the agency make clear that each hospital caring for patients who may have suicidal ideations must have policies in place identifying the actions it will take to keep patients safe from self-harm, and then instruct surveyors to review those policies and the hospital’s compliance with its own policies. Hospitals share CMS’ goal of protecting patients and have access to available scientific and other information on risks for self-harm. They know the communities and populations they serve. They are able to craft policies that appropriately manage the risks for their patients while allowing treatment of their mental and physical health issues.

The AHA has a robust and engaged membership with vast expertise in behavioral health, and we are eager to provide insight to ensure our patients are safe while in our care.

We thank you for your consideration of our requests. Please contact me if you have questions or feel free to have a member of your team contact Caitlin Gillooley, director of policy, at cgillooley@aha.org or (202) 626-2267.

Sincerely,

/s/

Ashley B. Thompson
Senior Vice President

__________

¹ “The High Cost of Compliance: Assessing the Regulatory Burden on Inpatient Psychiatric Facilities.” National Association for Behavioral Healthcare, March 2019. https://www.nabh.org/wp-content/uploads/2019/03/The-High-Cost-of-Compliance.pdf
² The AHA does not have discrete data for the cost of implementing these requirements in general acute care hospital units.
³ S&C Memo: 18-06 Hospitals, “Clarification of Ligature Risk Policy,” December 8, 2017. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-18-06.pdf
⁴ QSO: 18-21 All Hospitals, “CMS Clarification of Psychiatric Environmental Risks,” July 20, 2018. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO18-21-Hospitals.pdf  
⁵ Ref: DRAFT-QSO-19-12 Hospitals, “DRAFT ONLY –Clarification of Ligature Risk Interpretive Guidelines – FOR ACTION,” April 19, 2019. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO-19-12-Hospitals.pdf
⁶ Behavioral Health: National Patient Safety Goals; First published date: June 27, 2018. Last reviewed by Standards Interpretation: February 1, 2022. https://www.jointcommission.org/standards/standard-faqs/behavioral-health/national-patient-safety-goals-npsg/000002201/  ⁷ Stryker Spirit® Behavioral Health Bed: https://www.stryker.com/content/dam/stryker/acute-care/products/spiritselect/resources/Spirit%20Behavioral%20Health_SS_Mkt%20Lit-1059.pdf
⁸ National Mental Health Services Survey (N-MHSS): 2020, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, September 2021. https://www.samhsa.gov/data/sites/default/files/reports/rpt35336/2020_NMHSS_final.pdf
⁹ “Assessing Medicare’s Payments for Services Provided in Inpatient Psychiatric Facilities,” MedPAC, October 4, 2018. https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/default-document-library/psych-pps-october-2018-public-final.pdf
¹⁰ Williams, S. “Incidence and Method of Suicide in Hospitals in the United States,” The Joint Commission Journal on Quality and Patient Safety, 2018; 44:643-650. https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-topics/suicide-prevention/nvdrs_williams_2018.pdf
¹¹ Mills, P. “Suicide Risk in the Hospital,” WebM&M: Case Studies, Agency for Healthcare Research and Quality, May, 2018. https://psnet.ahrq.gov/web-mm/suicide-risk-hospital