June 5, 2024

On May 2, 2024, CMS released its proposed rule regarding Quality Programs Requirements, which is open for public comments until June 10, 2024. This rule is intended to promote the use of safety measures throughout CMS’s quality programs “to identify and measure quality gaps and processes, and to make that information transparent and available to the public.”

CMS notes that while within its hospital quality measurement programs there are already “a number of outcome and process measures in use that capture specific conditions or procedures such as the Severe Sepsis and Septic Shock: Management Bundle measure, Patient Safety and Adverse Events Composite measure, Severe Obstetric Complications electronic clinical quality measure (eCQM), and the Safe Use of Opioids—Concurrent Prescribing eCQM,” these measures are not in themselves sufficient as they “do not address the overall culture in which the care is provided.” Thus, CMS is proposing a systems-level safety measurement – the Patient Safety Structural measure.

The proposed Patient Safety Structural measure is “a new attestation-based measure that assesses whether hospitals demonstrate a structure, culture, and leadership commitment that prioritize safety” and includes five complementary domains, each containing a related set of statements that aim to capture the most salient, evidenced-based, structural and cultural elements of safety.” These domains are:

1.  Leadership commitment to eliminating preventable harm;

2.  Strategic planning and organizational policy;

3.  Culture of safety and learning health system;

4.  Accountability and transparency; and

5.  Patient and family engagement.

Under the proposed rule, hospitals would annually attest to whether they engage in specific evidence-based best practices within each of these domains to achieve a score from zero to five out of five points (one point for each domain). For example, Domain 1: Leadership Commitment to Eliminating Preventable harm includes the following attestations:

1.  Our hospital senior governing board prioritizes safety as a core value, holds hospital leadership accountable for patient safety, and includes patient safety metrics to inform annual leadership performance reviews and compensation.

2.  Our hospital leaders, including C-suite executives, place patient safety as a core institutional value. One or more C-suite leaders oversee a system-wide assessment on safety (examples provided in the guidance document), and the execution of patient safety initiatives and operations, with specific improvement plans and metrics. These plans and metrics are widely shared across the hospital and governing board.

3.  Our hospital governing board, in collaboration with leadership, ensures adequate resources to support patient safety (such as equipment, training, systems, personnel, and technology).

4.  Reporting on patient and workforce safety events and initiatives (such as safety outcomes, improvement work, risk assessments, event cause analysis, infection outbreak, culture of safety, or other patient safety topics) accounts for at least 20% of the regular board agenda and discussion time for senior governing board meetings.

5.  C-suite executives and individuals on the governing board are notified within 3 business days of any confirmed serious safety events resulting in significant morbidity, mortality, or other harm.

A hospital would need to affirmatively attest to all of the above statements within this domain to receive a point for the domain.

Notably, Domain 4: Accountability and Transparency includes reporting “serious safety events, near misses and precursor events to a Patient Safety Organization (PSO) listed by the Agency for Healthcare Research and Quality (AHRQ) that participates in voluntary reporting to AHRQ’s Network of Patient Safety Databases.”

CMS plans to require reporting under these five domains to begin with the CY 2025 reporting period as part of the Hospital Inpatient Quality Reporting (“IQR”) Program and the PPS-Exempt Cancer Hospital Quality Reporting (“PCHQR”) Program.

Hospitals who participate in the IQR or PCHQR Programs should review the proposed Patient Safety Structural measures. We will be monitoring these potential changes closely.

If you have any questions regarding CMS’s Quality Program Requirements or would like guidance regarding PSOs, please contact a member of Hancock Daniel’s Patient Safety and PSOs team.

Click here for a full PDF version of the advisory.

The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C., is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson, P.C. be liable for any direct, indirect, or consequential damages resulting from the use of this material.

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