Executive Summary
Centers for Medicare & Medicaid Services is planning to introduce new requirements intended to promote patient safety. Scores will be tied to reimbursement.
- Failure to affirmatively attest to each measure could have reputational harm and potential financial consequences.
- Hospitals will need to determine their level of commitment to the measures.
- Compliance may require additional capital and staff.
Centers for Medicare & Medicaid Services (CMS) is planning to introduce additional requirements to improve patient safety, and risk managers would be wise to anticipate how those new measures might affect their operations.
Dora Hughes, MD, acting chief medical officer and acting director of the CMS Center for Clinical Standards and Quality, recently said during a public event in Baltimore that CMS is working with other Health and Human Services (HHS) branches to develop a 10-point patient safety strategy that will be announced later this year. The strategy may include new patient safety-related conditions of participation and value-based payment measures.
On April 10, 2024, CMS issued the fiscal year 2025 Medicare hospital inpatient prospective payment system (IPPS) and long-term care hospital prospective payment system (LTCH PPS) proposed rule. The proposed rule outlines the adoption of a new Patient Safety Structural Measure (PSS Measure) as part of the Hospital Inpatient Quality Reporting (IQR) Program and PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program, explains Robert E. Slavkin, JD, an attorney with the Akerman law firm in Orlando, FL.
The proposed PSS Measure is part of CMS’ National Quality Strategy, launched in 2022, with a goal of achieving optimal health and well-being for all individuals, Slavkin says.
The proposed rule is available online at https://go.cms.gov/3UIhGTv.
Participating acute-care hospitals in the Hospital IQR Program that do not submit required quality data to CMS regarding measures selected by the HHS secretary will see payment reductions by CMS, he says. In the proposed rule, CMS discusses seven new proposed quality measures, one of which is the PSS Measure.
Slavkin says the purpose of the PSS Measure is to assess whether hospitals are prioritizing patient safety by requiring hospitals to attest to whether they engage in evidence-based best practices within each of the following five domains: leadership commitment to eliminating preventable harm; strategic planning and organizational policy; culture of safety and learning health system; accountability and transparency; and patient and family engagement.
Hospitals will be able to achieve a total PSS Measure score ranging from zero to five, Slavkin says. Each of the five attestation domains includes five attestation statements. A hospital must be able to provide a “yes” or “no” response to every attestation statement within a particular domain to receive a score of one for that particular domain, he says. “For example, if a hospital is only able to attest that it is in compliance with four of the five attestation statements within Domain 5, Patient & Family Engagement, the hospital will receive a score of zero points for Domain 5,” Slavkin says.
Coming in 2025
CMS proposes to begin the PSS Measure attestation requirement for the calendar year (CY) 2025 reporting period, which impacts a hospital’s fiscal year (FY) 2027 payment determination under the Hospital IQR Program, he explains. The proposed rule provides that a hospital would submit the PSS Measure data annually through the Centers for Disease Control and Prevention’s National Healthcare Safety Network (NHSN). Hospitals currently report quality measure data through this portal on a monthly or quarterly basis, depending on the measure, Slavkin notes.
“Hospitals participating in the Hospital IQR Program will be able to satisfy the reporting requirements of the PSS Measure so long as they provide yes or no responses to each of the five domains,” Slavkin says. “Hospitals receive credit merely for reporting their measures, regardless of whether they successfully implemented the requirements within a specific domain.”
However, Slavkin explains that the proposed rule provides that, beginning in fall 2026, CMS would publicly report the hospital’s PSS Measure score (a total score of 0 to 5 points), on an annual basis on Care Compare (https://www.medicare.gov/care-compare/).
“Hospitals, therefore, face potential reputational harm if they are not able to affirmatively attest to compliance with each domain,” he says.
In addition, CMS value-based purchasing programs use selected quality measures to reward providers for the quality of care they provide, Slavkin says. Therefore, another potential ramification of a low PSS Measure score is that if the PSS Measure is used by value-based purchasing programs to determine the quality of care provided by hospitals, a low PSS Measure could impact hospital reimbursement under the value-based purchasing programs, she says.
Hospitals Must Decide about Domains
The practical impact on hospitals and health systems is that they will need to decide whether they want to ensure they satisfy each of the proposed domains of the PSS Measure, says Danielle C. Gordet, JD, associate with the Akerman law firm in Miami, FL.
“So long as hospitals comply with submitting whether they are in compliance with each measure they will be in ‘compliance’ with the reporting requirement,” Gordet says. “However, failure to affirmatively attest to each measure could have reputational harm and potential financial consequences.”
Gordet notes that the PSS Measure currently is only part of a proposed rule, but she expects that it will be finalized and likely will not change dramatically from its current form. Although hospitals are not required to affirmatively respond to compliance with each domain, doing so is in the best of interest of hospitals to avoid potential reputational harm and other financial impacts, she says.
“Therefore, we recommend hospitals begin preparing now to ensure they are able to satisfy each element of each domain, once or if the PSS Measure is finalized,” she says.
To prepare for the strong possibility that the proposed PSS Measure will be finalized, Gordet says hospital risk managers should work with hospital leadership to prepare a task force approach to ensure implementation of all the attestation statements within each attestation domain.
For example, one of the five attestation statements within Domain 2 (Strategic Planning & Organizational Policy) requires the hospital to confirm whether the following is true: “Our hospital has implemented written policies and protocols to cultivate a just culture that balances no-blame and appropriate accountability and reflects the distinction between human error, at-risk behavior, and reckless behavior.”
“Implementation of this statement will require the Human Resources Department, Risk Department, Compliance Department, and C-suite leadership to all work together to ensure that the hospital will be on the same page moving forward and to ensure all departments are part of the creation of these new policies, if a hospital does not already have these policies in place,” Gordet says.
Aiming to satisfy all of the domains is in the best interests of patients, but hospitals will find the requirements challenging, Gordet says. Many different departments and executive leaders will need to work together within each hospital if their goal is to affirmatively attest to every domain, she says.
“In addition to taking up a substantial amount of staff time to ensure affirmative attestation, some of the requirements may also require hospitals to spend additional capital to reach the goal of affirmative attestations,” Gordet says. “For example, depending on a hospital’s current capabilities, it may need to contract with third parties to implement some of the required items, such as implementation of an annual hospital-wide survey regarding a culture of safety using a validated instrument, and implementation of a patient safety metrics dashboard.”
All Hospitals Under Same CCN
As an added layer to the work ahead, hospital systems that strive to be able to affirmatively attest to the five domains must ensure that all of the hospitals within the system that report under the same CMS Certification Number (CCN) are able to satisfy all of the same domains, Gordet says. A hospital system will not receive a score of 1 for a particular domain unless each of its CCN hospitals also are able to provide affirmative responses to that particular domain.
“Hospitals will face challenges if they want to be able to affirmatively attest to satisfaction of all of the domains,” she says. “Affirmative attestations will likely not be possible unless the hospital has sufficient resources to ensure its employees can handle the additional obligations required by many of these domains, such as ensuring the hospital has a dedicated team to conduct event analysis of serious safety events.”
Slavkin says the new PSS Measure could have a positive impact on the care that hospitals provide to their patients. CMS clearly has a vision to improve the quality and safety of healthcare for everyone, she says, and CMS will continue to put quality measure requirements on hospitals, such as the PSS Measure. These measures likely will become more rigorous each year, he says.
A necessary tool for implementation is not only buy-in from the C-suite, but also ensuring the effectiveness of the hospital’s risk and compliance programs, he says. Without effective programs, these measures will not be able to be implemented. Slavkin says this is why it is important to for risk and compliance programs to be reviewed regularly to determine their effectiveness.
“Hospitals that ignore the need to focus on improving quality now will be left in a panic as these types of measures continue being rolled out by CMS,” Slavkin says. “Hospitals that take active steps now to improve quality will have the most success moving forward.”
Sources
- Danielle C. Gordet, JD, Akerman, Miami, FL. Telephone: (305) 982-5609. Email: [email protected].
- Robert E. Slavkin, JD, Akerman, Orlando, FL. Telephone: (407) 419-8438. Email: [email protected].
Centers for Medicare & Medicaid Services is planning to introduce additional requirements to improve patient safety, and risk managers would be wise to anticipate how those new measures might affect their operations.
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