RAPIDS (Regulation And Policy for Infectious Disease Stewardship) Network: Recommendations to Further the Goals of the Infection Prevention and Control and Antibiotic Stewardship Program Conditions of Participation

The following organizations have participated in the creation or review of this policy brief: Steering Committee: Association of American Medical Colleges (AAMC), Federation of American Hospitals (FAH), Cepheid, Rubrum Advising

Participating Organizations: Cepheid, Common Spirit Health, HCA Healthcare, University of Wisconsin Health, Infectious Diseases Society of America (IDSA)

Introduction

The RAPIDS (Regulation And Policy for Infectious Disease Stewardship) Network is co-convened by Rubrum Advising, the Federation of American Hospitals (FAH), and the Association of American Medical Colleges (AAMC). Members include a variety of infectious disease stakeholders whose goal is to improve the quality of care for patients in hospitals through the enhancement of Antimicrobial Stewardship Programs (ASPs). To execute this goal, a series of working groups around the topics of (1) Quality Measures, (2) CMS Conditions of Participation, and (3) Interoperability are being held to develop policy and regulatory recommendations. This policy brief has been developed based on discussions within the CMS Conditions of Participation (CoPs) working group, consisting of representatives from nine organizations, spanning hospital associations, health systems, infectious disease professional societies, academic institutions, diagnostic manufacturers, and other regulatory experts. This policy brief does not represent an official endorsement by any of the listed organizations.

The primary objective of the RAPIDS Network CMS CoPs Working Group was to identify opportunities to further the goals of the Condition of participation: Infection prevention and control and antibiotic stewardship programs (IPC & ASP CoPs). This policy brief is intended to provide key stakeholders, including relevant federal agencies, with proposed actions towards improving hospital outcomes through compliance with the existing IPC & ASP CoPs. We underscore the alignment of the group’s recommendation with the administration’s priority of decreasing burden of regulatory agencies while upholding programs that prioritize the health and safety of patients across the nation.

Background

The IPC & ASP CoPs, published as a final rule in 2019 and implemented in March 2020, mandated hospitals to have active “programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship” to participate in the Medicare & Medicaid programs.¹ The accreditation organizations deemed by CMS—TJC and DNV—use the interpretative guidance published in the CMS State Operations Manual (SOM) to determine whether hospitals meet or exceed the minimum standards set forth in the CoPs. The CMS SOM requires hospitals to not only identify issues related to infection prevention and control and/or antibiotic use, but also to address them in a hospital-wide quality assessment and performance improvement (QAPI) program. The QAPI program is not unique to antimicrobial stewardship programs: All hospitals that participate in Medicare and Medicaid must have detailed QAPI programs that 1) reflect the hospitals’ complexity of organization and services; 2) outline how the facility will measure, analyze, and track quality indicators; and 3) detail how the data will be used to identify opportunities to drive quality improvement.

Recommendation

We recommend maintaining the IPC & ASP CoPs and the State Operating Manual as written to continue mandating QAPI programs to promote routine surveillance and allow hospitals flexibility in allocating resources towards impactful initiatives. We believe that hospitals should not routinely design custom solutions to common issues but rather implement evidence-backed solutions specifically outlined in the multiple CDC Core Elements guidance documents. As such, we recommend that when surveillance identifies an infection prevention and control or antimicrobial use problem, CMS should encourage hospitals to use the multiple CDC Core Elements guidance documents to develop a plan that mitigates potential or real infection- related harm as part of the hospital-wide QAPI program. We recommend that CMS encourage hospitals to use high-value, high-impact interventions to prevent infection spread and optimize antimicrobial and diagnostic test utilization.

Rationale

First, the group analyzed the effectiveness and burden of all IPC & ASP CoPs sections. Given that small and rural hospitals or urban safety net hospitals are held to the same standards, the CoPs represent a reasonable set of minimum requirements achievable in resource-limited settings. Due to an infectious disease physician shortage, many of these rural, smaller, or urban safety net hospitals rely on pharmacists to lead the antimicrobial stewardship programs; however, pharmacists are not eligible for separate payment for professional services. Opportunities for creative, low-burden initiatives may allow such hospitals to meet the IPC & ASP CoP requirements. While telemedicine stewardship pilot programs have demonstrated improved antimicrobial utilization through partnership between academic medical centers, inability to fund partnership through the QAPI program often stifles continued partnership progress. Therefore, we propose that antimicrobial stewardship services should be centralized and accessible through telemedicine, and hospitals should be allowed spending flexibility on QAPI programs, as documented in cost reports.

The working group identified that the key barriers to achieving the CoPs goals de facto were low accountability standards and financial constraints. Opportunities exist to improve surveillance per SOM, such as holding hospitals accountable for choosing effective solutions that balance both the cost of implementation and the impact on quality of care. Consistent with value-based medicine practices and the importance of curbing antimicrobial resistance, CMS should encourage hospitals to choose best practices outlined in the CDC guidance documents that not only mitigate infection spread but also optimize antimicrobial and diagnostic test utilization.

These CDC guidance documents include the Core Elements of Hospital Antimicrobial Stewardship Programs, Core Elements of Hospital Diagnostic Excellence, and Implementation of Antibiotic Stewardship Core Elements at Small and Critical Access Hospitals.