CMS Proposed Changes to RoPs – Delays Ahead? (Part 3)

Here is the third and final part of CMSCG’s look into the proposed rule, “Medicare & Medicaid Programs; Requirements for Long-Term Care Facilities; Regulatory Provisions to Promote Efficiency and Transparency.” In this post, we will look at changes proposed to the Administration regulatory group, including the Facility Assessment, Quality Assurance and Performance Improvement and Compliance and Ethics. We will also look at proposed changes to the Infection Preventionist requirement and how the proposed rule could delay some of those looming Phase 3 Requirements.


CMS has proposed a handful of changes under the Administration regulatory group. These include:

  • Facility Assessment (F838)
    • CMS proposed removing unnecessary requirements under the Facility Assessment regulation and clarified that data from the Facility Assessment “can be utilized to inform policies and procedures for other LTC requirements,” such as Nursing Services, Behavioral Health Services and Food and Nutrition Services. Data collected under the QAPI requirement would also be used to meet portions of the Facility Assessment requirements and the Facility Assessment data could also be used for QAPI.
    • Additionally, CMS proposed that the Facility Assessment would be changed to a biennial refresh as opposed to the current annual requirement to conduct a Facility Assessment.
    • Emergency Preparedness Facility-Wide Assessment – CMS identified that the requirements for the Emergency Preparedness Plan (EPP) regarding the requirement to conduct a facility and community-based risk assessment is duplicative to part of the requirement for the Facility Assessment. As such, CMS has proposed to remove the requirement that facilities conduct and document a facility-wide assessment for both daily operations and emergencies from the Facility Assessment requirements.
  • Quality Assurance and Performance Improvement
    • The proposed rule includes potential revisions to the QAPI requirements in order to provide more flexibility to facilities so they can develop a program that meets their individual needs.
    • The proposed revision to F865 would remove all the criteria in the sub-paragraphs, leaving the requirement to state only: “§483.75(b) Program design and scope. – A facility must design its QAPI program to be ongoing, comprehensive, and to address the full range of care and services provided by the facility.”
      • View CMSCG’s Ftag of the Week posts for F685 to see the current regulatory requirements – F865 Part 1 and F865 Part 2.
    • The proposed revision to F866 (Phase 3 requirement) would remove all the criteria in the sub-paragraphs, leaving the requirement to state only: “Program feedback, data systems and monitoring. A facility must establish and implement written policies and procedures for feedback, data collections systems, and monitoring, including adverse event monitoring.
    • The proposed revision to F867 (Phase 3 requirement) would remove all the criteria in the sub-paragraphs, leaving the requirement to state only: “§483.75(d) Program systematic analysis and systemic action §483.75(d)(1) The facility must take actions aimed at performance improvement and, after implementing those actions, measure its success, and track performance to ensure that improvements are realized and sustained.”

Compliance and Ethics

CMS stated in the proposed rule that the requirement for facilities to have a Compliance and Ethics Program (Phase 3 requirement) was finalized, but it included additional training and personnel requirements that were not statutorily required. The following requirements have been proposed to be removed:

  • Designation of a compliance officer and designated compliance liaison for operating organizations with 5+ facilities – Each facility would need to assign a high-level staff member to oversee compliance.
  • Compliance and Ethics Program Contact Person – Instead, a facility would need to have a process in place to have a person who can be this contact rather than CMS mandating who that person should be.
  • Annual review requirement – A review would instead be required periodically to identify any necessary updates/changes.

CMS has proposed that the operating organization for each facility develop/implement/maintain an effective compliance and ethics program that includes written compliance and ethics standards and P&Ps that are “reasonable, capable of reducing the prospect of criminal, civil and administrative violations under the Act.” The Agency has also proposed that specific, high-level staff of the operating organization be responsible for overseeing compliance, but that person would not need to be the CEO/ members of the Board of Directors or other such individuals as currently written in the reg.

Infection Control

Another part of the proposed rule addresses the Infection Preventionist (Phase 3 requirement – F882 Infection Preventionist Qualifications/Role). The Infection Preventionist requirement is remaining in place, however, CMS has proposed some tweaks to the regulation related to the time spent in the facility. As it currently stands, the regulation states that the Infection Preventionist (IP) must work at least “part-time” in the facility, which CMS feels is ambiguous and could be better revised to require the IP to spend enough time in the facility to meet the objectives of the Infection Prevention and Control Plan (IPCP). View CMSCG’s Ftag of the Week posts for F880 Infection Prevention and Control (Part 1Part 2Part 3) and F882 IP for the current regulatory requirements.

Potentially Impacted Phase 3 Regulatory Areas

If the proposed rules is finalized, there are three areas listed that are effective Phase 3 that would be impacted. CMS is recommending a 1 year delay in these areas if the rule is finalized. These include:

  • Infection Preventionist — Designation/Training. The requirements for the IP, otherwise, including the participation on the QAA Committee, will be implemented as is for Phase 3.
  • Quality Assurance and Performance Improvement
  • Compliance and Ethics Program

For a comprehensive look at the proposed rule, “Medicare and Medicaid Programs: Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Efficiency, and Transparency,” and the changes potentially impacting LTC providers, view Part 1 and Part 2 of the CMSCG Blog Series.

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