Are you almost at the finish line?

Three years ago, the Centers for Medicare & Medicaid Services delivered one of the most sweeping changes to long-term care compliance in more than three decades and turned up the heat on the industry’s already intense regulatory environment. “Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities” (81 FR 68688), dubbed the Mega Rule, contains hundreds of compliance changes and clarifications for skilled nursing and nursing facilities. The planned November 28, 2019 deadline for implementation of the last of the regulation’s three phases will be here tomorrow. However, at this time, CMS has not released any interpretative guidance on the requirements. A November 22 letter from CMS’ Quality, Safety & Oversight Group indicated not to expect guidance until the second quarter of 2020.

Additionally, some proposed changes to requirements have caused uncertainty about the future of Phase 3. In July, CMS announced a proposed change to the Mega Rule aimed at lessening the burden on facilities so they can focus more on care. If finalized, “Medicare & Medicaid Programs; Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Efficiency and Transparency” (CMS-3347-P) will remove requirements deemed unnecessary or excessive. The announcement included a proposal to delay the implementation of some Phase 3 requirements until the date specified in the rule. The period for public comment has ended, leaving the fate of parts of Phase 3 hanging in the balance for now.
Meanwhile, facilities need to move forward with 2016’s requirements. Now is a good time to take stock and check how prepared you are to reach the Mega Rule finish line.

What’s required?
Phase 3 addresses 10 areas, including Quality Assurance and Performance Improvement (QAPI) implementation, Infection Control, Compliance and Ethics, and Physical Environment. Some of the regulations in these areas have been partially implemented in the previous phases. For example, the rule addressed care planning earlier but in Phase 3, Section §483.21 (Comprehensive Person-Centered Care Planning) requires that care plans are culturally-competent and trauma-informed.
Phase 3 mandates the development and implementation of an effective QAPI program that includes several elements. Section §483.70 (Administration) requires that the responsibility for the QAPI program is included in the obligations of the governing body. Section §483.12 (Freedom from Abuse, Neglect, and Exploitation) also requires that facilities integrate abuse, neglect, and exploitation into their QAPI program.
Phase 3 focuses heavily on several employee training and staff competencies. For example, Section §483.40 (Behavioral Health Services) requires the development and implementation of a process to assess staff competencies for caring for residents with a history of trauma and/or post-traumatic stress disorder. Finally, Section §483.95 (Training Requirements) calls for new training to be implemented for staff, contractors and volunteers for topics such as communication, resident’s rights, abuse, neglect, infection control, and compliance and ethics.

The last phase also necessitates facilities to add some new personnel responsibilities. Section §483.80 (Infection Control) calls for the hiring or the designation of an infection preventionist who is responsible for the Infection Prevention and Control Program. Section §483.85 (Compliance and Ethics Program) requires that a plan be developed for implementing components of a compliance and ethics program as well as putting a schedule in place to annually review and update the program.

Help available
The Compliance Store is the only comprehensive web-based regulatory compliance management resource for long-term care facilities. This website supports providers across the nation. The Compliance Store gives facilities access to regulatory and government agency information, update alerts, education, and templates tailored specifically for long-term healthcare. Whether you’re on time to meet requirements or a little behind, this site has a wealth of resources to help get you on track. Find out how The Compliance Store can help at


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