Final, long-awaited guidance related to nursing home Requirements of Participation may soon be here. The rules were fundamentally rewritten and implemented in three phases starting in 2016 but still have not been fully realized five years out.
The interpretive guidance would have been out “months ago” if not for a mid-year rise in COVID-19 cases, one official said earlier in October. But federal officials have indicated that they are ramping up non-COVID related enforcement and plan to begin addressing compliance issues if cases continue to decline.
Among new information coming from the Centers for Medicare & Medicaid Services will be guidance on how operators should implement specific Phase 3 rules and how surveyors will monitor them. That could mean providers will finally get critical information on how to meet infection preventionist, ethics, care planning and other requirements.
So what should providers expect between now and then, and what should they be doing to prepare for the publication of guidance?
“While we wait for interpretive guidance on the Phase 3 elements, we would expect the surveyors not to go beyond the regulations written for the Phase 3 requirements,” said Sean Fahey, a skilled nursing and assisted living attorney at Hall Render in Indianapolis. Fahey presented on the industry’s compliance challenges at the American Health Care Association / National Center for Assisted Living convention earlier this month.
“Still, even with little interpretive guidance beyond the regulations, nursing homes need to comply with the regulations and be prepared to show what they are doing to implement the Phase 3 requirements with good faith efforts,” Fahey told McKnight’s Long-Term Care News.
What’s in Phase 3
Providers participating in the Medicare and Medicaid programs must conform to the Rules of Participation. Updated rules rolled out starting with Phase 1 in 2016 and Phase 2 in 2017, with Phase 3 elements given a two-year window for adoption after that.
Rules governing them were initially set to be enforced starting Nov. 28, 2019.
But two week prior to implementation, CMS announced it would not be releasing updated interpretive guidance and training for the Requirements for Participation in time for the launch.
Phase 3 covers a wide swath of topics including improving resident care plans to include specialized or rehab services; ensuring certain residents receive trauma-informed care; adding a governing body to be responsible for implementing and reporting on a facility’s Quality Assurance and Performance Improvement (QAPI) program; appointing an infection preventionist; implementing new compliance and ethics standards; implementing bedside call systems; and formalizing training programs.
“While the regulations will be effective, our ability to survey for compliance with these requirements will be limited until the interpretive guidance is released,” the agency said at the time.
That guidance was expected in the second quarter of 2020.
In addition, CMS also proposed in 2019 to delay implementation of elements of the QAPI program and compliance and ethics program requirements for one year after the rule was finalized.
Then COVID-19 arrived.
There has been no further guidance nor a final rule issued in the intervening two years.
Fahey said Phase 3 F-tags with little or official guidance include:
• F659 – Comprehensive Care Plans
• F699 – Trauma-Informed Care
• F882 – Infection Preventionist
• F940, F941, F942, F944, F945, F946, F949 – Training Requirement
• F895 – Compliance and Ethics Program
For the time-being, CMS has been true to its word regarding enforcement. Fahey said online CASPER data for 2020 and 2021 “reflects that citations have not been issued for several Phase 3 elements including trauma informed care, compliance and ethics programs, and certain training requirements.”
Is time up?
But the delay on guidance around those issues may soon be over, according to Evan Shulman, director of the CMS Division of Nursing Homes. He acknowledged that more guidance “would have been out months ago,” if not for the continued pressures of COVID.
“A lot depends on how things go over the next few months,” Shulman said. “We’re trying to be as sensitive as we can to what’s being asked of (providers). … We have done what we can to hold off on some things. But we do have to get it out there. We can’t just delay forever.”
Despite the lack of guidance, Shulman said there are several elements of Phase 3 for which providers “don’t need to wait for us,” including appointing an infection preventionist.
“The regulations are actually pretty darn specific. Everyone of you should have an IP in place, every single one of you,” he said. “And they should all have taken the training (through CDC, AHCA or vendors.) There’s no shortage of training.”
“Look in the Phase 3 requirements and pull out what you can,” regarding existing requirements, he advised.