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COVID-19 PHE: CMS Re-sets Key Rules for Nursing Homes

The parameters of the COVID-19 public health emergency (PHE) are shifting at a rapid pace for nursing homes. In the midst of their work to implement (and document) a staff vaccination plan that includes a tracking mechanism and an exemption and accommodation process, providers also must open their buildings to resident visitations while maintaining core infection prevention and control principles—and be ready for recertification surveys to resume with some key shifts in focus from state surveyors. The regulations and guidance driving these changes are as follows:

During the Nov. 23 National Nursing Home Stakeholder Call, officials with the Centers for Medicare & Medicaid Services (CMS) provided insights about steps that providers need to take to ensure that they successfully meet all three challenges:

Staff vaccination key dates: Dec. 6, 2021, and Jan. 4, 2022

The staff vaccination interim final rule applies to all Medicare- and Medicaid-certified healthcare facilities that are regulated under the conditions of participation (CoPs) aka the requirements of participation (RoPs), noted officials. The rule lists 15 provider and supplier types that are subject to this regulation, including skilled nursing facilities (SNFs) and nursing facilities (NFs), hospitals, home health agencies, comprehensive outpatient rehabilitation facilities, and end-stage renal disease facilities.

“CMS’s statutory authority does not extend to some other kinds of facilities, such as assisted living facilities, group homes, and physician’s offices,” stressed officials. “These requirements apply to facilities regulated under the CoPs.”

The staff vaccination interim final rule includes two phases, each with its own deadline, according to officials:

  • Dec. 6, 2021: Phase 1 requires that by Dec. 6, 2021, facilities have “all processes and plans in place for vaccinating eligible staff, providing [medical and religious] exemptions, and tracking the staff vaccinations,” said officials. “It also requires that staff at all healthcare facilities included within the regulations must have received—at a minimum—the first dose of a primary series or a single dose of the COVID-19 vaccine prior to staff providing any care, treatment, or other services for the facility and/or its patients.”
  • Jan. 4, 2022: “Phase 2 requires that [by] Jan. 4, 2022, staff must have received the shots necessary to be fully vaccinated, again with the exception of those who have been granted exemptions from the COVID-19 vaccine or those for whom the COVID-19 vaccination must be temporarily delayed as recommended by the CDC,” said officials.

CMS could release new subregulatory guidance for implementing the staff vaccination interim final rule as early as this week. “We understand that this needs to get out on the street as soon as possible, so it won’t be long,” said officials. Note: CMS typically puts out guidance via QSO memos, which are posted here when available.

However, agency officials still tackled several questions about the rule during the call:

* This person comes to our nursing home. Do they need to be vaccinated? “Here’s the bottom line: The rule specifically requires [vaccination for] ‘facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement,’” said officials. “So, the question is, Do they provide services for the facility and/or its residents under contract or by other arrangement? And if the answer to that question is yes, then that individual is subject to the rule and must be vaccinated.”

The interim final rule allows exceptions for two types of services, according to officials:

  • Ad hoc, infrequent nonhealthcare services. “Facilities are not required to ensure vaccination of vendors or professionals who infrequently provide ad hoc nonhealthcare services, such as an elevator inspection or [repairs],” said officials.
  • Exclusively off-site services. Individuals who provide services “that are performed exclusively off-site or not at or adjacent to any site of patient care” are not subject to vaccination requirements, said officials. For example, this may include an accounting department that does not come on-site or telemedicine services.

This umbrella question has many variations, including the following:

  • Are staff who work in an assisted living facility attached to a nursing home required to be vaccinated if they provide services to the nursing home? “If you are an assisted living healthcare staff who also provides services to individuals in the nursing home, then you have to be vaccinated,” said officials.
  •  Do food delivery drivers need to be vaccinated? “They are providing services to the nursing home, and if they enter the facility, they have to be vaccinated,” said officials.
  • Are emergency medical services (EMS) providers subject to vaccination requirements? “While we don’t regulate EMS providers, if these providers provide services not on an ad hoc basis, then these individuals would be subject to the rule as well,” said officials. For example, this may include providers that provide nonurgent transportation.
  • Are pharmacy staff who come on-site to administer COVID-19 booster shots required to be vaccinated? “Yes, the individuals who are coming on-site to administer the vaccine are also subject to the vaccine mandate,” said officials.

* Can new hires who have received at least one dose of the vaccine provide any care or treatment or other services for the facility or its residents, or must they wait until they are fully vaccinated? “In this case, new hires can provide services to residents as long as they have received one dose of the vaccine,” said officials. “Facilities do need to implement additional precautions for these individuals because they are not fully vaccinated, and the rule does require facilities to implement additional precautions for those who are not fully vaccinated. But that doesn’t mean that they cannot provide any care to residents. We will address some of the questions about additional precautions in [the pending subregulatory] guidance.”

* What are considered recognized clinical contraindications for determining medical exemptions? CMS uses the recognized clinical contraindications established by the CDC and outlined in the Summary Document for Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States, said officials. Note: Appendix B, “Triage of People With a History of Allergies or Allergic Reactions,” of the full Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States has a handy color-coded chart detailing when there is a contraindication to vaccination, when there is a precaution to vaccination, and when vaccination may proceed.

* Is CMS requiring surveyors to be vaccinated? “We will develop additional guidance for state, federal, and CMS-contracted surveyors, but for right now, it is the responsibility of the state agency to ensure the safety of the surveyors,” said officials.

Providers can submit comments on the staff vaccination interim final rule through Jan. 4. 2022. “CMS will consider responsible comments as part of potential future rule-making,” said officials. Information about ways to submit comments is in the Addresses section of the rule, but the easiest way is to go to the rule’s permalink (i.e., permanent online home) and click on the Submit a Formal Comment button on the right-hand side of the page under the title.

Additional Resources  
CMS Omnibus COVID-19 Healthcare Staff Vaccination Requirements FAQs
COVID-19 Healthcare Staff Vaccination IFC-6 Infographic
COVID-19 Healthcare Staff Vaccination IFC-6 National Stakeholder Call Slides 
COVID-19 Healthcare Staff Vaccination IFC-6 National Stakeholder Call Video
Nov. 23, 2021, CMS National Nursing Home Stakeholder Call Transcript and Recording (when available)

Visitation: ‘There is no such thing as a no-risk scenario’

With the very grave exception of resident deaths, the “most heartbreaking” impact of the COVID-19 pandemic has been the need to restrict visitations and separate residents from their loved ones, stressed officials. “We know the value of visitation for the health and the well-being of the residents, as well as their families. Throughout the pandemic, we have heard stories of heartbreak about visitation from residents and advocacy organizations, and we are very pleased that at this point we can increase visitation dramatically. Visitation is now allowed for all residents at all times.”

A resident has the right to visitation unless it imposes on the rights of other residents, including health and safety rights, explained officials. “Earlier in the pandemic—pre-vaccine—there was too much of a risk to other residents. But now we have to also remember the other resident right, which is the resident’s right to make decisions about certain aspects of their life. Residents [or their representatives] who are aware of their risks can make that decision [to have visitations] per the federal requirements for resident rights that require facilities to let residents make decisions about their life.”

CMS made this move due to improving vaccination rates. As of Nov. 14, data from the CDC’s National Healthcare Safety Network (NHSN) COVID-19 Long-Term Care Facility Module shows that 86.4 percent of residents and 74.3 percent of staff nationwide are fully vaccinated. “Because 86 percent of residents are vaccinated, the risk of visitors transmitting the virus to other residents is greatly reduced,” said officials.

“There is no such thing as a no-risk scenario,” acknowledged officials. “There is always some risk.” Driving home that point, the number of confirmed COVID-19 cases in nursing homes has slightly increased over the past two weeks of data. A downward trend lasted from early September to Oct. 31, when nursing homes hit the latest low of 3,033 resident cases and 3,415 staff cases. As of Nov. 14, resident cases are up to 3,310, and staff cases have climbed to 3,599.

“CMS will continue to monitor the vaccination and infection rates, including the effects of COVID-19 variants on nursing home residents,” said officials. “We are going to keep residents safe.”

Despite the slight uptick in cases, “at this time, continued limitation on the vital resident right of visitation is no longer necessary,” reiterated officials. However, visitations should not be exactly the same as they were pre-pandemic because providers must adhere to the guidelines outlined in QSO-20-39-NH. “You still need to follow all of the core principles of infection prevention and control … that you all have been doing for the last 18 [or so] months,” they explained. “Don’t let the term ‘I’m vaccinated’ be an excuse for letting your guard down on all the things that we know that help reduce the spread of COVID-19.”

In addition to source control, physical distancing, hand hygiene, and other measures, these core principles include screening visitors to determine whether they have a positive COVID-19 viral test, have COVID-19 symptoms, or meet the CDC’s criteria for quarantine (i.e., they are unvaccinated and have had a close-contact exposure, or they are vaccinated and symptomatic in addition to having had a close-contact exposure), advised officials. “Those are reasons why visitors should not enter, but other than that, visitors should be allowed to enter.”

Providers also should avoid having large gatherings, such as parties, said officials. “When there are too many people in the facility, it becomes difficult for physical distancing to occur. We want to be very careful that we don’t create a situation where physical distancing cannot be maintained.”

Each resident still has the right to visitation, but providers may need to restructure visitations when physical distancing is likely to be at risk, said officials. For example, providers may need to structure time slots and schedule family visitations to ensure appropriate physical distancing throughout the facility.

“None of this restructuring really needs to happen on any other days where there is not a lot of expected high traffic,” added officials. “So, holidays are the main thing to worry about, but it could be birthdays too throughout the year.”

Officials also addressed three common questions about visitations:

* Can residents and their family members dine together? “Yes, they can eat together …, but please maintain physical distancing, especially from other residents and other family members,” said officials.

* Can residents leave the facility (e.g., to go home and participate in Christmas dinner)? “Yes, they can,” said officials. QSO-20-39-NH includes the following instructions:

Upon the resident’s return, nursing homes should take the following actions:  

Screen residents upon return for signs or symptoms of COVID-19.
– If the resident or family member reports possible close contact to an individual with COVID-19 while outside of the nursing home, test the resident for COVID-19, regardless of vaccination status. Place the resident on quarantine if the resident has not been fully vaccinated.
– If the resident develops signs or symptoms of COVID-19 after the outing, test the resident for COVID-19 and place the resident on Transmission-Based Precautions, regardless of vaccination status.
A nursing home may also opt to test unvaccinated residents without signs or symptoms if they leave the nursing home frequently or for a prolonged length of time, such as over 24 hours.
Facilities might consider quarantining unvaccinated residents who leave the facility if, based on an assessment of risk, uncertainty exists about their adherence or the adherence of those around them to recommended infection prevention measures.
Monitor residents for signs and symptoms of COVID-19 daily.

In addition, “the CDC has guidance on their website about what to do about residents who leave the facility [for 24 hours or longer] and come back—and whether or not they need to be quarantined,” said officials. “It is very specific guidance, so please review it.”

* Can a facility require a visitor to be vaccinated or tested? “No, a facility cannot require a visitor to be vaccinated or tested,” said officials. “Safe visitation can occur even when a visitor is not vaccinated. However, we do encourage facilities to educate visitors on the vaccine and to urge them to get vaccinated as well. A facility can ask a visitor if they are vaccinated; the visitor does not have to answer. If they don’t answer or if they reply no, then the facility and the visitor should follow the CDC’s guidance for unvaccinated individuals.”

Providers can offer to test a visitor, added officials. “But you cannot make it a condition of visitation. You can encourage visitors to get tested prior to coming, but again it cannot be a condition for visitation. And all of this is because of the high percent of residents who are vaccinated, the efficacy of that vaccine, and the adherence to the core principles of infection prevention and control.”

Nursing home survey priorities: CMS defines “the new normal”

In memo QSO-22-02-ALL, CMS guides state survey agencies on how to address the backlog of surveys that have accumulated throughout the pandemic since the agency suspended standard surveys, said officials. “It’s really part of our actions to get back to the new normal … and to restart and resume recertification surveys and other complaint surveys [i.e., complaint surveys not alleging an immediate jeopardy situation].”

The first step that CMS is taking to achieve this is to no longer require that state survey agencies conduct a focused infection control survey within three to five days after a facility reports new cases, said officials. “However, state survey agencies still may complete and conduct these surveys as they are conducting other surveys. Also, they may conduct them because they see a large outbreak, and they want to go ahead and do so. We have also embedded the procedure for the focused infection control survey into the standard survey process so that it will be evaluated on every standard recertification survey.”

The memo also guides state survey agencies on how to prioritize getting back to their recertification surveys, said officials. “If all of the facilities in your state are in need of a survey, then which ones would you go to first? You would go first to the ones where the residents are potentially at the most risk.”

CMS offers the following examples of issues where either a facility history of noncompliance or allegations of noncompliance could indicate that residents are potentially at high risk:

  • Abuse or neglect;
  • Infection control;
  • Violations of transfer or discharge requirements;
  • Insufficient staffing or competency;
  • Special Focus Facilities (SFFs) and SFF candidates; and/or
  • Other quality-of-care issues (e.g., falls, pressure ulcers, etc.).

When state surveyors are conducting surveys, they should “be on extra lookout for some issues that we have been seeing on the surveys that have been conducted,” said officials. CMS wants surveyors to be aware that the following areas may need additional investigation:

* Nurse competencies. During the PHE, CMS has waived some nurse aide training and certification requirements, acknowledged officials. “However, … we never waived the requirement for nurses to be competent to administer a resident’s care plan to meet their needs. So, we are guiding state agencies to be alert to any issues related to nurses not being able to deliver the necessary care to meet each resident’s needs.”

In particular, the memo singles out the ability of licensed and registered nurses, as well as nurse aides, to identify and address a resident’s change in condition as a key component of competency under F-tag 726 (Competent Nursing Staff), stating: “These competencies are critical in order to identify potential issues early, so interventions can be applied to prevent a condition from worsening or becoming acute. Without these competencies, residents may experience a decline in health status, function, or need to be transferred to a hospital. Surveyors should refer to the Sufficient and Competent Staffing Critical Element Pathway for further guidance in determining compliance with requirements related to nursing services.”

* The inappropriate use of antipsychotic medications. “We are also alerting state agencies to be on the lookout for the inappropriate use of antipsychotics, which has been a long-standing initiative from CMS to try to address,” said officials. In addition, the memo guides surveyors to highlight nonpharmacologic approaches and resident-centered care practices.

This renewed focus on antipsychotic medications comes on the heels of a September 2021 New York Times report that found that at least 21 percent of nursing home residents were on antipsychotic medications in calendar fourth-quarter 2020, according to MDS data, In comparison, the National Partnership to Improve Dementia Care in Nursing Homes: Antipsychotic Medication Use Data Report, tracking the quality measure Percent of Long-Stay Residents Who Received an Antipsychotic Medication, put that figure at 14.5 percent. The National Partnership data excludes residents with a diagnosis of schizophrenia, Huntington’s disease, or Tourette’s syndrome—an exclusion that opens up the possibility of an inappropriate or even false diagnosis being assigned to residents, the investigation suggested.

Note: For information on how to re-focus on resident-centered care practices, see the AAPACN article, “Resident-Centered Care: How—and Why—to Learn the Resident’s Story,” as well as the AAPACN article, “I Spy … Behavioral Symptoms.”

* Other pandemic-related concerns. “We are alerting state agencies to be aware of other issues that could have occurred perhaps as a result of the pandemic—or were exacerbated by the pandemic,” said officials. Examples of these concerns include unplanned weight loss, loss of function/mobility, depression, abuse/neglect, or pressure ulcers. The memo tells surveyors to “use the appropriate critical element pathways to thoroughly investigate these areas to ensure any noncompliance is identified and subsequently corrected.”

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