Patient-Safety Regulations Remain Suspended As Iowa And Other States Reopen


17 May

The Rowley Memorial Masonic Home in Perry, Iowa, was fined more than $100,000 last year due to numerous patient-care violations (Photo by Clark Kauffman/Iowa Capital Dispatch) 

By CLARK KAUFFMAN,  Deputy Editor | Iowa Capital Dispatch

With nursing homes now accounting for one-third of all COVID-19 deaths in the U.S., state and federal officials are continuing to hold in suspension dozens of regulations intended to protect residents of such facilities.

The regulatory rollback was initiated in March and is designed to eliminate bureaucratic hurdles that might exacerbate staffing shortages or make it harder for health care providers to maximize the use of medical personnel and equipment in the midst of a global public health emergency.

Although some states, Iowa included, are already easing restrictions on business activity and proclaiming they’ve “turned the corner” on fighting the virus, many of the regulations that once were in place to ensure patient safety in nursing homes, hospitals, hospice facilities and other settings remain suspended.

At Tuesday’s press conference, Gov. Kim Reynolds was asked whether she’s planning to eliminate some of the regulatory waivers as she reopens retail shops and restaurants around the state.

“Yeah, that probably won’t be a priority,” she said. “We’ll probably continue with most of those (waivers) at least until the end of the month. But our legal team, working in conjunction with the Department of Public Health and our various agencies, continue to review some of the regulatory relief that we put in place.”

Toby Edelman, senior policy attorney with the national Center for Medicare Advocacy, says some aspects of the regulatory rollback — such as the suspension of inspections and minimum levels of staffing, licensing and training — are “terrifying” and could have a direct effect on patient care in nursing homes.

“These waivers of protections for residents, and the waivers dealing with the aides who are providing care, they are very frightening,” she said. “These are very dangerous times, and there’s just no oversight.”

She noted that the suspension of patient-safety regulations coincides with staffing reductions and turnover triggered by the pandemic itself. “So I’m really worried about who is providing the care,” she said. “We know that a lot of staff are sick, obviously. It’s the residents and staff who are dying in incredible numbers. So who is coming in to provide care?”

Toby Edelman, senior policy attorney with the national Center for Medicare Advocacy, (Photo courtesy of the Center for Medicare Advocacy) 
Part of the problem, Edelman said, is that routine inspections have been suspended, long-term care ombudsmen in each state aren’t visiting the homes during the pandemic, and the facilities no longer have to report payroll data that would reveal their staffing levels. “So how would we even know what’s going on?” Edelman asked.

Some of the suspended regulations — such as those pertaining to group activities, shared rooms, and visits by friends and family — have obvious benefits in limiting the spread of a virus. But other changes — including waivers that suspend requirements for sufficient staffing, training for workers, background checks on workers and the testing of medical equipment — create other forms of risk for patients.

And, at the same time they rolled back health care regulations, state and federal officials also promised not to impose fines for violations of regulations that remain in effect.

The Center for Medicare and Medicaid Services says the suspension of federal regulations “puts patients over paperwork” and enables health care providers to “focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.”

John Hale, an Iowa consultant and advocate for nursing home residents, says most people understand that in the midst of a health crisis, some of the rules designed for normal times have to be modified or eliminated.

“But when we’re told that we’re no longer in crisis mode, those rules that were set aside need to be reinstated,” he said, “particularly those that exist to protect the health and safety of hospital patients, nursing home and assisted living residents, et cetera.”

Hale says most of the suspended rules “are common-sense ones,” such as making sure care providers have all the training and certifications needed to adequately perform their jobs.

“I realize you just can’t flip a switch and put everything back as it was, but we ought to be moving in that direction very quickly so we can assure Iowans that the people and organizations they look to for assistance are once again fully prepared to serve them well,” Hale said.

But with long-term care facilities accounting for at least one-third of all COVID-19 deaths in the United States, the American Health Care Association, the industry’s main lobbyist, is looking for more than regulatory relief. It is now asking Congress for $10 billion in additional funding for facilities, as well as liability protection from lawsuits filed by residents and their families.

According to the Associated Press, at least 15 states — Iowa not among them — have already enacted laws or imposed orders that provide nursing homes some level of protection from lawsuits tied to COVID-19.

The AHCA recently sent its members talking points and scripts to use when fielding questions from the media about COVID-19.  Among the public statements the nursing homes are encouraged to make:

“Resident safety is a top priority for (facility name). This virus is especially dangerous to our population —  older adults with underlying health conditions — so, this is a critical issue that requires our immediate attention. (Facility name) is in close contact with our local and state health departments, as well as the CDC, to stay up to date on the information to prevent and manage the spread of Coronavirus.”

The regulatory changes now in effect 

Not every type of health care facility is regulated by both the state and federal government, but for those that are, the regulations and their accompanying waivers often overlap, as seen in the list below.

Not all of these suspensions and waivers have been automatically granted to every facility. In some cases, health care providers have to request a waiver from the federal Center for Medicare and Medicaid Services or the state in order to take advantage of the regulatory rollback. Some of these waivers are considered retroactive to March 1 and will last through the end of the federal emergency declaration related to the pandemic.

Among the waivers that are already approved or available from the state of Iowa or the federal government:

Federal regulation of nursing homes

Assessments: CMS is waiving requirements for nursing homes to assess new residents within 30 days. After 30 days, new patients admitted to nursing homes with a mental illness or intellectual disability should be assessed as soon as the home is able.

Resident rooms: Areas not normally used as resident rooms — such as activity rooms, meeting rooms, conference rooms and dining rooms — can now be used as resident rooms as long as the residents are safe and comfortable.

Physician visits: CMS has waived the requirement for physicians to perform in-person visits for nursing home residents, allowing those visits to instead be conducted by telehealth (audio-video conferencing).

Physician tasks: CMS has waived the requirement that prevents a physician from delegating to others a task that a physician must perform. The waiver allows doctors to delegate tasks to a physician’s assistant, a nurse practitioner or a clinical nurse specialist.

State regulation of nursing homes

Background checks: The regulations requiring nursing facilities to complete a criminal history check prior to the employment of an individual are suspended. A facility may employ an individual once the criminal-history check is requested, even if it has yet to be completed.

Fines and penalties: Fines against nursing facilities are suspended to the extent that they may be imposed in suspension, with no payment required.

Use of nursing students: Regulations that say nursing students can administer medications in nursing facilities only after successful completion of a medication-aide course or exam are suspended. The facility must have training and supervision measures in place to ensure each student’s competency.

Nurse aide training: The state has suspended rules that say a nurse aide who has not completed the state-approved 75-hour nurse’s aide program must participate in a structured on-the-job training program of 20 hours’ duration. Aides may now complete a “comparable” training course or complete at least 20 hours of the state-approved 75-hour training program.

State regulation of assisted living programs

Background checks: Normally, assisted living centers must complete a criminal history check on prospective employees before the individuals report for work. Now, the state allows employment of individuals once a criminal history check is requested, even if it has yet to be completed.

Fines: Financial penalties for regulatory violations are now waived, but they may be issued in suspension, with no payment required.

Resident service plans: The regulations requiring facilities to formalize an up-to-date plan of services to meet each resident’s needs, and to do so within 30 days of admission, is suspended.

Medication: The rule requiring a person administering medications in an assisted living program to have passed a medication management course and test, is suspended.

Management and nursing: The regulations that require a new assisted living manager and nurse-manager to complete a management class or assisted-living nursing class within six months of their being hired is suspended.

Federal regulation of hospitals

EMTALA: The Emergency Medical Treatment and Labor Act requires hospitals to treat, or at least stabilize, patients before transferring them or denying them admission. CMS is waiving the enforcement section of that law, allowing hospitals, psychiatric hospitals, and critical access hospitals to screen patients at an off-site location.

Verbal medication orders: Regulations require that medication administration be based on a written, signed order, but hospitals can use verbal orders if the practitioner responsible for the patient authenticates the order in writing as soon as possible.

Death reporting: CMS had required that hospitals report instances of ICU patients dying of medical conditions while in soft wrist restraints. This rule is now being waived although any cases in which the restraints may have contributed to a patient death must still be reported.

Patient discharges: CMS is waiving the requirement that hospital patients discharged to a nursing home or referred for home health care have in their discharge plan a list of all the nursing services available to them. Hospitals are also relieved of the requirement that they disclose in the patient’s discharge plan any financial interest they have in the home health agency or nursing home to which the patient is being sent.

Hospital privileges: CMS will allow physicians whose privileges are expiring to continue practicing in the hospital and will allow new physicians to begin practicing before the hospital’s medical staff or governing body gives their approval.

Physician oversight: Medicare patients in hospitals will not be required to be under the care of a physician, allowing the hospitals to use other medical practitioners to oversee the individuals’ care.

Nursing: CMS is waiving the requirement that a hospital’s nursing staff develop and keep current a nursing care plan for each patient.

Respiratory care: CMS is waiving the requirement that hospitals designate in writing the personnel who are qualified to perform specific respiratory-care procedures and the amount of supervision required for them to carry out those procedures.

CAH doctors: CMS is waiving the requirement that critical access hospitals have a doctor of medicine or osteopathy physically present to provide medical direction, consultation, and supervision for the services provided in the hospital. However, a physician still must be available through direct radio or telephone communication, or electronic communication, for consultation and assistance.

State regulation of hospitals

Inspectors: The law that requires hospital inspectors to be free of conflicts of interest has been suspended.

Expired licenses: The state has suspended all rules that prohibit the practice of medicine and surgery, osteopathic medicine and surgery, nursing, respiratory care, and practice as a physician assistant, by a licensee whose license is inactive or lapsed. Suspension of these rules is limited to licenses that have lapsed or expired within the past five years and is further limited to the provision of medical and nursing care and treatment of victims of the pandemic.

Background checks: The regulations requiring a hospital to complete a criminal history check prior to employing an individual are suspended to the extent that an individual can be hired once a criminal history check is requested but not yet completed.

Nurses: Regulations that require the clear definition of authority, responsibility, and function of each nurse are suspended to the extent that there is evidence that each nurse is considered competent in the areas they are assigned.

Staffing levels: Regulations that require nursing service to have an “adequate” number of licensed registered nurses, licensed practical nurses, and other personnel to provide patient care are suspended although the hospital has to have made “all reasonable efforts” to maintain a sufficient level of staffing.

Equipment: Regulations requiring hospital equipment to be selected, maintained and utilized in accordance with the manufacturer’s specifications are suspended “to the extent it is not feasible to do so.”

Federal regulation of home health agencies

Assessments: CMS has extended the requirement that new patients be given a comprehensive assessment within five days. The new deadline for completion is 30 days.

On-site nurse visits:  CMS is waiving the requirement for a licensed nurse to conduct an on-site visit at least once every two weeks to determine whether the home health aides are providing quality care. The agency is also temporarily suspending the requirement for two weeks of supervision of aides by a registered nurse.

Federal regulation of hospices

Volunteers: CMS has waived the requirement that hospices use volunteers for at least 5% of all patient-care hours since it’s expected that the pandemic will reduce the availability of volunteers.

Assessments: The timeframe for updating the comprehensive assessments of patients has been extended from 15 days to 21 days.

Peripheral services: CMS is waiving the requirement for hospices to provide certain non-core services, such as physical therapy, occupational therapy and speech-language pathology.

Supervision: CMS is waiving the requirement for a licensed nurse to conduct an on-site supervisory visit every two weeks to determine whether aides are providing adequate care.

Training: The rule that required a hospice aide whose competency is being evaluated to be observed performing certain tasks with patients has been modified to allow hospices to use “pseudo patients” (people engaged in role-playing or a computer-driven mannequin) in lieu of actual patients. CMS is also waiving the requirement that hospices must assure that each aide receives 12 hours of in-service training in a 12-month period.

State regulation of intermediate care facilities for individuals with intellectual disabilities

Background checks: The regulations requiring  a facility to complete a criminal history check prior to employing an individual are suspended to the extent that an individual can be hired once a criminal history check is requested but not yet completed.

Financial penalties: All fines for regulatory violations at intermediate care facilities are waived, although fines may be issued in suspension with no requirement to pay.

State regulation of residential care facilities

Background checks: The requirement that residential care facilities complete a criminal history check prior to employment of an individual in a facility is suspended. A facility may employ an individual once a criminal-history check is requested, even if it’s not yet completed.

Fines and penalties: Fines for residential care facilities are waived, but may be imposed in suspension, requiring no payment.

Residents’ service plans: The rules requiring a residential care facility to update a resident’s service plan within 30 days of admission is suspended.

Staff health: The rules requiring a residential care facility employee have a physical examination within one year being hired is suspended, as is the requirement facilities   screen and test employees for tuberculosis.

Medication aides: The rules requiring all staffers who administer medication in a residential care facility to complete a state-approved medication-aide course and pass a state-approved medication-aide exam is suspended, although those staffers must successfully complete a state-approved medication manager course and pass a related exam.

Federal regulation of end-stage renal dialysis centers

Employee checks: The requirement for timely, periodic audits of the operators of critical water-dialysate equipment are waived “to allow for flexibilities,” according to CMS.

Equipment maintenance: CMS has waived the requirement for preventive maintenance of dialysis machines and ancillary dialysis equipment.

CPR certification: CMS has waived the requirement that dialysis facilities demonstrate the patient care staff have current CPR certification.

Patient assessments: CMS is waiving the requirement for an initial comprehensive assessment of new patients within 30 days or within their first 13 dialysis sessions.

Physician visits: CMS is waiving the requirement for a monthly in-person visit by a physician, nurse practitioner, clinical nurse specialist, or physician’s assistant at least monthly, but only if the patient is considered stable.

Staff certification: CMS normally requires that patient care technicians be certified for the job within 18 months of being hired. Citing the challenges that technicians are facing with the closure of testing sites, the agency is allowing individuals to work as patient care technicians even if they have not achieved certification within 18 months of being hired or met the requirements for certification renewal.

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