The Balance of Prescriptive and Dynamic Regulatory Policies in Nursing Homes: Lessons learned from the COVID-19 pandemic (2024)

History of NH Regulations

In 1987 the Omnibus Reconciliation Act (OBRA 87) established sweeping reform to regulations that govern NH healthcare services. This included establishing federal standards that NHs must follow in order to receive CMS funding, including minimum nursing coverage and periodic medical assessments. States may add more stringent regulations; however, states cannot remove federal regulations. As a result, NHs are one of the most highly regulated industries in the U.S., second only to nuclear energy.

OBRA 87 achieved some of its goals, including reductions in the use of urinary catheters and physical restraints in many facilities.¹ OBRA 87 also espoused the creation of a standardized resident assessment system, the Minimum Data Set, which remains an integral data source for measuring quality in NHs. Yet even before the pandemic, many NHs struggled to meet key quality metrics.

Regulatory Challenges during the Pandemic

From the onset of the pandemic, regulations to manage COVID-19 outbreaks in NHs were directed by multiple authorities, including the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration, local and state Departments of Public Health (DPH), as well as institutional policies. COVID-19 testing strategies rapidly evolved, and at times, policies were at odds with each other. For example, beginning in July 2020 the federal government distributed SARS-CoV-2 antigen testing kits to facilities across the country, yet in Massachusetts and other states, DPH required Polymerase Chain Reaction (PCR) tests for screening residents until April 2021.² As a result, many NHs continued using PCR tests for resident screening: by late September 2020, approximately one-third of facilities reported turn-around time for resident testing was more than two-days.³ In addition to conflicting guidance on testing strategies, NHs received conflicting guidance on visitation policies, use of PPE, and staff vaccination.

Another implementation challenge was that COVID-19 regulations were often at odds with other regulations to uphold patient-centered outcomes. For example, in many states, DPH has standards for NHs to provide a “program of activities and recreation suited to meet the interests of and support the physical, mental and psychosocial well-being of each resident…”;⁴ however, infected and exposed residents were required to quarantine in their rooms, resulting in accelerated functional decline, weight loss, and falls. Visitation was curtailed during the early pandemic, further isolating residents and hastening decline. While Massachusetts was early to resume social visits,⁵ visitation continued to be highly regulated.

A third barrier to implementing regulations during the pandemic were regulations too difficult for all NHs to achieve. As an example, small, rural facilities may not be able to identify or support an onsite infection-preventionist, forcing them to close. A recent report from the American Health Care Association found an alarming rise in NH closures, with small facilities disproportionately affected.⁶

Finally, there was little flexibility in enforcement of regulations during the early pandemic, and in fact, enforcement appeared punitive. After the first NH COVID-19 outbreak at Life Care Center in Kirkland, Washington, CMS fined the organization $600,000 citing a failure to implement infection control policies.⁷ While this fine was appealed and ultimately adjusted, the punitive trends continued as more than 3,400 facilities were fined for regulatory violations in the first six-months of the pandemic.⁸ This occurred despite very strong evidence that COVID-19 outbreaks in NHs were related to the size and location of the facility and not a consequence of bad care.⁹

Prescriptive versus Dynamic Regulations

Since OBRA 87, NH regulations tend to be static and prescriptive rather than dynamic and flexible. Early in the pandemic, there was rapid growth of knowledge about COVID-19 resulting in a series of relatively rigid regulations that were sometimes conflicting. Because these recommendations offered little flexibility, they required frequent modifications: in Massachusetts DPH regulations on COVID-19 testing in NHs changed ten times between March 2020 and July 2022. Further, COVID-19 regulations remained at odds with other, prescriptive regulations. For example, to promote safety from intruders, DPH forbids opening windows on a NH’s first four floors unless screens have been installed.¹⁰ During the pandemic this regulation had the unintended consequence of prohibiting facilities from opening windows when a resident tested positive for COVID-19 and could not isolate from their roommate. In addition to creating internal confusion, these prescriptive and rapidly changing regulations contributed to an erosion of trust between NHs and key regulatory agencies.

Some prescriptive COVID-19 regulations were met with success. Firm COVID-19 vaccine mandates increased staff vaccination rates with modest impacts on staff turnover;¹¹ whereas, flexible vaccine regulations with a test-out option had little impact on staff vaccination rates and outbreaks.¹²

There have also been examples of dynamic regulations introduced during the pandemic, notably allowing providers to use telemedicine for NH patient care visits when PPE was in short supply. Additionally, CMS waived the three-night hospital stay requirement for post-acute care when many hospitals were exceeding capacity.

How then should regulatory agencies decide on whether to enact prescriptive versus dynamic regulations to improve care in NHs? First, prescriptive regulations are appropriate when there is strong evidence to support the regulation and little risk for future modification. In the case of staff vaccine mandates, CMS did not announce a firm mandate until Fall 2021, after there was sufficient evidence to support the safety and effectiveness of the vaccines in this setting.¹³ Second, prescriptive regulations are fitting if they are designed to improve care in all NH facilities rather than target low performing facilities. Very few facilities met the target staff vaccination rate,¹⁴ and so most facilities benefitted from a prescriptive regulation. In contrast, there is tremendous variation in psychotropic medication use across NHs.¹⁵ Prescriptive regulations for psychotropic use may burden high performing facilities without adequately changing practice in low performing facilities. Third, regulations should avoid being prescriptive if they could have negative consequences on other patient-centered outcomes. For example, injurious falls are strongly associated with mobility in NH residents.¹⁶ An unintended consequence of an inflexible regulation to reduce injurious falls could be increased functional decline and dependency. Regulations regarding medications run the same risk: excluding benzodiazepines from the Medicare Part D benefit increased prescribing of other sedative prescriptions.¹⁷ More recently, regulatory efforts to discourage other sedatives resulted in increased trazodone prescriptions.¹⁸ The goal should be to reduce the adverse effects of all sedating medications, not to regulate which ones are used for the treatment of life-altering anxiety. Finally, prescriptive regulations must come with resources. Without resources, prescriptive value-based payment models will exacerbate health inequities as low performing facilities care for the most disadvantaged patients.¹⁹ Without resources, struggling NHs will continue to struggle or will close.

While practice standards are helpful in achieving high quality healthcare, there must also be some flexibility, especially since local resources affect implementation. NH workers are highly diverse with respect to age, race/ethnicity, education, and vocational training²⁰. Each facility has a unique case-mix of patients, staff experience, and physical architecture. Flexible regulations promote creative problem solving that is key to achieving the best possible outcomes; for example, the behavioral management and protection of residents with dementia when quarantine is not possible. Increasingly COVID-19 regulations recognized the need for flexibility: in September 2022, the CDC announced that screening asymptomatic NH workers is at the discretion of the facility.

Implications for Practice and Policy

The COVID-19 pandemic exposed long-standing weaknesses of U.S. NHs. The National Academies of Science, Engineering and Medicine (NASEM) Report to Improve NH Quality summarizes these weaknesses and outlines recommendations moving forward.²¹ Subsequently, members of this committee have published a series of articles which describe key aspects of the report,^19,22–25 as well as important gaps that the report did not address,^26,27 such as whether post-acute care and long-term care services can be successfully integrated. While no single intervention will fix these problems, there is strong consensus that we must begin with a series of financial and regulatory reforms. We applaud the NASEM committee recommendation that new federal and state regulations should prioritize patient-centered outcomes. We believe this may be best achieved by setting clear goals for facilities to achieve. When deciding between a prescriptive versus dynamic regulation to achieve a goal, authorities should consider the strength of evidence, the number of facilities that stand to benefit, any unintended consequences of the regulation, and resources available for implementation. When these conditions are not met, regulations should allow for some flexibility so that facilities can leverage their unique resources. Ensuring these changes will have a positive impact on the quality of care in NHs that endures far beyond the COVID-19 pandemic.

Acknowledgements

Funding: This work was supported, in part, by the National Institutes of Health’s National Institute on Aging, U54 AG063546.

Sponsor’s Role: The sponsor (NIA) had no role in the preparation of this manuscript.

Footnotes

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