The overall goal of regulatory enforcement is to ensure facilities are compliant with regulatory requirements. When promoting quality care is also the goal of the enforcement agency, then regulatory requirements and enforcement sanctions should be designed to influence the improvement of quality care instead of focusing on the liability of the provider. Federal nursing home enforcement actions do not improve or influence the sustained quality of care in nursing homes. This is evidenced by the fact that several citation categories have remained in the top ten list for over twenty years, and some categories have shown a steady increase over time. Contributing factors to lack of improvement include the oversight process is not consistent or designed around a quality improvement framework, enforcement remedies are not tied to the promotion of quality care, and the design and alignment between the Centers for Medicare and Medicaid Services (CMS) regulations and conceptualization is inconsistent. 

The World Health Organization (WHO) identifies quality of care as the extent to which the services provided to individuals improves the desired health outcomes (2019). Federal nursing home regulations do not define quality care. Instead, the regulations prescribe that a “facility must ensure residents receive treatment and care in accordance with standards of practice, the care plan, and resident choice” (42 CFR § 483.25). Quality improvement is a deliberate and goal oriented process that uses measures to identify change. The measurement of quality is accomplished by using a framework of structural, process, and outcome measures (AHRQ, 2015).  Measures are used to ascertain whether changes are actually improvements. The nursing home quality measures used by CMS are derived from the Minimum Data Set (MDS) and self reported data which facilities are required to submit to CMS. CMS describes the purpose of their quality measures as the provision of information for the public to use in choosing or assessing the care in a nursing home, and for facility quality improvement efforts (CMS, 2019). CMS uses the quality measures to develop the 5 star rating system for facilities and in the selection of residents for review during the certification survey. The measures are designed to meet the clinical assessment domain requirements of the IMPACT Act of 2014. Current measures include changes in skin integrity, falls with injury, and drug regimen review. The data used to calculate these measures is self reported by the facility in the MDS. CMS describes the inclusion of IMPACT Act requirements as helpful in meeting the requirements of the Meaningful Measures initiative which helps identify priorities for quality improvement (CMS, 2018). Although offered as a measure of quality to the public, CMS asserts that their measures are not benchmarks, guidelines or standards of care and represent global measures that are not representative of the care any one individual will receive (CMS, 2019). The Institute for Healthcare Improvement (IHI) argues that measures are used differently for quality improvement than they are for research and should not be confused (IHI, 2019).  Measurement in research is used to discover new knowledge and spans a long duration of time, while measurement in quality improvement is used to add knowledge to practice over a short period of time (IHI, 2019). Because CMS data is being collected and tied to quality measures over time, it is in the research domain. In order to be used in a quality improvement domain, data would need to be tied to measures and used to change practice at the facility level. While CMS makes the data available to facilities for quality improvement, CMS does not use the data to direct enforcement. In 2016, CMS revised the nursing home regulations to require a facility to develop a quality assurance and performance improvement program that is data driven and focused on systems of care, outcomes of care, and added a new compliance and ethics program requirement (42 CFR § 483.85, 2017). While federal regulations have incorporated quality improvement requirements at the individual facility level, the framework of oversight and enforcement does not align with quality improvement theory. Enforcement actions are not based on consistent measures and are not used to sustain change over time. Rather, they are used as a quick response to the identification of negative change at the facility level.

Nursing homes are licensed through the state and certified for Medicare and Medicaid by the federal government. The state serves as the agent of CMS in federal oversight and enforcement duties related to certification. This dual relationship can create confusion and duplicate enforcement remedies if a facility is sanctioned by both the state and CMS. States are given considerable discretion by CMS when selecting enforcement remedies and the calculation of civil monetary penalties which can lead to inconsistency within and across states. CMS defines substantial compliance with the regulations as the level of compliance with requirements of participation where any identified deficiencies pose only minimal harm, and noncompliance being any deficiency that prevents substantial compliance (42 CFR § 488.301). CMS does not define minimal harm, which leaves the interpretation by the individual surveyor inconsistent and potentially arbitrary. When non-compliance is identified, citations are assigned a rating of “A” to “L”,  based on the scope and severity of harm associated with the deficient practice. A rating of “D” is isolated and associated with no actual harm but with potential for more than minimal harm. At a rating of “G”, physical or emotional harm has already occurred for one patient. In 2018, there were over 130,000 total citations, with 61% cited at a “D” level and 3% cited at a “G” level (QCOR, 2019). From a global perspective, this citation data indicates that noncompliance with the regulation resulted in no harm to a resident, but resulted in a situation that could potentially cause harm if not corrected. Facilities are required to submit a plan of correction in response to a citation. In addition, CMS provides eleven federal remedies which the state agency may impose for non-compliance, including temporary management, denial of payments, civil monetary penalties, transfer of residents, directed plan of correction, directed training, or other remedies approved by CMS (42 CFR §488.406). These enforcement remedies can be categorized based on the underlying intent of the enforcement action as oversight, punitive, or educational. Some remedies may serve more than one category. Examples of an oversight remedy would be temporary management or state monitoring. A punitive remedy is intended to inflict punishment and includes civil monetary penalties and the denial of payment for new admissions. Educational remedies include directed in-service training or other remedies that may be approved by CMS. 

Walshe argues that the impact of regulatory oversight on quality of care is difficult to research due to the absence of a control group, the constant changes in the regulatory process, and unreliable data (2001). In addition, CMS is not transparent in it’s oversight activities of state agencies or state agency performance. The State Operations Manual(SOM) states that CMS is responsible for evaluating the performance of state agency operations, providing assistance to state agencies in developing their capabilities and providing feedback (SOM, 1006). 

CMS performs these functions through the State Performance Standards System (SPSS). The SPSS assesses state performance based on a framework of frequency, quality, and enforcement. The measures include the timeliness of the state agency in imposing the mandatory DPNA remedy, the enforcement of termination related to immediate jeopardy, and the surveying of special focus facilities (CMS, 2017). None of these measures can be directly linked to the quality of care at the facility, state, regional or national level. In addition, CMS does not publicize data on how states perform over time. These concerns are supported by recent government accountability studies. The U.S. Government Accountability Office (GAO) found that CMS has been lax in their oversight duties of states. In 2019, GAO found that the state of Oregon did not follow federal requirements for the oversight and investigation of abuse for at least 15 years. They also found that CMS has not ensured that all states are in compliance with the federal requirements related to the oversight and investigation of abuse (GAO, 2019). An analysis by the Office of Inspector General (OIG) also found that CMS data did not clearly show whether quality of care improved with an increase in deficiencies over time (OIG, 2019). The OIG also found that CMS was not ensuring that state agencies verified facility compliance with their plan of correction. Rather, some states were accepting the plan of correction as the proof of compliance without further evidence (OIG, 2019).

CMS policy and the conceptualization of the oversight and enforcement process is inconsistent and not fully defined. CMS defines one of their roles in the implementation of the Social Security Act is to “promote efficiency and quality within the total healthcare delivery system” (CMS, 2004). This goal is not supported by CMS’s conflicting stance regarding their own quality measures. The promotion of quality should include a quality improvement framework and measures that can actually be used to improve quality within the entire healthcare system. The lack of a definition of quality prohibits CMS from promoting quality care within the healthcare system. In addition, the lack of alignment between quality measures and enforcement actions does not influence quality improvement. Changes in the quality of care must be able to be measured and influenced in order to be changed, and CMS enforcement remedies have not been designed to influence quality measures or care. CMS describes the Meaningful Measures initiative as helpful to clinicians and providers by allowing them to focus on improving quality of care (CMS, 2018). However, enforcement actions do not consider the measures or their impact. When viewed as a measure, citations can help illustrate the changes in care and practice over time. The top ten citations for 1998 included food sanitation, accident prevention, quality of care, pressure sores, accident hazards, dignity, restraints, housekeeping, care plans and dignity (IOM, 2001). Twenty years later, accident hazards, care plans, food sanitation, and pressure injuries are still in the top ten citations issued (QCOR, 2018). Accident hazards and infection control were the top two citation categories from 2016 to 2018 (QCOR, 2019). Within this same time frame, citations for food sanitation, drug storage, care planning, quality of care and the use of unnecessary drugs remained in the top ten most frequently cited category (QCOR, 2019). Of additional concern is the fact that accident hazards rose from 14.7% of citations in 1998 to 30.4% in 2018 (IOM, QCOR). This steady increase in accident hazards, and the consistency in the top ten categories over the past twenty years illustrate that enforcement remedies have not influenced or improved the quality of care. In order to promote quality care at the facility level, CMS enforcement remedies should support or influence the facility in their efforts to improve a quality measure. As an enforcement remedy, civil monetary penalties serve as a punitive action and do not positively support or influence the resources or processes a facility uses to achieve an outcome. Arguably, restricting funding negatively affects a facility by decreasing its access to resources needed to facilitate care processes. In addition to federal civil monetary penalties, the state may also collect a civil monetary penalty for a citation which can be viewed as excessively punitive. The denial of payment for new admissions (DPNA) does not prohibit a facility from accepting new patients, it only restricts the funding they receive. As an enforcement remedy, a DPNA is intended to affect the facility but in reality it negatively affects the residents. Adequate funding is an essential resource for the provision of safe, quality care. Arguably, CMS and the state may be liable for any inadequate provisions of care during or following a punitive enforcement remedy by allowing a facility to accept responsibility for the provision of care while deliberately withholding or reducing adequate financial resources. Under the Federal Tort Claims Act (FTCA), civil suits can be brought against government entities or agencies who have caused personal injury in the scope of their work. In addition, the enforcement remedies used by CMS are not based on a quality improvement framework or just culture that benefits facilities and residents. This is evidenced by the fact that CMS favors timeliness over sustainability and effectiveness when enforcing noncompliance. According to CMS, the purpose of a remedy is to “address a facility responsibility to promptly achieve, sustain and maintain compliance” and the appropriate remedy should be chosen to achieve compliance quickly (2018). However, a facility is only given 10 days to submit a plan of correction in response to a citation. Without a meaningful analysis of the process and structure leading to the outcome of noncompliance, the facility will not be able to achieve sustainable improvement in the quality of care provided. Unless a remedy is designed to address the root cause of noncompliance, it will be ineffective and potentially viewed as punitive. In a just culture, errors are acknowledged to be an inherent part of humanity and systems and only punished when they are reckless or malicious. Boysen points out that a just culture improves patient safety by empowering employees to monitor and report on system failures (2013). Employees who fear retaliation or punishment are hesitant to speak up regarding failures and areas for improvement. A punitive enforcement culture does not empower people or systems to improve a process, it only forces them to endure a punishment. Because the outcome of the survey process is an acceptable plan of correction and not a demonstrated improvement in quality care, facilities are unable to create meaningful and sustainable change.  This is evidenced when reviewing repeat deficiencies and their associated enforcement remedies. A review of facility level citation data from 2017 reveals that Pennsylvania had 27 facilities which were classified as “double G” indicating they had repeat harm deficiencies within the same survey cycle. One facility had five citations related to pressure injuries and was fined $120,000 in civil monetary penalties. The enforcement did not influence the facility to sustain meaningful change and they were cited for a harm citation for pressure injuries again the following year (QCOR, 2019). 

The Social Security Act prohibits any “supervision or control over the practice of medicine, medical services, or the administration and operation of a provider” by the federal government (42 U.S.C.1395 § 1801). The prohibition restricts the CMS’s direct involvement in the provision of care, but permits oversight of the outcome of care. Regulatory oversight can be viewed from both a compliance and a deterrence perspective. A deterrence perspective assumes that an entity is attempting to break rules and therefore a punitive and sanction oriented approach is used while a compliance perspective assumes that an entity is trying to comply with regulations and therefore a supportive and developmental approach is used (Walshe, 2001). Walshe argues that an adaptive, or responsive approach which combines the compliance with the deterrence perspective is the most beneficial (2001). Currently the enforcement framework is implemented mostly from a deterrence approach. In 2018, there were 3,993 federal enforcement actions with 90% being a civil monetary penalty or denial of payment for new admissions while only 10% of were directed at monitoring or educational approaches (QCOR, 2019). The deterrence approach alone does not support an effective compliance program. In order to create an ideal balance between the compliance and deterrence approach to oversight, more supportive efforts such as education, transparent feedback and oversight processes, and long term corrective action goals must be incorporated. Currently, the facility decides in its plan of correction how long it will take to achieve compliance. A more effective compliance approach requires the addition of long term monitoring similar to the Corporate Integrity Agreements(CIA) used by the OIG. Long term monitoring and reporting requirements such as those used in the CIA require a facility to commit periodic monitoring and a focus on actual care improvement instead of meeting the short term enforcement requirement. 

In addition to the inconsistencies across states, CMS is also inconsistent in the conceptualization of all its policies and services. Medicare coverage of skilled nursing services is not dependent on whether a patient’s underlying condition is likely to improve. Rather, coverage is based only on whether a patient requires the assistance or supervision of a skilled professional for maintenance. In 2010, The US District Court in Pennsylvania ruled that CMS denied coverage based solely on a beneficiaries’ restoration potential instead of on the beneficiaries’ need for ongoing rehabilitative maintenance therapy (Papciak, 742 F.Supp.2d 765). In 2013, the US District Court in Vermont ruled that claim determinations for the coverage of skilled care do not require an improvement standard and therefore Medicare coverage cannot be denied based on a beneficiaries recovery potential. (Jimmo, WL 5104355). For payment purposes, the expectation that services must improve a condition does not exist. Without an improvement standard and definition of quality, it is difficult to promote quality of care at the citation level under a quality improvement framework. The lack of an improvement standard for payment purposes also creates an dilemma for enforcement methods. Arguably, if payments are being made regardless of improvements in function, then enforcement remedies should be limited to deliberate non-compliance with the regulation. Discerning between non-preventable natural declines in function and preventable decline requires the use of adequate measures.

The framework of the regulatory oversight process and theory needs to change in order to provide meaningful congruence between enforcement remedies and quality of care improvements. The identification of a potentially harmful situation is the ideal starting point for a quality improvement project. While the majority of deficiencies resulted in no harm, enforcement remedies continue to focus on restricting funding instead of improving care and processes. These punitive enforcements affect not only the facility, but also the residents who CMS and the states are paying for. Punitive civil monetary penalties, a deterrence approach, and inconsistencies at the state and federal level contribute to a lack of meaningful and sustained improvement ability at the facility level. The dual role of CMS as both payer and enforcer must be congruent in order to prevent concerns related to liability.

References

Agency for Healthcare Research & Quality (2018). Six Domains of Healthcare Quality. Retrieved from https://www.ahrq.gov/talkingquality/measures/six-domains.html

Appendix PP: Guidance to Surveyors for Long Term Care Facilities, 42 CFR §483.25 (2018)

Boysen, P.G. (2013) Just Culture: A foundation for balanced accountability and patient safety. The Ochsner Journal, 13(3): 400–406. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3776518/

Centers for Medicare and Medicaid Services (2019). Quality Measures. Retrieved from https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/NHQIQualityMeasures.html

Centers for Medicare and Medicaid Services (2018). State Operations Manual(SOM): Chapter 1-Program Background and Responsibilities, 1006. Retrieved from https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c01.pdf

Centers for Medicare and Medicaid Services (2018). Meaningful Measures Hub. Retrieved from https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html

Centers for Medicare and Medicaid Services (CMS) (2017). Fiscal Year 2018 State Performance Standards System Guidance. Retrieved from https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Admin-Info-Letter-18-02.pdf

Centers for Medicare and Medicaid Services (2018). State Operations Manual: Chapter 7-Survey and Enforcement Process for Skilled Nursing Facilities. Retrieved from https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107c07.pdf

Institute for Healthcare Improvement (2019). Science of Improvement: Establishing Measures. Retrieved from http://www.ihi.org/resources/Pages/HowtoImprove/ScienceofImprovementEstablishingMeasures.aspx

Institute of Medicine (IOM) (2001). Improving the Quality of Long-Term Care. National Academy Press, Washington D.C.

Jimmo v. Sebelius, WL 5104355, No. 5:11–cv–17 (U.S. Dist. Ct., D. Vt., Oct. 25, 2011)

Kievet, P.J., Oomes, J., Schoorl, M. & Bartels, P. (2018). The missing link: Toward an assessment of innovation capacity in health care organizations. International Journal of Quality Innovation, 4:3. Retrieved from https://link.springer.com/article/10.1186/s40887-018-0023-3#citeas

Office of Inspector General (OIG). (2019) Trends in deficiencies at nursing homes show that improvements are needed to ensure the health and safety of residents. Retrieved from https://oig.hhs.gov/oas/reports/region9/91802010.asp

Papciak v. Sebelius, 742 F.Supp.2d 765, No. 09-1354 (U.S. Dist. Ct., W.D. Pa., Sept. 28, 2010).

Quality Certification & Oversight Reports (QCOR): Nursing Home Provider Deficiency Count Report Calendar Year 2019 (2019). Retrieved from https://qcor.cms.gov/report_select.jsp?which=0

Quality Certification & Oversight Reports. (2018). Citation Frequency Report. Retrieved from https://qcor.cms.gov/report_select.jsp?which+0

Quality Certification & Oversight Reports (QCOR): Nursing Home Provider Citation Frequency Report Calendar Year 2016 -2019 (2019). Retrieved from https://qcor.cms.gov/report_select.jsp?which=0

Quality Certification & Oversight Reports (QCOR): Nursing Home Provider Deficiency Count Report Calendar Year 2019 (2019). Retrieved from https://qcor.cms.gov/report_select.jsp?which=0

Title XVIII: Health insurance for the aged and disabled. Prohibition against any federal interference, 42 U.S.C. 1395 § 1801 (1965). 

State Operations Manual: Appendix PP-Guidance to Surveyors for Long Term Care Facilities, 42 CFR § 483.25 (2017). 

State Operations Manual: Appendix PP-Guidance to Surveyors for Long Term Care Facilities, 42 CFR § 483.85 (2017).

Survey, Certification and Enforcement Procedures, 42 CFR § 488.406 (1995). 

Survey, Certification and Enforcement Procedures: Definitions, 42 CFR § 488.301 (1995). 

U.S. Government Accountability Office(GAO). (2019) CMS needs to address gaps in federal oversight of nursing home abuse investigations that persisted in Oregon for at least 15 years. GAO-19-313R. Retrieved from https://www.gao.gov/products/GAO-19-313R

Walshe, K. (2001). Regulating U.S. Nursing Homes: Are We Learning From Experience? Health Affairs, 26(6). Retrieved from https://www.healthaffairs.org/doi/full/10.1377/hlthaff.20.6.128

Walshe, K. & Harrington, C. (2002). Regulation of Nursing Facilities in the United States: An Analysis of Resources and Performance of State Survey Agencies. The Gerontologist, 42(4): 475-487. Retrieved from https://academic.oup.com/gerontologist/article/42/4/475/686614

World Health Organization (WHO). (2019) What is Quality of Care and why is it important? Retrieved from https://www.who.int/maternal_child_adolescent/topics/quality-of-care/definition/en/