Does your Skilled Nursing Facility (SNF) or Nursing Facility (NF) have a compliance program in place? Has your organization developed quality assurance practices? Are performance improvement metrics integrated throughout your operations? If your SNF or NF does not have or is not utilizing these programs, you may find yourself in violation of the Affordable Care Act (ACA) in the very near future. Under Section 6102 of the ACA, each SNF and NF is required to develop a compliance and ethics program and participate in a quality assurance and performance improvement program. These programs are consistent with the goals of the ACA to promote accountability for patient care and to redesign care processes to ensure high quality and efficient service delivery. Each of these programs are discussed in more detail below.
Compliance and Ethics Programs
Compliance and ethics programs are important part of the ACA. Under the ACA, each Medicare and/or Medicaid certified nursing facility must have in operation a compliance and ethics program three years after the effective date of the act. As such, the deadline to implement a compliance and ethics program is March 23, 2013.
According to the ACA, the programs must be effective in preventing and detecting criminal, civil, and administrative violations and in promoting quality of care. To accomplish these goals, the ACA outlines eight components required for a compliance and ethics program:
1. The organization must have established compliance standards and procedures to be followed by its employees and other agents that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations.
2. Specific individuals within high-level personnel of the organization must have been assigned overall responsibility to oversee compliance with such standards and procedures and have sufficient resources and authority to assure such compliance.
3. The organization must have used due care not to delegate substantial discretionary authority to individuals whom the organization knew, or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations under the law.
4. The organization must have taken steps to communicate effectively its standards and procedures to all employees and other agents, such as by requiring participation in training programs or by disseminating publications that explain in a practical manner what is required.
5. The organization must have taken reasonable steps to achieve compliance with its standards, such as by utilizing monitoring and auditing systems reasonably designed to detect criminal, civil, and administrative violations under this Act by its employees and other agents and by having in place and publicizing a reporting system whereby employees and other agents could report violations by others within the organization without fear of retribution.
6. The standards must have been consistently enforced through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect an offense.
7. After an offense has been detected, the organization must have taken all reasonable steps to respond appropriately to the offense and to prevent further similar offenses, including repayment of any funds to which it was not entitled and any necessary modification to its program to prevent and detect criminal, civil, and administrative violations.
8. The organization must periodically undertake reassessment of its compliance program to identify changes necessary to reflect changes within the organization and its facilities.
Three years after the compliance programs are put into place, the United States Department of Health and Human Services (HHS) is required to evaluate the programs to determine the extent to which the programs have led to changes in deficiency citations and quality performance, and make a report to Congress.
The ACA required the Centers for Medicare and Medicaid Services (CMS) to issue regulations by March 23, 2012 related to nursing facility compliance plans. CMS did not meet this deadline. However, one should expect the regulations to be forthcoming given the Supreme Court’s recent decision upholding the constitutionality of the ACA. In the interim, the eight areas outlined above should be used by SNFs and NFs to structure compliance plans or modify existing compliance plans.
The requirements that will be imposed by the new regulations will likely vary with the size of the organization that operates the facility. The ACA states that:
Larger organizations should have a more formal program and include established written policies defining the standards and procedures to be followed by its employees. Such requirements may specifically apply to the corporate level management of multi-unit nursing home chains.
It should be noted that the Office of the Inspector General (OIG) has listed nursing facility compliance plans in its 2012 Work Plan. The 2012 Work Plan states:
We will review Medicare- and Medicaid-certified nursing homes’ implementation of compliance plans as part of their day-to-day operations and whether the plans contain elements identified in OIG’s compliance program guidance. We will assess whether CMS has incorporated compliance requirements into Requirements of Participation and oversees provider implementation of plans. Section 6102 of the Affordable Care Act requires nursing homes to operate a compliance and ethics program, containing at least 8 components, to prevent and detect criminal, civil, and administrative violations and promote quality of care. The Affordable Care Act requires CMS to issue regulations by 2012 and SNFs to have plans that meet such requirements on or after 2013.
The OIG has previously released compliance program guidance for nursing facilities. In the past, facilities may have viewed these OIG releases as optional. This is no longer the case. By putting nursing facility compliance plans in its 2012 Work Plan, the OIG appears to be prepared to enforce these guidance provisions. At a minimum a nursing facility’s compliance plan should meet the standards outlined in the OIG’s guidance releases.
Quality Assurance & Performance Improvement Programs
Section 6102 of the Affordable Care Act also requires HHS to establish and implement a quality assurance and performance improvement program (“QAPI program”) for facilities, including multi-unit chains of facilities. The ACA required that the regulations for the QAPI program be completed by December 31, 2011. Here too, it does not appear that CMS met this deadline. However, CMS’s webpage indicates that a national rollout of the QAPI program is set for summer 2012. Here, CMS will post early prototypes of some of the tools and resources it has been developing for the QAPI program. CMS states that this will be an opportunity for nursing facilities to try out these tools and provide feedback. The tools can be downloaded off of CMS’s website. Ultimately, it does not appear that the QAPI program will be fully operational this summer, as CMS is still in the testing and evaluation stage of the program. However, nursing facilities must be prepared to implement a QAPI program in the very near future. The five key elements discussed below should serve as a starting point to creating a QAPI program that will be compliant with the forthcoming federal regulations.
Under the ACA, the Secretary shall establish standards relating to quality assurance and performance improvement with respect to facilities and provide technical assistance to facilities on the development of best practices in order to meet such standards. As noted above, these regulations have not been completed. However, CMS has released guidance as to the five key elements of a QAPI. They are as follows:
1. Element 1: Design and Scope – A QAPI program must be ongoing and comprehensive, dealing with the full range of services offered by the facility, including the full range of departments. When fully implemented, the program should address clinical care, quality of life, resident choice, and care transitions. It aims for safety and high quality with all clinical interventions while emphasizing autonomy and choice in daily life for residents (or resident’s agents). It utilizes the best available evidence to define and measure goals. Nursing facilities will have in place a written QAPI plan adhering to these principles.
2. Element 2: Governance and Leadership – The governing body and/or administration of the nursing home develops and leads a QAPI program that involves leadership working with input from facility staff, as well as from residents and their families and/or representatives. The governing body assures the QAPI program is adequately resourced to conduct its work. This includes designating one or more persons to be accountable for QAPI; developing leadership and facility-wide training on QAPI; and ensuring staff time, equipment, and technical training as needed for QAPI. They are responsible for establishing policies to sustain the QAPI program despite changes in personnel and turnover. The governing body and executive leadership are also responsible for setting priorities for the QAPI program and building on the principles identified in the design and scope. The governing body and executive leadership are also responsible for setting expectations around safety, quality, rights, choice, and respect by balancing both a culture of safety and a culture of resident-centered rights and choice. The governing body ensures that while staff are held accountable, there exists an atmosphere in which staff are not punished for errors and do not fear retaliation for reporting quality concerns.
3. Element 3: Feedback, Data Systems and Monitoring – The facility puts in place systems to monitor care and services, drawing data from multiple sources. Feedback systems actively incorporate input from staff, residents, families, and others as appropriate. This element includes using Performance Indicators to monitor a wide range of care processes and outcomes, and reviewing findings against benchmarks and/or targets the facility has established for performance. It also includes tracking, investigating, and monitoring Adverse Events that must be investigated every time they occur, and action plans implemented to prevent recurrences.
4. Element 4: Performance Improvement Projects (PIPs) – The facility conducts Performance Improvement Projects (PIPs) to examine and improve care or services in areas that are identified as needing attention. A PIP project typically is a concentrated effort on a particular problem in one area of the facility or facility wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements. PIPs are selected in areas important and meaningful for the specific type and scope of services unique to each facility.
5. Element 5: Systematic Analysis and Systemic Action – The facility uses a systematic approach to determine when in-depth analysis is needed to fully understand the problem, its causes, and implications of a change. The facility uses a thorough and highly organized/ structured approach to determine whether and how identified problems may be caused or exacerbated by the way care and services are organized or delivered. Additionally, facilities will be expected to develop policies and procedures and demonstrate proficiency in the use of Root Cause Analysis. Systemic Actions look comprehensively across all involved systems to prevent future events and promote sustained improvement. This element includes a focus on continual learning and continuous improvement.
Not later than 1 year after the date on which the regulations are promulgated, a facility must submit to the Secretary a plan for the facility to meet such standards and implement such best practices, including how to coordinate the implementation of such plan with quality assessment and assurance activities conducted under sections 1819(b)(1)(B) and 1919(b)(1)(B), as applicable.
Ultimately, facilities should begin to create QAPI programs that are consistent with the elements released by CMS in advance of the federal regulations. Facilities should also consider downloading the prototype programs released by CMS this summer so that they are familiar with the direction CMS is taking and can prepare to be ahead of the curve.
Under the ACA, the regulatory environment for Skilled Nursing Facilities and Nursing Facilities has drastically changed. These changes will likely impact facilities’ policies, operations and management practices. Therefore, it is important that facilities take the appropriate steps to be ready for upcoming changes in the law under the ACA. In addition, facilities should currently have procedures in place consistent with the OIG’s guidance on compliance programs. Facilities should consult with experienced health care and business counsel in order to develop compliance, ethics, quality assurance and performance improvement programs.
© 2012 Michael P. James, J.D., M.B.A., CSSGB
To find out more about the changing regulatory environment for nursing facilities, contact attorney Michael James at firstname.lastname@example.org, 810-936-4040 or www.michaeljameslaw.com. Michael James provides representation and counseling related to all facets of business enterprise and healthcare matters.