Regulatory and Accreditation PDF

# Section 3: Regulatory and Accreditation ## Luc R. Pelletier and Christy L. Beaudin ### Section Contents * Introduction * Laws and Regulations * Federal laws * Federal rules and regulations * Federal agencies * Federal role in quality * Federal resources...

# Section 3: Regulatory and Accreditation ## Luc R. Pelletier and Christy L. Beaudin ### Section Contents * Introduction * Laws and Regulations * Federal laws * Federal rules and regulations * Federal agencies * Federal role in quality * Federal resources * State laws and regulations * Private quasi-regulators * Accreditation, Certification, and Recognition * Value of accreditation * External credibility * Improved quality * Organizational learning * Staff effectiveness * Reduced costs * Accreditation, Certification, and Recognition Programs * Association for the Advancement of Blood & Biotherapies * Accreditation Association for Ambulatory Health Care * Accreditation Commission for Health Care * American College of Radiology * American College of Surgeons * College of American Pathologists * Commission of Office Laboratory Accreditation * CARF International * Community Health Accreditation Partner * DNV Healthcare * The Joint Commission * National Association of Boards of Pharmacy * National Committee for Quality Assurance * National Dialysis Accreditation Commission * The Compliance Team * URAC * Accreditation and Certification Terms and Concepts * Requirements * Standards * Standards compliance * Application * Costs * Performance Measures * Reportable Events * Continuous Readiness * Leadership Commitment * Management Accountability. * Compliance Oversight * Continuous Survey Readiness * Organizational Assessment * Survey Readiness Oversight * Technology, Tools, and Strategies * Checklists * Work plans * Tracers * Staff Education * Leading the Survey Process * Survey Duration * Surveyors * Survey exit conferences * Postsurvey activities * Summary * References * Suggested Readings * Online Resources ## Introduction Compliance with laws, regulations, and accreditation standards is vital to the success of any organization. And a vital role of the healthcare quality professional is advising on myriad requirements and helping their organization attain and sustain compliance. This includes ensuring an infrastructure for safety, quality, and performance improvement programs supports continuous readiness and understanding the nuances of regulations or standards applicable to the healthcare setting. This section will address how to * promote awareness of local and national statutory and regulatory requirements within the organization; * develop, deploy, and support processes for evaluating, monitoring, and improving compliance with state and federal requirements; * evaluate appropriate accreditation, certification, and recognition options; and * maintain survey or accreditation readiness. Through leadership commitment, individual accountability, organizational assessment, and robust survey procedures, the healthcare quality professional can promote the adoption and/or adherence to approaches to meet and exceed locally and nationally recognized regulatory and accreditation quality and safety standards. ## Laws and Regulations There are differences between laws and regulations and how they impact the work of the healthcare quality professional. ### Federal Laws These are bills passed by both houses of Congress and signed by the U.S. president, passed over the president's veto, or allowed to become law without the president's signature. Individual laws, also called Acts, are arranged by subject in the United States Code. Regulations are rules made by executive departments and agencies and are arranged by subject in the Code of Federal Regulations (CFR). ### Federal rules and regulations The CFR is a codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government. The Federal Register is published every business day by the National Archives and Records Administration. It contains federal agency regulations; proposed rules and notices; and executive orders, proclamations, and other presidential documents. ### State-specific laws and regulations There are healthcare laws and regulations that govern healthcare practices at the state level. Typically, state laws and regulations supersede federal laws and regulations if more stringent including licensure, privacy of medical records, durable power of attorney, certificate of need, and mandated healthcare coverage. ### Quasi-regulatory Accreditation agencies are differentiated from federal and state regulatory and lawmaking entities but are recognized as quasi-regulatory. Accreditation "sets standards that are considered optimal and achievable, more rigorous than the minimum standards of licensure, and with a stated intent to foster a culture of improvement." Accreditation may be considered voluntary but is frequently required to participate in third-party payer programs such as Medicare, Medicaid, and health plans. For example, The Joint Commission (TJC) enforces standards that meet the federal conditions of participation. "Deeming" authority is granted to TJC by the Centers for Medicare & Medicaid Services (CMS). If the healthcare organization receives "deemed status" after being surveyed by TJC, it would not be subject to the Medicare survey and certification process. Laws, regulations, and accreditation/certification standards are dynamic and ever changing. This requires organizations to maintain an infrastructure and dedicated resources to sustain performance and ensure compliance, which is important for maintaining an organization's public reputation for providing safe, effective, reliable, and person-centered care. Healthcare is not a unique industry in this regard; other industries are also highly regulated (e.g., the airline industry). Like these other industries, there is an opportunity for staff to have specialized knowledge and skill sets focusing on regulatory and accreditation compliance. Titles of these professionals may vary, but large organizations often have personnel titles or department names, such as standards and compliance, regulatory affairs, accreditation and regulatory readiness, or licensing. Other organizations might use an integrated approach in which the quality or administration departments and operational leaders assume these responsibilities. Alternatively, organizations may outsource or purchase consultation services in this area. Healthcare quality professionals are responsible for supporting the organization in ensuring ongoing compliance with laws and regulations pertaining to business operations. This includes working with federal, state, and/or local regulatory agencies on specific requirements for relevant business lines. For example, requirements for an outpatient medical practice are different from those for an outpatient ambulatory surgery center, a critical access hospital, a comprehensive medical rehabilitation hospital, a hospice organization, or a freestanding acute psychiatric hospital. General acute care hospitals have different requirements than medical homes, disease management programs, home infusion therapy providers, or accountable care organizations. ## Federal Laws and Regulations The healthcare industry is regulated by all levels of government - federal, state, and local - presenting challenges for healthcare organizations and quality professionals, such as being confident that they possess an understanding of regulatory requirements. A simple Internet search on "healthcare regulation" yields about 420 million citations - an overwhelming place to start. Healthcare regulations create circumstances in which healthcare quality professionals spend inordinate amounts of time responding to changing rules concurrently with demonstrating compliance with complex existing rules. For example, according to the American Hospital Association, health systems, hospitals, and post-acute providers must comply with 629 discrete regulatory requirements across nine domains: 1. Quality reporting 2. New models of care/value-based payment models 3. Meaningful use of medical records 4. Hospital conditions of participation 5. Program Integrity 6. Fraud and Abuse 7. Privacy and Security 8. Post-acute care 9. Billing and coverage verification requirements Further, providers spend nearly $39 billion per year solely on administrative activities related to regulatory compliance; this amounts to 59 full-time employees dedicated to regulatory compliance for an average size hospital. In a dynamic marketplace, organizations are driven to expand and refine the services offered to meet the needs of the community. This creates an ongoing need for healthcare quality professionals to research and interpret regulations that are applicable to the organization's new or unique situation. Although there are federal laws and regulations significantly impacting healthcare organizations, healthcare quality professionals will want to become familiar with the following foundational federal laws and regulations: * **Emergency Medical Treatment and Active Labor Act (EMTALA)** EMTALA was enacted by Congress in 1986 as part of the Consolidated Omnibus Budget Reconciliation Act of 1985. Referred to as the "anti-dumping" law, it was designed to prevent hospitals from transferring uninsured or Medicaid patients to public hospitals without, at a minimum, providing a medical screening examination to ensure they were stable for transfer. Any hospital participating in Medicare and offering emergency services must provide a medical screening examination when a request is made for examination or treatment for an emergency medical condition, including active labor, regardless of an individual's ability to pay. The hospital is then required to provide stabilizing treatment for patients with emergency medical conditions. If a hospital is unable to stabilize a patient within its capability, or if the patient requests, an appropriate transfer should be implemented. * **Clinical Laboratory Improvement Amendments (CLIA)** In 1988, Congress passed CLIA, which established quality standards for all laboratories (regardless of where the test was performed) to ensure the accuracy, reliability, and timeliness of patient test results. There are different certificates that can be issued (e.g., Certificate of Waiver, Certificate for Provider-Performed Microscopy Procedures, Certificate of Registration, Certificate of Compliance, and Certificate of Accreditation). CLIA regulations are stratified based on the complexity of the test method: waived complexity; moderate complexity, including the subcategory of provider-performed microscopy; and high complexity. The regulations specify quality standards for laboratories performing moderate- and/or high-complexity tests and require waived laboratories to enroll in CLIA and follow manufacturers instructions. * **Health Insurance Portability and Accountability Act (HIPAA) of 1996** HIPAA is a federal law that created national standards to protect sensitive patient health information from being disclosed without the patient's consent or knowledge. The U.S. Department of Health & Human Services (HHS) issued the HIPAA Privacy Rule to implement the requirements of HIPAA. The HIPAA Security Rule protects a subset of information covered by the Privacy Rule and sets rules about who can have access to protected health information. * **Health Information Technology for Economic and Clinical Health (HITECH) Act** Initiated in 2009, this law promotes the adoption and meaningful use of health information technology. HITECH, in concert with HIPAA, has helped safeguard patient privacy with the electronic transmission of health information, especially in the era of COVID, where telehealth became an alternative to face-to-face healthcare encounters. * **Patient Safety and Quality Improvement Act of 2005 (PSQIA)** Signed into law in 2005 and implemented in 2009, PSQIA was a response to the initial Institute of Medicine (now the National Academy of Medicine) report, To Err Is Human: Building a Safer Health System. The law created a framework for patient safety organizations that identified and reduced risks to patient safety; reporting and analysis of data related to near miss and patient safety events; and maintaining a culture of safety that included anonymous reporting and confidentiality and legal protections for reporters. * **Patient Protection and Affordable Care Act (PPACA or ACA)** The ACA was signed into law in 2010, putting in place comprehensive U.S. health insurance reforms that greatly impact accountability. The intent of the ACA was to transform and modernize the American healthcare system. The Act created new programs and payment models with goals of rewarding value and quality. These models include accountable care organization models, medical home models focused on primary care, and new models of bundling payments for episodes of care. In these alternate payment models (APMs), healthcare providers are accountable for the quality and cost of the care they deliver to patients and have a financial incentive to coordinate care for their patients who are therefore more likely to receive evidence-based, team-based care. The start of 2017 saw a strong push, under a new president and federal administration, to repeal the ACA. In 2021, the Supreme Court upheld the ACA. * **Medicare Access and CHIP (Children's Health Insurance Program) Reauthorization Act Quality Payment Program** This Act was signed into law in 2015, and a final rule was issued in late 2016. The Act impacts the way providers are reimbursed through a merit-based incentive payment system and alternate payment model, collectively referred to as the Quality Payment Program. Healthcare quality professionals are encouraged to refer to the most up-to-date CMS information as elements of this law continue to go into effect. While this Act provides an incentive for providers working together, the Physician Self-Referral Law (i.e., the Stark law), prohibits physicians from referring patients to receive designated health services payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. * **21st Century Cures Act** The Cures Act became Public Law No. 114-255 in December 2016. The intent was to improve the flow and exchange of electronic health information, including advancing interoperability, prohibiting information blocking, and enhancing the usability, accessibility, and privacy and security of health information technology (IT). The Act also clarified HIPAA privacy rules and supporting substance use and mental health services. The Cures Act defined interoperability as the ability to exchange and use electronic health information without special effort on the part of the user and as not constituting information blocking. ## Federal Agencies There are federal agencies with which the healthcare quality professional interfaces. A huge government agency, the U.S. Department of Health & Human Services (HHS) has 11 operating divisions, including eight agencies in the U.S. Public Health Service and three human services agencies. These divisions administer a wide variety of health and human services and conduct life-saving research for the nation, protecting and serving all Americans. HHS's mission is "to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services for individuals, families, and communities, including seniors and individuals with disabilities." It works to accomplish its mission through the individual and collaborative efforts of the operating divisions and staff divisions within the office of the secretary. The primary goal of the office is to provide leadership, direction, and policy and management guidance to the department. HHS is working to integrate strategic planning, performance measurement and management, enterprise risk management, and evaluation into its management approach. HHS works closely with state and local governments, and because many HHS-funded services are provided by state or county agencies, or through private sector grantees, it may be difficult for healthcare professionals to distinguish between the federal role in regulation versus the role as an insurer, and the state role acting on behalf of the federal programs. Several of the HHS agencies are described next. * **Administration for Children & Families (ACF)** Promotes the economic and social well-being of families, children, individuals, and communities through a range of educational and supportive programs in partnership with states, tribes, and community organizations. As a division of HHS, ACF encourages strong, healthy, supportive communities to provide a positive impact on quality of life and the development of children. * **Administration for Community Living (ACL)** Brought together the Administration on Aging, the Administration of Developmental Disabilities, and Office on Disabilities upon its founding in 2012. ACL increases access to community support and resources for the unique needs of older Americans and people with disabilities by funding services and supports provided primarily by networks of community-based organizations, and with investments in research, education, and innovation. * **Agency for Healthcare Research and Quality (AHRQ)** Produces evidence to make healthcare safer, of higher quality, more accessible, equitable, and affordable, and it works within HHS and with other partners to make sure that the evidence is understood and used. AHRQ accomplishes its mission by focusing on three core competencies - health systems research, practice improvement, and data and analytics. * **Agency for Toxic Substances and Disease Registry (ATSDR)** Prevents exposure to toxic substances and the adverse health effects and diminished quality of life associated with exposure to hazardous substances from waste sites, unplanned releases, and other sources of environmental pollution. * **Centers for Disease Control and Prevention (CDC)** Works 24/7 to protect America from threats to health, safety, and health security, both from foreign sources and in the United States. Whether diseases start at home or abroad; are chronic or acute, curable, or preventable; or are the result of human error or deliberate attack, CDC fights disease and supports communities and citizens to do the same. CDC increases the health security of the United States. * **Centers for Medicare & Medicaid Services (CMS)** Combines the oversight of the Medicare program, the federal portion of the Medicaid program and State Children's Health Insurance Program, the health insurance marketplace, and related quality assurance activities. * **Food & Drug Administration (FDA)** Protects the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also plays a significant role in the nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats. * **Health Resources & Services Administration (HRSA)** Provides equitable healthcare to people who are geographically isolated and economically or medically vulnerable. HRSA's programs also support health infrastructure, including through training of health professionals and distributing them where they are needed most, providing financial support to healthcare providers, and advancing health. * **Indian Health Service (IHS)** Responsible for providing federal health services to American Indians and Alaska Natives. IHS is the principal federal health center provider and health advocate for Indian people, and its goal is to raise their health status to the highest possible level. * **National Institutes of Health (NIH)** Comprises the U.S. medical research agency - making important discoveries that improve health and save lives. NIH supports biomedical and behavioral research with the United States and abroad, conducts research in its own laboratories and clinics, trains promising young researchers, and promotes collecting and sharing medical knowledge. * **Office of Inspector General (OIG)** Stands at the forefront of the efforts since 1976 to fight fraud, waste, and abuse and to improve the efficiency of Medicare, Medicaid, and more than 100 other HHS programs. OIG is the largest inspector general's office in the federal government, with most of the resources going toward the oversight of Medicare and Medicaid. OIG's mission in protecting the most vulnerable is to "provide objective oversight to promote the economy, efficiency, effectiveness, and integrity of HHS programs, as well as the health and welfare of the people they serve." The five most important federal fraud and abuse laws that apply to physicians are the False Claims Act, the Anti-Kickback Statute, the Physician Self-Referral Law (called the "Stark law"), the exclusion authorities, and the Civil Monetary Penalties Law. * **Substance Abuse and Mental Health Services Administration (SAMHSA)** Leads public health efforts to advance behavioral health in the United States. SAMHSA's mission is to reduce the impact of substance abuse and mental illness on America's communities. Leadership for the HHS operating divisions is divided into geographic regional offices; these are the offices with which healthcare quality professionals work directly in addition to state-level agencies. Healthcare quality professionals may be involved with one or more HHS operating divisions depending on the segment of healthcare where they are employed. The federal government plays a role in directing laws and regulations for managed care, which is "a health care delivery system organized to manage cost, utilization, and quality." Health plans pay the cost of medical care. Healthcare quality professionals working with health plans will want to understand the regulations specific to their situation in the state where business is conducted and healthcare delivery occurs. The federal government regulates managed care and other health plans sponsored by the private sector. However, the states regulate the business of insurance, which includes managed care organizations (MCOs) such as health maintenance organizations (HMOs) that offer managed care policies to individuals, employers, or other purchasers. To add to the complexity, if a private sector employer sponsors a plan that is not purchased from an MCO (e.g., the plan is self-insured), then the plan is regulated solely by the federal government. If that employer contracts with an MCO to provide managed care services to employees, then the regulation depends on who bears the risk: if it is the MCO, the plan is regulated by the state; if the risk is borne to any degree by the employer, then the plan is subject to federal law only. This complex division of regulatory responsibilities between the federal and state governments resulted from provisions of several federal laws and subsequent decisions of federal courts. The Employee Retirement Income Security Act of 1974 preempted the states from regulating health plans offered by private sector employers but left to the states the regulation of the business of insurance. Although the HMO Act of 1973 established certain federal standards for HMOs that elected to operate under federal law, almost all other regulatory authority over the business of health insurance remained with the states. This deferral to state regulation of insurers was altered in 1996 with the passage of HIPAA, which applied federal minimum requirements to state-regulated insurers as well as to employer-sponsored plans, including managed care plans. Managed care regulations vary state by state, although there are many state laws and regulations based on the National Association of Insurance Commissioners HMO Model Act. The Commissioners published model laws on quality assessment and improvement, provider credentialing, network adequacy, grievance procedures, and standards for utilization review. ## Federal Role in Quality The Social Security Act mandated the establishment of minimum health and safety standards that must be met by providers and suppliers participating in the Medicare and Medicaid programs. In 1935, the Social Security Act was signed by President Franklin D. Roosevelt to provide benefits for retirees and the unemployed. This was amended in 1965, signed by President Lyndon B. Johnson, to create the Medicare and Medicaid programs. As a federal insurance program, Medicare provides a wide range of benefits for most people 65 years and older, Social Security beneficiaries younger than 65 years who are entitled to disability benefits, and individuals needing renal dialysis or renal transplantation. Care is rendered by providers and suppliers participating in the Medicare program, which entitles them to receive reimbursement from Medicare. In Medicare terminology, providers include patient care institutions, such as hospitals, critical access hospitals, hospices, nursing homes, and home health agencies. Suppliers are agencies for diagnosis and therapy rather than sustained patient care, such as laboratories, clinics, and ambulatory surgery centers. Providers and suppliers are subject to federal healthcare quality standards; thus, the federal government plays a large role in setting quality standards and oversight of compliance to these standards for Medicare beneficiaries. CMS developed conditions of participation (CoP) and conditions for coverage (CfC) that healthcare organizations must meet to participate in the Medicare and Medicaid programs and receive reimbursement for services. These standards are the foundation for improving quality and protecting the health and safety of beneficiaries. CoP and CfC apply to all types of healthcare organizations like comprehensive outpatient rehabilitation facilities, federally qualified health centers, home health agencies, intermediate care facilities for individuals with intellectual disabilities, and programs of all-inclusive care for the elderly. Although each program's CoP or CfC will be different, the table of contents from the hospital program provides an example to gain insight into the kinds of regulations found in the CoP and how they are organized. These federal quality standards are organized in state operations manuals as conditions, with subsidiary standards under each condition. There are individual sets of conditions or requirements for each type of provider or supplier subject to certification. The condition or requirement in the SOMs is expressed in a summary paragraph, which describes the quality or result of operations to which all the subsidiary standards are directed. The HHS secretary delegates to CMS regional offices the authority for ensuring healthcare providers and suppliers participating in the Medicare, Medicaid, and CLIA programs meet applicable federal requirements. CMS regional offices use state health agencies to determine whether healthcare entities meet federal standards. This process is called certification. State and local agencies with agreements under section 1864(a) of the Act perform the following functions: * Survey and make recommendations regarding the organization or providers' ability to meet the Medicare CoP or requirements. * Conduct validation surveys of deemed status facilities, providers, and suppliers. * Perform other surveys and carry out other appropriate activities and certify their findings to CMS. * Make recommendations regarding the effective dates of provider agreements and supplier approvals in accordance with §489.13. State agencies that evaluate healthcare entities against federal regulations are usually the same agencies responsible for state licensing; however, they are reimbursed with federal funds for this work. There are also provisions for CMS-approved accreditation bodies to determine if healthcare entities meet the Medicare CoP. These providers are referred to as "deemed status" providers for participation, also known as the "deeming process." Therefore, CMS-certified healthcare entities can receive a visit from federal, state, or accreditation agencies to evaluate federal standards for certification or recertification, for compliance investigations, or as part of random validation programs to confirm accreditation or state survey findings as valid and reliable. CMS-approved accrediting organizations for various programs include but may not be limited to Accreditation Association for Ambulatory Health Care, Accreditation Commission for Health Care, American Association for Accreditation of Ambulatory Surgery Facilities, Center for Improvement in Healthcare Quality, DNV-Healthcare, National Association of Boards of Pharmacy, The Compliance Team, The Joint Commission, and Utilization Review Accreditation Commission. To ensure evaluations are done in a consistent manner by these agencies, the SOMs are published and available publicly on the Internet. Healthcare quality professionals are encouraged to search for the relevant SOMs and review them for further guidance in preparing an organization for on-site surveys. They include very explicit survey methods and processes as well as specific interpretive guidance for determining if an organization meets a standard. The survey process varies depending on the services under review and may vary slightly depending on individual state resources, such as the staff or disciplines available to conduct surveys. During a survey, healthcare professional surveyors determine if each standard is met by conducting document reviews; interviewing staff, leaders, and patients; and observing routine procedures and patient care. After a CMS survey, the state agency (acting as a CMS surveyor) prepares a certification report for the CMS regional office and sends the healthcare organization a statement of deficiencies. The healthcare organization needs to respond to CMS with a plan of correction for each cited deficiency. Once the plan of correction is accepted by CMS, it is ultimately made available publicly through the Freedom of Information Act. Even though an organization may fail to comply with one or more of the subsidiary standards during any given survey, it cannot participate in Medicare unless it meets every condition. If the healthcare organization does not come into compliance with all conditions within the period accepted as reasonable by CMS, it is certified as noncompliant, and a termination process begins for the Medicare and Medicaid programs. Termination means the healthcare entity cannot receive federal reimbursement for services, which typically represents a financial loss for organizations. Healthcare quality professionals are familiar with the National Practitioner Data Bank (NPDB), which is a federal data bank created because of the Medicare and Medicaid Patient and Program Protection Act of 1987 to serve as a repository of information about healthcare providers in the United States. NPDB was designed to protect program beneficiaries from unfit healthcare practitioners and required reporting of adverse licensure, hospital privilege, and professional society actions against physicians and dentists related to quality of care. In addition, NPDB tracks malpractice payments made for all healthcare practitioners. The passage of HIPAA in 1996 led to the creation of the Healthcare Integrity and Protection Data Bank (HIPDB). HIPDB served as a tracking system to alert users that a comprehensive review of the practitioner, provider, or supplier's past actions may be prudent. It was suggested that HIPDB's information be used in combination with information from other sources in making determinations on employment, affiliation, certification, or licensure. Section 6403 of the ACA authorized the secretary of HHS to cease the operation of HIPDB and to consolidate the operation of HIPDB with NPDB. The goal was to eliminate duplication between NPDB and HIPDB. In May 2013, NPDB and HIPDB merged into one database - NPDB. This data bank was established with strict confidentiality protections; the HHS Office of Inspector General has the authority to impose civil money penalties on those who violate the confidentiality provisions. NPDB authorizes the government to collect information concerning sanctions taken by state licensing authorities and entities against healthcare practitioners. In 1990, Congress amended the law by broadening the language to include any negative action or finding by these authorities, not just sanctions. Intended to improve the quality of healthcare, this law encourages state licensing boards, hospitals, professional societies, and healthcare organizations to identify and discipline those who engage in unprofessional behavior, to report medical malpractice payments, and to restrict the ability of incompetent physicians, dentists, and other healthcare practitioners to move between states without disclosure or discovery of their previous history. Examples of adverse actions include revocation or alteration to licensure, clinical privileges, and professional society membership, as well as exclusions from Medicare and Medicaid. Government peer-review organizations and private accreditation organizations are required to report negative actions taken against healthcare practitioners or organizations. ## Federal Resources Finding information about federal regulations is progressively easier because the government invested in publicly available electronic databases accessed through the Internet. Healthcare quality professionals are encouraged to take advantage of the Internet in seeking the most up-to-date federal regulations through the review of information posted on official governmental sites. The Federal Register is the official daily publication for rules, proposed rules, and notices of federal agencies and organizations, as well as presidential executive orders. CFR is the codification of these rules published in the Federal Register, which is divided into 50 titles that represent broad areas subject to federal regulation. It is updated by amendments that appear daily in the Federal Register. Each volume of the CFR is updated once each calendar year. Twice a year, federal agencies publish a new edition of the Unified Agenda of Regulatory and Deregulatory Actions. This agenda can be very helpful for healthcare quality professionals to understand the direction for selected federal agencies in the coming year. As an example, the HHS plan provides not only the annual priorities for the fiscal year as an overview but also the detailed information about each of the priorities (whether the priority is an unfunded mandate, legal authority, statement of need, legal basis, alternative, cost and benefit, risk, timetable, and contact information). These documents are useful communication tools for healthcare quality professionals to understand future directions for regulations. The process to change regulations can be slow and frustrating, resulting in outdated regulations. There are many challenges to keeping evidence-based regulatory standards current. Federal, state, and local government regulators must provide due process to those affected by their actions - this provides the healthcare industry the opportunity to review proposed changes with any known supporting evidence and to provide written feedback or testimony prior to changes in the regulation. Individuals, members of professional associations, and healthcare associations like NAHQ can comment on proposed regulations. ## State Laws and Regulations State governments maintain state health departments that operate licensing programs for healthcare providers and organizations. Licensing requires organizations, providers, and practitioners to meet legal requirements to practice or provide services. In addition to providing licensing services, these departments usually operate enforcement programs for both state licensing requirements and federal certification requirements. In some states, local governments, such as counties and municipalities, can also have their own health departments (which may be branches of the state health department). Licensure for practitioners may be the responsibility of state health departments or separate entities accountable for disciplinary investigations and actions. State regulations vary greatly in content, detail, and organization of regulations. This requires regulatory professionals to possess state-specific knowledge to guide organizations within the given state. Corporate healthcare entities that operate in multiple states depend on regulatory and quality professionals who play a critical role to navigate requirements within each state. State healthcare surveys appear much like federal surveys and likely have the same personnel performing the survey. State regulators survey healthcare organizations for licensure, for enforcement of regulations, and in response to complaints made to the agency by consumers of the healthcare service, their family members, or concerned staff. Licensure visits may be routine inspections within defined time periods or may be random, unannounced visits conducted based on the resources available to the state agency. State laws may dictate reporting requirements of licensed organizations for serious reportable or adverse events, and the law may require the state agency to investigate certain self-reports within a given time frame. Discretion on how the agencies respond to and investigate complaints may be allowed, based on the nature of the complaint and the severity of the allegation. As with federal surveys, state agencies provide organizations with deficiency reports and require written responses (corrective actions) within a defined period. If organizations are not able to become compliant with state regulations, they risk loss of both licensure within the state and the ability to provide healthcare services. In addition, states report their actions to CMS and accrediting bodies that may initiate their own investigations. Reports of investigations and the organization's response to citations may also become public information or released upon request. Healthcare quality professionals are encouraged to become familiar with relevant state healthcare regulations impacting their practice setting. Most state regulatory agencies post an abundance of relevant information on the Internet. ## Private Quasi-Regulators Although regulation is primarily a government role, there are also private organizations that serve as quasi-regulators in healthcare. Field provides a rich historical perspective on regulation in healthcare, as well as an introduction to private regulators. The American Medical Association (AMA) may be the most well-known organization. AMA sponsored creation of organizations with oversight roles for the medical profession to supplement government regulators, such as organizations that accredit medical schools, administer licensure examinations, and certify specialists. State medical boards, for example, use privately administered examinations in granting medical licenses, and the Medicare program relies on specialty certification as an indicator of physician quality. **Key Points: Laws and Regulations** * Develop a process to receive, review, and communicate updates within the organization since laws and regulations continuously change. * Become familiar with federal HHS agencies and State Operations Manuals. * CMS-certified healthcare entities may receive a visit from federal, state, or accreditation agencies to evaluate compliance with federal standards. * Adopting a continuous compliance strategy ensures alignment with federal and state regulations, accreditation standards, and contractual obligations. ## Accreditation, Certification, and Recognition Accreditation and certification are terms used in many industries in the United States, including healthcare. The terms are often used incorrectly or interchangeably, which may create confusion. * **Accreditation** May be defined as an official authorization or approval, or recognition of conforming to standards. Accreditation is voluntary and granted by private sector organizations (trade associations, professional societies, or independent businesses). * **Certification** Is the recognition of meeting standards and qualifications within a field. Certification can be provided by either private-sector organizations or government agencies. * **Recognition programs** Empower employers, health plans, patients, and consumers to make informed healthcare decisions based on quality. Participation in a National Committee for Quality Assurance (NCQA) Recognition Program, as an example, demonstrates compliance with guidelines and standards that support quality healthcare delivery and evidence-based practices and clinical protocols (e.g., Diabetes Recognition Program, Patient-Centered Medical Home Recognition Program). In healthcare, **accreditation** commonly refers to a process reviewing an entire organization's operations (e.g., ambulatory surgery center), whereas **certification** commonly refers to a review of part of the organization's operations or care for a specific population or competency (e.g., sepsis). Certification may also be a reference to an individual's competency (e.g., ambulatory care nursing) or the determination of an organization's eligibility to participate in a government program. Federal certification requirements are found across the healthcare continuum. For example, a federal certification requirement is CMS regulations for all laboratory testing performed on humans through CLIA. All clinical laboratories must be certified to receive Medicare or Medicaid payments. CLIA maintains a list of CMS-approved accrediting organizations that may perform laboratory inspections, whose requirements are deemed as being equivalent to or more stringent than CMS requirements (CMS accepts the accrediting organization's inspection in lieu of its own inspection). Another federal certification requirement is found in the Mammography Quality Standards Act (MQSA) as amended by the Mammography Quality Standards Reauthorization Acts of 1998 and 2004, which requires that all facilities providing mammography must be certified by FDA. To become certified, a facility must be accredited by FDA-designated accrediting bodies. As of October 1, 2021, there are over 8700 mammography facilities certified. ## Value of Accreditation Although many hospitals and many health plans are accredited, accreditation is not uniformly adopted across all segments of the healthcare industry. Home care and hospice agencies, among the fastest growing segments of the continuum, may also be accredited. Nursing home accreditation continues to evolve. A study comparing accredited and nonaccredited nursing homes confirmed previous findings that demonstrate a consistent pattern of superior performance among accredited nursing homes. There are not the same financial incentives to seek accreditation since legislation does not authorize deemed status in Medicare or Medicaid for private accrediting bodies to substitute for government oversight. CMS (for Medicare and Medicaid) and the states (for Medicaid) have regulatory standards and government survey and certification programs to enforce nursing home regulations. In the primary care setting, an increased focus is placed on attainment of patient-centered medical home recognition or certification. Recognition signifies that patient treatment is coordinated through a primary care provider who ensures the patient receives the necessary care when and where needed and in a manner that the patient can understand. As the healthcare industry faces ongoing pressure for cost containment, questions surface as to the value of accreditation in relation to the cost. Literature continues to grow about the benefits of accreditation, which include improved accountability and transparency. One of the most extensive reviews of accreditation value is a literature review published by Accreditation Canada, which summarizes literature findings on the value and impact of healthcare accreditation. This information may be helpful to articulating the value proposition and business case for quality and safety. The review includes results and conclusions from research, gray literature, and experience-based articles. Accreditation is an integral part of healthcare services in more than 70 countries, as either a voluntary or government-mandated requirement. **Benefits of Accreditation, Certification, and Recognition Programs** * **Better Care** * Improves patient’s health * Improves organization’s reputation among end users and stakeholders * Enhances consumer awareness and perception of quality care as well as overall satisfaction level * Provides a framework to improve operational effectiveness and advance positive health outcomes * **Organizational Effectiveness** * Promotes a quality and safety culture * Increases the healthcare organization’s compliance with quality and safety * Demonstrates credibility and a commitment to quality and accountability * Supports the efficient and effective use of resources in healthcare services * Sustains improvements in quality and organizational performance * Promotes the sharing of policies, procedures, and best practices among healthcare organizations * Provides healthcare organizations with a well-defined vision for sustainable quality