Quality Improvement, Management, and Assurance Improvement Organizations

Issues of Concern

Background and History

Quality improvement standardization has been a work in progress for at least 200 years and perhaps longer. For example, handwashing is now a common practice to reduce the spread of pathogens, but it was not common until at least the 19th century.[1] In 1918, the American College of Surgeons established minimum standards for hospitals, thereby developing and adopting regulations and policies regarding their work. Compliance with these standards rapidly spread among hospitals nationwide, and the college used its influence to educate the public to improve their expectations of the care they received.[2] Within the next decade, the American Society for Clinical Pathology established its standards for adequate laboratory services, another growth signal in this quality improvement area.[2] In 1966, Dr. Avedis Donabedian developed a framework for modern healthcare quality, in which the quality of care delivered can be broken into 3 components—structure, process, and outcome.[3] Structure refers to the actual setting in which healthcare services are provided and includes, but is not limited to, personnel, equipment, and facilities. Process refers to the actual patient-doctor dynamic and relationship as care is delivered and received. Outcome is defined by the results of services provided and includes disease status, patient satisfaction, and costs. The structure-process-outcome model has been the basis for measuring healthcare quality in the United States for decades.[3][4][5]

Health care in the United States has had several areas of deficiency, including inappropriate care for both acute and chronic medical issues ranging from cataracts to alcohol abuse, leading to increasing costs and iatrogenic harm.[6] In response, the federal government has established several national agencies and programs focused on quality assurance and improvement in health care. In 1971, Congress authorized the development of Experimental Medical Care Review Organizations (EMCROs) to evaluate the services provided to Medicare beneficiaries.[7] In 1972, President Richard Nixon signed an amendment to the Social Security Act to establish Professional Standards Review Organizations (PSROs) to replace EMCROs. The formation of federally funded physician peer review organizations was one of the first national initiatives to improve healthcare quality and ensure that Medicare and Medicaid beneficiaries received medically necessary care.[8] In 1982, these organizations were replaced by the Medicare Utilization and Quality Control Peer Review Organization (PRO) program, which later changed its name to QIOs as they are recognized today. PROs had the same mission of improving the effectiveness, efficiency, economy, and quality of care but introduced a prospective payment system based on diagnosis-related groups (DRGs) to motivate providers to reduce care costs, aiming to control Medicare costs.[9]

Government-Based Quality Improvement Agencies and Programs

Agency for Healthcare Research and Quality: The Agency for Healthcare Research and Quality (AHRQ) operates under the Department of Health and Human Services (HHS) to support research aimed at improving clinical safety and quality. The agency has developed metrics and other quality indicators to monitor hospital performance and patient outcomes, including postoperative venous embolisms, postoperative sepsis, and accidental needle punctures.[10][11]

Medicare Improvements for Patients and Providers Act: The Medicare Improvements for Patients and Providers Act (MIPPA) not only expanded access and affordability primarily for older, low-income, and minority beneficiaries but also catalyzed various initiatives, including the CMS value-based care program.[12][13]

Hospital Value-Based Purchasing Program: The Hospital Value-Based Purchasing (HVBP) program is an incentive-based program initiated by CMS designed to reward hospitals not based on the volume of services provided, similar to the traditional fee-for-service reimbursement model, but rather on the value of their services. This value is determined by assessing quality measures across various domains, including clinical care, efficiency, cost reduction, care coordination, and safety.[14]

Hospital Value-Based Purchasing Extension Programs: HVBP Extension programs encompass initiatives such as the Merit-Based Incentive Payment System (MIPS), Hospital Readmissions Reduction Program (HRRP), and Hospital-Acquired Condition (HAC) Reduction Program, all designed to enhance healthcare quality, coordination, and patient outcomes through incentivized performance measures.

• Merit-Based Incentive Payment System: An extension of the HVBP program is the Merit-Based Incentive Payment System (MIPS), which determines payment adjustments such as bonuses and penalties based on quality performance.[15]

• Hospital Readmissions Reduction Program: The Hospital Readmissions Reduction Program (HRRP) rewards facilities for effective communication and care coordination in reducing unplanned readmissions following patient discharge.[16]

• Hospital-Acquired Condition Reduction Program: The HAC Reduction Program aims to improve patient safety by reducing infections associated with healthcare facilities, such as central line–associated bloodstream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs).[17][18][19]

Independent Quality Improvement Organizations

Independent or not-for-profit organizations such as the National Committee for Quality Assurance (NCQA) and The Joint Commission (TJC) also exist to promote more effective communication and offer services such as hospital accreditation, physician credentialing, and population health program direction.[20][21][22] Although there have been improvements in health care nationwide in some previously deficient areas of care, limited data exist regarding how these individual improvements are attributable to QIOs or any other independent QIOs.[23][24] A review of previous QIO work is presented below.

CMS-directed organizations: Currently, CMS directs 2 types of QIOs—Quality Innovation Network (QIN or QIN-QIOs) and Beneficiary and Family-Centered Care (BFCC or BFCC-QIOs).

• QIN-QIOs: These organizations focus on data analysis to improve clinical quality, promote community health, and facilitate the organization of effective healthcare initiatives at a regional level. In total, 12 QIN-QIOs operate across regions spanning between 2 and 6 states to help spread data-driven initiatives locally (CMS: Quality Improvement Organizations).

• BFCC-QIOs: These organizations manage appeals and disputes from Medicare beneficiaries by reviewing the quality of care delivered by hospitals and other healthcare institutions. These organizations ensure that the integrity of the Medicare Trust Fund is protected by determining whether services rendered and paid for by Medicare are reasonable and necessary. In addition, they address individual complaints, such as appeals for decisions to be discharged from hospitals and the discontinuation of other services or any potential violations of the Emergency Medical Treatment and Labor Act (EMTALA). EMTALA is a federal statute requiring hospital emergency departments that accept payments from Medicare to provide adequate medical screening exams to all patients seeking treatment, regardless of their ability to pay. BFCC-QIOs encourage Medicare beneficiaries to engage in their healthcare decisions, empowering them to improve healthcare outcomes and prevent errors (CMS: Quality Improvement Organizations).

Other initiatives currently include the Hospital Quality Improvement Contractors (HQICs) initiative, the American Indian Alaska Native Healthcare Quality Initiative (AIANHQI), and the Opioid Prescriber Safety and Support (OPSS) initiative.

Clinical Significance

Past Work

QIN-QIOs operate under a statement of work (SOW), or 5-year contracts, delineating key initiatives outlined by CMS for each geographic region served by QIN-QIOs. One of the first quality improvement initiatives from the PROs in the mid-1990s was the Cooperative Cardiovascular Project (CCP), focusing on treating Medicare patients with acute myocardial infarction. Performance on quality indicators, including clinical practice guidelines, length of stay, and mortality, all saw improvement in the 4 pilot states of the CCP.[25] As the program expanded nationwide over the next 2 contract cycles and transitioned from PRO to QIO, studies showed continued improvement in the quality of care received by Medicare beneficiaries for acute myocardial infarction.[24][26][27] QIOs broadened their focus to analyze quality of care indicators for other conditions, such as heart failure, atrial fibrillation, stroke, and pneumonia. Multiple studies suggested similar improvements in processes of care.[24][27][28][29][30]

However, as aforementioned, direct causality between participation in the QIO program and improvement in quality indicators is difficult to establish without a control group. A small-scale study suggested that there may be no significant difference between baseline and follow-up on many of these quality indicators when comparing hospitals participating in the QIO program and those that do not.[31] Nonetheless, QIOs continued to sponsor larger collaborations nationwide, such as investigating quality improvement measures to reduce surgical site infections, which proved beneficial.[23][32][33][34] The tenth SOW reported over a 50% improvement in CLABSIs in an intensive care unit and other inpatient settings, avoidance of over 40,000 adverse drug events among Medicare beneficiaries, and more than 200,000 cases reviewed by BFCC-QIOs on behalf of beneficiaries, families, and referral agencies. These accomplishments underscore the continued growth of these organizations (CMS: Quality Improvement Organizations, Past Work). Another significant area of historical involvement for QIOs has been the promotion of vaccination. Multiple analyses have shown higher rates of pneumococcal and influenza vaccination among adults after initiatives by QIOs, including educational campaigns, toolkit distribution, and audit and feedback initiatives.[35][36][37]

A separate area of focus of QIOs has been nursing home care and home healthcare agencies. A study examined the value of the CMS investment in QIOs and found good value in healthcare dollars for funds directed towards educational conferences, collaborative learning sessions, and technical assistance provided to nursing homes.[38] The ninth SOW named nearly 4000 nursing homes performing poorly on quality metrics, such as pressure ulcers and restraint use, and targeted improvement in those facilities, representing a shift in spending strategy from previous years in response to criticisms that QIO resources were not being used efficaciously.[39] Another aim of QIOs directed towards nursing homes and long-term care facilities was the reduction of HACs. The National Healthcare Safety Network (NHSN) was consequently launched in 2012 to monitor the incidence of urinary tract infections, Clostridium difficile, and multidrug-resistant organisms; a retrospective study found a positive correlation between nursing home facility participation in QIN-QIO initiatives with knowledge of and enrollment in the NHSN.[40]

A subsequent focus of QIN-QIOs in following contracts was antibiotic stewardship; survey studies again showed positive correlations between nursing home partnerships with QIN-QIOs and the implementation of infection control training and comprehensive Antibiotic Stewardship Programs (ASPs).[41] In addition, QIOs have forged partnerships with colleges of pharmacy and community pharmacists, leveraging combined data and resources to more effectively design and strengthen local market medication therapy management and quality improvement programs.[42]

Nursing, Allied Health, and Interprofessional Team Interventions

Funding and Current Aims

The Partnership for Patients (PfP) initiative fosters collaboration among diverse stakeholders, including physicians, nurses, hospitals, employers, patients, advocates, and federal and state governments, in a public-private partnership to improve healthcare quality, safety, and accessibility. These groups have integrated with QIN-QIOs to continue focusing on initiatives from the past while empowering beneficiaries to accelerate progress toward minimizing harm reduction in the Medicare program and committing to improving health equity.[43][44]

According to the 2022 Report to Congress, the total expenditure of the QIO program was $697,843,970. Medicare provided coverage for over 65.2 million beneficiaries, of whom 53.9 million were older than 65. BFCC-QIOs achieved timeliness above target goals on all 5 performance criteria measures. The 12th SOW goals, established in 2019, are as follows—to improve behavioral health outcomes, with a specific focus on opioid misuse; to increase patient safety; to increase chronic disease self-management, specifically focused on cardiac, vascular, and renal disease; to increase care coordination; and to improve nursing home quality. As with the 2 prior years, there was a significant focus on mitigating poor outcomes from COVID-19, and specific targeted response initiatives were found to support the pandemic response, particularly in nursing homes (CMS: Final FY 2022 QIO RTC).

Nursing, Allied Health, and Interprofessional Team Monitoring

Regulations

Although participation in quality improvement projects initiated by QIOs is voluntary for individual hospitals, QIOs are engaged with any hospital or individual provider who cares for patients with Medicare and reports quality measures to CMS.[31] QIOs focus on quality assurance and improvement, whereas CMS is responsible for enforcing payment penalties and reductions, and rewards for good performance. QIOs are not responsible for surveys, accreditation, or certification. Although there is no direct cost for hospitals to engage with QIOs, a few areas of their involvement have drawn some controversy. For instance, there has been an ongoing debate over whether the data collected by QIOs should be publicly accessible or remain internal for provider performance evaluation purposes only (NIH: Contracting for Quality: Medicare’s Quality Improvement Organizations).

Future Goals

CMS is preparing to release a new 13th SOW for the contract period spanning 2024 to 2029. Visions for the future of the QIO program include alignment with other HHS and CMS strategic plans, evidence-based targeted quality improvement, advancement from education to implementation of quality improvement to drive cultural change, identifying trends between BFCC-QIO and QIN-QIO activities, and improvements in IT systems, data analytics, machine learning, and artificial intelligence to position the QIO program as the nation’s resource for quality improvement (CMS: Quality Conference 2023). QIO-led initiatives can only be implemented if every member of the healthcare team plays an active role in appropriately caring for their patients and is empowered to contribute to quality improvement.