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Quality assurance, quality improvement, and total quality Management initiatives and programs have been used, to different degrees, in business, management, and healthcare settings for decades now. However, despite the obvious positive impact on all healthcare outcomes, diffusion and integration of these methodologies have been inconsistent across health systems, subspecialty disciplines, and programs. There are many causes and contributing factors to this lack of penetration, which include ongoing disparities in healthcare, a lack of accountability, the existence of diffuse and nonspecific goals, the use of measurements or metrics that did not always impact patient outcomes, and systems that encouraged volume over value.
At the same time, current healthcare costs are not sustainable, and we are moving toward healthcare coverage and regulations that incentivize and reward quality rather than quantity. The landscape of quality assurance is also set to change due to new managed healthcare plans (bundling of care, capitation, and accountable care organizations [ACOs]), federal and state regulatory requirements (increased reporting and accountability), technological advances (electronic medical records and systems, clinical decision support [CDS] at order entry, electronic closed-loop communication systems), the increased emphasis on preventative medicine (more screening rather than diagnosis and follow up), changes in patient attitudes (patient-centered imaging, patients as partners in healthcare), and globalization (telemedicine and teleradiology).
This chapter outlines the main influences (external and internal) that have governed quality assurance in the past and today and looks into the future of healthcare and the challenges that we will face. We outline the opportunities that we believe exist for diagnostic imagers to enhance the quality of imaging locally and nationally and make suggestions for overcoming barriers.
The cost of healthcare (and imaging) has been spiraling upward over the past couple of decades, such that payers, state and federal agencies/regulators, and government have taken major steps to contain it. These include the establishment of the federal government’s Medicare Shared Savings Program (Section 3022 of the Patient Protection and Affordable Care Act [PPACA]), which set the structural foundation for ACOs and established certain quality performance standards that ACOs must meet to receive payments for shared savings.
The ACO framework encourages cost control by guiding healthcare providers and hospitals toward more coordinated, higher-quality, patient-centered care for Medicare patients, and to replace the sometimes fragmented care received under the single payment, single provider system under the fee-for-service payment system. The ACO concept increases quality and access by tying participation in economic incentive programs to meeting certain quality performance goals. Under the PPACA, ACOs are accountable for the quality, cost, and overall care of the Medicare fee-for-service beneficiaries assigned to it and have processes in place to promote evidence-based medicine, coordinated care, and transparency.
Under ACOs, a capitated model of payment is intended to encourage better coordination of care and minimize duplication and inappropriate use of services. With capitated payment systems, physicians and other providers must assume considerable risk but are potentially rewarded by returning savings achieved beyond predetermined targets. This payment system shift (from fee for service to capitation) is converting specialty services such as diagnostic imaging from a profit center to a cost center. This gives health systems an economic incentive to further reduce the use of diagnostic imaging and encourage the use of potentially less efficacious alternatives.
ACOs potentially pose threats to radiology under fee-per-service (with decreased reimbursement per study, decreased utilization, and a shift toward less expensive imaging under cost containment initiatives, and by participation in ACO shared savings bonuses and penalties); under capitation (with potential financial risk to radiology for imaging utilization by other providers, mixed incentives for radiologists serving both fee-for-service and capitated patient pools); under health system integration (with reduced bargaining leverage for radiology groups, especially smaller ones); and increased malpractice risk for radiologists who are under pressure to decline imaging for financial reasons.
Given that imaging is critical to effective and efficient diagnosis and treatment of most patients with serious or chronic illnesses, radiologists should play an integral role in ACOs. In conjunction with primary care providers, radiologists can play an important role in screening programs and in the management of a variety of medical conditions by helping to provide the most effective care. Radiologists’ roles in patient care include recommending the appropriate use of imaging studies, which, if normal or negative, could limit unnecessary referrals to specialists or additional procedures by having the right test done initially. Functioning as imaging experts or consultants is critical, particularly with physician extenders such as physician assistants and nurse practitioners, who are providing an increasing amount of healthcare.
Although healthcare reform brings challenges, these may be the catalyst for radiology to show its value proposition, transform the existing service delivery model, and assume a central role in healthcare organizations. To decrease the risk of becoming increasingly marginalized and vulnerable with market forces threatening to cast radiology as a commodity, radiology groups need to safeguard and promote their position within healthcare systems. Accountable care provides opportunities for radiology groups by emphasizing the need for physician leadership with the clinical, technical, and operational areas to direct and promote cost-control initiatives while preserving quality of care. Radiologists are well equipped to assume these leadership positions by virtue of our whole-body clinical knowledge base; our broad interfaces with the complete spectrum of primary care and specialty physicians; our long history of innovation in information technology (IT), especially electronic image data management and processing of large volumes of patient encounters; our experience with the development and deployment of sophisticated and expensive diagnostic equipment; and our extensive involvement in hospital operations, including education, supervision, and management of technologists and nurses.
To capitalize on this opportunity, radiologists must alter their fundamental image of themselves. Radiologists are the imaging experts or consultants, just like any other subspecialist, and not just image readers. Physician-to-physician consultation (with a discussion of relevant patient history, symptoms, and signs) is essential in optimizing the appropriate imaging for a specific patient at the right time. This is challenging under the current model, which emphasizes throughput (scheduling and performing examinations and finalizing their reports) and provides less time to stop and think about what is better for the patient. The current metrics, which focus on turnaround times, are not always the best for the individual patient or the health system.
The Deficit Reduction Act (DRA) of 2005 directed the Agency for Healthcare Research and Quality (AHRQ) to develop program performance indicators and measures of client satisfaction for Medicaid beneficiaries receiving home- and community-based services. The AHRQ and its contractors analyzed promising claims-based quality measures, including adaptation of prevention quality indicators and recommended two sets of outcome measures: serious reportable events and potentially avoidable hospitalizations due to ambulatory care–sensitive conditions.
The DRA also delineated that for ACOs to share in any savings created, they had to prove they met various defined quality performance measures. These process and outcome measures span five quality domains: patient experience of care, care coordination, patient safety, preventive health, and at-risk population/frail health of older adults. Many of the proposed quality measures align with those used in other Centers for Medicare and Medicaid Services (CMS) quality programs, such as the Physician Quality Reporting System (PQRS), the Electronic Health Record (EHR) incentive program, and the Hospital Inpatient Quality Reporting (Hospital IQR) program. To date, most of the measures relate to medical conditions or surgical/procedural/iatrogenic complications and readmission rates. Rather than wait for nonradiologists and administrators to determine relevant metrics applicable to diagnostic imaging, this offers an opportunity for radiologists to get involved in defining measures pertinent to patient imaging. These metrics could focus on a variety of measures, for example, screening uptake rates, scheduling time for oncology patients, imaging appropriateness (particularly for areas with society guidelines, such as in the setting of suspected pulmonary embolism), waiting time, complication rates, and patient and physician satisfaction with report issuance.
Authorized by the 2003 Medicare Prescription Drug, Improvement, and Modernization Act (also called the Medicare Modernization Act) and the 2005 DRA, the Hospital IQR program requires hospitals to report on quality measures to receive full annual payment updates. Under Section 3001 of the PPACA, the CMS Hospital Value-Based Purchasing program was designed to improve quality, reduce inappropriate care, and promote better health outcomes and patient experiences during hospital stays through a system of financial incentives and penalties. These pay-for-performance (P4P) programs reduce Medicare reimbursement to hospitals and physicians who score below national performance benchmarks on selected quality measures. For hospitals, some of the areas measured include readmissions, hospital-acquired conditions, mortality, patient experience of care, and clinical process measures of heart attack, heart failure, and pneumonia.
Under this program, a hospital’s payments are adjusted based on its performance in four domains that reflect hospital quality: the clinical process of care domain, the patient experience of care domain, the outcome domain, and the efficiency domain. The Total Performance Score (TPS) comprises the clinical process of care domain score (weighted as 10% of the TPS), the patient experience of care domain (weighted as 25% of the TPS), the outcome domain score (weighted as 40% of the TPS), and the efficiency domain score (weighted as 25% of the TPS). Some of these are relevant to radiology, particularly the patient experience of care domain, the outcome domain, and the efficiency domain.
In the patient experience of care domain, patients are asked to rate hospital quality in eight areas including: nurses’ communication, doctors’ communication, responsiveness of hospital staff to their needs, controlled pain management, cleanliness and quietness of hospital environment, adequate communication about medicines, discharge and expected recovery information, and their overall rating of the hospital.
In the outcomes domain, metrics include inpatient measures (occurrence of hospital-acquired infections and other patient safety breaches such as falls and complications from procedures), outpatient measures (imaging efficiency patterns, emergency department [ED] throughput efficiency, use of health information technology [HIT], care coordination, patient safety, and volume), and measures related to physician offices (prevention of avoidable conditions, supporting physicians in providing treatment).
Within many of the domains, outcome measures related to imaging are not specified, which provides radiologists with an opportunity to participate in determining which quality metrics or measures they deem relevant. For example, under care coordination, imagers could base themselves within the oncology clinic unit and be available for reporting of studies and consultation, including direct face-to-face patient consultation. Radiology organizations such as the American College of Radiology (ACR) and the national radiology societies should use their collective expertise and be proactive in defining and constantly updating relevant outcomes within the TPS domains of the. Initiatives such as the National Oncology Positron-Emission Tomography (PET) Registry are collaborations among radiology organizations. These initiatives collect data, including the impact of PET imaging, to justify Medicare reimbursement for imaging. Similar initiatives and programs could be applied to other imaging modalities to provide evidence of their impact on patient care quality and outcomes to justify reimbursement. Imaging organizations should form study subgroups of experts in the various fields.
In the efficiency domain, hospitals that provide efficient care at a lower cost to Medicare are recognized. Radiology departments can easily demonstrate efficiency in imaging and patient pathways because they comprise various processes and pathways. This is an opportunity for radiology departments with excellent IT infrastructure, integrated with electronic medical record systems, to document, illustrate, and demonstrate efficiency and continued improvement of the processes and pathways. The publicly reported Hospital Outpatient Quality Reporting (Hospital OQR) program outpatient imaging efficiency measures payment determinations for the calendar year 2016 are depicted in Table 9.1 .
Imaging Modality | Measurement |
---|---|
MRI lumbar spine for low back pain (OP-8) | Number of MRIs without antecedent conservative therapy |
Mammography follow-up rates (OP-9) | Number of follow-up diagnostic mammograms, ultrasounds, or MRI within 45 days of screening mammogram |
Abdomen CT—use of contrast material (OP-10) | The number of combined studies (with and without contrast) |
Thorax CT—use of contrast material (OP-11) | The number of combined studies (with and without contrast). |
Cardiac imaging for preoperative risk assessment for noncardiac low-risk surgery (OP-13) | The number of stress echocardiography, SPECT MPI, and stress MRI studies performed at the hospital outpatient department within 30 days of noncardiac, low-risk surgery performed at any location |
Simultaneous use of brain CT and sinus CT (OP-14) | Number of studies with a simultaneous sinus CT study (i.e., on the same date, at the same facility as the brain CT) (Medicare OIE measures) |
Radiologists can also increase efficiency and reduce the volume of costly high-end imaging through a consultation and review model. If a consult with imaging experts (radiologists) became a requirement for advanced imaging requests such as cross-sectional imaging (computed tomography [CT], magnetic resonance imaging [MRI], nuclear medicine) and procedures, as would happen for other subspecialties, relationships between radiology and other subspecialty departments would improve, as well as the perception of radiology as a specialty.
Although desirable, there are significant challenges to applying P4P to radiology because of a lack of standardized radiology performance metrics and the difficulty of linking imaging with patient outcomes. The ACR has proposed several performance goals and activities ( Box 9.1 ).
Create a set of radiology performance measures and objectively measure the quality of radiology practices.
Create outcome and process metrics that have target benchmarks for performance.
Identify metrics that emphasize the added value of radiology and are useful in continuous quality improvement within radiology practices.
Promote the widespread use of registries such as the National Radiology Data Registry.
Continue to promote the use of the appropriateness criteria or other forms of Decision Support in Computerized Physician Order Entry as a tool to reduce inappropriate imaging.
Develop specific performance measures as part of program accreditation.
Diagnostic radiologists must look at the P4P systems that are in place in hospital systems, determine what part diagnostic imaging plays in meeting the hospital’s requirements, and participate in achieving the hospital’s goals. If radiologists do not do this, other stakeholders and specialists will determine radiology’s role, and imaging departments risk being undervalued or left out of the equation altogether.
The existing metrics for diagnostic imaging departments are not always relevant to patient outcomes or aligned with outcomes in the current value-based system. Current process and outcome metrics include turnaround times and percentage of fall incidents while the patient is in the radiology department. Additional metrics proposed by regulatory agencies and reported in the Hospital Consumer Assessment of Healthcare Providers and Systems survey include the use of intravenous contrast material in body (chest, abdomen, and pelvis) CT and early MRI in low back pain. Suggested metrics for radiologists to use in the future include value metrics such as imaging impact on prevention of complications (detecting appendicitis before rupture) and impact on prognosis (detecting a breast carcinoma while it is small and completely surgically resectable). Table 9.2 provides examples of current process and outcome metrics and proposed metrics for the value-based system.
Pathological Condition | Volume Metrics | Value Metrics |
---|---|---|
Abdominal pain | Turnaround time | Prevention of complications (e.g., perforation) |
Adverse events (e.g., contrast-induced nephropathy or extravasation) | Effect of imaging on length of stay in hospital or emergency room | |
Breast cancer | Access times | Percentage of patients diagnosed while cancer is surgically resectable |
Percentage of BIRADS type 3 reports | Percentage of patients requiring repeat imaging or biopsy | |
Stroke | Access times | Cost vs. outcomes of imaging (CT perfusion vs. MRI) in triage to therapy |
Stroke-to-revascularization time | Stroke-to-revascularization time |
Within the CMS PQRS, providers are encouraged to report information on quality of care to CMS and reimbursements are linked to this reported information. This allows providers to assess the quality of the care they provide and to quantify how often they meet particular quality metrics. Participation in PQRS was initially voluntary, but since 2015, all providers eligible for incentive payments who fail to participate are subject to penalties. Since 2016, the penalty for those who fail to report on the minimum measure set is a 2% reduction in reimbursement. The goal of PQRS is to incentivize discussion of quality-oriented questions between patients and providers, and to promote awareness among providers of opportunities for quality improvement in daily care. Examples of measures to be reported in 2016 include the percentage of CT or MRI reports for chest or neck and neck ultrasound for adult patients without known thyroid disease with a less than 1.0 cm thyroid nodule noted incidentally with follow-up imaging recommendations.
Radiology benefits managers (RBMs) are companies that are employed by third-party payers (insurance companies) to provide preauthorization for imaging using society guidelines and evidence or propriety algorithms. Some RBMs merely consult and advise; others may impose small consequences on the referring physician, and others may deny coverage if the patient actually receives the imaging as requested at the specific location. The process by which the RBM decides where patients can go for imaging should be based on evidence or quality factors, rather than on other factors such as lower cost, nearby location, or convenience. Some view the formation of RBM companies as a challenge to maintaining good relationships between radiologists and referring physicians, whereas others have criticized preauthorization programs for not always being transparent or evidence based, or because of perceived increased workflow or intrusions that could delay patient care. It is critical that doctors and nurses are involved in the authorization process, and radiologists should get involved so that they can participate in determining the structure and operation of RBMs in their health systems.
Utilization management requires that radiologists use their expertise in imaging to ensure that imaging studies are performed appropriately. Radiologists are being encouraged to align with primary care practitioners to guide the appropriate use of imaging and referral to subspecialists through meetings and education. These measures may decrease inappropriate utilization by requiring peer-to-peer consultation with a radiologist for low-yield examinations and offering a means of comparing utilization rates of individual providers to established benchmarks. Combining utilization management with decision support in the context of computerized order entry would enable tracking of appropriate and inappropriate utilization rates. This approach would be a natural expansion of the reading room consultation model and would help counteract potential commoditization of radiology by nonphysician resource management groups and improve the face of radiology and its relationships with other departments.
Specific interventions addressing the cost of imaging, including reducing fee-for-service reimbursement rates (Section 5102 of the DRA of 2005), may not necessarily improve quality because providers might try to increase quantity at the expense of quality. As part of the national and regional healthcare reform debates, many leading policy makers have advocated a major shift in the method of payment for medical services, moving away from fee-for-service care to bundled or capitated payments to hospitals and physicians for managing the health of a defined population of patients. Bundled payments are implemented through the ACO, based on a bundled episode of care or global (capitated) payments. Within episodes of care, a fixed payment is provided that is based on the diagnosis-related group (DRG), regardless of the number and complexity of diagnostic and other testing that might take place. Bundling is now occurring for inpatient episodes and will likely be extended to other care venues, so it is critical for radiologists to pay close attention to the parts of their work that are bundled, how the bundling is done, and the rules that govern the bundling. Radiologists must participate in deciding how and when to parcel episodes for bundling of payments by knowing what and when imaging is appropriate.
In addition to being subject to healthcare changes at the government level, there are multiple external agencies and reviewers who oversee quality in American healthcare. These include the Department of Health and Human Services (DHSS), the CMS, The Joint Commission (TJC), the Institute of Medicine (IOM), the AHRQ, the National Committee for Quality Assurance (NCQA), and the National Quality Forum (NQF).
The law directs the DHSS to create a strategic plan that identifies critically important areas for improvement, sets goals, and selects measures to be used in federal programs. This plan relies on input from affected stakeholders, including hospitals, patients, purchasers, insurers, and public policy experts.
TJC is a government nonprofit organization with the intended function of providing voluntary accreditation of hospitals based on a rubric of defined minimum quality standards. Its objective is to improve the quality of healthcare by evaluating healthcare organizations and providing guidance on the elements necessary to deliver care that optimizes quality and value. TJC performs regular reviews of health systems and hospitals, and radiologists can get involved in their local quality improvement committees to ensure that accreditation efforts are being met.
In 1970, the National Academies of Science established the IOM, which has since launched numerous concerted efforts focused on evaluating, informing, and improving the quality of healthcare delivery. The IOM has issued landmark reports, several of which have focused on quality concerns in healthcare (including To Err Is Human and Crossing the Quality Chasm ), with their most recent report in 2015, Improving Diagnosis in Healthcare , focused on diagnostic errors in healthcare. The recommendations from their 2015 report include promoting more effective teamwork, enhancing professional education, encouraging HIT support of the diagnostic process, developing approaches to identify and learn from diagnostic error, establishing nonpunitive work cultures that support improving the diagnostic system, developing an environment to enable learning from diagnostic errors and near misses, designing a payment system that rewards diagnostic process, and providing dedicated funding to improve the diagnostic process. Given that diagnostic imaging is a large component of most patient care pathways, radiologists are ideally poised to improve upon and refine the diagnostic process.
The precursor to the current-day AHRQ was established in 1979 in response to reports of wide geographic variations in practice patterns without supporting clinical evidence, with reports of misuse and overuse of procedural treatments. Its roles include investing in clinical effectiveness, treatment outcomes, and evidence-based practice guidelines. The AHRQ’s initiatives include the US Preventative Services Task Force and the National Guidelines Clearinghouse. Many guidelines relate to screening and diagnosis, in which imaging plays a central role. There have been recent revisions to the guidelines for breast cancer screening with mammography and some confusion exists within the community and the medical profession. Radiologists have an opportunity to get involved and contribute to researching and developing revisions of the screening and diagnostic guidelines.
The NCQA is a private nonprofit organization established in 1990 with the objective of improving healthcare quality by managing accreditation programs for individual physicians, health plans, and medical groups. It measures accreditation performance through the administration of the Healthcare Effectiveness Data and Information Set and the submission of the Consumer Assessment of Healthcare Providers and Systems survey. Radiologists can get involved in ensuring that their health systems meet the standards required to be accredited by the NCQA or by participating as a member.
In 1999, the NQF, a nonprofit organization, was set up with its mission to improve the quality of US healthcare. The forum works to define national goals and priorities for healthcare quality improvement, to build national consensus around these goals, and to endorse standardized performance metrics for quantifying and reporting on national healthcare quality efforts. The NQF’s endorsement of programs has become the gold standard for healthcare performance measures and is relied upon by healthcare purchasers including the CMS. The forum’s membership includes a wide variety of stakeholders including hospitals, healthcare providers, consumer groups, purchasers, accrediting bodies, and research and healthcare quality improvement organizations.
One of the key provisions of the PPACA centered on quality was the creation of a nonprofit Patient-Centered Outcomes Research Institute (PCORI) to conduct comparative effectiveness research (CER) in clinical care to inform decision making. This research will determine which interventions are most effective for different patient populations under various circumstances, and findings will be used to guide treatment pathways that support patient-centered, evidence-based, high-quality care. Gazelle and colleagues have proposed a framework for assessing the value of imaging on outcomes of interest to assist PCORI in selecting imaging for CER. They suggested that imaging technologies that could affect larger numbers of patients with smaller expected anticipated clinical benefits should require higher levels of outcomes data (Fryback and Thornbury’s diagnostic imaging efficacy hierarchy). If these imaging technologies also have the potential to substantially increase costs or not be cost-effective, the need for higher-level outcomes evidence is reinforced. Alternatively, if imaging technologies that would potentially affect a smaller number of patients, with higher anticipated clinical benefits, have a lower impact on overall costs and are likely to be cost-effective, then lower levels of outcomes data would be required.
In imaging, patient-centered outcomes extend beyond the traditional metrics of patient satisfaction. Instead, these outcomes should encompass all potential benefits and harms, focus on outcomes that are relevant to patients, and provide information to inform decision making. Therefore, it is important that radiologists be involved and participating on key committees that will set national agendas for patient-centered outcomes research, determine funding priorities, and communicate and disseminate evidence leading to integration of the best imaging evidence into policy.
In addition to enhancing their role in population screening, radiologists need to be at the forefront of CER, using their human capital, from the beginning of residency training, to pursue studies that demonstrate radiology’s value in affecting population-based health outcomes. Radiology organizations and societies should be contributing to discussions on the value of imaging and imaging-based interventions. Current and future efforts at improving population health will benefit from the collection of pooled data and the creation of robust registries, and radiology should be at the forefront of managing these large databases. The diagnostic work of radiologists benefits patients predominantly through directing care pathways. Decisions as to whether to treat, and how to treat, are often based on the results of a diagnostic imaging exam. The cognitive work of radiologists therefore plays a role in managing care and affects the costs of care. In an era in which population health will become a greater focus of policymakers, it is critical for radiology to stress the importance of its care management roles and to be reimbursed for its services. The explosion in imaging that has occurred over the past 20 years underlines the greater need for radiologists to act as stewards of appropriate imaging resources. The growth in imaging has resulted in an increase in incidental findings. Managing these findings consistently, to optimize patient health and effectively use imaging and healthcare resources for the population, is an important goal for radiology to pursue.
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