The qualified clinical data registry (QCDR) represents a merging of two concepts in healthcare: first, collecting large volumes of clinical data to research and improve the quality of care provided and second, reimbursement adjustments based on the care quality. A provider's reported quality of care – and any associated reimbursement adjustments – therefore, depends on what measures of quality are used to gauge performance. To properly understand the current state of quality measurement in urology, we will examine the regulatory acts that brought quality measurement into everyday practice and eventually gave rise to QCDRs. We then will examine existing QCDRs that contain quality measurements for urological conditions, what those measures entail, and how these QCDRs can improve the quality of urology care provided.
HISTORY OF QUALITY MEASURES AND REIMBURSEMENT ADJUSTMENTS
The practice of adjusting reimbursements based on measures of quality began in the United States with the Tax Relief and Healthcare Act of 2006 , which prompted the Centers for Medicare & Medicaid Services (CMS) to create the Physician Quality Reporting Initiative (PQRI) that allowed physicians to report quality performance measures for a potential 1.5% increase in Medicare reimbursements . The PQRI initially used claims-based data submissions to track performance on 74 measures that were developed in conjunction with the American Medical Association, The National Committee for Quality Assurance, and other physician specialties . Six of these measures pertained to perioperative care (focused on antibiotic and venous thromboembolism prophylaxis) and only three measures were specific to a urological condition (female incontinence) .
In 2008, CMS certified 32 registries to collect clinical data on the measures and submit this registry data (in lieu of claims based data) to CMS on behalf of physicians, such registries have since been known as ‘Qualified Registries ’. With the passing of the Patient Protection and Affordable Care Act in 2010 , the PQRI program's permanence was established, and it became known as the Physician Quality Reporting System (PQRS). Although the total number of measures expanded to over 200 by 2014, only six pertained to urological conditions: the original three for female incontinence, and two measures on prostate cancer clinical care and one measure on prostate cancer pathology reports .
Policymakers recognized that defining and measuring quality of care by these relatively generic PQRS measures did not capture the scope of practice for many physicians, and with the passing of the American Taxpayer Relief Act of 2012 , Congress allowed for the development of specialty-specific metrics by medical associations . Putting this into action, in 2014 CMS began to certify previously established clinical data registries to develop and report these specialty-specific measures of quality in addition to and/or in lieu of the PQRS measures for reimbursement adjustments . Such measures were referred to as ‘Non-PQRS measures’ and the certified registries as QCDR. The ability to develop and report their own measures tailored to their specialty focus in addition to PQRS measures is one of the main differences between QCDR and qualified registries – as qualified registries only report PQRS measures.
With the passing of the Medicare Accessibility and Children's Health Insurance Program reauthorization Act of 2015 (MACRA) , PQRS was incorporated into the quality arm of the merit-based incentive payment system (MIPS) [9▪▪], under which physicians can participate in the Quality Payment Program (QPP) to receive up to a 4% payment increase on Medicare reimbursements in 2019, rising to 9% by 2022 . Conversely, physicians who decline QPP participation (i.e., not tracking or reporting any measures) will receive a 4% Medicare payment penalty in 2019, also increasing to 9% by 2022. Under MACRA, physicians can also participate in an Alternative Payment Model (APM) program as an alternative to MIPS, but to date few if any APMs exist which are relevant to urology care .
Thus, given the fiscal impact of quality measurement and performance, the importance of the measures included in a QCDR is profound. The original PQRS measures are now referred to as ‘MIPS Quality Measures,’ and the measures created by each QCDR are ‘QCDR Measures’. For 2018, 10 of the 275 MIPS Quality Measures pertain to urological conditions, two for female incontinence, three for prostate cancer, and five for pelvic organ prolapse (Supplemental Table 1, http://links.lww.com/COU/A14) . Of the 18 MIPS quality measures currently under development by CMS for future use, none pertain to urology . Thus, the need for QCDRs with urology-specific measures is significant to not only monitor and improve the quality of urological care across our specialty, but also to appropriately reflect the efforts of urologists who provide high-quality healthcare for urological conditions.
QUALIFIED CLINICAL DATA REGISTRY CERTIFICATION AND QUALIFIED CLINICAL DATA REGISTRY MEASURES
To become or maintain certification as a QCDR, each registry must self-nominate to CMS each year . The current QCDR requirements include: being a preexisting registry that collects clinical data for quality improvement and disease tracking on all patients (not just Medicare beneficiaries) from at least 25 providers, provide certification that clinical data and quality measures are audited, accurate, and complete, and electronically submit data to CMS .
When submitting the QCDR application to CMS, each registry may also propose QCDR measures. There are no strict measure development rules per se; however, CMS provides recommendations [13,15] and also states that ‘performance measures should be well established in the literature and clinical practice guidelines,’ and that measures ‘should not be based on emerging or controversial clinical procedures ’. CMS does state the measures should not focus on care standards that likely have high performance rates, rare diseases/occurrences, elements that are simply documentation-based, or measures beyond the eligible clinician's control .
In order for a proposed measure to be considered for approval, it must address at least one of the six national quality strategy  priorities: 1), person and caregiver-centered experience and outcomes, 2), patient safety measure, 3), communication and care coordination, 4), community/population health, 5), efficiency and cost reduction, 6), effective clinical care . Furthermore, most proposed measures are classified as either a process measure or an outcome measure. Process measures are healthcare activities that when executed will increase the probability of achieving a desired outcome  (e.g., providing appropriate antibiotics prior to prostate biopsy to decrease postbiopsy infections). Outcomes measures are the results of clinical care  (e.g., percentage of patients undergoing prostate biopsy with postbiopsy admission for sepsis). Outcomes measures also include Intermediate Outcomes which may not be perceivable to patients (e.g., blood pressure goals in patients with chronic kidney disease) and patient reported outcomes (e.g., urinary control following radical prostatectomy based on patient survey) . To the extent that measures are developed in concert with practice guidelines, it is important to recognize that the desired outcomes relevant to a given guideline are often assumed and unspoken. For example, the American Urological Association (AUA) guideline on the surgical treatment of female stress incontinence  naturally does not state ‘Do not cause a mesh erosion’; rather it includes process recommendations intended to avoid that adverse outcome. Thus, reoperation rates may be a relevant outcome measure even though not specifically mentioned in the guideline.
Additional measure types include cost/resource use (e.g., limiting use of diagnostic ultrasound in boys with uncomplicated unilateral cryptorchidism), structural measures that pertain to system wide healthcare infrastructure (e.g., reporting computed tomography scan radiation doses to a radiation registry), and patient engagement/experience measures which pertain to a patient's report of their healthcare experience (e.g., satisfaction survey) . Each provider submitting to MIPS using a QCDR must choose at least six quality measures including at least one outcome measure.
Each QCDR determines which aspects of quality care it wishes to measure given the clinical focus of that QCDR. CMS then reviews each proposed QCDR measure for approval based on the above recommendations. Given the relatively open-ended recommendations for QCDR measure development, the approval process can be somewhat subjective. Based on public correspondence from the Physician Clinical Registry Coalition (a group of medical societies that sponsor clinical data registries, including the AUA), the approval process for 2018 QCDR measures lacked standardization, transparency, and consistency . However, the process allowed for appeals and direct discussions between QCDR leadership and CMS. This approval process doubtlessly will be refined and standardized in future years.
THE UROLOGY QUALIFIED CLINICAL DATA REGISTRIES
For 2018, there are four QCDR that have urology-specific QCDR measures (Table 1) . The number and clinical conditions of QCDR measures varies between the registries. We did include the QCDR from the American Urogynecological Society (AUGS) given that urologists who focus on pelvic organ prolapse would find this registry more relevant to their practice. As noted in Table 1, these QCDRs do share some measures; however, between these four QCDRs there are 43 unique urology-specific QCDR measures for 2018. These include 33 process measures (77%), seven outcome measures (16%), two patient experience measures (5%), and one measure of cost/resource use (2%). Supplemental Table 2, http://links.lww.com/COU/A15 lists all the QCDR measures offered by each QCDR . To assess what these QCDRs are using as a basis for measure creation, we also determined which measures were in part or completely derived from guidelines, best practice statements, and/or position statements from the AUA, National Comprehensive Cancer Network, or American College of Obstetricians and Gynecologists. In total, 29 of all the 43 (67%) QCDR measures were derived from clinical guidelines/statements. Focusing just on the process measures (given that, as noted above, outcomes are often implicit), 28 of the 33 (85%) are derived directly from the clinical guidelines/statements (Supplemental Table 2, http://links.lww.com/COU/A15). Thus, the available urological QCDRs are using published recommendations as the foundation for measuring the quality of urological care. Although there will never be consensus among all urologists on every guideline statement, nor are guidelines meant to be blindly applied to all patients with a urological condition, the guidelines do serve as the most reasonable basis for measuring and assessing processes of urological care between providers. Next we will briefly review each of the four urological QCDRs and how they have or plan to utilize their measures of quality to improve urological care.
MICHIGAN UROLOGICAL SURGERY IMPROVEMENT COLLABORATIVE
Michigan Urological Surgery Improvement Collaborative (MUSIC) is the longest established urology QCDR, having achieved certification from CMS every year since 2014. The collaborative was initially established in 2011 with financial support from Blue Cross Blue Shield of Michigan (BCBSM) as a quality improvement collaborative of urologists across the state of Michigan with a focus on prostate cancer care . The financial support from BCBSM allows data collection via manual abstraction at each participating practice, as well as analytical and administrative support of the collaborative . MUSIC now represents over 85% of urologists in Michigan , and has an impressive track record of measuring and improving multiple aspects of prostate cancer care, including initial prostate biopsy [24,25], appropriate imaging for staging [23,26], and active surveillance use [27,28]. Two recent review articles have further explored the methodology behind collaborative quality improvement [29▪] and the use of clinical registries to improve quality [30▪] that have led to MUSIC's successes.
From the perspective of MUSIC as a QCDR, it offers participants the ability to track eight QCDR measures on prostate cancer care, from proper antibiotics at biopsy to active surveillance use and length-of-stay in hospital after radical prostatectomy (Supplemental Table 2, http://links.lww.com/COU/A15) . MUSIC certainly serves as the gold-standard of what can be accomplished within in a quality improvement collaboration; the hope is that these same principles will carry over to other QCDRs, where motivations to participate may initially be driven by MIPS reimbursement incentives.
AMERICAN UROLOGICAL ASSOCIATION QUALITY REGISTRY
The American Urological Association Quality (AQUA) Registry was initially launched by the AUA as a national urological disease registry with goals of improving quality and outcomes in addition to supporting research efforts on urological care . AQUA is by far the most representative urology QCDR in terms of both urologists represented and urologic conditions captured. AQUA successfully applied for QCDR certification in 2016. The registry collects data directly from the electronic health record (EHR) of each enrolled practice using software provided by FIGmd, Inc. (Rockford, Illinois, USA), which obviates much of the administrative burden of manual abstraction. The FIGmd software is able to integrate with over 60 commonly used EHRs . The AQUA Registry has participation from 448 urology practices across 47 states as of April 2017 .
For 2018, the AQUA Registry provides the most QCDR measures across the broadest spectrum of urological diseases (Table 1, Supplemental Table 2, http://links.lww.com/COU/A15). This list is expected to grow, in explicit concert with development and update of the AUA Clinical Guidelines, such that QCDR measures will be available for essentially all aspects of urology. Also, the AQUA Registry offers the first patient reported outcomes measures, which revolve around incontinence and erectile function following radical prostatectomy (AQUA29 and 30, Supplemental Table 2, http://links.lww.com/COU/A15). AQUA is younger than MUSIC, and while it has not yet matched the publication success of MUSIC, there is optimism that the same principles of feedback, benchmarking, and collaboration will lead to improved urological care across the country while providing a new resource for research endeavors.
AMERICAN UROGYNECOLOGICAL SOCIETY UROGYNECOLOGY QUALITY REGISTRY
AUGS Urogynecology Quality Registry (AQUIRE) is a national registry that is focused on measuring and reporting quality and outcomes for urogynecological conditions . CMS certified AQUIRE as a QCDR for 2017 with 10 QCDR measures mainly focused on prolapse and female incontinence (Table 1). Currently, the registry requires manual abstraction of data by participating practices, but the AUGS is currently working with FIGmd for EHR integration and abstraction to begin in 2019 . For those urologists who have a practice focused on urogynecological conditions, this registry may provide an ideal environment for quality improvement, benchmarking, and MIPS participation in addition to supporting research objectives.
INTRINSIQ SPECIALTY SOLUTIONS
IntrinsiQ Specialty Solutions (IQSS) (subsidiary of AmerisourceBergen Corporation, Conshohocken, Pennsylvania, USA) is the developer of UroChartEHR, which is an EHR marketed specifically to urologists . The company has also created a clinical registry that integrates directly with UroChartEHR, and this was certified by CMS as a QCDR in 2017 . The IQSS QCDR offers six QCDR measures across a small number of clinical domains (Table 1). This QCDR offers relatively seamless participation in MIPS for UroChartEHR practices; however, the quality data for these practices is ultimately controlled by a for-profit EHR vendor rather than a urologist-driven specialty society or quality collaborative.
QCDRs and their specific measures provide an infrastructure for quality improvement. Although QCDR participation for some will undoubtedly be initiated primarily for reimbursement adjustments, with the experience of feedback and benchmarking, each practice will hopefully be driven to improve its clinical performance. In this scenario, the positive payment adjustments will eventually prove a byproduct of the true goal: to improve the quality of urological care. No matter what the goal, however, the ongoing national conversation about urological care quality must be driven by urologists.
Financial support and sponsorship
Conflicts of interest
M.R.C. is the Senior Physician Advisor for the AQUA Registry.
REFERENCES AND RECOMMENDED READING
Papers of particular interest, published within the annual period of review, have been highlighted as:
- ▪ of special interest
- ▪▪ of outstanding interest
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