Quality Measures: Q&A with Pharmacy Quality Alliance

Ann Schwemm, PharmD, MPH, BCOP
Associate Director, Clinical Oncology
Flatiron Health, Inc
New York, NY

Ben Shirley, CPHQ
Director of Performance Measurement
Pharmacy Quality Alliance
Alexandria, VA

Quality measures are tools commonly used in healthcare today to help quantify various processes, outcomes, and patient perceptions. The Pharmacy Quality Alliance (PQA) is central to medication-related quality measures, which are often adopted by organizations, such as the Centers for Medicare and Medicaid (CMS) and integrated into value-based or quality-based payment programs.

Below, Ben Shirley, CPHQ, from PQA shares a bit about the organization and the processes around measurement development.

Can you share what the Pharmacy Quality Alliance (PQA) is and a bit about your role?
The PQA is a national quality organization dedicated to improving medication safety, adherence, and appropriate use. A measure developer, researcher, educator and convener, PQA’s quality initiatives support better medication use and high-quality care. PQA members include pharmacies, payers, providers, life sciences companies, academics, vendors, and more.

My role at PQA is Director of Performance Measurement, and I’ve been with PQA for about two and a half years. My work pertains to all things quality measures, including development of new measures, maintenance of endorsed measures, providing technical assistance to measure users, and supporting the implementation of PQA measures in quality programs like the Medicare Part D Star Ratings and the Health Insurance Exchange Quality Rating System.

Can you highlight some measures PQA has worked on and how they might impact oncology pharmacists?
PQA’s measure portfolio includes 32 health plan and 10 pharmacy measures. Most recently, PQA developed a standardized Specialty Pharmacy Turnaround Time (SP-TAT-PH) measure, which was endorsed in December 2021. This measure includes a medication list composed of specialty therapies across various categories. One of the categories includes oral oncolytics. The measure can be used by oncology pharmacists to understand their average turnaround time for new prescriptions for these products and can serve as a tool to assess progress when implementing quality improvement initiatives focused on optimizing turnaround time.

Later this year, PQA will convene national leaders to inform and prioritize PQA’s oncology-focused quality and research strategies, including opportunities for pharmacists and other providers to improve oncology medication use quality.

Can you share, at a high level, what it means that PQA is a “measure developer”?
Simply put, measure developers are organizations that create quality measures. As the healthcare system has increasingly shifted from paying for volume to paying for value, the importance of metrics that can accurately and fairly assess quality of care has grown considerably. Measure developers are specialized organizations that combine expertise in clinical care, measurement science, statistics, program management and population health to develop rigorous quality measures that meet high standards.

PQA’s development process also integrates patient partners to ensure the patient voice and preferences are reflected in quality measurement. Because of PQA’s multi-stakeholder, consensus-based measure development process, once PQA measures are endorsed by our membership, they are suitable for their intended use in the marketplace and can be adopted into various programs. Visit our measure-development page at pqaalliance.org to learn more.

It’s important to note that PQA is not only a measure developer, but also a measure steward. After developing and endorsing measures, PQA uses a systematic, consensus-based maintenance process to ensure those measures continue to align with current evidence and guidelines and remain relevant over time. As a steward, we support use of our measures and work closely with program administrators to ensure accurate implementation. We also provide technical support to measure users, create educational content and webinars, and more.

What key characteristics does PQA consider when developing a measure?
PQA uses standard measure criteria to evaluate measures, which closely align with criteria used by other organizations such as the National Quality Forum and CMS in the Measures Management System Blueprint.

The first criterion is importance, which looks at how important a given concept is to measure and report. For example, is the measure evidence based? What is the size of the patient population included in the measure, and to what extent are those patients affected by the processes or outcomes assessed in the measure? Is there a gap in performance such that there’s opportunity for improvement?

The second criterion is scientific acceptability, which is broken down into two concepts: validity, which tells us if we’re truly measuring what we intend to measure, and reliability, which tells us if our measurements are consistent, and whether differences in score are due to quality or just due to statistical noise or chance. These questions are answered through the measure testing process and through expert input.

The third criterion is feasibility. A measure may be important, valid and reliable, but if we can’t measure it due to data availability, it doesn’t do us much good. Feasibility addresses whether we have the tools, the data, and the reporting infrastructure to implement the measure without introducing too much burden.

The final criterion is usability. It’s helpful to think of this as if we build it, will they come? Is there an opportunity for implementation in programs or contracts? Are the results meaningful to the users of the measure, and can they be used to drive improvement? Finally, are there any concerns about unintended consequences?

What do you recommend those using the measures for quality improvement consider?
Accurate measurement is a critical part of any quality improvement initiative. Many quality improvement initiatives use a “plan-do-study-act” (PDSA) approach to evaluate interventions. Without appropriate measurement, the ‘study’ portion of the PDSA cycle will not be successful. Therefore, using quality measures to set targets and track progress towards those targets can be an excellent way to improve quality over time.

The measures created by PQA are often integrated into various quality or value-based payment programs. What process does PQA go through to prioritize measures to develop?
Deciding which new measures to develop, especially given a finite amount of time and development resources, is an important consideration for PQA. To that end, the first stage of the PQA measure development lifecycle is conceptualization, which focuses on systematically prioritizing measure concepts for development.

The conceptualization process begins with environmental scanning and gap analyses that evaluate measurement needs in current programs. For example, a recent round of conceptualization identified a lack of health plan measures focused on the chronic obstructive pulmonary disease (COPD) population. Following the environmental scan, potential measure concepts are shared with and discussed by a Measure Concept Advisory Group (MCAG). The MCAG is a group of experienced PQA members representing a diverse mix of stakeholders who are charged with evaluating potential measure concepts based on criteria like importance, feasibility, and usability to advise PQA on priorities.

Measure concepts recommended for development by the MCAG are then released by PQA for a round of public comment to gain further insight. Based on public comments, MCAG input, and staff deliberation, PQA finalizes priorities, launches Technical Expert Panels for chosen concepts, and begins the specification process.

Is there anything else in the measure development process our readers should know?
Developing measures takes time! The timelines can vary based on the complexity of the measure, but 18-24 months is a common end-to-end development for a relatively straightforward measure. Whether it’s initial conceptualization, convening and meeting with our expert panels, the testing process, or achieving PQA-endorsement through our consensus-based process, there’s a lot of work that goes into creating a quality measure.

Beyond development, implementing measures into programs also takes time. For example, a measure being added to the Medicare Part D Star Ratings might start out in the Patient Safety Reports for health plan internal quality improvement. If a measure is being considered for Star Ratings, it would be added to the Display Page for at least two years, and then go through the rulemaking process before moving into the Star Ratings. All in all, the process can take quite a long time.

Can you share with us considerations related to current medication adherence measures and why they may not be able to be directly applied to oral anticancer agents?
PQA’s adherence measures are calculated using prescription claims data based on the proportion of days’ covered (PDC) methodology. This approach has been empirically validated, and use of the PDC measures has been associated with substantial impacts on patient health and cost reductions in reports like the CMS National Impact Assessment.

The PDC methodology may not be appropriate for assessing adherence to certain medication classes. For example, it is not possible to discern the rationale for medication discontinuation using prescription claims data. For that reason, it’s important to only include medication classes expected to be used on an ongoing basis. This can introduce challenges with oral oncolytics given the possibility for decreased dosage or discontinuation due to toxicity. Another important aspect of PDC measures is a clear evidence base for the medications included in the measure. Oral oncolytics have a highly complex evidence base that varies across specific regimens, which can introduce substantial complexity with fairly assessing adherence when individuals switch among different regimens.

In internal evaluations and in external groups and task forces PQA has participated in, adherence or persistence to oral oncolytics has been noted to be quite challenging for measurement due to these considerations, and additional pre-development analyses and research may be needed to inform potential development. Other areas, such as provider-patient communication or screening for medication access challenges have been raised as potential alternatives.