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SQA letter to CMS regarding PQRI

April 17, 2009

Michael Rapp, MD, JD
Director, Quality Measurement and Health Assessment Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244
PQRITemp@cms.hhs.gov

RE: 2010 Physician Quality Reporting Initiative (PQRI) Reporting Options

Dear Dr. Rapp,

The Surgical Quality Alliance (SQA) thanks the Centers for Medicare & Medicaid Services (CMS) for the opportunity to offer recommendations on reporting options for the 2010 Physician Quality Reporting Initiative (PQRI). The SQA’s mission is to bring surgical specialties and anesthesiology together to define principles of surgical patient quality and to develop meaningful tools for surgical quality improvement. The SQA enthusiastically supports programs that are truly designed to improve the quality of patient care, and we continue to demonstrate our commitment to delivering high quality care by helping to develop performance measures and by participating in public and private performance measurement programs. However, we are concerned about the lack of evidence that current programs, such as the PQRI, are having a positive effect on quality.

In considering reporting options for the 2010 PQRI, it is critical that CMS keep in mind that one model of quality reporting does not necessarily best fit all specialty care. CMS should therefore continue to offer various options through which a physician may report quality measures adopted or endorsed by a consensus organization (such as the NQF or AQA), including claims-based submission and reporting through registries and electronic health records (EHRs). By offering a range of alternatives, CMS can help ensure that the PQRI is actionable and meaningful for a range of patients and physicians. It is important that CMS also consider the level of physician burden that each reporting option would create and whether a reporting option would hinder CMS’ ability to make accurate eligibility determinations or provide physicians with meaningful and timely feedback. Reporting options that are overly complicated would call into question the effectiveness of the program for both physicians and their Medicare beneficiaries.

While the SQA appreciates CMS’ effort to expand PQRI reporting options, we also recommend that the agency seriously consider broadening the scope of quality improvement activities that would qualify a physician for the PQRI incentive payment. The long-term potential of the PQRI to truly improve quality across different specialties lies in its ability to accommodate multiple mutually reinforcing quality improvement strategies. Therefore, physicians should be recognized for a range of efforts that result in higher quality care and not simply the reporting of claims-based process-of-care measures.

While claims data are easy to collect, the claims system was developed for billing purposes only and not for quality measurement. As a result, claims data are limited in clinical scope and rife with inaccuracies and attribution errors. The SQA appreciates recent efforts by CMS to incorporate registries into the PQRI. However, the current registry reporting option is simply an alternative way for physicians to funnel limited claims data to CMS. Although it makes it easier for some physicians to participate in the PQRI, it does not take advantage of the detailed clinical data that can be accrued from registries.

The SQA is equally concerned about the relevance of the process measures currently used under the PQRI. While process measures can be readily acted upon and may be important in some clinical settings, such as primary care, they are poor indicators of the quality of surgical care and are not necessarily consistent with improved clinical outcomes. The inherent challenges of performing randomized controlled trials for surgical procedures often results in marginal consensus among clinicians on what constitutes best practice, which subsequently makes it difficult to identify high-leverage process-of-care measures for most surgical procedures.

Due to the limitations of process measures and claims data, the SQA requests that CMS consider expanding the PQRI so that it also recognizes physicians who engage in other, more robust quality improvement activities, such as prospective reporting to a clinical data registry or other similar database. Clinical data registries, especially those linked to electronic medical records, offer the benefit of claims data while also allowing for more accurate attribution and the collection of more detailed data over time, such as quality of life, patient experience and outcomes data. Continuous data collection through registries also is an excellent method for identifying specific patient characteristics that could serve as predictors of improved outcomes and for identifying and validating meaningful process measures.

The SQA envisions a pay-for-participation model where CMS would offer bonus payments to surgeons and other physicians who prospectively and continuously report to a clinical registry or other data collection instrument, and who use the collected data to reflect on their care, to link clinical processes to outcomes, and to make meaningful conclusions about the quality and cost of care. All of these attributes could be reflected in a “structural” measure, which would define minimum requirements, including: minimum case reporting requirements; the use of standardized definitions to ensure uniformity; the collection of specific information related to both processes and outcomes (including quality of life and patient experience data); and the registry host’s provision of timely, confidential feedback reports to participants, including analyses that link specific processes to outcomes and summaries of a physician’s performance relative to that of his/her peers. National specialty societies and other stakeholders would be responsible for the development, validation, and management of the registry, but CMS would have the authority to deem registry reporting that qualifies for this “structural” measure (similar to the current process CMS uses to select registries for the PQRI).


Due to a lack of adequate risk-adjustment mechanisms and the potential for unintended consequences, such as the misinterpretation and misuse of data, the SQA strongly advises against the publicly reporting of individually-identifiable physician data collected through registries. We believe that CMS could have a more significant impact on quality by instead focusing on incentivizing physicians to engage in behaviors that will make them more cognizant of the care they provide, such as the long-term collection and internal reflection of clinical data, and educating consumers about those physicians who engage in such practice.

The SQA would be more than happy to work with CMS to develop a structural measure that specifies criteria for appropriate data collection and quality benchmarking using
registries. In fact, there already exist a few nationally-endorsed structural measures dealing with participation in a national and/or regional registry that could serve as models, including a measure titled, “Participation in a Systematic Database for Cardiac Surgery,” which was endorsed by the National Quality Forum (NQF) and subsequently incorporated into the FY2010 Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) program.

Given the need for additional types of quality measures to enable more medical specialties and subspecialties to participate in the PQRI, the SQA appreciates that the Medicare Improvements for Patients and Providers Act of 2008 (P.L. 110-275) gives the Secretary the authority to select 2010 PQRI measures from a range of sources. While the Secretary is required to contract with a consensus-based entity, such as the NQF, that will supply CMS with standardized measures, the legislation also gives the Secretary the flexibility to select measures that are not so endorsed as long as they have been endorsed or adopted by another consensus organization identified by the Secretary, such as the AQA alliance. We encourage the Secretary and CMS to take advantage of this authority when considering uniquely structured quality measures that do not fit the typical measure mold, such as the registry reporting measure described above.

In an effort to identify current gaps in care and better understand and expedite the adoption of best practices, many surgical societies have launched, or are in the process of launching, specialty-specific clinical data registries. The surgical society members of the SQA are also now working to explore the feasibility of developing a common surgical data registry that would allow for the collection of more meaningful data across surgical specialties. The goal of these independent and collaborative efforts is to encourage a culture of continuous data collection and reflection, and to provide a standardized mechanism for surgeons to report data over time for multiple purposes, including public and private payer quality measurement programs, maintenance of certification, and general clinical research. These instruments will eventually allow surgeons to refine care processes that lead to better outcomes.

Unlike the PQRI, where data is often not available until a year after it is reported by a physician, clinical registries offer physicians real time feedback of meaningful and actionable information, which allows for the improvement of patient care in a timely fashion. The SQA is confident that CMS’ investment in this alternative reporting mechanism would be returned in the form of reductions in morbidity, mortality, and the costs associated with medical and surgical complications. Incentivizing registry reporting could also lead to decreased volume and better efficiency over time as physicians reflect on collected data, refine care processes that lead to better outcomes, and more clearly define indications for various procedures. CMS would also save valuable resources by making the collection and validation of data the responsibility of the registry’s host.

The SQA greatly appreciates CMS’ recent recognition of the need to accommodate the continued evolution of measures and reporting mechanisms, including increased attention to outcomes, increased recognition of the limitations of the current claims-based approach to data collection, and increased emphasis on the ability of clinical data sources, such as registries, to provide a more accurate picture of care provided. There is currently little empirical evidence supporting the superiority of one quality improvement strategy over the other and in most cases, the optimal model will depend on the clinical context. We therefore hope CMS will continue to “think outside of the box” when considering ways to expand the reach of the PQRI.

Should you wish to further discuss these recommendations, please feel free to contact Frank Opelka, MD, Chair of the SQA, at 504-568-6148 or fopelk@lsuhsc.edu.

Sincerely,

The Surgical Quality Alliance
American Academy of Ophthalmology
American Academy of Otolaryngology-Head and Neck Surgery
American Association of Neurological Surgeons/Congress of Neurological Surgeons
American College of Obstetricians and Gynecologists
American Academy of Orthopaedic Surgeons
American College of Osteopathic Surgeons
American College of Surgeons
American Pediatric Surgical Association
American Society of Anesthesiologists
American Society of Breast Surgeons
American Society of Cataract and Refractive Surgery
American Society of Colon and Rectal Surgeons
American Society for Metabolic and Bariatric Surgery
American Society of Plastic Surgeons
American Urogynecologic Society
American Urological Association
Society for Vascular Surgery
Society of American Gastrointestinal Endoscopic Surgeons
Society of Gynecologic Oncologists
Society of Thoracic Surgeons
The American Society of Transplant Surgeons