Below are some of the ways pathologists contribute to the six domains (listed in the order they appear on page 2 of the Strategy):

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1 January 10, 2014 Center for Medicare and Medicaid Services U.S. Department of Health and Human Services 7500 Security Boulevard Baltimore, Maryland Re: CMS Quality Strategy Submitted electronically to The College of American Pathologists (CAP) appreciates the opportunity to comment on CMS s Quality Strategy 2013-Beyond, released on November 18, The CAP is a medical society serving 18,000 physician members and the global laboratory community. It is the world's largest association composed exclusively of board-certified pathologists and is the worldwide leader in laboratory quality assurance. The CAP advocates for accountable, high-quality, and cost-effective patient care. The CAP s Laboratory Accreditation Program is responsible for accrediting more than 7,000 clinical laboratories worldwide. BACKGROUND: THE PRIORITIES OF THE NATIONAL QUALITY STRATEGY The CAP supports the Triple Aim (better care and lower costs, prevention and public health, and expanded health care coverage) as well as the six priorities of the National Quality Strategy. Indeed much of what pathologists do aligns with the six priorities, as described below. Pathologists contribute to each of the six domains. Diagnostic information that pathologists provide is used to inform decisions of treating physicians, patients, healthcare systems, payers, and policymakers. However, in some of these areas, pathologists contributions apply to a patient population as a whole, but are difficult to associate with an individual patient. Further, pathologists play pivotal roles in assuring the quality of laboratory results for all CLIA regulated laboratories in the United States. The benefits of these activities accrue to all patients who have laboratory services performed as physicians directly use laboratory results in their decision-making process. However, while the notion of incentivizing physician behaviors so they align with all aspects of the quality strategy might seem a reasonable approach, requiring all specialists to demonstrate alignment to all of the domains of the quality strategy is impracticable. Federal policy should incentivize physician behavior that aligns with the quality strategy, but demonstrating such alignment does not require an all-or-nothing approach for individual physicians. Below are some of the ways pathologists contribute to the six domains (listed in the order they appear on page 2 of the Strategy): 1. Patient Safety: Testing Protocols: Pathologists who provide medical leadership to hospital laboratories play a key role in identifying, testing and developing protocols that improve the care of every patient (e.g. protocols to avoid specimen misidentification, reduce blood use and deliver timely test results.) Accurate Diagnosis: Through laboratory testing and interpretation, pathologists also play a key role in ensuring patients get the correct diagnosis which is central to ensuring appropriate care. 2. Patient and Family Engagement: Communication of Test Results to Patients: Pathologists have traditionally typically worked behind the scenes to provide diagnostic services to patients by working with other clinicians. 1

2 Pathologists in some states are stepping out to meet directly with patients to discuss laboratory and pathology diagnostic findings. However, in many states, this is not possible because of restrictive state laws defining the authorized person under CLIA which prohibit pathologists from providing laboratory results directly to patients. CMS in cooperation with the HHS Office of Civil Rights and Office of the National Coordinator for Health Information Technology has issued a proposed rule to preempt more restrictive state rules to which CAP has previously commented. We understand that a final rule addressing this issue will be released soon. However, even under the final rule, pathologists may still be prohibited in some states from initiating contact. 3. Care Coordination: Laboratories as Key Sources of Information: The daily medical decisions made by pathologists and the laboratories they direct produce critical diagnostic information which is without question a key influence on health care, driving an estimated 70% of clinical decision making. Data produced in the pathology department and the clinical laboratory comprises a large portion of any patient EHR and influence a significant amount of medical spending. Pathologists work with their clinical colleagues to report critical information clearly. 4. Implementing Evidence-based Prevention and Treatment plans: Wellness Strategies: Pathologists participation in the creation of wellness testing panels and review of biopsies taken during screening procedures such as colonoscopies for patients over 50 years old is a critical component of evidence-based prevention and treatment plans. Disease Management: Pathologists also play a key role in diabetes management by monitoring HbA1C levels and managing testing strategies for blood clotting medicines such as warfarin. Appropriate Test Selection: Pathologists are increasingly serving as clinical consultants to their ordering physician colleagues on appropriate test selection and the delivery of patient-specific, expert driven narrative interpretations of complex clinical laboratory evaluations. 5. Population and Public Health: Wellness Screening: Pathologist s oversight of the clinical laboratory is central to creating meaningful data to be used in the health and wellness screening of populations. Public Health: Pathologists are important to ensuring public health through reporting cancer cases to state cancer registries as well as reporting cases of infectious diseases to other state public health reporting mechanisms. Pathologists also direct laboratories that play a lead role in infection control by identifying infectious agents and determining their likely causes (e.g. in the case of a hospitalized patient is a pathogen the result of a nosocomial infection or communityacquired.) 6. Making Quality Care More Affordable by Developing and Spreading New Delivery Models: Pathologists as Data Stewards and Providers of Medical Oversight: As physicians responsible for the medical oversight of the clinical laboratory, a service that touches patients throughout the spectrum of care, pathologists have a unique role in assuring effective clinical processes that reach patients beyond the laboratory. Pathologists run laboratories that must report and maintain quality systems for laboratory data and continuously monitor performance and evaluate errors. These skills lend to pathologists acting as data stewards and leading the way on integrating data that serves as the basis for ACO quality measures. Testing Protocols for Cost-Effective Care: Pathologists provide a value add in coordinated care systems such as by developing protocols for laboratory ordering, resulting in reduced costs for unnecessary tests and better outcomes as patients are more likely to get the right test at the right time; engaging in population health management, resulting in better outcomes and lower costs for patients with chronic illness; and improving physician access in the EHR to actionable data from the laboratory. CMS QUESTIONS AND THE CAP s ANSWERS 1. What are the top three quality strategies that you think CMS should focus on? 2

3 While all these strategies are important, Patient Safety, Evidence-based Practice and Population and Public Health are of the highest importance and most relevant to the practice of pathology and laboratory medicine. We would urge CMS to recognize the different ways that specialists can contribute to each goal. In particular, we ask CMS to not require individual providers to demonstrate adherence to all of the priorities given that not all are applicable to all specialty practices. Finally, we suggest that appropriate metrics be identified and we note that many important contributions to the goals are not easily reduced to quality metrics codeable using ICD-9/10 and CPT that are applicable to Medicare Part B billings. 2. Do you see your organization reflected in the strategy? If so, how will your organization help execute the CMS quality strategy? CAP does see pathologists reflected in the strategy at a high-level as indicated above, particularly with respect to harm reduction. Pathologists are responsible for infection control, avoiding specimen misidentification, use of wrong blood products, etc. Beyond the significant contributions of its individual members, the CAP as a medical society can contribute to a culture of safety through our various quality improvement programs. These are detailed in the attached Appendix. The CAP also helps to improve evidence-based practice through the CAP Pathology and Laboratory Quality Center. The Center develops evidence-based guidelines and consensus statements related to the practice of pathology and laboratory medicine. To view guidelines developed by the Center and current projects, see: We are disappointed that in CMS s discussion of Partners on page 7 that the CAP was not included. Like the Joint Commission, the CAP s has an accreditation program which plays a vital role in ensuring health care quality. CAP s Laboratory Accreditation Program is deemed by CMS as an inspector of laboratories for compliance with CLIA requirements, and accredits over 7000 laboratories. We note that CMS is focusing on partners that strive for better care throughout the healthcare system, however, as indicated above laboratory systems and data affect an estimated 70 percent of clinical decisions. Lastly, we would note that the Strategy emphasizes care coordination as patients move across settings of care, as well as partnering with federal, state and local public health entities to promote successful interoperability of health IT systems. Aligned with the Strategy, pathologists play significant roles in delivering timely laboratory results that can support care transitions and reduce duplication of testing. In addition to the delivery timely and accurate laboratory results, pathologists help guide subsequent treatment and care through their participation in multi-disciplinary tumor boards and other patient-centered conferences. Unfortunately, CMS definition of coordination of care in programs such as the Medicare and Medicaid EHR incentive program (AKA Meaningful Use) tends to be defined narrowly (e.g. it focuses on hand-offs between a patient s visit to a primary care doctor s visit and his or her visit to a specialist like a cardiologist) and does not recognize how physicians such as pathologists play a vital role in care coordination. 3. Please select the goal most applicable to your organization and provide your thoughts on how your organization can contribute to CMS efforts to achieve this goal. The goals of the Quality Strategy that are most applicable to the CAP are Evidence-Based Practice and Patient Safety. The work of the CAP s Center described above and the many CAP quality programs detailed in the Appendix show how CAP contributes to the Strategy in general and in particular to these goals. While the CAP supports the notion that payment incentives should accrue to those physicians with better health outcomes (such as reducing mortality from cardiovascular disease,) diagnostic physicians should not be penalized for activities of other physicians downstream in the patient s treatment. Instead, CMS should recognize that pathologists work to provide timely, accurate and actionable diagnostic information. Furthermore, we would encourage CMS to look beyond Medicare Part B in linking pathologists to the Strategy as many of pathologists contributions are in Part A or in new coordinated care arrangements. 3

4 Additionally, while CAP supports the principle of strengthening patient and family engagement, pathologists do not have significant direct patient contact. To the extent the federal government s strategy for pay-forperformance requires patient engagement, pathologists are at a disadvantage. While the Strategy notes the essential role of electronic data in CMS quality improvement activities, CAP has serious concerns about the lack of recognition for laboratory information systems (LISs) as an important use of technology, as well as about the potential for oversimplification or corruption of patient test results as data moves across the healthcare system from the LIS through electronic health records and perhaps even onto health information exchanges. CONCLUSION The CAP appreciates the opportunity to comment on this important document. We look forward to working with CMS to advance the Agency s Quality Strategy. Should you have any questions on our comments, please contact Julie Cantor-Weinberg, Director, Economic & Regulatory Affairs at (202) or via at jweinbe@cap.org or Fay Shamanski, PhD, Assistant Director, Economic & Regulatory Affairs at (202) or fshaman@cap.org. 4

5 APPENDIX: ILLUSTRATIVE EXAMPLES OF THE CAP S QUALITY PROGRAMS CAP Accreditation. CAP Laboratory Accreditation Program is responsible for accrediting more than 7,000 clinical laboratories worldwide. Pathologists must demonstrate compliance with over 2500 total quality standards primarily by means of an onsite inspection once every two years, plus demonstration of sustained compliance during the accreditation period as demonstrated by continuous monitoring of proficiency testing data, self inspection results, timely communication of laboratory-initiated changes for personnel and scope of services, and reporting of other quality metrics. Many of these programs are used in the American Board of Pathology s Maintenance of Certification (MOC) Programs and are thereby recognized by the CMS MOC PQRS programs. Evalumetrics: The CAP has developed a quality-monitoring tool for use in evaluating performance of pathologists based on a collection of 100 evidence-based metrics. This web-based software quality monitoring system meets The Joint Commission requirement for demonstration of provider competency using objective quality monitors to support the granting and maintenance of practice privileges in a healthcare organization. However, the tool does focus on measuring, monitoring, and reporting on pathologist specific performance. OPPE covers the six competency areas as defined by the Accreditation Council for Graduate Medical Education (ACGME) and American Board of Medical Specialties (ABMS): (1) patient care; (2) medical/clinical knowledge; (3) practice-based learning and improvement; (4) interpersonal and communication skills; (5) professionalism and (6) systems-based practice. The system provides a rules-based list of recommended metrics for each provider, based on the practice focus and scope. It covers both anatomical and clinical pathologists, as well procedural services that are conducted by pathologists. CAP Proficiency Testing: The CAP offers proficiency testing beyond what is required under CLIA regulation. CAP s accreditation program is recognized by CMS s CLIA program. The CLIA regulation lists specific tests that require proficiency testing, some of which are outdated. The CAP s program allows pathologists and laboratories to assess their ability to get accurate results on the most current tests in a laboratory s practice. Proficiency testing provides a quality tool to continually monitor the accuracy of testing results and compare individual results against their peers. Dermatopathology (DPATH); Virtual Biopsy Program (VBP); and Neuropathology (NP): The Dermatopathology program assesses pathologists, dermatopathologists, and dermatologists on their diagnostic skills in dermatopathology. Features of this educational program include digital image technology, and clinical images. (Two cases yearly, each including six diagnostic challenges.) The Virtual Biopsy Program assesses pathologists on their diagnostic skills in surgical pathology. Features of this program include use of digital image technology, and inclusion of gross, radiologic, or endoscopic images as appropriate. (Four cases yearly, each including five diagnostic challenges.) The Neuropathology Program helps anatomic pathologists and neuropathologists assess and improve their diagnostic skills and learn about new developments in neuropathology. Two mailings per year each including eight cases that cover the spectrum of neoplastic and nonneoplastic disorders. In addition to the cases, each mailing also includes a mini-symposium that focuses on a specific problem area in neuropathology, which relates to four of the eight cases. Like proficiency testing, these programs measure individual performance and provide a benchmark against peers. 5

6 Performance Improvement Program in Surgical Pathology (PIP). This program provides a performance based approach to surgical pathology and gives pathologists a method of assessing their diagnostic skills and comparing their performance with that of their peers. Similarly, the Clinical Pathology Improvement Program (CPIP) is designed to keep clinical pathology skills up to date. Cancer Care. An example of how pathologists facilitate quality care and coordination are the standardized cancer protocols known as Cancer Checklists. These are required for the American College of Surgeons (ACS) accreditation of cancer centers because they specify how cancer tissues should be examined in order to provide the necessary information to report and stage the cancer so patients can be appropriately treated after surgical resection. In order to assist pathologists in summarizing diagnostic information generated during the diagnostic review of cancer resection specimens, CAP has created these checklists which assist in the collation of the necessary information to report and stage the cancer so that patients can be appropriately treated by their treating providers after surgical resection. These checklists also are useful to hospitals who are seeking accreditation for their oncology programs by the American College of Surgeons. The information in these checklists produced by pathologists is the foundation of tumor registries across the country. These evidence-based checklist protocols are now available in electronic form, Electronic Cancer Checklists (eccs). The content of these Cancer Checklists are evidence-based and generally require evidence of level III-2 or higher (e.g. randomized or pseudo-randomized trial, a prospective cohort study or a comparative study that includes a concurrent control group) before a data element is included. The electronic version enables a synoptic format that allows the entry and retrieval of discrete data elements. Q-PROBES/Q-TRACKS. CAP offers a number of programs focused on laboratory improvement through data collection and comparison to other laboratories. The Quality Management Programs are designed to assist laboratories with issues specific to laboratory science and patient care and safety. The Q-TRACKS and Q-MONITORS topics are selected due to the impact feedback to the participating laboratories can have on patient safety and care issues such as Patient Identification Errors, Blood Culture Contamination Rates, and Completeness of Cancer Reporting. Data collection for the monitors is continuous across an entire year. The Q-PROBES are shorter-term studies whose topics origins are problems or issues laboratories may just be encountering. Q-TRACKS help to ensure accurate diagnoses, patient safety, and appropriate care through ongoing monitoring. Its monitors reach beyond the testing phase to evaluate the quality of processes both within and beyond the laboratory that can impact test results and patient outcomes. Q-PROBES are an external peer-comparison program that addresses process-, outcome-, and structure-oriented quality assurance issues. Participants establish benchmarks through external database comparisons and compare performance to establish laboratory goals and improve performance. Q-MONITORS are customized programs that address process-, outcome-, and structureoriented quality assurance issues. Participants establish benchmarks through external database comparisons and compare performance to establish goals for performance improvement. 6