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November 17, 2015

Mr. Andrew M. Slavitt Centers for Medicare & Medicaid Services Attention: CMS-3321-NC P.O. Box 8016 Baltimore, MD 21244-8016

Re: Request for Information Regarding Implementation of the Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models

Dear Acting Administrator Slavitt,

The American Society for Clinical Pathology (ASCP) is grateful for the opportunity to present comments in response to the Request for Information (RFI) Regarding Implementation of the Merit-Based Incentive Payment System (MIPS), Promotion of Alternative Payment Models (APMs), and Incentive Payments for Participation in Eligible APMs (EAPMs). The ASCP is a 501(c)(3) non-profit medical specialty society representing more than 100,000 members. We are one of the nation’s largest medical specialty societies and the world’s largest organization representing the field of laboratory medicine and pathology. ASCP membership is uniquely diverse, consisting broadly of board certified pathologists, other physicians, clinical scientists, certified medical technologists and technicians, and educators. Together, our mission is to provide excellence in education, certification, and advocacy on behalf of patients, pathologists, and laboratory professionals in an effort to advance medicine and improve patient care.

THE MERIT-BASED INCENTIVE PAYMENT SYSTEM (MIPS)

ASCP appreciates the Centers for Medicare and Medicaid Services’ (CMS) collaborative effort with Congress to achieve meaningful and substantial payment and delivery system reform through the establishment of the MIPS in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). For years, pathologists have faced difficulty successfully participating in the Physician Quality Reporting System (PQRS), while being entirely precluded from participating in the Electronic Health Record (EHR) Incentive program. Similarly, it has more recently become apparent that the Value-Based Payment Modifier (VBM) program is also structured in a manner that is not capable of capturing pathologists’ quality reporting and improvement efforts. In response to these challenges, ASCP is truly grateful to CMS for reaching out to the pathology and laboratory community for feedback and input throughout its efforts to reform these very narrowly structured pay-for-performance programs. Accordingly, it is the Society’s hope that the Agency make a genuine attempt to improve and expand these quality reporting programs so that they more effectively capture a broader array of specialty providers’ quality improvement efforts along the entirety of the patient care continuum. Absent movement toward more robust quality measures and flexible program requirements, CMS is merely amplifying participation challenges and hindering quality improvement efforts with the consolidation of these three currently flawed quality reporting programs. Simply put, ASCP cautions that three wrongs don’t make a right.

In line with these fears, prior to providing specific feedback on the questions posed in this RFI, ASCP stresses the importance that CMS consider making fundamental changes to each of the programs in order for them to be effective upon consolidation. The Society reiterates its concern that the programs

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were not developed with specialty providers in mind. Accordingly, the current programs are limited not only in their ability to capture specialists’ quality reporting and improvement efforts, but also in their ability to capture and influence the full scope of the patient encounter. In demonstration of the innate incongruities between the current quality reporting program traits and the traits of the pathology specialty, ASCP presents the following chart. The Society chose to present this information upfront, as it lays the groundwork for many of ASCP’s comments and may dually serve as a foundation of CMS understanding throughout the Agency’s review of this comment letter.

MIPS Eligible Professional (EP) Identifier

ASCP advocates for the use of a MIPS EP identifier that is both simple and flexible. Therefore, the Society encourages CMS to maintain identification via each EP’s Tax Identification Number (TIN)/ National Provider Identifier (NPI) combination. ASCP believes that the use of the TIN/ NPI combination will streamline program consolidation and advancement, resulting in a seamless and non-disruptive transition from the current quality reporting programs to MIPS. Conversely, the Society cautions that the introduction of a unique MIPS identifier may yield additional administrative burden for both CMS and EPs, require time-consuming and expensive infrastructure investments, present timely registration challenges for many EPs, and potentially require an additional field on the 1500 claims form.

ASCP is aware of the administrative and operational challenges currently faced when an EP bills under multiple TINs and/ or moves from one TIN to another during a reporting period. Accordingly, the Society suggests the use of the Clinical Laboratory Improvement Amendments (CLIA) Number in lieu of a TIN for pathologists. This is the ten digit number given to all laboratories for laboratory-level identification upon reporting of quality management and assurance efforts in accordance with CLIA requirements. CMS could use an NPI/ CLIA # combination for individual pathologist identification or consider the option of tracking laboratory-level quality measures at the group-level solely with the CLIA #.

Nonetheless, whether CMS uses the TIN or the CLIA # to assess group-level performance under MIPS, ASCP urges the Agency to allow EPs under a single TIN or CLIA # to report via multiple reporting mechanisms in lieu of requiring reporting via a single mechanism. Accordingly, sub-groups of EPs representing different subspecialties may want to report under different subspecialty-specific Qualified Clinical Data Registries (QCDR). Additionally, some EPs may have access to EHRs for the reporting of electronically-specific Clinical Quality Measures (eCQMs), while others may not have access or the eCQMs may not be applicable to their practice. As such, ASCP also encourages CMS to afford individual EPs the opportunity to utilize multiple reporting mechanisms for successful reporting of individual measures. Of note, it’s important to clarify that ASCP is not requesting that CMS allows EPs to report a

Key Conflicting Traits Pathology Specialty CMS Quality Reporting Programs

Place of Service Laboratory/Hospital Physician Office/Outpatient Hospital

Medicare Billing Part A and Part B Part B Only

Service Type Test Consultation/Treatment

Service Goal Accurate and Timely Diagnosis Improved Health Outcome

Essential Phase Along Care Continuum Pre- and Post-Analytic Analytic

Patient Interaction Lack of Face-to-Face Meaningful Face-to-Face

Utilization Referral-based Clinician-driven

Care Management Population-level Patient-level

Primary Electronic Information System LIS/APIS/Transfusion Systems EHRs

Quality Improvement Assessment System-level

(i.e. hospital-/laboratory-wide) Patient-level

(cond.-/trmt.-specific; auditable via claims)

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single measure multiple times through various reporting mechanisms. Lastly, the Society encourages CMS to maintain all currently available reporting mechanisms and consider the approval of additional reporting mechanisms in line with a broader range of providers’ practice patterns and locations.

Virtual Groups

ASCP restates its request for maximum flexibility and minimum additional administrative burden for physicians, small practices, and other EPs seeking to form virtual groups. In particular, the Society requests no initial, annual, or other limits placed on the maximum number of virtual groups approved each year. Similarly, ASCP urges CMS not to impose additional limits on the size, geographic proximity, and/ or specialty type of each virtual group. The Society asserts that such limitations could harm practices with limited resources and administrative support. ASCP further notes that this would be counter-intuitive given that smaller groups with limited resources are exactly the groups anticipated to benefit from the option to join a virtual group.

Nonetheless, ASCP strongly recommends that the option to create or join a virtual group remains an option and does not become mandatory. Moreover, the Society cautions CMS that poorly performing EPs may seek to game the system with this option and thus urges the Agency to consider ways to prevent against EPs “cherry-picking” or “gerrymandering” upon establishment of virtual groups.

Quality Performance Category

Current PQRS Reporting Mechanisms & Criteria

As stated in ASCP’s comment letter in response to the CY 2016 Medicare Physician Fee Schedule (PFS) Proposed Rule, the Society appreciates that CMS has finally clarified that EPs who practice in independent laboratories will be held harmless from negative payment adjustments because they are unable to participate in PQRS through no fault of their own. However, ASCP implores the Agency to more specifically clarify that it is unable to assess claims billed with POS 81 under the laboratory National Provider Identifier (NPI) at the provider-level for purposes of provider-level assessment under PQRS. Accordingly, the Society encourages CMS to address the nearly 1,400 pathologists that billed under Medicare Part B in CY 2013 but were not eligible for PQRS.

More broadly, ASCP reiterates its ongoing concern regarding the inapplicability of the PQRS program to the pathology specialty. Though an increasing number of pathologists are able to “participate” in PQRS, the Society notes a few participation trends that suggest diminishing applicability of the individual pathology-specific PQRS measures and thus the PQRS program as a whole to the pathology specialty. First, upon review of the CY 2013 PQRS Experience Report Appendix, it is apparent that the number of EPs decreases for each of the eight available pathology-specific PQRS measures when comparing eligibility for the CY 2012 reporting period with the CY 2013 reporting period. In fact, eligibility for each of the eight measures decreases by a range of 7.5 percent to 12.3 percent. This is exemplary of the measures’ diminishing applicability to the clinical workflow, practice locations, and subspecialty types of pathologists and therefore also the program’s diminishing ability to capture the quality improvement and reporting efforts of the pathology specialty.

Additionally, 12 of the 17 percentage point increase in the number of pathologists eligible to participate in PQRS from CY 2012 to CY 2013 is attributable to an increase in the number of pathologists electing to participate via the Group Practice Reporting Option (GPRO). While ASCP appreciates that CMS made the GPRO an available reporting mechanism for the pathology-specific PQRS measures in CY 2013, the Society cautions the Agency not to interpret this increase in pathologists’ overall PQRS participation as an indicator of enhanced program applicability to the pathology specialty. Rather, the nature of this

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increase is not necessarily substantive because not all EPs participating via GPRO have to directly report provider-level measures. Instead these EPs may simply draft behind the majority of the other EPs within their TIN who are capable of successfully reporting on applicable quality measures. Of note, all of the nearly 1,700 pathologists participating via GPRO in CY 2012 drafted behind non-pathologist physicians. However, the proportion of pathologists that reported measures versus drafted behind either non-pathology measures or pathology-specific measures in CY 2013 is unclear upon review of the CY 2013 PQRS Experience Report Appendix. Regardless, ASCP simply notes that an increase in PQRS participation does not directly translate to an increase in the number of EPs meaningfully impacting the quality of care delivered to an increasing count of Medicare beneficiaries.

Moreover, in addition to this deficit in the quality of existing pathology-specific PQRS measures, ASCP reiterates its concern with the inadequate quantity of pathology-specific measures. Specifically, the Society restates its concern with CMS’ decision to require the reporting of nine measures when there are currently only eight pathology-specific PQRS measures available for reporting. While ASCP appreciates that the Agency has clarified that EPs will only be held accountable for successfully reporting the number of measures applicable to their specialty, the Society maintains that CMS should not establish reporting thresholds until all physicians participating in Medicare Part B have at least one applicable PQRS measure. Furthermore, ASCP questions the purpose of a reporting threshold if CMS truly intends to continue to uphold its promise to only hold EPs accountable for reporting on the maximum number of measures applicable to their specialty. Accordingly, the Society reiterates its message that the Agency does not need to strive toward uniformity for the sake of uniformity if it doesn’t drive quality improvement. Moreover, certainly ASCP would discourage CMS from reinforcing uniform measures thresholds if doing so actually threatened providers’ ability to improve the quality of the unique care they deliver.

Additionally, the Society asserts that it is especially inappropriate for CMS to maintain this high measures threshold for reporting given the introduction of the additional performance category known as the Clinical Practice Improvement (CPI) activities. ASCP anticipates that these CPI activities will inherently target a wider array of quality interventions and thus span across multiple National Quality Strategy (NQS) Domains. As such, the Society encourages CMS to revoke its current specification that the required nine measures must span across at least three of the NQS domains. Rather, ASCP encourages the Agency to provide more flexibility for measures to satisfy multiple domains. The Society also urges CMS to consider use of the Domains merely as a loose guide for measuring national quality goals rather than as stringent guidelines.

Quality Measure Types & Weighting

ASCP understands that the MIPS quality performance category will be based on both the current PQRS measures as well as the three outcome measures assessed under the Value-based Payment Modifier (VBM) program. This is disconcerting given that the current program applicability challenges that pathologists’ face when attempting to participate in PQRS are only further exacerbated under the VBM program. In particular, this is due to the dependency of the value modifier calculation on an EP’s quality performance under PQRS. Accordingly, many pathologists do not have any applicable PQRS measures and therefore there is nothing for CMS to assess for this portion of assessment under the VBM program’s quality composite. The remaining metrics within the quality composite are intended to assess the outcomes resulting from treatment administered during the analytic phase of the patient care continuum. Unfortunately, these three outcome metrics are therefore also not applicable to pathologists, who primarily administer patient services at the pre- and post-analytic phase. Worse yet, even in the case in which one could argue that pathologists do have control over patient outcomes and hospital readmissions for a chronically ill patient, pathologists will not likely have large enough patient

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sample sizes for assessment because the VBM program’s patient attribution methodology is based on primary care services.

ASCP understands and supports CMS’ stated intention to move toward more patient outcome measures. However, the Society maintains that the establishment of and adherence to evidence-based process measures are foundational steps prior to developing and reinforcing outcome measures. Accordingly, ASCP reiterates that the definition of a “high value” measure is not uniform across all specialties. Rather, measure applicability varies based on specialty and practice setting, as well as a host of additional clinical and operational variables. For example, it is challenging to attribute the patient’s health outcome at the end of the patient’s care continuum to the correct, appropriate, and timely diagnosis at the forefront of the patient care continuum. However, if CMS is flexible with its definition of “outcome,” the Agency may accept measures that assess outcomes at each of the three significant phases along the patient care continuum: diagnosis, treatment, and care management. As such, CMS might consider measuring the outcome of effective diagnosis, which could include timely and directed patient treatment decision-support and care coordination efforts.

Regardless of whether or not outcome measures are applicable to pathologists, ASCP strongly recommends that CMS address all of the methodological issues underlying currently available outcome measures. In particular, the Society requests that the Agency significantly improve the risk-adjustment and attribution methodologies behind existing outcome measures prior to considering the assignment of additional weight to outcome measures. Accordingly, the Society notes several findings reported in the CY 2013 PQRS Experience Report Appendix that indicate poor risk-adjusting and benchmarking capabilities and thus bring into question the VBM program’s effectiveness in accurately, fairly, and meaningfully capturing and comparing provider performance on cost and quality metrics. For example, the Appendix reports that higher performing providers were less likely to treat high-risk beneficiaries, including beneficiaries with the four targeted chronic conditions. Similarly, high performing providers under the VBM program had fewer admissions, on average, for Acute and Chronic Ambulatory Care Sensitive Conditions (ACSCs) compared to providers receiving lower scores on both cost and quality metrics.

More broadly speaking, current attribution methodology has led to small sample sizes that threaten the validity of the data. Additionally, CMS’ risk-adjustment approach has not successfully stratified enough relevant variables to fairly and accurately assess provider-level accountability. Meanwhile, infrastructure challenges remain. Not only are there general interoperability challenges impeding CMS’ ability to completely and accurately extract all of the necessary data needed in order to tie a patient outcome to an individual provider, but there remain specific challenges with patient-reported outcome measures and experience of care measures. Furthermore, the lack of uniform patient identifiers presents an ongoing challenge for EPs seeking to longitudinally track patient outcomes over time and across multiple provider settings.

Nonetheless, until outcome measures are feasible for all specialty-types, ASCP maintains that it is unfair to assign them additional weight, even once methodological issues are resolved. Similarly, the Society opposes any requirement for EPs to report on a certain minimum number of outcome measures. In fact, ASCP urges CMS not to require the reporting of any specific types of measures. Rather, the Society cautions that any effort to specify and restrict the types of measures required for reporting may actually hinder participation and measure development.

In lieu of CMS prospectively designated required measures types, ASCP suggests that measures are developed in response to the needs of the providers’ unique and diverse patient populations. Accordingly, while ASCP appreciates CMS’ acknowledgement of “non-patient-facing professionals” in the MACRA legislation, it is unclear what the Agency means when it says that it will apply “alternative

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measures or activities that fulfill the goals of the applicable performance category.” Rather than try to establish these alternative measures or activities within the confines of the quality performance category, ASCP recommends that CMS allow for the transferring of weight from the performance category to the CPI activities category. The Society maintains that such an approach would likely prove the least administratively burdensome, while also proving the best way for establishing measures that are flexible enough to capture pathologists’ broad quality improvement efforts. As such, ASCP anticipates that many of the activities captured in the CPI activities category are more likely to meaningfully and accurately represent the current quality assurance and management efforts of pathologists. In summary, the Society requests that EPs and groups of EPs have the flexibility to adjust the weights of the four performance categories in a manner that best aligns with their practice patterns, location, and subspecialty, as well as the HIT tools readily available to them.

Lastly, ASCP implores CMS to consider expanding its definition of “hospital-based providers” and allow for the attribution of hospital-level quality performance scores to individual EPs deemed hospital-based accordingly. Currently, roughly 65 percent of all pathologists practice in a hospital-based laboratory. As such, EP’s quality improvement impact often expands beyond the individual patient to the population-level across all hospital patients. Accordingly, hospital-based pathologists provide diagnoses for both inpatients and outpatients. Should CMS fail to extend this as an option to pathologists, ASCP encourages the Agency to consider allowing laboratory-level measures under the CPI activities performance category.

Balancing Data Quality and Accuracy

Data Stratification: Stratifying data by key demographic variables is important not only from a patient access standpoint but also in ensuring accurate and fair quality performance comparisons among like providers. However, if CMS wishes for EPs to stratify data by variables such as race, ethnicity, and gender, it should ensure that EPs have full access to this data, regardless of their practice location or the HIT available to them. Accordingly, ASCP requests that the Agency consider providing QCDRs with more open access to CMS claims and EHR data. Additionally, the Society requests that CMS work with both the Office of the National Coordinator of HIT (ONC) and the Office of the Inspector General (OIG) to prohibit data blocking. Absent easy and affordable access to robust patient data, administrative burden and costs may inhibit EPs ability to stratify data by these variables. Of note, CMS must consider reduced sample size as a potential negative byproduct of data stratification, as it threatens both the validity and statistical significance of the data. As such, ASCP recommends that the Agency take action to counter this effect as much as possible.

Data Testing: It is essential that CMS validate all calculated reporting and performance rates as data is submitted via all reporting mechanisms and HIT systems. In flagging errors on both data format and values, CMS is maintaining and enhancing data integrity. Accordingly, ASCP recommends ongoing data validation and auditing. Additionally, the Society recommends that CMS begin to require preliminary CMS-sponsored data submission testing, rather than simply encouraging it.

Data Standards: ASCP supports the 2015 Edition Certification requirement that all HIT modules must be at least certified to the QRDA standard prior to the electronic submission of Clinical Quality Measures (CQM) data. While the Society understands the interoperability benefits of adhering to standards for data capture and transmission, ASCP also reminds CMS of the substantial operational technicalities and infrastructure investments underlying implementation of these standards. As such, the Society requests that the Agency provide ample notification, testing periods, and conversion guidelines to allow previous users who report data in the XML format to transition towards QRDA I and III formats in order to remain in programmatic compliance.

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Beyond standards for data transmission, ASCP supports the establishment of standards for data structure. The Society encourages CMS to align the process and timelines for the MU program and PQRS measures development and program advancement with ONC’s EHR/ HIT certification process. Nonetheless, the Society notes that when data elements aren’t already structured, it delays adherence to certification requirements. Therefore, ASCP requests that CMS cease requiring the collection of certain data elements until such elements are identified as needed for a specific quality measure. Instead, ASCP urges CMS to work with specialties to consider data elements of specialty-specific importance and require capture accordingly. The Society also requests that the Agency put out a list of required structured data elements and work with vendors to ensure capabilities to completely and accurately capture these data elements in a structured format prior to requiring the reporting of measures containing these data elements. Accordingly, ASCP emphasizes that it semantic interoperability across Laboratory Information Systems (LISs) and EHRs or QCDRs is only achieved upon standardizing both data transmission and data format. However, the Society reiterates that neither of these tasks is easy or cheap and therefore ASCP encourages CMS to work with vendors, subsidize related infrastructure investments, and resist enhancing certification requirements beyond vendor capabilities and evidence of widespread adoption of existing standards.

Data File Format Review and Qualification: It is critical that QCDRs know prior to reporting whether or not their file formats are accurate. Hence, ASCP requests that CMS provide QCDRs specifications and access to the testing portal within a reasonable time period prior to the CMS approval date (currently May). As long as QCDRs demonstrate their ability to test data for both format and validity, the Society urges CMS to ensure that it is capable of accepting varying data submission formats in line with the unique needs of each specialty. If a QCDR, qualified registry, or EHR is still not submitting accurate, complete, and reliable data after being given adequate opportunity for initial testing, validation, and data correction, then ASCP supports CMS placing the vendor on a corrective action plan. However, the Society urges the Agency to consider a mechanism for holding harmless the EPs utilizing this vendor, given reporting compliance was not in their direct control. Lastly, ASCP strongly encourages CMS to notify any impacted EPs through written mail when data is deemed invalid.

Resource Use Performance Category

Current Measures and Weights

It is ASCP understanding that this category will be based solely on the cost measures within the current VBM program. Unfortunately, also due to pathologists’ position at the forefront of the patient care continuum and to the referral-based nature of the pathology specialty, it’s very challenging to fairly allocate costs or assess and attribute Medicare spending per beneficiary. Accordingly, while the VBM program was intended to expand upon PQRS and capture a broader picture of quality with the introduction of comparative and cost elements, it actually may be even less applicable to pathologists than PQRS. Moreover, due to the VBM program’s primary care service-based attribution methodology, its inability to capture valid and reliable data on cost and quality metrics expands beyond pathologists to other specialty providers as well. This is evident upon review of the 2015 Value-Based Payment Modifier Program Experience Report, which reveals that roughly 17 percent of the EPs that elected the quality tiering option did not have adequate data for reporting. Worse yet, the 2015 Value Modifier Results reveal that the application of quality tiering to all groups of 100 or more EPs actually increases this number to almost 21 percent. In response to these figures and the increasing likelihood of program inapplicability to the pathology specialty, ASCP requests that CMS either default to an “average” score for both the cost and quality composites or completely exempt EPs from resource use performance category assessment absent adequate data for either cost or quality measures.

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Furthermore, ASCP emphasizes the unique challenges in attempting to attribute total patient cost to a referral-based provider with no direct control over decisions involving the selection of diagnostic tests or follow-up treatments with varying price tags. Conversely, though pathologists don’t always have control over diagnostic test or treatment decisions, measures indicating the existence and/ or use of diagnostic and treatment algorithms, appropriate use criteria, and test compendiums may be more appropriate for this referral-based specialty at the forefront of the patient care continuum. Accordingly, ASCP maintains that CMS would be better served to allow pathologists to weigh this category at zero and report on resource-use measures under the CPI activities module instead. Nonetheless, the Society cautions that an EP that weighs a category zero will face added pressure to perform well in the three remaining categories for which the weight has been redistributed. ASCP encourages CMS to find a way to compensate for this negative byproduct of partial program inapplicability to an EP’s practice.

Similarly, while Appropriate Use Criteria (AUCs) and Choosing Wisely measures may serve as a foundation for many resource use measures for reporting under the CPI activities category, ASCP does not condone mandatory reporting of AUCs or Choosing Wisely measures for partial or total fulfillment of MIPs and thus maintains that it is premature to directly tie the programs to MIPS. Moreover, specialties vary in the number of AUCs developed based on the ability of the specialty to first reach consensus on evidence-based guidelines. For example, the field of pathology is somewhat behind in the development of AUCs because it takes significant time to develop evidence-based guidelines when the number of possible diagnostic tests for each patient condition is constantly increasing and the number and type of referring clinicians that could potentially be consulted during guideline development is thus constantly expanding. Additionally, while ASCP serves as the proud leader of the Choosing Wisely initiative on behalf of the national pathology and laboratory community, the Society notes that many of the pathology measures are based on clinical pathology tests, rather than anatomic pathology tests, and thus cannot be assessed at the provider-level for incorporation in existing quality reporting programs. However, if CMS considers expanding quality reporting and improvement assessment to the laboratory-level, many of these Choosing Wisely measures may be able to be adapted into resource use measures. Nonetheless, absent such program expansion, even the measures involving anatomic pathology tests would need to be reconfigured for inclusion in MIPS. Regardless, ASCP reiterates that the program is new and thus it is premature for any direct correlation between it and MIPS.

Finally, in addition to program applicability challenges, ASCP notes that challenges regarding clinical relevance in addition to fair and accurate cost attribution expand beyond pathologists to many other specialty providers. Moreover, concerns with these challenges are only validated by the VBM program’s quality tiering results reported in the CY 2013 PQRS Experience Report Appendix, which confirm that EPs with more high-risk/ high-cost patients perform worse than those with healthier and less costly patients. Accordingly, Congress acknowledged the VBM program’s seriously flawed risk-adjustment and patient attribution methodologies and therefore initially weighted this category at only 10 points. As such, ASCP encourages CMS to respond to the concerns of both the provider community and Congress. In particular, the Society urges the Agency to devote the necessary data analysis and resources needed to replace, not expand, the current VBM program cost measures.

Episode-Based Cost Measures

As previously mentioned, the current VBM program fails to accurately and completely assess provider-level cost-containment efforts via appropriate resource use. ASCP notes that such failure may either stem from an inadequate patient sample size for reliable assessment as a result of the VBM program’s primary care service-based attribution methodology, or from the EP’s inability to directly influence patient costs within its typical clinical workflow, location on the patient care continuum, and/ or level of patient interaction. ASCP reiterates that pathologists in particular lack direct control over patient costs

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as a result of the pathology specialty’s referral-based nature. Additionally, while pathologists may recommend follow-up treatments based on diagnostic outcomes, there is nothing that they can do to make clinicians follow the recommended treatment protocols. Accordingly, if CMS wishes to compare providers across resource use metrics, the Agency may more effectively risk-adjust and attribute providers’ patient panels by narrowing performance comparisons to condition-specific and/ or episode-specific analysis. ASCP anticipates that drilling down to compare cost and quality metrics for multiple providers on the same patient condition or procedure will prove far less complicated than the longitudinal claims-analysis, meticulous data stratification, and challenging risk-adjustment efforts underlying the task of identifying “like” providers with similar patient risk portfolios for comparison.

Nonetheless, the Society does not understand why CMS is expanding this category in the direction of episode-based payment while simultaneously promoting APMs and specifying that participation in the latter exempts an EP from participation in the former via MIPS. Moreover, ASCP reiterates its grave concern around the existing VBM program and urges the Agency not to cave into pressure to build off of this broken program for the sake of an additional performance category. Rather, the Society encourages CMS to follow through with its current effort to seek separate comment from the provider community regarding episode-based payment models, but then apply its findings to APMs rather than this performance category. ASCP asserts that developing and implementing episode-based payment models is an effort on the part of both CMS and providers that merits a separately recognized and adequately rewarded program via APMs. Accordingly, the Society provides feedback on its ideal episode-based payment model in the APM section of this comment letter.

Peer Group Comparisons

ASCP restates its belief that episode-based payment models may aid in CMS’ risk-adjustment efforts by narrowing “like” providers to those that treat patients with a particular condition or perform a specified procedure. However, there are still many more unique variables that CMS must effectively delineate and adjust for in order to enhance the accuracy and fairness of peer-level performance comparisons. For example, given the pathology specialty’s 37 subspecialties, ASCP highly recommends that the Agency consider adjusting for subspecialty. Similarly, while the subspecialty variable may partially inherently adjust for site-of-service, the Society recommends a targeted adjustment for this variable as well given that it often correlates with the severity of patient condition.

Clinical Practice Improvement (CPI) Activities Performance Category

Types of Qualifying Activities

ASCP is grateful for the new CPI activities performance category, which the Society anticipates will allow CMS to finally capture many of the quality assurance and control efforts already in place at both the provider- and laboratory-level. Accordingly, the Society requests that CMS aim to enhance program alignment and streamline reporting by crediting EPs for fulfilling the requirements of existing programs already focused on improving the quality and safety of pathology and laboratory service delivery. However, ASCP maintains that an EP’s ability to report on another program’s quality measures should remain optional and not evolve into a backdoor approach to mandating participation in additional quality programs. Moreover, ASCP discourages any restrictions on the number or type of CPI activities required for reporting and instead suggests that the six CPI categories specified in MACRA serve merely as a guide for defining and selecting CPI activities. Likewise, the Society encourages CMS to allow for the broadest possible interpretation of CPI activities in order to maximize program reach across all specialties and practice locations.

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Upon consideration of meaningful measures for inclusion and assessment under this performance category, ASCP wishes to bring to CMS’ attention the vast array of existing quality reporting programs currently in place for the pathology and laboratory community. First, CLIA establishes quality standards for all laboratory tests to ensure the accuracy, reliability and timeliness of results regardless of place of service. Accordingly, CLIA requires laboratory monitoring, assessment, and correction of any problems identified in the pre-analytic, analytic, and post-analytic systems. More broadly, CLIA specifies quality standards for Proficiency Testing (PT), patient test management, quality control, personnel qualifications, and quality assurance. Similarly, Maintenance of Certification (MOC) Part IV: Improvement in Medical Practice includes many of the same quality assurance and improvement activities regulated under CLIA. However, under the College of American Pathologists’ (CAP) Laboratory Accreditation program, pathologists must demonstrate compliance with more than 2,500 separate quality standards every two years. Laboratories must also demonstrate ongoing compliance throughout the accreditation period via continuous monitoring of PT data, self-inspection results, timely reporting of lab-initiated changes regarding personnel or scope of services, and reporting on additional quality measures.

In lieu of reviewing the long lists of measures associated with each of the programs mentioned above, ASCP references a fourth program deemed perhaps most relevant to the CPI activities performance category. Accordingly, the Joint Commission established the “Ongoing Professional Practice Evaluation” (OPPE) initiative, requiring the ongoing continuous evidence-based evaluation of each pathologist’s performance across six areas of general competency, including: 1.) Patient Care; 2.) Medical Knowledge; 3.) Practice-Based Learning and Improvement; 4.) Interpersonal and Communication Skills; 5.) Professionalism, and; 6.) Systems-Based Practice. Due to the broad scope of OPPE quality metrics, many have been adopted from previously existing laboratory accreditation, CLIA, and MOC Part IV metrics, and therefore dually fulfill program requirements. For example, the CAP requirement that accredited laboratories have a quality management plan in place, including the benchmarking of key performance measures, fulfills OPPE. Similarly, quality assurance and improvement activities’ turnaround time (TAT) measurements, error rates, and correlation of frozen-section diagnosis with final diagnosis are all commonly used for OPPE measures and thus may be considered for CPI activities as well. ASCP notes that adoption of even one of these overlapping measures into the MIPS CPI activities category further reinforces the goals of these high-value quality programs while providing the opportunity for enhanced program alignment and streamlined reporting.

Nonetheless, while OPPE measures may appear to present the most direct opportunity for measures adoption, there are a host of additional programs available that may also present the opportunity. ASCP notes that some of these programs are even subspecialty-specific. For example, CMS may consider allowing Performance Improvement Programs (PIPs) in Surgical Pathology for credit under the CPI activities performance category.

In addition to the multitude of readily available measures via the pathology and laboratory community’s existing quality assurance and control programs, ASCP hopes to promote targeted resource use measures that will empower pathologists to take on a more proactive and assertive leadership role in guiding appropriate diagnostic test selection and treatment follow-up. Specifically, ASCP suggests the following potentially high-impact measures categories for consideration upon development of pathologists’ CPI activities. Of note, the Society provides associated CPI activities merely for example and reiterates its opposition to required reporting of any CPI activity category types.

Appropriate Use: Clinical Efficiency, Cost-Containment & Patient Safety: As laboratories transition from revenue centers to expense centers, pathologists are uniquely positioned to curb the rampant overutilization of certain high-volume, high-cost, diagnostic laboratory tests via the development and

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reinforcement of Appropriate Use Criteria (AUC). In addition to the cost-savings upfront, CPI activities involving reference and adherence to laboratory test AUCs may also yield trickle down cost-savings beyond the diagnostic point-of-care. The development of CPI activities involving AUCs presents the opportunity to collaborate with payers to ensure that medical necessity is adequately assessed and documented for the purposes of administrative simplification and, most importantly, patient safety. Though there is an infinite amount of use cases for potential CPI activities adaptation, ASCP provides the following examples:

AUC potential for lipid, thyroid, and allergy panels as well as drug screening, etc.

Adherence to appropriate Immunohistochemistry (IHC) utilization rate

Quality Controls: Best Practices to Ensure Operational Efficiency, Test Result Accuracy & Patient Safety: Given their position at the forefront of patient care, pathologists face enhanced pressure to avoid clinical errors while accurately and efficiently diagnosing patient condition. A clinical error or delay at the point of diagnosis could result in disastrous effects further down the care continuum, potentially resulting in further misdiagnosis and mistreatment of the patient condition. Accordingly, it would be highly beneficial to develop CPI activities that reinforce best practices while ensuring operational efficiency, test result accuracy, and patient safety. Though many hypothetical use cases exist, ASCP presents the following examples:

Anatomic pathology discrepancy rate

Turnaround time for getting a patient diagnosed with C. Difficile on antibiotics

Number of revised reports

Clinical Quality Processes: Post-Test Decision Support: Also given their position at the onset of patient care, pathologists are often responsible for follow-up treatment and/ or secondary diagnostic test recommendations based on the patient’s initial test results. In a way, the pathologist is the quarterback responsible for passing the patient off to the next appropriate provider. As such, there are many potential CPI activities that could ensure pathologists follow appropriate protocols dependent on initial diagnostic test results:

Breast Biopsy (for Calcification) Correlation with Radiology - Develop with RSNA

Gyn cyto-surg path correlation - Abnormal paps and correlation with follow-up, either another pap or biopsy

GI Biospy (for Mass Lesion) Correlation with Endoscopy

Though ASCP has provided several test-specific resource use activities above, the Society also encourages condition-specific resource use activities. Accordingly, ASCP promotes the use of CAP’s standardized cancer protocol and biomarker templates for the development of condition-specific diagnostic and treatment algorithms. The Society suggests EP reference and/ or adherence to such algorithms as potential CPI activities for MIPS. However, ASCP encourages CMS to allow for an interpretation of CPI activities that expands beyond both test- or condition-level specification. Rather, the Society advocates for an interpretation that is broad enough to encompass system-level measures, such as reference or adherence to general care management benchmarks and the evaluation of population-level measures.

For a more comprehensive list of suggested CPI activities, please reference the Attached Appendix.

Attestation and Reporting

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ASCP advocates for a simple annual attestation process facilitated through a web-based portal. Accordingly, the Society recommends that CMS permit but not require the transmission of CPI activity results via EHRs and/ or QCDRs. Additionally, ASCP asserts that it may be meaningful for certain activities to be reported on and/ or collected from CMS claims.

Given the anticipated overlap between CPI activities and certification requirements, the Society also suggests that CMS uphold program alignment when needed by allowing certain CPI activities to be granted by a certifying organization for more than a one-year period. The EP participating in the CPI activity would then be required to self-attest each year until the certification expires. Additionally, ASCP maintains that the certifying entity should have the ability, both legally and operationally, to directly report the EPs’ CPI activities to CMS. Similarly, the Society believes that an APM entity should be permitted to provide participation rates for EPs participating in the APM.

Thresholds and Quantifying Activities

Just as ASCP promotes a broad interpretation of CPI activities, so does the Society advocate for a broad definition of “successful” participation. For example, the Society suggests that CMS assess provider performance based on completion or ongoing participation of a CPI activity. Accordingly, ASCP strongly discourages very detailed participation requirements involving hourly participation assessments. Moreover, the Society even more strongly opposes any required use of CEHRT upon completion of CPI activities. Such a requirement would be disproportionally unfair to small and rural practices as well as specialties, such as pathologists, that do not use EHRs as their primary HIT tool for information input.

Nonetheless, regardless of specific participation requirements, the Society recommends that CMS make this performance category available to both individual and groups of EPs participating in MIPS. For group-level performance assessment, ASCP suggests that the Agency scale the number of required CPI activities according to practice size.

Meaningful Use of Certified EHR Technology Performance Category

Current MU Measures and Certification Requirements

At a certain point, CMS needs to decide whether or not it’s going to adapt this program so that it’s possible for pathologists to formally participate. Absent substantial changes to eligibility and participation requirements, the Agency should allow for EPs to weigh this quality performance category zero under MIPS without any negative repercussions. Similarly, CMS should modify the APM incentive payment eligibility requirements related to required use of CEHRT.

As previously reported to CMS in the Society’s comment letter in response to Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements (RIN 0991–AB92), “though pathologists are unable to participate in the Meaningful Use (MU) program, the pathology community is responsible for inputting more than 50 percent of an EHR‘s contents – which drive nearly 70 percent of all medical decision-making.” Moreover, even though laboratories are now thankfully prohibited from funding EHR systems in exchange for referrals, referring clinicians are still managing to withhold referrals in exchange for laboratory-funding of the electronic interfaces needed between EHRs and LISs.

Accordingly, also in the Society’s comment letter, ASCP asserts that “as the MU program advances, the significant informational, operational, and financial contributions of the pathology and laboratory community become both more apparent and more essential.” For example, CMS is steadily increasing laboratory-related measures thresholds throughout MU program advancement. Similarly, the Agency is

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increasingly looking to regulate non-EHR HIT tools, such as LISs, in an effort to ensure the semantic interoperability necessary for successful completion of several MU measures requiring the seamless transmission and integration of standardized laboratory data across care settings. Additionally, CMS continues to enhance related HIT certification requirements and has increasingly proposed the possibility of expanding such requirements in a manner that aligns with and thus reinforces laboratories’ CLIA reporting requirements.

Hardship Exemptions

In response to the regulatory trends identified above, ASCP anticipates that the role of the pathologist/laboratory will only continue to expand as the role of laboratory test results is increasingly leveraged and included in MU program requirements. Accordingly, ASCP continues to call upon ONC and CMS to recognize the important role of the pathologist in securing and financing, the accurate, timely, comprehensive, meaningful, and directive incorporation of diagnostic information into a patient‘s EHR. However, if the Agencies are unable to adapt current MU program requirements in a manner that recognizes LISs as the primary reporting tool for pathologists and rewards pathologists’ existing reporting efforts without adding undue administrative costs and burden, then the Society requests that CMS and ONC hold pathologists harmless, indefinitely, from penalties associated with failure to meaningfully use CEHRT. More specifically, ASCP requests that CMS grant pathologists a permanent exemption from participating in this program in lieu of temporary annual hardship exemptions capped at five years.

Hospital-based Provider Attribution

Given the additional weight added to the remaining MIPS performance categories when an EP elects to weigh one MIPS category zero, ASCP seeks to maximize pathologists’ applicable MIPS categories. As such, the Society encourages CMS to consider broadening its definition of “hospital-based” under the MU program to include hospital-based pathologists. In doing so, the Agency would inadvertently allow for attribution of hospital-level MU measures performance to individual pathologists, thereby generating available data for assessment under the MU category of MIPS. Given that hospital-based pathologists already input structured laboratory data into HIT systems for the fulfillment of a number of existing MU measures, ASCP believes that provider-level attribution of hospital-level measures would be a very appropriate solution for the pathology specialty.

ALTERNATIVE PAYMENT MODELS (APMs)

ASCP appreciates that CMS has consulted the physician community to aid in the design and development of innovative APMs that support and enhance the quality, efficiency, and care coordination underlying the delivery of patient services. If designed fairly and effectively, the Society maintains that APMs are capable of achieving better care for patients, lower spending for payers, and financial viability for physician practices. Accordingly, ASCP encourages CMS to promote and reward participation in APMs that:

Allow for flexible care delivery throughout a more comprehensive interpretation of patient services and supports;

Ensure adequate and predictable payment that has been appropriately risk-adjusted in order to sustain patient access to quality and affordable services, and;

Reinforce provider accountability for costs and quality in a manner that reassures providers that they will only be held accountable for aspects of spending and quality within their control while

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also assuring patients and payers that spending will be controlled or reduced and quality will be maintained or improved.

In addition to the above design recommendations, ASCP cautions CMS of two relevant barriers to successful APM implementation under the current Fee-For-Service (FFS) payment system. Accordingly, the Society encourages the Agency to develop and promote creative approaches to overcoming and compensating for these systemic challenges within the structural design of APMs. The first barrier to successful APM implementation results from the current FFS system’s failure to recognize and compensate many high-value quality control services capable of reducing avoidable spending. In response to this barrier, CMS could incentivize designated high-value/ low-cost quality control services by incorporating marginal payment increases into targeted episode-based and/ or condition-based payment amounts established under an APM. Accordingly, ASCP anticipates that in reimbursing many of these formerly uncompensated services, the Agency will demonstrate that minimal investment at the forefront of patient care has the potential for substantial cost-savings further down the patient care continuum.

For example, there may be times when it would be valuable for a pathologist to push back on a referral for a particular diagnostic laboratory test and recommend a more appropriate and/ or cost-effective test in its place. As such, a mere five minute conversation between the pathologist and referring clinician could lead to the selection of a more effective, accurate, and/ or less expensive diagnostic test. In fact, the quality and efficiency benefits derived from this simple task may even extend beyond the point of diagnosis, resulting in expedited and more appropriate follow-up treatment. Moreover, there is currently no requirement that pathologists directly communicate results to a designated provider for follow-up treatment and/ or that the pathologist recommend the most appropriate treatment based on patient diagnosis. As such, in compensating for pathologists’ care coordination at the pre- and post-analytic phases of care, CMS could incentivize this best practice, compensate for any lost revenue resulting from reallocation of physician time to services not reimbursed through traditional FFS, and perhaps help offset the costs of any related HIT infrastructure investments.

The second barrier to successful APM implementation within the current payment system may only be overcome by a model that recognizes and potentially adjusts for the operating losses that can occur when a physician practice’s/ laboratory’s overhead costs remain constant but its revenues decrease as a direct byproduct of successful participation in an APM. Accordingly, an APM’s success in decreasing test utilization and/ or increasing the use of lower-cost test options translates to direct cost-savings for the health system as a whole. Conversely, at the physician practice-/ laboratory-level, successful APM participation translates to lost revenue, potentially buffered by an incentive payment that is not likely scaled to actual cost-savings. In order to better align payer and provider incentives and ensure the long-term sustainability of APMs, it is essential that CMS ensure that an adequate portion of an APM’s cost-savings is being reallocated to the APM for ongoing investment in the necessary resources for continued quality-enhancement and cost-containment efforts. Likewise, it’s equally important that the Agency recognize and consider subsidizing the APM investment required to achieve many of the structural, quality control measures representing services that are not billable but high-impact on cost-containment. Alternatively, ASCP suggests that CMS consider placing greater weight on the reward for successful completion of these services.

Payment Incentive for APM Participation

ASCP encourages CMS to trust Eligible APMs (EAPMs) with the allocation of payments to individual APM physicians. The Society notes that the level of individual physician accountability for patient outcomes within an APM varies according to the point and duration of the physician’s patient encounter(s) along

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the care continuum. Additionally, each EAPMs unique organizational structure and designated revenue pathway impacts the level of patient interaction with each of its APM physicians. Accordingly, EAPMs are well-equipped with the firsthand knowledge required to fairly and accurately allocate incentive payments in accordance with each APM physician’s portion of shared risk.

Moreover, by relying on EAPMs to determine the revenue shares attributable to each APM physician, CMS could ensure that payment for specific high-value, uncompensated services are incorporated into allocated revenue shares. Additionally, EAPMs reimbursed on a capitated basis, rather than FFS, will be granted the autonomy to determine the best approach for physician-level payment allocation. Lastly, upon CMS distribution of payment at the TIN-level, the designated EAPM will direct the bifurcated allocation of incentive payments to individual physicians for APM versus MIPS participation.

MACRA Participation Thresholds

An APM’s ideal method for meeting the established MACRA participation thresholds will vary based on its size, specialty mix, (primary) specialty type, and (primary) practice location. Accordingly, smaller practices that treat a disproportionate share of high-cost/ high-need patients may wish to meet the participation threshold via revenue shares. Conversely, an APM consisting of physicians primarily from one specialty typically not associated with high-cost services may wish to meet the threshold via calculated percentage of patient count, rather than payments.

On the individual physician-level, ASCP requests clarification regarding the minimum threshold of involvement in a patient’s care for qualifying or partially qualifying APM participants. The Society anticipates that some APM entities may wish to assess plurality of charges while others may want to prospectively establish single episode trigger codes based on targeted high-cost conditions and/ or procedures. As such, ASCP urges CMS to allow each EAPM to establish its own methodology for designating qualifying and/ or partially qualifying APM participants. Additionally, the Society strongly discourages implementation of a single attribution methodology based on primary care services.

Nominal Financial Risk

As previously mentioned, the primary financial risk to a physician practice/ laboratory participating in an APM is that the revenue generated via APM participation may not cover the costs required to successfully participate. ASCP notes that the enhanced care coordination and cost-containment efforts underlying APM participation often pull the EAPM’s resources away from the delivery of high-cost services and toward the provision of high-value quality control services not reimbursed under the FFS payment system. Examples of uncompensated high value services with the ability to control overall costs include, the development of multidisciplinary treatment plans, improving the appropriateness of test ordering, hiring care managers, and developing/ implementing/ participating in a clinical data registry. Accordingly, assessment of nominal financial risk should not be based on relative gain or loss to the Medicare Trust Fund, but rather to the EAPM.

ASCP requests that CMS limit the amount of nominal risk assumed by EAPMs in instances when actual expenditures exceed expected expenditures for the first few years of APM implementation. The Society maintains that it is more important that CMS first ensure that EAPMs develop meaningful, fair, and accurate risk allocation methodologies prior to exacerbating the impact of these methodologies via increasing the amount of risk that each EAPM is required to assume.

Lastly, ASCP implores CMS to consider specialty-specific limitations regarding the ability to impact patient outcomes as well as varying treatment-specific timetables for realizing patient outcomes. Further, the Society encourages the Agency to adjust risk in a manner that accounts for these limitations

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rather than holding physicians accountable for spending outside of their control or prematurely determining that a physician has failed to achieve a desired patient outcome.

Quality Measures

ASCP encourages the reporting of CPI activities measures in order to fulfill both MIPS and APM requirements. This new category for performance improvement appears to present the greatest opportunity for diverse, flexible, and structural measures applicable to the broadest array of specialty types. Accordingly, the Society asserts that the ability to customize measure type and structure in order to align with the typical practice locations and HIT tools associated with specific procedures and/ or conditions would likely benefit episode-based APMs. Likewise, ASCP anticipates a substantive overlap of resource use measures between MIPS and APMs. However, as it stands, the Society does not promote the recycling of the current VBM program cost measures for reporting in either program. Additionally, while ASCP appreciates CMS’ recent RFI around episode-based payments, the Society finds it confusing that the Agency is creating an entire performance category based on APM participation, given APM physicians’ exemption from participation in MIPS. As such, ASCP requests further clarification around APM and MIPS program alignment. Furthermore, while the Society appreciates CMS’ intentions to streamline program requirements and administration, ASCP cautions the Agency that aligning measures that have not been properly validated or risk-adjusted augments the impact of inaccurate and/ or unfair performance assessments.

Use of CEHRT

As previously stated in this comment letter, pathologists are unable to participate in the EHR Incentive program because their primary HIT tool is a LIS, rather than an EHR. Also noted, though laboratories do not directly input patient information into an EHR, they often fund LIS-EHR interfaces between the laboratory and referring clinician’s office and are also responsible for roughly 50 percent of the patient information contained in the EHR. Nonetheless, laboratories have no control over whether or not referring clinicians have certified their EHRs to the latest certification standards or even if the clinician has an EHR. Yet despite pathologists’ inability to participate in the MU program, CMS and ONC appear to be increasing the laboratory test-related measures’ thresholds and increasingly suggesting the certification of non-EHR HIT systems and even modules. Accordingly, ASCP urges CMS to broaden the definition of “CEHRT” to include certified HIT tools, modules, and systems. In doing so, the Agency could enable pathologists to fulfill this APM eligibility requirement through demonstrated adherence to CLIA requirements via the use of Laboratory Observation Identifiers Names and Codes (LOINC) and Systemized Nomenclature of Medicine – Clinical Terms (SNOMED-CT) standards upon the transmission of laboratory data to an EHR. Regardless, ASCP maintains that pathologists should not be required to purchase additional technology solely to fulfill APM participation requirements.

Physician-Focused Payment Models (PFPM)

While ASCP appreciates the establishment of Physician-Focused Payment Models (PFPMs), the Society fears that the establishment of a separate category of APMs intended for specialty providers may result in CMS developing the primary APM program in a manner that does not adequately align with specialists’ unique practice patterns, thereby precluding specialists from the program actually tied to incentive payments. Accordingly, ASCP encourages CMS not to designate the CMS-developed APMs for primary care providers or even physician practices with model representation of physician specialties. Rather, the Society urges the Agency to consider PFPMs as mechanisms for expedited, physician-led, APM pilots in a preliminary phase of APM participation pending CMS testing and approval. As such, ASCP requests that CMS provide a streamlined process for PFPMs to transition from approval by the

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Payment Model Technical Advisory Committee (PTAC) to CMS implementation as qualified APMs. The Society does not support the Agency subjecting PFPMs to a separate proposal process for official CMS qualification. Additionally, ASCP urges the Agency to consider a pathway to implementation that allows for participating physicians to earn MACRA incentive payments. One way of doing this may be establishing PFPM criteria that closely align with qualified APM criteria. CMS could then establish a stepwise program for increasing thresholds and increasing risk until PFPMs evolve into fully qualifying APMs.

Specialty Practitioner Payment Model Recommendations

ASCP strongly encourages CMS to review the Society’s recommendations included in its comment letter in response to the Agency’s Request for Information on Specialty Practitioner Payment Model Opportunities. In the comment letter, the Society recommends the following key elements as crucial to the success of bundled payment initiatives for outpatient services: (1) Leverage the Role of the Pathologist; (2) Strategically Define the Episode; (3) Carefully Operationalize the Episode; (4) Encourage Participation; and (5) Assess and Regulate Impact on Service Delivery and Reimbursement.

Leverage the Role of the Pathologist: ASCP notes that pathologists are uniquely positioned at the forefront of patient care and thus have the ability to guide appropriate utilization for both diagnostic tests as well as the necessary follow-up treatments required based on patient diagnosis. More broadly, the laboratory’s forte in screening for disease prevention and testing to reach a diagnosis is critical to shortened hospital stays, quicker recovery, and returning to a productive lifestyle—all important in containing rising medical costs. In an era when value-based purchasing is increasingly important, laboratory testing facilitates cost-effective care via early detection and enhanced management of clinical conditions. Nonetheless, despite these significant contributions during the diagnostic and care management phases of patient care, current payment models tend to focus on quality and cost-containment efforts within the treatment phase of care. Given that this phase, in the middle of the care continuum, is largely outside of the pathologist’s control, pathologists have been inadvertently excluded from participating in currently available payment models, such as Accountable Care Organizations (ACOs).

Strategically Define (and Structure) the Episode: ASCP maintains that truly effective bundled payment initiatives should create an accountability infrastructure that promotes care coordination across the entire episode while recognizing the evidence-based, condition-specific variance in the standard time spent, services rendered, and resources consumed within each of the episode’s three separate service delivery segments: diagnosis, treatment, and care management. Accordingly, a fair bundled payment model would be two-tiered and involve payment distribution at the episode segment-level rather than broadly at the episode-level. Specifically, the first payment would be based on cost-savings at the episode segment-level, following assessment of the actual versus ideal cost of service(s) provided within each segment. The second payment would then be based on cost-savings at the episode-level. However, the episode’s total accrued savings/penalty incurred would be distributed at the segment-level and weighted to reflect condition-specific variance in the standard time spent, services rendered, and resources consumed within each segment. The assumption behind the condition-specific weights applied to each segment-specific payment is: as the amount of time spent and services rendered within a specific segment increases, so does the proportion of shared risk for the provider(s) in that segment. Accordingly, greater weights would be applied to the segment’s sub-bundle payment to reflect greater accountability for patient outcomes at the end of the episode of care.

Carefully Operationalize the Episode: It is essential that the billing codes that will trigger a condition-based episode are made public information in advance so that providers are aware that they have

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initiated an episode when billing with these codes. Moreover, ASCP supports an attribution methodology that identifies all of the providers billing Medicare for a specific beneficiary within a meaningful, condition-specific range of time. Specifically, ASCP encourages an attribution methodology that identifies primary providers at the episode- and episode segment-levels, perhaps based on the plurality of charges and/or frequency of patient encounters. The attribution methodology should also allow for a system of ranking/spreading risk among providers based on the level of accountability for patient outcomes according to the point and duration of the provider’s patient encounter(s) along the care continuum.

Additionally, ASCP suggests that CMS provide an administrative infrastructure, likely authorizing or providing a neutral third party entity, to facilitate care coordination and billing across multiple, unaffiliated entities providing services within a single episode of care. Private sector experience suggests the need for case managers to help the patient to navigate the multiple entities involved in the episode of care and resolve any claims issues/concerns. Though Medicare does not currently provide case managers, perhaps it could look to Medicare Administrative Contractors (MACs) to take on this role.

Moreover, it would also be beneficial for CMS to provide funding for entities looking to develop HIT features and functions in support of bundled payment initiatives across non-affiliated entities. According to a recent McKesson publication, multi-facility data integration and analytics will require dynamic contracting between entities – operationalizing episodes of care terms and definitions via HIT features and functions.

ASCP acknowledges the unique challenge in establishing average costs in the diagnostic segment sub-bundle given that there are currently about 5,000 clinical laboratory tests that pathologists have to choose from when diagnosing a condition. Specifically, the large number of available test options for each patient condition presents challenges for the pathology specialty upon attempting to establish evidence-based guidelines. Accordingly, there are not many consensus-based guidelines available to determine standard costs for testing a patient with a particular condition or even via a particular test. Therefore, ASCP suggests that it may be better to assess cost thresholds for each segment after the tests have been selected rather than prospectively.

Lastly, ASCP maintains that it is extremely important that episodes are defined in a way that allows for flexibility and loosely accounts for cost variables unique to/reflective of the individual patient’s health status and demographic characteristics. Accordingly, while ASCP promotes a model that allows for a controlled amount of variance in test and treatment selection, the Society advocates for a valid risk-adjustment methodology to control for the patient-level characteristics necessitating this variance. Furthermore, it will be difficult but necessary to develop benchmarks to compare performance at the episode and episode-segment levels across providers with differing patient risk portfolios.

Encourage Participation: Logic suggests that providers will not want to participate in a model that doesn’t accurately and fairly attribute patients, spread/assign risk, and compare/reward quality. In order to maximize participation, the model must balance provider incentive to coordinate care/share accountability with nonaffiliated provider (groups) with provider confidence in the model’s ability to fairly and accurately allocate risk across participating providers within a single episode. Meaningful risk allocation will hold certain providers more accountable than others based on the point and duration of patient responsibility within the episode. The intent is to minimize the impact of the poor performance of certain providers within one episode segment on the higher quality performing providers within another segment of that same episode of care. Other factors that will influence providers’ participation decisions may include:

The availability of data to model impacts in advance

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Pre-defined payment levels based on current costs and pre-defined savings

Timely data for monitoring performance

Ability to adjust payment if original data are inaccurate or unforeseen problems occur

Assess and Regulate Impact on Service Delivery and Reimbursement: For years, the inappropriate inclusion of anatomic pathology services under the In-Office Ancillary Services (IOAS) exception to the Stark law has increasingly resulted in increased overutilization, costs, and potential patient harm within the field of pathology and laboratory medicine. Accordingly, it is vital that CMS ensure that bundled payment initiatives do not incentivize harmful self-referral arrangements.

ASCP cautions that, while bundled service arrangements create an incentive to contain cost within each bundle, they do not prevent clinicians from initiating multiple bundles under their own practice’s jurisdiction to increase the practice’s revenue. In other words, if clinicians are unable to increase the quantity of services provided within a bundle, they may very likely increase the quantity of bundles initiated. This incentive is further exacerbated by the fact that in doing so, the treatment will likely result in positive health outcomes, since the patient may not have had the condition being tested for/treated in the first place. Meanwhile, subjecting the patient to the treatment actually increases unnecessary costs for Medicare and for the patient, while exposing the patient to a potentially harmful and unnecessary procedure – all in the name of profit for the treating clinician. As such, it is essential that CMS ensure that bundled payment models are developed in a manner that allows for physician pushback on referrals and/ or multi-physician consensus on bundle triggers.

ASCP appreciates the opportunity to present these comments. If we can be of further assistance, please do not hesitate to contact Kaitlin Cooke, MPP, Senior Manager for Advocacy and Public Policy, at Kaitlin.cooke@ascp.org or by phone at (202) 347-4450.

APPENDIX. Example Clinical Practice Improvement (CPI) Activities For Consideration in MIPS

Suggested CPI Activities Potential Measures

Pre-Analytic

Establishment of a Laboratory Formulary Documented Evidence of Laboratory Formulary Onsite/ Electronically

Establishment of a Physician-led Utilization Committee

Documented Evidence of EP/ Laboratory Participation in a Physician-led Utilization Committee

Appropriate Use of Molecular Testing in Anatomic Pathology

% of Cases in which the Use of Molecular Testing Adheres to Established AUCs

Appropriate Use of Immunohistochemistry (IHC) Services

% of Cases in which the Use of IHC Adheres to Established AUCs

Effective and Efficient Treatment and Diagnosis of Cancer Patients

Demonstrated Reference and/ or Adherence to Consensus-based Cancer Protocol and Biomarker Templates

Development of Evidence-based Clinical Guidelines for Inclusion in Laboratory Order Sets

Documentation of Laboratory Order Sets, Which May Include Accompanying Clinical Decision Support (CDS) Tools

Development of Diagnostic Test Algorithms

Demonstrated Reference and/ or Adherence to Diagnostic Test Algorithms

Patient ID Accuracy Wristband Error Rate

Blood Culture Contamination Prevention Blood Culture Contamination Rate

Laboratory Specimen Acceptability Specimen Rejection Rate

Patient Satisfaction with Outpatient Specimen Collection

Overall patient satisfaction score/ patients “more than satisfied” with outpatient phlebotomy services

Use of Automated CDS at the Point-of-Care

Examples: Automated Reflex Testing; Interference Checking; Automated Add-Ons; Controlled # of Automated Daily Labs

Establishment of a Quality Assurance Program for Point-of-Care Testing

Demonstration of Quality Controls, Such As Documentation of Initial Device Performance and Reagent/ Control Lots

Analytic

Establishment of Diagnostic Test Result Consensus Mechanism

Frequency of laboratory use of second opinion and/ or relationship of second opinion requirements with specific test types

Turnaround Time (TAT) of Troponin Median Troponin Order-to-Report TAT (Minutes); Troponin TAT Compliance Rate (%)

Gynecologic Cytology Outcomes: Biopsy Correlation Performance

Correlation of cervicovaginal cytology (Pap test) findings with cervical biopsy results

Proficiency Testing Proficiency Test Scores; Frequency of Monitoring and Reporting Results

HER2 Pathologists Competency Assessment

Demonstrated and documented performance in related proficiency testing program

Quality Assurance in Anatomic Pathology Anatomic Pathology Discrepancy Rate

Non-Gynecologic Cytology TAT Median Order-to-Report TAT (Minutes); TAT Compliance Rate (i.e. 80% of reports on routine cases completed within 2 days of receipt)

Diagnostic Accuracy of Frozen Section Diagnoses

Frozen Section/Intraoperative Consultation–Final Diagnosis Correlation

Monitoring Surgical Pathology Disagreement with Unsolicited Extra-Departmental Review

Quarterly #/ % of Revisions for Interpretive Discrepancy in Surgical Pathology

APPENDIX. Example Clinical Practice Improvement (CPI) Activities For Consideration in MIPS

Routine Biopsy Specimen TAT Median Order-to-Report TAT (Minutes); TAT Compliance Rate (%); Example: Breast Biopsy TAT - % of Routine Cases Reported within 24 Hours

Post-Analytic

Demonstrated Accuracy of Laboratory Test Results

Test Result Correction Rate, including documentation of reason for correction – ranging from errors that meaningfully impacted patient care to clerical mistakes

Adequacy of Cancer Reporting Assessment of completeness of cancer reports, including documentation of the % of reports using a synoptic format

Medical Error Prevention Timely and Accurate Critical Value Reporting

Development of Follow-Up Treatment Protocol Algorithms

Documentation of Communicating Results and Recommending Diagnosis-based Treatment Protocol to Appropriate Provider

Monitoring for Potential Abuse of Self-Referring Clinicians

Identification of Outliers with a High % of Patients on which they are Performing Prostate Biopsy Analysis but do not have Cancer

Demonstrated Care Coordination for GI Patients

GI Biospy (for Mass Lesion) Correlation with Endoscopy

Demonstrated Best Practices in Women’s Health – OB/GYN

Gyn cyto-surg path correlation (Abnormal paps and correlation with follow-up, either another pap or biopsy)

Demonstrated Best Practices in Women’s Health – Breast Tissue

Breast Biopsy (for Calcification) Correlation with Radiology - Develop with RSNA

Enhanced Role in Guiding Evidence-Based Treatment Decisions

Use of Pharmacogenomics to direct customized patient treatment protocols