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20555 VICTOR PARKWAY LIVONIA, MI 48152 p 734-343-1000 newhealthministry.org September 2, 2014 The Honorable Sylvia Burwell Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445 G Hubert H. Humphrey Building 200 Independence Avenue SW Washington, DC 20201 RE: CMS 1612 P Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015 (Federal Register, Vol. 79, No. 133, July 11, 2014) Dear Secretary Burwell, CHE Trinity Health appreciates the opportunity to comment on the Center for Medicare & Medicaid Services (CMS) proposed rule that addresses changes to the physician fee schedule and other Medicare Part B payment policies for calendar year (CY) 2015 as published in the Federal Register on July 11, 2014. CHE Trinity Health is one of the largest multi-institutional Catholic health care delivery systems in the nation, serving people and communities in 20 states from coast to coast with 84 hospitals, 109 continuing care facilities, and home health and hospice programs that provide nearly 2.8 million visits annually. The organization formed in May 2013, when Trinity Health and Catholic Health East joined to strengthen our shared mission, increase excellence in care, and advance transformative efforts with our unified voice. With annual operating revenues of about $13.3 billion and assets of about $19.3 billion, the new organization returns almost $1 billion to its communities annually in the form of charity care and other community benefit programs. Combined, CHE Trinity Health employs more than 87,000 people, including 3,200 physicians. CHE Trinity Health applauds CMS efforts to continue to focus on care coordination, accurate payments, and improvements to the Medicare Shared Savings Program. Following this cover letter, CHE Trinity Health has provided detailed comments on the proposed rule. We appreciate this opportunity to respond to the proposed rule changes. If you have any questions, please contact Tonya Wells at wellstk@trinity-health.org or 734-343- 0824. Sincerely, Tonya K. Wells Vice President, Public Policy & Federal Advocacy CHE Trinity Health 1

MEDICARE SHARED SAVINGS PROGRAM Trinity Health is currently participating in 5 MSSP ACOs and was part of one Pioneer ACO that withdrew from the Program. CHE Trinity Health is committed to the ACO model, which is clearly demonstrated by our recent submission of 8 new MSSP applications. We encourage CMS to provide as many pathways possible to achieve success in the MSSP. Such a philosophy would be consistent with the overall intent of CMS to create a program that involves as many organizations as possible, allows as many to be successful as possible and encourages ongoing investments by making it easier in early years to earn sufficient funds for reinvestment in care improvement. General Remarks We believe that the SSP ACO model has great potential to improve quality and reduce costs. However, we also believe that the current payment structure of the program will not be sufficient to sustain provider engagement over the long term. Our organization is committed to transforming our care and business models to deliver better health etc. We are planning to have an SSP ACO in every market. However, we are doing this despite our concerns because we hope that overtime CMS will adjust the payment approach to provide more reimbursement opportunities. We offer the following suggestions to that end. 1. As has been shown from Physician Group Practice (PGP) Demonstration, other CMS activities, the early results from the Pioneer and SSP ACO programs, and the Massachusetts Alternative Quality Contract (AQC) it is possible but not easy to improve quality outcomes. 2. Those same experiences have shown that it is possible, but much more difficult to decrease cost trend against current benchmark approaches. 3. While commercial programs such as the AQC initiative have demonstrated significant improvement in quality metrics there remains great uncertainty about the benchmarking approach for quality measurement to be used in the SSP program. Particularly uncertain is any variation caused by differing measure collection methods between the ACO measures and the benchmark. 4. Quality Improvement and cost savings resource use initiatives require significant investments. 5. There is significant value in a stable measure set and targets so that providers can know what their quality improvement agenda is over a multi-year period and plan for significant progress on that constant set of measures. 6. Given the limited experience and knowledge to date, it is not clear that the payment opportunities available through the MSSP and Pioneer CMS ACO programs, as currently structured, will provide a return of shared savings that is sufficient to cover the cost of investments. 7. There is also the potential for the SSP quality adjustment mechanism to significantly reduce the amount of shared savings. 8. Nationally Medicare trend has been at historic lows over the past two years, as a result of changes in care delivery, attention to readmissions, payment policy changes for Hospitals, DME, Home Care and other services. These changes have varied impact in different markets. Using national trend makes it more difficult for ACOs in higher trend areas to be successful. 9. The high rate of aligned population turnover year to year, and the resulting benchmark adjustments makes it very difficult to understand the potential for shared savings thereby creating further uncertainty regarding the financial outcome for ACOs, even in the face of positive quality improvement. For all of these reasons we believe it is critical to Medicare ACO programs sustainability to minimize the costs of participating in the program and increase the potential for shared savings. This perspective leads to the recommendations we are providing in our comments. Considerations for Current Measure Future Measure Development Because ACO quality measure performance has a major impact on financial results, we encourage CMS to consider the following when finalizing the quality measures in the final rule and as it considers future quality measure development: 2

ACO providers have inherent strong drivers to improve quality outcomes for patients since these improvements will result in improved health outcomes, decreased costs, improved patient satisfaction and more persistent ongoing alignment of beneficiaries. Driving incentives with quality metrics that have direct ties to cost impact seems unnecessary and potentially duplicative e.g. readmission rates; avoidable admission rates; etc. These metrics certainly can be useful as transparent metrics to allow interested parties to understand the overall quality of care provided by the ACO. Quality metrics that are the basis for incentives should be used for four reasons: o To evaluate whether the ACO is actually improving the health of their population o To incent attention to important aspects of care that might not otherwise be addressed given ACO incentives o To allow consumers, through transparent reporting of ACO cost and quality performance, to identify better performing ACOs o Or, to identify ACOs that may be inappropriately limiting access to care. Patient experience/satisfaction measures should be paramount and patient reported measures of outcomes and functional status, while still in development, will be of great value and should be extended under a pay for reporting approach. There are significant costs, for providers and CMS, associated with the production and collection of ACO reported metrics. CMS should do more to provide alternative reporting approaches (e.g. electronic reporting from certified electronic health records and q-data intermediaries) and align measures with other programs such as PQRS, HVBP and the Value Modifier. Measures and performance targets should be maintained for the three-year contract period to ensure sufficient time to allow provider quality improvement plans to be effective. We recommend that CMS institute pay for reporting for 2 years for new measures so that the post-audit data can be used to establish benchmarks that are announced in advance of the pay for performance year. Socioeconomic (SES) factors should be included in evaluating quality performance. CMS should highlight ACO successes in eliminating health disparities. Given the challenges associated with obtaining shared savings we believe that CMS should strengthen the upside opportunity associated with positive quality performance and eliminate the negative adjustment that results in a decrease in payout of shared savings. Changes in CY 2015 Quality Measures CMS is proposing changes to the MSSP program s quality measures that ACOs would collect in CY 2015 and report to CMS in early 2016, Specifically CMS proposes to add 12 new measures, remove 8 existing measures and update two existing measures. The program would use a total of 37 measures. As it pertains to the proposals of CMS to add and modify measures, based upon the above considerations, we recommend the following: Any new measure should well defined, tested and designed to fill gaps in measurement without adding undue burden on providers. CMS should continue to work within the NQS framework and focus on outcomes measures of high impact conditions for which there is evidence that improvement opportunities exist The proposed addition of 12 new measures and the deletion of eight measures in CY 2015 along with the potential for numerous new measures in eight broad categories create several inherent problems. Changing two-thirds of the quality measures is too aggressive particularly for a large-scale program that has been in existence for little more than two years. We understand the need to drop the topped out measures. However, we believe it would be better to continue with the remaining metrics and work cooperatively with the industry to develop a second set of metrics for the next three-year contract cycle. Substantially changing the measure set also creates a great burden and compromises the ACOs ability to achieve the quality improvement it is seeking as compared to a more stable measure set. Aside from the added administrative burden to retool extracting and reporting data, there is the burden of reforming further ACOs' clinical practice design. Beyond working to actually meet or achieve the quality measures in the clinical practice setting the proposed changes would make worse the apparent difficulty ACOs are having in accurately reporting their quality measurement data. Furthermore, it challenges CMS ability to set appropriate performance targets. 3

Rewarding Quality Improvement CHE Trinity Health is pleased to see that CMS proposes a reward, of up to two points per domain, for those ACOs that improve their performance from one year to the next. An improvement score is important to ensuring that all providers can see more clearly the path to an incentive payment. We suggest that CMS increase the improvement incentive by making a reward of four points available for improvement rather than two points. Two bonus points adds only a maximum of 10-13% to an ACO's total domain score. This is insufficient to incent the behaviors sought by this policy especially since ACOs must first meet a defined minimum savings rate and shared savings are capped at 10%. Therefore, we recommend that greater recognition for improvement be made available by assigning 4 bonus points per domain. In addition, we believe that each domain should not be capped so that the bonus points are truly additive to the overall score. We appreciate that CMS is seeking other or additional alternative approaches to reward improvement. In that regard, we propose CMS award a quality financial bonus of 10% shared savings for those ACOs in the top 10% of total quality scores. We also suggest, that because the quality scoring system is still evolving, benchmarking data is not representative of the same population and quality of care varies enormously by region, ACOs be allowed to retain 50% of their earned savings if their overall quality score improves significantly year over year. If an ACO achieves overall improvement, they would retain the greater of 50% of their share of savings or the share of savings based upon benchmark attainment. CHRONIC CARE MANAGEMENT CHE Trinity Health supports the requirements outlined for chronic care management services and appreciates CMS efforts to align these requirements with the Joint Principles of the Patient-Centered Medical Home. We support the use of a chronic care management code as a way to ensure that physicians are appropriately reimbursed for the time and resources involved in improving the quality and coordination of care furnished to Medicare beneficiaries with multiple chronic conditions. However, we believe that the $42 per patient per month (our rough approximation) would be inadequate reimbursement for the services being provided. In CHE Trinity Health's experience, the initiation of chronic care management requires much more than the 20 minutes recognized under the current proposal. Successful patient support often includes a combination of an initial face-to-face assessment with the care manager and multiple telephonic patient encounters, which often results in several hours of work over the initial period of establishing a comprehensive and robust care plan. Our recommendation for best practice with the provision of these services includes a high frequency of touch over the first three months, sometimes six or more patient interactions, in order to support the care plan. The level of interactions may fluctuate at time, decreasing from the initial phase and increasing based on changes to the patient s health status. Therefore, it is important that providers have flexibility in identifying the level and intensity of their care management services. Therefore, we request that CMS allow for billing at a greater frequency for chronic care management. As we all work together to improve efficiency in the healthcare system, providing adequate reimbursement for such services will not only improve quality of care and patient satisfaction, but will also help to reduce unnecessary readmissions and improve efficiency within the healthcare system. We make specific recommendations on adjustments to CMS approach to chronic care management below. Ensure Appropriate Recognition of All Care Management Team Members As CMS is aware, providers have many approaches and utilize a range of staff to furnish chronic care management services. CHE Trinity Health is currently participating in chronic care management services through its participation in the Multi-Payer Advanced Primary Care Program in Michigan. Locally, this program is referred to as the Michigan Primary Care Transformation Project or the MiPCT project. In this project, Michigan uses masters prepared social workers (MSW) and registered nurses (RN) to provide chronic care management services, in addition to physician assistants (PAs) and nurse practitioners (NPs). Additionally, improved incorporation and recognition of pharmacists for these roles has also been proposed. Currently, our organization uses mid-level providers to do this work, and we have had success in addressing the core requirements for chronic care management as outlined in the proposed rules. As written, CMS proposal does not adequately reinforce the role of additional non-physician providers (NPPs) in care management teams. CMS should ensure 4

that time spent by NPPs such as RNs, MSWs, and pharmacists on care management services are appropriately recognized and reimbursed. Additionally, we urge CMS to consider alternatives that would directly recognize and reimburse these additional NPPs when functioning as care managers. Provide Additional Clarification Regarding Access to Beneficiary Electronic Health Record (EHR) CHE Trinity Health requests that CMS provide additional clarification on the requirement that the providers involved in these services have access at the time of service to the beneficiary s EHR that includes all the elements necessary to meet the most recent HHS regulatory standard for Meaningful Use. As written, it is unclear if beneficiary s EHR refers to the patient s summary of care record which must include specific elements in order to meet Meaningful Use requirements. If so, this requirement would hold physicians accountable for the actions of the patient s referring provider(s). Many hospitals working with patients needing chronic care management may not be attesting and those that have already attested are not required to share comprehensive summary of care records for all patients. As a result, requiring that providers must have access to care record elements to meet the complex care management standards is unreasonable. Waive Beneficiary Cost-Sharing For the Provision of Chronic Care Management Services CHE Trinity Health is in a demonstration project in which both government-funded and commercial payers provide for chronic care management services. Whether the services are funded by Medicare, Medicaid, or one of several commercial payers involved, the member who receives the care management services does not have a cost-share associated with the provision of these services, except for a small cohort of high deductible plan patients. These services are very new to the patient experience and often require patient education prior to acceptance of this model of increased patient engagement. This results in patients undervaluing these services at the outset of the care management relationship, however, once the relationship is established, patients are better able to understand and describe the value for the services that they receive. The proposed rules require that patients agree to the cost of these services, and we fear that this will result in very low engagement, particularly in a high-need challenging Medicare population. In fact, for the very small number of commercially insured patients with limited cost sharing (high deductible plans), we have found that member engagement is extremely poor. Patients often undervalue preventative care visits and services and chronic care management includes a strong focus on ensuring patients receive recommended preventative care in addition to other services. Therefore, we would recommend that chronic care management services be covered similar to preventative care and at no cost to the member. PRACTICE EXPENSES TRANSITION FROM FILM TO DIGITAL CHE Trinity Health supports CMS and the American Medical Associations Relative Value Scale Update Committee s (AMA RUC) initiative to appropriately capture practice expenses for advanced imaging services by removing supplies and equipment related to film while adding digital supplies and equipment. The AMA RUC recommended adding a Picture Archiving and Communication System (PACS). However, CMS proposed using a desktop computer as a proxy for the cost of a PACS due to the available invoices to determine actual costs. We disagree that a computer workstation is an appropriate proxy. Typical PACSs are subscription based software systems that require upfront costs for set up of the software, additional hardware and continuing investments for subscriptions. We believe that these should be considered a direct practice expense. The complete PACS would include the necessary computer workstation to run PACS technology, but the software and other expenses that are directly related to patient care are more costly. We recommend CMS add the computer workstation and maintain current film inputs until invoices for PACS are available and an appropriate inclusion approach is established. USING HOSPITAL OUTPATIENT DEPARTMENT COST DATA TO REVISE PRACTICE EXPENSE METHODOLOGY CMS is still seeking a better way to establish costs and prices for direct practice under the MPFS. CMS is seeking comments on using hospital outpatient department cost data (not the Ambulatory Payment Classification payment amount) to use in the MPFS practice expense methodology. Hospitals have much different cost structures and report data in a different way than physician practices. We recognize the need to collect accurate information on the practice expense utilized in the typical physician service at a procedure level, but we do not 5

believe hospital cost data is granular enough to be applied at the individual service level. We also do not believe that incorporating hospital data into the current practice expense methodology would be an accurate portrayal of non-facility costs. Hospitals have different purchasing power and patterns that may not align or reflect community physician costs. We encourage CMS to find alternate ways of ensuring accurate physician costs are included in the practice expense. TRANSITION OF ALL 10- AND 90-DAY GLOBAL PERIODS TO 0-DAYS CHE Trinity Health understands CMS rationale for proposing to convert all 10- and 90-day global periods to 0- days and its desire to mitigate overpayments, however we request CMS explain more fully how the billing for pre- and post-procedure evaluation and management services should be reported and how they will be reimbursed. The Protecting Access to Medicare Act of 2014 adds a new paragraph to Section 1848(c) of the Social Security Act that dictates that if a code s relative value units (RVUs) face a reduction of 20 percent or more in a given year, then the decrease needs to be transitioned over a two-year period. 1 We suspect that many of the 10- and 90-day global surgery codes may meet this threshold and therefore should be transitioned over two years (2017-2018 for 10-day globals; 2018-2019 for 90-day globals). If this transition period is finalized, we strongly encourage CMS to separately reimburse evaluation and management services within the global period to ensure the providers are adequately reimbursed. MEDICARE TELEHEALTH SERVICES CHE Trinity Health supports CMS' proposal to add psychotherapy services (CPT codes 90845 through 90847), prolonged visitations (CPT codes 99354 and 99355), and annual wellness visits (HCPCS codes G0438 and G0439) to its list of approved Medicare telehealth services. PHYSICIAN COMPARE WEBSITE We encourage CMS to take steps to make the information available via both Hospital Compare and Physician Compare as user-friendly as possible. We believe that the usability would be improved by making available downloadable excel files of Physicians Compare data for use by providers and other stakeholders. Ensure Physicians Have Sufficient Time to Review Data Prior to Its Release on Physician Compare CHE Trinity encourages CMS to ensure that data publicly reported through the Physician Compare website is approved by physicians for validity and accuracy prior to public display. The proposed rule also outlines CMS intent to create composite performance scores for select measures groups in CY 2016. We believe the necessary testing and vetting these individual and composite measures will require that CMS extend its timeframe for public reporting beyond 2015. We recognize the need to aggregate to make comparisons across providers, but the individual components need to be thoughtfully tested and the weighting of the components in a composite are critical. Streamline PQRS Reporting Requirements with Those in Other Programs CMS outlines in the proposed rule that for Claims, Qualified Registry and Direct EHR reporting, nine PQRS measures will be required, covering at least three of the National Quality Strategy domains for 50% of applicable patients. In addition, if an eligible professional (EP) sees at least 1 Medicare patient in a face-to-face encounter, the EP should report on at least 2 of the 18 cross-cutting measures for 2015. CHE Trinity supports the opportunity to submit data more frequently for PQRS reporting (e.g. quarterly), but recommends no mandates for more frequent submissions. CHE Trinity urges CMS to work to align hospital-based and physician-based reporting requirements, especially for those conditions in the hospital readmissions reduction program. CHE Trinity supports the American Hospital Association (AHA) in their position that the reporting requirements, measures and scoring methodology for PQRS/Value Based Payment Modifier (VBPM) are different from others, and that hospital-based physicians should be allowed to use Hospital Inpatient and Outpatient Reporting 1 Protecting Access to Medicare Act of 2014. H.R. 4302. http://www.gpo.gov/fdsys/pkg/bills-113hr4302enr/pdf/bills-113hr4302enr.pdf 6

(IQR/OQR) to meet PQRS and VBPM requirements. This would ease the burden of reporting for many providers, as well as streamline and increase alignment across federal reporting programs. Include a Subset of Hospital VBP Program Measures in VBPM for Hospital Based Physicians In the proposed rule, CMS is considering allowing groups that include hospital-based physicians or solo practitioners who are hospital-based to include Hospital Value Based Purchasing (VBP) Program performance in their VBPM in the future. CMS is considering three options to determine to determine what part of the Hospital VBP Program s Total Performance Score (TPS) to include in the VBPM: Including the entire TPS in the cost composite Include the efficiency and cost reduction domain score in the cost composite and include all or a subset of the other domain scores in the quality composite Include a subset of the measures in the cost and quality composite CHE Trinity encourages CMS not to include the entire TPS in the cost composite, and not to include efficiency and cost reduction domain scores in the cost composite while including all or a subset of other domain scores in the quality composite. CHE Trinity recommends CMS to include a subset of the Hospital VBP measures in the cost and quality composite that can be attributed to the physician specifically, so as to reduce duplicative payment adjustments. Continue to Utilize and Enhance the Physician Feedback System In the late summer of 2014, CMS plans to disseminate the Quality and Resource Use Reports (QRURs) based on CY 2013 data to all physicians. QRURs will provide performance on the quality and cost measures used to score the composites and additional information to help physicians coordinate care and improve the quality of care furnished. For the recently released 2012 Supplemental QRURs, CMS broke down episode types into 20 subtypes. In addition, CMS included six clinical episode-based measures adapted from those proposed for future inclusion in the Hospital VBP program. CHE Trinity supports CMS efforts to continue offer and improve upon a mechanism that allows providers to view their feedback. CHE Trinity also supports the continued use of episodebased measures adapted from the Hospital VBP program as described above. Incorporating these measures in QRURs creates additional incentives for coordination among hospitals and physicians as well as facilitates alignment between the Hospital VBP Program and the VBPM. 7