September 6, Submitted electronically via Re: Medicare Program: CMS 1654-P. Dear Acting Administrator Slavitt,

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1 20555 Victor Parkway Livonia, MI tel trinity-health.org September 6, 2016 Andrew M. Slavitt Acting Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS 1654-P 200 Independence Avenue, SW Washington, DC Submitted electronically via Re: Medicare Program: CMS 1654-P Dear Acting Administrator Slavitt, Trinity Health appreciates the opportunity to provide comments on the Centers for Medicare and Medicaid Services (CMS) Proposed Rule, Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model. Our comments and recommendations to CMS reflect a strong interest in public policies that support better health, better care and lower costs to ensure affordable, high quality, and peoplecentered care for all. Trinity Health is one of the largest multi-institutional Catholic health care delivery systems in the nation, serving diverse communities that include more than 30 million people across 22 states. We are building a People-Centered Health System to put the people we serve at the center of every behavior, action and decision. This brings to life our commitment to be a compassionate, transforming and healing presence in our communities. Trinity Health includes 93 hospitals, 120 continuing care programs including PACE, senior living facilities and home care and hospice services that provide nearly 2.5 million visits annually. We employ approximately 97,000 full-time employees, including more than 5,300 employed physicians, and have 13,800 physicians and advanced practice professionals committed to 19 Clinically Integrated Networks across the country. Trinity Health has committed to having 75 percent of our revenue in value-based arrangements by 2020 as a member of the Health Care Transformation Task Force. However, our commitment goes much further than principles and theoretical support. Trinity Health is currently participating in 14 Medicare Shared Savings Plan (MSSP) ACOs and has five markets partnering as a Next Generation ACO. We are participating in 98 non-cms APM contracts. In addition, we have 43 hospitals participating in the Model 2 Bundled Payments for Care Improvement (BPCI) program, 13 Skilled Nursing Facilities (SNFs) in Model 3 BPCI, and 2 hospitals in the Comprehensive Care for Joint Replacement (CJR) program. We are firmly committed to transforming our delivery system into a People-Centered Health System focused on delivering the triple aim in our communities. Sponsored by Catholic Health Ministries

2 Our comments reflect our best suggestions for improvements that we believe will facilitate the transformation of the American health care system towards better health, better care and lower costs to ensure affordable, high quality, and people-centered care for all. As described further in this letter, Trinity Health recommends a number of changes to CMS CY 2017 PFS NPRM, including recommendations that CMS should: Improve reimbursement and create beneficiary cost-sharing waivers for primary care, mental and behavioral healthcare, and services for those beneficiaries with cognitive impairments or mobility-related impairments for models that hold providers accountable for total cost of care. Clarify that the hospital UB-04 claim for the radiology technical component would not be required to include any information on the ordering professional s Appropriate Use Criteria consultation. Aldvance beneficiary alignment, measure use, audit processes to improve the functionality MSSP program. Expand the Medicare Diabetes Prevention Program (DPP) Model. Add ESRD-related services advance care planning codes and telehealth consultations for a patient requiring critical care services to the Medicare telehealth list. If you have any questions on our comments, please contact me at wellstk@trinity-health.org or Sincerely, Tonya K. Wells Vice President, Public Policy & Federal Advocacy Trinity Health 2

3 Improving Payment Accuracy for Primary Care, Care Management, Patient-Centered Services and Patients with Disabilities CMS is proposing several revisions to the PFS billing code set in an effort to more accurately recognize the work of primary care and other cognitive specialties to accommodate the changing needs of the Medicare patient population. CMS is proposing a series of coding changes which involve the creation of new codes and the establishment of payment for existing codes that currently are not payable by CMS. Specifically, CMS is proposing the following: Primary Care and Care Coordination: CMS is proposing revisions to payment for chronic care management, including payment for new codes and for extra care management following the initiating visit for patients with multiple chronic conditions. Mental and Behavioral Health: CMS is proposing to pay for specific behavioral health services furnished using the Collaborative Care Model (CoCM), which has demonstrated benefits in a variety of settings. Cognitive Impairment Care Assessment and Planning: CMS is proposing a new code to pay for cognitive and functional assessment and care planning for patients with cognitive impairment (e.g., for patients with Alzheimer s). Care for Patients with Mobility-Related Impairments: CMS is proposing to increase payment for furnishing services to beneficiaries with mobility-related impairments. Trinity Health believes that effective payment systems must hold providers accountable for better health, better care and lower cost. Without that accountability, reimbursement for care coordination and care management is merely another fee-for-service opportunity that can be used to increase services provided to patients without assuring outcomes. We believe that the reimbursement changes proposed by CMS in this rule should be available to physicians/providers participating in total cost of care models, such as an ACOs or bundled payment programs. CMS is also proposing a number of revisions to the scope of service for chronic care management (CCM) codes with the intent of reducing the administrative burden of reporting these services. In previous comments, Trinity Health, along with many other stakeholders, encouraged CMS to reduce the reporting burden for CCM services and to better align the reporting requirements with how these services are provided in actual clinical practice. We are pleased to see the agency respond to these comments and urge CMS to implement these proposed changes. Trinity Health supports the agency s proposal to improve payment for primary care, mental and behavioral healthcare, and services for those beneficiaries with cognitive impairments or mobilityrelated impairments. While we are pleased that CMS has established separate payment for these services, we encourage the agency to monitor utilization to ensure that they are being appropriately covered by local contractors. Trinity Health recommends that CMS identify opportunities to allow cost-sharing waivers for care coordination codes, so that a very important barrier to accessing care management for chronic conditions is removed. Trinity Health also recommends that these enhanced reimbursement levels be excluded from benchmark calculations as they were not included in the historical data. Appropriate Use Criteria for Advanced Diagnostic Imaging Services CMS discusses the third Appropriate Use Criteria component, which has two parts: 1) the ordering professionals will need to consult with a clinical decision support mechanism (CDSM) and (2) the "imaging supplier/furnishing professional" would then need to include information about the ordering professional's consultation on their Medicare claim. CMS has indicated that specific proposals around the third AUC component will be included in the CY 2018 proposed rule. 3

4 Trinity Health supports the use of AUC for advanced diagnostic imaging. AUC can provide highly patient-centered and specific guidance to providers, which in turn can facilitate evidence-based decisionmaking and reduce unnecessary utilization. Trinity Health is greatly concerned about the potential impact of the coming requirements of the "imaging supplier/furnishing professional" and would like to provide requests for clarification and comments in advance of the CY 2018 proposed rules. We noted that for this third AUC component different terminology is used in the two proposed rules. In the CY 2017 OPPS Proposed rule, CMS refers to "imaging supplier" and in the CY 2017 Physician Fee Schedule Proposed Rule, CMS refers to "furnishing professional." The PAMA statute uses the term furnishing professional. We would ask that CMS use consistent terminology for the parties furnishing the radiology service, and that CMS more clearly define the parties/entities that would fall into the standard term. Transmittal 1699 (CR 9707) SUBJECT: Appropriate Use Criteria for Advanced Imaging Analysis and Design published on August 5, 2016, states: "The furnishing professional in these scenarios will be the radiologist that interprets the image. PAMA 218(b) identifies additional information that must be appended to the furnishing practitioner s claim." Trinity Health strongly recommends that CMS clarify that the hospital UB-04 claim for the radiology technical component would not be required to include any information on the ordering professional s AUC consultation. We believe this requirement should strictly be placed on the Radiologist's professional claim. It would be very difficult and burdensome for the hospital to provide information on the furnishing professional. It is often difficult to obtain all current order requirements and we are very concerned about the additional information that will need to be provided on an advanced radiology order to allow the furnishing provider to meet the requirements. All of the billing burden and risk of payment denial will fall to the entity providing the service and not on the ordering professional. We do not feel the burden of proof that the ordering professional followed regulation and consulted the CDSM should be placed on other unrelated parties. CMS should develop a verification mechanism that would be required of the ordering professional, perhaps a yearly attestation or data collection HCPCS codes what would be reported on the ordering professional's claim to indicate they ordered an advanced diagnostic imaging service and that they consulted CDSM. Medicare Shared Savings Program CMS established the Medicare Shared Savings Program (MSSP) to facilitate coordination and cooperation among providers to improve the quality of care for Medicare Fee-For-Service (FFS) beneficiaries and reduce the rate of growth in health care costs. CMS proposes in this proposed rule a number of changes to the MSSP quality reporting program, in part to align it with the recommendations of the Core Quality Measures Collaborative as well as measures proposed for the QPP under the MACRA. Trinity Health is currently participating in 14 MSSP ACOs and has 5 markets participating as a Next Generation ACO. We are committed to the ACO model and encourage CMS to provide as many pathways as 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 many to be successful and encourages ongoing investments by making it easier in early years to earn sufficient funds for reinvestment in care. Our comments in this area are grounded in our support and belief in the Medicare ACO program. 4

5 Sustainability Trinity Health's recommendations reflect a strong interest in seeing the MSSP achieve the long-term sustainability necessary to reduce health care costs, enhance care coordination and improve the quality of care for Medicare beneficiaries. Aspects of the current MSSP program make it difficult for the ACOs to obtain a positive return. We urge CMS to continue to improve the program to improve the deal to entice continued and expanded participation in the MSSP program. For example, Trinity Health believes as expressed in our comments to the proposed Benchmarking rule that CMS will be best served by creating a benchmark that presents real opportunity for savings, thereby encouraging providers to aggressively invest and manage quality and cost. As such, we are concerned about continued participation given the greater potential for losses. Quality measures We believe that ACO participants have ample incentive to improve quality and outcomes, but that measure reporting can be an expensive and burdensome activity. CMS should focus on outcome measures for high impact conditions for which there is evidence that improvement opportunities exist. Any new measure should be well-defined, tested and designed to fill gaps in measurement without adding undue burden on providers. Quality measures used for payment should be limited such that there are no more than 5 clinical measures and 2 patient experience measures. These measures should be primarily patient reported functional status outcome measures. Quality metrics should also include other components that are critical to accurately assessing the role of a provider in affecting patient outcomes, and ease provider burden across multiple programs. There are significant costs, for providers and CMS, associated with the production and collection of reported metrics across multiple programs. These costs are especially acute for primary care practices that may be smaller or independent. As a result, 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 Medicare measure reporting programs. We believe there are too many measures, however given the current approach, Trinity Health supports the addition/replacement of measure ACO-12, Medication Reconciliation Post-Discharge to replace ACO-39 as this measure is deemed to be a better more accurate measure. Trinity Health does not support the additional of measure ACO-44 Use of Imaging Studies for Low Back Pain as the case number will be very small since the measure assesses care for individuals ages Trinity Health does not support the addition of ACO-43 Ambulatory Sensitive Condition Acute Composite because we don t believe it adds value to the measure set. The incentive to reduce unnecessary hospitalizations is already embedded in the MSSP program with strong spending targets. Trinity Health supports the CMS proposal to remove/retire the following measures: ACO-9 and ACO- 10 Ambulatory Sensitive Condition Admissions Measures ACO-21, Preventive Care and Screening: Screening for High Blood Pressure and Follow-up Documented ACO-31, Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD) ACO-33, Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for patients with CAD and Diabetes or Left Ventricular Systolic Dysfunction (LVEF<40%) Trinity Health supports the proposed modifications of measure ACO-11, Percent of PCPs Who Successfully Meet Meaningful Use Requirements. CMS proposes to alter the specifications of the measure to assess an ACO on the level of CEHRT use by all providers and suppliers designated as eligible clinicians under the QPP proposed rule who participate in the ACO. This modification will ensure alignment between MSSP policy and the Advanced APM requirements. 5

6 Validating ACO Quality Data Trinity Health supports the proposals by CMS to increase the number of records reviewed during the audit process to achieve a higher level of confidence. We strongly recommend that CMS hold to no more than 50 as it will add workload/burder to the ACOs. To allow sufficient time for adjustment to new method, Trinity Health recommends that CMS delay the following changes until the 2018 reporting period: Conducting the audit in a single step Calculating an overall match rate instead of a match rate for each measure Penalties for audit match rates below 90 percent Technical Changes Trinity Health supports the following clarifications proposed by CMS, but urges CMS to finalize the language for these technical changes and make it available as soon as possible to ensure the greatest awareness, understanding and compliance by ACOs: Clarification that there is one overall quality performances standard that must be met in each performance year, even though there are also standards that must be met for each measure and in each domain. Clarification that CMS will take into account all measures when determining whether a compliance action should be taken based upon ACO quality performance at the domain level. Beneficiary Alignment Trinity Health supports CMS proposals to incorporate voluntary beneficiary alignment into MSSP assignment for all three MSSP tracks. Trinity Health is very pleased to see that CMS is proposing that it would design a process by which beneficiaries could designate their main doctor or another health care provider that they believe is primarily responsible for their care. If that provider participates in an ACO, the beneficiary would be assigned to that ACO. CMS proposes to incorporate voluntary beneficiary alignment for all three MSSP ACO tracks, beginning in performance year However, Trinity Health urges CMS to ensure that an automated process is in place and available for all MSSP ACOs regardless of Track such that beneficiaries can designate their main doctor directly to CMS (e.g., via or Medicare). We don t believe there should be a difference in how the beneficiary attestation is handled for the three Tracks. Trinity Health urges CMS to ensure that safeguards are built into the automated approach such that existing beneficiary alignment is only overridden when a beneficiary has at least one primary care service during the previous or current performance year with their designated ACO professional. Beneficiary Protections Trinity Health supports the following beneficiary protections: A 90-day grace period that would permit payment for SNF services for beneficiaries who are originally assigned to the ACO but are later excluded during the quarterly exclusion process because they do not meet criteria for ACO assignment (for example, dropping Part B coverage). Holding the beneficiary harmless, in the event that the SNF provides services to a beneficiary who was never assigned to the ACO (or assigned but later excluded and the 90-day grace period has lapsed) and the claim is rejected because of a lack of qualifying inpatient stay. Expansion of the Diabetes Prevention Program (DPP) Model The DPP is a structured lifestyle intervention that includes dietary coaching, lifestyle education, and moderate physical activity, all with the goal of preventing the onset of diabetes in individuals who are prediabetic. In March 2016, the Department of Health and Human Services announced that the CMS Office of 6

7 the Actuary certified the pilot DPP model as a cost savings program that reduced net Medicare spending. In light of this certification, CMS is now proposing to expand the DPP model beginning January 1, CMS proposes to designate the Medicare DPP as an additional preventive service. Trinity Health endorses CMS s proposal to expand the DPP. Targeting efforts on preventing chronic conditions that affect a broad range of Medicare beneficiaries is wise policy to help prioritize resources and selecting a program that has a proven track record in the Medicare population is a reasonable approach to addressing this high priority area for Medicare. Similar to our comments supporting the expansion of payment for primary care and other related services, we believe this proposal will have a positive impact on the overall Medicare program and the health of its beneficiaries. Trinity Health supports the agency s proposal to establish the Medicare Diabetes Prevention Program. Medicare Telehealth Services CMS maintains a list of Medicare telehealth services. When services on the list meet conditions specified by CMS (related to location, technology, authorized provider, eligible telehealth individual, etc.), Medicare pays a facility fee to the originating site and makes a separate payment to the distant site practitioner furnishing the service. For CY 2017, CMS is proposing to add the following services to the list of approved Medicare telehealth services: ESRD related services ( ); Advance care planning services ( ); and Telehealth consultations for a patient requiring critical care services (GTTT1-GTTT2). Trinity Health has always been a strong advocate for the expansion of telehealth services in the Medicare program and we are pleased that CMS is now proposing to expand the Medicare telehealth program for CY This expansion will increase access to these important services for a greater number of providers and the patients they serve. Over the years, telehealth has consistently demonstrated a wide range of positive outcomes including: better access to care regardless of the location of the patient, increased patient satisfaction, enhanced communication with providers and reduced costs. For these reasons, Trinity Health encourages the use of telehealth to promote health and well-being across outpatient, inpatient and community-based settings. Trinity Health supports the addition of ESRD-related services ( ), advance care planning codes ( ), and telehealth consultations for a patient requiring critical care services (GTTT1-GTTT2) to the Medicare telehealth list. 7

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