December 3, 2010 SUBMITTED ELECTRONICALLY

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1 December 3, 2010 SUBMITTED ELECTRONICALLY Donald M. Berwick, MD, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445 G Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC Cabot Drive Novi, MI ph Twelve Mile Road Farmington Hills, MI ph Attention: CMS 1345 NC Dear Dr. Berwick: Trinity Health is pleased to submit comments on the Centers for Medicare & Medicaid Services (CMS) Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program, published in the Federal Register on November 17, Trinity Health is a faith-based organization devoted to a ministry of healing. We serve persons through a network of hospitals, health care services, and advocate partnerships at the community, regional, and national levels. Formed by the Sisters of Mercy Regional Community of Detroit and the Congregation of the Sisters of the Holy Cross, Catholic Health Ministries draws upon a rich history extending more than 140 years. Trinity Health is the fourth-largest Catholic health system in the United States (based on Operating Revenue). We have 19 Ministry Organizations, encompassing 46 hospitals (34 owned, 12 managed), 379 outpatient clinics/facilities, 29 long-term care facilities, numerous home health and hospice programs, and senior housing communities in nine states. Additionally, we have more than 8,000 active staff physicians and over 220 physician practices in Michigan, Idaho and Ohio that have achieved recognition as patient-centered medical homes (PCMHs) by the National Committee for Quality Assurance (NCQA). In Trinity Health, we are called to be innovative in improving health care delivery, and we support the transition to accountable care organizations (ACOs). We are working to create accountable health networks with other providers in our communities, and offer our lessons learned to CMS to inform how the Medicare Shared Savings Program could operate. We appreciate your consideration of our comments in shaping both the Medicare Shared Savings Program and possible ACO demonstrations under the Center for Medicare and Medicaid Innovation (CMMI). Participation by solo and small practice providers Trinity Health is well-versed in the challenges of solo and small practice providers because of our experience with both our employed practices and affiliated physicians. We recommend that CMS focus on policies and standards that drive simplification and alignment across initiatives.

2 For example, the structural requirements for ACOs should be consistent with other accreditation criteria, like those recently released for comment by NCQA, as well as the established and widely-adopted NCQA recognition criteria for their Physician Practice Connections- Patient- Centered Medical Home (PPC-PCMH) program. We would also suggest that CMS begin the Shared Savings Program with minimal requirements related to health information technology (HIT). Trinity Health has had great success in our PCMH initiatives with use of registries; we have not required fully-functional electronic health records (EHRs). Lastly, we recommend that CMS should encourage solo and small physician groups to partner with a hospital-centered ACO that would be able to shoulder more of the associated administrative costs. Additionally, an anti-kickback safe harbor and Stark exception should be put into place to ease clinical integration among loosely affiliated providers (i.e., solo/small practices that are not employed by a hospital). Access to capital Trinity Health believes that additional resources should be provided up front to encourage ACO development. CMS should provide grants to physicians and hospitals to support financing of costs associated with creating an ACO. While the shared savings model is generally seen as upside risk only, the model does not fully contemplate the costs required to be an ACO (e.g., start-up costs, HIT system investments, culture changes, etc.). Because the financial incentives are available only after the ACO is formed and able to meet certain financial and clinical performance metrics, a sufficient return on the investment might never be realized. This misalignment of incentive may act to discourage solo and small physician groups, particularly in rural areas, from forming ACOs. Alternatively, CMS could provide some shared savings payments prospectively to assist in the development of required capabilities and infrastructure. A fund that allows ACOs to receive some payment up front and use the money for critical ACO related investments (e.g. EHRs, care coordinators) may assist them in reaching the goals. Those prospective payments could later be reconciled with actual spending they could be a down payment on shared savings payments, or could be returned to CMS if the ACO exceeds the threshold. Patient attribution models Trinity Health feels strongly that patients are an essential member of the care team, and should be notified of their providers participation in an ACO, as well as their own responsibilities in achieving greater value healthcare. We, therefore, encourage CMS to assign beneficiaries to ACOs prospectively, and to allow beneficiaries to opt out by choosing primary care providers that are not participating in an ACO. Beneficiaries should be assigned before the start of the program based on past claims data so that providers know the beneficiaries for which they are responsible. There should also be a semi-annual or annual process to add newly-enrolled Medicare beneficiaries. At the end of each three-year measurement period, the beneficiaries should be reassessed for the following three-year period.

3 We do not recommend CMS elect an approach that allows beneficiaries to exclude their data from the calculating of the ACO s performance. Under that approach, we feel the risks to beneficiary access might be unreasonably limited by providers seeking to boost ACO performance by encouraging high-risk and high-cost beneficiaries to opt out. In addition to notifying beneficiaries of their assignment to an ACO, we encourage CMS to employ innovative benefit designs that encourage beneficiaries to take equal responsibility for ensuring good outcomes. CMS could explore reduced cost sharing arrangements, or could require a portion of the shared savings go directly to beneficiaries as an incentive for them to participate actively in their care. Assessing beneficiary and caregiver experience Trinity Health is dedicated to delivering the highest quality, safest and the most efficient care for every patient, every time, in every Trinity Health location. In this context, we assume that caregiver refers to families or friends that provide care to beneficiaries, and not to professional healthcare providers. To assess beneficiary and caregiver experience with an ACO, CMS should require a certain set of specific questions to be included in an experience survey. The survey should be offered periodically using several different modes (e.g., phone, paper, web, or in-office kiosk). To ease the burden on providers of collecting and reporting this data, CMS should seek to align with existing beneficiary experience measure sets, such as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) or the Healthcare Effectiveness Data and Information Set (HEDIS). Questions should cover areas such as: Effectiveness of care Satisfaction with the experience of care Use of services Cost of care Informed healthcare choices Shared decision making Patient-centeredness criteria Trinity Health, along with the Catholic Health Association, believes that every person is invested with inherent dignity and therefore fostering the well-being of each individual patient throughout the life span must be the goal of our health care system. This principle must be at the center of every health care related decision that is made, whether by care providers or by CMS as it develops rules for ACOs. Patient-centered care implies the coordination of a person s health care through time and across care settings. ACOs can provide a new structure to allow health care providers doctors and other health professionals, hospitals and nursing homes, and others to coordinate the care they provide and to accept joint accountability for outcomes. It also refers to how a patient is treated while receiving care. Patient-centered care makes sure that care is designed to meet the needs of the patient, rather than the patient being subjected to

4 the needs of the care regimen and the caregivers. It focuses on whether the patient is fully informed and involved in the decision making process. We believe that patient-centeredness is crucial to the success of health system transformation. CMS should consider the following factors when establishing patient-centeredness criteria for the Medicare Shared Savings Program: Whether the patient is given information about his or her condition and treatment options in a form and manner that is understandable Whether the patient is actively involved in the decision making process Whether transitions between care settings or from a health care facility to the home are conducted so that the patient fully understands his or her part in ongoing treatment, what to do, and whom to contact with questions Whether care is delivered in a manner that respects and accounts for linguistic and cultural differences, so that all patients understand the information they receive and are able to make choices that accord with their preferences Whether the patient s wishes concerning the involvement of family members or friends are respected Whether patient pain is managed appropriately, and whether patients have access to palliative care Whether patients have clearly defined care plans Whether patients and their ACO providers have access to personalized information and education on prevention measures A patient-centered focus can also contribute to improving population health. For example, an ACO should do a comprehensive assessment of a beneficiary s social, cultural, literacy and mental health status in addition to medical status. This information can assist in efforts to reduce disparities in health care. Trinity Health strongly recommends that CMS align the patient-centeredness criteria for ACOs to the requirements for physician practices participating in patient-centered medical home or advanced primary care demonstration projects, such as the NCQA PCC-PCMH criteria or the CMS version of those criteria created for the Medicare Medical Home Demonstration. Quality measures ACOs should be measured on how well they meet the triple aims : Improve the health of the population; Enhance the patient experience of care (including quality, access, and reliability); and Reduce, or at least control, the per capita cost of care. As such, performance measures both financial and clinical should seek to measure patient outcomes, and not be as focused on structures or processes. Additionally, the quality measures chosen for the Medicare Shared Saving Program should be endorsed by the National Quality Forum, and should align with CMS other quality reporting programs like the Physician Quality Reporting System, the Hospital Inpatient Quality Reporting Program, and the EHR Incentive Program. This alignment will help reduce the burden of reporting on providers.

5 CMS should also work towards creating new cross-cutting measures that examine quality over an entire episode of care, not just a single point in time. These types of measures will allow CMS to truly understand the aggregate performance of an ACO. Additional payment models CMS should consider testing risk-based payment models that may create stronger financial incentives for providers to improve quality and reduce spending. We would recommend that global payments be tested in the Medicare Shared Saving Program or the CMMI. This model could be more beneficial to low-cost providers in low-spending areas, who may not stand to benefit as much under a shared savings model. Global payment has both strengths and weaknesses: To combat the potential negative unintended consequences of the global payment model such as under-treatment of high-risk or high-cost patients CMS should condition a significant amount of payment on performance on clinical quality measures. Additionally, CMS should adequately risk-adjust the payments for patient characteristics, perhaps requiring a health risk assessment for Medicare beneficiaries that participate in an ACO to gauge risk when using global payments. *** We appreciate this opportunity to provide input as CMS develops its proposed rule to implement the Medicare Shared Savings Program and shapes the direction of the CMMI. We look forward to continuing to work with CMS on these important initiatives. Please feel free to contact me directly at with any questions or if you need additional information on our comments. Sincerely, Tonya K. Wells Vice President, Federal Public Policy & Advocacy

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