December 3, Donald M. Berwick, M.D. Administrator Centers for Medicare and Medicaid Services Posted to Regulations.gov. File code CMS-1345-NC

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1 December 3, 2010 Donald M. Berwick, M.D. Administrator Centers for Medicare and Medicaid Services Posted to Regulations.gov File code CMS-1345-NC Dear Dr. Berwick: The American Urological Association (AUA), representing over 90 percent of the practicing urologists in the United States, welcomes the opportunity to respond to the Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program published in the Federal Register on November 17, The long-standing mission of the AUA is to promote the highest standards of clinical urological care through education, research, and formulation of health care policy. The public health burden of urological disease in the United States is large and growing. Urologists are the specialists who most often diagnose and treat prostate cancer, the second leading cause of cancer deaths among men in the U.S. In addition, urologists diagnose and manage the care for kidney stones, bladder cancer, urinary incontinence, urinary tract infections, benign prostatic hyperplasia, and other diseases that are prevalent among Medicare beneficiaries. We appreciate your attention to the concerns of America s urologists. The AUA supports the goals of the Affordable Care Act in creating Accountable Care Organizations (ACOs) to improve the quality of health care services and to lower health care costs. We feel it is essential to the success of this new initiative that physicians in all specialties and practice settings have the opportunity to participate if they wish. We appreciate that CMS recognizes the participation barriers that may confront solo and 1

2 small practice physicians. Rural physicians may also find ACO participation problematic due to low physician and population density. We hope and expect that CMS regulations now under development will facilitate ACO participation by the multiple provider arrangements identified in the ACA and will not be more favorable to large health care systems or hospital networks and their employed physicians. We will address the questions posed in the RFI in order: What policies or standards should CMS consider adopting to ensure that groups of solo or small practice providers have the opportunity to participate in ACO models and the Medicare Shared Savings Program? Access to capital and payment models: Many solo and small practices, and even associations of solo and small practices, may lack the start-up capital necessary to create the infrastructure to implement the integrated and coordinated care processes that are fundamental to ACO efforts to improve quality and lower cost. Solo and small practices may be most successful in participating in ACOs when they join with larger existing physician organizations or other eligible structures. The AUA recommends that the federal government provide implementation financing for building coordination capabilities and infrastructure in such new organizations. In particular, perhaps HHS, either through CMS or the new Center for Medicare and Medicaid Innovation (CMMI) can provide upfront resources, such as grants and loans, to facilitate the formation of ACOs, particularly those that will include solo and small physician practices. Such financing should be available to specialists as well as primary care physicians. We also suggest that, to foster the sharing of electronic health record (EHR) software with community/small practice physicians involved in ACOs, the Stark exception for EHRs (42 C.F.R (w)) and the anti-kickback safe harbor for EHRs (42 C.F.R (y)) be extended past their current sunset date of December 31, The AUA also recommends that CMS support multiple payment approaches in the ACO implementing regulations. Such approaches should include: risk-adjusted capitation, partial capitation, bundled payments, medical-home payment, and care management fees, as well as traditional Medicare fee-for-service. We recognize that solo and small 2

3 practices that lack experience with capitation are likely to be most successful in fee-for-service arrangements. However, we feel a range of payment approaches should be available to meet the needs of ACOs of all sizes, structures, and levels of sophistication. CMS should be careful to avoid establishing barriers to the participation of small practices, for example, by setting savings thresholds that must be surpassed before a physician can begin to share savings with Medicare or by raising the minimum number of beneficiaries necessary to establish an ACO beyond the 5000 specified in the ACA. Physicians will be more reluctant to participate in an ACO if the likelihood of achieving a shared bonus is highly uncertain. Policies that provide greater predictability to participants will be more attractive to physicians. The ACO spending targets should be adjusted for differences in geographic practice costs and should be risk adjusted for patient risk factors as is currently done for Medicare Advantage payment. It is very important that ACOs not be penalized for caring for sicker and more complex patients. Development of a risk-adjustment model should involve open and transparent consultation with practicing physicians and methodologists. The model should be open to public inspection and comment and should be finalized before payment targets are set. We recognize that a well-designed risk adjustment methodology is necessary but may not be sufficient to protect ACOs from extreme costs associated with individual patients with unique problems that require unusually expensive care not adequately captured by the methodology. Even a single patient of this type could be financially devastating to the ACO. Thus, we suggest that, in addition to appropriate risk adjustment methodologies, CMS should establish limits on an ACO s accountability for the total cost of services to any individual patient. The AUA also recommends that CMS provide timely and detailed data to physician practices to enable them to identify opportunities and successfully implement new strategies to reduce costs and improve quality of care during the performance period. CMS should also provide data on services received by ACO patients in the prior year, and all data should be provided in a format that permits analysis. Feedback should be provided to practices before ACO implementation and on a regular basis after start-up to allow physicians to monitor the care of their patients provided in all settings. 3

4 Beyond grants or loans and payment methods, CMS should make patient self-referral laws and antitrust laws more flexible for physicians participating in ACOs. In an ACO setting, self-referral for ancillaries may be preferred for care coordination purposes and to achieve the lowest cost procurement of quality services. Importantly, physician collaboration with hospitals in forming ACOs should not require that physicians become employees of the hospital or ACO to avoid existing regulatory barriers. Process of attributing beneficiaries to an ACO: There are two important questions about attribution of patients to physicians and ACOs that must be resolved in the implementing regulations. The first question is: how will individual patients be attributed to specific ACOs and will this attribution take into account only services by primary care physicians? The second key question about attribution is: which period should be used for attribution, the year before the beginning of the contract period, or the end of the contract/performance period? If the prior period is optimal, should patients be informed of their assignment to the ACO before the contract period begins? If so, who should inform them and should the patients have the opportunity to opt out of participation in the ACO? The AUA feels that CMS should attribute individual patients to ACOs by identifying each patient s physician who accounts for the majority of evaluation and management costs in the base period. Alternately, CMS could attribute patients to ACOs based on the patient s physician who is responsible for the majority of the patient s overall care costs in the base period. Where two or more of the patient s physicians participate in an ACO, their cost percentage could be aggregated. We assume patients will not be assignable to multiple ACOs, as this would defeat the goals of the program. Patients with substantial care costs split between physicians in two ACOs would have to be addressed by CMS. One open question is whether physicians will be able to participate in more than one ACO. Furthermore, specialists who have an ongoing relationship with patients they are treating for chronic conditions, such as prostate cancer, should be allowed to continue treatment of these patients. In addition, specialists should be eligible to have these patients attributed to them using the established forumula in the same manner as patient attribution to primary care physicians. 4

5 The AUA strongly recommends that ACO patients be identified/assigned before the contract period and be given prior notice and the opportunity to opt-out. Opting-out should not, however, require the patient to leave his or her physician. Patients should be able to continue seeing their physicians while opting out of data reporting and cost attribution for the ACO. We feel it is incumbent upon CMS to notify patients of their assignment to an ACO with standardized explanatory material about the benefits of ACO participation and the rights of patients to opt-out. Since the ACA requires CMS to assign patients to ACOs, it requires (by implication) that CMS be responsible for explaining to patients why they were chosen and how their health care delivery will be different in the ACO setting. The alternative, to require physicians to carry out this responsibility, not only imposes a great time burden on physicians to ensure that beneficiaries fully understand the program, but also allows unacceptable variation in explanations to beneficiaries about the key aspects of the program. Thus, we believe greater consistency in beneficiary understanding can be achieved if CMS takes the lead on beneficiary notification and education about ACOs. This would also eliminate any suspicion that physicians might discourage higher cost patients from remaining with the ACO. However, we recommend that CMS develop standardized educational materials and distribute these materials as well as FAQs to physicians and their staffs that they can use to reinforce CMS messages and further explain the ACO program. We also encourage CMS to develop incentives for beneficiaries to participate in ACOs, such as reduced cost-sharing. Quality measures and performance standards for ACOs: Quality measures for ACOs should target the results desired from ACOs, such as improved coordination of care and transitions in care. Requirements for ACO measure selection/development should be aligned with measure development for the PQRS. Measures should be validated by relevant specialties. All measures approved by the National Quality Forum, as well as other evidence-based measures developed through an open and expert process, should be eligible for selection, as appropriate. We recommend that evidence-based process measures constitute the majority of measures employed for ACOs. Outcome measures, such as emergency room use, hospital readmissions, and preventable admissions, are also options for consideration. 5

6 Surgeons in ACOs should be measured for effectiveness in care, efficiency in care, and for patient experience of care. Programs like the ACS National Surgical Quality Improvement Program (NSQIP), by their very design. measure the quality of outcomes provided within a system of care, and support the ACO s goals of quality, safety, care coordination, and patient experience. ACOs could also reward participation in other proven, physician-led quality improvement programs that promote quality outcomes for patients, such as the National Cancer Center Database (NCDB), the National Trauma Data Bank (NTDB), and the Trauma Quality Improvement Project (TQIP). Performance measurement reporting should employ national targets. There should also be benchmarks for improvement within the ACO over time and compared to peer ACOs, based on similar size and structure and other relevant characteristics. In order to minimize redundancy in measure reporting, one-time data extraction for certain measures that are common to more than one quality reporting program (e.g. PQRS and meaningful use) should be facilitated by electronic health record vendors. To make this possible, standards for database fields, vocabularies, and data transmission must be established. For example, currently, there is no industry consensus or regulatory standard on how to digitize clinical quality measures in order to develop electronic specifications to guide vendors and providers in moving to the CMS Continuity Assessment Record and Evaluation (CARE) standard. Electronic health record vendors should be expected to include such reporting functions to maintain their CCHIT certification. We also recommend that participation in ACO electronic quality measurement reporting be translated into credit for meaningful use activity. This should be optional for physicians, not mandatory, since not all will participate in ACOs. We recommend that CMS use appropriate versions of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey (including the newly approved Surgical CAHPS or S-CAHPS as well as Ambulatory CAHPS) to assess patient experience of care and patientcenteredness of the ACO. CAHPS is administered as a special survey of patients, and the lack of resources available to conduct such surveys has been a principal barrier slowing their implementation. We recommend that CMS provide financial support for the collection and reporting of patient 6

7 experience-of-care data, as has been the case with Medicare health plans. Encouragement by the ACO of patient use of a personal health record (PHR) could be considered another valid measure of patientcenteredness. Consideration should be given to assessment of explicit process of care approaches that are intended to ensure that care is delivered in a patient-centered manner. For example, the Cancer Quality Alliance developed recommendations for how to create a process of care that is intentionally and clearly patient-centered. We encourage CMS to be cautious about public reporting of ACO performance data. In most instances, ACOs will be start-up organizations and will need time to perfect systems and reporting mechanisms. The PQRS system has demonstrated that accurate processing of measures and reports requires a significant learning curve for physicians and regulators. Thank you for your attention to the concerns of America s urologists. We look forward to working collaboratively with CMS and our members to support successful implementation of ACOs. If you have any questions on this letter, please contact Inger Saphire-Bernstein, Manager of Regulation, at (isaphirebernstein@auanet.org). Sincerely, Steven M. Schlossberg, MD, MBA Chair Health Policy American Urological Association 7

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