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RPA ACO CMS Comment Letter

Creation/Revision Date: December 03, 2010

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December 3, 2010 

Donald Berwick, MD 
Centers for Medicare and Medicaid Services 
Department of Health and Human Services 
Room 445-G, Hubert H. Humphrey Building 
200 Independence Avenue, SW 
Washington, DC 20201 

Re: Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program; 75 Fed. Reg. 70,165 (November 17, 2010); CMS-1345-NC. 

Dear Dr. Berwick: 

The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with renal disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with renal disease. We are writing to provide responses to the questions posed by the Agency regarding shared savings programs and Accountable Care Organizations in the recently published request for information. 

What policies or standards should we consider adopting to ensure that groups of solo and small practice providers have the opportunity to actively participate in the Medicare Shared Savings Program and the ACO models tested by CMMI?  
  RPA commends CMS for prospectively seeking to address the issue of how groups of solo and small practice providers can participate in the Medicare Shared Savings Program and the ACO models, as a preliminary review of the means necessary to participate would favor large institutions and health systems with the resources, infrastructure, and patient base to take part in an ACO model from day one, at the expense of small providers. 

We believe that one apparent barrier to small provider participation in shared savings programs/ACOs is the legislatively mandated minimum census of 5,000 patients. One possible solution would be for the Agency to develop a regionalization strategy that would utilize pods or pools of providers to assist small providers in complying with the 5,000 patient minimum. This would also facilitate the integration of multiple specialties, provider types, and settings of care that would seem to be characteristic of a successful shared savings program or ACO. RPA believes that the kidney care community’s extensive experience in providing coordinated care to a defined patient population in capitated and bundled payment environments and utilizing reiterative data gathering and feedback mechanisms would qualify a kidney-specific ACO as an excellent opportunity for early success of the ACO model. A kidney-specific ACO would incorporate nephrologists, dialysis providers, and other members of the kidney care community. However, use of a pod system that would allow the pooling of providers to satisfy the 5,000 patient minimum is necessary to achieve that success and provide the scale to achieve measurable analytics about performance of the delivery system.

  CMS should also explore methods for minimizing or otherwise reducing the administrative burden that ACO participation would present to solo and small practices. RPA recognizes that certain system-based validation processes must be in place to ensure that the participants in the shared savings programs/ACOs are in compliance with the broad objectives of these programs, but to the extent that the addition of one or more full-time employees (FTEs) are necessary to assure that compliance, the personnel cost associated with the administrative staff requirements will by itself be prohibitive. 
  Finally, we concur with the AMA and others that CMS should provide relief in the form of explicit safe harbors from antitrust enforcement and waivers of the Civil Monetary Penalty (CMP) statute, the Anti-Kickback statute, and the Stark regulations. While we believe that such relief should be available to physician practices of all sizes, solo and small physician practices are least likely to have the resources necessary to comply with the federal oversight framework in the absence of such safe harbors.
Many small practices may have limited access to capital or other resources to fund efforts from which ‘‘shared savings’’ could be generated. What payment models, financing mechanisms or other systems might we consider, either for the Shared Savings Program or as models under CMMI to address this issue? In addition to payment models, what other mechanisms could be created to provide access to capital? 
  The issues of access to capital and implementation of appropriate payment models and financing mechanisms are exceptionally complex, and the timeline for this information request does not lend itself to extensive deliberation of these points. RPA does support the comments of the AMA that CMS should create payment models that enable ACOs to self-finance improvements, minimize the use of requirements that necessitate substantial upfront capital, and develop loan, loan guarantee, and technical assistance programs that will facilitate the ability of small practices to participate in the ACO coordinated care delivery model. RPA does believe that whichever financing mechanisms and payment models are chosen for the short term should have an emphasis on sustainability and predictability. 
  As the Agency determines how issues such as financing mechanisms and payment models are to be resolved, RPA urges CMS to prospectively give consideration to the next generation(s) of shared savings programs/ACOs. The likelihood of these programs experiencing a ‘plateau’ effect several years in the future in both a fiscal sense and with regard to reaping the benefits of care coordination is real, particularly in the current environment of severe fiscal restraint and flux in healthcare delivery.
The process of attributing beneficiaries to an ACO is important to ensure that expenditures, as well as any savings achieved by the ACO, are appropriately calculated and that quality performance is accurately measured. Having a seamless attribution process will also help ACOs focus their efforts to deliver better care and promote better health. Some argue it is necessary to attribute beneficiaries before the start of a performance period, so the ACO can target care coordination strategies to those beneficiaries whose cost and quality information will be used to assess the ACO’s performance; others argue the attribution should occur at the end of the performance period to ensure the ACO is held accountable for care provided to beneficiaries who are aligned to it based upon services they receive from the ACO during the performance period. How should we balance these two points of view in developing the patient attribution models for the Medicare Shared Savings Program and ACO models tested by CMMI? 
  RPA strongly believes that attribution must occur prior to the performance period. In the renal patient population this is a relatively straightforward proposition that can be achieved via the use of the 2728 form that certifies a patient as having end stage renal disease (ESRD), the applicable ICD-9 codes indicating the stage of the patient’s chronic kidney disease and associated diagnoses in coordination with verifying distinct laboratory values such as the estimated glomerular filtration rate (eGFR). It is our opinion that assigning attribution retrospectively puts the care coordination team and the ACO in general at a significant disadvantage in providing effective care to both individual patients and the defined patient populations under their management. RPA also recommends that as attribution issues are resolved, CMS account for those providers of care who currently provide high quality and highly efficient care and thus may demonstrate a lesser degree of quality improvement and savings than less efficient providers. 


How should we assess beneficiary and caregiver experience of care as part of our assessment of ACO performance? 
  It is RPA’s opinion that use of a survey-based process probably represents the most efficient and expedient method for evaluating both beneficiary and caregiver experience. There is considerable precedent for such a process, with the Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys being among the most prominent of these efforts. Further, there are existing structures such as the Quality Improvement Organizations (QIOs) and, specific to renal care, the ESRD Networks, that have over the years had extensive involvement in the compilation and dissemination of information for beneficiary and caregiver experience that could serve as clearinghouses for the data gathering and feedback mechanisms necessary to assess the effectiveness of ACOs. 
  It must be noted that absent the appropriate degree of commitment on the part of CMS, assessment of beneficiary and caregiver experience will be of limited utility and will likely not fulfill the Agency’s objectives in this area. Such commitment would be encompassed by not only meaningful assignment of fiscal resources to this component of ACO implementation but also by deliberation by CMS on how beneficiary and caregiver experience assessment would be structured in this and future models of shared savings programs. 
The Affordable Care Act requires us to develop patient-centeredness criteria for assessment of ACOs participating in the Medicare Shared Savings Program. What aspects of patient-centeredness are particularly important for us to consider and how should we evaluate them? 
  RPA believes that CMS should focus on criteria that emanate from the patient’s ‘on-the-ground’ interactions with the ACO. Such aspects of patient-centeredness might include ease of scheduling, ease of information exchange, uniformity of information exchange and the degree to which the care coordination team seeks to involve the patient in their own care through educational opportunities and self management where possible. The survey process for beneficiary experience noted in the previous question provides a likely conduit for evaluating the patient-centered criteria created when the program is finalized. RPA also recommends that CMS account for the patient’s role in determining the quality of their care in order to minimize the possibility of patient de-selection or ‘cherry-picking.’ 
In order for an ACO to share in savings under the Medicare Shared Savings Program, it must meet a quality performance standard determined by the Secretary. What quality measures should the Secretary use to determine performance in the Shared Savings Program? 


While RPA understands CMS’ solicitation of specific quality measures to determine performance in the Shared Savings program, it is our belief that the measures themselves are an end product of the continuous quality improvement process, and as such it is more important to focus on the process before decisions are made than on use of specific measures. An extensive body of science surrounds quality measure development, selection, and implementation, and RPA in the strongest terms possible urges CMS to strictly adhere to the principles of that science. 
  An appropriate process for selection of quality measures would be evidence-based and reflective of the most recent literature to the greatest extent possible, in order to account for the constant evolution in measure development. Use of an appropriate process would test and vet measures to ensure that they are clinically relevant, reproducible, consistent across geographies, predictive, and easy to capture, among other qualities. As a member of the National Quality Forum (NQF) and lead nephrology organization for the AMA’s Physician Consortium for Performance Improvement (PCPI) for developing ESRD and CKD measures, RPA is fully committed to the development and adoption of evidence-based quality improvement measures. As such, we endorse the NQF process and urges CMS to adhere to the NQF process to the greatest extent practicable. 
What additional payment models should CMS consider in addition to the model laid out in Section 1899(d), either under the authority provided in 1899(i) or the authority under the CMMI? What are the relative advantages and disadvantages of any such alternative payment models?


RPA will defer on the issues of specific alternate payment models and the relative advantages and disadvantages of these payment models, but would urge CMS to maintain its focus on adoption of payment models that will contribute to the ultimate success of the ACO model. These include but are not limited to payment models that will (1) foster the ability of small practices to participate in ACOs; (2) account for the physician’s leadership role of the coordinated care team; and (3) preserve physician autonomy in order to serve as the advocate for the patient.

As always, RPA welcomes the opportunity to work collaboratively with CMS in its efforts to improve the quality of care provided to the nation’s kidney patients, and we stand ready as a resource to CMS in its future endeavors. Any questions or comments regarding this correspondence should be directed to RPA’s Director of Public Policy, Rob Blaser, at 301-468-3515, or by email at


Edward Jones signature
Edward R. Jones, M.D. 

Renal Physicians Association

1700 Rockville Pike
Suite 220
Rockville, MD 20852

Phone: 301-468-3515
Fax: 301-468-3511

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