Read the attached The Final Rule for the Medicare Shared Savings Program. In 400 to 500 words, address the following: -Describe the board’s roles, functions, and liabiliti

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THE FINAL RULE FOR THE MEDICARE SHARED SAVINGS PROGRAM

The Affordable Care Act authorizes the Centers for Medicare and Medicaid Services (CMS) to establish a Medicare Shared Savings Program that would create a new category of health care provider, called accountable care organizations (ACOs), in the Medicare program. On March 31, 2011, CMS released a proposed rule for implementing the new program and solicited public comment.1 On October 20, 2011, CMS released the final rule for implementing the new program.2 The following is a detailed summary of the final rule. OPERATIONAL DEFINITION OF AN ACCOUNTABLE CARE ORGANIZATION FOR THE MEDICARE SHARED SAVINGS PROGRAM

CMS defines an ACO as a legal entity that is recognized and authorized under applicable state, federal, and tribal law and composed of certified Medicare providers or suppliers. These participants work together to manage and coordinate care for a defined population of Medicare fee-for-service (FFS) beneficiaries and have established a mechanism for shared governance that provides appropriate control over the ACO’s decision-making process. ACOs that meet specified quality performance standards are eligible to receive payments for shared savings if they can reduce spending growth below target amounts. ELIGIBILITY REQUIREMENTS TO PARTICIPATE IN THE MEDICARE SHARED SAVINGS PROGRAM

Eligible Providers A core principle of the Medicare Shared Savings Program is that providers should be able to innovate in terms of care delivery. Accordingly, CMS has made an effort to avoid being overly prescriptive in the eligibility requirements. In fact, CMS expands the list of providers eligible to apply for the program beyond the four specified in the Affordable Care Act: 1) professionals (i.e., physicians and other clinicians) in group practice arrangements; 2) networks of individual practices; 3) joint venture arrangements between hospitals and professionals; and 4) hospitals employing professionals. In addition to these four, eligibility will be open to a subset of critical access hospitals (CAHs), rural health clinics (RHCs) and federally qualified health clinics (FQHCs). The eligibility of CAHs is limited to those that are paid by Medicare in a manner that supports the collection of cost and utilization data needed to assign patients to providers. It should also be noted that while other providers (such as home health agencies, hospice facilities, and dialysis centers) cannot independently participate in the ACO program, any provider can participate in the program by partnering with eligible providers. For example, a home health agency can partner with a network of individual practices. This will allow for participation from a broad range of provider configurations.

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Legal Entities ACOs that want to participate in the Medicare Shared Savings Program are required to be a legal entity such as a corporation, partnership, limited liability company, or foundation recognized and authorized to conduct its business under applicable state, federal, and tribal law. It must be capable of:

• receiving and distributing shared savings;

• repaying shared losses;

• establishing, reporting, and ensuring all its participating providers comply with program requirements, including quality performance standards; and

• performing the other requisite ACO functions identified in the statute. An ACO with operations in multiple states would have to certify that it is recognized as a legal entity in the state in which it was established and that it is authorized to conduct business in each state in which it operates.

Existing organizations that meet the legal requirements can participate. That is, a self- encompassing ACO entity, such as a hospital employing providers, is eligible and would not have to form a new legal entity. However, an ACO formed by two or more otherwise independent participants (such as a hospital and a large physician group) must form a new legal entity separate from any of its participants. Each ACO must have a tax identification number (TIN) that will be used to identify all ACO participants. The ACO itself is not required to be a certified Medicare provider separately from its component providers.

Governance Requirements The final rule requires that an ACO must establish and maintain a governing body, such as a board of directors or board of managers, with adequate authority to execute the statutory functions of an ACO. This governing body is to be largely composed of its participating providers (or their designated representatives), include Medicare beneficiaries served by the ACO, and possess broad responsibility for the ACO’s administrative, fiduciary, and clinical operations. ACOs are also encouraged to have community representation on the board to satisfy a requirement for partnering with community stakeholders. If the ACO is composed of multiple participants (such as multiple physician group practices), it will need to form a new governing body that is separate and unique to the ACO. However, the representatives on the ACO governing body could serve in a similar manner for organizations that are components within the ACO. On the other hand, if the ACO is an existing entity, the ACO governing body may be the same as the governing body of the existing entity.

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The ACO participants (i.e., providers) must have at least 75 percent control of the ACO’s governing body. This leaves room on the board for nonprovider participation, as it is expected that some ACOs, particularly those composed of small-group practices, will need to partner with managerial companies and health plans, as they may not have the capital or infrastructure necessary to administer an ACO. If the ACO cannot meet the 75 percent criteria or explicitly include a Medicare beneficiary on the board, the ACO must describe why it cannot meet those requirements and identify alternative ways to meaningfully involve its participants and beneficiaries in the governance process. This flexibility will allow existing entities with consumer-led boards that have more that 25 percent participation to meet eligibility requirements. It will also allow ACOs in states with Corporate Practice of Medicine restrictions to structure beneficiary representation accordingly. It should also be noted that although CMS requires ACO participants to have at least 75 percent control of the governing body, it does not require “proportionate control” by each ACO participant (thus, not every provider group or other participant needs to have equal voting rights). This should add further flexibility for ACOs to develop an effective governance structure.

Leadership and Management Structure ACOs must have a leadership and management structure that includes clinical and administrative systems. In addition, ACOs must meet the following criteria:

• Operations are managed by an executive who must certify that all ACO participants are willing to become accountable to and report on quality, cost, and overall care of the Medicare beneficiaries assigned to the ACO. In addition, the appointment and removal of the executive must be under the control of the organization’s governing body and the executive’s leadership team must have demonstrated the ability to effectively direct clinical practice to improve efficiency processes and outcomes.

• Clinical management and oversight is managed by a senior-level medical director who is a board-certified physician, licensed in the state in which the ACO operates, and reside in that state.

• Providers must make a meaningful commitment—either financial or human (i.e., labor) investment —to the ACO’s clinical integration program.

The final rule allows flexibility for innovative management and leadership structures, but ACOs will have to provide evidence that alternative structures can meet the same goals. Also, as part of its application, the ACO must describe how it will establish and maintain an ongoing quality assurance and process improvement program, overseen by an appropriately qualified health care professional.

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Processes to Promote Evidence-Based Medicine, Patient Engagement, Reporting, Coordination of Care, and Patient-Centeredness The ACO must provide documentation in its application that describes its plans to: 1) promote evidence-based medicine; 2) promote beneficiary engagement; 3) report internally on quality and cost metrics; and 4) coordinate care. ACOs are given the flexibility to choose the tools for meeting these functional requirements that are most appropriate for their practitioners and patient populations. Over time, as CMS learns more about successful strategies in these areas, CMS may become more prescriptive. CMS will be monitoring strategies undertaken by ACOs to ensure that they do not impede the ability of the beneficiary to seek care from providers outside the ACO’s network. In their plans to improve care management and coordination, ACOs must also exhibit a strong patient-centeredness element. This includes developing individualized care plans—based on the person’s unique needs, preferences, values, and priorities—that are regularly assessed and evaluated for improvement opportunities. Care should also be integrated with community resources that beneficiaries require to maintain well-being. In addition, beneficiaries (and their caregivers or family members, where applicable) should be encouraged to be partners in care and should have access to their own medical records and to clinical knowledge to make informed choices about their care. Furthermore, transitions in care among providers in the ACO, as well as providers outside the ACO, should be supported, consistent with the patient-centeredness goals. Based on these principles, ACOs must demonstrate how they will meet several specific actions to ensure patient-centeredness, including:

• A beneficiary care experience survey in place and a description in the ACO application of how the ACO will use the results to improve care over time. This survey will be used as part of the ACO performance assessment. CMS is requiring that ACOs use the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey in their efforts so performance data can be standardized across ACOs.

• Patient involvement in ACO governance by representation in the governing body.

• A process for evaluating the health needs of the ACO’s assigned population, including diversity considerations and a plan to address the needs of their population.

• Systems in place to identify high-risk individuals and processes to develop individualized care plans for targeted patient populations, including integration of community resources (e.g., employers, commercial health plans, local businesses, local government agencies, local quality improvement organizations, or collaboratives such as health information exchanges) to address individual needs.

• A mechanism in place for the coordination of care (e.g., via use of enabling technologies or care coordinators).

• A process in place for communicating clinical knowledge/evidence-based medicine to beneficiaries in an understandable way. This process should allow for beneficiary

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engagement and shared decision-making that takes into account beneficiaries’ unique needs, preferences, values, and priorities.

• Written standards in place for beneficiary communication and a process to allow beneficiaries to access their medical record.

• Development of an infrastructure and internal processes for measuring clinical or service performance by physicians across the practices, and using these results to improve care and service over time.

The patient-centeredness requirements are more extensive and prescribed than those for promoting evidence-based medicine, beneficiary engagement, internal quality and cost reporting, and care coordination. However, many of the patient-centeredness requirements can serve to meet those process objectives as well. Sufficient Number of Primary Care Providers and Beneficiaries All ACOs will be required to have at least 5,000 Medicare beneficiaries assigned to it for each performance year. If the number of assigned beneficiaries falls below 5,000 during the performance period, CMS will issue a warning and place the ACO on a corrective action plan. The ACO agreement will be terminated if the ACO fails to meet this 5,000-beneficiary requirement by the completion of the next performance year and the ACO will not be eligible for shared savings that year. The Affordable Care Act specifies that each ACO must include sufficient primary care professionals for the number of Medicare FFS beneficiaries assigned to it. However, CMS has chosen not to be prescriptive as to the specific number, type, or location of providers that are included as ACO participants. Program Integrity Requirements ACOs must also have a compliance plan that addresses how the ACO will meet applicable legal requirements. The plan must include: 1) a lead compliance official who reports to the governing body; 2) mechanisms for identifying compliance problems; 3) a method for ACO employees or contractors to report suspected problems; 4) compliance training; and 5) a requirement to report suspected violations to the appropriate law enforcement agency. In addition, the ACO must have a conflict of interest policy. CMS recommends that the ACO coordinate its compliance programs with those of its participating provider groups. CMS will screen ACOs, including ACO participants, for a history of program integrity issues. Although the Medicare program includes screening procedures for enrolling providers and suppliers, ACOs may not be subject to those procedures to the extent that they are not Medicare- eligible entities separate from their components. ACOs and the component providers and suppliers that are eligible to enroll in Medicare will be subject to screening in accordance with applicable regulations, and their program integrity experience will be considered when reviewing the ACO’s application for the Shared Savings Program.

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The final rule prohibits ACOs from utilizing preferential referral agreements with its ACO providers for care to beneficiaries that ACOs know will not be assigned. Such arrangements could result in inappropriate cost-shifting, as ACOs are not held accountable for the cost of nonassigned patients. ACOs will also be prohibited from providing gifts, cash, or other remuneration (such as gift certificates) to beneficiaries as inducements for receiving services. ACOs could use such incentives to keep patients within their ACO provider network. However, consistent with guidance from the Office of the Inspector General describing waivers of certain fraud and abuse protections (which are discussed below), ACOs may provide beneficiaries certain services or items for free or below fair-market value. The items or services must be directly related to the medical care of the beneficiary. They must also be either preventive or advance a clinical goal for the beneficiary (e.g., adherence to treatment or drug regimen). For example, an ACO provider could give blood pressure monitors to patients with hypertension to encourage regular blood pressure monitoring. ACO MARKETING GUIDELINES

The Centers for Medicare and Medicaid Services wants to ensure that accountable care organizations avoid engaging in activities that prevent its assigned beneficiaries from taking advantage of the full range of benefits they are entitled to under the traditional Medicare fee-for- service program. In addition, CMS wants to limit the potential for ACOs to market themselves as endorsed Medicare ACOs or for marketing materials to misrepresent the Shared Savings Program. Toward those ends, all ACO marketing communication materials must be filed with CMS. After five days, if CMS has not disapproved the materials, ACOs are permitted to use them. However, CMS can still disapprove the marketing materials at any time and require that they be withdrawn, even after the five-day period. ACOs must also certify in advance that any marketing materials they use comply with the applicable marketing requirements. In addition to avoiding the concerns discussed above, these requirements include using template language supplied by CMS whenever available and being clear, concise, and well-organized in compliance with the Plain Writing Act of 2010. Failure to comply will render the ACO not in compliance with patient-centeredness requirements and result in it being placed on a corrective action plan. REQUIREMENTS FOR AN ACO TO COMMIT TO A THREE-YEAR PARTICIPATION AGREEMENT

By statute, ACOs must agree to participate in the Shared Savings Program for at least three years. According to the final rule, for applications that are approved to participate in 2012, the start date will be either April 1, 2012, or July 1, 2012. The first performance period for ACOs that begin in 2012 will be from their start date through December 31, 2013. The following two performance periods will be on a calendar-year basis, extending through December 31, 2015 (Exhibit 1).

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For applications approved for 2013 and subsequent years, the start date will be January 1st of that year and the term of the agreement will be three years, with the performance period on a calendar-year basis.

New Program Standards Established During the Three-Year Agreement Period It is likely that CMS will make changes to the ACO regulations in future rules. During the three- year contract, ACOs will be subject to all regulation changes with the exception of eligibility requirements concerning the governance of ACOs, the calculation of the sharing rate, and beneficiary assignment. Thus, ACOs would have to comply with any changes related to quality- performance standards. For these and other required changes, ACOs would have to submit a supplement to their original application explaining how they would address them or would face a corrective action plan and potential termination. ACOs will also have the option of voluntarily terminating their agreement without penalty. Managing Significant Changes to the ACO During the Agreement Period ACOs may initiate changes during the three-year contract period. Changes to ACO provider composition are of particular concern. ACOs may be allowed to add or subtract providers during the three-year agreement, but must notify CMS within 30 days of the change. More generally, an ACO must notify CMS within 30 days of any event that would result in it being unable to meet eligibility or program requirements. These changes could result in adjustments to the ACO’s benchmark or risk-adjustment calculations, but continue to allow the ACO to participate in the Medicare Shared Savings Program. However, some changes may result in a termination of

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agreement, such as losing a primary care practice that would cause the ACO’s assigned patient population to dip below the minimum requirement of 5,000 Medicare beneficiaries. DATA SHARING

ACOs will be required to submit TINs and national provider identification numbers for each participating provider. This information will support beneficiary assignment and allow CMS to create data reports tailored to ACO-specific populations. CMS will make available aggregated data reports on the ACO populations at the beginning of the first performance period and then on a quarterly basis. It will do this in conjunction with yearly financial and quality reports used to assess performance. In addition, CMS will make available limited beneficiary identifiable data (name, date of birth, sex, and health insurance claim number). This information can be very useful to ACOs for planning how to target their resources to improve care. ACOs will also be able to receive claims data on assigned beneficiaries on a monthly basis. This data would cover Medicare Part A, B, and D costs and utilization, and would come in a standardized format that is limited to the minimum information required to meet the ACO’s needs. The ACO will be required to explain how it intends to use data to evaluate the performance of its providers, conduct quality assessment and improvement activities, and conduct population-based activities to improve the health of its assigned beneficiaries. In addition, the ACO will need to sign a data-use agreement and give beneficiaries a chance to opt out of having their data shared. However, even if beneficiaries opt out, it will not impact their assignment to an ACO. METHODOLOGY FOR ASSIGNING BENEFICIARIES TO AN ACO AND PATIENT NOTIFICATION

Medicare beneficiaries will be assigned to ACOs based on where they receive specified evaluation and management (i.e., primary care and preventive) services for the most recent 12 months.3 CMS will assign beneficiaries to ACOs that serve the plurality of the beneficiaries’ primary care services. The plurality of allowed charges—as opposed to the volume of services— will be used for this purpose. CMS will use a two-step process to make beneficiary assignments. In the first step, beneficiaries will be assigned based on their visits to primary care physicians (specified as general practice, family practice, internal medicine, and geriatric medicine physicians). A beneficiary is assigned to an ACO if the primary care physicians in that ACO account for the largest amount of total Medicare allowable charges for that beneficiary’s primary and preventive services in comparison with primary care physicians in any other ACOs or all those not participating with any ACO.

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In the second step, CMS will review the claims for the remaining, unassigned beneficiaries who have had at least one primary or preventive service by a provider, regardless of specialty, in an ACO. This excludes all beneficiaries who had any primary and preventive services from primary care physicians, whether in or out of any ACO. This step recognizes that many Medicare beneficiaries may get their primary and preventive care from specialists and other providers aside from primary care physicians (i.e., specialist physicians, as well as nurse practitioners, physician assistants, and clinical nurse specialists). CMS will assign beneficiaries to ACOs whose professionals (regardless of specialty) account for the largest total amount of Medicare allowed charges for primary care and preventive services in comparison with professionals in any other ACO or all professionals unaffiliated with an ACO. It should be noted that any providers used for assignment must be exclusive to the ACO. Other ACO participants who are not used for assignment need not be exclusive. For each performance period, CMS will use a preliminary prospective assignment methodology with a final retrospective reconciliation. This means that ACOs will receive a preliminary list of assigned beneficiaries before each performance year using the most recent 12 months of claims data. During the performance period, CMS will update the list quarterly using a rolling 12-month claims history. A final reconciliation will be conducted at the end of the performance year using the claims incurred during the performance period. The initial list should help ACOs in identifying opportunities to improve care and enable ACOs to provide beneficiaries with advance notification of their participation in the Medicare Shared Savings Program and their intention to request beneficiary-identifiable data. The quarterly lists will allow the ACO to track newly assigned beneficiaries, as well as those who leave the ACO. Savings and losses will be based on the final reconciliation. In terms of patient notification, the final rule requires ACO participants to post signs in their facilities indicating participation in the Shared Savings Program and to make standardized written information available in all settings where primary care services will be delivered to traditional Medicare FFS beneficiaries. The written notification will cover the patient’s potential participation in the Shared Savings Program along with data sharing. A form will accompany the written notification for beneficiaries who want to opt out of data sharing. QUALITY MEASURES AND THE METHODOLOGY FOR MEASURING ACO PERFORMANCE

ACOs participating in the shared-savings-only payment model (i.e., the one-sided model) will be able to share in up to 50 percent of their achieved savings, depending on how well they exceed minimum quality performance standards. For ACOs sharing in the losses as well as savings, the percentage is 60 percent. Any shared-savings payment is contingent on meeting quality performance standards, regardless of the amount of cost reduction. Before describing how the

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shared savings will be determined, the following section describes the measures that will be used to gauge ACO performance and how they will be scored. Measures CMS will require ACOs to report on 33 measures in performance year 1. (See Appendix for a complete list.) The measure set includes process, outcome, and patient experiences-of-care measures. Measures are grouped into the following four domains: patient/caregiver experience (seven measures); care coordination/patient safety (six measures); preventive health (eight measures); at-risk population (12 measures). CMS is working with the measure development community to ensure specifications are as up-to- date as possible. Because the measures are frequently updated by their developers (such as the National Quality Forum) to take into account evolving clinical guidelines and best practices, CMS expects to release the specifications for performance year 1 for most of the measures in the fourth quarter of 2011 or the first quarter of 2012. The specifications for the CAHPS survey measures will be released later in 2012. For future years, CMS will add and remove measures as appropriate through the rule-making process. Data Sources CMS lists data sources for these measures as survey instruments (7), claims (3), electronic health record (EHR) incentive program data (1), and the Web interface for the Group Practice Reporting Option (GPRO) data collection tool (22). The GPRO tool is based on the data collection tool currently used in the Physician Quality Reporting System (PQRS) and Physician Group Practice (PGP) demonstration. In fact, CMS will allow ACOs to qualify for the PQRS incentive payment on behalf of all of its providers (not just those used for assignment), which could alleviate some of the burden of reporting requirements for ACO providers. The payment incentive is equal to 0.5 percent of the ACO’s eligible providers’ total estimated Medicare Part B physician fee schedule charges during the performance year. The PQRS bonus for ACO providers is not contingent on meeting the ACO’s requirements for shared savings. CMS will supply all the claims data, fund the survey for the first two performance years, and will make the GPRO tool available to all ACOs. The GPRO tool will be used for enhanced claims data (e.g., from electronic medical records and registries) and will require a random sample of assigned beneficiaries for each measure domain of at least the minimum of 411, or 100 percent of the assigned beneficiaries. CMS plans on auditing this data. Scoring and Standards According to the final rule, the first year will essentially be a pay-for-reporting arrangement in order to allow ACOs an opportunity to ramp up and CMS an opportunity to learn about the process and establish improvement targets. Thus, ACOs will be eligible for shared savings if they report accurately on 100 percent of the measures, regardless of their actual performance.

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After the first performance period, most of the measures will begin to be used on a pay-for- performance basis. In performance period 2, 25 of the 33 measures will be based on actual performance, with the other eight continuing to be on a pay-for-reporting basis. In performance period 3, 32 measures will be based on actual performance and one measure—the health status/functional status survey-based measure—will continue to be on a pay-for-reporting basis. (See Appendix for more details on when each measure moves to pay-for-performance status.) After the first performance period, a scoring system will be used to determine how much of the 50 percent (or 60 percent for ACOs with two-sided risk models) in shared savings ACOs will receive. With the exception of the EHR measure, each measure within a domain would be worth a maximum of two points and a minimum of zero. The EHR measure is double-weighted to signal the importance of EHR adoption for ACO success. However, the final rule diverges from the proposed rule by not requiring meaningful use of EHRs by a majority of providers in the ACO. An ACO would get a single score for the domain based on the percentage of total points it achieved. The average of the four domain scores would be the overall score, which determines the percentage of shared savings ACOs receive. The measure-specific benchmarks ACOs must achieve for scoring purposes will be made known prior to the second performance year and will be mostly based on national FFS and Medicare Advantage (MA) performance levels. Exhibit 2 describes the basis of the scoring system CMS plans on using after the first performance year.

Exhibit  2.  ACO  Scoring  System  for  Quality  Measures  

ACO  Performance  Level  

Quality  Points   (all  measures   except  EHR)  

90+  percentile  FFS/MA  Rate  or  90+  percent   2  points  

80+  percentile  FFS/MA  Rate  or  80+  percent   1.85  points  

70+  percentile  FFS/MA  Rate  or  70+  percent   1.7  points  

60+  percentile  FFS/MA  Rate  or  60+  percent   1.55  points  

50+  percentile  FFS/MA  Rate  or  50+  percent   1.4  points  

40+  percentile  FFS/MA  Rate  or  40+  percent   1.25  points  

30+  percentile  FFS/MA  Rate  or  30+  percent   1.10  point  

<30  percentile  FFS/MA  Rate  or  <30  percent   No  points  

Source:  Centers  for  Medicare  and  Medicaid  Services,  Medicare  Shared  Savings  Program  Final  Rule,   CMS–1345–F.  

According to the scoring system, performing above

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