See page 16. Thomas A. Vallas

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1 Compliance TODAY July 2014 a publication of the health care compliance association What s the key to successfully merging two large hospital systems? an interview with Michael R. Holper Senior Vice President, Integrity & Audit Services CHE Trinity Health See page Overcoming the challenges of conducting a thorough and meaningful risk assessment Charro Knight-Lilly 31 Getting ahead of the ACA compliance program mandate Thomas A. Vallas 39 Provider-based departments: Managing risk Stephen Sonnenfeldt-Goddard 43 Ensuring ADA compliance: Revising the employment and medical staff application process Andrea Bell This article, published in Compliance Today, appears here with permission from the Health Care Compliance Association. Call HCCA at with reprint requests.

2 by Rita Isnar, JD, MPA A primer on CMS-regulated Accountable Care Organizations A CMS-regulated ACO is a group of doctors, hospitals, and other healthcare providers who voluntarily and jointly coordinate high-quality care to their Medicare patients. There are different types of CMS-regulated ACO models, including the Medicare Shared Savings Program (MSSP) and the Advance Payment model. CMS has developed and implemented compliance plan regulatory requirements for MSSPs. The CMS regulatory requirements for MSSPs are not as prescriptive as the typical seven elements of a compliance program, which may make implementation more difficult. Make effective use of existing resources, particularly during the implementation phase, and use CMS regional contacts and existing regulations as guidance. Rita Isnar (risnar@strategicm.com) is Senior Vice President with Strategic Management Services, LLC in Alexandria, VA. Isnar The Centers for Medicare & Medicaid Services (CMS) defines an Accountable Care Organization (ACO) as a group of doctors, hospitals, and other healthcare providers, who voluntarily and jointly coordinate high-quality care to their Medicare patients. For the purpose of this article, these are defined as CMS-regulated ACOs. The goal is to ensure that all patients receive the most cost effective and results-based care on a timely basis. This is especially true for chronically ill or sicker patients; CMS has expressed that the intended objective is to avoid unnecessary duplication of services and to prevent medical errors for these patients. The costs and outcomes of such successful coordinated care will be rewarded. When an ACO succeeds in delivering high-quality care and spending health care dollars more wisely, 1 the ACO will share in the savings it achieves for the Medicare program. Therefore, the allocated shared savings to the ACO serve as the incentive for healthcare providers to participate in an ACO. Various types of regulated ACOs CMS is using several different models to develop the program, based on the types and sizes of organizations interested in participating in some form of shared savings. The following is a discussion of the different models employed by CMS. Medicare Shared Savings Program (MSSP) This program helps a group of Medicare Fee-For-Service (FFS) program providers become a CMS-regulated ACO. The purpose is to facilitate coordination and cooperation among providers to improve the quality of care for Medicare FFS beneficiaries and reduce unnecessary costs. On its website, CMS notes that the Shared Savings Program is designed to improve beneficiary outcomes and increase value of care by: Promoting accountability for the care of Medicare FFS beneficiaries; Compliance Today July

3 Compliance Today July 2014 Requiring coordinated care for all services provided under Medicare FFS; Encouraging investment in infrastructure and redesigned care processes. 2 This voluntary program is intended to reward and incentivize CMS-regulated ACOs that can demonstrate lower growth in healthcare costs while also meeting performance standards established by CMS on quality of care and putting patients first. A helpful resource for MSSP regulations is available on the CMS webpage. Topics include: Statutes, regulations, and guidance Applications Quality measures and performance standards CMS s standard MSSP ACO Agreement CMS Regional Office contacts for CMS-regulated ACOs Applicable regulatory MSSP requirements on can be found at 42 CFR 425. The MSSP regulations have specific requirements related to the compliance plan (42 CFR ). Generally, the compliance program requirements are less prescriptive than the traditional healthcare compliance program requirements. Specifically, CMS-regulated (MSSP) ACOs must have a compliance plan that includes at least the following elements: A designated compliance official or individual who is not legal counsel to the ACO and reports directly to the governing body. (The CMS-regulated ACO s existing entities may use the current compliance officer if he/she meets these requirements). regulatory requirements relating to MSSPs are not as prescriptive as Medicare Managed Care or other programs overseen by CMS. Mechanisms for identifying and addressing compliance problems related to the ACO s operations and performance. A method for employees, contractors, and others (e.g., participants, providers/suppliers, and other individuals or entities that perform functions or services related to the CMS-regulated ACO s activities) to anonymously report suspected problems related to the compliance officer. Compliance training for the CMSregulated ACO, its participants, and providers/suppliers. A requirement to report probable violations of law to an appropriate law enforcement agency. The ACO s compliance plan must be updated periodically to reflect changes in law and regulations. 3 Regulatory requirements related to the MSSP exist and are outlined by CMS; however, regulatory requirements relating to MSSPs are not as prescriptive as Medicare Managed Care or other programs overseen by CMS. This is a new program and the government is permitting the industry to further develop efficiencies in models of care which can be refined in the future. Consistent with this, certain program fraud and abuse waivers in relation to the MSSP have been implemented in relation to the Anti-Kickback Statute (AKS), Stark Law, and Gainsharing under civil monetary penalties (CMP) law. 4 CMS has provided additional information related to the final waivers in connection with the Shared Savings Program. There are five waivers addressing different circumstances, including:

4 Senior Vice President, Integrity & Audit Services CHE Trinity Health An ACO pre-participation waiver of the Stark (physician self-referral) Law, the federal AKS, and the Gainsharing CMP that applies to ACO-related start-up arrangements in anticipation of participating in the Shared Savings Program; An ACO participation waiver of the Stark Law, the federal AKS, and the Gainsharing CMP that applies broadly to ACO-related arrangements during the term of the ACO s participation agreement under the Shared Savings Program and for a specified time thereafter; A shared savings distributions waiver of the Stark Law, federal AKS, and Gainsharing CMP that applies to distributions and uses of shared savings payments earned under the Shared Savings Program; A waiver of compliance with the Stark Law, the Gainsharing CMP, and the federal AKS for ACO arrangements that implicate the Stark Law and meet an existing exception; and A patient incentive waiver of the Beneficiary Inducements CMP and the federal AKS for medically related incentives offered by ACOs under the Shared Savings Program to beneficiaries to encourage preventive care and compliance with treatment regimes. These waivers are intended to protect Medicare beneficiaries and the program from fraud and abuse while furthering the quality, economy, and efficiency goals of the Shared Savings Program. It should be noted that an arrangement need only fit in one waiver to be protected. Further, it may be the case that an arrangement may meet the criteria of more than one waiver. 5 Advance Payment ACO model This is a supplementary incentive program for selected participants in the Shared Savings Program. This model is designed to accommodate physician-based and rural providers who have voluntarily coordinated to serve their Medicare patients with high-quality care. The Advance Payment model allows for selected participants to receive upfront and monthly payments, which they can in turn use to make investments in their care coordination infrastructure. Authors Earn CEUs: Every month Compliance Today offers healthcare compliance professionals information on a wide variety of enforcement, regulatory, legal, and compliance program development and management issues. We are particularly interested in articles covering compliance concerns involving hospitals, outpatient services, behavioral health, rehab, physician practices, long-term care/homecare/hospice, ambulatory surgery centers, and more. CCB awards 2 CEUs to authors of articles published in Compliance Today Compliance Today needs you! Articles are generally between 1,000 2,500 words (not a limit). Submit your article as a Word doc with limited formatting. The article title and author s contact information must be included in the article. A PUBLICATION OF THE HEALTH CARE COMPLIANCE ASSOCIATION 27 Overcoming the challenges of conducting a thorough and meaningful risk assessment Charro Knight-Lilly Compliance TODAY July Getting ahead of the ACA compliance program mandate Thomas A. Vallas What s the key to successfully merging two large hospital systems? an interview with Michael R. Holper 39 Provider-based departments: Managing risk Stephen Sonnenfeldt-Goddard 43 Ensuring ADA compliance: Revising the employment and medical staff application process Andrea Bell corporatecompliance.org with your topic ideas, format questions, and more. See page 16 Compliance Today July

5 Compliance Today July 2014 This is a much smaller program than the MSSP. CMS has reported approximately 35 participants in this program. These participants are located in the following states: Arkansas Missouri California Nebraska Connecticut New Hampshire Florida North Carolina Indiana Ohio Kentucky Rhode Island Maryland Tennessee Massachusetts Texas Mississippi The Advance Payment ACO model was developed by CMS in response to comments and concerns from stakeholders received on the proposed rule for the Shared Savings Program in Basically, the concern set forth by some providers related to the lack of capital and funds needed to invest in larger infrastructure and staff for effective care coordination, and thus successful participation in a CMS-regulated ACO. The Advance Payment ACO model is intended to facilitate participation by smaller ACOs that have less access to capital. This model allows for the selected organization to receive advance payments on the shared savings they are expected to earn. CMS reports that the participating ACOs will receive three types of payments: Upfront fixed payments where each ACO will received a fixed fee; Upfront variable payments where each ACO will receive a payment based on the number of its historically-assigned beneficiaries; and A monthly payment of varying amount depending on the size of the ACO and the number of its historically-assigned beneficiaries. 6 The Advance Payment ACO model is intended to facilitate participation by smaller ACOs CMS indicates that advance payments are structured in this way to address the fact that new ACOs will have both fixed and variable start-up costs. Pioneer ACO model This is a program designed for early adopters of coordinated care. CMS is no longer accepting applications for this program. The Pioneer ACO Model was designed for health care organizations and providers that are already experienced in coordinating care for patients across care settings. This model allowed provider groups to move more quickly from a Shared Savings Payment model to a population-based payment model on a track consistent with, but separate from, the Medicare Shared Savings Program. This model is also designed to work in coordination with private payers by aligning provider incentives, which will improve quality and health outcomes for patients across the ACO, and achieve cost savings for Medicare, employers and patients. There are approximately 23 participants in this program and these are located in the following states: Arizona California Illinois Indiana Iowa Massachusetts Maine Michigan Minnesota New Hampshire New York Pennsylvania Wisconsin The payment models being tested in the first two years of the Pioneer ACO Model include a shared savings policy which CMS reported has generally higher levels of shared

6 savings and risk for Pioneer ACOs than levels currently proposed in the Medicare Shared Savings Program. In the third year of the program, participating ACOs that have demonstrated certain standards and/or level of savings will be eligible to move a substantial portion of their payments to a populationbased model. These models of payments will also be flexible to accommodate the specific organizational and market conditions in which Pioneer ACOs work. 7 Best practice tips and recommendations CMS has provided a number of different avenues for interested entities and providers to participate in a CMS-regulated ACO model and receive the potential benefits related to participation. Best practices include: Make effective use of CMS regional contacts These programs are still relatively new. Typically CMS Regional contacts are fairly active in engaging in monthly calls with CMS-regulated ACO organizations, particularly during the implementation phase of the program, to answer questions and to provide assistance. They serve as a helpful and important partner and resource for getting it right. Use existing regulations as guidance The MSSP ACO regulations are intentionally not as prescriptive as Medicare Managed Care regulations. However, the Medicare regulations may serve as regulatory guidance on how to implement CMS-regulated ACO programs where there is either (albeit intentionally) insufficient or a lack of regulatory criteria. Read between the lines The MSSP compliance plan regulations are definitely not as robust as typical compliance program requirements (i.e., the seven elements). This does not mean that CMS-regulated ACOs are not held to the same or similar standards of effective compliance program implementation. There are allowances made with regard to auditing and monitoring and/or sanctioned screening requirements. However, CMS sets some clear expectations related to audit preparedness, monitoring, records retention, and screening of participants. (See 42 CFR Sections , 316, and 304 respectively.) Make use of existing compliance program resources Chances are that healthcare entities are applying for participation in the MSSP or other ACO programs as part of a much larger repertoire of services and products. The best approach is to integrate the CMS-regulated ACO compliance program requirements into the existing compliance program structure. With expected and careful modifications or carve outs, doing so will ensure that your organization is most effectively using resources in implementing an effective CMS-regulated ACO compliance program. Be prepared to think outside the box Overall, there are fewer regulations related to CMS-regulated ACO programs, which forces them to be creative and work harder to develop and implement an effective compliance program. Coupling this with your own state laws and regulations may make implementation of the program challenging. 1. CMS: Medicare Fee-For-Service/Accountable Care Organizations. Available at 2. CMS: Medicare Shared Savings Program. Available at 3. Federal Register: MSSP ACO Final Rule. November 2, Available at CFR vol 76 at Federal Register: Waivers in Connection with the Shared Savings Program. November 2, CFR vol 76 at Federal Register: Waivers in Connection with the Shared Savings Program. November 2, CFR Vol 76 at 67992, CMS: Advance Payment ACO Model. Available at 7. CMS: Pioneer ACO Model. Available at Compliance Today July