Accountable Care Organizations

Transcription

1 Building a Healthy ACO Compliance Program: Good Help ACO s Experience in Building Healthy Communities While Leveraging Existing Resources to Establish a Healthy and Effective ACO Compliance Program. Mary C. Malone, Esq., Hancock, Daniel, Johnson & Nagle, P.C. Jeffrey C. Oak, PhD., Bon Secours Health System, Inc. 1 Accountable Care Organizations In CMS s words: ACOs are voluntary groups of physicians, hospitals, and other health care providers that are willing to assume responsibility for the care of a clearly defined population of Medicare beneficiaries attributed to them on the basis of patients use of primary care services. Donald Berwick, Administrator of CMS New England Journal of Medicine Making Good on ACOs Promise 2 1

2 Accountable Care Organizations Private Payer Model: Insurance carriers are beginning to experiment with offering ACO models to the private insurance markets Medicare Model: Pioneer The first experimental model that placed participants at higher financial risk if Medicare savings goals were not realized. MSSP Reduces the amount of financial risk for ACOs. Many providers that started in the Pioneer program are switching to the MSSP. Advanced Payment Selected MSSP ACOs can apply for this special payment program that pays ACOs for projected savings to help with fixed and variable start-up costs. 3 The MSSP The Centers for Medicare & Medicaid Services (CMS) established the Medicare Shared Savings Program to facilitate coordination and cooperation among providers to improve the quality of care for Medicare Fee-For-Service (FFS) beneficiaries and reduce unnecessary costs. The Shared Savings Program will reward ACOs that lower their growth in health care costs while meeting performance standards on quality of care and putting patients first by sharing a portion of the savings. 4 2

3 Legal Backdrop MSSP Accountable Care Organizations Affordable Care Act Section Enacts Section 1899 of the Social Security Act establishing the Medicare Shared Savings Program. Code of Federal Regulations - Part 425 outlines the regulations implementing the requirements for ACOs participating in the Medicare Shared Savings Program. Other Laws Applicable to ACOs - Anti-Trust Statutes; - Anti-Kickback Statute; - Stark Law; - Civil Monetary Penalties; - False Claims Act; and - State Specific Laws. 5 See Attachment 1:Checklist of MSSP ACO Requirements Primary Goals of the MSSP The Triple-Aim Lower Growth of Expenditures Better Health for Populations Better Care to Individuals 6 Successful ACOs will be rewarded with a slice of the shared savings pie. 3

4 ACO Program Integrity Although not specifically required by the ACA, CMS enacted several program integrity requirements for MSSP ACOs. For example: ACO must have a compliance plan and official. ACO must maintain ultimate responsibility for compliance with the ACO agreement. All contracts or arrangements between or among the ACO and its participants must require compliance with the ACO s participation agreement as well as other laws. 7 ACO Program Integrity Continued ACO governing body must adopt a conflicts of interest policy that applies to members of the governing body. ACOs must adopt screening procedures for participants (program integrity history, sanctions, affiliations with excluded individuals, etc.). This is consistent with current Medicare regulations prohibiting payment to individuals excluded from federal health programs. 8 4

5 Mandatory Compliance Plans Along with other program integrity requirements, CMS finalized regulations for Mandatory ACO Compliance Plans (42 C.F.R (a)). Generally, the elements required for ACO compliance plans are similar to the elements outlined by the OIG for other individual provider types (i.e. hospitals, nursing facilities, small physician groups, home health and ambulance suppliers). 9 Mandatory Compliance Plans (Continued) ACOs can use existing guidance to anticipate CMS s and the OIG s expectations. Compliance guidance are available on the OIG s Website: ACOs can also refer to the Final Rule for CMS s comments on the elements of an effective ACO compliance plan. 10 5

6 Mandatory Compliance Plans (Continued) Over the years, the government has used the terms compliance plan and compliance program interchangeably. The term compliance plan seems to describe the document that sets forth the general framework of a compliance program; whereas, the compliance program is the operationalized compliance plan (i.e., a living, breathing part of the organization). CMS requires ACOs to have a compliance plan, although more likely, the expectation is that the ACO have a fully implemented, operational, dynamic, and effective compliance program 11 ACO Compliance Plan Does your ACO Compliance Plan contain all of the elements? There is one question on the ACO Application about compliance plans. When completing the ACO MSSP Application, an ACO must attest that it has a compliance plan in place that meets the minimum requirements. 12 See Attachment 2: Sample ACO Compliance Plan 6

7 ACO Compliance Plan Here is what the attestation looks like on the ACO application. NOTE that ACOs are not required to submit a copy of the compliance plan with the application, but must make it available to CMS upon request. 13 Image captured from 2013 MSSP Application The Elements of an Effective ACO Compliance Plan (42 C.F.R (a)) 1) Designated compliance official who is not legal counsel to the ACO and reports directly to the ACO s governing body Legal counsel to the ACO and the compliance officer must be different individuals, in order to ensure independent and objective legal reviews of financial analyses of the organization s compliance efforts and activities by the compliance officer. ACOs may use their current compliance officer provided that the compliance officer is not legal counsel to the existing organization. 14 7

8 The Elements of an Effective ACO Compliance Plan (42 C.F.R (a)) 2. Mechanisms for identifying and addressing compliance problems related to the ACO s operations and performance ACO compliance officials must ensure that policies and procedures adequately define how ACO participants can report potential compliance and quality issues so that the compliance officer can take steps to investigate or audit ACO activities. This also includes collecting and reporting on various quality measures. There are currently 33 such measures. 15 The Elements of an Effective ACO Compliance Plan (42 C.F.R (a)) 3. A method for employees or contractors of the ACO, ACO participants, ACO providers/suppliers, and other individuals or entities performing functions or services related to ACO activities to anonymously report suspected problems related to the ACO to the compliance officer Compliance plans on their own do not stop fraud and abuse; however, compliance programs provide a resource for: Increased likelihood of identifying and preventing unlawful and unethical conduct; Providing a centralized source for distributing information on health care statutes, regulations, and other program directives related to fraud and abuse; and Creating an environment that encourages employees and others to anonymously report potential problems. 16 8

9 The Elements of an Effective ACO Compliance Plan (42 C.F.R (a)) 4. Compliance training for ACO, ACO participants and the ACO providers/suppliers. Requiring compliance training for the ACO and all of its ACO participants and ACO providers/suppliers helps to ensure that every ACO participant, ACO provider/supplier, and contractor understands their legal obligations with respect to the ACO s operations and performance, as well as the requirements of the compliance program and the manner in which their ACO is implementing such requirements. 17 The Elements of an Effective ACO Compliance Plan (42 C.F.R (a)) 5) A requirement for the ACO to report probable violations of law to an appropriate law enforcement agency. The OIG has outlined industry best practices for compliance programs as well as a description of the risks of fraud and abuse that various providers may face. CMS suggests that providers without experience developing compliance programs review the various resources that are available from the OIG s web site to help determine the risk of fraud and abuse in the ACO and when an activity may rise to the level of a violation that may need to be reported. CMS encourages the use of the OIG Self-Disclosure Protocol to determine which activities amount to a probable violation. 18 9

10 ACO Fraud and Abuse Waivers CMS Adopted 5 MSSP ACO Waivers ACO Pre-Participation Waiver Protections against the AKS, Stark and Gainsharing CMP. ACO Participation Waiver Protections against the AKS, Stark and Gainsharing CMP. Shared Savings Distribution Waiver Protections against the AKS, Stark and Gainsharing CMP. Compliance With Stark Exception Waiver Protections against the AKS and Gainsharing CMP. Patient Incentives Waiver Protections against the AKS and Beneficiary Inducement CMP. 19 ACO Fraud and Abuse Waivers Pre-Participation Waiver Protections begin in the year preceding the ACO s target year of Participation Only one party to the financial arrangement must be an ACO or ACO participant However, the party cannot be a DME Drug/Device, or Home Health Supplier The ACO Governing Body must make a bona fide determination that the financial arrangement is reasonably related to the MSSP s triple-aim. Parties must maintain adequate documentation for the financial arrangement including the diligent steps toward becoming an ACO by the selected target year. 20 See Attachment 3A: Pre-Participation Flow Chart 10

11 ACO Fraud and Abuse Waivers Participation Waiver Protections are available to ACOs that are in good standing under an ACO participation agreement. Only one party to the financial arrangement must be an ACO or ACO participant The ACO Governing Body must make a bona fide determination that the financial arrangement is reasonably related to the MSSP s triple-aim. Parties must maintain adequate documentation for the financial arrangement. 21 See Attachment 3B: Participation Waiver Flow Chart ACO Fraud and Abuse Waivers Shared Savings Distribution Waiver Protections are available to ACOs that are in good standing under an ACO participation agreement. Protects financial disbursements of earned shared savings. Disbursements can be made at any time as long as the savings were earned during the term of the ACO s participation agreement Disbursements can be made to: Current ACO participants, providers and suppliers; Individuals or entities that were ACO participants, providers or suppliers during the year that the shared savings were earned by the ACO; or To other parties if their activities are reasonably related to the MSSPs triple-aim. Disbursements from hospitals cannot be intended to prevent physicians from referring patients for medically necessary services. 22 See Attachment 3C: Shared Savings Distribution Waiver Flow Chart 11

12 ACO Fraud and Abuse Waivers Compliance with Physician Self-Referral Waiver Protections are available to ACOs that are in good standing under an ACO participation agreement. The financial arrangement must be reasonably related to the MSSP s triple-aim. The financial arrangement must fit into one of the Stark Law s current exceptions (42 C.F.R through ). 23 See Attachment 3D: Compliance With Physician Self-Referral Flow Chart ACO Fraud and Abuse Waivers Patient Incentives Waiver Protections are available to ACOs that are in good standing under an ACO participation agreement. ACOs and ACO participants, provider and suppliers may offer items or services for free or below market value to Medicare beneficiaries. Items and services must be in-kind. NO CASH INCENTIVES Items and services must be meant to promote preventative care or the advancement of patient care goals. 24 See Attachment 3E: Patient Incentives Waiver Flow Chart 12

13 ACO Fraud and Abuse Waivers (Continued) ACOs can enjoy broad applicability of Waivers to financial arrangements with non-aco participants. Activities Reasonably Related to the MSSP s Triple-Aim can qualify for Waiver protections. Only one party to most agreements must be an ACO or ACO participant. In many cases, Waiver protections will not be triggered because the arrangement fits within an existing exception or safe harbor. 25 ACO Fraud and Abuse Waivers (Continued) CMS has indicated that it is willing to consider additional Waivers as ACOs begin to offer services to beneficiaries. May include ability to offer cash incentives for beneficiary participating in preventative health screenings. Waivers may need to be expanded to pre-empt applicable state fraud and abuse laws. However, there is no guarantee that the CMS or the OIG will not tighten the Waiver requirements as time goes on

14 Conflict of Interest for ACOs MSSP requires 75% of the ACO s Board to be ACO Participants. This means that board members will also have financial interests in the operation of the ACO. MSSP requires disclosure of Conflicts of Interest. Conflict of interest policy must: Provide for disclosure of financial interests; Create procedure for identifying and addressing conflicts; and Establish remedies for violation of policy. 27 See Attachment 4: Sample Conflict of Interest Policy 28 Other ACO Compliance Functions Adhering to Marketing Limitations 42 C.F.R Complying with Patient Engagement Requirements 42 C.F.R Ensuring Freedom of Choice 42 C.F.R (c) Proper Record Management and Retention 42 C.F.R Protecting Privacy of Patient Data (HIPAA) 42 C.F.R et seq. Appropriate Billing and Coding 42 C.F.R (b) The ACO must agree, and must require its ACO participants, ACO providers/suppliers, and other individuals or entities performing functions or services related to the ACO's activities to agree, or to comply with all applicable laws including 14

15 CMS Monitoring of ACOs ACO compliance plans should include policies and procedures for proactive internal audits to ensure that all 5 elements of the compliance plan are effective. This means that compliance officials should have access to all patient charts and medical records to confirm quality and utilization information. Consider the use of integrated EHR and other centralized electronic communications systems for consistent data collection. Compliance Officers must be able to identify and correct deficient practices before issues become sanctionable noncompliance. 29 CMS Monitoring of ACOs WHEN not IF CMS has indicated that ACOs will be audited through: Analysis of financial and quality measurement data reported by ACO; Site visits; Beneficiary and provider complaints; and Claims analysis, chart reviews, beneficiary surveys, coding audits. Because CMS will be auditing ACO activity, it is important that ACOs implement their compliance plans early, self-audit often, and revise policies periodically

16 ACO Compliance First Steps If an ACO is comprised of participants that have never operated under a compliance plan, compliance program development should start with a Readiness Assessment. If an ACO is able to leverage an ACO participant s existing compliance program, compliance program development should start with a Gap Analysis. 31 ACO Compliance First Steps (Continued) Compliance Program Readiness Assessment A Readiness Assessment should focus on the ACO s and ACO participants infrastructure to ensure that all ACO participants start on equal footing in the compliance program. Factors to consider: Teamwork; participant buy-in; and current business cultures Technologies; EHR compatibility; and communication systems Costs and charges 32 16

17 ACO Compliance First Steps (Continued) Compliance Program Gap Analysis should focus on the ACOs current compliance needs and resources and how they compare to the best practice. Best practice may be difficult to assess at this early stage but, some factors to consider include: Quality Assurance Data Collection Practice Billing and Coding Compliance Clinical Integration Patient Engagement Efforts Reporting Obligations (public reporting and CMS reporting) 33 GoodHelp ACO In 2013, Bon Secours Health System began operations of an MSSP ACO under the name GoodHelp ACO. Serving more than 57,000 Medicare Fee-for-Service Beneficiaries. GoodHelp ACO includes a wide variety of providers including 5 Bon Secours health systems across several states, and the St. Clair Regional Medical Center in Morehead, Kentucky

18 GoodHelp ACO s Compliance Roots Bon Secours Health System has successfully implemented a system-wide Corporate Responsibility Program, using tools such as: Case Specific Training; Routine Audits; Open Door Discussion Forums; and System-Wide Policy and Procedure Implementation. 35 GoodHelp ACO s Compliance Roots (Continued) Bon Secours Key Preventative Activities Education and Awareness: New Employee Orientations Annual Mandatory Compliance and HIPAA Training Education for Medical Staff and Physician Practices Billing Coding and Compliance Newsletters 36 18

19 GoodHelp ACO s Compliance Roots (Continued) Bon Secours Key Preventative Activities Robust Policies Covering: Fraud and Abuse Compliance Risk Assessments Non-Retaliation Conflicts of Interest HIPAA Business Courtesies Government Inquiries 37 GoodHelp ACO s Leveraging Ability Almost all of the participants in the GoodHelp ACO are also Bon Secours Providers or Physicians. This means that GoodHelp ACO s participants already operate under a very structured and proven compliance program. By performing a simple Gap Analysis on how the current compliance program could be adjusted to comply with the elements for an effective ACO compliance program, GoodHelp ACO was able to leverage Bon Secours Corporate Responsibility Program to fit GoodHelp ACO s Compliance Plan needs

20 GoodHelp ACO s Compliance Strategy Bon Secours Health System developed GoodHelp ACO with the ability to adapt Bon Secours existing resources, infrastructure, compliance capabilities, training and culture. By Leveraging Bon Secours existing compliance program in developing GoodHelp ACO s compliance plan, GoodHelp ACO was able to maintain consistent compliance practices throughout the ACO providers community. 39 Quality of Care as a Compliance Issue In recent years, CMS s focus on the provision of quality services has led to the emergence of compliance related risks associated with: Ineffective care and provision of unnecessary services; Failure to credential medical staff; and Falsifying quality data

21 Quality of Care as a Compliance Issue Because the MSSP focuses on the provision of quality and effective care, GoodHelp ACO already has training in place to avoid Quality of Care compliance issues. Training emphasizes: Not ignoring the conduct of top billers. Adopting conflict of interest policy and following it. Constantly review (and understand) quality and performance data. Listen to the concerns expressed by employees, they have first hand knowledge of what is happening with patients. 41 What Can Be Learned from GoodHelp ACO Not all ACOs have the ability to leverage such a comprehensive widely accepted compliance program. GoodHelp s ability to leverage an existing compliance program, however, raises many questions that some ACOs may not have thought about in implementing their own compliance plans

22 Questions Asked and Answered by GoodHelp ACO How did GoodHelp ACO determine who would serve as a compliance official? The regulations make it clear that an existing compliance official can serve as the ACO s compliance official. Jeff Oak is the Chief Compliance Officer of the Bon Secours Health System and GoodHelp ACO. CMS provides generous leeway to structure the compliance program to meet the needs of the individual ACO. 43 Questions Asked and Answered by GoodHelp ACO How did GoodHelp ACO determine who would serve as a compliance official? GoodHelp ACO is likely to use provider-level corporate responsibility officers responsible for monitoring individual providers or practice groups. These individuals have the ability to interact with participants every day to ensure that the ACO s compliance goals are incorporated into the provider s culture. GoodHelp ACO is also considering the need for additional staffing resources auditing and reporting. Take Away Appoint a compliance official that makes sense for your ACO and use the resources that fit the needs of your ACO. Smaller ACOs may need only one individual to accomplish their compliance goals

23 Questions Asked and Answered by GoodHelp ACO How is GoodHelp ACO able to monitor and address compliance problems? In such a large ACO, the key to addressing compliance problems is getting everyone on board with the ACO s compliance goals. Because GoodHelp ACO benefits from Bon Secours years of compliance centered training and culture of compliance, the ACO s employees and participants are already aware of the policies and procedures for identifying compliance related issues and feel comfortable bringing those issues to upper management. Preventative audits, monitoring and education are emphasized and allow corporate responsibility officers to track deficiencies and report any questionable practices to the compliance officer and the governing body. 45 Questions Asked and Answered by GoodHelp ACO How is GoodHelp ACO able to effectuate system-wide buy-in to the compliance program, especially in physician practices? Smaller ACOs are likely to identify this as the greatest challenge in implementing an effective ACO compliance program. Physician practices have remained relatively unregulated. Therefore, many practices are likely to push back against an ACO compliance program because of differences in business philosophy and additional burden. However, by adopting a value proposition philosophy, GoodHelp ACO is able to demonstrate to all participants, including clinicians, the benefits of being a participant in a larger organization beyond the mere business case factors. Increased billing and coding efficiency; Decreased claims denials; Faster payments; Reduced fraud and abuse liability exposure for improper billing; and Increased trust and confidence in the patient community

24 Questions Asked and Answered by GoodHelp ACO What is GoodHelp ACO s value proposition? When GoodHelp ACO approaches an independent physician group, the group must understand what the benefits are of giving up their autonomy and buying in to compliance oversight. Those benefits are: Assuring that care is medically necessary; Removing obstacles/distractions to the provision of care; and Assuring that coding is accurate for purposes of fully and accurately representing the care that was delivered. 47 Questions Asked and Answered by GoodHelp ACO What does GoodHelp ACO do that allows participants to report compliance issues? Compliance is always treated as an open discussion where employees and participants are encouraged to report issues that may cause compliance sanctions. GoodHelp ACO offers an anonymous compliance hotline that puts participants in touch with the compliance officer at any time. ACOs without a current hotline may find that setting one up is as easy as leasing a number or establishing one of their own. GoodHelp ACO also allows participants to the compliance official to put their concerns in writing. All participants are assured that good faith compliance related grievances will not be subject to retaliation from management

25 49 Questions Asked and Answered by GoodHelp ACO How does GoodHelp ACO provide training to all of its participants? GoodHelp ACO participants have received compliance training through Bon Secours Corporate Responsibility training program for many years. Participants will continue to receive compliance training, but a point will be made to avoid duplication of efforts. Additional training modules will be developed to focus on ACO specific case examples and compliance challenges (i.e. evidence-based medicine and patient engagement). As with all of GoodHelp ACO s training, education materials focus on ACO provider-specific cases. Experience has shown that stock or one-size training modules are far less engaging for participants than training that has been developed using specific examples from within the organization. Stock training programs can provide for a good start, but over time, each ACO should strive to develop meaningful examples of how the ACO is achieving compliance goals. Questions Asked and Answered by GoodHelp ACO How does GoodHelp ACO handle probable violations of the law? No health system is perfect and sometimes a mistake turns into a reportable compliance violation. Once a problem is identified, GoodHelp ACO investigates the issue and determines how to best remedy the situation. With the help of the governing body and legal counsel, GoodHelp ACO determines the best way to report compliance violations to CMS, the OIG, or when needed, to local law enforcement. The key is to document the problem and the immediate steps taken to correct the non-compliant practice. It is important to remember that not every mistake is reportable and not every reportable event is fraud

26 GoodHelp ACO Still has Questions GoodHelp ACO, like every other MSSP ACO, is still waiting for answers to some questions What are CMS s ACO Compliance Audits going to look like and how will non-compliance be addressed? For the most part, GoodHelp ACO is mainly composed of Bon Secours Health System. However, the ACO also has independent physician practices and an independent hospital. How will non-compliance arising from those entities affect the ACO as a whole and the other participants? Will ACO audits lead to provider specific audits? Many current providers have never been through an OIG audit. Once CMS comes to audit the ACO, will the individual providers be subject to additional scrutiny? 51 GoodHelp ACO Still has Questions Too How will the Waivers be interpreted over time to allow ACOs to implement effective programs to reduce costs and utilization of services to treat preventable conditions? As it is today, ACO enjoy relatively broad applicability of the waivers to structure programs with outside vendors. How long will this last? How can ACOs provide incentives to beneficiaries that will encourage proactive treatment to avoid preventable acute conditions? CMS allows Waivers of the beneficiary inducement CMP but restricts incentives to in-kind items and services. Some ACOs may find that cash is king when trying to get beneficiaries to take charge of their health. Should cash incentives be allowed by the Waiver to increase patient engagement? 52 26

27 Predictions for the Future of ACO Compliance Plans Litigation Issues Because of the loose language used in many of the ACO regulations (i.e. reasonably related, bona fide determination, etc.), there is ample opportunity for CMS and the OIG to interpret and reinterpret how ACO s should operate. Litigation may include: Waiver applicability; Participation Agreement obligations; and Individual provider fraud and abuse liability. 53 Predictions for the Future of ACO Compliance Plans Waiver Evolution CMS will evaluate the need to reduce or expand Waiver protections as ACOs and the MSSP program evolves. One definite hurdle for the near future is the fact that the Waivers do not operate to pre-empt applicable state fraud and abuse laws. For example, compliance with the federal ACO Participation Waiver rules does not automatically assuage an ACO s obligations to comply with state physician anti-kickback statutes (i.e. Virginia False Claims Act (Va. Code et. seq.) and Anti-kickback Statute (Va. Code ))

28 Predictions for the Future of ACO Compliance Plans How much will Compliance Cost? It is likely that many providers entering into compliance plans for the first time will have to devote a great amount of resources to aligning themselves with partners that can provide compliance program training and tools. Will shared savings be enough to make the expenses worth it? Audits of the ACO will likely cause greater scrutiny on individual providers. What will the cost be for those participants when audits reveal compliance deficiencies for time periods pre-dating the ACO participation agreement and compliance plan implementation? 55 We are in this together. GoodHelp ACO, like all other ACOs are all in the same boat trying to figure out how to operationalize an effective compliance program. This is also new territory for CMS. By using the existing guidance and CMS s comments in the final rules, ACOs can at least anticipate CMS s compliance expectation and begin to adopt policies and practices that minimize ACO compliance risks