Northwest Kidney Care Alliance

Corporate Compliance Plan

 

Adopted by the Board of
Directors on December 12, 2016

 

 

I.               Purpose.

Northwest Kidney Care Alliance (the "ESCO") is a Washington nonprofit corporation that is organized to provide a platform for participation in the Medicare Comprehensive ESRD Care Model (“CEC Model”) demonstration project.  The ESCO is committed to conducting its activities in compliance with all federal, state and local laws and regulations and in conformance with the highest standards of business integrity.  The policies, standards and procedures outlined herein reflect the dedicated commitment of the ESCO's Board of Directors to ongoing compliance with legal, regulatory and ethical standards.  This Corporate Compliance Plan (the "Compliance Plan") is designed to assist ESCO’s Participant-Owners, ESCO Collaborating Organizations, members of the ESCO Board of Directors, and ESCO Provider/Suppliers achieve these objectives by establishing a general overall framework for conducting activities with integrity and accountability.  In particular, this Compliance Plan is established in order to prevent, detect and correct non-compliance with requirements related to the CEC Model.  While this Compliance Plan cannot address every possible issue that may arise in the connection with ESCO's services, it does provide the overall policies and standards to guide all to whom the Compliance Plan applies. 

II.             Definitions.

  • CEC Model – The Comprehensive ESRD Care Model demonstration project created by CMS under authority granted by section 1115A of the Social Security Act.

 

  • Contractor – All other persons or entities who have entered a contract with the ESCO including, without limitation, any provider, supplier, facility or practitioner who provides medical items or services to persons covered under ESCO’s participation agreement with CMS and entities or persons who provide administrative, management or similar services to the ESCO whether by contract or subcontract.

 

  •  ESCONorthwest Kidney Care Alliance, an ESRD seamless care organization.  The CEC Model requirements provide that the ESCO be a legal entity that is recognized and authorized under applicable State, Federal, or Tribal law; identified by a TIN; and formed by ESCO participant owners, who must include the following: (1) at least one dialysis facility and (2) at least one nephrologist and/or a nephrology group practice, with the opportunity for other eligible Medicare-enrolled providers or suppliers to be owners, including physicians and non-physician practitioners, but excluding DMEPOS suppliers, ambulance suppliers, and drug/device manufacturers. The ESCO and its Participants must agree to participate in the CEC Model pursuant to a written agreement with the ESCO.

 

  • ESCO Collaborating Organization – Individuals or entities that have contracted with the ESCO or ESCO Participants, but are not ESCO Participants. ESCO Collaborating Organizations are not ESCO Participants for a range of reasons.  For example, an ESCO Collaborating Organization may not have a Medicare-enrolled TIN or it may already participate in the Medicare Shared Savings Program.

 

  • ESCO Provider/Supplier – An individual or entity that (1) is a Medicare-enrolled provider or supplier identified by an NPI or CCN; (2) bills for items and services furnished to Medicare beneficiaries under a Medicare billing number assigned to a tax identification number of an ESCO Participant Owner or Participant Non-Owner; (3) has agreed to participate in the CEC Model pursuant to a written agreement with the ESCO; (4) may, but is not required, to receive Shared Savings Payments; (5) may, but is not required to, be liable for Shared Losses Payments; and (6) is included on the ESCO Participant List.

 

  • Director – A member of the ESCO’s Board of Directors.

 

  • ParticipantAn individual or entity that is a Participant Owner, a Participant Non-Owner, or an ESCO Provider/Supplier.

 

  • Participant Non-OwnerAn individual or entity that (1) is a Medicare-enrolled provider or supplier identified by a TIN and either a NPI or a CCN; (2) does not have any direct or indirect ownership or investment interest in the ESCO; (3) has agreed to participate in the CEC Model pursuant to a written agreement with the ESCO; (4) may, but is not required to, receive Shared Savings Payments; (5) may, but is not required to, be liable for a portion of Shared Losses Payments; and (6) is included on the ESCO Participant List.

 

  • Participant OwnerAn individual or entity that (1) is a Medicare-enrolled provider or supplier identified by a TIN and either a NPI or a CCN; (2) has a direct ownership or investment interest in the ESCO; (3) has agreed to participate in the CEC Model pursuant to a written agreement with the ESCO; (4) may, but is not required to, receive Shared Savings Payments; (5) is liable for Shared Losses Payments; and (6) is included on the ESCO Participant List. 

 

III.           Introduction

The ESCO has designed and implemented a comprehensive compliance program that establishes various compliance procedures and structures, and sets forth the Code of Conduct that apply to all of the ESCO's Participant Owners, Directors and applicable ESCO Collaborating Organizations and ESCO Provider/Suppliers and all individuals associated with the ESCO are expected to follow in their employment or course of dealings with the ESCO or when providing services for the ESCO (the “Compliance Program”).  Failure to comply can have serious consequences for the ESCO and for any employee or agent of the Participant Owner, Director or applicable ESCO Collaborating Organization or Provider/Supplier who does not comply.  Remedial action will be taken in the event of non-compliance with this Compliance Plan.  Should a Corrective Action Plan (CAP) be issued, the Quality and Patient Engagement Committee is responsible to review, address, and create an internal action plan. The ESCO’s Board of Directors reviews and adopts the Compliance Plan, policies and procedures and the Code of Conduct.

IV.           Overview.

This Compliance Plan has been developed based, in part, on the seven (7) key elements that have been consistently identified by the federal government as being very important to the effectiveness of a compliance program.  In addition, this Compliance Plan includes specific policies related to the ESCO’s participation in the CEC Model demonstration project.  Aspects of both the seven (7) key elements as well as the specific policies have been adapted to the unique nature of the ESCO and its activities related to the CEC Model. 

The key elements are:

  • written policies, procedures and standards promoting a commitment to compliance and that describe the expectations as to the code of conduct;

 

  • a designated Compliance Officer who has responsibility for operating the compliance program and reporting to the ESCO Board of Directors on the ESCO's compliance with applicable laws;

 

  • regular, effective education and training of Participant Owners, Directors, and applicable Collaborating Organizations and Provider/Suppliers;

 

  • lines of communication and communication processes to enable and promote effective confidential communication of potential issues to those who are responsible for ensuring the ESCO's compliance;

 

  • publicized disciplinary mechanisms to enforce standards and deter noncompliant activity and promote good faith participation in the compliance program;

 

  • effective evaluation and monitoring techniques including audits and the like designed to monitor compliance and identify potential compliance risks; and

 

  • procedures, systems and policies for responding to compliance issues and for corrective action and preventative measures.

Each of these seven (7) elements is described in greater detail below.

V.             Element 1: Written Compliance Policies, Procedures and Standards

  • The Code of Conduct – The ESCO’s Code of Conduct and this Compliance Plan are at the core of the ESCO’s Compliance Program.  They will be made available on the ESCO’s website.  Copies of the Code of Conduct may be obtained from the ESCO Compliance Officer.  The Code of Conduct is attached to this Compliance Plan as Exhibit A. 

 

  • Policies and Procedures – In addition to the ESCO’s Code of Conduct and this Compliance Plan, the ESCO may develop and implement formal, written Compliance Policies and Procedures to describe in more detail existing ESCO compliance processes and procedures to further demonstrate the ESCO’s commitment to compliance.  Attached as Exhibit B is a description of the ESCO’s policies, processes, and quality assurance program. 

 

  • The ESCO Board of Directors will meet at least annually to discuss and approve any changes, if necessary to these or any other Compliance Program documents.

VI.           Element 2: Oversight of the Compliance Program

  • The ESCO has designated a Compliance Officer who oversees the operations of the Compliance Program.  The ESCO's Compliance Officer will oversee all day-to-day aspects of the ESCO’s compliance program and will be responsible for developing, coordinating, and implementing education and training regarding various aspects of ESCO’s compliance activities.  The Compliance Officer is also responsible for developing policies and procedures designed to promote a culture of compliance and to monitor whether the ESCO is, in fact, meeting its obligations.  The Compliance Officer will regularly report directly to the Board of Directors on the progress regarding the ESCO's ongoing compliance with applicable laws.  The Compliance Officer will provide background information so that the Board of Directors may exercise oversight regarding the implementation and effectiveness of the compliance program.

 

  • The ESCO Board of Directors has the ultimate responsibility and oversight of the ESCO's compliance activities.  As such, the ESCO Board of Directors will approve any substantive changes to the Compliance code of Conduct or the Compliance Plan.  In addition, it will receive periodic reports from the Compliance Officer as to the operation of the compliance Program, as well as to the investigation and resolution of any material compliance issues that may arise.

 

  • The Quality and Patient Engagement Committee shall include, at minimum, the President, Vice President, Secretary/Treasurer, and Compliance Officer, as well as one (1) nephrologist and one (1) Medicare beneficiary diagnosed with ESRD, or an independent consumer advocate.  The committee reports to the ESCO Board of Directors and oversees the ESCO’s quality and compliance reviews, addresses and resolves quality and compliance issues, facilitates the peer review process to investigate cases of potentially suboptimal care and addresses a Corrective Action Plan (CAP) issued by CMS.  The Quality and Patient Engagement Committee meets at least twice annually.

VII.         Element 3: Education and Training

The Compliance Officer is responsible for ensuring that the Code of Conduct, quality measures and the Compliance Plan are made accessible to all ESCO’s Participant Owners, Directors and applicable ESCO Collaborating Organizations and Provider/Suppliers.  In addition, as noted above, the Board of Directors will receive specific training so that the Directors may effectively exercise oversight over the ESCO's Compliance Program.  Parties who have entered into a participation agreement will be provided with a copy of this Compliance Plan and related Compliance Program materials and will be contractually committed to adhering to applicable laws and regulations.  Such parties will, however, be deemed to have met the education and training standards of the ESCO if they certify that they have met the fraud, waste and abuse certification requirements required for enrollment in the Medicare Program.  Periodic training will be provided so that Directors are equipped to comply with applicable legal and ethical responsibilities.  These training refreshers will occur at least on an annual basis or more frequently, as deemed appropriate by the Compliance Officer or the ESCO Board of Directors.  The Compliance Officer will maintain a record of completion of training.

VIII.       Element 4: Communication Processes Including Hotline

Entities such as the ESCO are subject to numerous federal and state laws and regulations.  Therefore, it is vitally important for all Participant Owners, Directors, ESCO Collaborating Organizations and Provider/Suppliers to be vigilant regarding compliance within this complex legal and financial system.  Accordingly, it is the responsibility and expectation of all to report concerns regarding suspected noncompliance.

To assist and facilitate in the confidential identification of potential compliance issues, the ESCO has established mechanisms for private communication of potential compliance issues.  These mechanisms include:

  • a confidential hotline (to be set up once ESCO signs participation agreement) by which any person (including any ESCO Participant Owner, Director, Collaborating Organization or Provider/Supplier) may report any issue on an anonymous basis, although s/he may also feel free to identify himself or herself if s/he prefers so that we can ask additional questions to aid in our resolving the issue; and

 

  • open communication with the Compliance Officer whose duty it is to further the goal of total compliance by the ESCO.  At any time, any ESCO Participant Owner, Director, ESCO Collaborating Organization or Provider/Supplier may seek clarification or advice from the Compliance Officer with regard to the Compliance Program or any compliance questions or issues.  Questions and responses will be documented by the Compliance Officer or designee.

It is the policy of the ESCO that good faith participation in the compliance program, including the reporting of any suspected noncompliance or other issue, will not result in retaliation against the participant.  Individuals shall not be intimidated or retaliated against in response to their good faith adherence to this compliance program.

The Compliance Officer will maintain a record of reports of violations of the Compliance Program and its Code of Conduct or of relevant law and regulations received by the Compliance Officer.  A summary report will be furnished periodically to the Quality and Patient Engagement Committee and the ESCO Board of Directors.

IX.           Element 5: Well-Publicized Disciplinary Measures

All ESCO Participant Owners, Directors and applicable ESCO Collaborating Organizations and Provider/Suppliers are expected to adhere to the Code of Conduct and to follow the principles of this Compliance Plan.  Also, as noted above, it is an expectation of all that they report compliance issues and identify illegal or unethical behavior.  Failure to comply with this requirement can result in disciplinary actions.  The type and severity of the disciplinary action will depend on the particular facts and circumstances but serious deviations from these requirements can result in possible termination of the relationship with a party.  It is the policy of the ESCO that it will institute timely, consistent and effective enforcement of the standards described in this Compliance Plan.  Disciplinary or remedial action may be taken in response to the following:

  • Failure to perform any obligation or duty required relating to compliance with the ESCO Compliance Program or applicable laws or regulations;
  • Failure to detect non-compliance with applicable policies and legal requirements and the ESCO Compliance Program where reasonable diligence would have led to the discovery of any violations or problems; and
 
  • Issuance of a Corrective Action Plan (CAP) by CMS.

If the Compliance Officer concludes, after an appropriate investigation, that the Code of Conduct or applicable laws or regulations have been violated, then the compliance Officer will inform the Quality and Patient Engagement Committee and the ESCO Board of Directors as appropriate.  Appropriate discipline, remedial process and disciplinary actions up to and including termination of participation in the ESCO, will be taken.

X.             Element 6: System For Routine Monitoring and Identification of Compliance Risks

Ongoing monitoring and auditing are critical to a successful compliance program.  The Compliance Officer will periodically review aspects of the ESCO's operations especially in areas that have been identified by government enforcement agencies as potentially problematic for entities engaged in contracting under the CEC Model.  A particular area of focus will be the ESCO's compliance with its regulatory and contractual commitments under the CEC Model.

  • Tracking New Developments – The Compliance Officer, or a designee, will make his or her best efforts to ensure that all relevant publications issued by government or third-party payers regarding compliance rules and protocols are reviewed and appropriately implemented focusing in particular on rules, regulations and guidance as to the operation of the ESCO.

 

  • Quality and Compliance Reviews – Along with the Quality and Patient Engagement Committee, the ESCO Compliance Officer will make his or her best efforts to ensure to the extent possible appropriate quality and compliance reviews are conducted.  Such reviews will be conducted on a sampling, census or other basis.  Reviews may include, but are not limited to: quality reviews of medical charts; data extraction and analysis based on applicable quality measures; patient satisfaction or other surveys.  Feedback and education will be provided as appropriate and if needed.

In conjunction with the Quality and Patient Engagement Committee, the ESCO Compliance Officer will also see that other compliance reviews are periodically conducted of ESCO operations to support and advance the goal of continued compliance with regulatory requirements.  Such reviews may include:

  • Reviews of the processes for submitting required certifications to Medicare to confirm accuracy and completeness;

 

  • Reviews of the processes for using or distributing shared savings dollars for compliance with the regulatory requirements and the methodology established by the ESCO Board of Members; and

 

  • Reviews to confirm that ESCO participants have been appropriately checked against government exclusion lists or are otherwise appropriately licensed and credentialed.

XI.           Element 7: Responding to Detected Noncompliance

Any report received will be treated very seriously and will be thoroughly investigated.  If upon review it is determined that the ESCO have been noncompliant in some regard, the ESCO will promptly take actions that it deems appropriate under the circumstances.  The actual response will vary depending on the unique circumstances but in all cases there will be steps taken to promote, support, and encourage future compliance.  Incidences of suspected misconduct related to payment from Medicare or related to services provided under that program will result in a timely inquiry into the conduct.  In some cases, the ESCO may be required to voluntarily self-report the matter to an appropriate authority. The ESCO will promptly take such steps.

  • Investigation, Corrective Action and Responses to Suspected Violations – whenever a compliance problem is uncovered, regardless of the source, the Compliance Officer will first conduct and document a thorough investigation.  Based on the results of the investigation, the Compliance Officer will work with the Quality and Patient Engagement Committee to implement appropriate and effective corrective action, as appropriate.

 

  • Any corrective action and response implemented must be designed to prevent the recurrence of the violation or problem, or reduce the likelihood that it will re-occur. 

XII.         A Shared Commitment By All

The ESCO's compliance with its legal duties depends on the actions of each and every Participant Owner, Director, ESCO Collaborating Organization and Provider/Supplier.  The consequences of noncompliance can be extremely serious and even one individual may jeopardize the future of the ESCO by not taking their responsibility seriously.  Those in a managerial or supervisory role have a special responsibility to make their best efforts to ensure that those who they are responsible for fully understand and completely adhere to this Compliance Plan.  The Board of Directors must take an active lead in promoting compliance.  All have a unique responsibility for the ESCO's compliance with the law and together we can ensure that the ESCO's mission will continue into the future with the highest of standards.

XIII.       Questions/Resources

If any individual or party involved with the ESCO has questions or concerns, he or she should contact the appropriate supervisor or the Compliance Officer listed below:

Bruce Elkington

Compliance Officer

700 Broadway

Seattle, WA 98122

 

In addition, if any individual or party believes there may be a situation that possibly violates the law, the Code of Conduct or this Compliance Plan, he or she should leave a message on the ESCO's anonymous hotline.

 

EXHIBIT A

CODE OF CONDUCT

 

The ESCO's Commitment to Legal and Ethical Conduct

Purpose of the Code of Conduct:

This Code of Conduct has been adopted by the ESCO's Board of Directors as part of ESCO's Compliance Plan in order to provide standards by which all Participant Owners, Directors and applicable ESCO Collaborating Organizations and Provider/Suppliers will conduct themselves.  The ESCO is committed to full compliance with all federal, state and local laws and regulations.  It shall endeavor to conduct activities at all times in conformance with the highest standards of business integrity.  The ESCO shall also promote individual conduct that protects and promotes integrity and enhances the ESCO's ability to achieve its organizational mission.  This Code of Conduct is intended to serve as a guide to help all to whom it applies make sound ethical and legal decisions during their day-to-day activities so the ESCO achieves the level of compliance required by law.

The standards and principles contained in this Code of Conduct apply to all Participant Owners, Directors, as well as applicable ESCO Collaborating Organizations and Provider/Suppliers.  The ESCO Board of Directors fully embraces the concepts contained herein and have formally adopted this Code of Conduct as the policy of the ESCO.  Failure to comply can have serious consequences for the ESCO and for those who do not comply.

Compliance with Laws and Regulations

The ESCO is committed to operating in accordance with high legal, moral, and ethical standards and with all applicable laws, regulations, and standards.

The ESCO will not tolerate false statements to a government agency or other payor.  Deliberate misstatements to government agencies or other payors will be grounds for disciplinary action.

The ESCO will not pay physicians or health care providers for referral of clients, or accept payments for referrals we make.

The ESCO will strive to ensure that all reports or other information required by any federal, state, or local government agency are filed timely, accurately, and in conformance with the applicable laws and regulations.

The ESCO will not engage, either directly or indirectly, in any corrupt business practice, including bribery, kickbacks or payoffs, intended to induce, influence, or reward favorable decisions of any client, contractor, vendor, government personnel, or anyone in a position to benefit the ESCO in any way.

The ESCO will not participate in surveys conducted by a competitor, nor survey competitors concerning competitively sensitive topics such as prices for goods and services or physician services, terms of contracts, employment contracts, terms of equipment, supply or service contracts and joint bidding or joint venture arrangements.

The ESCO will undertake its activities in a manner that puts the best interests of its patients ahead of any financial or business motivation.

The ESCO will at all times honor its patients’ freedom to choose the healthcare provider of the patient’s choosing.

The ESCO will not hire or contract with any individual or entity who is currently excluded, suspended, debarred, or otherwise ineligible to participate in the federal health care programs or has been convicted of a criminal offense related to the provision of health care items or services and has not been reinstated in the federal health care programs after a period of exclusion, suspension, debarment, or ineligibility.

The ESCO will conduct itself in an ethical manner compliant with all relevant laws and regulations and correct wrongdoing.

The ESCO has a responsibility to report any activity by any Participant Owner, Director, ESCO Collaborating Organization or Provider/Supplier that appears to violate applicable laws, rules, regulations, accreditation standards and standards of medical practice, Federal healthcare conditions of participation, or this Code of Conduct.

 

 

EXHIBIT B

ESCO POLICIES, PROCESSES, AND QUALITY ASSURANCE PROGRAM

All Participant Owners, Directors and applicable ESCO Collaborating Organizations and Provider/Suppliers are expected to know the basic laws and regulations that apply to the ESCO and its participants.  If any individual or party involved with the ESCO has questions, such questions should be promptly directed to the Compliance Officer.  All are also expected to know and follow the ESCO policies and procedures and to utilize its processes and systems in accordance with those policies and procedures.

Suspected violations of law or ESCO policy must be promptly reported.

I.          ESCO Compliance Policies.

A. Compliance With CEC Project Requirements.  The ESCO is a participant in the CEC Model and as such is subject to various laws, regulations and guidelines related to that demonstration program.  The CEC Model imposes various requirements on those participating in this innovative program.  The following list, while not exhaustive, details a number of the requirements that the ESCO and all its contractors are committed to satisfying:

  • Compliance with all standards and requirements related to any legal waivers granted by CMS pursuant to its authority granted under section 1115A of the Social Security Act;

  • Adherence to the governance structure requirements contained in CMS’ Request For Applications, as may be amended by CMS from time to time;

  • A prohibition against restricting beneficiary access to necessary care;

  • Honoring a beneficiary’s freedom to choose their provider of service;

  • Development and implementation of a quality assurance strategy designed to prevent suboptimal care;

  • A prohibition against overutilization, underutilization or cost shifting; and

  • Compliance with the terms and conditions of the CEC Model Participation Agreement.

B. Confidentiality/Privacy Issues.  The ESCO will endeavor to comply with all federal and state laws relating to confidentiality of protected health information.

C. Fraud & Abuse Laws. The ESCO will strive to comply with all federal and state fraud and abuse laws.

D. Conflicts of Interests.  Directors and employees should avoid conflicts, as well as the appearance of conflicts between their private interests and the interests of the ESCO.  A conflict of interest occurs if a business or personal relationship with another person or entity interferes with a party’s ability to perform duties for the ESCO in an objective manner.

E. Excluded Persons or EntitiesThe ESCO will not employ or contract with any person or entity that is "excluded" from participation in any governmental payment program by the Office of Inspector General ("OIG") or any comparable list of debarred or "excluded" providers issued by any other governmental agency with authority over the ESCO.  In addition, ESCO will conduct periodic checks of the OIG's list of excluded parties. 

II.        Quality Assurance Program.

The ESCO is dedicated to providing, through its participating providers' high quality, cost-efficient care to ESRD beneficiaries.  Accordingly, the ESCO has adopted a quality assurance strategy; the goal of which is to protect ESRD beneficiaries and ensure that they receive all necessary services for the care of their medical condition.  This strategy includes review of clinical data to guard against the under-utilization and promote the furnishing of high quality care within the context of the innovative approach inherent in the CEC Model.  Data extract information will be provided to the Quality and Patient Engagement Committee for review.

Peer Review Process – The peer review approach enables the Quality and Patient Engagement Committee to recognize structural or procedural issues that may have contributed to suboptimal clinical outcomes.  In this approach, the committee must look to identify changes to those structures and processes—or suggest new ones, to reduce the risk of such errors occurring in the future. This peer review approach is to evaluate medical errors in the context in which they occurred and to determine whether changes in the system of care can reduce the risk of future errors and poor clinical outcomes.

The Quality and Patient Engagement Committee has oversight and manages the:

  • Evaluation of issues
  • Opportunities for constructive change
  • Key individuals to establish a dialogue regarding the opportunities for improvement
  • Proposals of change
  •  Determination of relative costs and benefits, cross-functional impacts and feasibility of proposals

The Quality and Patient Engagement Committee will review data and reports pertaining to quality measures for the CEC Demonstration.  The process will include the following steps:

  • The Quality and Patient Engagement Committee will meet at least twice annually.
  • The Quality and Patient Engagement Committee will receive and review data and reports on an ongoing basis regarding quality measures for the CEC Demonstration.
  • Minutes will be recorded at each meeting.
  • The Compliance Officer is responsible for confirming that reports are forwarded as needed and facilitates the discussion.
  • Issues identified will be assigned an owner and delivery date for action.
  • Proposals of change require full Committee agreement.

The ESCO Compliance Officer will maintain documentation of peer review cases investigated.

III.       Corrective Action Plan (CAP) Process

The Quality and Patient Engagement Committee is responsible for addressing a Corrective Action Plan (CAP) issued by CMS.  The Committee is responsible to provide insight on possible causes of errors, communicating the CAP progress to the ESCO Board of Directors and others as determined, developing strategies and making all decisions on the planning, implementation and evaluation of corrective actions. The severity of the CAP will determine the disciplinary actions of the individual participants that caused the CAP. Action plan steps will include education and remonitoring. Disciplinary actions will be tied to the severity of the CAP including possible termination and suspension of eligibility for net shared savings.          

The Quality and Patient Engagement Committee’s process to address a CAP involves the six phases below;

1. Report Analysis – Review, report on, and address the CAP issued by CMS to clarify problem(s) and compliance-related issues. Review policies and procedures, quality reports, characteristics, and other essential information to support analysis.

2. Program Analysis – Review the findings of the report analysis to determine, report on, and address the most upstream causes to which the errors are attributed (root cause analysis).

3. Corrective Actions – Based on Report and Program Analysis results, determine the corrective actions to be implemented. These may include but are not limited to:

o   Changes to policies and processes

o   Training

o   Changes in management system and tools

o   Creation of management tools

4. Implementation – Develop an implementation schedule for each corrective action plan initiative. The implementation schedule should identify major tasks, key personnel responsible for each activity, timeline for each action including completion dates, and monitoring to completion.

5. Evaluation – Determine means and method to evaluate and assess improvements against the cause for the CAP. Assign ownership for reporting on a regular basis to committee.

6. Disciplinary Actions stemming from issuance of a CAP by CMS will vary based upon the specific facts and circumstances and may range from suspension of eligibility for net shared savings to immediate termination.

o   Intent to falsify documents, results, outcomes, and/or CAP will result in immediate termination

Additional circumstances of a participant termination are based on five (5) quality measures;

  • Preventive Health
  •  Chronic Disease Management
  • Care Coordination and Patient Safety
  • Patient and Caregiver Experience
  • Patient Quality of Life

IV.       Antitrust Compliance Plan

The Antitrust Compliance Plan is designed to establish safeguards against improper exchanges of prices or other competitively sensitive information among competing participants that could facilitate collusion and reduce competition in the provision of services outside the ESCO.  A policy is attached as Exhibit C that is approved by the ESCO Board of Directors addressing antitrust (the “Antitrust Policy”).  Appropriate training regarding the Antitrust Policy, as determined by the Compliance Officer, is mandatory for all Directors serving on the ESCO Board of Directors, so that such Directors are equipped to provide further direction to their respective organizations.  In addition, the Antitrust Policy shall be acknowledged and reviewed at every meeting of the ESCO Board of Directors.      The ESCO Board of Directors will ensure that the ESCO will not use its market leverage to raise its commercial reimbursement rates to levels significantly disproportionate to growth in Medicare reimbursement rates.              

V.        Remedial Processes

In the event that an ESCO Participant Owner, Director, ESCO Collaborating Organization or Provider/Supplier fails to comply with the CEC Model Participation Agreement, Medicare regulations, and/or is otherwise not adhering to ESCO performance standards, internal policies and procedures, including corrective action plans (CAPs), remedial action will be taken by the ESCO Board of Directors to rectify the noncompliant behavior.   The remedial process will be a tiered approach that utilizes the most appropriate remedy for the specific circumstances.  These remedial steps will be referenced in the participation agreement between the ESCO and the Participants.  While the remedial steps are designed to be graduated in their approach, the ESCO will apply the remedial action most appropriate under the circumstances up to and including expulsion.

Steps will include:

  1. Verbal review with Medical Advisor or other ESCO leadership, as appropriate
  2. Written review and action plan
  3. Holding shared savings
  4. Termination

 

EXHIBIT C

Northwest Kidney Care Alliance

POLICY DESCRIPTION – Communications with Competitors Concerning Prices, costs of Service and other Competitively Sensitive Topics

PAGES: 1 OF 2

EFFECTIVE DATE:

APPROVED BY:  ESCO Board of Directors

PURPOSE: Antitrust violations may subject the ESCO to severe civil and criminal monetary fines, civil liability for treble damages and injunctions that could expulse the ESCO from participation in the Medicare Comprehensive ESRD Care (CEC Model) demonstration project.  Antitrust violations may also subject individual employees to imprisonment, personal liability, and substantial monetary fines.  The ESCO Code of Conduct therefore requires not only compliance with the law but avoidance of activities which, though not illegal, may pose unnecessary risks of litigation, government investigation, or injury to the ESCO reputation.  The following limitations on information exchanges with Competitors are designed both to aid compliance with antitrust laws and protect the competitive and financial interests of ESCO Participant Owners, Directors and applicable ESCO Collaborating Organizations and Provider/Suppliers.

POLICY: ESCO Participant Owners, Directors and applicable ESCO Collaborating Organizations and Provider/Suppliers shall comply with the following:

  1. Prohibited Communications – ESCO Members, Directors and Provider/Suppliers shall not communicate with a Competitor, either directly or through other employees, medical staff, consultants or other third parties about the following:

a. Prices charged for goods or services, including physician services

b. Costs of goods, supplies, equipment, or services, including physician services

c. Employee salaries, wages, or benefits, compensation policies, staffing policies, employment contracts or severance agreements

d. Terms of managed care contracts

e. Terms of commercial contracts

f. Terms of equipment, supply or service contracts

g. Allocation among competitors of customers, services or territories

h.Exclusion of any existing or potential competitor or supplier from the market

i. Joint bidding or joint venture arrangements

These topics are referred to in this policy as Competitively Sensitive Topics.  An exception to the above is with the legal advice from the Legal Counsel for the ESCO.

2. Permissible Communications – There are many legitimate business reasons to communicate with Competitors.  This policy is not designed to prohibit communications with Competitors concerning, but not limited to:

a. Medical treatment

b. Physician credentialing and privileging

c. Development of Electronic Health Records (EHR) databases

d. Improvement of patient quality of care

e. General trends in the healthcare industry

f. Non-business matters

Even when discussing permissible topics, however, ESCO Participant Owners, Directors and applicable ESCO Collaborating Organizations and Provider/Suppliers must still abide by requirements to protect privileged, proprietary or confidential information as set forth in the Code of Conduct.

3. Surveys – ESCO Participant Owners, Directors and applicable ESCO Collaborating Organizations and Provider/Suppliers may not survey competitors concerning Competitively Sensitive Topics listed under Prohibited Communications, nor participate in such surveys conducted by a Competitor.  Any requests to participate in outside party surveys regarding pricing, costs, compensation or employee benefits are to be communicated to the ESCO Legal Counsel.

Definitions

For purposes of this policy, a “Competitor” is any person or entity that provides products or services that are similar to, or are viable alternatives to, products and services provided by participating ESCO participants.  A “Competitor” may also be a person or entity that competes for supplies, labor, equipment contracts or other inputs that affect costs to the ESCO. 

For purposes of this policy, “Communicating” with Competitors includes providing or receiving documents, sending or receiving letters, memos, emails, text messages, engaging in phone or personal conversations, or participating in meeting or seminars to include trade association meetings or industry conferences.