5-31-2012 ESRD FFP Competitive RFP with TOC.docx

TABLE OF CONTENTS

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Description of Services

The purpose of this contract is to provide services for an operation of End Stage Renal Disease Organizations (ESRD) in accordance with Title XVIII of the Social Security Act as amended by Section 1881(c), as described in Section C, “Statement of Work/Services.”

B.2 Type of Contract

This is a firm fixed price contract. The services of the ESRD contract will be severable.

B.3 Consideration and Payment

A. The total firm fixed price for this contract is $___________________.

B. The total firm fixed price for the transition period is $_____________________.

C. The total firm fixed price for the base year is $___________________.

D. The total firm fixed price for Option 1 is $___________________.

E. The total firm fixed price for Option 2 $___________________.

F. Reimbursement

Monthly vouchers shall be submitted in accordance with contract Section G.2, Submission of Invoices and Payment.

G. Table of Total Estimated Firm Fixed Price

The ESRD contractor shall provide the necessary personnel, materials, services, facilities and supplies(except as may be otherwise specified in the contract) and otherwise do all things necessary for, or incident to, the performance of the work as set forth in Section C, Statement of Work/Services. In consideration of successful contract performance, based on the evaluation criteria set forth in Section C, the ESRD contractor will be reimbursement as stated in B.4, Schedule for Payment for Fixed Price.

B.4 Schedule for Payment for Fixed Price

The Government shall pay the ESRD contractor for performing this contract the fixed price specified in the schedule below. Payment of the fixed price will be made in accordance with the schedule provided below:

A. Base Year Transition Period – November 1, 2012 through December 31, 2012 (if applicable)

B. Base Year Performance Period - January 1, 2013 through December 31, 2013

C. Option 1 – January 1, 2014 through December 31, 2014

D. Option 2 – January 1, 2015 through December 31, 2015

Note: Regardless of the period of performance of a Special Innovation Project, the associated fixed price shall be allocated across the remaining months of the contract period (not the period of performance for the Special Innovation Project). Therefore, as these projects are incorporated into the contract, the Section B.4, Schedule for Payment of Fixed Price will be modified accordingly.

B.5 Special Innovation Projects (SIPs)

As provided in Section C and in accordance with the procedures contained in Section G, CMS reserves the right to direct the ESRD contractor to initiate a SIP not currently defined in the Statement of Work/Services or to approve an application submitted by the ESRD contractor to conduct a SIP. SIPs will be negotiated and awarded on a FFP basis. The table provided below will be completed (through executed of a formal contract modification) as SIPs are incorporated into this contract.

B.6 Transition Services

In the event that CMS required transition services from the incumbent ESRD contractor to a successor ESRD contractor, CMS will request a separate technical and business proposal for these services. Refer to Section H.18 for guidance. These services will be incorporated into the contract, if applicable. The transition period will be from November 1, 2012 through December 31, 2012.

SECTION C – STATEMENT OF WORK/SERVICES

C.1 Purpose of the Statement of Work (SOW)

The purpose of this Statement of Work (SOW) is to delineate tasks to be conducted by each End Stage Renal Disease Network Organization (ESRD Network) contractor in support of achieving national quality improvement goals and statutory requirements as set forth in Section 1881 of the Social Security Act and the Omnibus Budget Reconciliation Act of 1986. The term “Network” is used in this SOW to refer to the ESRD Network contractor. The tasks described in this SOW are intended to:

Align ESRD Network activities with the Department of Health and Human Services (HHS) National Quality Strategy (NQS), the CMS Three Aims, and other CMS priorities designed to result in improvements in the care of individuals with ESRD

Measure performance and impact of the Network in achieving stated goals.

Background information on the ESRD Network Program can be found in the Medicare ESRD Network Organizations Manual (ESRD Network Manual).

C.2 Contractor Performance Objectives

This section outlines the objectives, priorities, and strategies of the ESRD Network Program and the role of the Network in carrying out activities as reflected in this SOW.

C.2.1 Domains

The Network shall promote positive change relative to three AIMs outlined in the NQS and CMS priorities. The AIMs are interpreted for purposes of this SOW as:

AIM 1: Better Care for the Individual through Beneficiary and Family Centered Care

AIM 2: Better Health for the ESRD Population

AIM 3: Reduce Costs of ESRD Care by Improving Care.

The three AIMS are subdivided into multiple domains, as defined in this SOW (see Table 1). Many factors influence these domains, including patient characteristics, patients’ social support/environment, and aspects of the health care delivery system. To substantively impact these domains, the Network may need to deploy interventions that target patients, dialysis/transplant providers, other providers, and other stakeholders.

The Network shall incorporate a focus on disparities in conducting all of the activities outlined in this SOW. In each domain, the Network shall analyze data and implement interventions aimed at reducing disparities.

Table 1. AIMS, Domains, and Sub-Domains

Involve Patients/Families in CMS Meetings

Convene/Support Patient Engagement Learning and Action Network (LAN)

Promote Use of In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) and/or Any Similar Survey Identified by CMS

Address Issues Identified through Data Analysis

Address Patients at Risk for IVD/IVT and Failure to Place

Generate Monthly Access to Dialysis Care Reports

Reduce Catheter Rates for Prevalent Patients

Support Facility Vascular Access Reporting

Spread Best Practices

Provide Technical Support in the Area of Vascular Access

Establish HAI LAN

Reduce Rates of Dialysis Facility Events

Increase Hepatitis B (HBV), Influenza, and Pneumococcal Vaccination Rates or Improve Dialysis Care Coordination with a Focus on Reducing Hospital Utilization or Improve Transplant Coordination or Promote Appropriate Home Dialysis in Qualified Beneficiaries or Support Improvement in Quality of Life

Assist Facilities in Improving their Performance on QIP Measures

Assist CMS in Monitoring the Quality of and Access to Dialysis Care

Assist Beneficiaries and Caregivers in Understanding the QIP

Support for Facility Data Submission to CROWNWeb, NHSN, and/or Other CMS-Designated Data Collection System(s)

C.2.2 Role of Network

The Networks are critical to achieving bold CMS goals for health care transformation. The successful Networks will be patient care navigators and lead transformation by:

Serving as conveners, organizers, motivators, and change agents

Leveraging technology to provide outreach and education

Serving as a partner in quality improvement with other health care organizations, beneficiaries, health care providers, practitioners, and stakeholders

Securing commitments to create collaborative relationships

Achieving and measuring changes at the patient level through data collection, analysis, and monitoring for improvement

Disseminating and spreading best practices including those relating to clinical care, quality improvement techniques, and data collection through information exchange

Participating in the development of a CMS national framework for providing emergency preparedness services.

The Network is uniquely positioned to ensure full participation of the ESRD community in achieving the AIMS of the NQS. Therefore, this SOW emphasizes:

Network relationship with Medicare beneficiaries

Ensuring representation of Medicare beneficiaries in shared decision making related to ESRD care in order to promote person-centeredness and family engagement (NQS Principle 1) Protecting Medicare beneficiaries’ access to and quality of dialysis care especially for vulnerable populations (NQS Principle 3).

Network relationship with ESRD facilities (NQS Principle 4)

Identifying opportunities for quality improvement at the individual facility level and providing technical assistance (NQS Principle 5) Promoting all modalities of care, including home modalities and transplant, as appropriate, to promote patient independence and improve clinical outcomes. (NQS Principle 5) Facilitating processes to promote care coordination between different care settings (NQS Principle 8) Ensuring accurate, complete, consistent, and timely data collection, analysis, and reporting by facilities in accordance with national standards and the ESRD QIP (NQS Principle 6).

Coordination and sharing across 18 Networks

Using standardized procedures to collect data and address grievances to promote consistency across Networks (NQS Principle 6) Collaborating to share information such as patient migration across Networks to promote care coordination (NQS Principle 8) Coordination with regional Quality Improvement Organizations (QIOs) and other recognized subject matter experts in the field Sharing information to promote care coordination for ESRD patients (NQS Principle 8)

Sharing best practices to improve quality of care for ESRD patients, including Network involvement in LANs (NQS Principle 5).

Network acting on behalf of CMS

Conveying information from CMS to facilities on HHS and CMS goals, strategies, policies, and procedures including the ESRD QIP Maintaining integrity of information and tone of messaging consistent with CMS expectations for entities acting on behalf of the agency Interpreting and conveying to CMS or its designee information relevant to the ESRD health care system to assist with monitoring and evaluation of policy and program impacts including the effects of the ESRD QIP.

The objectives of the IQI Program are to support and foster continuous quality improvement in Network processes in order to improve the timeliness, effectiveness, efficiency, and management control of Network activities.

The Network shall develop a written IQI Plan that encompasses the work to be performed under this contract including administrative functions, financial management, and activities in support of the three AIMs.

The Network shall have an internal reporting system for all IQI activities, and shall make reports available to its Medical Review Board (MRB) and to CMS, on request, for monitoring purposes.

The Network IQI Program shall include built-in processes for rapid identification and correction of problems.

The Network IQI Plan shall be submitted to the Contracting Officer Representative (COR) for review no later than 45 days after the beginning of the contract year, unless otherwise directed by CMS. Upon request by the COR, the Network shall supply IQI reports and analyses to document adherence to established processes and response to problems that arise in performing contract requirements.

C.3.2 Compliance

The Network shall comply with all requirements outlined in this SOW, all additional instructions from CMS, and all relevant statutory and regulatory requirements.

C.3.3 Independence

The Network, acting independently and not as an agent of the Federal Government, shall furnish the necessary personnel, materials, services, facilities, and supplies (except as otherwise specified in the contract) and otherwise do all things necessary for, or incident to, the performance of work as set forth by this SOW.

C.3.4 Corporate Structure

The Network must establish a corporate structure that supports the Network’s operations and meets all statutory requirements. The corporate structure shall include a Network Council, Board of Directors, Medical Review Board, and Patient Action Committee at a minimum. Network key personnel (Executive Director, Quality Improvement Director, Patient Services Director and Data Manager are required. All aspects of the corporate structure must meet ESRD Manual requirements. (See the ESRD Network Manual for additional information.)

C.3.5 Communication Requirements

The Network shall work with patients and providers in its service area to improve the quality of care and quality of life of ESRD patients by providing informational material and technical assistance on ESRD-related issues. All Network correspondence to patients and providers for distribution to patients shall be clear, concise, well-organized, and easily understood on the first reading by readers who are literate in English, regardless of functional or health literacy status and professional or academic background. Materials shall be appropriately translated for non-English speakers, as applicable. In addition, all Network correspondence to patients and facilities for distribution to patients shall contain the following language: “To file a grievance please contact [insert Network name] at [insert Network phone number and website URL].”

The Network shall perform the following functions:

Maintain a national user-friendly, toll-free telephone number: The Network’s toll-free number shall be answered by a staff person during normal working hours. After hours, the system shall allow messages to be left. Systems shall be in place to ensure that a Network staff member can be reached by telephone in the event of an emergency or disaster.

Maintain a Network website: The Network website must be Section 508 compliant and follow all CMS standards and guidelines. The Network website shall include, at a minimum, a description of the Network grievance process; a list of the Network’s goals; the Network’s most recent Annual Report; a link to the Dialysis Facility Compare website (http:www.medicare.gov/dialysis); information on all Network committees, including information on how to become a member of the committee; a link to the ESRD QIP site and other specified federal websites as directed by CMS; and in the event of an emergency or disaster, the open and closed case status of providers and other information to assist patients and providers.

Prepare a cover letter for the New ESRD Patient Orientation Package (NEPOP): Using Network stationary, the Network shall make a letter available for duplication and distribution to new ESRD patients in the Network’s service area. The letter shall be provided to the National Coordinating Center (NCC) to distribute in the NEPOP, with a copy to the Network's COR when the content is revised or as otherwise directed by CMS. The letter shall:

Explain the role of Network Give the Network’s toll free number, mailing address, and website address Provide the address(es) and phone number(s) for the State Survey Agency(ies) in the Network’s service area Provide information on the functions of State Survey Agencies, including the role of the State Survey Agency in receiving and investigating grievances.

Include information on how to contact the Network in order to file a grievance (phone number, e-mail address, and mailing address).

Investigate and resolve situations in which NEPOPs are undeliverable: Using an IQI process, the Network shall track the error rate and set an acceptable target for the error rate for distribution of the packet on initial mailing. The Network shall report on these activities quarterly.

Provide educational information: The Network shall determine the most effective strategies for the distribution of informational materials, utilizing the basic principles of marketing and consumer engagement. The process for distributing informational material shall be based on a thorough knowledge of the specific needs of the ESRD patient population in the Network’s service area. The Network shall use an IQI process to determine the need for educational/informational materials for its community, determine the most effective method of distribution for each type of material, and evaluate the overall effectiveness of the materials and the method of distribution. To the extent possible and practical, the Network shall utilize information that is already available through CMS, other CMS contractors (e.g., other Networks, the NCC, QIOs), other federal agencies, renal partners (e.g., renal advocacy groups, provider groups, and provider associations), and other sources. As applicable, the Network shall utilize the Patient Advisory Committee and Network Council in fulfilling these requirements. Educational/outreach materials must include information on:

The role of the ESRD Network The Network's process for receiving, reporting, resolving, and tracking patient grievances Treatment options and new ESRD technologies available to patients, with an emphasis on those that have been shown to support patient independence (e.g., transplantation, home therapies, in-center self-care) Information to educate and encourage patients to achieve their maximum level of rehabilitation and to participate in activities that will improve their quality of life (e.g., vocational rehabilitation programs, volunteerism); contact information for state/regional vocational rehabilitation programs available in the Network’s service area Information on vascular access procedures The Network’s toll-free number, mailing address, and website address Information on how to access and use the Dialysis Facility Compare website Information on how to interpret a facility’s QIP Performance Score Certificate Information on all Network committees, including information on how to become a member of the committee Information on the importance of receiving vaccinations (including HBV, influenza, and pneumococcal vaccinations) and information related to the importance of disease management, the Welcome to Medicare Physical, heart-healthy living, diabetes self-management and training, and (if requested) smoking cessation Information on the benefits of the Medicare Prescription Drug Program (Medicare Part D) and on how to enroll, and any other guidance or materials related to this program of specific benefit to the individual with ESRD, as directed by CMS.

C.3.6 Data Confidentiality and Disclosure

Pursuant to §1881(c)(8) of the Social Security Act, the Network must comply with the QIO data confidentiality requirements found in §1160 of the Act and 42 CFR, Part 480.

C.3.7 Information Collection/Survey Activities

Unless otherwise specified, a Network seeking to conduct surveys or collect data as a part of any of the activities included in this SOW shall do so only with pre-approval of the COR and in accordance with the Paperwork Reduction Act, the ESRD Network Manual, and other administrative directives.

C.3.8 Network Reporting

The Network shall maintain meeting minutes required for the tasks identified in the SOW and the Schedule of Deliverables. The Network shall report to CMS as directed in the SOW and in the Schedule of Deliverables. As specified in this contract and approved by CMS, the Network may conduct data analysis and produce data reports relevant to the local provider community and/or CMS. The Network shall maintain a repository of all data acquired and reports generated. No new data collection may be implemented by the Network without CMS approval.

The Network shall report to CMS as directed in Section F – Schedule of Deliverables. The Network shall adhere to all requirements in the ESRD Network Manual to manage and report work performed under this SOW.

The Network shall submit the following reports to the COR and Government Task Leader (GTL) for approval:

Monthly Reports Quarterly Progress and Status Reports Semi-Annual Cost Report Annual Report of Network Activities Other deliverables as directed by this Scope of Work and the Schedule of Deliverables.

C.3.9 Meetings

The Network shall host, participate in, and attend meetings as directed in Section F – Schedule of Deliverables. ESRD Network meetings shall include:

Contract Post-Award meeting with CMS (QIG/OAGM);

Monthly Meetings with the COR/GTL: The Network shall prepare an agenda and meeting minutes for each meeting. The meeting shall address each AIM—progress in meeting Deliverable schedule and other contract requirements—and shall include a review of the Network IQI Plan. The IQI Plan shall be electronic and allow for a WebEx-based meeting in which the COR is able to see the progress of the Network;

The annual QualityNet conference or another CMS quality meeting(s) designated by CMS as requiring in-person Network participation. The Networks are expected to participate in QualityNet meetings as presenters and/or conveners of learning sessions as directed by CMS.;

National meetings related to Network task areas requiring - Network attendance and participation as directed by CMS;

Other national meetings as specified in this SOW or as directed by CMS;

Learning and Action Network Meetings/Conferences shall include ongoing, active participation and advocacy for improved transitional and quality of care afforded to ESRD patients in at least one state’s QIO community-based Learning and Action Network Meetings/Conference. If a Network cover more than one state/jurisdiction then the Network shall actively engage with at least one of the four QIO Learning and Action Networks and advocate for better coordinated and improved quality of care for ESRD patients in that state/jurisdiction;

Meetings related to the ESRD QIP as directed by CMS.

C.3.10 Collaboration with Network Coordinating Center

The Network Coordinating Center (NCC) will function as a knowledge repository of Network- generated information (including best practices, lessons learned) and perform aggregate data analysis and interpretation of data from the Networks.

The Network shall:

Assist with the NCC’s knowledge repository and data analysis function by submitting data generated from its activities to the NCC as specified by CMS

Focus its activities based on trends detected or analyses performed by the NCC as directed by CMS.

Participate in the collection and dissemination of best practices and other forms of knowledge transfer.

Assist as directed by CMS in projects related to ESRD deliverables:

a. Participate in approved Learning and Action Networks to foster knowledge exchange and serve as subject matter experts in the field of ESRD

b. Review and remain current with project information, best practices, and lessons learned, and utilize findings to develop ESRD related quality improvement projects.

C.3.11 Collaboration with State Survey Agency

The Network shall engage the State Survey Agency as a partner in achieving common goals to improve access to and quality of care for dialysis patients. Regular two-way communications shall be maintained.

The Network shall communicate with the State Survey Agency and CMS (Network program staff and Survey and Certification staff) on a formal basis at a minimum of every other month and share issues and/or findings related to quality, access and coordination of care. The Network must promptly contact the State Survey Agency and coordinate management of a response plan when the issue reported may result in harm to the patient.

The State Survey Agency shall be invited to participate as a member of the Network Patient Engagement LAN.

C.3.12 Sanctions

The Network shall recommend sanctions pursuant to SSA§1881(c)(2) and procedures outlined in the ESRD Network Manual. The Network shall conduct a thorough review of a facility reporting several IVD/IVTs to ensure regulatory/statutory compliance and consider exercising its authority to recommend sanctions against recalcitrant facilities. Network interventions shall primarily focus on beneficiaries and their families/caregivers as well as facility process improvements. The Network shall consider recommending sanctions for facilities that:

Endanger the lives of patients being treated for ESRD, and/or engage in inappropriate practice patterns

Demonstrate a pattern of not accepting the Network’s offers of technical assistance

Demonstrate a pattern of non-adherence to Network recommendations

Do not meet Network-determined benchmarks in the domains as required by CMS

Do not meet CMS and Network goals relative to clinical performance measures and ESRD QIP measures

Do not demonstrate evidence of effective quality improvement activities that result in continuous quality improvement for those clinical areas not reaching benchmarked national standards.

C.3.13 Reporting of Discrimination

If it is suspected that care is being compromised or denied due to discrimination on the basis of race, color, religion, national origin, age, sex, familial status, sexual orientation, gender identity, disability, or veteran status, the case should be referred to the Office for Civil Rights (OCR) for investigation. The CMS COR, GTL, and the Contracting Officer must also be notified.

C.3.14 Emergency Preparedness

The Network shall provide an Emergency Preparedness Plan to CMS and cooperate with the NCC in coordinating emergency preparedness activities for the renal community. The Network shall provide technical assistance to dialysis facilities when needed so that facilities develop feasible, comprehensive emergency plans. The Network shall comply with the emergency preparedness duties outlined in the ESRD Network Manual.

The Network shall participate in an annual emergency preparedness drill in conjunction with the NCC. The Network shall coordinate the date and activity with the appropriate local stakeholders (state disaster agencies, State Survey Agencies, CMS Regional Office Division of Survey & Certification, etc.) and the NCC utilizing data to support the selection of the focus of the drill that is deemed most important to the Network’s service area (e.g., earthquake, tornado, terrorist activity). At the completion of the drill, the Network will perform and document the results of an assessment of strengths, weaknesses, opportunities for improvement, and lessons learned. Copies of the assessment will be sent to the NCC, GTL, and COR within 30 calendar days of the completion of the drill.

C.3.15 Data Systems

The Network shall not develop software products for use by facilities or other Networks without written prior approval from CMS. In addition, no funds from this contract shall be used for data collection activities not specified in this contract without prior approval from the COR and in accordance with other CMS administrative guidance.

C.3.16 Infrastructure Operations Support and Data Management

Unless otherwise directed by CMS, the Network shall adhere to the most current version of the policies and procedures outlined and posted on the QualityNet and NCC websites. These include, but are not limited to, the ESRD Network Infrastructure Operations and Support Manual, the ESRD Network Information Technology (IT) Administrator Manual, the SDPS Database Systems Administrator Guide, the QualityNet System Security Policy, and the QualityNet Incident Response Procedures. The Network shall comply with all present and future statutes as well as federal, Department of Health and Human Services (DHHS), and CMS regulations and program instructions relating to providing a secure computer operations environment. Additional policies and procedures may be released, requiring the Network to comply.

The Network shall maintain all necessary documentation that meets or exceeds the performance standards specified in the Infrastructure Operations Support and Data Management chapter of the ESRD Network Manual and deliverables specified in Section F – Schedule of Deliverables.

C.3.17 Hardware/Software

CMS, either directly or through a CMS contractor, shall provide each Network with a file/print server, a domain controller, a database server, and a workstation and/or laptop for each 0.5 or greater full-time equivalent (FTE) employee. The servers, workstations, and laptops shall be equipped with a standard operating system and a software suite following approved CMS Federal Desktop Core Configuration (FDCC) standards. If a Network requires additional hardware and/or software, the Network must receive approval from the Engineering Review Board (ERB). The Network must pay for the additional equipment and software out of Network contract funds. No additional hardware peripherals or non-approved software may be connected or installed to any Government Furnished Equipment (GFE) without prior written approval by CMS.

C.3.18 Security

C.3.18.A Certification by Information System Security Officer (ISSO) for Compliance with CMS Systems Security Requirements

The Network ISSO or equivalent, also referred to as the Security Point of Contact (SPOC), shall assist the CMS QualityNet ISSO in the security certification of existing controls and compliance with the CMS systems security requirements as described in the CMS Acceptable Risk Safeguards (ARS) and the Federal Information Security Management Act (FISMA), Title III of the E-Government Act of 2002 (Public Law 107-347, 44 U.S.C. Ch 36).

C.3.18.B Administer Security Program

The Network shall comply with all CMS security program requirements as specified in the CMS Information Security (IS) “Virtual Handbook” (a collection of CMS policies, procedures, standards, and guidelines that implements the CMS Information Security Program) and the QualityNet Security Policy. The Virtual Handbook can be found at http://www.cms.hhs.gov/informationsecurity and the QualityNet Security Policy is located at http://qualitynet.org/.

The Network shall comply with all security controls outlined in the CMS Information Security (IS) Acceptable Risk Safeguards (ARS) for “Moderate” systems. Appropriate references are the CMS IS ARS, Appendix B, and the CMS System Security Levels by Information Type (located at http://www.cms.hhs.gov/informationSecurity in the Info Security Library).

The Network shall comply with the CMS Policy for the Information Security Program (PISP) and all CMS methodologies, policies, standards, and procedures contained in the CMS PISP unless otherwise directed by CMS in writing.

The Network shall comply with CMS and OIG audits, reviews, evaluations, tests, and assessments of Network systems, processes, and facilities. The Network shall provide all related artifacts upon request. The Network shall deliver the artifacts in the format and method prescribed by CMS.

The Network shall visit the CMS security website (http://sww.cms.hhs.gov/informationsecurity) at least every 30 calendar days for updates.

The Network shall visit the QualityNet Conference website (http://www.qualitynetonline.com/) with appropriate frequency for QualityNet Program and Security briefings and training opportunities.

The Network shall participate in CMS Security Best Practices conferences and audio conferences as directed by CMS.

The Network shall document its compliance with CMS security requirements and maintain such documentation in the Network System Security Plan (SSP) and the Information Security (IS) Risk Assessment (RA) as directed by CMS.

C.3.18.C Correct Deficiencies

The Network shall correct any security deficiencies, conditions, weaknesses, findings, or gaps identified by all audits, reviews, evaluations, tests, and assessments, including but not limited to Office of Inspector General (OIG) audits, self-assessments, Network internal review, Network security audits, and vulnerability assessments in a timely manner.

C.3.18.D Security Review and Verification

The Network shall comply with the CMS Security Assessment and Authorization (SA&A) methodology, policies, standards, procedures, and guidelines for contractor facilities and systems (http://www.cms.hhs.gov/InformationSecurity/14_standards.asp).

The Network shall conduct or undergo, as specifically selected and directed by CMS, an independent evaluation and test of its systems security program in accordance with CMS Reporting Standard for Information Security (IS) testing and adhere to the prescribed template (http://www.cms.hhs.gov/InformationSecurity/14_standards.asp) The Network shall support CMS validation and accreditation of contractor systems and facilities in accordance with CMS’ SA&A methodology.

The Network shall provide annual certification in accordance with SA&A methodology that certifies it has examined the management, operational, and technical controls for its systems supporting the Network contract function and considers these controls adequate to meet CMS’ security standards and requirements.

CMS strives to promote health care that is respectful of and responsive to individual patient preferences, needs, and values. Network patient-centered domains to achieve AIM 1 are:

Patient and Family Engagement Patient Experience of Care Patient-Appropriate Access to Outpatient Dialysis Care Vascular Access Management Patient Safety: Healthcare-Acquired Infections (HAIs).

In CMS’ view, most Network activities will be enhanced by the patient’s voice. The Network shall take a two-tiered approach to incorporating the patient’s voice in the activities of the Network and the renal community as a whole. The two tiers are: (1) engagement at the dialysis facility level to foster patient and family involvement; (2) development and implementation of a beneficiary and family centered care focused Learning and Action Network to promote patient and family involvement at the Network level. Both tiers are essential and work together to promote beneficiary and family engagement to improve quality of care.

C.4.1.A Foster Patient and Family Engagement at the Facility Level

The Network shall assist providers in adjusting to the heightened focus on patient and family centered care, aiming to help them optimize customer service. Specifically, the Network shall:

Develop and submit to the COR within 30 days of the start of the contract a marketing plan that integrates the concepts of family engagement and patient-centered care (see the ESRD Network Manual)

Fully implement the marketing plan within 120 days of contract award

As part of any onsite visits to dialysis facilities, incorporate discussion, education, and evaluation of how the dialysis facility has implemented patient and family centered care. For example:

Review and discuss with the facility whether the Quality Assurance Performance Improvement Program includes patient and family participation Review for the presence of patient and family meetings (e.g., patient council, support groups, vocational rehabilitation groups, new patient adjustment groups) Review and discuss patient and family involvement in the governing body of the facility Review and discuss policy and procedures related to family participation in the patient’s care such as involvement in the development of the individualized plan of care and cannulation Determine the percentage of patients and or family members who participate in plan of care meetings By the fourth quarter of the base contract year, synthesize information on dialysis facilities’ patient and family engagement in the Network service area to determine needs and future social marketing efforts for Option Years 1 and 2.

C.4.1.B Involve Patients/Families in CMS Meetings

The Network shall incorporate patients/family members into CMS meetings as follows and record attendance in the meeting minutes:

Attendance by at least one Patient SME, family member, and /or other caregiver in a portion of a COR/Network monthly monitoring meeting at least one per quarter

Attendance by at least one Patient SME, family member, and/or other caregiver during a portion of the Network’s annual evaluation site visit

Participation in other CMS meetings as directed. Please see the ESRD Manual for additional guidance.

The Network shall collaborate with the appropriate State Survey Agency(ies) to support patient and family engagement. The Network shall provide signed affidavits from the patient per each requirement in ‘b’ above. See the ESRD manual for additional guidance.

C.4.1.C Convene/Support Patient Engagement Learning and Action Network

Learning and Action Networks (LANs) are mechanisms by which large-scale improvement around a given aim is achieved through the use of various change methodologies, tools, and/or time-bounded initiatives. LANs manage knowledge as a valuable resource. They engage leaders around an action-based agenda. LANs create opportunities for in-depth learning and problem solving. While all dialysis facilities and other ESRD providers in a given state or ESRD Network service area may not receive direct ESRD Network interventions, LANs create an opportunity for communities, with assistance and guidance from the ESRD Network, to harness the knowledge, skills, and abilities of community partners to reach a critical mass of the appropriate stakeholders in the community concerned with a common aim(s).

The Network shall develop and facilitate a sustainable LAN in the Network area to promote patient and family engagement, or participate in and support patient and family engagement in an existing LAN. The LAN shall be patient-driven with topics chosen by the patient SMEs participating in the LAN.

The Network shall also participate in any CMS-supported and/or facilitated LANs that will function to support ESRD Network activities at the local level through spreading knowledge gained from counterparts across the country such as dialysis facilities and other ESRD providers, large dialysis organizations (LDOs), the National Institutes of Health National Kidney Disease Education Program (NIH/NKDEP), the Centers for Disease Control and Prevention (CDC), and other entities such as the United States Renal Data System (USRDS), the University of Michigan Kidney Epidemiology and Cost Center (UMKECC), and QIOs as directed by CMS and as resources allow.

Patient Subject Matter Experts (Patient SMEs) are committed and informed patients who are representative of the demographic characteristics of the Network’s service area, and who participate in the Network-convened or Network-supported Patient Engagement LAN. These patients will provide the patient perspective for Network improvement activities.

CMS staff will participate in the Patient Engagement LAN on a consistent basis.

The Network shall:

Develop and submit to CMS within 30 days of the start of the contract a Patient Learning and Action Network Plan. The Plan shall include, at a minimum, the Patient SME participation list, additional stakeholders included in the LAN (Providers, Patient advocacy groups, local/state/federal government representatives and other renal community members), the intended roles of the LAN participants, frequency of meetings, proposed patient-driven area(s) of focus, and the intended result of LAN activities with target milestones. (see the ESRD Network Manual)

Provide at least 20% of facilities located in the Network area with patient representative forms to identify 10 patients to participate in the Network-convened or Network-supported LAN within 30 days of contract award.

Recruit at least 10 Patient SMEs for the Network-convened or Network-supported LAN within 60 days of contract award, three of whom must be eligible patients on the transplant waitlist.

Submit the Patient SME agreement and recruitment list to CMS (see the ESRD Network Manual)

Provide an update on the number of participants who remain active in the LAN throughout the course of the initiative. Active involvement can be demonstrated by multiple means including lists of attendance at meetings, webcasts, conference calls; documented requests for technical assistance; documented requests for resources; or an attestation of participation signed by the participant.

Document the active participation of Patient SMEs and their contributions in the Monthly Report.

At the regional level, the input from Patient SMEs and their family members and/or caregivers will be used by the LAN to help guide Network activities. If the Network establishes and/or leads the LAN, the Network shall use technology such as conference calls or webinars to conduct meetings; schedule meetings when patients can likely attend, and help patients understand how they can best contribute and add value to the meetings.

During the base contract year, the Network will establish the LAN with 10 or more patients or ensure participation by 10 or more patients in an existing LAN. The Network shall maintain 100% membership with 60% attending required meetings and activities throughout the course of the project 60 days after first meeting.

The Network shall ensure that at least four LAN meetings are held with patient participation during the base contract year, documenting the goals and accomplishments of the meetings. A copy of the minutes of these meeting shall be provided to the COR and GTL electronically within 15 days of each meeting.

The Patient LAN, including the 10 Patient SMEs, as well as providers and stakeholders shall accomplish the follow for each contract year:

Identify ways to spread best practices and design and implement QIAs that promote patient-centered care and protect the interest of beneficiaries, such as QIAs that focus on empowering patients to share in decision-making, enhancing quality of life, and exploring treatment modalities including home dialysis (QIA plan by the end of the 2nd quarter for the Base contract, and by the end of 1st Quarter for Option years 1 and 2.) The QIA must be approved by the COR. The QIA Plan must incorporate sound methodology as provided by the ESRD Network Manual, and shall identify a single primary process or outcome measure for evaluation purposes. The QIA methodology shall impact at least 10% of the Network population, and demonstrate at least a 5% relative improvement on the pre-specified primary measure. Additional measures can be employed at the Network’s and Patient SMEs’ discretion. Monthly results from the QIA shall be provided to CMS electronically as directed by CMS.

Ensure implementation of at least two campaigns developed by the LAN (by the end of the 2nd quarter of the base contract year, and by the end of the 1st quarter of Option years 1 and 2). Campaigns must include development of educational materials intended for beneficiaries such as materials focused on health literacy, effectively navigating the dialysis system, treatment modalities, disease management, heart healthy living, ways to optimize quality of life, patient…