J-2 ESRD Manual reference.docx

ESRD Network Manual Reference Matrix

C.4.1.B.1. Evaluate and Resolve Grievances

Grievance Investigation and Resolution Process (Include Required Documentation)

C.4.1.B.1. Evaluate and Resolve Grievances

Documentation Required for the Grievance Investigation And Resolution Process

C.4.1.D.3. Support Facility Vascular Access Reporting

Exclusions Related to Dialysis Facilities Submission of Vascular Access Data

The release of the ESRD Network Manual will occur at a later date. The attached ESRD Manual Reference Matrix (Reference Matrix) is provided to address the topic areas of the SOW where the ESRD Network Manual is referenced. See table 1 below.

The Reference Matrix is being offered to provide guidance for bidding purposes only. The language contained in the Reference Matrix has been drafted for inclusion in the ESRD Network Manual. Prior to the release of the final version of the ESRD Network Manual, the language provided in the Reference Matrix may be changed or updated to include descriptive examples, provide additional guidance and/or definitions. CMS does not expect the language contained in the Reference Matrix to have a cost impact or require amendment to the Request for Proposals (RFP). CMS anticipates that the language in the Reference Matrix will be the same or similar guidance to that which will be provided in the official version of the ESRD Network Manual.

ESRD Network Manual Reference Matrix

Manual Reference #

Statement of Work Task Area

Draft Language for ESRD Network Manual

Background on ESRD Program

The 1972 Social Security Amendments (P.L. 92-603) extended Medicare coverage to individuals with end stage renal disease (ESRD) who require dialysis or transplantation to sustain life.

The ESRD Network Program was established in 1978 (P.L. 95-292) when §1881 was added to the Social Security Act authorizing the creation of ESRD Network Organizations. The following items represent statutory and other changes that have influenced the ESRD Network Program:

· The Omnibus Budget Reconciliation Act of 1986 Sections 9335(d) through (h) amended §1881(c) (2) of the Social Security Act by establishing at least 17 ESRD Network areas and delineating Network functions.

· Medicare payment to ESRD facilities for outpatient maintenance dialysis services furnished to Medicare beneficiaries with End-Stage Renal Disease (ESRD) was based on a prospective payment system known as the basic case-mix adjusted composite payment system.

· The ‘‘Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities.’’ Final Rule was published. It established updated conditions for coverage that dialysis facilities must meet to be certified under the Medicare program. The final rule has a heightened focus on the patient and the results of care provided to the patient. It also encourages patients to actively participate in their plan of care and treatment.

· Medicare Improvements for Patients and Providers Act (MIPPA) was enacted July 15, 2008

· MIPPA § 153(b) implemented a (bundled) payment system under which a single payment is made to a service provider or a renal dialysis facility for renal dialysis services in lieu of any other payment

· MIPPA §153(c) Instituted a system of quality incentives for service providers and renal dialysis facilities in the end-stage renal disease (ESRD) program

· National Strategy for Quality Improvement in Health Care (National Quality Strategy) was released March 21, 2011. The strategy was called for under the Affordable Care Act and is the first effort to create national aims and priorities to guide local, state, and national efforts to improve the quality of health care in the United States.

AIMs of the National Quality Strategy

· Better Care for the Individual through Beneficiary and Family-Centered Care

· Better Health for the ESRD Population

· Reduce Costs of ESRD Care through Improvement of Care

Corporate Structure

The ESRD Network will establish an organizational structure that includes at minimum a Board of Directors (BOD), committees that support the role and function of the governing body, and a management structure and staffing pattern that support Network operations and meet statutory requirements and the requirements set forth in the ESRD Statement of Work (SOW).

The Network will:

· Establish a BOD that sets overall policy and direction for the Network and retains oversight responsibility;

· Establish the responsibilities of the governing BOD and delineate these in bylaws that are updated annually. These responsibilities will include at minimum attendance and participation in no fewer than 75% of board meetings; participation in an ongoing training plan that addresses ethics, compliance with CMS goals, cultural awareness, and other relevant topics; and participation in subcommittees of the BOD

· Establish committees and subcommittees to support the governing body. At minimum, the Network will establish a Network Council, a Medical Review Board, and a Patient Advisory Committee. The Network may establish additional committees and subcommittees as deemed necessary by the governing body;

· Publish on its website (at minimum) information identifying the members of the BOD – including those serving on subcommittees. The published information should include at minimum:

a. Number of members;

b. Length of appointment;

c. Term limitations;

d. When appointments are made;

e. What percentage of governing body or subcommittee members is typically appointed each year; and

f. Names, affiliations, and compensation (as permitted) of members;

· Specify in writing the roles, responsibility, and relationship of the BOD and its subcommittee; and

· Main documentation of committee meeting and actions.

NOTE: No committee or subcommittee member may review the ESRD services of a provider in which he or she has a direct or indirect financial interest (as described in §1126(a) and (b) of the Social Security Act), has or had any professional involvement, received reimbursement, or supplied goods. See §1881(c)(1)(C) of the Act.

Board of Directors (BOD)

The Network will be governed by a BOD composed of representatives from the Network area, including at least two patient representatives in accordance with Section 1881(c)(1)(A)(i) of the Social Security Act. CMS encourages diversity in consumer representation to help the Network maintain a focus on the consumer as a customer.

The Network will specify the number of members on its BOD, which should not exceed 20 members except when appropriate justification is provided to CMS. The Network will adopt policies ensuring that the BOD membership includes representatives of a variety of healthcare setting relevant to the ESRD population (e.g. hospital, hospice, nursing homes): a variety of disciplines; as well as individuals with non-healthcare backgrounds. The Network should seek to include statisticians, epidemiologists, medical record managers, and other health and information management professionals, as well as experts from outside the health care filed, on the BOD.

The BOD or Executive Committee (EC) of the BOD will meet quarterly, with at least two meeting per year by teleconference or in person, to ensure the successful operation of the Network At minimum, the BOD or EC will:

Supervise and be responsible for the performance of the Network's management staff in meeting contract requirements and deliverables as well as responding to CMS’ requests;

Supervise and be responsible for the financial operation of the Network including the Internal Quality Control (IQC) Program

Review and approve the Annual Report prior to submission to the Contract Officer’s Representative (COR);

Approve requests for modifications to the Network's contract that involve requests for additional funding; and

Review and approve any recommendations from the Medical Review Board (MRB) to sanction ESRD facilities prior to submission to CMS.

Network Council

The Network will establish and maintain a Network Council that meets the statutory requirements of §1881(c) of the Social Security Act. The Network Council must:

· Be composed of individuals representing renal dialysis and transplant centers located in the Network area;

· Be representative of the geographic distribution and types of dialysis facilities and transplant centers in the Network area; and

· Include at least two dialysis and/or transplant patients receiving services in the Network area.

At minimum, the Network Council will meet at least three times a year, in person or by electronic communication, to provide input into the activities of the Network and serve as a liaison between the Network and providers. The Network will support and coordinate the activities of the Network Council Medical Review Board (MRB)

The Network will establish a committee that meets the statutory requirements of §1881(c) of the Social Security Act to function as the Network's MRB. The MRB must be composed of at least two patient representatives and representatives of each of the professional disciplines (i.e., nephrologists, vascular surgeons, transplant surgeons, registered nurses, dietitians, and social workers) engaged in ESRD Care. MRB members must be qualified to evaluate the quality and appropriateness of care delivered to patients with ESRD. This committee must meet as necessary (by teleconference or in person).

The functions of the MRB include the following:

· The MRB will serve as an advisory panel to the Network on the care and appropriate placement of ESRD patients on dialysis in the Network area.

· The MRB will also serve as the primary advisory panel for all Network quality improvement activities.

· The MRB will assist Network staff in the development, implementation and evaluation of quality improvement projects.

· The MRB will work with Network staff to recommend sanctions to CMS for dialysis facilities, as necessary.

NOTE: An MRB member must not review the ESRD services of a provider in which he or she has a direct or indirect financial interest (as described in §1126(a) and (b) of the Social Security Act), has or had any professional involvement, received reimbursement, or supplied goods. See §1881(c)(1)(C) of the Act.

Patient Advisory Council

The Network shall compose a Patient Advisory Committee (PAC) consisting of at least 10 patients; with patients able to serve on more than one committee. Patient SMEs may also be members of the PAC.

Key Personnel

The following Network staff positions are considered Key Personnel:

· Executive Director;

· Quality Improvement Director;

· Patient Services Director; and

· Data Manager

PRA Information Collection/Surveys

Surveys and other information collection mechanisms must comply with the provisions of the Paperwork Reduction Act (PRA) of 1995 (Public Law 104-13). These provisions generally prohibit an agency from conducting or sponsoring a collection of information (as that term is defined in the PRA) unless, in advance thereof, the agency reviews the collection of information, publishes a 60-day notice in the Federal Register, evaluates comments received pursuant to such notice, and receives approval and a control number from the Office of Management and Budget (OMB). (See 44 U.S.C. 3506 and 3507.) Regulations at 5 CFR, Part 1320, implement the provisions of the PRA. These regulations require OMB approval prior to implementation of a collection of information from 10 or more public respondents in response to identical or similar questions in a standardized format. The provisions of the PRA apply to information collected through oral interviews and information collected in writing.

In the regulations at 5 CFR, Part 1320, some items are not deemed to be "information" under the PRA, and thus do not require OMB clearance. See 5 CFR, Part 1320, for information on additional PRA requirements. Section 50 of this chapter addresses the requirements for OMB clearance.

Any proposed QIA surveys or collection of information MUST receive COR notification of OMB approval or COR notification of OMB exemption before initiation.

Network Reporting

Networks shall submit the identified CMS reports utilizing CMS provided templates. Templates will provide a summary of Network activities related to the deliverables on a monthly, quarterly or ad hoc basis.

Sanction Procedures

The Network will alert the COR of its intent to recommend a sanction after the Network has provided full documentation to the facility, in writing, of the facility's failure to comply with Network goals and objectives. The Network will submit two copies of its documentation and a cover letter to its COR. These documents will include:

· The name, address, and Medicare provider number of the involved facility;

· The Network goal(s) or objective(s) with which the facility has failed to comply;

· A brief summary of the basis for the sanction recommendation;

· Compilation of supporting evidence;

· An outline of what action(s) the facility must take, due dates, and documentation that must be submitted in order to remove the sanction;

· The individual in the Network whom CMS can contact for further information and assistance; and

· The name and phone number of the Network's COR.

The Network will organize the information in notebook form with a chronological summary and a table of contents.

Emergency Preparedness Duties

The Network emergency preparedness duties for the renal community will include:

The Network shall be responsible for the following activities related to natural, accidental or man-made emergency/disaster preparedness and response:

· Assist providers/facilities in developing plans for local emergencies/disasters as specified under Task 2.d.and in accordance with §494.100(c)(1)(vii) of the ESRD Conditions for Coverage

· Maintain a phone system to ensure that Network staff members can be contacted as necessitated by the emergency/disaster;

· When an emergency or disaster affects any portion of the Network’s area, communicate with facilities to identify affected facilities. Networks shall track availability of services and assist patients in identifying dialysis facilities that can provide ESRD services. The Network shall track and make available to the public the open and closed status of the facilities in the affected area. This information may be posted on the Network’s Web site or a link may be provided to a central Web site, as available;

· Assist family members and treating facilities in locating displaced patients and exchanging critical medical information for those patients. In the event of an emergency or disaster, CMS will provide direction related to HIPAA regulations.

· If a family member is able to provide sufficient identification of the displaced patient, the Network shall give the family member contact information for the current treating facility, if known. If the current treating facility is able to provide sufficient identification of the displaced patient, the Network shall give the facility critical medical information, as available, and contact information for the dialysis facility where the patient was formerly treated;

· Organize or participate in national and/or regional calls with providers, emergency workers, and other essential persons to ensure coordination and that the needs of individuals with ESRD are being met;

· As directed by CMS, assist other Networks in carrying out contract requirements during the initial phase of an emergency and/or disaster and during the recovery phase;

· When an emergency or disaster affects any portion of the Network’s area, the Network shall provide status updates via telephone or email to COR and the Kidney Community Emergency Response Coalition (KCER) Status updates shall include an approximate number of impacted facilities; an approximate number of impacted patients; the priorities and concerns (e.g. lack of staff, utility outages, etc); and whether the Network needs Contracting Officer’s Representative and/or KCER assistance.

· Establish a partner relationship with another Network to provide back-up assistance in the event of an emergency/disaster.

Infrastructure Operations Support and Data Management

Information pertaining to the infrastructure operations support and data management could be found by accessing the following:

The ESRD Infrastructure Support Manual: http://esrdncc.org/index/information-for-esrd-networks.

The ESRD Infrastructure IT Administrator Manual: http://esrdncc.org/index/information-for-esrd-networks .

Patient SMEs’ Agreement Forms

The signed agreement form will demonstrate the patients understanding and agreement to serve as a patient subject matter expert volunteer in a Network patient engagement Learning and Action Network.

Marketing Plan that Integrates the Concepts of Family Engagement and Patient-Centered Care

The Network s will develop a marketing plan that will promote and educate invested stakeholders (e.g. providers, patient advocates, and relevant local and federal entities) in the concepts of beneficiary and family engagement centered care.

Involve Patients/Families in CMS Meetings Additional Guidance

In one COR/Network monthly meeting per quarter, the Network will dedicate an agenda item(s) to patient-related topic(s) and provide the attending Patient SME(s) with a 10 minute opportunity to address the agenda topic, raise additional for discussion and/or provide an agenda item for the next quarter meeting.

During the Network’s annual evaluation site visit, the Network and its COR will dedicate at least an hour of time to provide the attending Patient SME(s) with an overview of Network operations, an overview of CMS oversight and an opportunity for the Network and/or COR to answer Patient SME questions.

Attendance/Participation may occur in-person or by audio teleconference, video teleconference, webinar or any equivalent participation activity approved in advance by the COR.

Learning and Action Networks Learning and action networks are mechanisms by which large scale improvement around a given aim is fostered, studied, adapted and rapidly spread regardless of the change methodology, tools, or time-bounded initiative that is used to achieve the aim. Learning and action networks consciously manage knowledge as a valuable resource. They engage leaders around an action based agenda. LANs create opportunities for in depth learning and problem solving, it accepts all offers of support seeking to catalyze interested parties, and it is transparent, flexible, interchangeable, and purposeful.

While all facilities and providers in a given service area may not receive direct ESRD Network intervention, learning and action networks create an opportunity for patients and other renal stakeholders, with assistance and guidance from the ESRD Network, to harness the knowledge, skills, and abilities of their peers and vested partners to reach a common aim(s). It is expected that the ESRD Network will facilitate and assist patients in developing sustainable learning and action networks within their respective Network service areas, as well as participate in CMS supported and facilitated Learning and Action Networks which will function to support ESRD Network activities through spreading knowledge gained from counterparts across the country which may provide additional information for improving quality of care delivered to ESRD beneficiaries.

Definitions--Supporting and Convening Learning and Action Networks

The definitions provided below shall pertain to the work performed under Section C.4.1.A.3. Convene/Support Patient LAN

1. Network Coordinating Council (NCC) Patient LAN: The NCC will lead a national effort to convene ESRD Network Patient SMEs in achieving specified goals specific to a topic of importance to CMS, beneficiaries, and other stakeholders. The Network Coordinating Council will serve as a central point of entry to send, receive and spread information to the ESRD Network LAN participants, collect and report data, establish and maintain contact with national experts and participants, and gather or develop quality improvement tools.

2. Spread: The act of expanding an improvement from an area of success to another area within a system for the purpose of accelerating the rate of implementing proven interventions in order to improve performance in strategic areas.

3. Best Practice: A technique or methodology that, through experience and/or research, has been proven to be one of the most efficient (least amount of effort) and effective (best results) way of accomplishing a task or achieving an outcome, based on repeatable procedures that have proven themselves over time.

4. Sustainability: Establishing a plan that will help to increase the probability that the quality improvements attained, through the Patient LAN’s work during the course of the contract, are maintained or improved when the ESRD Network has completed its formal work with the participants.

Quality Improvement Activities (QIAs) Development Using Sound Methodology (Manual Reference #12, 16 and 22)

· The Network will design and conduct QIAs as directed by the SOW. For some of these activities, the topic area and/or evaluation measures are pre-determined. Performance criteria with regard to the number of facilities and/or patients utilized, as well as the amount of improvement required, may also be pre-defined for any QIA.

· CMS may direct (or redirect) the Network to develop specific QIAs based on identification of performance issues.

· If Network resources allow and with approval from it’s COR, the Network may develop QIAs based on identification of performance problems in the ESRD community.

· CMS-directed QIAs take precedence over Network-developed QIAs.

QIA Development and Monitoring

Network QIAs will be developed using individuals with knowledge and experience specific to the QIA topic and measures. Additionally, the Network will conduct a root cause analysis (RCA) for development of all QIAs whether required by the SOW, otherwise required by CMS, or initiated by the Network.

The interventions utilized for the QIA will be based on results of the RCA, previous evidence of successful implementation, and a logical rationale for probability of success.

Network QIAs must include a monitoring process which ensures the effectiveness of interventions; Networks must conduct reassessments of the effectiveness of their interventions through a rapid cycle quality improvement process. The rapid cycle process should not take more than 2–3 months per cycle. Intervention(s) should be modified to address ineffective efforts.

Network QIAs are performance based. Failure to achieve specified goals (either interim or final) will subject the Network to contract actions to be determined by the Contracting Officer.

Grievance Investigation and Resolution Process (Include Required Documentation)

The term complaints no longer exist and all patient concerns are classified as grievances. The process for resolving grievances remains intact. The Network advocates for patient rights with the understanding that the patient is responsible for his/her behavior. Patient rights are found at 42 CFR 405.2138. The NW must implement procedures for evaluating and resolving patient grievances as required in §1881(c)(2)(D) of the Act and CMS regulations at 42 CFR 405.2112(g). In making a determination, the Network should utilize recognized standards of care to assure proper treatment for ESRD patients when determining the action(s) needed to assist the complainant and to resolve the concern. In resolving a grievance gather information on the telephone, by letter/email, by conducting on-site reviews, or by performing other investigative activities concerning care provided by a facility or a provider as appropriate (as determined by the MRB and 42 CFR 405.2112).

The Network is responsible for documenting all grievances in the Network Patient Contact Utility and to report in the Monthly and Quarterly Report summation of patient grievances; Network actions and interventions, and information on whether or not the complainant is satisfied with the conclusion and actions taken during the Network grievance process, and/or if the patient is educated on why a change in process cannot occur.

Enter data on grievances into the Patient Network Contact Utility (NCU) tool or other CMS-designated database. The process for resolving grievances remains intact. The Network shall document patient grievances directly reported to the Network by patients and/or grievances reported to facilities by patients. The Network shall work with the NCC to conduct patient satisfaction surveys relative to satisfaction with the grievance process..

Comprehensive vs. Quarterly Review Criteria For the purposes of section: C.4.1.B.2. Contract Monitoring and Evaluation: C.4.1.B.1. Evaluate and Resolve Grievances, Quarterly Review Criteria refers to grievances received by the end of the quarter being evaluated. Comprehensive Review Criteria refers to the review of 100% of the grievances received by the Network from the beginning of the contract cycle

Quality Improvement Activities (QIAs) Development Using Sound Methodology (Manual Reference #12, 16 and 22)

· The Network will design and conduct QIAs as directed by the SOW. For some of these activities, the topic area and/or evaluation measures are pre-determined. Performance criteria with regard to the number of facilities and/or patients utilized, as well as the amount of improvement required, may also be pre-defined for any QIA.

· CMS may direct (or redirect) the Network to develop specific QIAs based on identification of performance issues.

· If Network resources allow, the Network also has the option to develop QIAs, with approval from it’s COR, and based on identification of performance problems in the ESRD community.

Network QIAs will be developed using individuals with knowledge and experience specific to the QIA topic and measures. Additionally, the Network will conduct a root cause analysis (RCA) for development of all QIAs whether required by the SOW, otherwise required by CMS, or initiated by the Network.

The interventions utilized for the QIA will be based on results of the RCA, previous evidence of successful implementation, and a logical rationale for probability of success.

Network QIAs must include a monitoring process which ensures the effectiveness of interventions; Networks must conduct reassessments of the effectiveness of their interventions through a rapid cycle quality improvement process. The rapid cycle process should be no longer than 2–3 months per cycle. Intervention(s) should be modified to address ineffective efforts.

Appropriate Terms and Definitions/Criteria for Documenting IVDs/IVTs Detailed Tasks/Procedures for Patient and/or Facility Report of IVDs/IVTs

Involuntary Transfers - a transfer of a patient’s care, , from one provider to another that was not made at the request of the patient in response to the following:

· The facility is unable to meet the medical needs of a complex patient (i.e.trached or vented patient); or

· Due to facility closure or merger.

Involuntary discharges involve discharge of the patient after attempts to resolve the grievance fail, the nephrologist discharges the patient from his care, and/or patient behavioral issues (threatening or abusive behavior) are not resolvable and the facility wants to discharge the patient to another facility. The Network will oversee that the facility provides advance discharge notice, preferably 30 days, before discharge, and that the facility assists with alternate placement. If a patient has been discharged from a unit and the unit was unable to place the patient in another outpatient dialysis facility and the patient is no longer being followed by a dialysis facility social worker, the Network may assist the patient with placement if requested by the patient. Network assistance does not guarantee placement of the patient in another facility.

Characteristics of Patients that May be Indicative of Disparities in Care The Network will document characteristics of patients that may be indicative of disparities in care, including race, ethnicity, complex medical care issues, history of mental illness, vascular access. This list is not self limiting.

Failure to place refers to the following:

· the inability of a referring physician or facility (i.e. hospital) to place a patient, who is new to dialysis treatment, into a Medicare certified facility under the care of an accepting nephrologist; OR

· A patient who has been discharged from a dialysis facility after a 30 day absence and is not accepted back into their previous facility or into the care of a nephrologist in a different facility.

If requested, the Network will assist the facility/provider/patient with placement. Network assistance does not guarantee placement of the patient in another facility.

Exclusion Categories from Home Dialysis for Patients

The Network may contact CMS to discuss any questions or concerns related to the selection criteria and suitability of patients for home hemodialysis or peritoneal dialysis. Examples of exclusion criteria include but are not limited to environment of care (e.g. sanitation, plumbing ); evidence of inability to learn or successfully perform procedures(e.g. eye-hand coordination, cognitive skills)

Submissions of Monthly Access Reports to CMS and the Appropriate State Survey Agency(ies).

Network service area Access to Dialysis Care will be reported monthly using the CMS provided templates referenced in the Network Reporting

Exclusions Related to Dialysis Facilities Submission of Vascular Access Data

Networks must obtain approval from their COR to place or remove a facility from the ineligible facility list.

A facility may be deemed ineligible when it is:

_ An acute care hospital facility;

_ A Veterans’ Administration facility;

_ A pediatric center;

_ Closed, either permanently, or temporarily _ A facility that provides peritoneal dialysis service only, or _ A special purpose facility.

Temporary closures may be due to renovation, lack of utilities, storm or flood damage, etc. A facility will be considered temporarily closed or “undergoing transition, when it is:

_ Temporarily closed for at least 30 days with a current provider number; or _ Temporarily closed with a valid provider number at the end of the reporting period.

1.

Quality Improvement Activities (QIAs) Development Using Sound Methodology (Manual Reference #12, 16 and 22)

· The Network will design and conduct QIAs as directed by the SOW. For some of these activities, the topic area and/or evaluation measures are pre-determined. Performance criteria with regard to the number of facilities and/or patients utilized, as well as the amount of improvement required, may also be pre-defined for any QIA.

· CMS may direct (or redirect) the Network to develop specific QIAs based on identification of performance issues.

· If Network resources allow, the Network also has the option to develop QIAs, with approval from it’s COR, and based on identification of performance problems in the ESRD community.

Network QIAs will be developed using individuals with knowledge and experience specific to the QIA topic and measures. Additionally, the Network will conduct a root cause analysis (RCA) for development of all QIAs whether required by the SOW, otherwise required by CMS, or initiated by the Network.

The interventions utilized for the QIA will be based on results of the RCA, previous evidence of successful implementation, and a logical rationale for probability of success.

Network QIAs must include a monitoring process which ensures the effectiveness of interventions; Networks must conduct reassessments of the effectiveness of their interventions through a rapid cycle quality improvement process. The rapid cycle process should be no longer than 2–3 months per cycle. Intervention(s) should be modified to address ineffective efforts.