Attachment 1 - NDSC PWS.pdf

DEPARTMENT OF VETERANS AFFAIRS

VHA Office of Integrated Veteran Care Integrated External Networks

National Dialysis Services Contract (NDSC) Modernization Performance Work Statement

Version 6.0 March 5, 2024

Acquisition Sensitive Information –

For VA Internal Planning Purposes Only

For VA Internal Planning Purposes Only

Table of Contents

X.X PERFORMANCE WORK STATEMENT

GENERAL INFORMATION

1.1 Definitions

1.2 Title of Project

1.3 Scope of Work

1.4 Background

2.0 PROJECT MANAGEMENT

2.1 Kickoff Meeting

2.2 Project Management Plan (Project Plan)

2.2 Project Management Plan (Project Plan) ....................................................................... Error! Bookmark not defined.

2.3 Contractor Designated Personnel Roles and Responsibilities

2.4 Operational Quality Reporting Requirements

3.0 NETWORK REQUIREMENTS

4.0 CUSTOMER SERVICE

5.0 REFERRALS AND SCHEDULING

6.0 MEDICAL DOCUMENTATION

7.0 CLAIMS PROCESSING AND ADJUDICATION FOR NDSC SERVICES RENDERED

8.0 CLINICAL QUALITY AND MONITORING

9.0 SPECIAL CONSIDERATIONS

10.0 DELIVERABLES

For VA Internal Planning Purposes Only

X.X PERFORMANCE WORK STATEMENT

GENERAL INFORMATION

1.1 Title of Project

National Dialysis Services Contract (NDSC) purchased under the authority of 38 United States Code (U.S.C.) § 8153, “Sharing of Health-care Resources.”

1.2 Scope of Work

The Department of Veterans Affairs (VA) has a requirement to provide chronic dialysis and Acute Kidney Injury (AKI) services from community-based dialysis service providers. The Contractor shall provide, supervise, and monitor outpatient chronic dialysis and Acute Kidney Injury (AKI) services to Veterans within the Contractor’s facilities and provide home dialysis training to Veterans.

The Contractor shall meet all requirements outlined in this contract and follow CMS quality standards.

Outpatient-based dialysis services shall utilize Contractor or Subcontractor resources, Contractor or Subcontractor owned and maintained equipment, Contractor or Subcontractor staff, and the Contractor or Subcontractor equipment necessary or required for dialysis services.

1.3 Background

VA is committed to providing Veterans with timely, accessible, and high-quality care. VA intends to honor this commitment by improving performance, promoting a positive culture of service, increasing operational effectiveness and accountability, advancing healthcare innovation through research, and training future VA clinicians.VA recognizes that while the healthcare landscape is constantly changing, VA’s unique population and broad geographic demands will continue to require community-based care for Veterans. A Veteran enrolled in the patient enrollment system of VA, established, and operated under 38 U.S.C. § 1705, may receive services under this contract. Healthcare services will be provided in each state as defined in 38 U.S.C. § 101(20).

This contract will not be used to acquire services for inherently governmental functions as defined by FAR 7.503 or personal services as defined by FAR 37.104. The Contractor will not perform work reserved for performance by Federal employees, and the Government will manage the Contractor consistent with its responsibility to perform all inherently governmental functions and maintain control of its mission and operations in accordance with requirements of Office of Federal Procurement Policy Letter 11-01.

2.0 PROJECT MANAGEMENT

2.1 Kickoff Meeting

The Contractor shall create a Kickoff Meeting Presentation describing the details of the approach to delivering all services under this contract in a Project Management Plan (Project Plan) as defined in Section 2.2, “Project Management Plan” in accordance with the Schedule of Deliverables. The Contractor shall coordinate with the Contracting Officer (CO) to establish dates, location, and agenda for the kickoff meeting. The Contractor shall take meeting minutes and provide them to VA in accordance with the Schedule of Deliverables.

Deliverable: (See Section 10.0, “Schedule of Deliverables” for details.)

A. Kickoff Presentation B. Kickoff Minutes

2.2 Project Management Plan (Project Plan)

The Contractor shall be responsible for project management and delivery performance of the requirements of the contract. The Contractor shall create a Project Plan to be approved by VA to capture all elements of managing the NDSC. The Project Plan, at a minimum, shall include the Contractor’s plan for implementation, deployment, contract execution, to include a work breakdown structure (WBS), and risk management.

The Project Plan shall be submitted five (5) days prior to the Kickoff Meeting and reviewed, updated, and approved annually by the Contractor and VA, in accordance with Section 10.0, “Schedule of Deliverables.

Deliverable: (See Section 10.0, “Schedule of Deliverables” for details.)

A. Project Plan

2.3 Contractor Designated Personnel Roles and Responsibilities

Prior to the kickoff meeting, the Contractor shall provide a Key Personnel List of the positions listed below and include the following: name, position, and contact information.

1. Contract Administrator: The Contractor shall designate a contract administrator(s) to handle contractual matters and serve as a business liaison. In addition to the Key Personnel List, the assigned Contract Administrator shall be listed in Section X.X, 1a of this contract.

2. Contractor Coordinator: The Contractor shall designate a coordinator(s) for each contracted facility. It is allowable for the Contractor Coordinator to oversee more than one facility. The Contractor Coordinator(s) shall be responsible for communication with the VA Medical Center (VAMC) designated point of contact. Upon reassignment or changes of the Contractor Coordinator(s), the Contractor shall notify the VA within 30 business days.

Deliverable: (See Section 10.0, “Schedule of Deliverables” for details.)

A. Key Personnel List

2.4 Operational Quality Reporting Requirements

The Contractor shall use the following to ensure effective management of the program:

1. The contractor shall utilize Facilities Status, Attachment X, to provide information on facility demographics to VA (e.g. change in ownership (CHOW)). The Facilities Status shall be submitted to VA no more than five (5) days following the scheduled kickoff meeting and monthly thereafter in accordance with the Schedule of Deliverables. VA maintains the right to modify Attachment X, the Facilities Status template. Should changes occur, the Contractor will have 90 days to implement changes to the format. The Contractor shall continue to submit facility updates via email or other means as directed by VA. When submitting changes on Attachment X, Facilities Status, the Contractor shall not make changes to the template provided by the VA. The Contractor shall notify VA, using Facilities Status, Attachment X, for disqualifying or adverse administrative events, as specified below:

a. Disqualifying Event

The Contractor shall notify the authorizing VAMC personnel, COR, and Contracting Officer using the Facilities Status, Attachment X of all adverse actions by the CMS Medicare Program to include exclusion from participation from the Medicare program, Medicaid program, and other federal programs by the Contractor, its agents, employees, assigns or successors. Notification shall be provided if the below occurs, according to the cadence outlined on Attachment X, QASP.

b. Adverse Administrative Events:

1. Adverse Impact to CMS Certification

The Contractor shall notify the referring VAMC, COR, and Contracting Officer in writing and include information detailing the reasons for, and circumstances related to the loss or adverse impact, in accordance with CMS Medicare Program reporting. Notification shall be provided if the below occurs, according to the cadence outlined on Attachment X, QASP and the Schedule of Deliverables:

• Any action affecting the status as a certified CMS Medicare Program provider of dialysis services to Veterans, or any other action affecting any of the dialysis facility’s federal or state licenses and CMS certification.

• Any investigations by the CMS Medicare Program into the business and/or billing practices of the dialysis facility that results in negative findings.

• Any other actual or pending legal or Governmental investigation, incident, claim, action, suit, or proceeding against the dialysis facility, which would impact the dialysis facility’s ability to carry out its duties and obligations under this contract.

• Exclusion from the CMS Medicare Program of any individuals employed by, or contracted with, the dialysis facility for the provision of ESRD services.

• Revocation of required federal or state licenses of any individuals employed by, or contracted with, the dialysis facility for the provision of ESRD services; and

• The lapse, for any reason, of the dialysis facility’s medical malpractice insurance coverage.

2. Quality Assurance Plan (QAP)

The Contractor shall establish and maintain a Quality Assurance Plan (QAP). The Contractor’s QAP shall demonstrate how the Contractor’s performance shall adhere to the QASP (see Attachment X “Quality Assurance Surveillance Plan (QASP)).

The Contractor shall meet performance targets established by the QASP. To provide for changing quality assurance and quality performance conditions, either VA or the Contractor may request changes to the components of QASP measurement and reporting. VA will utilize the QASP to monitor the quality of the Contractor’s performance.

The QASP shall be finalized upon award and a copy provided to the Contractor after award. The QASP is a living document and may be updated by VA as necessary and executed upon bilateral agreement with the Contractor. The Contractor shall address all QASP performance metrics and whether the performance threshold missed, met and/or exceeded for each standard in the QASP Summary Report. The QASP Summary Report shall be submitted in accordance with Section 10.0, “Schedule of Deliverables.”

If problems have not been completely resolved, the Contractor shall provide a corrective action plan (CAP) with an explanation, including its plan and timeframe for resolving the issue. The Contractor shall participate in ad hoc project related meetings with VA.

Deliverable: (See Section 10.0, “Schedule of Deliverables” for details.)

A. Facilities Status B. Quality Assurance Plan (QAP) C. QASP Summary Report D. Corrective Action Plan (CAP)

2.5 Transition

2.5.1 Transition Out

The Contractor shall perform the Transition Out and residual service tasks below for this contract.

Transition Out activities require collaboration with a team comprised of VA and/or successor Contractor personnel. The term Transition Out is related to activities taking place at the expiration of the contract, in which the Contractor is transferring duties and responsibilities to a VA appointed designee, whether a government entity, another Contractor or both.

In accordance with FAR clause 52.237-3 Continuity of Services, the Contractor shall furnish phase-in, phase-out services for up to 90 days after this contract expires. , but the Contractor continues to process claims, appeals, grievances, and provide customer service for healthcare that was delivered in the first 12 months of the last option period and in accordance with existing contract requirements.

The Contractor shall ensure minimal disruption of services to Veterans receiving care and providers delivering care.

Transition Out activities shall include the following:

1. Delivery of a Transition Plan inclusive of a timeline of major events, key positions responsible for each of the functional areas involved in the Transition Out and processing of residual service inventories (e.g., claims, appeals, grievances, data transfers), and staffing and other resources (e.g., transition project manager, transitions stakeholders) within 180 days after award in accordance with Section 10.0, “Schedule of Deliverables.”

2. Processing of all open healthcare claims inventories. The outgoing Contractor shall submit weekly status reports of claim inventories and phase-out activities to VA beginning the 20th calendar day after notification from the CO).

3. Providing a current inventory of all government-owned assets used by the Contractor over the life of the contract along with full support in the reconciliation of the inventory as needed.

4. Providing “shadowing” and other knowledge transfer meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor.

5. Providing current and accurate program management documents.

6. Removal and purging of all non-public or other protected Government Furnished Information (GFI) from any Contractor owned system, and certification execution.

7. Update of the Transition Out Plan seven (7) days after request from the Contracting Officer to accommodate updates and the successor/incoming Contractor’s Transition-In Plan.

8. Development of a customer service phone line transition message stating the line is no longer in service as of end date of contract and to contact X number for assistance. This shall be maintained 90-days post PoP end date.

The list above is not exhaustive. The CO may discuss additional items or considerations related to phasing out services prior to the expiration of the contract. The Contractor shall receive a notice in writing signaling the commencement of phase-in, phase-out activities in accordance with FAR 52.237-3 Continuity of Services – (Jan. 1991). The Transition Out Plan and Update shall be delivered to VA in accordance with Section 10.0, “Schedule of Deliverables.” The Transition Out Plan and Update submitted by the

Contractor shall be incorporated into the contract upon VA approval. The Contractor shall have 180 days from award to develop a Transition Out Plan.

Deliverables: (See Section 10.0, SCHEDULE OF DELIVERABLES, for details.)

A. Transition Out Plan and Update B. Weekly status report of claims inventories and phase-out activities

2.6 Contractor Maintained Records

Upon written request from VA or the VA Office of Inspector General (OIG), the Contractor shall provide any and all records, information, and data in their possession, custody, or control in the requested format, including, but not limited to, claims data, raw electronic data interchange (EDI) data and metadata, claims images, medical records, facility agreements, credentialing documentation, potential quality issues submitted by VA facilities and all related reviews, data, and actions taken in response to potential quality issue concerns, education materials and related correspondence, applications, communications, and bank/payment records. The Contractor shall also ensure timely and reasonable access to their personnel for the purpose of interview and discussion by VA or VA OIG officials conducting an audit, inspection, or investigation. The Contractor shall include VA’s and the VA OIG’s right to access facility/subcontractor records, information, and data as described in this paragraph in any and all provider agreements entered into pursuant to this contract.

Deliverables: (See Section 10.0, SCHEDULE OF DELIVERABLES, for details.)

A. Contractor maintained records, information and data

3.0 NETWORK REQUIREMENTS

3.1 Accreditation and Credentialing

Healthcare delivery cannot commence until the dialysis facility meets accreditation standards set forth herein. The Contractor shall be accredited by CMS and comply with CMS standards for relevant services and applicable Federal and State laws. The Contractor shall maintain documentation of all accreditations, certification, credentialing, delegation of credentialing, and licensing for its accredited components or programs and providers performing services under this contract. The Contractor shall provide a copy of its accreditation documentation in accordance with Attachment X, Attestation Statement, in accordance with Section 10.0, “Schedule of Deliverables,” or as requested by VA. VA reserves the right to perform random reviews of the accreditation, certification, credentialing, federal exclusionary list matching, delegation of certification agreements, competency measures, and licensing files for the accredited programs and providers in the dialysis facility. The Contractor shall provide access to the aforementioned content within 5 business days following notification of such review.

Any issues identified during VA review, will be sent to the Contractor for a correction. The Contractor shall provide an action plan for resolution to the CO and COR.

3.1.1 Accreditation Requirements

Dialysis services are required in the United States, the District of Columbia, Puerto Rico, Guam, the U.S.

Virgin Islands, American Samoa, and the Commonwealth of the Northern Mariana Islands. The Contractor shall provide community-based dialysis services within its network of CMS Medicare Program certified dialysis facilities. The Contractor shall only include facilities that meet the contractual requirements and are CMS End Stage Renal Disease (ESRD) certified on the Facility Status, Attachment X.

3.1.2 Credentialing Requirements

As stated in, B.2, Schedule of Services, Personnel assigned by the Contractor to perform the services covered by this contract shall be licensed in the State, Territory, or Commonwealth of the United States or the District of Columbia where the services are provided, as applicable. All licenses held by the personnel working on this contract shall be full and unrestricted licenses.

Deliverable: (See Section 10.0, “Schedule of Deliverables” for details.)

A. Attestation of CMS Accreditation

4.0 CUSTOMER SERVICE

The Contractor must establish and maintain customer service capabilities in support of the NDSC. In the event the Veteran chooses not to use the VA Call Center, these capabilities, detailed in Sections 4.1 and 4.2 must include:

1. Managing Veteran disputes, complaints, grievances, and appeals based on established procedures.

2. Establish a Veteran-facing Escalation pathway to receive and resolve Veteran disputes, complaints, and grievances.

3. Providing monthly reporting to VA and maintaining communication between VA and the Contractor on performance in all areas of customer service.

4. Managing and reporting timeliness of all correspondence, including Congressional Direct and VA inquiries as well as all received disputes, complaints, grievances, and appeals.

4.1 Veteran Complaints and Grievances

All Veteran complaints and grievances will be directed to the VA Community Care Call Center (C4). In the event a Veteran does not want to use C4, the Contractor shall develop a process to intake all disputes, complaints, grievances, and claims payment issues should they be received directly from Veterans or their personal representative designee. The process shall include formal intake, reporting, all disputes, complaints, grievances and appeals to VA and resolving all disputes, complaints, grievances and appeals, when possible, within two (2) business days of receipt.

In the event that the Veteran has a claims payment issue, the Contractor shall provide the Veteran with a contact number for the Financial Services Center (FSC) in addition to reporting the issue back to the VA as part of the complaints and grievances process.

If the Veteran or their personal representative designee contacts the Contractor rather than the Community Care Call Center(C4), ..." The Contractor shall forward all Veteran disputes, complaints, grievances, and appeals received to VA within two (2) business days of receipt. The Contractor shall provide VA and the Veteran or their designee all relevant background information regarding the dispute, complaint, grievance or appeal within three (3) business days of the notification to VA; to include actions taken to resolve the dispute, complaint, grievance or appeal. Actions shall include a full written response describing the issue, actions taken to resolve the issue, and the final resolution to the issue. The written response shall include copies of all documentation on file with the Contractor.

VA and the Veteran or their designee reserves the right to request supplemental information relating to Veteran disputes, complaints, grievances, appeals, and customer service at any time. When VA requests information from the Contractor, the Contractor shall confirm receipt of the request within one (1) business day. Notification of receipt can be accomplished electronically via an agreed-upon mechanism with VA. The Contractor shall provide the VA and the Veteran or their designee full written response to the request for supplemental information within five (5) business days of the request. A full response shall consist of what has been requested as supplemental information. The written response shall include copies of all documentation on file with the Contractor with the exception of any Contractor internal or proprietary documentation.

The Contractor shall submit a Veteran Complaints and Grievances Report, detailing all Veteran disputes, complaints, grievances, and appeals, monthly, in accordance with Section 10.0, Schedule of Deliverables.

Deliverable: (See Section 10.0, “Schedule of Deliverables” for details.)

A. Veteran Complaints and Grievances

4.2 Congressional and VA Inquiries

The Contractor must establish a point of contact (POC) for Congressional Direct and VA inquiries. All Congressional Direct and VA inquiries shall be utilized to measure Contractor’s performance. These measurements shall also include those inquiries received by VA and forwarded to the Contractor. The Contractor shall report to VA all VA Inquiries with or without a Referral ID, whether received in writing or verbally, and the Contractor shall report to VA all Congressional Directs with or without a Referral ID, received in writing. The Contractor shall forward to VA all inquiries received, directly by the Contractor from a Congressional office and a copy of the full written response back to the Congressional office and VA, within five (5) business days of an inquiry. VA reserves the right to request information relating to the inquiry at any time. When VA requests supplemental information from the Contractor, the Contractor shall confirm receipt of the request within one (1) business day.

Notification of receipt can be accomplished electronically via an agreed-upon mechanism with VA. The Contractor shall provide the full written response within five (5) business days of VA’s request. A full response shall consist of a description of the issue, actions taken to resolve the issue, and the final resolution to the issue. The written response shall include copies of any and all responses to the Congressional representative, Veteran, or other involved party.

The Contractor shall submit a Congressional and VA Inquiries Report monthly, in accordance with Section 10.0, Schedule of Deliverables.

A. Congressional and VA Inquiries

5.0 REFERRALS AND SCHEDULING

5.1 Referral and Authorization Process

1. Patient Eligibility: VA has sole authority and responsibility to establish and confirm Veteran eligibility prior to issuing an authorization based off a Veteran being referred to community care.

2. Authorization Process: VAMC staff will issue authorizations to the Contractor via VA’s referral and authorization system designated by the CO or COR.

3. Authorization Form: All authorizations will be created by the initiating VAMC’s staff through VA’s referral and authorization system. Contractors shall not perform any services under this contract without prior authorization, without exception.

Authorization is defined as Contractor acceptance, as well as initial scheduling of appointment between VA and contracted facility and subsequent authorization populated into VA’s referral and authorization system. Contractors may retrieve authorizations via VA’s referral and authorization system.

5.2 Scheduling

5.2.1 Scheduling Process

VAMC staff will issue an authorization via VA’s referral and authorization system designated by the CO or COR. The Contractor shall confirm receipt of the authorization and approve or deny the authorization within two (2) business days. Services shall be initiated within 30 days of receipt of the authorization.

If the Veteran cannot receive their first dialysis service within 30 days of receipt of the authorization, the Contractor shall deny the authorization. Elements of an authorization for verification include, but are not limited to:

1. Authorization Period

2. Correct modality (Services Authorized)

3. Facility Name and Address (Cross check with NPI Number)

4. Onset Date

5. Unique Authorization Number

For authorization issues or questions the Contractor shall contact the authorizing VAMC staff or C4 Call Center at (877)-881-7618.

When the Contractor has confirmed the Veteran is accepted to the facility, the Contractor’s authorized personnel and the VAMC staff will collaborate and coordinate the Veteran’s care.

There are three types of authorizations applicable to this contract: new, renewal, and transient.

1. New Authorization: A new authorization is created to begin a Veteran’s treatment. The period of validity will be stated in the authorization. The Contractor shall contact the authorizing VAMC within 72 hours if the authorization is not populated into the VA referral and authorization system within 72 hours following the Veteran’s first appointment being scheduled.

Below are the four modes of care:

Center-Based Hemodialysis (HD): Includes in-center dialysis.

Home-Based HD: Care shall be provided using Method I as described by the CMS Medicare Benefit Policy Manual, Chapter 11 – End Stage Renal Disease. Method II is unallowable.

Peritoneal Dialysis: This includes the types of Peritoneal Dialysis (CAPD, CCPD, etc.) described in CMS Medicare Benefit Policy Manual, Chapter 11 – End Stage Renal Disease.

Training for Home-Based Modalities: Authorization and payment for home dialysis training will be in accordance with the CMS Medicare and Medicaid Programs; Medicare Benefit Policy Manual, Chapter 11 – End Stage Renal Disease, paragraph 30.2. A training authorization is required for all new home-based patients. Additional training must be preauthorized by the VAMC staff.

Changes in modality of care are not included under the existing authorization and must be authorized by the authorizing VAMC prior to a change in modality.

2. Renewal Authorization: A renewal authorization is required to continue treatments once the current authorization has expired. This authorization is initiated by designated VAMC staff and will be provided to the Contractor prior to the authorization expiring. If the Contractor does not receive a renewal authorization 30 business days prior to the expiration of the previous authorization, the Contractor shall contact the authorizing VAMC to request a renewal authorization. If the Contractor still has not received a renewal authorization within 15 business days of the expiration of the previous authorization, the Contractor shall notify the authorizing VAMC that there is a potential for an interruption of services unless a new authorization is received.

3. Transient Authorization: Transient dialysis treatments are defined as treatments delivered for less than a 60-calendar day period at a contracted facility other than the Veteran’s originally referred facility. A transient authorization is effective for 60-calendar days or less to cover a patient’s travel beyond the normal support of the regular community dialysis unit.

There must be close coordination between the regular provider, referring VAMC, and the temporary provider, to ensure uninterrupted dialysis treatments to the Veteran while in a travel status. The transient authorization will be placed based on patient needs and proximity to the Veteran’s transient location; it may or may not be with the same Contractor providing services at the Veteran’s regular location. Travel extending beyond 60 calendar days will require a new authorization from the home VAMC staff.

The Contractor shall submit a Percent of Veteran Referrals Accepted Report per the QASP, in accordance with the Schedule of Deliverables.

A. Percent of Veteran Referrals Accepted

5.2.2 Expected and Unexpected Referral Disruption/Cancellation:

If the Contractor considers the expected discharge of a Veteran for any reason and at any time after the receipt of acceptance or after initiation of treatment of the Veteran, the Contractor shall provide a 10 business days termination notice in writing to the designated VAMC personnel and Contracting Officer’s Representative (COR). The designated VAMC personnel will review all Contractor notices and the VAMC staff will issue additional authorizations for the Veteran, as needed. The designated VAMC personnel will aid and assist in the transfer of the Veteran to a new facility, as appropriate.

Below are the two types of unexpected discharges and the processes required to ensure continued Veteran care.

1. VA Initiated – There are times when the VAMC encounters unexpected situations

(e.g., contaminated water, power loss, natural disasters, etc.) when they are temporarily unable to provide dialysis services to Veteran patients within their in-house dialysis facilities. In such situations, the VAMC may send an unusually large number of patients to contracted facilities, and possibly only for a short, undetermined, period. Once the urgent situation has been resolved, the VAMC will coordinate with the contracted facility to return the treatment of these patients back to the VAMC.

2. Contractor Initiated – There are also unexpected situations when the authorized, contracted facility is unable to provide the Veteran patients continued dialysis treatments at that facility (e.g., contaminated water, power loss, natural disasters, etc.). In such situations, the Contractor may temporarily transfer VA patients to a nearby in-network, community facility, with the VAMC approval, until the originally authorized facility can resume treatments. However, the Contractor must contact the authorizing VAMC and COR within 1 business day, to obtain a temporary authorization for the new facility. The authorizing VAMC will provide a temporary authorization to the Contractor.

The Contractor shall comply with CMS regulations 42 C.F.R. Parts 405, 410, 413, 414, 488 and 494 and implement all future revisions to the CMS Conditions for Coverage measures at no cost to the Government. The Contractor’s dialysis facilities are required to be CMS Medicare Program certified and comply with all applicable certification standards and levels of care delivered. Upon written request by the Contracting Officer’s Representative (COR) or Contracting Officer, the Contractor shall provide, within 5 business days, a copy of all applicable permits, licenses, and other facility documents.

In compliance with CMS regulations, the Contractor shall provide and ensure maintenance of all dialysis equipment. As required by 42 C.F.R. § 494.40, water purity testing must meet the standards of the most current guidelines cited by the Association for the Advancement of Medical Instrumentation.

When a Contractor receives information regarding a facility status change whether it be a change in CMS certification or any of the specified administrative changes below, the Contractor will provide changes to the COR team and CO as defined in Section 10.0, Schedule of Deliverables and outlined in Attachment X, QASP.

6.0 MEDICAL DOCUMENTATION

The Contractor shall be responsible for ensuring each facility authorized to provide dialysis care under this agreement return medical documentation to the VA. The Contractor shall ensure documentation is sent to the authorizing VAMC utilizing an interoperable (e.g. HL7, FHIR) pathway and completed, verified, and authenticated by the submitting provider or practitioner. Authentication consists of a written signature, written initials, and/or electronic signatures. Content of the medical record documentation shall be in accordance with all applicable CMS Medicare Program guidelines relating to the provision of dialysis services at the time the service is rendered.

6.1 Medical Documentation Submission Plan

The Contractor shall create and maintain a Medical Documentation Submission Plan to be reviewed and approved by the VA during implementation and annually thereafter. Within the Medical Documentation Submission Plan, the Contractor shall describe their proposed education, processes, and procedures to ensure compliance with interoperable medical documentation return, including the roles, responsibilities, and escalation pathways if one of their facilities authorized to provide care under the NDSC fails to return medical documentation back to the VA timely.

Deliverable: (See Section 10.0, SCHEDULE OF DELIVERABLES, for details.)

A. Medical Documentation Submission Plan

6.2 Medical Documentation Data Elements for Inclusion

The Contractor shall return all medical documentation associated with the Veteran’s dialysis care, including, at a minimum:

1. Interdisciplinary Care Plan: The Contractor shall create an interdisciplinary care plan for each Veteran within 30 days of acceptance to the facility, at 90 days and 120 days of treatment, and annually thereafter.

2. Monthly Comprehensive Dialysis Note: The Contractor shall provide a Monthly Comprehensive Dialysis Note to the authorizing VAMC, which shall include, at a minimum:

a. Veteran Information: Veteran Unique Identifier, full name, date of birth and referral number

b. Facility Demographics: Facility name, phone number and provider/practitioner authentication (including full name and authenticating signature

c. Treatment Information: Current dialysis prescription, requirement for assessment of blood pressure and volume, anemia bone and mineral disease, nutrition status, dialysis access, home dialysis and transplant evaluation and status., vaccination and cardiovascular disease prevention.

d. Progress notes as available.

6.3 Medical Documentation Submission Timeframes

The Contractor shall educate its facilities that medical documentation is to be delivered under the following timeframes:

1. The Interdisciplinary Care Plan shall be returned to the authorizing VAMC within 30 days of creation of the plan.

2. The Monthly Comprehensive Dialysis Note shall be returned to the authorizing VAMC within 10 days following the end of the calendar month for which the note was created to summarize.

6.4 Medical Documentation Return Compliance

The Contractor shall be responsible for ensuring that facilities authorized to provide care are compliant with medical documentation return, and thus shall maintain a minimum of 90% medical documentation return compliance within their network. The Contractor shall use Attachment X, Medical Documentation Return Compliance Report Template, to provide regular updates to VA on medical documentation return compliance for all facilities authorized to provide care under the NDSC, according to Section 10.0, Schedule of Deliverables.

Should the Contractor fail to meet the medical documentation return compliance metric for more than 1 consecutive year, the Contractor will outline and execute a CAP to improve medical documentation return compliance. The Contractor will submit the CAP within 30 days of the 1st day following the consecutive year of non-compliance for VA review and approval and provide quarterly updates to the VA Program Manager on improvements.

Deliverable: (See Section 10.0, SCHEDULE OF DELIVERABLES, for details.)

A. Medical Documentation Return Compliance Report

7.0 CLAIMS PROCESSING AND ADJUDICATION FOR NDSC SERVICES RENDERED

The Contractor shall receive, process, and adjudicate Claims for all services provided pursuant to this contract. The Contractor will be reimbursed in accordance with the Schedule of Services solely for claims paid in accordance with Section.

7.1 Claims Billing

Claims for services rendered in accordance with the terms of the contract shall be submitted by the Contractor to VA on a monthly basis in arrears. The Authorization Number must be on all claims.

1. Standard Billing: The Contractor shall submit invoices in the form of health care claims to VA for payment of services. The health care claims shall be submitted via Health Insurance Portability and Accountability Act (HIPAA) compliant Electronic Data Interchange (EDI) transactions sent through VA’s designated clearinghouse within 180 calendar days from the date of service.

Claims filed after 180 calendar days shall not be paid. Medical claims shall contain the Payer ID for the VA Purchased Care Program, which is VA FSC.

2. Vendor Onboarding: VA requires all vendors to submit VA Form 10091, VA- FSC Vendor File Request Form, via the FSC Customer Engagement Portal

(CEP) at https://www.cep.fsc.va.gov/, prior to submitting claims for services or goods provided to VA. Contractor should confirm with VA FSC Customer Service Helpdesk that vendorization has been completed prior to submitting claims. For vendorization questions contact the C4 Call Center at (877)-881- 7618 or the VA-FSC Vendor Station Care Center at 1-866-372-1141.

3. Timely Filing: The Contractor shall submit complete claims for services no later than 180 calendar days from the date of service. Claims filed after this time period may not be paid.

4. Billing Requirements: The Contractor shall bill the VA utilizing the current

CMS Medicare Program guidelines for separate line-item billing as contained in the Medicare Claims Processing Manual. The Contractor will be reimbursed according to current CMS Medicare Program billing guidelines at the applicable percentages found in X.X, Schedule of Services.

5. Rejected / Denied Claims / Resubmissions:

a. Rejected Claim: A claim that cannot be accepted by the clearinghouse due to improper invoice formatting. A notification will be sent to the Contractor with the reason for the rejection.

b. Denied Claim: A claim that cannot be approved for payment because it contains erroneous claim/authorization information. An Explanation of Payment (EOP) notification will be sent from Financial Services Center FSC to the Contractor identifying the reason for the denial. A vendorization error will also result in a denied claim. Denied claims will first be addressed by the VA FSC Customer Service.

6. Required Revenue Codes: In addition to appropriate Current Procedural

Terminology (CPT) codes, the Contractor shall utilize the appropriate revenue code and, when applicable, condition codes per current CMS Medicare Program guidelines.

7.1.1. Billing for Transient Dialysis Services

Transient treatments, as defined in Section 5, will be billed at the contract rate applicable to the transient treatment facility location. Prior to the expiration of the Veteran’s 60 calendar day period, unless extended, the Veteran shall be transferred back to their home community dialysis facility, as the billing authorization and transient period have expired. Transient dialysis services require a separate VA generated authorization.

7.1.2 Billing for Incomplete Treatments

If a dialysis treatment is started, (i.e., a Veteran is connected to the machine and a dialyzer and blood lines are used), but the treatment is not completed, the Contractor shall be paid based on the full per treatment price. This should be a rare occurrence and fully documented at VA request. This event must also be fully documented by the Contractor in the Veteran’s medical record.

7.1.3 Billing for No Shows

If a facility sets up in preparation for a dialysis treatment but the treatment is never started, (i.e., the Veteran never arrives), there shall be no service claim or other fee claimed by the Contractor for those intended services and there will be no payment or penalty fee paid by the Government. Additionally, the Contractor shall not bill the Veteran and/or the Veteran’s other insurance (if applicable) for these services.

7.1.4 Billing the Veteran

Under no circumstances shall the Contractor ever seek any monetary recompense from a Veteran for services provided under this contract.

7.2 Claims Processing

The Contractor may check the status of their claim submission, Electronic Funds Transfer (EFT) or payment status and EOP status through a secure web portal. The Contractor shall provide requisite security information when they sign up for access to the VA Electronic Claims Management System (eCAMS) electronic Provider Portal (ePP), which allows the Contractor to view authorizations and EOP.

Contractors should contact the Landing Page - Office of Community Care eCAMS Provider Portal (https://www.occepp.fsc.va.gov) for registration information.

7.3 Claims Appeal Process

If the Contractor receives a payment that it deems to be not in accordance with the terms of the contract, or no payment, the Contractor shall first attempt to resolve the matter by:

1. Contacting the Financial Services Center (FSC) Customer Support Help Desk and, if not resolved, then by;

2. Contacting the Contracting Officer’s Representative (COR). The COR will investigate the circumstances surrounding the payment issue and if possible, provide a remedy for the payment issue. The COR will document the findings and communicate with the Contracting Officer. If the Contracting Officer agrees, the CO and/or COR will send a determination to the Contractor. If the Contractor disagrees with the determination, the Contractor may request a final determination. If the Contractor disagrees with the final determination, the Contractor may appeal in accordance with the FAR 52.212-4 (d) Disputes.

7.4 Claims Auditing

The Contractor shall establish and operate a dedicated Program Integrity function to ensure that only medically necessary dialysis services are provided to eligible Veterans by authorized providers and reimbursed to eligible providers under existing law, regulation, and VA instructions. The Contractor shall develop and implement a strategy that is committed to health care fraud prevention and detection in their facilities. The strategy shall include processes focused on healthcare care fraud awareness, education, processes to identify health care fraud, correction, prevention, referral of health care fraud cases, prosecutorial support, and deterrence of health care fraud.

The Contractor shall perform an annual fraud and abuse risk assessment to determine areas of vulnerability, high risk areas, specific fraud and abuse schemes, significance of risks, and mitigation measures with the scope of the contract. The Contractor shall provide in its annual assessment an estimate of annual improper payments in the susceptible programs and activities identified. The Contractor shall identify and implement cost-containment strategies and anti-fraud strategies to combat and prevent unnecessary spending that supports medically necessary and appropriate care in the dialysis facilities.

7.4.1 Comprehensive Program Integrity Plan

The Contractor shall detail its approach to implementing and maintaining a program for detection, prevention, correction, deterrence, of fraud, waste, and abuse (FWA) within dialysis services delivery in a Comprehensive Program Integrity Plan (CPIP) and provide to the VA in accordance with Section 10.0, Schedule of Deliverables.

The CPIP shall include the Contractor’s approach to identification, review, follow-up, recovery, and other actions it may take when FWA is discovered and validated. The CPIP shall include details for both automated and manual FWA identification and monitoring.

A. Comprehensive Program Integrity Plan

7.4.2 Cost Avoidance and Recoupments Report

The Contractor shall report the cost avoidance and recoveries/recoupments achieved, at the patient level, as a result of improper payment reviews conducted by the Contractor. The Contractor shall create a Quarterly Cost Avoidance and Recovery/Recoupments Report to include: i) A summary of errors by reason category to include number of cases and dollar value; ii) Trending of overpayments from inception and suggested corrective action and iii) A detailed narrative with graphical and statistical information and provide to the VA in accordance with Section 10.0, Schedule of Deliverables.

1. Overpayments Established – This component of the report shall: a) present the number of cases on which the Contractor has performed its initial assessment, b) indicate if the Contractor has requested and received additional documentation from VA and the timeframes associated with those documentation requests, and c) indicate the date the case was established and the date the Contractor recommends moving on to the collection phase.

2. Overpayments Collected – Collected amounts shall only be included in this report if the amount has been successfully collected. Collected amounts shall be shown in a way that allows relation of the collected amount to a specific claim or invoice.

3. Underpayments Identified – Indicate the number of cases that have been identified as having been underpaid and, if available, the estimated value of the underpayments.

4. Overpayments Adjusted – During the course of the audit, there may be situations where the overpayment amount needs to be adjusted. This report shall present any of those situations where adjustments have been required and the associated date of those adjustments.

5. The number of reviews completed during each month of the quarter.

6. Variance analysis for any reporting category with a greater than 15% increase or decrease from the current quarterly report to the previous report, to include any unusual activity even if it does not exceed the percentage.

Each Quarterly Cost Avoidance and Recovery/Recoupments Report for the final quarter of the applicable contract year shall include an annual analysis of the full Period of Performance (PoP). The report for the final quarter shall include summarized information in presentation format (i.e., Microsoft Word, Excel, or PowerPoint) in laymen’s language appropriate for leadership review. The report for the final quarter shall include lessons learned and shall reflect unusual activity that persists throughout all four quarters. The report shall include suggestions for improvements, implemented corrective action, and roll-up summaries from the prior quarterly reports.

A. Quarterly Cost Avoidance and Recovery/Recoupment Report

8.0 CLINICAL QUALITY AND MONITORING

8.1. Clinical Quality Monitoring Plan (CQMP)

The Contractor must develop and submit a written Clinical Quality Monitoring Plan (CQMP) to VA. The CQMP must include an articulation of the quality monitoring activities for patient safety, clinical quality assurance, and clinical quality improvement. The Contractor’s CQMP must include a detailed description of the purpose, methods, proposed goals, and objectives designed to ensure the highest quality of clinical care under this contract. The Contractor must provide a copy of its CQMP to VA in accordance with the Schedule of Deliverables.

A. Clinical Quality Monitoring Plan

8.2 Clinical Quality and Patient Safety Issues Identification

Identification of quality issues applies to medical and ancillary care services. The Contractor shall identify, track, trend, and report interventions to resolve any Potential Safety Issues (PSIs), Identified Safety Issues (ISIs), Potential Quality Issues (PQI) and/or Identified Quality Issues (IQI) using the most current National Quality Forum (Serious Reportable Events, CMS Hospital Acquired Conditions, and Agency for Healthcare Research and Quality Patient Safety Indicators).

The Contractor shall leverage processes identified in VA guidance (e.g., VHA Directive 1050.01 and Patient Safety Events in Community Care: Reporting, Investigation, and Improvement Guidebook) to manage adverse events and close calls involving VA beneficiaries.

The Contractor shall apply appropriate medical judgment, evidence-based medicine, and best medical practices when identifying, evaluating, and reporting on all PQI/IQI. The Contractor shall process to completion ninety-five (95) percent of all PQIs, IQIs, PSIs, and ISIs within ninety (90) days from date of identification. The Contractor may extend the remaining five (5) percent of PQI/ IQI to be completed within one hundred eighty (180) days of identification to address issues that require a longer timeframe. PQI, IQI, PSI, and ISI cases requiring Corrective Action Plans (CAPs) may be completed outside of the 90/180-day limit, if required. The Contractor shall prepare a Quarterly Clinical Quality and Patient Safety Issues Report, which shall be submitted in accordance with the Schedule of Deliverables.

The Contractor shall implement appropriate IQI and ISI interventions using evidence-based medicine and best medical practices to address and resolve each identified quality and patient safety issue.

When the Contractor confirms an PQI, IQI, PSI, and/or ISI or determines there is deviation in the standard of practice or care, the determination shall include assignment of an appropriate severity score and describe the actions taken to resolve the quality problem or patient safety issue.

VA and the Veteran or their designee reserves the right to request supplemental information relating to Veteran safety issues at any time. When VA requests information from the Contractor, the Contractor shall confirm receipt of the request within one (1) business day. Notification of receipt can be accomplished electronically via an agreed-upon mechanism with VA. The Contractor shall provide the VA and the Veteran or their designee full written response to the request for supplemental information within five (5) business days of the request. A full response shall consist of what has been requested as supplemental information. The written response shall include copies of any and all documentation on file with the Contractor with the exception of any Contractor internal or proprietary documentation.

A. Quarterly Clinical Quality and Patient Safety Issues Report

Reference publicly available VHA Directive 1050.1, VHA Quality and Patient Safety…