Attachment A - PWS - ProgramPayment Support for VAs Cryopreservation Program.docx

PERFORMANCE WORK STATEMENT (PWS)

Title: Program/Payment Support for VA’s Cryopreservation Program

1. GENERAL INFORMATION (PWS 1.0)

1.1 Introduction:

The Department of Veterans Affairs (VA) Veterans Health Administration (VHA) Office of Integrated Veteran Care (IVC) is responsible for administration of the benefit of long-term embryo and gamete Cryopreservation storage for eligible Veterans. Services are managed under VHA Directive 1334 – IN-Vitro Fertilization Counseling and Services Available to Certain Eligible Veterans and their Spouses along with VHA Directive 1332(2) Fertility Evaluation and Treatment.

1.2 Background:

In September 2016, Congress passed legislation to provide IVF services for Veterans with a service connected (SC) condition resulting in the inability of the Veteran to procreate without the use of fertility treatment. In March 2019, VA adopted its final rules authorizing in vitro fertilization (IVF) and assisted reproductive technologies (ART) to certain eligible Veterans to include Cryopreservation storage. VA does not have the capacity to provide long-term Cryopreservation storage and has determined storage of cryopreserved gametes and embryos will take place at independent facilities in the community. VA will reimburse the costs of Cryopreservation storage and courier services at independent community laboratories. This PWS seeks to obtain the capability to support up-front and ongoing payment along with associated program management of VA’s long-term embryo and gamete Cryopreservation storage and associated courier services.

1.3 Scope of Services:

The objective of this acquisition is to obtain a qualified contractor that can provide Program Management and Payment Processing in support of VA’s Cryopreservation storage needs. Primary functions include, but are not limited to, receiving VA authorizations, outreach to storage facilities, facilitate reimbursement of storage services with storage facilities, processing requests for storage and courier service payment, coordinating and submission of reports to the VHA, and invoicing the government for reimbursement. The Contractor shall serve as the intermediary for payment of long-term Cryopreservation storage and courier services as designated by VA and provide associated program management services. Program management shall include coordinating for and tracking of payments, storage providers, Veterans and beneficiaries, reporting, and other data management. The Contractor shall manage and maintain a payment processing system. Payments shall be promptly reported to VA upon either monthly reporting or ad-hoc upon request by VA. As the VA designates new service providers, new Veterans or beneficiaries, or other required reports, those inclusions shall be absorbed into all program management and established processes. The Contractor shall only bill for those payments made and received by authorized providers of services, plus administrative costs. The Contractor shall be reimbursed for those payments, as well as administrative costs, in the applicable CLIN as noted in the Schedule of Services.

2.0 PROJECT MANAGEMENT

2.1 Post Award Meeting

Within fourteen (14) business days after contract award, the Contractor shall lead a Post Award Meeting with VA stakeholders and Contractor representatives on a date and location to be mutually agreed upon by the Contractor and VA Contracting Officer (CO). The purpose of the meeting is to do the following:

· Initiate the communication process between VA and Contractor including:

· Introduction of Contractor and VA personnel performing work related to this project

· Identification of Contractor and VA stakeholder’s roles and responsibilities

· A brief overview of project administration and reporting

· Establish dates, locations, expectation and discuss agenda Kickoff Meeting Deliverable: (See Section 6.0, “Schedule of Deliverables” for details.)

· Post Award Meeting

· Post Award Meeting Minutes

2.2 Kickoff Meeting

The Contractor shall participate in a Kickoff Meeting within twenty (20) business days after contract award on a date and location agreed upon by the Contractor and VA. The Contractor shall create and present a Kickoff Meeting Presentation for all deliverables and services under the contract. The Contractor shall describe and explain in detail the following:

· Approach to all deliverables and services under this contract in a Project Management Plan as defined in Section 2.3

· Explanation and description of implementation strategy

· Name and points of contact for key personnel The Contractor shall coordinate the agenda with the Contracting Officer's Representative (COR) ahead of time to ensure adequate SME participation to present, explain, and collect feedback on all the deliverables. The Contractor shall take meeting minutes. The meeting minutes shall include documentation of any major issues, agreements, or disagreements and agreed upon actions and timelines to resolve any major issues or disagreements discussed during the Kickoff Meeting.

Deliverables: (See Section 6.0, “Schedule of Deliverables” for details.

· Kickoff Meeting

· Kickoff Meeting Presentation

· Kickoff Meeting Minutes

2.3 Project Management

The Contractor shall create a Project Management Plan to be approved by VA that is reflective of the scope of work required in the PWS. At a minimum, the Project Management Plan must include a Work Breakdown Structure (WBS), an internal staffing plan and subsequent changes in key personnel, and an outline of the procedures that the contractor will use to maintain payments, quality, timeliness, responsiveness, customer satisfaction, bilateral communication and coordination with Cryopreservation storage facilities, process to communicate and respond to Veteran inquiries and redirect to the appropriate Veterans Affairs Medical Center (VAMC) and Community Care Call Center (C4), and any other requirements set forth in this solicitation. The Project Management Plan shall be submitted five (5) business days prior to the Kickoff meeting and updated as needed thereafter.

Deliverable: (See Section 6.0, “Schedule of Deliverables” for details.)

· Project Management Plan

2.4 Orientation Document

Within twenty (20) business days of award the Contractor shall develop, for VA approval, an orientation document to be provided to existing facilities and for each new storage facility. The orientation document shall include the following.

· Statement that VA is the primary payer, and no private insurance can be billed

· Instructions for submission of invoice to the Contractor for payment

· A Contractor POC and back-up POC that includes name, email address, and telephone number

· Instructions to refer to the authorization for VA POCs should the storage facility need to communicate with the VA

· Instructions on how to notify VA if a catastrophic event occurs that impacts its ability to provide storage services, as described in Attachment X.

· Where to direct the Veteran to VA for any issues related to the authorization and/or services

· When applicable, instructions regarding the authorization of courier services

· Instructions on how to notify the Contractor and VA should a Veteran initiate termination of storage

· Difference between the Contractor role and responsibilities for payment of long-term storage and VA Community Care responsibility using a third-party administrator (TPA) for payment of ART/IVF treatment and short-term storage (less than one-year), as described in Attachment X.

· Statement that the Veteran is not responsible for any co-payments or unpaid debt for authorized care.

Deliverable: (See Section 6.0, “Schedule of Deliverables” for details.)

· Orientation Document

3.0 OPERATIONAL SUPPORT

The Contractor shall provide a monthly update, utilizing the Program Status Report, Attachment X, which includes the status on the receipt of authorizations, reportable events, verification of FDA registration, authorization cancellations, and payment for services.

3.1 Requirements for Long-term Cryopreservation Storage Authorizations 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. Authorizations will be created by the initiating VAMCs and will be issued to the Contractor via secure fax or other system designated by the CO or COR. The initiating VAMC will also upload the authorization in the VA SharePoint site. Within five (5) business days of receipt of an authorization, the Contractor shall validate the authorization has been uploaded in the VA SharePoint site and contact the facility to verify the scope of the authorization to ensure there are no discrepancies and provide the orientation document to the facility. The Contractor shall notify the VA IVF and COR Team within five (5) business days of any discrepancies or missing data after contacting the facility. Monthly, the contractor shall provide a report of all authorizations, current status, and any known discrepancies in the Program Status Report as provided in Attachment X

Deliverable: (See Section 6.0, “Schedule of Deliverables” for details.)

· Program Status Report

3.2 Communication of Reportable Event

The contractor shall report events that may negatively impact Veteran care that take place at the facility. The contractor shall notify the VA IVF and COR team via email within three (3) business days of when the contractor receives notice of a reportable event. The authorizing VAMC may provide a new authorization to transfer specimens if applicable.

Reportable events include but are not limited to:

· Any event that prevents or limits the service such as power outage, natural disaster, etc.

· Destruction of specimen

· Notification of transfer of specimen without VA authorization

· Facility closure

· Facility loss of FDA registration The Contractor shall include a summary of reportable events in the Program Status Report.

Deliverable: (See Section 6.0, “Schedule of Deliverables” for details.)

· Program Status Report

3.3 Verification of FDA Registration

Within three (3) business days of receipt of a new authorization, following instructions provided by VA, the Contractor shall verify the storage facility is FDA Registered and lists their HCT/Ps (Human cells, tissues, and cellular and tissue-based products) in accordance with Title 21 Code of Federal Regulations (CFR) Part 1271. The Contractor shall perform an annual verification of FDA registration based on the one-year anniversary of the facility authorization.

The Contractor shall report within (5) five business days of contractor notification to the VA IVF and COR team via email any facility that is not or no longer registered with the FDA. The Contractor shall document initial and annual verification on the VHA SharePoint and in the monthly Program Status Report.

Deliverable: (See Section 6.0, “Schedule of Deliverables” for details.)

· Program Status Report

3.4 Authorization Cancellations

If the Contractor is made aware that either the Veteran, storage facility, or VA facility cancels or intends to cancel a Cryopreservation storage service for any reason or at any time, the Contractor shall notify the VA IVF Team and COR Team within (3) business days via email. The contractor shall track and report all cancellations on the Monthly Program Status Report.

The Contractor shall terminate payment per the terms provided by the government. The contractor shall track and report payment terminations on the Program Status Report.

Deliverable: (See Section 6.0, “Schedule of Deliverables” for details.)

· Program Status Report

3.5 Payment for Services

The Contractor shall validate the payment and shall pay for Cryopreservation storage and courier services for eligible Veterans and spouses for services provided pursuant to this contract. The Contractor shall have the ability to use various methods of payment for Cryopreservation storage (i.e., portals, credit cards, checks). The contractor will be reimbursed in accordance with the Schedule of Services for invoices paid in accordance with Section B.2 Schedule of Services. The Contractor shall ensure payments made within the scheduled due date. The VHA is not responsible for payment of unauthorized services and the contractor shall never bill the Veteran. The Contractor shall not pay for services without an invoice from the Cryopreservation storage facility.

The Contractor shall perform the following tasks as part of the Cryopreservation payment process.

· Review and match the authorized services on the active VA authorization against the Cryopreservation facility invoice to ensure the authorization matches the invoice and the period of the authorization.

· Communicate invoice and authorization discrepancies to the storage facility in an initial attempt to resolve within five (5) business days of identifying the discrepancy.

· Document payment on the VA SharePoint site and Program Status Report.

· Notify the VA IVF and COR team via email with three (3) business days of any discrepancies it is unable to resolve. The Contractor shall notify the storage facility of the discrepancy and advise payment is on hold until resolution. The Contractor shall document discrepancies on the Program Status Report.

Deliverable: (See Section 6.0, “Schedule of Deliverables” for details.)

· Program Status Report

3.6 Invoice Processing

Prior to submitting an Invoice to the VA, the contractor shall provide a Pre-Invoice to the VA COR team. The Pre-Invoice shall include the receipts and government provided spreadsheet, as annotated in attachment X, with applicable fields entered. Pre-Invoices shall be submitted electronically by the contractor to the VA COR Team monthly in arrears in accordance with the terms of the contract.

The schedule of services sets forth the amount VA pays for the services it purchases through this contract. The Cryopreservation Storage Contract Line-Item Numbers (CLINs) shall include only the price for Cryopreservation storage and courier services. All other costs are to be included in the administrative fee CLIN.

Once the Pre-Invoice is approved by the VA COR Team, the Contractor shall use an approved VA system to submit the invoice to the VA to be reimbursed for the authorized payments that were made.

Deliverable: (See Section 6.0, “Schedule of Deliverables” for details.)

· Pre-Invoice & Invoice Report

3.6.1 Payment Tracking

The Contractor shall implement and maintain a system to proactively ensure all invoices are paid promptly to avoid overdue payments. The Contractor shall track payment due dates per the terms of each agreement and proactively contact the storage facility to inquire about the status of an invoice should an invoice not be received within ten (10) business days of a payment due date. The Contractor shall notify the VA IVF and COR team via email within three (3) business day of a payment due date of any discrepancies or inability to obtain an invoice.

4.0 SPECIAL CONSIDERATIONS

This contract does not include payment for medical evaluation, treatment, tests, procedures, or ancillary services related to gamete retrieval or assisted reproductive technology (ART). The Contractor shall not be responsible for payment of non-VA-approved transportation of cryopreserved eggs, sperm, or embryos.

4.1 Personnel

The Government expects the Contractor to plan for and have readily available staff suitable to meet the Government’s requirements. The Contractor shall provide the appropriate level of labor mix to accomplish the work reflected within the body of this PWS.

4.2 Domain Knowledge

The Contractor shall ensure the personnel assigned to this contract shall have domain knowledge of the Microsoft software such as Excel, SharePoint, and medical billing practices.

4.3 Transition In and Out

The Contractor shall work with the Government to transition payment and activities currently in progress at the time of award from the current contracting team to the awarded contract team, if applicable.

4.4 Onboarding of Contractor Personnel

The Contractor shall begin the onboarding of staff designated as requiring background investigations with five (5) business days after award. Onboarding includes:

• The VA COR Team receives Personnel List from Contractor

• Creation of a Training Management System Profile/account

• Complete required Privacy and Security Training

• Current fingerprint submission and obtaining subsequent adjudication results

• Obtain a VA network email account

• Initiate background investigations

• Request PIV issuance

• Request Remote Access A Contractor Onboarding POC and backup shall be designated by the Contractor that submits/uploads and tracks the onboarding documents and reports on status of all Contractor personnel. The Contractor Onboarding POC shall be responsible for accurate and timely submission of all required VA onboarding paperwork to the COR. The Contractor shall be responsible for tracking the status of all its staff’s onboarding activities. The Contractor Onboarding POC must have a valid VA network account and working access to fulfill this role.

Deliverable: (See Section 6.0, “Schedule of Deliverables” for details.)

· Onboarding Status Report

4.5 Training

All Contractor and Subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to the VA information and its systems:

A. VA Privacy and Information Security Awareness and Rules of Behavior course (TMS #10176) and complete this required privacy and security training annually.

B. Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Rules of Behavior, VA Handbook 6500, Appendix D relating to access to VA information and information systems. Provide a PDF copy of the Signed and dated ROB to the COR C. Privacy HIPAA Focused Training (TMS 10203)

4.6 Position Sensitivity

Table 1: Security and Privacy Position Sensitivity

Position Sensitivity

Background Investigation (in accordance with Appendix A of Department of Veterans Affairs 0710 Handbook, “Personnel Suitability and Security Program,”)

Low / Tier 1 Tier 1 / National Agency Check with Written Inquiries (NACI) A Tier 1/NACI is conducted by the Office of Personnel Management (OPM) and covers a 5-year period. It consists of a review of records contained in the OPM Security Investigations Index (SII) and the DOD Defense Central Investigations Index (DCII), Federal Bureau of Investigations (FBI) name check, FBI fingerprint check, and written inquiries to previous employers and references listed on the application for employment. In VA it is used for Non-sensitive or Low Risk positions.

Moderate / Tier 2 Tier 2 / Moderate Background Investigation (MBI) A Tier 2/MBI is conducted by OPM and covers a 5-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD Defense Central Investigations Index (DCII), FBI name check, and a FBI fingerprint check], a credit report covering a period of 5 years, written inquiries to previous employers and references listed on the application for employment; an interview with the subject, law enforcement check; and a verification of the educational degree.

High / Tier 4 Tier 4 / Background Investigation (BI) A Tier 4/BI is conducted by OPM and covers a 10-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD Defense Central Investigations Index (DCII), FBI name check, and a FBI fingerprint check report], a credit report covering a period of 10 years, written inquiries to previous employers and references listed on the application for employment; an interview with the subject, spouse, neighbors, supervisor, co-workers; court records, law enforcement check, and a verification of the educational degree.

The position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the Performance Work Statement.

Position Sensitivity and Background Investigation Requirements

The tasks identified above, and the resulting Position Sensitivity and Background Investigation requirements identify, in effect, the Background Investigation requirements for Contractor individuals, based upon the tasks the Contractor individual will be working.

5.0 ACRONYMS AND DEFINITIONS

Definitions (Acronyms/Definitions)

ACRONYMS/DEFINITIONS:

The following terms, when used in this contract, will be interpreted as follows:

6.0 DELIVERABLES

The Contractor shall always be prepared to comply with requests for information, including those originating from Congress, using company letterhead, complete sentences, and professional English. The Contractor shall comply with the request of Government and independent auditors during audits of this contract and all associated contract documentation, including but not limited to, invoices and medical records.

6.1 Method of Delivery

Electronic copies must always be delivered using Microsoft Office suite of tools (for example, Word, Excel, PowerPoint, Project, or Access format) unless otherwise specified in the PWS or by the CO/COR.

6.2 Government Acceptance

The COR will have ten (10) business days after receipt to review deliverables, notate deficiencies, or make other comments. The Contractor will have five (5) business days after receipt of returned deliverables to make corrections. Upon receipt of the resubmitted deliverables, the COR will have five (5) business days for final review prior to acceptance or providing documented reasons for rejection for failure to comply with Contract requirements.

In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor will have five (5) business days to correct the rejected deliverable and return it per delivery instructions.

6.3 Schedule of Deliverables

Monthly deliverables shall be delivered on the 5th day after the end of the previous month, unless otherwise specified in the PWS. VA’s fiscal year begins October 1 and ends on September 30.

The Contractor shall provide the following Deliverables:

* Annotates government provided template

Do Not Disclose – Source Selection Sensitive Information – See FAR 2.101 and FAR 3.104 – For VA Internal Planning Purposes Only