Preconference QA_0005.pdf

NDSC

Pre-Conference Questions

1. B.2 IT Contract Security:

Who is required to complete the IT Contract Security Training requirements?

VA: In Section B.2, all contractors and subcontractors requiring access to VA information and VA information systems.

2. B.3 Price/Cost Schedule:

Are we required to submit a proposal for the PMPM Admin Fee or Implementation Fee if we prefer to simply propose a percentage of the Medicare rates for dialysis services only?

VA: The contractor must propose a specific rate for the Active PMPM Administrative Fee as part of their price proposal. This is a required element of the proposal. Proposing a percentage of the Medicare rates for dialysis services only is not permitted IAW the solicitation.

3. 11.2 Miscellaneous Considerations (Prescriptions):

Will VA continue to follow Medicare on payment of the TDAPA medications?

VA: TDAPA (Transitional Drug Add-on Payment Adjustment) medications are a specific Medicare payment mechanism for certain new ESRD drugs and biologicals. The contract requires that all services and billing follow current CMS Medicare Program guidelines and rates.

4. Deliverables PWS 2.5 Transition Out – Weekly Status Report of

Claims/Invoices/Phase Out Activities:

Why would this be a weekly requirement when claims are submitted monthly?

VA: This deliverable has been revised in Section 2.5 and 13.3 of the PWS to reflect a monthly submission rather than weekly.

5. How does the VA justify that Medicare level pricing will allow for dialysis vendors to cover their full cost of providing care as Medicare pricing does not cover total cost of care?

VA: In Section B.3, The Price/Cost Schedule includes a separate “Active Per- Member Per-Month (PMPM) Administrative Fee” CLIN to reimburse the contractor for administrative services required to manage and deliver the services purchased under this contract. This fee is in addition to the Medicare rate for dialysis services. The contractor must propose a specific rate for the Active PMPM Administrative Fee as part of their price proposal.

a. Based on RFP content, can you advise on PMPM being an annual payment and/or monthly payment? Explain the annual reconciliation.

VA: Active PMPM Administrative Fee is a monthly payment for each active Veteran receiving dialysis services in a designated month.

Annual PMPM Reconciliation Report: Please reference Section 3 of the

PWS.

b. Is there a rate ceiling for the PMPM?

VA: No

c. Why is PMPM shown applicable per modality and not across the entirety of the contract?

VA: The Active PMPM Administrative Fee shall be applied regardless of modality.

d. Why is the VA requiring annual reconciliation report to be filed in lieu of paying based on Members served monthly? Instead, a reconciliation report can be used annually to close out under/overpaid claims to true up any variances of PMPM received throughout the year. It is important provider receive PMPM monthly.

VA: Active PMPM Administrative Fee is a monthly payment for each active Veteran receiving dialysis services in a designated month. PMPM is billed monthly with annual reconciliation.

The VA requires PMPM Administrative Fees to be invoiced and paid monthly upon VA approval of the healthcare claim or invoice.

• The annual reconciliation report is required to close out any unpaid PMPM fees and to true up any variances at the end of the contract year, not as a substitute for monthly payment.

• Providers are to receive PMPM monthly, and the annual reconciliation is a close-out process for any under/overpayments.

In conclusion, the VA does not require the annual reconciliation report to be filed in lieu of monthly PMPM payments. The reconciliation report is used to close out and true up any variances at year-end, while monthly PMPM payments are still required and expected.

6. Do the Veterans have OON benefits and if so, will they be able to choose to stay with their current provider if the provider is OON effective 1/1/26?

VA: Veterans preference is reviewed and considered upon VA authorized referral.

7. How will VA manage patients who may refuse to change dialysis provider if their provider goes OON?

VA: Veterans preference is discussed with the referring provider at the time of VA’s authorization. As this occurs on an individual basis VA is unable to provide a general answer.

8. Section 2.3 and Attachment C:

Att C Project Risk Register: How and/or what system will the VA download and record all of the data content of this file? What will be the cadence and use of this file to manage back with the dialysis provider?

VA: The Project Risk Register is a proactive contract management tool used to identify, track, and mitigate risks that may impact performance, Veteran care, implementation progress, or compliance. While the RFP does not specify a dedicated VA system for automated ingestion of the Risk Register, the contractor is required to submit the Risk Register in a VA-accepted format (e.g., Excel or structured PDF).

9. Section 2.1 & 2.2:

Why must existing, contracted providers be required to develop and implement transition meetings, it appears, again, all the burden is on the provider? What is this accomplishing?

VA: In Section 2.2 of the PWS, planned transition meetings are required to ensure continuation of dialysis services delivery with minimal disruption to Veterans and VA under the terms and conditions of the new contract(s).

10. Section 2.3, 2.4, 2.6, 5, 9, 10:

All of the concerns expressed in the original prelim RFI submitted earlier this year provided very detailed information regarding labor intensive and burdensome processes, which appear to still be present in the current RFP; will the VA accept revisions to these processes based on provider alternative recommendations? For example, using CMS quality and risk data in lieu of provider having to create duplicative programming for data already provided to CMS?

VA: VA will not accept any revisions to processes in the RFP based on provider alternative recommendations.

11. Question #6: (Page 9, RFP) “This CLIN is priced and reimbursed at 100% of the applicable locality adjusted Medicare Rate.”

a. What is specifically included in the "applicable locality adjusted Medicare rate"? Is this rate intended to reflect the full Medicare payment methodology, or does it only incorporate certain CMS adjustment categories? If only some adjustments are included, which specific categories are factored into the calculation? For example:

1. Are facility-level adjustments included?

VA: No. Yes.

2. Are patient-level adjustments considered?

VA: No. Yes.

VA: The "applicable locality adjusted Medicare rate" refers to the payment rates set by Medicare for services provided to beneficiaries, adjusted for geographic differences in the cost of delivering healthcare”

12. Question #7: (Page 9, RFP) “Active Per-Member Per-Month (PMPM) Administrative

Fee:

Administrative Services will reimburse the contractor for the administrative services required to manage and deliver the services purchased under this contract. This includes costs related to dialysis services, authorized through an Approved Referral, that occur to maintain availability and accessibility of an adequate number of CMS Medicare Program certified dialysis facilities, qualified healthcare providers, and necessary resources to meet the needs of Veterans requiring dialysis treatment.

This CLIN is reimbursed at the Active PMPM Administrative Fee based on each Active Veteran receiving dialysis services in a designated month.

a. How will this PMPM be applied for members who receive dialysis services at multiple locations within the same month? Additionally, how will potential crossover between different dialysis providers (different contract awards) be handled?

VA: VA will provide PMPM reimbursement to multiple Contractors for each Veteran who receives at least one authorized treatment within a given calendar month.

b. The statement of the minimum guarantee for the contract implies that payment of the Active Per-Member Per-Month (PMPM) Administrative Fee is not guaranteed, even for a healthcare claim or invoice approved for payment.

Please clarify and confirm that the PMPM fee will be paid for each active Veteran receiving an approved dialysis service each month.

VA: Please reference Section B.3. The minimum guaranteed amount has been revised.

13. Question #9: (Page 36, RFP) “The Contractor shall return all medical documentation to VA no later than 30 calendar days following the date of service. Required information may include but not limited to: lab data, outcome data, medication list, social work, and/or nutrition summary. Additional documentation may also be required such as administrative records. Records created by the contractor in the course of treating Veterans under this agreement are the property of the contractor and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. The contractor shall be responsible for

Veterans’ records under its control and shall ensure that Veterans’ privacy and confidentiality is maintained.”

a. Is the request to return medical documention to the VA for every VA patient and every date of service? Or does this requirement only apply to specific requests for specific VA patients as requested by the VA? What specfic medical documentation is requested? Is this simmilar to the Care plans the VA required under prior NDSC’s that were discontinued or is this expected to be single requests as needed?

VA: Please reference Section 7.3 Medical Documentation Submission Timeframes.

14. Question #10: (Page 37, RFP) “Provider/Practitioner Authentication (including typed name and provider phone number)

All medical documentation shall be complete, verified, and authenticated by the submitting provider or practitioner. Authentication consists of electronic signatures that comply with HIPAA regulations. The Contractor shall ensure medical documentation is accurate and complete in accordance with the above elements prior to submission to VA”

a. Can you please elaborate on what ‘authenticated’ means in this section.

What does Authentication include outside of name and phone number of the provider?

VA: Per Section 7.2 Medical Documentation Data Elements for Inclusion, authentication consists of electronic signatures that comply with HIPPA regulations.

15. Question #11: (Page 38, RFP) “The Contractor will partner with VA during implementation and annually thereafter to ensure medical documentation compliance reports and cadence meet the needs of VA for understanding the compliance. Additionally, the Contractor shall participate in ad hoc virtual Progress Report meetings. Within 30 days of request by VA, the Contractor will report on medical documentation return compliance in Attachment D, Progress Report.”

a. Can you elaborate on what "Contractor will partner with VA during implementation and annually thereafter…" entails. What will specifically be required under this section?

VA: Please reference Section 7.4 of the PWS for the following revision:

The Contractor shall provide timely medical documentation compliance reports to VA upon request during implementation and annually thereafter.

16. Question #12: (Page 38, RFP) “Within 30 days of request by VA, the Contractor will report on medical documentation return compliance in Attachment D, Progress Report.”

Can you list what is specifically required in "medical documentation return"? What documents/data will be required here? At what freguency will it be required as this is an ongoing course of treatment.

VA: Please reference Section 7.2 Medical Documentation Data Elements for Inclusion and Section 7.4 Medical Documentation Compliance.

17. Question #14: (Page 47, RFP) “The Contractor, its employees, and agents who, in the course of Contractor responsibilities, have reason to see/handle the Veteran’s Personal Health Information (PHI) are required to provide Attestation of the completion of HIPAA compliance training in Attachment E, Contractor Training Report, at the Kickoff Meeting and annually thereafter. The Contractor Training Report shall be maintained and kept current by the Contractor and shall be available for periodic audit inspection and verification by designated VA personnel, the COR, and Contracting Officer.”

Can you confirm that the Contractor and its employees satisfy this requirement if the Contractor’s employees satisfy all training requirements required under CMS, including HIPAA compliance?

VA: No, satisfying only CMS training requirements, including HIPAA compliance, is not sufficient. Section 12.1 of the PWS has been updated to identify training requirements.

18. Question #16: (Attachment 1 - Facility Listing, RFP) “Column U: Current Utilization (Incenter, Home, Both)”

For this column, do you want the total utilization in the clinic for all patients or utilization by VA referred patients? If this data is provided, please confirm this information has the ability to be kept as a confidential field.

VA: Yes, the Government will keep all information supplied through this contract as confidential.

Column U has been updated within Attachment 1 – Facility List_0003 and Attachment B – Facilities Status Report_0003 to “Current Utilization of VA referred patients (Incenter, Home, Both).

19. Question #17: (Page 37) “7.3 Medical Documentation Submission Timeframes The Contractor shall return medical documentation to VA in accordance with the following timeframes:”

Could you please clarify what specific "Medical Documentation" is required? This is an ongoing course of treatment occurring multiple times per week. Does the VA expect documentation to be submitted after each individual treatment session? If not, what is the required frequency for submitting documentation, and what specific types of documentation are needed (e.g., progress notes, treatment summaries, prescriptions)?

VA: Please reference Section 7.2 Medical Documentation Data Elements for Inclusion and Section 7.4 Medical Documentation Compliance. 6.2 Medical Documentation Data Elements for Inclusion

20. Question #18: (Page 21, RFP) “The Deployment and Implementation Strategy shall also contain the Contractor’s Transition-in Plan that includes, but not limited to:

1. Planned transition meetings and schedule

2. Transition execution steps with associated milestones ensuring continuation of dialysis services delivery with minimal disruption to Veterans and VA

3. Expected VA inputs to ensure effective transition”

a. What specifically are the “Expected VA inputs” that will be given to ensure effective transition?

VA: “Expected VA inputs to ensure effective transition” has been removed from Section 2.2 Deployment and Implementation.

21. Question #19: (Page , RFP) “• VA-provided Ticketing Tool for communication between VA staff and the Contractor”

What is the schedule for the VA to provide training on the VA-provided Ticketing Tool post award?

VA: VA will establish a training schedule for the VA Provided Ticketing Tool upon contract award through kick-off meetings. Section 5.1.1 of the PWS has been updated.

22. Question #21: (Page 33, RFP) “PWS Section 6.1, Referral and Authorization Process.”

Please confirm that the authorizations issued to order dialysis services for a Veteran will also be deemed to include authorization to the Contractor to invoice for the corresponding PMPM Administrative Fee owed for the dialysis services provided to the Veteran under the authorization.

VA: Yes, the authorization will be used in the determination of PMPM.

23. Question #22: (Page 39-41, RFP) “PWS Section 8, BILLING”

The PWS section addressing "Billing" does not address how the contractor is to bill for the Active PMPM Administrative Fee CLIN (CLIN X002 in the Price/Cost Schedule). Please clarify how the Contractor is expected to bill for the PMPM fee associated with treating a Veteran during the preceding month. Should that fee be included as a separate, single line item in the health care claim submitted for an individual Veteran for a specific month of treatment, as described in PWS Section 8.1? Or should the Contractor submit a separate invoice to the VA for the PMPM Administrative Fee CLIN each month?

VA: Yes, separate Invoices for PMPM should be submitted to VA monthly.

Section ” 8.1.5 Billing for Each Active Veteran” has been added to the PWS.

24. Question #23: (Page 58, RFP) “C.3 52.216-18 Ordering (AUG 2020)”

Please confirm that the issuance of an authorization as described in PWS Section

6.1 will be deemed an order under the contract for the authorized services (including the PMPM Administrative Fee associated with providing services to the Veteran that is subject to the authorization), within the meaning of the Ordering clause (FAR 52.216-18). Please also confirm that every order for dialysis treatments under CLIN X001 of the Contract for a Veteran will include an order for payment of one "unit" of the PMPM Administrative Fee for each month of dialysis service ordered for the Veteran.

VA: Please reference Section 1.4 in the PWS, “Active Veteran” definition:

Those Veterans who have availed of contractor services (i.e., received care) in a particular month. A Veteran is counted as active (count=1) in a particular month if they have sought care at least once in that month. PMPM is not paid for all enrolled Veterans but for only those Veterans that have sought care one or more times in that month.

Active PMPM Administrative Fee is a monthly payment for each active Veteran receiving dialysis services in a designated month.

Task orders will be issued accordingly for the implementation period, base period, and resulting option periods. The task orders authorize services for the respective period to include any authorizations issued by VAMC staff per Section 5.1.

25. Question #24: (Page 80, RFP) “FAR 52.222-55, Minimum Wages for Contractor

Workers Under Executive Order 14026 (JAN 2022)”

The RFP indicates that the FAR clause implementing Executive Order 14026 will be included in the resulting contracts. However, President Trump rescinded Executive Order 14026 via Executive Order 14236 of March 14, 2025. Please confirm that contractors will not be required to comply with rescinded Executive Order 14026 in the contracts to be awarded under this RFP, and please amend the RFP to remove this "X" next to this clause to clarify that point.

VA: FAR 52.222-55 is un-checked within 52.212-5.

26. Question #26: (Page 97-98, RFP) “Description of what costs could be included in

"Administrative services and activites" subject to Active PMPM Administrative Fee”

This VA contract imposes requirements that are not applicable to Medicare patients and therefore are not encompassed within the base Medicare payment provided for under CLIN X001. Please confirm that that offerors can incorporate the increased costs of providing dialysis services to a Veteran throughout a full month under the terms of the NDSC within the pricing proposed for the CLIN X002 Active Per-Member Per-Month Administrative Fee.

VA: Active PMPM Administrative Fee is a monthly payment for each active Veteran receiving dialysis services in a designated month.

In Section B.3, The contract Price/Cost Schedule includes a separate “Active Per-Member Per-Month (PMPM) Administrative Fee” CLIN to reimburse the contractor for administrative services required to manage and deliver the services purchased under this contract. This fee is in addition to the Medicare rate for dialysis services.

27. Section B.2.a IT Contract Security (p. 6-8) “The Government shall receive unlimited rights to data/intellectual property…”

a. What is the applicability and relevance of Section B.2.a and FAR 52.227-19:

Commercial Computer Software License to the work performed by the NDSC contractor? Please explain.

VA: Reference for 52.227-19 will be removed from the IT Contract Security section.

b. What are some examples of “data/intellectual property first produced and delivered” in the performance of the NDSC contract?

VA: The VA does not anticipate any data/intellectual property being produced in the performance of this contract.

c. Will VA reconsider the requirement to provide complete segregation of Veteran patient data, as it is not reasonable or feasible for the contractor and is not a clinical best practice when managing population health? Please explain why or why not.

VA: No, VA will not reconsider this requirement to provide complete segregation of Veteran patient data, as it is mandated by Federal and VA information security requirements.

28. Section B.2.d IT Contract Security (p. 6-8) “VA reserves the right to conduct scheduled or unscheduled audits…”

a. What are VA’s plans for scheduled audits? Is there a cap on the number of scheduled audits? Please explain.

VA: Audits will be scheduled by VA on an as needed basis. There is no cap and no proposed schedule for this requirement at this time.

b. For the “additional cyber security or privacy training” as stated in the RFP, can the VA provide greater detail on the specific trainings, applicable roles, training frequency, and how VA will communicate when such additional training is required?

VA: Privacy and HIPPA Focused Training (Talent Management System (TMS) #10203 has been added to Section B.2 and Section 12.1 of the PWS.

29. PWS Section 2.3 Risk Management (p. 22) “The Contractor shall adhere to Attachment C, Project Risk Register…”

a. The proposed Risk Management requirements, including adherence to Attachment C, Project Risk Register (PRR) are not dialysis industry standards and would create a parallel process to the CMS Medicare Program reporting, which are reported to the VA. What is the rationale for requiring PRR vs. the Customer Service and Veteran Safety provisions and the risk reporting processes in the current NDSC contracts? Are there shortcomings of the current process that PRR aims to address and how exactly would PRR achieve that?

VA: By requiring ongoing, proactive risk identification and mitigation planning, the PRR helps prevent issues before they affect Veterans or service delivery.

• It creates a formal mechanism for the Contractor and VA to collaborate on risk management, ensuring transparency and accountability.

• The PRR’s structured format enables VA to monitor trends, prioritize resources, and enforce corrective actions more effectively than ad hoc or reactive processes.

In summary, the PRR is designed to provide a more proactive, comprehensive, and structured approach to risk management than the customer service and Veteran safety provisions or previous risk reporting processes. It addresses potential gaps in the current process by requiring the Contractor to systematically identify, assess, report, and mitigate risks across all aspects of contract performance, thereby supporting continuous improvement and minimizing service disruptions for Veterans.

b. The RFP states that “The Contractor shall adhere to Attachment C, Project Risk Register which shall consist of self-reported (not facility level) risk and issue management processes.” What does VA mean by “self-reported risk and issue and management processes” in this section? How should contractors interpret “not facility level”, as the contractor’s facilities can be organized by regions, divisions, groups, or company-wide?

VA: Section 2.3 of the PWS has been updated to the following:

The Contractor shall adhere to Attachment C, Project Risk Register which shall consist of self-reported (not facility level) risk and issues identified and reported by the Contractor at an organizational or contract-wide level, rather than risks/issues that are specific to an individual facility.

30. PWS Section 2.4.1 Quality Assurance Surveillance Plan (p. 22-23) “The Quality Assurance Surveillance Plan (QASP) will be finalized…”

a. Can VA confirm the removal of the QASP Summary Report from the RFP, including the removal of interim reporting against QASP metrics?

VA: The RFP does not include a QASP Summary Report. Please reference “Attachment A – Quality Assurance Plan” for reporting requirements and measures.

b. Can VA please confirm that the QASP reporting has been replaced by the Contract Discrepancy Report and that the Contract Discrepancy Report will only be required upon request by VA, if performance targets are not met in accordance with the deliverable schedule at 13.3?

VA: The QASP Summary Report is no longer a requirement for this solicitation. The Contract Discrepancy Report template will only be required upon VA request when performance does not meet contractual requirements and/or acceptable quality levels. Please reference “Attachment A _ Quality Assurance Surveillance Plan” Section 8:

Documenting Performance.

31. PWS Section 2.5 Transition Out (p. 23-24) “The Contractor shall perform the Transition Out and residual service tasks below for this contract…”

a. How are the activities in Section 2.5 of the RFP applicable to an NDSC provider? For example, providing an inventory of government-owned assets, providing “shadowing”/knowledge transfer, processing all open healthcare claims, etc.

VA: An Optional CLIN was added to Section B.3 for Transition Out services if needed in accordance with Section 2.5.

b. For each step of the Transition Out activities, can VA provide SLAs or timelines for each item that needs to be completed?

VA: Yes, the Contracting Officer may discuss additional items or considerations related to phasing out services prior to the transition period. Additionally, the services required to Transition Out will only be exercised in the event of a need for an actual transition.

32. PWS Section 3 Annual close out of administrative fees (p. 26-29) “The Contractor shall submit electronic copies (in approved Microsoft Office format) of its annual Per Member Per Month (PMPM)…”

a. The annual PMPM Reconciliation Report File Format provided in Section 3 of the RFP is unclear and difficult to follow. Can VA provide the Reconciliation Report File in a separate attachment with enhanced formatting such as Excel?

VA: The example in Section 3 of the PWS is an extraction of the Reconciliation report file.

b. Is PMPM being defined as tying to the administrative services performed for the Veterans covered under this contract, or provider dialysis claims, or something else?

VA: Active PMPM Administrative Fee is a monthly payment for each active Veteran receiving dialysis services in a designated month. PMPM is billed monthly with annual reconciliation. Please reference Section 3 Annual Close Out of Administrative Fees within the PWS. PMPM is tied to the administrative services performed for each Active Veteran who receives dialysis services in a given month under this contract, not to the provider dialysis claims themselves or to any other basis.

33. PWS Section 4.1 Accreditation and Credentialing (p. 29-30) “Healthcare delivery cannot commence until…”

a. Can VA confirm the removal and replacement of the Corrective Action Plan with Attachment F - Contract Discrepancy Reports, which is to be completed on an as-requested basis?

VA: If the established performance target is not met, VA may request the development of Corrective Action Plans (CAP) through Attachment F - Contract Discrepancy Report. The Contract Discrepancy report template will only be required upon VA request when performance does not meet contractual requirements and/or acceptable quality levels. Please reference “Attachment A _ Quality Assurance Surveillance Plan” Section 8: Documenting Performance.”

34. PWS Section 7.1 Medical Documentation Submission (p. 36-37) “The Contractor shall return all medical documentation to VA…”

a. Does VA consider "[r]ecords created by the contractor in the course of treating Veterans under this agreement [that] are the property of the contractor and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations" to be "medical documentation [to be returned] to VA" under 7.1?

VA: No.

35. PWS Section 7.2 Medical Documentation Data Elements for Inclusion (p. 37) “Medical documentation shall include…”

a. The RFP is not clear on how the medical documentation sharing requirement will be operationalized utilizing either existing or new systems.

VA: The Vendor will submit medical documentation to VA through locally established methods with the referring VAMC. Section 7.1 of the PWS has been updated.

b. Will VA supply the Veteran’s ICN or DoD EDI-PI in a way that allows integration into provider systems?

VA: No.

c. Is PDF/Paper submission acceptable, or is VA expecting structured data (e.g., HL7, FHIR)?

VA: The Vendor will submit medical documentation to VA through locally established methods with the referring VAMC. Section 7.1 of the PWS has been updated.

d. Will VA provide a template or standardized document format for these submissions?

VA: No.

36. PWS Section 7.3 Medical Documentation Submission Timeframes (p. 37-38) “The Contractor shall return medical documentation…”.

a. Section 7.3 of the RFP does not indicate how ad hoc or urgent requests should be shared by the provider outside of the monthly medical documentation reconciliation process.

VA: Section 7.3 of the PWS has been updated to include the following:

Any ad hoc medical documentation requested by VA shall be acknowledged within 14 calendar days and provided to VA within 30 calendar days following the request.

b. Can VA clarify how they intend to handle ad hoc or urgent requests — will this come through a portal, secure message, or other? How will VA triage “urgent” requests?

VA: The Vendor will submit medical documentation to VA through locally established methods with the referring VAMC. Please reference Section

7.3 Medical Documentation Submission Timeframes.

c. Will documentation expectations be tiered by priority (e.g., labs vs. nutrition

vs. admin)?

VA: No.

37. PWS Section 7.5 Critical Findings (p. 39) “The Contractor shall communicate critical findings…”

a. Section 7.5 of the RFP does not provide a clear indication on how responsibility transitions between the provider and the VA once critical findings are reported, nor is there a requirement for documenting proof of reporting.

b. Once critical results are verbally reported, does the provider retain responsibility for clinical follow-up, or does it transition to VA?

c. What documentation or proof of reporting (verbal and written) will be required of contractors?

VA: Section 7.5 of the PWS has been updated to include the following:

Contractors must document the verbal notification of critical findings, including time, date, and recipient name. This documentation serves as proof of compliance. Once the critical finding is reported and received, clinical responsibility transfers to VA.

38. PWS Section 7.6 Medical Documentation and Audit (p. 39) “The VA reserves the rights to review, inspect, or otherwise audit…”

a. Compliance and audit processes are defined in concept, but lack operational detail (frequency, data formats, transmission method, etc.) in Section 7.6 of the RFP.

VA: Contractors should be prepared to: Maintain complete medical documentation in a retrievable format, Respond to ad hoc VA audits, and Comply with HIPAA and VA IT security standards (see PWS Sections 2.5 and 4.1–4.2).

b. Can VA define the parameters for audit activities (e.g., advance notice, scope, frequency)?

VA: VA reserves the right to audit activities throughout the performance of this contract. Audits will be scheduled by VA on an as needed basis.

There is no cap and no proposed schedule for this requirement at this time.

c. What format will be required for audit submissions (e.g., electronic pull

vs. push)?

VA: VA will provide the Vendor audit parameter upon notification of an audit occurring.

39. PWS Section 8.1.1 Standard Billing (p. 39-40) “The Contractor shall submit health care claims to VA for payment of services…”

a. Today, only ESRD is billed to and paid by the FSC and AKI services are not processed by the FSC. The RFP only references the FSC. Can VA provide guidance and clarity on who and how AKI billing and payment will be managed?

VA: The RFP lists the FSC as the billing/payment entity for all services, without distinction.

40. PWS Section 8.1.2 Vendor Onboarding (p. 39-40) “VA requires all vendors to submit VA Form 10091…”

a. The use of VA Form 10091 via the FSC Customer Engagement Portal represents a change from the existing contract.

VA: Correct.

b. Can VA confirm that the Vendor Onboarding process described in this section will not require the re-vendorization of all facilities presently included in the contract and completed via SAM.gov?

VA: The VA will provide instructions for vendorization upon contract award at the kick-off meeting. (Ref. PWS 8.1)

41. PWS Section 9 Anti-Fraud Controls for the Prevention, Detection, and Deterrence of Fraud, Waste, and Abuse (p. 42-43) “For all reports in PWS Section 8, “Anti-Fraud Controls for the Prevention, Detection, and Deterrence of Fraud, Waste, and Abuse,” the Contractor shall…” Contractors effectively satisfy Section 9 of the RFP with robust internal compliance programs that meet all seven elements of OIG’s recommended compliance program, in addition to CMS requirements. This program includes multiple methods of preventing and detecting FWA, including a method of reporting and communication for compliance concerns.

a. Will the VA amend PWS Section 9 to state that a contractor whose compliance program meets all seven elements of OIG’s recommended compliance program and all applicable CMS requirements will be deemed compliant with these Section 9 requirements?

VA: No.

b. Can VA confirm the Section 9 introduction should be a reference to 'PWS Section 9' rather than Section 8? [Language copied here for reference: For all reports in PWS Section 8, “Anti-Fraud Controls for the Prevention, Detection, and Deterrence of Fraud, Waste, and Abuse,” the Contractor shall include the following statement at the bottom of each page: “The recipients of this report are hereby advised that it contains information that is Law Enforcement Sensitive."]

VA: Yes.

42. PWS Section 10.1 Clinical Quality Monitoring Plan (p. 43) “The Contractor must develop and submit a written…”

Can VA provide the proposed formats and/or templates for the suggested monitoring plan?

VA: The contractor develops and submits its plan to VA. There is no template as the contractor is required to develop one.

43. PWS Section 10.2 Clinical Quality and Patient Safety Issues Identification (p. 43-45) “When VA or the Contractor identifies clinical quality…”

a. Can VA provide greater clarity regarding what criteria VA will use for identifying concerns, which metrics will be prioritized from the National Quality Forum (NQF), and what thresholds will be used?

VA: VA will prioritize dialysis-specific National Quality Forum (NQF)– endorsed metrics and those aligned with the CMS ESRD Quality Incentive Program (QIP) and VA clinical practice guidelines.

b. How will VA differentiate metrics that don’t apply to the outpatient chronic dialysis space?

VA: The VA will apply metrics contextually and only within the scope of outpatient chronic dialysis services as defined in the contract.

c. How will VA adjudicate source of origin for issues (e.g. came from a hospital that isn’t a VA contractor, so outside of provider control)?

VA: The VA acknowledges that not all clinical quality issues originate within the contractor’s control. During issue evaluation, the VA will conduct a source-of-origin analysis using available medical documentation, contractor input, and care timelines.

d. Can VA provide a definition of “shall process” in the context of this provision?

Is processing reporting, putting a plan in place, or resolution?

VA: “Shall” has been deleted and replaced with “complete” in Section

10. 2.

e. Regarding the Peer Review Committee, who will be included on the committee and does the provider determine who is included?

VA: The Peer Review Committee is a contractor-established internal clinical oversight body, and the provider is responsible for its composition.

44. Section C.2 Basic Safeguarding of Covered Contractor Information Systems (p. 56-

58) “Covered contractor information system means an information system…”

Can VA provide guidance on the applicability of Section C.2. of the RFP for subcontracts not associated with delivering care to Veterans which are already in place today?

VA: As prescribed in FAR 4.903, The contracting officer shall insert the clause at 52.204-21, Basic Safeguarding of Covered Contractor Information Systems, in solicitations and contracts when the contractor or a subcontractor at any tier may have Federal contract information residing in or transiting through its information system.

45. Section C.11.d Contractor operations required to be in United States (p. 64) “Custom software development and outsourced operations must be located…” https://www.acquisition.gov/far/part-52#FAR_52_204_21

a. Can VA provide an example of a detailed Information Technology Security Plan prior to the proposal submission deadline?

VA: An example will not be provided. If applicable, the Contractor / Subcontractor must include a detailed Information Technology Security Plan, for review and approval by the Contracting Officer, specifically to address mitigation of the resulting problems of communication, control, and data protection in accordance with VAAR 852.204-71 (d).

b. Will VA reconsider the requirement to provide complete segregation of Veteran patient data, as it is not reasonable or feasible for the contractor and is not a clinical best practice when managing population health?

Please explain why or why not.

VA: The requirement to logically segregate VA patient data is based on Federal information security mandates, including VA Handbook 6500 (Information Security Program), FISMA (Federal Information Security Modernization Act), NIST SP 800-171 (Protecting Controlled Unclassified Information in Nonfederal Systems).

46. Section C.11.f.9 Firewall and web services security controls (p. 66) “The Contractor/subcontractor’s firewall and web services…”

Can VA provide the VA Configuration Guidelines so that contractors can fully assess this requirement?

VA: There are no configurations required within this contract.

47. Section C.11.f.11.g Report of known or suspected security/ privacy incident (p. 67-

69) “The Contractor, subcontractor, third-party affiliate or business associate, and its employees…”

a. Is the VA open to amending the notice period for a suspected security/privacy incident and the remediation deadline from one hour and 5 days respectively to a term that holds the contractor to a requirement to inform the VA of a data breach without reasonable delay or as soon as possible?

VA: No.

b. For subsection 2 & 3 under section B, is VA referring to a response to a security incident or are these sections focused on system patching/vulnerability remediation?

VA: Security incident.

48. Section E.2 52.212-1 Instructions to Offerors (p. 85-98)

a. P.86 of the RFP states that “Offerors are encouraged to submit multiple offers” while p.89 of the proposal states, “Multiple offers from one

Offeror will not be accepted in response to this solicitation.” This is a patent ambiguity. Please clarify whether VA will consider multiple offers from a single offeror and whether VA will conform the RFP accordingly.

VA: Section E.2 52.212-1 (e) will be tailored in accordance with FAR 12.302 to the following:

(e) Multiple offers. Offerors are encouraged to submit multiple offers. Each offer submitted will be evaluated separately.

The following in Section E.2 Addendum to 52.212-1, 1(a) will be deleted:

“Multiple Offers from one Offeror will not be accepted in response to this solicitation”.

b. Does the VA intend to allow offerors to submit more than one offer, but in the event more than one offer is submitted only make one contract award per vendor that meets the VA’s best value criteria?

VA: Section E.2 52.212-1 (e) will be tailored in accordance with FAR 12.302 to the following:

(e) Multiple offers. Offerors are encouraged to submit multiple offers. Each offer submitted will be evaluated separately.

The following in Section E.2 Addendum to 52.212-1, 1(a) will be deleted:

“Multiple Offers from one Offeror will not be accepted in response to this solicitation”.

c. Please confirm VA will consider alternative line item proposals under

FAR 52.212-1(e) per the clause term stating, “Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with FAR subpart 4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation.”

VA: VA will not consider alternate line-item proposals. Section E.2 52.212-1

(e) will be tailored in accordance with FAR 12.302 to the following:

(e) Multiple offers. Offerors are encouraged to submit multiple offers. Each offer submitted will be evaluated separately.

d. Please confirm consistent with FAR 52.212-1(e) incorporated in the RFP that VA will deem offers that do not conform to the stated pricing structure (CLIN 0001 and 0002) in the RFP as being responsive and acceptable. In other words, that an offer will not be deemed unacceptable on the basis of offering a different pricing structure from that identified in the RFP.

e. Please identify any clear parameters or criteria that VA considers offerors must follow for an acceptable alternative line item proposal, per FAR 52.212-1(e).

f. Please state whether VA will be separately incorporating FAR 52.204-22 into the RFP or whether VA will rely on FAR 52.212-1(e) with regard to the consideration and acceptance of multiple offers including those with alternative line item proposals.

VA: FAR 52.204-22 will not be incorporated into the RFP. VA will not consider alternate line-item proposals. Section E.2 52.212-1 (e) will be tailored in accordance with FAR 12.302 to the following:

g. Will VA consider an offeror’s revisions to terms and conditions if provided in its proposal?

VA: Please reference Section E.2 Addendum to 52.212-1 1(b)(i-iv):

The Offeror’s proposal shall include all the requested information and shall be submitted in accordance with these instructions. Failure to provide proposals in compliance with the instructions specified in this RFP may render the Offeror’s proposal incomplete, and that proposal may not be further evaluated for an award. The following acts or omissions by an Offeror may result in the CO finding an Offeror ineligible for award:

i. Failing or refusing to assent to any of the terms and conditions of the solicitation or its amendments; or

ii. Proposing additional terms and conditions of this solicitation; or

iii. Failing to submit any of the information required by this solicitation; or

iv. Failure to submit complete Volumes in accordance with the instructions and submission requirements.

h. Will VA consider negotiating with offeror that submits additional terms or takes exception to existing terms before eliminating it from consideration?

VA: Please reference Section E.2 Addendum to 52.212-1 Volume I – Solicitation, Offer and Award Documents and Certifications/Representations (h):

h. Any Offeror-imposed terms and conditions which deviate from the Government’s material terms and conditions established by the Solicitation, may render the Offeror’s proposal ineligible for award.

49. Section E.2 Addendum to FAR 52.212-4 (1)(j) And Section E.11 (p. 90 & p. 106)

Will VA consider revising the SAM registration requirement that “offerors must maintain an uninterrupted registration in System for Award Management (SAM) https://sam.gov/ at the time of proposal submission, throughout the evaluation process, and through award” to be consistent with FAR 52.204-7 which states rather that “An Offeror is required to be registered in SAM when submitting an offer or quotation and at time of award” which is incorporated at E.11?

VA: The additional language in the Addendum to 52.212-(j) will not be revised.

50. Section E.2 Addendum to FAR 52.212-4 j And Section E.11 (p. 90 & p. 106) Please advise whether FAR 52.204-7 as incorporated at E.11 or Section E.2 Addendum to FAR 52.212-4 (1)(j) is the intended standard in this RFP.

VA: Offerors must maintain an uninterrupted registration in System for Award Management (SAM) https://sam.gov/ at the time of proposal submission, throughout the evaluation process, and through award.