E.2 - PPI MEDIC Questions Response_Amendment 1.xlsx
XLSX spreadsheet 31 KB Posted
- Solicitation number
- 260656J
About this file
This is a Questions and Answers (Q&A) document responding to inquiries submitted by potential offerors regarding the Plan Program Integrity Medicare Drug Integrity Contractor (PPI MEDIC) solicitation (75FCMC26R0041). The document provides clarifications on proposal submission requirements, evaluation criteria, eligibility requirements, workload assumptions, and Statement of Work (SOW) scope across multiple topics.
Key submission requirements include: Phase 1 proposals are due April 22, 2026, at 10:00 AM local time (Baltimore, MD), containing only Volume I technical proposal documents with a 6-page limit for technical approach and no separate acronym lists permitted; Phase 2 proposals (if invited) must include Volumes II, III, and IV with detailed technical, business, staffing, and past performance information; all documents must be compatible with Microsoft Office 365 (.docx, .xlsx, .pptx formats); and offerors must maintain active Women-Owned Small Business (WOSB) SBA certification at Phase 1 submission, Phase 2 submission, and time of award. The Phase 1 advisory notification will recommend whether offerors should proceed to Phase 2, though all Phase 1 respondents may elect to submit Phase 2 proposals; evaluation uses a Best Value Tradeoff Process with three technical factors listed in descending order of importance without specific weightings. This is a 100% WOSB set-aside requiring eligible contractors to perform Medicare Parts C and D program integrity oversight, audits, data analysis, and fraud/waste/abuse prevention activities. The contract includes a base year plus four option years with workload varying by audit type (beneficiary-level analysis for self-audits and larger national audits), and offerors must propose their own staffing levels, key personnel roles, travel budgets, and third-party data licensing costs (Medispan, NCPDP, First Databank) as Other Direct Costs.
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Questions
| Document Name | Section Number | Section Name | Page No. | Question/Comment | Response |
| Solicitation Questions | |||||
| E.1 - Solicitation Sections L & M | L.5 | TECHNICAL PROPOSAL INSTRUCTIONS (VOLUME I & II) | 5 | Are offerors allowed to include a title page in the Technical Proposal? If yes, can CMS confirm that it does not count towards the page limit for Volume I (during Phase 1) and Volume II (during Phase 2)? | As stated on pages 5 and 6 of Exhibit E.1, offerors may include a Cover Letter for each of the Phase 1 and 2 Technical proposals. The Cover Letters should not exceed 2 pages, and the pages will not count toward to the Total Page Count. |
| E.1 - Solicitation Sections L & M | L.5 | TECHNICAL PROPOSAL INSTRUCTIONS (VOLUME I & II) | 5 | Are offerors allowed to include a list of acronyms in the Technical Proposal? If yes, will CMS consider excluding it from the page limit for Volume I (during Phase 1) and Volume II (during Phase 2)? | Offerors will not be permitted to include a separate list of acronyms in the Technical Proposal. |
| E.1 - Solicitation Sections L & M | L.5 | TECHNICAL PROPOSAL INSTRUCTIONS (VOLUME I & II) | 5 | To allow offerors to propose a sound approach to the five identified tasks as well as demonstrate sufficient previous experience, would CMS consider increasing the page limit from 6 pages to 12 pages for the "Technical Approach" of Factor 1 for Volume I? | CMS will not increase the page limit. |
| Exhibit E.1 – Solicitation Sections L & M | L.4 | Proposal Instructions | 4 | Will CMS permit the use of 8.5 x 11‑inch paper size in both portrait and landscape orientation? | Yes |
| Exhibit E.1 – Solicitation Sections L & M | L.5 (b) | TECHNICAL PROPOSAL INSTRUCTIONS (VOLUME I & II) | 6 | For Scenario 2, what baseline payment year should offerors assume when applying policy considerations related to the Inflation Reduction Act (IRA)? | We are not providing a baseline payment year, but for the timeframe you chose, apply applicable guidance. |
| Exhibit E.1 – Solicitation Sections L & M | L.5 (b) | TECHNICAL PROPOSAL INSTRUCTIONS (VOLUME I & II) | 6 | For Scenario 2, will the government share the Immunosuppressant audit methodology documentation submitted by the incumbent and approved by CMS for prior PPI MEDIC national audits? | CMS will not share this information. |
| Exhibit E.1 – Solicitation Sections L & M | L.5 (b) | TECHNICAL PROPOSAL INSTRUCTIONS (VOLUME I & II) | 6 | For Scenario 1, is it correct to assume that the proposed FWA Part C audit methodology should be complementary and not duplicative of Risk Adjustment Data Validation (RADV) activities? | This is correct. |
| Exhibit E.1 – Solicitation Sections L & M | M.5 | SECTION M - EVALUATION FACTORS FOR AWARD | 21 | Can CMS please clarify the rating system being used to determine reasonableness as outlined in the evaluation criteria? | As stated in Section M.5, the Government will assign a confidence rating for each Technical Evaluation Factor. |
| Exhibit E.1 – Solicitation Sections L & M | M.4 | SECTION M - EVALUATION FACTORS FOR AWARD | 20 | In the two-phased evaluation process outlined in Section M.4, will confidence ratings and scores from Phase 1 carry forward to Phase 2? If so, can bidders assume that all Offerors advancing to Phase 2 have achieved "high confidence" for Factor 1 to maintain fairness? If not, how does CMS plan to address the importance of Factor 1 if some Offerors with "some confidence" proceed? | Section M.5 of Exhibit E.1 lists the Technical Factors in descending order of importance. As stated in Section M.3, the award will be based on a Best Value Tradeoff Process. All Technical Factors (Phase 1 and 2) will be considered in the Best Value Determination in accordance with the order of importance outlined in Section M.5. In accordance with Section M.4 of Exhibit E.1, Offerors who are the most highly rated for Factor 1 will be advised to proceed to Phase II of the proposal submission process. |
| E.1 - Sections L & M | L.5 / M.4 | Two-Phased Approach | 1–2 | Section M.4 references an "Advisory Notification" following Phase 1 evaluation. Please clarify: (a) Will the Advisory Notification indicate a rating, ranking, or narrative assessment of the Phase 1 submission, or will it simply indicate whether the offeror is invited to participate in Phase 2? (b) Will offerors who do not receive a favorable Advisory Notification be formally eliminated from the competition, or may they still elect to submit a Phase 2 proposal? | As stated in Section M.4, the Advisory Notification will advise the Offeror of the Government’s advisory recommendation to proceed or not to proceed with the Phase II submission. Offerors who are the most highly rated for Factor 1 will be advised to proceed to Phase II of the proposal submission process. Offerors who were not among the most highly rated will be advised that they are unlikely to be viable competitors, along with the general basis for the Government’s advisory recommendation. The intent of this distinction is to minimize quote development costs for those vendors with little or no chance of receiving an award. |
However, notwithstanding the advice provided by the Government in response to their Phase 1 submissions, all respondents who submitted a Phase 1 proposal may participate in Phase 2.
| Solicitation | B.4 | Fixed Fee Payment Schedule | 3 | Section B.4 states that the Level of Effort (LOE) for each CLIN is "TBD." For purposes of cost proposal preparation, should offerors propose their own estimated LOE for each CLIN based on their staffing plan and technical approach, or will CMS provide the specified LOE values prior to the Phase 2 submission deadline? | The offeror is to propose their own LOE for each CLIN. Section B.4 will be completed at time of award based on the Successful Offerors proposal. There is a "Fill-In" tab within Exhibit E.8 for each offeror to provide their proposed LOE. | |
| E.1 - Solicitation Sections L & M | L.3 | PROPOSAL SUBMISSION | 3 | Would CMS consider extending the Phase 1 due date by 1 work week if integrated responses to submitted questions and solicitation amendment are not posted on the System for Award Management website by the afternoon of Friday, April 10, 2026? | The Phase 1 proposal due date has been extended to April 22, 2026, 10:00:00 AM local time, Baltimore, MD. See updates to Exhibit E.1, Section L.3. | |
| Exhibit E.1 – Solicitation Sections L & M | L.6 | BUSINESS PROPOSAL (VOLUME III) INSTRUCTIONS | 6 | In subsection 10 "Joint Ventures or Teaming Arrangements (if applicable)" the Government describes the requirements for Joint Ventures, but not Teaming Agreements. Will the Government please provide clarification on whether or not Teaming Agreements are required to be submitted for named subcontractors? | Teaming Agreement information for agreements other than Joint Ventures is required to be submitted under the requirements of Section L.6.9 - Consent to Subcontract. Exhibit E.1 - Sections L & M has been amended to make this more clear. | |
| Exhibit E.1 – Solicitation Sections L & M | M. 5 | TECHNICAL PROPOSAL EVALUATION | 21 | The Government states that Factors 1-3 are numbered in descending order of importance. Will the Government please provide a specific weighting for these individual Factors? | The factors are listed in order of importance, there is no specific weighting for these individual factors. | |
| Exhibit E.1 – Solicitation Sections L & M | L.5 / M.4 | Phased Evaluation Approach | 6–8 | How will Phase 1 (scenario responses) and Phase 2 (technical, staffing, and past performance) be weighted in the overall best-value determination? | Section M.5 of Exhibit E.1 lists the Technical Factors in descending order of importance. There is no specific weighting for these individual factors. As stated in Section M.3, the award will be based on a Best Value Tradeoff Process and details that technique. | |
| Exhibit E.1 – Solicitation Sections L & M | L.5 | Technical Proposal Instructions | 5 | Please confirm which documents are required at Phase 1 submission versus those only required upon invitation to Phase 2 (e.g., Prime Proposal Checklist, Consent to Subcontract). | The only documents required in Phase 1 are the Volume I documents as detailed in Sections L.4 and L.5 of Exhibit E.1. If an offeror chooses to participate in Phase 2, documents for Volumes II, III, and IV should all be submitted in that phase as detailed in Sections L.4, L.5, L.6, and L.7 of Exhibit E.1. | |
| Exhibit E.1 – Solicitation Sections L & M | L.5.a | Cover Letter / Table of Contents | 6 | Are there any required elements for the Cover Letter? | No, there are no required elements for the Cover Letter. | |
| Exhibit E.1 – Solicitation Sections L & M | L.4.a | General | 4 | Please confirm the required file format(s) for proposal submissions. Specifically, should all proposal documents be submitted in Microsoft Word (.docx), or are other formats (e.g., PDF) acceptable? Additionally, must submissions meet Section 508 accessibility requirements, and if so, which standards or checklist should Offerors follow? | As stated in Exhibit E.1, Section L.4, each proposal shall be compatible with Microsoft Office 365 (MS Word, MS Excel, and PowerPoint with formats of .docx, .xlsx, .pptx.). Please see Sections L.4, L.5, L.6, and L.7 for further details. While offerors should strive to make all documents 508 compliant, per the Solicitation, Offerors who decide to proceed to Phase 2 submissions should complete the checklist(s) that correspond to each expected SOW deliverable format(s) (MS Word, Excel, PowerPoint etc.). The Government will evaluate the apparent successful offeror’s CMS Accessibility Checklist for adherence to applicable Section 508 standards. | |
| SAM Notice & | ||||||
| Solicitation - 75FCMC26R0041 | SAM Posting Classification, "SBA Certified Women-Owned Small Business (WOSB) |
Program Set-Aside (FAR 19.15)" and 52.219-1 RFO Small Business Program Representations. RFO DEVIATION NOV 2025 FAR Clauses SAM Posting "Classification" and 52.219-1 RFO Small Business Program Representations. RFO DEVIATION NOV 2025
| FAR Clauses | 13 CFR 127.300 | Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127) | 74 of 79 | Per the SAM.gov posting, this requirement is designated as an SBA Certified Women-Owned Small Business (WOSB) Program Set-Aside (FAR 19.15). The solicitation further incorporates 13 CFR 127.300, which defines a WOSB concern as one that is certified by SBA or an approved third-party certifier. Based on these requirements, please confirm that offerors must have an active WOSB certification in SBA’s certification database (e.g., SBA portal/DSBS) at the time of proposal submission and at the time of award to be considered eligible. Additionally, please confirm that the Government will validate WOSB eligibility using SBA certification records rather than relying solely on representations made in SAM.gov. | CMS confirms that offerors must have an active WOSB SBA certification at both time of proposal submission (Phase 1 & Phase 2) and at time of award. The Government will validate WOSB eligibility. Exhibit E.1, Section M.2 has been updated to provide clarification. |
| E.1 - Solicitation Sections L & M | Section M.2 | ||
| Section M.4 | Eligibility for Award & | ||
| Two-Phased Approach | 20 - 21 | Per the SAM.gov posting, this requirement is designated as an SBA Certified Women-Owned Small Business (WOSB) Program Set-Aside (FAR 19.15), and the solicitation incorporates 13 CFR 127.300, which requires WOSB certification. |
| Given the two-phased evaluation approach described in Section M.4 and the eligibility requirements in Section M.2, please clarify whether WOSB certification will be treated as a pass/fail eligibility requirement for participation in Phase 2 and/or for award. Specifically, will offerors that do not have an active SBA-certified WOSB status at the time of proposal submission and award be considered ineligible for further evaluation or award, regardless of technical merit? | CMS confirms that WOSB SBA certification is requirement at the time of Phase 1 submission, the time of Phase 2 submission, and the time of award. Offerors that do not have an active WOSB SBA certification status at any of these points will be ineligible. Exhibit E.1, Section M.2 has been updated to provide clarification. | |
| E.1 - Solicitation Sections L & M | Section L.3, |
Section M.2 & Section M.4 Eligibility for Award, Proposal Submission &
| Two-Phased Approach | 12 & | |
| 20 - 21 | Following the designation of this requirement as an SBA Certified Women-Owned Small Business (WOSB) Program Set-Aside (FAR 19.15), please clarify whether offerors are required to demonstrate and provide proof of active SBA WOSB certification (e.g., SBA certification portal/DSBS record) as part of their Phase 1 proposal submission. Additionally, please confirm whether WOSB certification will be validated prior to issuance of Phase 2 advisory notifications, such that only eligible WOSB-certified offerors are advised to proceed. | Offeror's are not required to provide proof of WOSB SBA certification. The Government will validate the status of each Offeror's WOSB SBA certification at time of Phase 1 submission, the time of Phase 2 submission, and the time of award. Exhibit E.1, Section M.2 has been updated to provide clarification. |
| E.1 - Solicitation Sections L & M | Section L.6 - 5., |
Section M.2 Section M.4 Eligibility for Award & Two-Phased Approach
| Adequate Accounting and Estimating Systems | 12 & |
| 20 - 21 | Section L.6(a)(5) states that the Offeror’s accounting system must be determined acceptable or adequate at the time of proposal submission and that an offeror will only be eligible for award if this requirement is met. Given that Phase 1 proposals constitute the initial proposal submission under the two-phased approach described in Section M.4, please confirm whether offerors are required to have an acceptable or adequate accounting system at the time of Phase 1 submission, and whether this requirement will be validated prior to issuing Phase 2 advisory notifications. |
| Additionally, please clarify whether offerors that do not meet this requirement at the time of Phase 1 submission would be considered ineligible to proceed to Phase 2. | Exhibit E.1, Section L.6(a)(5) has been amended to state, "The Offeror’s accounting system must be determined acceptable or adequate at the time of Phase 2 proposal submission." | |||||
| Solicitation - 75FCMC26R0041 | H.1 | CONFLICT OF INTEREST | 33 - 36 | Given that the PPI MEDIC will be responsible for oversight, audit, and validation of Medicare Part C and Part D plan activities, please clarify whether a contractor that provides services to MAOs or PDPs in areas that directly affect payment accuracy, risk adjustment, or audit response would be considered to have an impaired objectivity OCI that is not reasonably mitigatable, due to the contractor effectively supporting and overseeing the same entities. | Conflict of Interest mitigations will be evaluated on a case-by-case basis. As stated in Exhibit E.1, Section M.2, CMS will not enter into a contract with an entity that it determines has, or has the potential for, an unresolved organizational conflict of interest unless it is determined to be in the best interest of the Government to do so. | |
| Solicitation - 75FCMC26R0041 | H.1 | CONFLICT OF INTEREST | 33 - 36 | The solicitation identifies potential organizational conflicts of interest arising from financial relationships between the PPI MEDIC and Medicare Part C and Part D plan sponsors (MAOs, MA-PDs, and PDPs), particularly where such relationships may create impaired objectivity in performing audit, oversight, and enforcement activities. |
Given that the Contractor will be responsible for evaluating compliance and validating activities of these same entities, please clarify whether these OCI considerations apply equally to subcontractors and affiliates supporting a prime contractor. Specifically, would a subcontractor that provides services to MAOs or PDPs in areas such as risk adjustment, payment validation, or audit support be considered to have an impaired objectivity OCI, even if performing work under the direction of a prime contractor?
| Additionally, please clarify whether such conflicts would be considered inherently conflicting due to the overlap in subject matter, or whether CMS anticipates that these types of subcontractor conflicts can be adequately mitigated. | Conflict of Interest mitigations will be evaluated on a case-by-case basis. As stated in Exhibit E.1, Section M.2, CMS will not enter into a contract with an entity that it determines has, or has the potential for, an unresolved organizational conflict of interest unless it is determined to be in the best interest of the Government to do so. | |||||
| E.1 - Solicitation Sections L & M | L.6 | BUSINESS PROPOSAL (VOLUME III) INSTRUCTIONS | 11 | Please confirm the (a) VOLUME III (not II) - BUSINESS PROPOSAL: The Business Proposal shall consist of the following elements, at a minimum: | The Solicitation has been updated to correctly identify the business proposal in Exhibit E.1, Section L.6(a) as Volume III. | |
| Solicitation Sections L & M | L.3 | Proposal Submission | 3 | Will CMS consider a 1-week extension to the Phase 1 submission deadline? | The Phase 1 proposal due date has been extended to April 22, 2026, 10:00:00 AM local time, Baltimore, MD. See updates to Exhibit E.1, Section L.3. | |
| Solicitation | Contract Clauses | 45 | Are self-certified woman owned small businesses allowed to respond to this RFP? | No, offerors must have an active WSOB SBA certification at the time of award. | ||
| Solicitation | Contract Clauses | 45 | If a SBA certification is required, is it acceptable to show that the certification application is in progress at the time of proposal submission? | Offerors must have an active WSOB SBA certification at the time of award. | ||
| Assumptions Questions | ||||||
| E.3 - Assumptions | N/A | Audits-Part D | 1 | Could CMS clarify the expected number of audits associated with Task 2.5 Medicare Prescription Payment Oversight? | Please refer to Exhibit E.3 - Assumptions under recurring internal reports for the M3P report expectations. The expectation is to provide and develop recommendations for oversight of this program. There are no specific audits tied to this task. | |
| E.3 - Assumptions | N/A | Presentations/Conferences (assume travel is required for all) | 2 | The assumptions document identifies four conferences for "Conferences Outside of CMS Hosted Events (may include, but not limited to: PIAM, NHCAA and Durable Medical Equipment (DME) Coordination Meeting (DCM))" |
| Can CMS clarify whether PIAM and DCM will count as two of the four conferences outside of CMS hosted events? | Yes, these are counted in the total number. | |||||
| Exhibit E.3 | NA | Audit- Appeals | 1 | What is the basis of the quantities listed under the assumed number of appeals? Does this represent the number of PDE records, beneficiaries, or plan sponsors? | The estimated quantities are based off past available appeals information from the Part D RAC program. This was based off the number of appeals received by contract and PDE record. | |
| Exhibit E.3 - Assumptions | N/A | Audits - Part C | 1 | The Government notes that of the 22 Ad-hoc Audits, 20 of them will require no data analysis. Will the Government please clarify whether this is true for only the Base Year, or for all Option Years as well? | This is for all option years. | |
| Exhibit E.3 - Assumptions | N/A | N/A | 1 | Will the Government please provide an estimate of how many open Audits, and other items such as Congressional inquiries or FOIA requests, are currently active with the incumbent that will need to be transitioned? | The remaining inventory for transition will be shared via the transitional deliverable schedule during the time of transition. | |
| Exhibit E.3 – Assumptions | Audit Workloads | Audits - Part C | ||||
| Audits - Part D | 1 | In order to appropriately develop a cost and staffing approach, can CMS provide additional detail on the anticipated scope and unit of analysis for each audit type (e.g., record-level, beneficiary-level, contract-level), and whether audit sizing is expected to be standardized or vary significantly by audit topic? | Currently audits are mainly conducted at the beneficiary-level and the sizing of audits vary significantly by audit type and topic. Self-audits are smaller, while National audits tend to be larger in size. | |||
| Exhibit E.3 – Assumptions | Workload | Workload Projections | 1–3 | For purposes of staffing and pricing, should Offerors base assumptions on average workload, peak workload, or a defined surge model when considering the stated ±10% variability? | Average workload. | |
| Exhibit E.3 – Assumptions | Workload | Workload Projections | 1–3 | Are there known periods of increased audit or analytic activity (e.g., seasonal trends, policy-driven surges) that Offerors should consider in staffing and pricing approaches? | Workload is on a rolling basis, so there is not a set seasonal trend. | |
| SOW Questions | ||||||
| J.1 - PPI MEDIC- Statement of Work | 2.4 | CMS Medicare Parts C and D Plan Correspondence Mailboxes | 7 | Could CMS clarify whether the PPI MEDIC is expected to use software outside of Microsoft Outlook to "log" communication received through the Parts C and D Mailboxes? If so, could CMS confirm whether the platform/software used by the current contractor for this purpose is provided by CMS? If it is not, could CMS identify the platform/software currently used to help offerors facilitate continuity? | The contractor would need to log the communications outside of Microsoft Outlook. The contractor would have discretion on the format of logging the communications received. | |
| J.1 PPI MEDIC - Statement of Work | 2.6 | Audits | 7 | "The PPI MEDIC shall be responsible for collecting, tracking, and responding to any inquiries from plan sponsors as a result of RAPs/CAPs." | ||
| Does the scope include monitoring the progress of the plan sponsors against the issued RAPs/CAPs? | Yes, it includes all stages of an issued RAP/CAP. To include, but not limited to, review/approval of submitted RAPs/CAPs, ensuring successful completion of RAPs/CAPs, provide reasonable assessment to CMS, and provide guidance to implement the validation phase of all RAPs/CAPs. There has been an update to Attachment J.1 - PPI MEDIC Statement of Work, Section 2.6 - Audits, to correct language regarding the RAP/CAP. | |||||
| J.1 PPI MEDIC - Statement of Work | 2.6.1.3.2 | Appeal Support to CMS (All Appeal Levels) | 12 | "The Contractor shall establish a process and utilize a CMS designated system for reviewing first-, second-, and third-level appeal submissions and supporting documentation." | ||
| Could CMS clarify which systems are designated or approved for use? | The system currently used is the Payment Recovery Information System Medicare Parts C and D Plan Portal (PMPP). | |||||
| J.1 PPI MEDIC - Statement of Work | 2.6.1.3.2 | Appeal Support to CMS (All Appeal Levels) | 12 | Can CMS confirm whether the scope of support includes the Information Collection Request? | No. | |
| J.1 - PPI MEDIC- Statement of Work | 3.1 | Incoming Transition Requirements | 18 | "Receiving all appropriate data, files, and information from the outgoing contractor. The PPI MEDIC shall verify that all files and information have been received and are in a usable format." | ||
| Can CMS confirm that the code used to produce past data/deliverables will be provided as part of the transition? If so, will the incoming contractor need to convert the code from SAS to a preferred language (e.g., SQL, Python) for recurring deliverables (e.g., quarterly reports)? | The incoming contractor will receive code as part of the transition. Code not already converted into SQL, Python, etc. may need to be converted. | |||||
| J.1 - PPI MEDIC- Statement of Work | 5.5.1 | Primary Sources of Data | 24 | Can CMS clarify what data is needed from Medispan, NCPDP, and First Databank that is not already available in the IDR/One PI and requires a separate license? | As stated in the SOW, the contractor should assume that it will obtain access to these systems independently from the government and should prepare for any licensing fees accordingly. What data may be available in the IDR is not relevant to this determination. | |
| J.1 - PPI MEDIC- Statement of Work | 6.1 | Key Personnel Requirements | 26 | Can CMS confirm whether the determination of the number and types of key personnel roles is at the discretion of the offeror? | Yes, it is at the discretion of the offeror. | |
| Exhibit E.1 | ||||||
| J1. - SOW | M.5.b.1 | |||||
| 6.1 | Key Personnel | |||||
| Key Personnel Requirements | 23 | |||||
| 26 | Are there specific positions that will be designated as key personnel by CMS? What are the requirements for each of the positions? | No, it is at the discretion of the offeror based on the requirements of the SOW and the Offeror's technical approach. | ||||
| SOW | 2.6.1.3.1 | First Level of Appeal (Reconsideration) | 10 | Will the members of the Medicare Part D appeals team be prohibited from working on other contract SOW tasks unrelated to audits? | No, they would be prohibited only on working on tasks related to the audits. | |
| SOW | 2.6.2 | Program Integrity (PI) Audits | 13 | The SOW states: "The PPI MEDIC, as directed by CMS, shall accompany CMS to conduct virtual and onsite audits of plans to review documentation and systems related to risk assessments." How many onsite audits does CMS expect in the base year and each option year? | The workload assumptions assume four PI audits for Base and Option Years. Offerors should assume two onsite and two virtual PI audits for each contract year. For estimating purposes, assume travel to CMS headquarters in Woodlawn, MD for each onsite audit. Exhibit E.3 - Assumptions, has been updated to include this clarification. Also, Attachment J.1 - PPI MEDIC- Statement of Work has also been updated to include "and/or" in section 2.6.2, Program Integrity (PI) Audits, to ensure flexibility in audit location (i.e. virtual or onsite). | |
| J1. PPI Medic Statement of Work | 2.5 | Medicare Prescription Payment Plan Oversight | 7 | Can CMS clarify the expected volume and scope of oversight activities related to the Medicare Prescription Payment Plan (e.g., frequency of audits, complexity of data validation)? | Please refer to the workload assumptions under recurring internal reports for the M3P report expectations. The expectation is to provide and develop recommendations for oversight of this program. There are no specific audits tied to this task. | |
| J1. PPI Medic Statement of Work | 2.5 | Medicare Prescription Payment Plan Oversight | 7 | Will CMS define an ROI framework for evaluating vulnerabilities and overpayment recoveries, or should the contractor propose its own methodology? | The SOW is tasking the contractor to propose recommendations, strategies and methodologies. | |
| J1. PPI Medic Statement of Work | 3.2 | Outgoing Transition Requirements | 19 | Can CMS provide the expected size of the transition inventory (open audits, PSAs, PARs, active UCM cases, open RFIs, or pending appeals) that will be handed over from the outgoing contractor? | The remaining inventory for transition will be shared via the transitional deliverable schedule during the time of transition. | |
| J1. PPI Medic Statement of Work | 2.9 | Pi Reporting for FWA Reporting Module | 15 | Does CMS anticipate changes to PI Portal data elements or reporting standards during the contract period that the contractor should plan for? | CMS does not anticipate changes at this time to the data reporting elements or standards. | |
| J1. PPI Medic Statement of Work | 5.5 | Examples of Medicare Data Sources | 24-26 | Can CMS clarify which specific datasets (IDR, OnePI ADMs, HPMS modules, FPS, etc.) will be fully available to the incoming PPI MEDIC on Day 1 versus those that may require phased access or onboarding? | Access to any CMS systems will require onboarding and obtaining required job codes. | |
| J1. PPI Medic Statement of Work | 2.6.1.3.1 | First Level of Appeal (Reconsideration) | 11 | What specific criteria must the contractor apply when evaluating “good cause” exceptions to the 60 day filing deadline for reconsiderations? | They will be approved on a case by case basis. | |
| J1. PPI Medic Statement of Work | 2.6.2 | Program Integrity (PI) Audits | 13 | For the PI Audits, is it correct to assume that the PPI MEDIC would coordinate with CM compliance audit activities, or would PPI MEDIC activities be completely independent? | PPI MEDIC activities will be completely independent from the CM compliance audits. | |
| J.1 - SOW | Section 6.1 | Key Personnel Requirements | N/A | Section 6.1 of the 2026 SOW (Draft) establishes general Key Personnel requirements but does not include the specific position titles, minimum work experience, and educational requirements that were detailed in Section C of the prior RFP's SOW (e.g., Program Director, Audit Manager, Chief Statistician, Pharmacy Specialist, Medical Director). Will CMS release a section of the SOW specifying the named Key Personnel positions and their minimum qualifications, or should offerors propose Key Personnel roles based on their own assessment of the SOW's critical needs? | CMS will not release specific key personnel requirements. Key Personnel roles are at the discretion of the offeror based on the requirements of the SOW and the Offeror's technical approach. | |
| J.1 - SOW | Section 2.8 | Outreach and Education | N/A | Section 2.8 describes National FWA Training and Outreach and Education Missions. The workload assumptions in Exhibit E.3 identify "Presentation Materials (Number of Events)" but do not specify the number of National FWA Training events or Outreach Missions separately. Should offerors assume that the "Presentation Materials" workload projection encompasses all outreach and education activities, or should offerors propose additional capacity for National FWA Training events beyond what is specified in E.3? | Please refer to Exhibit E.3 - Assumptions for the number of National Training Events (1) and Outreach and Education Missions (3). The offeror should provide presentation materials for all of Section 2.8. | |
| J.1 - SOW | Section 3.1 | Incoming Transition/Implementation Requirements | The SOW states that "the outgoing contractor shall remain in effect during the three-month transition period to assist the incoming PPI MEDIC with transition activities." Please confirm: (a) Will the incumbent (Qlarant) be contractually required to cooperate with the incoming contractor during the transition? (b) Will CMS facilitate introductions and data transfer between the outgoing and incoming contractors, or is the incoming contractor expected to initiate all transition coordination independently? | Yes, the incumbent will be held to contractual transition-out language. CMS will facilitate initial introductions between contractors. |
| J.1 - SOW | Section 2.9 | PI Portal for FWA Reporting Module | N/A | Section 2.9 references the PI Portal for FWA Reporting Module. Please clarify the scope of the contractor's responsibility regarding this module. Specifically: (a) Is the contractor expected to develop, maintain, or modify the technical platform itself, or is the contractor's role limited to data entry, monitoring, and reporting within an existing CMS-maintained system? (b) Are there IT development or system enhancement requirements associated with this task that would require specialized IT staff beyond program analysts? | No, the PPI MEDIC is not expected to develop, maintain, or modify the technical platform. There are no system development or enhancement requirements for this task. | |
| J.1 - SOW | Section 2.6.3 | Ad Hoc Audits | N/A | Section 2.6.3 references "Ad Hoc Audits," and Section 2.6.3.1 specifically addresses Part C Oversight Audits. Does CMS anticipate additional ad hoc audit types beyond Part C Oversight Audits under Section 2.6.3 during the period of performance? If so, should offerors account for additional ad hoc audit capacity in their staffing plans and cost proposals? | These audits are ad hoc and the workload may change accordingly. | |
| J.1 - SOW | Section 2.6.1.3 | Appeals | N/A | The 2026 Business Proposal Template (E.8) includes "Task 2.6.1.3 Appeals" as a separate column for labor hour allocation. However, the 2026 SOW (J.1) does not appear to contain a standalone Section 2.6.1.3 with the level of detail provided in the prior RFP's SOW for Appeals support (which described three levels of appeal: Reconsideration, Hearing Official Review, and Administrator Review). Could CMS confirm whether the Appeals requirements from the prior SOW are carried forward in full in the 2026 SOW, and if so, where the detailed Appeals requirements are located? | The SOW section 2.6.1.3 does outline the three levels of appeals. Section 2.6.1.3.1 outlines the expectations for the offeror in regards to reviewing the 1st level of appeals, the reconsiderations and Section 2.6.1.3.2 outlines the expectations of the offeror in regards to assisting CMS with rebuttals for all three levels of appeals. | |
| J.1 - SOW | Section 2.5 | Medicare Prescription Payment Oversight | N/A | The SOW Table of Contents references Section 2.5 — Medicare Prescription Payment Oversight, but we were unable to locate the full text of this section in J.1. Could CMS please provide the complete requirements for Section 2.5, or confirm whether this section has been incorporated into another task? | This section is in Attachment J.1 on page 7. | |
| J.1 - PPI MEDIC- Statement of Work | 5 | CMS Systems and Data Support | 21 | When a program integrity analytical need is identified that cannot be fully addressed using the tools listed within OnePI/IDR will it be permitted, as a part of the offered strategy for obtaining and analyzing data, to propose and use supplemental analytical tools or platforms? | All work should be done using tools provided within the OnePI/IDR. | |
| Attachment J.1 - Statement of Work | 2 | Tasks | 5 | The SOW states the PPI MEDIC shall perform "a range of FWA proactive data analysis" and collaborate with CMS when data sources are "not fully available." What is the current status of data availability in the IDR and OnePI portal, and are there any known gaps or access limitations the incoming contractor should anticipate? | The contractor should assess the data and work with CMS to address any limitations identified. | |
| Attachment J.1 - Statement of Work | 3.1 | Incoming Transition Requirements | 17 | Will the government please provide the identity an contract number of the current (outgoing) PPI MEDIC contractor that will be active during the three-month transition-in period? | The existing PPI MEDIC contract number is 75FCMC20C0021 and the contractor is Qlarant Integrity Solutions, Inc. | |
| Attachment J.1 - Statement of Work | 3.1 | Incoming Transition Requirements | 17 | Section 3.1 requires the incoming contractor to assume all new workload at contract start while the outgoing contractor completes deliverables due within the three-month transition period. Can CMS clarify how "new workload" will be defined and distinguished from inherited workload? Will there be a written inventory of open cases, audits, and outstanding tasks provided at award? | Work assigned by CMS on or after the contract start date would be considered "new workload". Deliverables that are included on the "Transition Deliverable List" are "inherited" and would be assumed in accordance with the SOW. Attachment J.1 - PPI MEDIC Statement of Work, has been updated to provide clarification on the transitions. | |
| Attachment J.1 - Statement of Work | 3.1 | Incoming Transition Requirements | 17 | Section 3.1 requires all personnel to complete security onboarding before beginning work. What is the typical timeline for CMS security credentialing (ICT) to be completed for a new contractor? | Contractor onboarding, review, and approval is estimated to take 30-39 days. | |
| Attachment J.1 - Statement of Work | 2.6.1.3.1 | First Level of Appeal (Reconsideration) | 10 | The SOW requires the appeals team to be "organizationally and operationally separate" from the audit team, including a "separate supervisory chain of command." Does the Government have an anticipated number of annual appeals so that the Offeror may include this in the pricing for Audits? | Please refer to the workload assumptions "Audit-Appeals". | |
| Attachment J.1 - Statement of Work | 5.5.1 | Primary Sources of Data | 24/25 | Section 5.5.1 notes that Medispan, NCPDP, and First Databank must be obtained independently by the contractor, with the contractor responsible for any associated licensing fees. Can the Government please confirm whether these are the only third-party data sources the contractor is expected to procure and license independently? Are there any other data systems in Sections 5.5.1 or 5.5.2 that will not be government-furnished, so offerors can fully account for licensing costs in their proposals? | Any third-party sources that the contractor needs to procure independently have been listed in the SOW. | |
| Attachment J.1 - Statement of Work | 6.2 | Joint Operating Agreements | 26/27 | JOAs are required with UPICs, I-MEDIC, PIMASCs, QIOs, and SMRC. Are there existing JOA templates that the incoming contractor would use as a starting point, or must these be negotiated from scratch? Will copies of the current JOAs be made available in at transition? | There are existing templates that can be provided to the incoming contractor, however, the incoming contractor must do their due diligence to ensure they are up to date and following all current Agency requirements. | |
| Attachment J.1 – Statement of Work (PPI MEDIC) | 2.6.1.3.1-2 | First Level of Appeal (Reconsideration) | ||||
| Appeal Support to CMS (All Levels) | 10–11 | The SOW requires the Part D appeals function to be independent from the audit function, while also indicating that the audit team supports CMS at all appeal levels. Can CMS clarify the intended operating model, including expectations for organizational separation, to ensure compliant staffing and workflows? | The SOW section 2.6.1.3.1. and 2.6.1.3.2 outline two distinct audit tasks. Section 2.6.1.3.1 outlines the task for the PPI MEDIC to act as the reviewer for the first level of appeal, the reconsideration. This team must be distinctly separate from the audits team. Section 2.6.1.3.2 outlines the task for the PPI MEDIC to assist CMS in the rebuttals for all three appeal levels. This team can be the team that performed the audit. | |||
| Attachment J.1 – Statement of Work (PPI MEDIC) | Section 3 | Transition Requirements | 13–15 | How does CMS define a successful transition-in period, particularly with respect to continuity of ongoing audits, analytics, and stakeholder coordination? | CMS defines successful as a seamless process in which the stakeholder does not notice a shift in activity. | |
| Attachment J.1 – Statement of Work (PPI MEDIC) | Section 2.6 | Audits | 7–13 | What is the expected balance between contractor-initiated analyses/audits and those directed by CMS? | The proportion of contractor-initiated versus CMS-directed analyses and audits is flexible and will be determined by CMS program needs and priorities at any given time. | |
| Attachment J.1 – Statement of Work (PPI MEDIC) | Section 9 | Stakeholder Coordination | 27–31 | Can CMS provide additional clarity on expected coordination and delineation of responsibilities between the PPI MEDIC and other program integrity contractors (e.g., I-MEDIC, UPICs, PIMASC)? | Refer to the SOW tasks for coordination expectations. | |
| Attachment J.1 Statement of Work | 4.1 and 4.2 | Requests for Information from Outside Entities and Requests for Assistance from Outside Entities | 20 | Please confirm the intended role and scope of the contractor’s internal tracking system referenced in Sections 4.1 and 4.2 of the SOW. Specifically, is the internal tracking system intended to support broader workload activities described in the SOW, such as audits and related activities, data analytics efforts, Congressional inquiries, and other program integrity support requests, beyond RFIs and RFAs? | Yes. | |
| Attachment J.1 Statement of Work | Exhibit B, 1, b, ii. and 1.a. | Information Security Requirements and HHS FedRAMP Privacy and Security Requirements | 44 and 52 | In relation to the internal tracking system described above, please clarify whether the requirement for a FISMA High / FedRAMP High ATO applies to any contractor-developed internal tracking system, given that the primary systems and data sources (e.g., IDR, OnePI, HPMS, UCM) are CMS-provided and operate within CMS-authorized FISMA High environments. If the contractor implements an internal tracking or workflow tool, would that system be required to obtain a separate FISMA High ATO, or would it operate within (or be covered by) the CMS system ATO? In addition, what specific types of sensitive information (e.g., PII, PHI, CUI, case-level data) are anticipated to be stored within the contractor system that would necessitate a separate High ATO? | If awarded the contract, the Offeror must obtain a moderate FISMA/FedRAMP ATO for their internal tracking system. Specific sensitive information is not applicable as this work does not warrant a high ATO. |
| Attachment J.1 Statement of Work | 1.3 | Retention and Destruction of Records | 6 | Please provide an estimate of the total cubic footage of boxes currently stored. | We do not have this information. | |
| Attachment J.1 – PPI MEDIC Statement of Work | Section 5 & | |||||
| Appendix B | CMS Systems and Data Support & | |||||
| Information Security Requirements | 21 - 26 & | |||||
| 52 | Section 5 of the SOW indicates that the PPI MEDIC shall utilize CMS-provided systems and datasets (e.g., IDR, OnePI, PMPP, UCM, HPMS) and operate within CMS environments to perform required activities. However, Appendix B includes requirements related to FedRAMP ATOs and obligations applicable to contractor-operated systems and cloud service providers. |
| Please clarify whether the PPI MEDIC is expected to perform all work within CMS-provided systems, or whether the contractor is required or permitted to host, process, or store CMS data within a contractor-operated system. Additionally, please clarify under what circumstances a FedRAMP-compliant ATO would be required for this effort. | If awarded the contract, the offeror can operate their own internal tracking system which would require a moderate FedRAMP ATO. | |||||
| Appendix B- Information Security Requirements | 1 - 6 | HHS FedRAMP Privacy and Security Requirements | 52 - 56 | When interacting with or receiving outputs derived from CMS Medicare data, and not directly storing or processing raw CMS source data, does CMS consider those systems subject to the full FedRAMP ATO requirement, or does the ATO obligation apply only to systems that directly store or process raw CMS-provided data as defined in the DUA? | Any system even if it does not store or process data must still have a FedRAMP ATO. |
Appendix B- Information Security Requirements 1 - 6 HHS FedRAMP Privacy and Security Requirements 52 - 56 Where the Offeror's FedRAMP-authorized system receives CMS-derived analytical outputs , does CMS require such systems reside within a CMS-operated cloud environment, or may they reside in the Offeror's own FedRAMP-authorized environment provided all DUA, FISMA, and TIC 3.0 requirements are met? If awarded the contract, the Offeror may work within the CMS-operated cloud environment.
| Other | |||||
| E.8 - Business Proposal Template | ODCs | Other Direct Costs | N/A | The SOW (J.1, Section 2 — Systems Access/Maintenance) requires the contractor to obtain "Licenses for relevant prescription drug data sets (for example, First Databank, Medispan, NCPDP, Redbook)." Should the cost of these third-party data licenses be proposed as Other Direct Costs (ODCs) in the E.8 template, or does CMS provide access to these datasets through existing government licenses? | Yes, these licenses are billed under Other Direct Costs (ODCs). |
| E.8 - Business Proposal Template | TRAVEL | Travel Estimates | N/A | The prior RFP's Business Proposal Template (Amendment 0001) instructed offerors to "assume $60,000 in travel per year." The 2026 E.8 template does not include a similar travel assumption. Should offerors propose their own travel estimates based on their understanding of the SOW, or will CMS provide a travel budget assumption for the 2026 solicitation? | Offerors should propose their own travel estimates based on their understanding of the SOW |
| N/A | N/A | N/A | N/A | Will the Government please consider extending the submission deadline to April 23rd to allow quoters 15 full government business days to develop a solicitation response that represents the best value to CMS? | The Phase 1 proposal due date has been extended to April 22, 2026, 10:00:00 AM local time, Baltimore, MD. See updates to Exhibit E.1, Section L.3. |
| N/A | N/A | N/A | N/A | Will the Government please confirm that this is solicitation is 100% WOSB set-aside. | This award will be made as a total Women-Owned Small Business Set-Aside in accordance with FAR 52.219-30 RFO. |
| Exhibit E.8 - Business Proposal Template | Summary Tab | Fee/Profit Percentage | Row 152 | Can CMS confirm if the "6%" value associated with the "Fee/Profit Percentage" row in the Business Proposal Template is meant to be representative? | This was included in error and has been removed in the amended version of the Exhibit E.8 - Business Proposal Template. |
| E.8 - Business Proposal Template | Tabs for: CLIN 001-Base Year, CLIN 002-Option Year 1, CLIN 003-Option Year 2, CLIN 004-Option Year 3, CLIN 005-Option Year 4, and ODCs | Tabs for: CLIN 001-Base Year, CLIN 002-Option Year 1, CLIN 003-Option Year 2, CLIN 004-Option Year 3, CLIN 005-Option Year 4, and ODCs | N/A | Where on the E.8 - Business Proposal Template should the offeror price the costs associated with 1.3 Retention and Destruction of Records (from J.1 - PPI MEDIC - Statement of Work)? The E.8 - Business Proposal Template does not include a section for item 1.0 or sub-item 1.3 from the Statement of Work. | The costs associated with Task 1 in Attachment J.1 - PPI MEDIC - Statement of Work should be accounted for under Task 6 - Administrative Requirements. The Exhibit E.8 – Business Proposal Template has been updated to provide this clarification. |
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