Amendment_2_and_Remaining_Questions.docx

RFP-CMS-MIDS-2013-0001

Amendment 0002 Responses to Solicitation Questions and Solicitation Amendments

AMENDMENT 0002

UMBRELLA IDIQ

1. Under SECTION J – Attachments:

(a) REPLACE the following attachments:

J.2 – C ESRD Schedule of Deliverables J.3 – C ESRD Schedule of Deliverables

(b) Attachment J.3-B, Section A – Statement of Work (SOW), REVISE Chapter 7 - Reports/Approval Packages TO READ:

In accordance with (IAW) Chapter 7 of the MIDS USOW, the contractor shall carry out all work/tasks described in sections 7.A. – 7.G. Work/tasks required in section 7.H. are not required for this TO SOW.

(c) Attachment J.3-B, Section A – Statement of Work (SOW), Chapter 9 – Public Reporting/Compare Sites, part b.12, DELETE:

See USOW Chapter 2 § D-508 Compliance

REPLACE WITH:

See Section H.7 SECTION 508 – ACCESSIBILITY OF ELECTRONIC AND INFORMATION TECHNOLOGY under the BASE IDIQ

2. Under Subsection L.15 TECHNICAL PROPOSAL INSTRUCTIONS

(a) Subsection L.15.C - Task Order 0001 Response, ADD the following:

(Task Order 0001 page limit is independent from the Volume II page limit. There is a 35 page limit for task order 0001 proposal, which is not part of the 60 page limit of the Technical Proposal)

TASK ORDER 0002

1. Under TECHNICAL PROPOSAL INSTRUCTIONS, Section B - Past Performance, ADD the following language:

Offerors and proposed subcontractors shall limit the number of Past Performance Questionnaires (PPQs) submitted to no more than 10 each.

2. Under PROPOSAL INSTRUCTIONS, Section D - Proposals Submission, REVISE the date that proposals shall be mailed or hand-delivered so that they are received, no later than 2:00 PM local prevailing time on July 8, 2013.

3. Under EVALUTION CRITERIA, DELETE Business Proposal Evaluation Criteria and REPLACE WITH the following:

Award will be made to the Offeror(s) whose proposal offers the best overall value to the Government. This will be determined by a trade-off technique that allows the Government to consider award to other than the lowest cost Offeror or other than the highest technically rated Offeror. It permits tradeoffs among cost and non-cost evaluation factors. Offerors are advised that primary consideration will be given to the technical quality of the proposals in the evaluation process. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. The non-cost evaluation factors are as follows:

The non-cost evaluation factors are approximately equal in importance to each other, with the exception of Technical Approach which is of the highest importance. CMS will conduct a cost realism analysis.

TASK ORDER 0003

1. Under TECHNICAL PROPOSAL INSTRUCTIONS, Section B - Past Performance, ADD the following language:

Offerors and proposed subcontractors shall limit the number of Past Performance Questionnaires (PPQs) submitted to no more than 10 each.

2. Under PROPOSAL INSTRUCTIONS, Section D - Proposals Submission, REVISE the date that proposals shall be mailed or hand-delivered so that they are received, no later than 2:00 PM local prevailing time on July 8, 2013.

3. Under EVALUTION CRITERIA, DELETE Business Proposal Evaluation Criteria and REPLACE WITH the following:

Award will be made to the Offeror(s) whose proposal offers the best overall value to the Government. This will be determined by a trade-off technique that allows the Government to consider award to other than the lowest cost Offeror or other than the highest technically rated Offeror. It permits tradeoffs among cost and non-cost evaluation factors. Offerors are advised that primary consideration will be given to the technical quality of the proposals in the evaluation process. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. The non-cost evaluation factors are as follows:

The non-cost evaluation factors are approximately equal in importance to each other, with the exception of Technical Approach which is of the highest importance. CMS will conduct a cost realism analysis.

END OF AMENDMENT

Attachments:

J.2-C HQI Schedule of Deliverables J.3-C ESRD Schedule of Deliverables

IDIQ QUESTIONS AND RESPONSES

1. Question: Would CMS consider extending the due date for proposal submission?

Response: The due date for the Umbrella IDIQ and Task Order 0001 will remain unchanged at June 27, 2013. However, the due dates for task orders 0002 and 0003 are being extended to July 8, 2013. Please see amendment for changes.

2. Section Number: H.5 CMS INFORMATION SECURITY (APR 2013) Section & Title: All sections of the CMS Information Security Document Question: The new (April 2013) CMS Information Security Document is written as if the audience and applicable contractors and subcontractors are organizations that are engaged in the business of running CMS Computer Facilities and/or have outsourced contracts from CMS for the purpose of processing significant amounts of CMS information. This document does not appear to take into account small businesses, contractors, or sub-contractors who are doing very specific, limited in breadth and duration, research and analysis on behalf of CMS. The requirements seem to be inappropriate for a much different class of contractor and size of organization. Would you please clarify the intent of these new requirements and the breadth of expectations?

Response: The intent of these requirements are to ensure that all CMS Information is protected and that process used to protect this information is in line with Federal Information Security and Management Act (FISMA). These requirements are to be implemented as a method of protecting all CMS information and information systems by small businesses, contractors and subcontractors. Those organizations that are research are often managing sensitive information are required to protect any CMS sensitive data, and must meet the requirements for protecting this information including the background checks required for managing any sensitive information.

3. Section Number: H.5 CMS INFORMATION SECURITY (APR 2013) Section & Title: All sections of the CMS Information Security Document Question: Does CMS consider any system used by the Contractor and Subcontractors in response to this project a Federal Information System? Alternatively, please provide a clear definition of “Federal Information System” so that we can make a determination of what systems will or will not need to meet those requirements.

Response: Yes, it is expected that any information system that stores, processes, or manages CMS information should be part of a CMS FISMA system. Otherwise, it would be considered a data breach. Such a designation will require a substantial amount of regulatory compliance so we wish to be clear in our understanding.

A Federal Information System is a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information in accordance with defined procedures, whether automated or manual. [OMB Circular A-130, Appendix III] An interconnected set of information resources under the same direct management control, which shares common functionality. A system normally includes hardware, software, information, data, applications, communications, and people. [OMB Circular A-130] A discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information. [NIST SP 800-53]

3. Section Number: H.5 CMS INFORMATION SECURITY (APR 2013) Section & Title: 1.2.2.1 POSITION SENSITIVITY DESIGNATIONS Question: Does Homeland Security Presidential Directive 12 (HSPD-12) apply to this project? Will CMS provide the associated card readers and what is the extent of applicability of these card readers, e.g., are they required on all clients (laptops and desktops) as well as servers?

Response: Yes, the Directive does apply. It is expected that the contractor/subcontractor has made the arrangements for implementing this Directive as a part of their responses to any requests for information.

4. Section Number: H.5 CMS INFORMATION SECURITY (APR 2013) Section & Title: 1.2.2.4 SYSTEM AUTHORIZATION AND ASSESSMENT Question: Are systems, which either exist or are developed for use by the Contractor and Subcontractor in response to this project considered to be Federal Government Information Systems? If they are considered Federal Government Information Systems, then a Government Authorization to Operate (ATO) is required. We need information explaining the process and time required to obtain such an ATO as the requirement is that this must be in place before going into operating and processing CMS information?

Response: Yes, as described in the above response. For information regarding ATO, please visit the following link where you will find the RMH Volume 1 Chapter 1 Risk Management in the XLC: http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-Items/RMH-Vol-I-Chapter-01-Risk-Management-in-the-XLC.html?DLPage=1&DLSort=0&DLSortDir=ascending. This will also identify all guidance Templates, Standards, and the Acceptable Risk Safeguards (ARS) 1.5 needed to implement Security Assessment and Authorization Process. They are available in the Information Security Library: http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Information-Security-Library.html.

5. Section Number: H.5 CMS INFORMATION SECURITY (APR 2013) Section & Title: 1.2.2.4.B SYSTEM AUTHORIZATION AND ASSESSMENT Question: Section B requires an “independent” Security Assessment. Please define “independent?” The requirements go on to state that the Contractor shall allow CMS employees (or designated third-parties) to conduct Security Assessment activities of the Contractor’s procedures, standards, systems, and infrastructure. As a major contractor to the Government and non-Government entities we conduct work for a number of organizations on shared computing facilities. Many of these organizations, chiefly the Department of Defense, prohibit us from allowing other parties access to our computing environment. How do we reconcile these incompatible requirements of two different Government agencies?

Response: Independent - Any individual or group capable of conducting an impartial assessment of an organizational information system. Impartiality implies that the assessors are free from any perceived or actual conflicts of interest with respect to the developmental, operational, and/or management chain associated with the information system or to the determination of security control effectiveness. Independent security assessment services can be obtained from other elements within the organization or can be contracted to a public or private sector entity outside of the organization. Contracted assessment services are considered independent if the information system owner is not directly involved in the contracting process or cannot unduly influence the impartiality of the assessor or assessment team conducting the assessment of the security controls in the information system. [NIST SP 800-53]

Regarding incompatible requirements, this is an architectural question that you may want to identify as early as possible.

6. Section Number: H.5 CMS INFORMATION SECURITY (APR 2013) Section & Title: 1.2.1.2 INFORMATION SECURITY AWARENESS TRAINING Question: In the first paragraph of Section 1.2.1.2 of the CMS Information Security Document, which is incorporated as part of section H.5, specifies "Contractor employees having the above access shall complete an annual CMS-specified refresher course during the period of performance of a contract." As an organization that has numerous contracts with various Federal agencies as well as non-government organizations we have standardized information security training that we require of all employees and users of our computing environment. To properly respond to your solicitation we need to understand what the "CMS-specified" training is. Would you please provide an appropriate reference or the material so that we can properly assess the extent of additional work required to accommodate "CMS-specified" training rather than using our standardized training?

Response: All users of CMS information systems must be exposed to security and privacy awareness materials at least every 365 days. Users of CMS information systems include employees, contractors, students, guest researchers, visitors, and others who may need access to CMS information systems and applications. This training is CMS specific and is provided prior to having access to the CMS network.

7. Section Number: H.5 CMS INFORMATION SECURITY (APR 2013) Section & Title: 1.2.2.1 COMMON SECURITY CONFIGURATIONS Question: The first sentences of this section states "The Contractor shall apply approved security configuration to IT that are used to process information on behalf of CMS." What mechanism / organization is being used to determine what is and is not an approved security configuration?

Response: The Department of Health and Human Services requires that all Operating Divisions utilize the following Minimum Security Configuration Standards for processing information on behalf of CMS: https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-Items/CMS1222638.html?DLPage=1&DLSort=0&DLSortDir=ascending.

8. Section Number: H.5 CMS INFORMATION SECURITY (APR 2013) Section & Title: All sections of the CMS Information Security Document Question: There are no references to Apple Macintosh systems or the MacOS Operating System. We utilize Microsoft Windows as well as Apple Macintosh OS systems for our work. We also make use of Linux, Solaris, and variants of the UNIX operating system. Can you please comment on any limitations or requirements with particular regard to MacOS based systems that you expect us to comply with?

Response: Please review the United States Government Configuration Baseline (USGCB) and the National Checklist Program (NCP) for any questions regarding the use of operating systems as a part of the CMS network. At this time, those are the only operating systems that are utilized on the CMS Network. See the following: https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-Items/CMS1222638.html?DLPage=1&DLSort=0&DLSortDir=ascending.

9. Section Number: H.5 CMS INFORMATION SECURITY (APR 2013) Section & Title: 1.2.2.2 TRACKING AND CORRECTING SECURITY DEFICIENCIES Question: In this section, there is a requirement that high-risk deficiencies are mitigated within 30-days and moderate-risk deficiencies are mitigated within 90-days. “The Government will determine the risk ration of identified deficiencies.” What is the means by which the Government will notify all Contractors and Subcontractors of a deficiency? Will CMS provide the specific means of mitigation? What will determine the date of identification?

Response: All contractors are notified of this deficiency immediately by the Enterprise Information Security Group regarding any deficiencies either High, Moderate, or Low. A recommendation will be provided to assist in mitigating the risk of the deficiency. These deficiencies are tracked via a repository and notifications are generated accordingly and the type of deficiency is reviewed. The date of identification is the date the deficiency was identified.

10. Section Number: L.17 VOLUME III – CONFLICT OF INTEREST AND COMPLIANCE PROGRAM PROPOSAL INSTRUCTIONS Section & Title: TAB A: Organizational Conflict of Interest – Summary List of Contracts Question: In defining “contracts”, are “grants” to be included in the Summary List of “Contracts”?

Response: If the grants are relevant and of similar work and meet the requirements under Section L.15.B.2, they should be included.

11. Section Number: N/A Section & Title: N/A Question: CMS’s response to Question 188 conflicts with the responses to Question 178 and 184. Can you please confirm what exactly is included in the 60 page limit for Volume II? If the 60 page limit includes Task Order 1, will you please consider increasing the page limit for the Umbrella proposal?

Response: In reference to questions 177, 178, 184, and 188, please disregard previous responses and the modified response is as follows: The 60 page limit for Volume II includes Technical Approach, Key Personnel, and Management Plan and Corporate Capacity. Past Performance does not count towards the page limit. CMS is changing its previous response and Task Order 0001 will have a page limit of 35 pages, which is not counted toward the 60 page limit for Volume II. Please refer to amendment.

12. Section Number: N/A Section & Title: N/A Question: CMS has made it clear in numerous responses that the Prime should not be submitting hourly rates with the IDIQ, since CMS will request this when a Task Order is awarded (e.g. responses 17, 18, 19, 47). In contrast, the RFP appears to request sample labor rates for the subcontractors (RFP Section L.14.d.2). Does CMS mean for the subcontractors to submit rates, but not the prime?

Response: The proposal should include actual labor rates for key personnel and the same applies to subcontractors. The responses that CMS provided in questions 17, 18, 19, and 47 was regarding T&M rates which do not need to be included at this time.

TASK ORDER 0001 QUESTIONS AND RESPONSES

STATEMENT OF WORK QUESTIONS

1. Section Number: J1-A Section & Title: TO0001 Outcome Measure Development SOW Question: Please clarify the total number of de novo measures to be developed under this TO contract; specifically, is the expectation that 5 new outcome/efficiency measures will be developed over the entire period of performance, or that 5 new measures will be developed in each year of the TO contract?

Response: Up to 5 new outcome/efficiency measures will be developed over the entire period of performance.

2. Section Number: J1-A Section & Title: TO0001 Outcome Measure Development SOW Question: Please clarify whether the new measures to be developed and the measures to be re-evaluated are intended to be publicly reported on Hospital Compare or on additional new or existing CMS public reporting sites?

Response: The new measures to be developed and the measures to be re-evaluated are intended to be publicly reported on Hospital Compare and/or on additional new or existing CMS public reporting sites such as Home Health Compare, Physician Compare and similar future CMS public sites that may be developed.

3. Section Number: J1-A Section & Title: TO0001 Outcome Measure Development SOW Question: Does CMS anticipate that some or all measures developed under this TO contract will be eMeasures derived from EHRs?

Response: Yes

4. Section Number: J1-A Section & Title: TO0001 Outcome Measure Development SOW Question: Does CMS anticipate that the successful TO contractor will take over responsibility for maintenance of existing hospital measures and if so how many measures would that include?

Response: This is a possibility for certain measures but unknown for certain at the present time and not specifically required in this task order. The number of current measures can be found at https://www.qualitynet.org/.

SCHEDULE OF DELIVERABLES QUESTIONS

22. Section Number: Task Order 0001, Schedule of Deliverables, page 14, J.1-B_Outcome_Measure_Development_Schedule_of_Deliverables.doc Section & Title: Deliverable 47 Question: Deliverable 47 states “Maintain Hierarchical Condition Category (HCC) System.” Is Deliverable 47 required for the Task Order response?

Response: No

TASK ORDER 0002 QUESTIONS AND RESPONSES

1. Section Number: Chapter 4.A.2 Section & Title: Quality Measure Development & Reevaluation/Additional Requirements/More Specific Details/IAW section 4.A.2, Public Comment Question: The RFP states, “The Contractor shall retrieve, review, categorize, summarize, and disseminate public comments received in response to the IPPS and OPPS proposed rules or others….” Can CMS please provide examples of other proposed rules that may require comment summarization?

Response: These are the only two proposed rules to be supported by this contract.

2. Section Number: J.2-A HQI Statement of Work Section & Title: Chapter 4. Quality Measure Development and Reevaluation (page 3) Question: For pricing purposes, please provide an estimate of the number of comments anticipated.

Response: 1,500 to 2,000 per rule.

3. Section Number: J.2-A HQI Statement of Work Section & Title: Chapter 9. Public Reporting/Compare Sites (page 5) Question: How many consumers does CMS anticipate requiring for consumer testing?

Response: Approximately 9 per round of testing. If a topic requires more than 9 subjects for consumer testing, OMB approval will be required.

4. Section Number: J.2-A HQI Statement of Work Section & Title: Chapter 9. Public Reporting/Compare Sites (page 6) Question: The SOW states, “Quarterly, generally beginning three (2) months prior to a HC update and ending with the HC update.” Is this three months or two months? Please clarify.

Response: Should be approximately 3 months prior.

SCHEDULE OF DELIVERABLES QUESTIONS

5. Section Number: [Attachment B; J.2-B] Section & Title: Schedule of Deliverables for MIDS Umbrella SOW Entitled, Hospital Quality Initiatives Measure Implementation Support Question: For CMS MIDS Task Order 0002, the deliverables 6-23 appear to be for IDIQ level and possibly Task Order 0001. Task Order 0002 instructions do not include USOW areas that cover those deliverables or sections of the SOW we are to respond to. The list of deliverables also does not include anything relative to Public Comment, which is included in Task Order 0002 requirements. Please clarify.

Response: Deliverables 6 – 28 do not apply to Task Order 0002. The requirements related to Public Comments are included in Deliverable 51, which is noted both the SOW and the list of deliverables.

6. Section Number: Deliverable No. 43 Section & Title: Schedule of Deliverables for MIDS Umbrella SOW Entitled, Hospital Quality Initiatives Measure Implementation Support/ Deliverable No. 43/“Compare Site” Files and Measures Question: Would CMS please elaborate on the expected content of Deliverable No. 43, “Compare Site” Files and Measures?

Response: This pertains to the final files that get posted to the compare website. We would be happy to provide examples of the formats at kickoff.

GENERAL QUESTIONS

7. Section Number: L.11 Section & Title: General Proposal Instructions for a Multiple Indefinite Delivery Indefinite Quantity (IDIQ) Contract and Task Orders Question: If a non-small business bids on the IDIQ contract and has a small business as part of its team, can the small business bid as the prime on Task Order 2 with the non-small business holding the IDIQ contract?

Response: No, the small business must be awarded the Umbrella IDIQ to receive a Task Order award as stated in the solicitation.

8. Section Number: L.11 Section & Title: General Proposal Instructions for a Multiple Indefinite Delivery Indefinite Quantity (IDIA) Contract and Task Orders Question: Understanding that Task Order 2 is a small business set aside, does the small business have to be the prime of its own IDIQ to bid?

Response: Yes

9. Section Number: Attachment J.2-A/A Section & Title: Technical Proposal Instructions/Technical Approach Question: May offerors include an appendix with the technical proposal?

Response: Yes

10. Section Number: Attachment J.2-A/A Section & Title: Technical Proposal Instructions Question: Will the appendix be excluded from the page limit for the technical proposal?

Response: Yes

11. Section Number: Attachment J.2-A/C Section & Title: Technical Proposal Instructions/Key Personnel and Essential Staff Question: Does the staffing for Task Order 2 require a full-time Clinical Director (a Physician) as described in Task Order 1’s Statement of Work under D. Key Personnel Requirements on page 4?

Response: No

12. Section Number: Volume II – Task Order 0002 Section & Title:

Question: Is the incumbent contractor that supports the hospital quality measurement work described in Task Order 0002 a small business?

Response: No

13. Section Number: N/A Section & Title: N/A Question: Will CMS consider extending the due date for proposals?

Response: CMS has extended the due date for Task Order 0002 and Task Order 0003 proposals to July 8, 2013 at 2:00 PM EST. The due date for the Umbrella IDIQ and Task Order 0001 remains unchanged at June 27, 2013 at 2:00 PM EST. Please refer to Task Order 0002 and 0003 amendments.

TASK ORDER 0003 QUESTIONS RESPONSES

1. Section Number: 1.B Section & Title: Chapter 1. Scope/1.B - Purpose Question: How will the MIDS contract work with the current ESRD Quality Incentive Program (QIP) measures?

Response: Measures developed under the MIDS contract may be considered for implementation in the QIP, in which case the developer will be expected to provide support for rulewriting and responding to stakeholder comments, as well as advising how the measure should be displayed and incorporated in the QIP. Additional support may be required if measure maintenance leads to changes in the measures.

2. Section Number: 1.B Section & Title: Chapter 1. Scope/1.B - Purpose Question: Will the MIDS contract use and validate the work done for the ESRD Quality measures?

Response: The MIDS contractor will develop and test (for validity and reliability) new ESRD quality measures and maintain existing measures. If this question refers to the QIP measures specifically, this contract does not support the production of the annual QIP payment calculation or determination.

3. Section Number: 4.A.1 and 4.B.4 Section & Title: Chapter 4. Quality Measure Development & Reevaluation/4.A – Quality Measure Development/4.A.1 – Technical Expert Panels (TEP)/4.B – Quality Measure Reevaluation/4.B.4 Technical Expert Panel/Additional Requirements/More Specific Description Question: The RFP states, “IAW Sections 4.A.1 and 4.B.4, the Contractor shall convene up to three Technical Expert Panels (TEP)….” May we assume that this means up to three TEP meetings?

Response: This language refers to the need for up to three distinct measure development projects, each requiring a separate panel of experts. The schedule and layout of meetings may depend on the scope of the project and should be proposed by the contractor, and discussed with the Government Task Lead for the contract.

4. Section Number: 5.A – 5.C.1 Section & Title: Chapter 5. Instrument/Item Development/5.A. Developing of Data Collection Tool/Assessment Instrument & Associated Instructions/5.B. – Standards/5.C. – Data Collection Tool/Assessment Instrument Updates/5.C.1. – Updates/Additional Requirements/More Specific Description Question: Since the contractor is to propose new data collection vehicles or changes to existing vehicles, will the contractor also be expected to assist in developing or changing those vehicles?

Response: The contractor will be expected to advise CMS and other relevant contractors on changes to existing data collection tools, such as CROWNWeb or Medicare Claims to support collection of data elements required for measures developed under the contract. It is not the contractor’s responsibility to develop new data collection tools.

5. Section Number: Attachment J.3-A Section & Title: ESRD Task Order 0003, Technical Proposal Instructions, D.4., p. 8 Question: With respect to the Management Plan and Corporate Capacity section of the Technical Proposal, can CMS clarify what is meant by “additional work” for the following requirement: “Address the method to be employed for obtaining labor for additional work?”

Response: In this respect, additional work refers to areas of specialty that are not included in the original project team, due to new areas of measurement identified by CMS, issues raised by TEPs that require additional expertise, or other unanticipated needs. For example, can the Contractor draw from a pool of experts in the field of ESRD, or will new hires be required to fulfill those needs?

6. Section Number: Attachment J.3-A, Section & Title: ESRD Task Order 0003, Technical Proposal Instructions, D.4., p. 9 Question: Can CMS please define the intended audience(s) for and purpose(s) of the “communication strategy.”

Response: The communication strategy should address the lines of communication and points of contact between CMS and the Contractor, as well as components of the Contractor’s project team. The purpose is to ensure that chain of command, authority, and responsibility are well understood by CMS and that CMS will be able to contact the appropriate individual or individuals with project-related questions.

7. Section Number: J3-B Section & Title: 1.B Purpose, Chapter 4. Chapter 6.

Question: How many measures are to developed, tested, and validated under this task order? For example, TO1 specifies 5 measures.

Response: As described in the TO3 SOW, up to three Technical Expert Panels will be convened each year to support the development of new quality measures. The precise number of measures developed under the TO in a given year will depend in part on the recommendations of the panels, as well as CMS program needs. Examples of previous measure development projects include Hemodialysis, Mineral Bone Disease, and Anemia Management.

8. Section Number: Attachment J.3-A Section & Title: Chapter 7. Reports/Approval Packages Question: The Government states that the contractor shall carry out all work/tasks described in sections 7.A-7.g, 7.I (of the USOW). However, the USOW does not include a section 7.I. Can the Government verify whether or not there is an omission from the USOW and provide any missing information that needs to be addressed in Section 7.I.?

Response: These items were renumbered after an adjustment to the USOW was made at a late date. Thank you for providing this correction. For your proposal, Sections 7.A-7.F and 7.H are relevant. Section 7.G, addressing OMB and PRA submissions is not relevant for the purposes of Task Order 3. Corrections to the SOW will be made.

9. Section Number: Section A, Chapter 7 Section & Title: A. Statement of Work, Chapter 7. Reports/Approval Packages Question: Chapter 7 states that all work/tasks in sections 7.A-7.G, 7.I of the MIDS USOW should be carried out and the work/tasks from section 7.H are not required. The Chapter 7 of the MIDS USOW only includes sections 7.A-7.H. Please clarify which section’s work/tasks are required.

Response: These items were renumbered after an adjustment to the USOW was made at a late date. For your proposal, Section 7.G, addressing OMB and PRA submissions is not relevant for the purposes of Task Order 3. Corrections to the SOW have been made.

10. Section Number: Chapter 9 Section & Title: Chapter 9: Public Reporting/Compare Sites Question: In b12, the Task Order #0003 statement of work says refers the contractor to review USOW Chapter 2, Part D-508 Compliance. USOW Chapter 2 does not delineate 508 compliance requirements. Can CMS clarify if and how 508 requirements apply to Task Order #0003?

Response: An earlier version of the USOW included 508 Compliance as part of Chapter 2. 508 Compliance is still required of all deliverables provided to CMS under Task Order 3. Information on this may be found on page 80 of the USOW, under Section H7. See amendment.

11. Section Number: J.3-A - ESRD Quality Measure Development and Maintenance Support Section & Title: Chapter 2. General Requirements Question: Paragraph 5, Sentence 1 refers to "IAW section 2.G., Ad Hoc Requests from CMS." There is not a 2.G. in the USOW. Should this refer to 2.F. of the USOW?

Response: These items were renumbered after an adjustment to the USOW was made at a late date. Corrections to the SOW have been made.

12. Section Number: J.3-A - ESRD Quality Measure Development and Maintenance Support Section & Title: Chapter 2. General Requirements Question: Paragraph 1, Sentence 1 states that "In accordance with (IAW) Chapter 2 of the MIDS USOW, the Contractor shall carry out all work/tasks described in sections 2.A. - 2.G." There is not a 2.G. in the USOW. Should this refer to 2.A. - 2.F. of the USOW?

Response: These items were renumbered after an adjustment to the USOW was made at a late date. Thank you for providing this correction. For your proposal, Sections 2.A-2.F are relevant. Corrections to the SOW will be made.

13. Section Number: J.3-A - ESRD Quality Measure Development and Maintenance Support Section & Title: Chapter 4. Quality Measure Development & Reevaluation Question: In the Additional Requirements listing, Paragraph 2, the SOW states, "Additionally, new or revised measures should measure intermediate outcomes rather than processes to the extent feasible." Will CMS please explain the meaning and provide an example of this statement?

Response: CMS has an interest in developing and implementing outcome and intermediate outcome measures in place of additional process measures where such outcome measures are supported by sufficient evidence. Process measures are acceptable where intermediate outcomes are not supported by currently available evidence. This is generally determined through the environmental scan and expert review from the TEP. As an example, a measure of the proportion of patients attaining an adequate level of dialysis is preferable to a process measure indicating how frequently dialysis adequacy is assessed.

14. Section Number: J.3-A ESRD Quality Measure Development and Maintenance Support Section & Title: Technical Proposal Instructions; C. Key Personnel and Essential Staff Question: Is there an hourly requirement for Key Personnel in the ESRD Task Order?

Response: Project management staff should be available for contact to respond to contract issues or needs within an hour of notification from CMS. This will generally be served by multiple staff with a clear chain of responsibility and authority, but a minimum hourly commitment is not specified. Physician and technical experts should be available to provide key input during periods in the contract dedicated to responding to comments, supporting rulewriting, and advising CMS on technical issues related to the measures.

15. Section Number: Attachment J.3-A Proposal Instructions Section & Title: Technical Proposal Instructions, Section C. Key Personnel and Essential Staff Question: The spectrum of issues listed in this section is very broad. Is this intentional or should personnel have more specialized experiences?

Response: In a given contract year, the required level of expertise may vary depending on the measures under development. Expert-level experience and input will be required for the development of new measures, and the maintenance of existing measures. Individual personnel may bring specialized experiences, but the project team must be able to address a broad array of issues as a consequence of the complex nature of ESRD and its treatment.

SCHEDULE OF DELIVERABLES QUESTIONS

16. Section Number: Deliverable Number 10 Section & Title: Schedule of Deliverables (SOD) for MIDS Umbrella Entitled, “End Stage Renal Disease (ESRD) Quality Measure Development, Maintenance, and Support,” Deliverable 10, Business case for measure concepts, topics and/or candidate measures Question: In fulfilling deliverable 10, may the contractor use the ESRD community guidelines and commonly accepted practices/empirical data for the business case?

Response: These are acceptable sources of information for developing a business case. Empirical data are generally preferable where available. Statutory authority and requirements are also acceptable sources of information for a business case.

17. Section Number: Deliverable 33 Section & Title: Deliverable 33: Award Fee Self-Assessment Question: This deliverable does not map correctly to the MIDS Umbrella IDIQ or the statement of work for Task Order #0003. Please advise.

Response: Deliverable 33 is an artifact from a previous version of the task order, and should not be included in the schedule of deliverables. The Offeror is not required to provide an Award Fee Self-Assessment, or address it in the proposal.

18. Section Number: J.3-B - ESRD Quality Measure Development and Maintenance Support Section & Title: IAW Chapter 8, Deliverable 42 Question: The deliverable is not assigned to any period of performance and there is not a defined Due Date. Will CMS please elaborate on this deliverable and indicate if it is a deliverable under this Task Order?

Response: Deliverable 42 is not a required deliverable under Task Order 3.

BUSINESS PROPOSAL QUESTIONS

19. Section Number: G Section & Title: G. Leave (as appropriate) Question: Will the Government please clarify this request for leave. There is no requirement for Leave in Section G of the contract.

Response: Some contractors include a rate for leave of their employees. If this is not applicable, you are not required to respond.

CONFLICT OF INTEREST QUESTIONS (On an as needed basis)

20. Section Number: Attachment J.3-A, Proposal Instructions Section & Title: Conflict of Interest Proposal Instructions, Tab B (page 11) Question: Will submitting Attachment J.7, Conflict of Interest Certificate, satisfy the requirements of Tab B: Conflict of Interest – Information and Detail?

Response: Please refer to the Umbrella Questions and Answers, question 123 and refer to the amendment which is referenced.

21. Section Number: Attachment J.3-A, Proposal Instructions Section & Title: Conflict of Interest Proposal Instructions, Tab B (page 11) Question: If Attachment J.7, Conflict of Interest Certificate, does not satisfy the requirements of Tab B, what information does CMS require for Tab B?

Response: Please refer to the Umbrella Questions and Answers, question 123 and refer to the amendment which is referenced.

22. Section Number: Attachment J.3-A, Proposal Instructions Section & Title: Conflict of Interest Proposal Instructions, Tab C (page 12) Question: Will CMS release an attachment for the compliance program attestation?

Response: Please refer to the Umbrella Questions and Answers, question 121, Attachment J.7

23. Section Number: Attachment J.3-A, Proposal Instructions Section & Title: Conflict of Interest Proposal Instructions, Tab C (page 12) Question: Does CMS intend for offerors to label both of these tabs as “C”?

Response: Please Refer to the Umbrella Questions and Answers, Question 110: For proposals, please submit TAB C entitled Compliance Program Attestation. Upon contract award, CMS reserves the right to require submission of the TAB C entitled Compliance Program documentation as a contract deliverable.

24. Section Number: Attachment J.3-A Section & Title: ESRD Task Order 0003, Volume III - Conflict of Interest Proposal Instructions, TAB A: Organizational Conflict of Interest – Summary List of Contracts, p. 10 Question: Can CMS clarify what is meant by “The Offerors or Contractors must disclose all contracts, both government (local, state and federal) and non-government currently held with CMS, other government health care agencies, or with non-government entities, as a Prime and/or as a Subcontractor, for itself, its parent company, subsidiaries or other affiliated entities?” The terms of some currently-held contracts have language protecting the identity of the member or client from disclosure.

Response: Please refer to the Umbrella Statement of work Questions and Answers as follows:

Question 112: Please list all contracts related to health care or any that you believe could present a conflict of interest together with a proposed mitigation plan. This requirement applies to the IDIQ and all task orders.

And Question 118: Offerors should ask their clients if the information could be disclosed to the government for award. Otherwise, it will be difficult to determine if a COI exists for the purposes of making an award decision.

25. Section Number: Attachment J.3-A Section & Title: ESRD Task Order 0003, Volume III - Conflict of Interest Proposal Instructions, TAB A: Organizational Conflict of Interest – Summary List of Contracts, p. 10 Question: Regarding Tab A - Organizational Conflict of Interest – Summary List of Contracts, please confirm that the offeror is required to only submit project information for healthcare related projects, not all projects.

Response: Yes, healthcare related projects and those affiliated with those healthcare related contracts, please refer to the answers for the Umbrella Statement of Work, question 112.

26. Section Number: Attachment J.3-A Section & Title: ESRD Task Order 0003, Volume III - Conflict of Interest Proposal Instructions, TAB B: Conflict of Interest – Information and Detail, p. 11 Question: Please confirm that only the prime contractor is required to submit an organizational Conflict of Interest Certificate.

Response: As state in the Responses for the Umbrella Statement of Work, question 120, The Contractor shall require its Subcontractors to follow the same procedures and submit.

27. Section Number: Attachment J.3-A Section & Title: ESRD Task Order 0003, Volume III - Conflict of Interest Proposal Instructions, TAB C: Compliance Program Attestation, p. 12 Question: Tab C – Compliance Program Attestation on Page 12 requires the offeror to submit a compliance program attestation in the format specified by CMS. Can CMS provide the specified format?

Response: Please refer to Attachment J.7 named “Compliance Program Attestation.”

28. Section Number: Attachment J.3-A Section & Title: ESRD Task Order 0003, Volume III - Conflict of Interest Proposal Instructions, TAB A - TAB D, pp. 9-12 Question: Can CMS please confirm if the conflict of interest requirements also apply to the subcontractor?

Response: As state in the Responses for the Umbrella Statement of Work, question 120, The Contractor shall require its Subcontractors to follow the same procedures and submit.

29. Section Number:

Section & Title:

Question: For Tab A: Organizational Conflict of Interest – Summary List of Contracts, are we required to disclose all currently held contracts and subcontracts or only those related to the statement of work for Task Order #0003?

Response: Yes, CMS would like to review all currently held contracts and subcontractors because of how this work will be aligned with the Umbrella Statement of Work.

GENERAL QUESTIONS

30. Section Number: Attachment J.3-A Section & Title: Technical Proposal Instructions (page 5) Question: May offerors include an appendix with the technical proposal?

Response: Yes

31. Section Number: Attachment J.3-A Section & Title: Technical Proposal Instructions (page 5) Question: Will the appendix be excluded from the page limit for the technical proposal?

Response: Yes, the appendix is excluded from the page limit for the technical proposal.

32. Section Number: Attachment J.3-A/F Section & Title: Proposal Instructions, Period of Performance Question: Does CMS have an estimate concerning when the period of performance would start for Task Order 3?

Response: The period of performance for Task Order 3 is anticipated to begin in late September 2013.

33. Section Number: Attachment J.3-A/C Section & Title: Technical Proposal Instructions/Key Personnel and Essential Staff Question: Does the staffing for Task Order 3 require a full-time Clinical Director (a Physician) as described in Task Order 1’s Statement of Work under D. Key Personnel Requirements on page 4?

Response: A full-time Clinical Director is not a strict requirement. That having been said, there are many instances, such as when providing responses to public comments, or during rulewriting, in which ready access to clinical experience will be necessary on relatively short notice (less than 8 hours), and the contractor will be expected to provide this.

34. Section Number: Attachment J.3-A Section & Title: Technical Proposal Instructions (page 5) Question: May offerors use Arial 10-point font for tables?

Response: Type size shall not be less than 12 point.

35. Section Number: L. 15 B Section & Title: ESRD Task Order 0003, Technical Proposal Instructions, Past Performance, p. 8 Question: To whom should we instruct our past performance references to submit their questionnaires? On page 8 of the Task Order 0003 ESRD proposal instructions it says, “…directly to the Contracting Officer…” (who according to page 125 of the RFP would be Brian Hebbel or Kimberly Tatum), but Attachment J.5 instructs references to return questionnaires “Irina Perl…Contract Specialist.”

Response: Please send Past Performance Questionnaires to Irina Perl as stated in Attachment J.5.

36. Section Number: Attachment J.3-A Section & Title: ESRD Task Order 0003, Technical Proposal Instructions, p. 5 Question: Please confirm that only the “Technical Approach,” “Key Personnel and Essential Staff,” and “Management Plan and Corporate Capacity” sections of the Task Order 0003 Technical Proposal are subject to the 35 single-sided page limit.

Response: Correct. However, the resumes of the key personnel are not included in the page limit.

37. Section Number: Attachment J.3-A Section & Title: ESRD Task Order 0003, Technical Proposal Instructions Question: May the offeror include any appendices–that would be considered outside the 35-page limit–to the proposal?

Response: Yes

38. Section Number: Proposal Instructions Section & Title: A. The Offeror’s proposal submission shall consist of:

Question: This list Volume III – Conflict of Interest Proposal. The Offeror is required to submit a comprehensive Volume III – Conflict of Interest and Compliance Program submission under the IDIQ. Please confirm that the Offeror and all Subcontractors are required to submit a separate Volume III – Conflict of Interest Proposal with its Task Order 3 proposal submission.

Response: Yes, however, the RFP notes that if the information duplicates any of the information from the Umbrella IDIQ, your response may refer to your proposed response for the base.

39. Section Number: Proposal Instructions Section & Title: Section C Key personnel Question: What are the educational requirements for these key positions - Program/Project Manager as well as the Principal Investigator (PhD?)

Response: The Principal Investigator, as the lead content expert, is required to possess a PhD and/or MD with a strong research background. The Project Manager, as the individual responsible for coordinating issues between the components of the project team and CMS should have a minimum of a master’s degree related or relevant to project management with experience sufficient for the needs of a project of this scale.

40. Section Number: Proposal Instructions Section & Title: Section D.8 Question: Management Plan and Corporate Capacity/Provide a plan for completing public reporting of ESRD quality measures beginning in January 2014 – is CMS requesting a detailed MS Office Project Plan?

Response: A detailed MS Office Project Plan is required for the project as a whole, but this is not a requirement of the proposal. Included in the proposal should be a method for addressing the needs of continuing quarterly public reporting. The first cycle of reporting supported by Task Order 3 occurs in January 2014. The proposal should include an approach for taking up the timeline and file production to ensure no or a minimal interruption occurs in public reporting on Dialysis Facility Compare (DFC). This includes providing a data file of quality measures to other CMS contractors and relevant documentation to support posting of data on DFC.

41. Section Number: Attachment J.3-A Section & Title: C. Key Personnel and Essential Staff Question: Can Offerors assume that CVs for key personnel, essential staff, support staff, consultants, etc., are excluded from the page limitation?

Response: Yes

42. Section Number: Attachment J.3-A Section & Title: Technical Proposal Instructions Question: Can Offerors assume that the title page, table of contents, and a cross reference matrix provided for ease of review are not counted in the page limitation?

Response: Correct

43. Section Number: J.3-A Section & Title: B. Past Performance Question: p. 7-8 on Past Performance: No limits on the number of PPQs are mentioned here, in contrast to the instructions for umbrella/TO1. Should we limit the number of past performance questionnaires to 10 as required in the IDIQ/TO 0001 response?

Response: Yes

44. Section Number: J.3-A Section & Title: B. Past Performance Question: p. 7-8 on Past Performance: For Past Performance references identified to be sent a Questionnaire for both the Base/TO1 proposal and the TO3 proposal, is it acceptable to ask our clients to complete and submit just one questionnaire that can be referenced for both purposes?

Response: Yes, if the work, evaluator, and all other aspects of the evaluation are the same.

45. Section Number: Proposal Instructions, Technical Proposal Instructions, Section B Section & Title: Proposal Instructions, Technical Proposal Instructions, Section B. Past Performance Question: Does Past Performance count in the 35 page limit?

Response: No, it is not included.