J.1 CAG ES SOW_11.09.2022.pdf

STATEMENT OF WORK

COVERAGE AND ANALYSIS GROUP (CAG)

Coverage Review Support

Contents

1. BACKGROUND INFORMATION

2. REQUIREMENTS

3. OBJECTIVE

4. SCOPE

5. Tasks

1. BACKGROUND INFORMATION

The Centers for Medicare and Medicaid Services (CMS) provides health coverage to more than 100 million people through Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace. CMS seeks to strengthen and modernize the Nation’s health care system, to provide access to high quality care and improved health at lower costs.

As part of the Center for Clinical Standards and Quality (CCSQ), the Coverage and Analysis Group (CAG) serves the crucial role of directing coverage policy for the agency. As a core function, CAG reviews evidence behind new and existing items and services to determine the conditions of coverage for Medicare beneficiaries. Based on its assessment of the evidence relative to the reasonable and necessary standard established by the Social Security Act, CAG may delegate determinations to Medicare Administrative Contractors or may instead undertake a national coverage analysis that forms the basis of a uniform national coverage policy.

The intent of this contract is to allow CAG to establish external contractor support to complete needed environmental scans (ESs) efficiently and quickly in support of timely policymaking.

CAG will identify up to 30 high-priority ESs to be completed by the contractor over the period of performance (POP) based on CMS priorities. CAG has identified the following nine (9) categories of scans:

1. Mature Environmental Scan

2. Mature Environmental Scan with Evidence Synthesis

3. Evidence Preview

4. New Technology Add-on Payments (NTAP) Review

5. Emerging Environmental Scan with Evidence Synthesis

6. Focused Literature Reviews

7. Policy Reviews

8. Clinical Outcome Reviews

9. Technology Assessments

2. REQUIREMENTS

Independently and not as an agent of the government, the contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the requirements of this Statement of Work

(SOW).

a. Government Ownership of Products:

1.a.1. All products, including software and all utilities (proprietary and non-proprietary) developed to support the activities and deliverables of this contract, are the property of CMS. The contractor shall deliver all products, including software and utilities

(proprietary and non-proprietary), and deliverables of this contract at the request of CMS or upon termination of this contract.

b. Risk Management:

1.b.1. The contractor should be prepared to conduct a risk assessment across the specified tasks, to identify any potential risks and necessary mitigation strategies in order to facilitate a smooth operation of the project parameters in the SOW. The contractor should maintain the risk matrix as a living document to be regularly updated in partnership with CMS to maintain proactive risk management.

c. Database Access:

In order to meet the terms and tasks of the contract the contractor shall maintain access to PubMed and EMBASE at a minimum as well as other context-specific databases as appropriate to the topics reviewed.

d. Requirements Regarding Permission to Disclose or Publish Findings Prior To Delivery Order End Date:

1.d.1. The contractor and any consultants or subcontractors agree not to release or disclose, verbally or in writing, information pertaining to the list of topics under review or the results or findings of work (including data collection, analyses, draft or final papers and reports) for the period of this delivery order without obtaining prior written approval of the Contracting Officer’s Representative (COR). The contractor(s) must request approval in advance (minimum 21 days prior to release) and in writing, specifying: who or what is generating the request for advance information; when and how project results/information will be released; and what information would be released. Failure to receive response from the COR does not constitute approval for releasing information.

e. Restrictions on Disclosure of Information and Rights in Data:

1.e.1. Information made available to the contractor(s) by the government for the performance or administration of this effort shall be used only for those purposes and shall not be used in any other way without the written agreement of the Contracting Officer (CO).

1.e.2. The contractor(s) agrees to assume responsibility for protecting the confidentiality of government records, which are not public information. Each contractor(s) or employee of the contractor(s) to whom information may be made available or disclosed shall be notified in writing by the contractor(s) that such information may be disclosed only for a purpose and to the extent authorized herein.

1.e.3. Contractor(s) personnel shall not divulge or release data or information developed or obtained in performance of this effort, until made public by the government, except to authorized government personnel or upon written approval of the CO.

The contractor(s) shall not use, disclose, or reproduce proprietary data that bears a restrictive legend, other than as required in the performance of this effort. Nothing herein shall preclude the use of any data independently acquired by the contractor(s) without such limitations or prohibit an agreement at no cost to the government between the contractor(s) and the data owner which provides for greater rights to the contractor(s).

3. OBJECTIVE

The objective of this acquisition is to complete ESs on up to 30 high priority items as determined by CAG to support CAG evidence review and coverage policy development objectives. During the course of the contract the contractor is expected to assist CAG in improving the efficiency of environmental scans and in improving the quality of the resulting documents. Environmental scans may be classified in nine (9) categories; these categories as well as institutional purposes are outlined below:

• Mature Technology Environmental Scan: Mature Technology Environmental Scans represent a systematic literature review of the available peer-reviewed evidence based upon prespecified patient, intervention, comparison, outcome and time (PICOTS) criteria established by CMS. These environmental scans are intended to represent the current state of the evidence and coverage status of items so that CMS can expedite a formal topic review.

• Mature Technology Environmental Scan with Evidence Synthesis: For these topics, the contractor shall complete the mature ES as above, but will add a qualitative evidence synthesis.

• New Technology Add-on Payment (NTAP) Reviews: These reports are designed to support our medical officers when reviewing externally submitted NTAP applications.

For these reports, the contractor will assist CAG by organizing, summarizing, and supplementing submitted applications within a standardized template.

• Evidence Previews: Evidence previews identify and summarize the available evidence for emerging technologies to support CMS engagement with external stakeholders, and in some cases, to expedite CMS coverage reviews. These reports are completed in a standardized template.

• Emerging Technology Environmental Scans with Evidence Synthesis: Emerging technology environmental scans represent a systematic literature review of the available peer-reviewed evidence based upon prespecified PICOTS criteria established by CMS.

Emerging technologies are those that are relatively new to market and/or those with a very limited evidence base. These environmental scans are intended to assess the current state of the evidence and coverage status of items.

• Focused Literature Reviews / Ad Hoc Supplemental Searches. These focused literature reviews may be used to supplement an Emerging or Mature Environmental Scan. They are intended to identify and summarize the available literature relevant to a focused topic that is related to a primary literature review. For example, after completing a systematic literature review on transcatheter aortic valve replacement, a supplemental literature review may be requested to identify literature supporting the value of the “heart team” in improving patient outcomes.

• Policy reviews. Policy reviews represent a systematic literature review of the available peer-reviewed evidence based on policy topics identified by CMS. These environmental scans are intended to summarize the current state of the evidence to support decision-making around particular policy issues identified by CMS. For example, what is the evidence that higher nursing to patient ratios improve patient outcomes?

• Clinical Outcome Reviews. These reports review the literature to identify appropriate clinical outcomes, meaningful clinical differences, and study durations for specific clinical conditions. These reports may be used to support CMS in interpreting clinical evidence and may be reviewed by expert panels to establish acceptable study outcomes for CMS beneficiaries.

• Technology Assessments. A technology assessment is a systematic review of a technology’s performance characteristics, safety, efficacy, effectiveness, outcomes, appropriateness, and/or economic impacts, with particular emphasis on applicability to the Medicare population.

4. SCOPE

Mature Technologies:

For Mature Technology ESs, the contractor shall review the items and service topic areas and scoping provided by CAG prior to conducting an ES. The contractor shall define an ES development protocol that:

• Applies the key words identified by CAG that will be used in the review of published research;

• Applies the inclusion/exclusion criteria that will be used when reviewing selected publications;

• Defines any specialized populations, criteria, or characteristics that are believed to be of key importance to the ES;

• Identifies any relevant guideline recommendations, consensus statements, and appropriate use criteria;

• Plans a survey of commercial payer coverage; and

• Reviews and summarizes any CMS coverage history.

CAG will review and provide feedback on the protocol. Once a protocol is approved, the contractor shall conduct the ES and provide a summary report to CAG within the applicable time frame. The ES should include English language, human studies, observational studies and randomized controlled trials (RCTs) that are published in the peer-reviewed literature.

Mature technologies have been available in the market for some time and may have a considerably larger evidence base. If the identified literature is very large, the contractor will work with CAG staff to revise the ES scope in order to reach an acceptable number of publications for review. Tables from these ESs will be published by CMS.

Mature environmental scans with evidence synthesis (ES) include the same requirements as a mature environmental scan, but add a detailed qualitative evidence synthesis and strength of evidence assessment. These reports should include a detailed discussion that puts the available evidence in the context of available alternative therapies. The contractor will engage appropriate clinical specialists for each mature environmental scan topic (with or without evidence synthesis) to ensure that the report is clinically accurate and consistent with contemporary practice standards.

During the period of performance of the contract, CAG will provide up to a total of five (5) mature technology scan topics, and CAG will provide up to two (2) mature technology scan topics with evidence synthesis see SOD # 9-10 for timeline.

Emerging Technologies:

For Emerging Technology ESs, the contractor will either receive a Summary of Safety and Effectiveness Data (an FDA document), a bibliography of published studies, and an assigned template or will conduct a systematic literature review of all available published studies. The contractor shall complete the template using the available evidence on the topic. The contractor will summarize any unpublished or peer-reviewed published studies using the standardized format from Appendix A.

Emerging technologies are expected to have relatively fewer published studies (generally < 20).

For emerging technology items and services, the ES purpose is to succinctly summarize a background on the item or service and any available study findings.

• New Technology Add-on Payment (NTAP) Reviews: The contractor will be responsible for reviewing NTAP application materials and any submitted documents. These documents will be abstracted and summarized within the NTAP review template (Appendix B). For any submitted clinical studies, the contractor will assess their strengths and weaknesses, consistent with instructions in Appendix A and will conduct a focused supplemental literature search for any related peer-reviewed publications. Any peer-reviewed publications that meet inclusion / exclusion criteria will be assessed for risk of bias and their applicability to the Medicare Population. During the period of performance, CAG will provide five (5) topics for review (See SOD # 16).

• Evidence Previews: Evidence previews summarize the available evidence for emerging technologies to support CMS engagement with external stakeholders. These reports include a brief background section that summarizes the clinical condition addressed by the technology, abstract information from the Safety & Summary of Effectiveness Document (SSED), and summarize the clinical evidence in the SSED as well as any other peer reviewed publications identified from a focused literature review. The contractor will research CMS coverage history according to instructions in Appendix A.

Any peer-reviewed publications that meet inclusion / exclusion criteria will be assessed for risk of bias and their applicability to the Medicare Population. The contractor will summarize the identified evidence, and will critically evaluate any methodologic limitations of the reviewed literature.

The contractor will engage appropriate clinical specialists for each Evidence Preview topic to ensure that the report is clinically accurate and consistent with contemporary practice standards. During the period of performance, CAG will provide five (5) topics for review; the contractor will produce a report in the format of Appendix C (See SOD # 14).

• Emerging Technology Environmental Scan with Evidence Synthesis: Emerging technologies generally have a less robust peer-reviewed evidence base (< 20 primary citations). For the purposes of this contract, an emerging technology environmental scan includes: (1) a focused literature review; (2) identification of any applicable clinical practice guideline recommendations, consensus statements, and appropriate use criteria;

(3) a summary of the identified literature in standardized text and tables, and (4) a survey of commercial payer coverage. The contractor will write a detailed summary of the identified evidence, complete a qualitative evidence synthesis, and assess the strength of the evidence. These reports should include a detailed discussion that puts the available evidence in the context of available alternative therapies. The contractor will engage appropriate clinical specialists for each topic to ensure that the report is clinically accurate and consistent with contemporary practice standards.

During the period of performance, CAG will provide one (1) topic for review (See SOD # 11).

Focused Literature Reviews:

For focused literature reviews, the contractor will conduct an ad hoc literature search to supplement an already-completed systematic literature review. These supplemental reviews will address a focused aspect of evidence review or policy. For these focused reviews, it is not necessary to create standardized tables. Instead, the emphasis is on creating a brief, polished, summary of the topic along with a bibliography of cited sources. These reviews are intended to address a specific aspect of coverage policy that is related to the parent systematic literature review. For example, a parent systematic literature review may evaluate the evidence that supports that transcatheter aortic valve replacement improves clinical outcomes for Medicare beneficiaries, while a supplemental review may assess whether there is evidence of learning curve for furnishing providers and/or a volume – outcome relationship, both of which may be relevant to conditions of coverage. Publications under this review should be limited to less than 20 and text will generally be only a few paragraphs. CAG will provide a total of three (3) of these report types across the POP (See SOD #15).

Policy Reviews:

CMS will periodically request a literature review of a policy topic when evaluating or reconsidering a policy issue. These reviews will include a systematic or targeted literature review that addresses the question of interest. The contractor shall summarize the search strategy applied, summarize the available evidence, and provide a bibliography of sources. For example, CMS may request a review of the available evidence on optimal nursing ratios in the long-term care setting. The contractor will engage appropriate clinical specialists for each topic to ensure that the report is clinically accurate and consistent with contemporary practice standards. Policy reviews should generally be limited to 50 or fewer citations. CAG will provide a total of three (3) policy review topics during the POP (See SOD # 17).

Clinical Outcome Reviews:

Clinical Outcome Reviews identify clinical outcomes that are applicable to a specific therapeutic area, investigate what constitutes a clinically meaningful difference for each outcome, and consider the optimal duration of study within clinical trials. These reviews may be helpful when assessing the literature for clinical interventions, and they may be used as background material to support expert panels. The report should be a polished document, and generally should not exceed 25 pages of text, exclusive of tables. The contractor will engage appropriate clinical specialists for each topic to ensure that the report is clinically accurate and consistent with contemporary practice standards. These reports should generally include fewer than 50 primary citations. CAG will provide a total of four (4) of these clinical outcome reviews during the POP (See SOD # 18).

Technology Assessments:

A technology assessment is a systematic review of a technology’s performance characteristics, safety, efficacy, effectiveness, outcomes, appropriateness, and/or economic impacts, with particular emphasis on applicability to the Medicare population. Technology assessments include a systematic literature review, qualitative evidence synthesis, and strength of evidence assessment. These reports should include a detailed discussion that puts the available evidence in the context of available alternative therapies. The contractor will engage appropriate clinical specialists for each technology assessment topic to ensure that the report is clinically accurate and consistent with contemporary practice standards.

These reports should generally include fewer than 50 primary citations, and CAG will provide a total of two (2) of these technology assessments during the POP (See SOD # 13).

Report Revisions:

CMS routinely meets informally with manufacturers and stakeholders to receive feedback on potential coverage policies; CMS always receives public comment on proposed coverage determinations. Through these interactions, CMS may determine that limited revisions are needed to a previously performed environmental scan. For mature environmental scans, in some cases, CMS may need to postpone a formal review beyond 6 months of the environmental scan date; CMS may also identify that an applicable study was inadvertently excluded from an environmental scan. For emerging environmental scans, some published studies may be missed in a conventional literature review due to changes in terminology or because of the timing of publications. Additionally, Evidence Previews are conceived as an iterative review process during which the manufacturer may provide feedback on a draft report.

If CMS concludes that changes or updates to a completed report are warranted, the contractor shall work with CMS to make any needed revisions. For mature environmental scans, the manufacturer will refresh or modify the report when needed to incorporate any missing studies.

For Evidence Previews, the manufacturer will review the manufacturers feedback and revise the report in a fashion that preserves high standards of scientific integrity. Where applicable, the contractor shall provide a rationale for why they disagree with stakeholder feedback. See Task 11 for further details. CAG encourages the contractor to collaborate with us in making operational improvements that avoid the need for revisions.

5. Tasks

Independently, and not as an agent of the government, the contractor shall provide the personnel and services necessary to successfully achieve the objectives of this acquisition.

1) Task 1: Project Management

a. Project Workplan (SOD #1): The contractor shall maintain a Project Work

Plan/Timeline which describes by task, deliverables, as appropriate; techniques or methodologies to be used to complete or manage the task; associated due dates;

staff assignment; quality assurance; and evaluation methods to be used to track and evaluate performance during the Project period. The contractor shall submit a draft Work Plan to the COR for comment and approval prior to the work plan being finalized. The Work Plan shall be maintained as a living document and include a list of any action items identified and the associated due dates as well as the responsible party for completing the action item. The Project Work Plan shall be submitted within 10 business days of the contract award. Any modifications made to the Work Plan across the POP due to unforeseen changes shall be submitted to the COR with the Monthly Progress Report at that time period.

b. Kick-off meeting (SOD #2): At the kick off meeting the contractor shall work with the CMS personnel to develop a project management plan, and lay out the relative timelines to meet all deliverables and work within the SOW. The meeting shall include at a minimum the following information:

i. A list and timeline of all deliverables necessary to ensure completion of the activities described in the Project Statement of Work (created and maintained in Microsoft Office format);

ii. Reporting expectations;

iii. Other general Project expectations and milestones; and

iv. A finalized report (SOD #3) of the kick-off meeting shall be submitted to the COR after the kick-off meeting with any relevant changes, assumptions, or addressed comments to the project management plan.

c. Weekly conference calls (SOD #4): The contractor shall arrange weekly conference calls with the COR, and project team to review the tasks outlined in the SOW and the details of the Project Management Plan and Work Plan, progress toward meeting the work plan tasks, barriers to completing the work, and other issues associated with the work in this Project. The contractor shall provide a meeting agenda (SOD #5) and any associated handouts to the COR. Minutes or a summary of the call (SOD #6) shall be submitted to the COR after the call. The minutes shall include at a minimum a list of all attendees, a high-level summary of the discussion, decisions and action items.

d. Ad Hoc Calls (SOD #7): The contractor should be prepared to facilitate ad hoc calls dependent on project team schedule to support ongoing project tasks, and technical discussions. Ad Hoc calls will not require Meeting Minutes or formal Agenda to be submitted.

e. Monthly reports (SOD #8): The contractor shall submit a progress report of the previous month’s efforts. Each report shall include at a minimum, any updates to the Work Plan and the following information organized by Task:

i. A summary of the previous month’s project activities accomplishments;

ii. The progress status and an update on each requirement by Task, potential problems encountered and plans for resolution, alerts, issues or risks;

iii. Upcoming deliverables in next four (4) months, and

iv. Any current and ongoing scans with appropriate categorization;

v. Planned versus actual expenditures to date of funds/hours remaining for clinical expertise utilization (discrepancies greater than 10 percent shall be noted).

2) NTAP Reviews

a. Abstract and distill applicant-submitted materials and SSED sections into NTAP review template.

b. Review submitted publications

c. Conduct supplemental literature search to identify related publications.

d. Create summary text and standardized tables (SOD #16).

e. Assess risk of bias and applicability of individual studies.

3) Develop Draft Protocol for each Mature Technology Environmental Scan with or without Evidence Synthesis

a. The contractor shall apply the key words to be used in the review of published literature and suggest refinements if required.

b. The contractor shall apply the inclusion/exclusion criteria that will be used when reviewing selected publications and suggest refinements if required.

c. The contractor shall examine any specialized populations, criteria or characteristics believed to be of key importance to the ES.

d. Provide draft defined protocol (SOD #9) to CMS as per the schedule of deliverables.

e. Complete a Commercial Payer Survey using a web search for any publicly available coverage policies from the largest five (5) commercial payers (United Healthcare; Kaiser Permanente; Anthem; Humana; and CVS Health). The contractor will summarize them in a commercial payer survey table (Appendix A).

f. Reviews and summarizes any CMS coverage history.

4) Develop Final Protocol for each Mature Technology Environmental Scan with or without Evidence Synthesis

a. The contractor shall conduct a web-based meeting, or consult with CAG staff and managers at the established weekly meetings to propose finalization of the draft protocol for each ES.

b. The contractor shall incorporate feedback from CAG, if provided, and share a final draft protocol via a web-based meeting, or weekly meeting if needed.

c. The contractor shall obtain CAG approval of the draft protocol and finalize the protocol

d. Provide final protocol (SOD #10) to CMS as per the schedule of deliverables.

5) Develop Emerging Technology Environmental Scan

a. The contractor will be provided an emerging topic and an SSED with bibliography or PICOTS criteria.

b. Write or modify topic-specific background information (condition, patient impacts, existing treatments, description of the item or service, description of the role the item or service plays in treating the condition).

c. Summarize relevant sections from the SSED document (item/service description, indications, contraindications, risks / benefits, FDA approval history, and preclinical evidence)

d. Produce tables consistent with Appendix A (SOD #11) for any unpublished or published, peer-reviewed literature,

e. The Emerging Environmental Scan may be defined as an Evidence Preview using the template in Appendix C or may be conducted in a similar fashion to mature environmental scans, with the sole distinction being that citations are anticipated to be fewer than 20. CAG will provide instructions for each topic (SOD #14).

6) Conduct Environmental Scan & Provide Summary Reports

a. The contractor shall execute the ESs within the agreed upon timeframe (e.g., 15 business days for Emerging, or 20 business days for Mature Technology reviews).

b. The contractor shall submit the ES summary reports (SOD #12) to CAG. Each report shall include at a minimum the following when applicable but not limited to:

i. a revised inclusion / exclusion table

ii. a standardized paragraph including information sources, search strategies, and study selection processes

iii. a literature flow diagram and a standardized description of included studies

iv. a study characteristics table

v. a study outcomes table

vi. a table listing any unincluded studies along with a brief rationale

vii. a table listing any applicable evidence-based guidelines, professional society recommendations, consensus statements, or appropriate use criteria

viii. a Commercial Payer Survey table

ix. a PDF copy of any referenced documents

x. improvements to Appendix A to provide greater clarity to reviewer

7) Conduct Focused Literature Reviews The contractor shall respond to up to three (3) requests from CAG within the agreed upon timeline (including review and approval by CAG) for completion.

Performance of the tasks shall include the following:

• CAG will identify a specific issue that requires additional investigation.

• The contractor will perform a focused literature review to identify peer-reviewed publications that address the issue.

• The contractor will write a focused summary of the available evidence

(generally less than 3 paragraphs) and provide the summary along with a bibliography and any associated PDFs (SOD #15).

8) Conduct Policy Reviews

a. Meet with CMS requestor to assist with clarifying and focusing a specific policy question.

b. Propose a search strategy, search terms, and time-period for search (e.g., studies, since 2015).

c. Conduct a literature review to identify applicable studies.

d. Product a report that includes a background section, question posed, search strategy, summary of identified evidence, assessment of identified studies, and a brief 1 – 2-page discussion of the findings (SOD #17).

9) Conduct Clinical Outcome Reviews

a. Meet with CAG to discuss and clarify the clinical topic and the review objectives.

b. Conduct focused review of outcomes of interest, clinically meaningful differences, and appropriate duration of study within clinical trials.

c. Group clinical outcomes by domain (E.g., intermediate, clinical outcomes, patient reported outcomes, quality of life outcomes, etc.)

d. Prioritize measures within groupings by citation frequency in the reviewed literature.

e. Create a formal report that identifies the topic, question, search strategy, and summarizes the findings. Display the outcomes in organized tables. Provide a bibliography. The report generally should not exceed 25 pages (SOD #18).

10) Technology Assessments

a. The contractor shall be prepared to provide up to a maximum of two (2)

Technology Assessments (SOD #13). As specified in §731 of the Medicare Modernization Act of 2003 (MMA), CMS is required under certain conditions to consult with outside experts during the NCD process. CMS purchases Technology Assessments (TA), systematic reviews and topic refinements to satisfy this requirement. A TA is the systematic review of a technology’s performance characteristics, safety, efficacy, effectiveness, outcomes, appropriateness and/or economic impacts.

TAs include a wide range of activities such as:

• Notification of technology selection and initial consultation with CAG,

• collecting and analyzing data,

• synthesizing and grading evidence, and

• return to CAG assessment and findings

TAs provide the best scientific and clinical evidence available concerning the effectiveness of various medical therapies, and the highest attainable level of expertise to evaluate that evidence. Given the intensive nature of TA’s, sourcing limitations will be established by CAG and the contractor to complete two (2) Technology Assessment (TA). CAG defines a TA as a systemic review with a maximum of up to 50 studies included for analysis and a return assessment no longer than 25 pages (SOD #13).

11) Feedback Loop/Quality Assurance Reviews / Environmental Scan Refresh

a. CAG will identify for the contractor appropriate scans requiring revision with addition of new materials or manufacturer details.

b. The contractor will work with the CAG project team to identify the scope of revisions necessary as well as any missed materials creating material changes to the documents

c. The contractor will conduct the necessary review and revisions and resubmit the revised materials to the project team.

12) Provide a Summary Document to CAG Capturing All Outputs of All Scans The contractor shall provide a summary document (SOD #19 Draft) to CAG that includes a description of all ESs, the defined purpose of each ES, and a brief summary of any literature identified by the ES. The key goal of this data collection is to establish an efficient way for us to produce periodic assessments of coverage policy development and the ES process. Note that not all fields will be available to the contractor when the ES is performed and should be left blank:

a. Number and type of environmental scans performed;

b. Timing of ES completion process;

c. Timing of coverage pathway progression;

d. Unpublished studies reviewed;

e. Published studies reviewed;

f. Generalizability to the Medicare population;

g. Duration of studies reviewed;

h. Nature out outcome variables studied;

i. Number of applicable guidelines and consensus statements.

CAG has developed a draft template (Appendix E) with a suggested structure and definitions. The contractor should provide recommendations on other data points that may inform the stated goals or structure changes to the spreadsheet. The spreadsheet may be provided in either Excel or Access format. The contractor shall submit the final summary document (SOD #19 Final) prior to the end of the base period and the option period(s). The contractor should be prepared to bring a draft version to Lessons Learned meeting as a point of discussion for improvement.

13) Conduct Lessons Learned Meeting with Project Team

The contractor will conduct a Lessons Learned Meeting (SOD #20) with CAG project team members to identify, and document potential process improvements, identified challenges across the work completed, future risks, and potential gaps in analysis that may provide value to the project team. The contractor should document the results of this meeting in an After-Action Report (AAR) (SOD #21), and provide a copy to the COR. The document will be maintained as a living document by the contractor to be updated across the Option Period and further refined.

14) Clinical Subject Matter Expert (SME)/Key Informant Support

Outside clinical subject matter expertise is used to supplement CMS' internal expertise and to allow an unbiased and current deliberation of "state of the art" technology and science. The clinical subject matter expert reviews and evaluates medical literature, reviews technology assessments, public testimony and examines data and information on the benefits, harms, and appropriateness of medical items and services that are covered under Medicare or that may be eligible for coverage under Medicare. The clinical expert judges the strength of the available evidence and makes recommendations to CMS based on current clinical evidence.

For Mature Environmental Scans, Mature Environmental Scan with Evidence Synthesis, Evidence Previews, Emerging Environmental Scans with Evidence Synthesis, Policy Reviews, Clinical Outcome Reviews, and Technology Assessments / Policy Assessments, CMS requires contribution and review by clinical subject matter experts appropriate to the topic. The clinical specialist should ensure that the report contents are consistent with contemporary clinical standards, appropriately reflect important clinical considerations, and that any findings are put in clinical context.

The contractor should be prepared to identify, incorporate, and onboard clinical subject experts as consultants as needed to support these reports. The number of hours allocated to each report type varies as follows:

(1) Mature Environmental Scan, 20 hrs;

(2) Mature Environmental Scan with Evidence Synthesis, 40 hrs;

(3) Evidence Previews, 20 hrs;

(4) Emerging Environmental Scans with Evidence Synthesis, 40 hrs;

(5) Policy Reviews, 40 hrs;

(6) Clinical Outcome Reviews, 20 hrs; and

(7) Technology Assessments / Policy Assessments, 160 hrs.

The degree of clinical support required for each report type is a general estimate, and if fewer hours are used for one report, they may be reallocated to another report based on need and approval by COR/Technical Lead. The total number of available hours should not exceed 840 hrs.

15) Coding Support (OPTIONAL)

a. To be exercised at the discretion of CAG, the contractor will be prepared to provide coding support to all five (5) individual Evidence Preview topics that require this specialized support.

b. A coding review will identify assess the available diagnostic and procedural codes that might apply to the topic, by setting.

c. The contractor should be prepared to conduct a horizon scan utilizing public materials, CMS provided data, etc. to identify any applicable codes.

d. SME Review and identification of applicable codes.

e. Document associated coding paradigms within report for CAG (SOD #22).