190778_FBO_Medicare_Data_Sharing_Sources_Sought_Notice.pdf

ACA Section 10332 – Medicare Data Sharing Program for Performance Measurement – Program Management Activity

This is a SMALL BUSINESS SOURCES SOUGHT NOTICE. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of qualified small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, and women-owned small business), that can assist CMS in managing the Qualified Entity Program as described in Attachment 1, Draft Statement of Work (SOW). The information from this market research will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered small business under the applicable NAICS code should not submit a response to this notice.

BACKGROUND

The Qualified Entity (QE) Program was established under Section 10332 of the Affordable Care Act (ACA) and expanded under Section 105 of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

The qualified entity regulations at 42 CFR Part 401, Subpart G, establish the criteria that entities must satisfy to obtain QE and quasi QE certification, and set forth the Center for Medicare and Medicaid Services’ (CMS) expectations for maintaining certification. In particular, the regulations provide requirements for entities in the following areas:

• Organizational structure and governance criteria, including necessary experience and expertise in the measures entities intend to use for public reporting;

• Expertise in combining Medicare claims data with claims data from other sources, or in the case of quasi QEs, clinical data;

• Expertise in establishing rigorous data security and privacy programs.

Please see Attachment 1 for additional Security & Technical Requirements.

190778-Medicare Data Sharing Sources Sought Notice

CAPABILITY STATEMENT INFORMATION

Please address your knowledge and experience and how you will provide each of the following points

(A) through (G). Reference where applicable specific items from the Requirements Overview in demonstrating your expertise and experience providing alternate format production and distribution.

(A) Demonstrate your understanding of the Qualified Entity Certification Program (QECP) and Application Process from Phase 1 through 4.

(B) Demonstrate your expertise and experience with techniques and strategies for successfully developing and managing a high profile, politically sensitive project of national scope, focused on measuring the performance of health care providers of service and suppliers, validating the measures, disseminating the results, and involving multiple stakeholders and project partners.

(C) Demonstrate your experience and expertise in successfully managing and overseeing a certification program for third party entities that will be accessing and using Medicare data.

(D) Demonstrate your experience and expertise in utilizing methods, approaches, and processes for evaluating, continually monitoring, and overseeing third party organizations.

(E) Demonstrate your expertise and experience in implementing a quality control process including measuring, reporting, and improving the quality of handling the production and distribution of summary of benefits type documents in alternate formats without degradation to operations and performance standards. Performance standards include document turnaround of five (5) business days from receipt of file, and maintaining formatting for large print documents (large print not applicable to MSNs).

(F) Demonstrate your experience and understanding of developing and evaluating health care quality and health care performance measures.

ADDITIONAL INFORMATION REQUESTED:

Interested parties having the capabilities necessary to perform this requirement may submit capability statements via email to Andrea Ormiston (andrea.ormiston@cms.hhs.gov). CAPABILITY

STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED

ABOVE. Please address each in order listed above under “Capability Statement Information.”

Capability statements shall also include the following information: (Capability Statements shall be limited to 10 pages and shall designate any/all teaming arrangements and the work proposed to be performed by each team member.)

Business Information --

1) DUNS

2) Tax ID

3) Company Name

4) Company Address

5) Company Point of Contact, Phone and Email address

6) Current GSA Contracts

a. Schedule

b. 8(a) STARS GWAC mailto:andrea.ormiston@cms.hhs.gov

c. Vets GWAC

d. OASIS SB Contract and Pool

7) Do you have a Government approved accounting system? If so, please identify the agency that approved the system.

8) Business Size Status (e.g., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) for the applicable 2017 NAICS code, 541990 All Other Professional, Scientific, and Technical Services. Additional information on NAICS codes can be found at www.sba.gov.

9) Any potential government contractor must be registered on the SAM located at https://www.sam.gov/portal/public/SAM/.

10) Point of Contact, Phone and Email address of individuals who can verify the demonstrated capabilities identified in the responses.

Responses must be submitted not later than January 22, 2019. Capability statements will not be returned and will not be accepted after the due date.

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Questions concerning submission requirements may be directed to Andrea Ormiston, Contract Specialist, andrea.ormiston@cms.hhs.gov. CMS will not entertain questions related to contracting strategy.

http://www.sba.gov/ https://www.sam.gov/portal/public/SAM/ mailto:andrea.ormiston@cms.hhs.gov

Attachment 1 ACA Section 10332 – Medicare Data Sharing Program for Performance

Measurement – Program Management Activity

Statement of Work

I. SCOPE

Program Background

The Qualified Entity Program was established under Section 10332 of the Affordable Care Act (ACA) and expanded under Section 105 of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

The qualified entity regulations at 42 CFR Part 401, Subpart G, establish the criteria that entities must satisfy to obtain QE and quasi QE certification, and set forth the Center for Medicare and Medicaid Services’ (CMS) expectations for maintaining certification. In particular, the regulations provide requirements for entities in the following areas:

• Organizational structure and governance criteria, including necessary experience and expertise in the measures entities intend to use for public reporting.

• Expertise in combining Medicare claims data with claims data from other sources, or in the case of quasi QEs, clinical data.

• Expertise in establishing rigorous data security and privacy programs.

Because Qualified Clinical Data Registries (QCDRs) must meet the QECP requirements with the exception of certain requirements, to become quasi QEs, unless specifically noted in the SOW, the use of the term QEs also includes quasi QEs.

The Qualified Entity Program facilitates the creation of actionable performance reports that cover all, or most, of a provider’s practice. Under the QE program, CMS is authorized to disclose standardized extracts of Medicare Parts A and B claims data and Part D prescription drug event data to “qualified entities” (QEs). QEs must combine the Medicare data with claims data from other sources (or in the case of quasi QEs, clinical data) to create public reports that evaluate provider performance. QEs are also permitted to use the Medicare to create non-public analyses and provide or sell such analyses to authorized users. In addition, QEs may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users.

The statute defines QEs as public or private entities that are determined by the Secretary to be qualified to use Medicare claims data to make such evaluations of provider/supplier performance, and that agree to meet specific requirements regarding the transparency of their methods and their use and protection of Medicare data. The statute requires that Medicare claims extracts be combined with other claims data (or in the case of quasi QEs, clinical data) The statute requires that the derived performance information about providers and suppliers be in reports in an aggregate form, released and made available to the public, after first making such reports available to any identified provider or supplier and affording an opportunity to appeal and correct errors. The statute also instructs the Secretary to take such actions as she deems necessary to protect the identity of individual beneficiaries, and authorizes her to establish additional requirements that she may specify for QEs to meet, such as ensuring the security of data.

QE Application Process

Any organization that meets the program requirements is permitted to apply. To become a QE, applicants must meet certain criteria; including, they must:

1. Have access to claims data from other sources to combine with the Medicare data (or in the case of quasi QEs, clinical data);

2. Have strong systems to ensure that the data are secure and protected; and

3. Have experience in a variety of tasks related to the calculation and reporting of performance measures, including:

• combining claims data from different payers,

• designing performance reports,

• sharing performance reports with the public,

• working with providers and suppliers regarding requests for error correction, and

• ensuring the privacy and security of data.

QE Review Process To assess an organization’s compliance with program requirements, the Qualified Entity Certification Program (QECP) implements a four-phase application process.

• Phase 1: The QECP team examines an entity’s organizational structure, its ability to successfully function as a QE, and its access to additional sources of claims data., or in the case of quasi-QEs, clinical data

• Phase 2: The QECP team examines the QE’s compliance with the data security and privacy requirements of the program.

• Phase 3: The QECP team examines the QE’s compliance with the remaining program requirements related to the QE's measurement, reporting, and corrections and appeals processes. Prior to submitting evidence for the Phase 3 review, the QE must integrate the QE Medicare data with its claims data from other sources and calculate provider performance measures.

• Phase 4: Public reporting, during which the QE engages providers in the corrections and appeals process and releases its public performance reports. The QECP team periodically reviews a QE’s public performance reports as part of Ongoing Program Administration (OPA).

The Qualified Entity Certification Program for Medicare Data (QECP), was launched on January 9, 2012 to implement the statutory requirements of the rule Medicare Program:

Availability of Medicare Data for Performance Measurement (the Medicare Data Sharing Program “Final Rule”).

The QE Consensus-Based Entity Certification (CBEC) program was developed so that qualified applicants can obtain CMS approval to become Consensus-Based Entities (CBEs) under the QE program. Certified CBEs may endorse measures as standard for use by QEs under the QE program.

The sharing of Medicare data with qualified entities through this program and the resulting reports produced by qualified entities will be an important driver of improving quality and reducing costs in Medicare, as well as for the health care system in general. Additionally, this program will increase the transparency of provider and supplier performance, and provide beneficiaries access to information that will help them make more informed decisions about their health care.

For more information on the QE Program visit:

QECP Website: https://www.qemedicaredata.org Final Rule Implementing the QE program: http://www.gpo.gov/fdsys/pkg/FR-2011-12- 07/pdf/2011-31232.pdf

Final Rule Modifying the QE Program:

https://www.federalregister.gov/documents/2016/07/07/2016-15708/medicare-program-expanding-uses-of-medicare-data-by-qualified-entities

Purpose

The purpose of this action is to procure the services of a contractor to assist CMS in managing the Qualified Entity Program.

For the purposes of this Statement of Work (SOW), the following definitions shall apply:

CMS and/or its Designee: CMS, CMS contractors/grantees, demonstration awardees, health plans, auditors, Quality Improvement Organizations, Clinical Data Abstraction Centers, other Federal or State Government agencies, etc.

Data Use Agreement (DUA): A legally binding agreement between CMS and an external entity (e.g., contractor, private industry, academic institution, other Federal government agency, or state agency), when an external entity requests the use of CMS personal identifiable data that is covered by the Privacy Act of 1974. The agreement delineates the confidentiality requirements of the Privacy Act, security safeguards, and CMS' data use policies and procedures. The DUA serves as both a means of informing data users of these requirements and a means of obtaining their agreement to abide by these requirements. Additionally, the DUA serves as a control mechanism through which CMS can track the location of its data and the reason for the release of the data.

Manual: Written document that communicates instructions, guidelines, policies, and/or procedures impacting Medicare/Medicaid programs. These include, but are not limited to, documents such as Operations Manuals, Survey Administration Manuals, Data Submission Manuals, Users’ Guides, etc.

https://www.qemedicaredata.org/ http://www.gpo.gov/fdsys/pkg/FR-2011-12-07/pdf/2011-31232.pdf http://www.gpo.gov/fdsys/pkg/FR-2011-12-07/pdf/2011-31232.pdf

Protected Health Information: The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, defines protected health information (PHI) as individually identifiable health information. Identifiable refers not only to data that are explicitly linked to a particular individual; it also includes health information with data items which reasonably could be expected to allow individual identification. Health information is any information, in any form or medium that is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual. HIPAA imposes strict privacy and security standards on the use, disclosure, and exchange of PHI.

Quality Assurance: Assessment to ensure contract compliance, such as the review and approval of interim or draft reports.

Quality Control: Periodic evaluation of the quality of work performed by the Contractor, such as progress report(s).

Section 508 Compliance: Section 508 of the Rehabilitation Act requires that Web sites and associated content created with federal funding, whether internal or external, government- or contractor-hosted, are accessible to persons with disabilities. The law has been in effect since June 21, 2001.

Support: Providing assistance to CMS and/or its Designee.

II. REQUIREMENTS

A. General

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 SOW.

To the extent possible, this contract shall develop deliverables that are cost-efficient, yet maintain acceptable standards for quality (i.e., purposeful measures, data integrity, etc.).

All products of this contract shall be made available to CMS and/or its Designee, and the general public, if appropriate, and at no additional cost, unless otherwise specified in the contract.

B. Tasks to Be Performed

TASK 1: Project Management and Quality Assurance TASK 2: Operations Oversight and Technical Support TASK 3: Qualified Entity Certification Program Policy and Operations Manual TASK 4: Evaluation and Certification of Qualified Entities TASK 5: Monitoring and Ongoing Program Administration TASK 6: Policy, Evaluation, and Ongoing Program Administration of QE Consensus-

Based Entities TASK 7: Develop and Implement Outreach Program TASK 8: Assist CMS with Preparation of PRA Package TASK 9: Ad Hoc CMS Policy/Program Analyses TASK 10: Implementation Process Evaluation Report

TASK 1 PROJECT MANAGEMENT AND QUALITY ASSURANCE

The Contractor shall, in general, at a minimum, develop and implement a project work plan, provide a monthly report of progress, including a status update by task and discussion of significant problems, provide updates to CMS, and coordinate seamlessly with other organizations collaborating on the project.

The Contractor shall, at a minimum:

Task 1.1 Develop and submit a project work plan for CMS approval that describes the operational details of implementing the contract and project timetables, methods for quality assurance, and project evaluation. Maintain and update both the project work plan and the quality assurance plan as appropriate.

Task 1.2 Provide electronic monthly progress reports (MPR) to the Contracting Officer’s

Representative (COR), and contract specialist (CS) regarding the status of all tasks, including a financial report, in accordance with Sections II.C, Report Requirements and III, Quality Assurance of this SOW.

Task 1.3 Coordinate regular communication between CMS, subcontractors if applicable, and other contractors collaborating on this project to facilitate project management activities. This activity shall be included in the Monthly Progress Report in accordance with Section II.C, Report Requirements.

Task 1.4 Manage subcontractor performance to ensure compliance with contract requirements. This activity shall be included in the Monthly Progress Report in accordance with Section II.C, Report Requirements.

Task 1.5 Work closely with other collaborating organizations to support the strategic goals and objectives of the program.

Task 1.6 Respond to all organizations making initial contact with the Medicare Data Sharing Program.

Task 1.7 Work collaboratively with the current contractor to ensure a seamless transition of organizations currently participating – at all phases – of the Medicare Data Sharing Program.

Task 1.8 Assume full operational responsibility for all organizations currently participating – at all phases – of the Medicare Data Sharing Program (approximately 20 organizations).

TASK 2: OPERATIONS OVERSIGHT AND TECHNICAL SUPPORT

The Contractor shall provide technical and operational oversight for all aspects of managing the QE program, including obtaining advice and comments from subject experts, and discussing the status of technical and operational oversight in the Progress Report in accordance with Section II.C, Report Requirements.

In consultation with CMS and in accordance with the laws and regulations governing this program, the Contractor shall:

Task 2.1 Provide ongoing technical support to CMS, Qualified Entities, Consensus-Based

Entities and other interested parties such as prospective QECP and QE CBEC program applicants. This activity shall be ongoing, and status and discussions shall be included in the Progress Report in accordance with Section II.C, Report Requirements.

Task 2.2 Maintain and continuously improve the public QECP website (including, but not limited to, dissemination/listing of Certified QEs and Certified QE CBEs and their respective dates of certification and updating technical guidance and QE program information).

Task 2.3 Maintain and continuously improve individual secure QECP application software (administrative QECP website).

Task 2.4 Develop and maintain protocol documents that explain procedures for managing and interacting with QECP applicants; managing the public and administrative QECP websites; and managing the QE questions.

TASK 3 QUALIFIED ENTITY CERTIFICATION PROGRAM POLICY AND

OPERATIONS MANUAL

In consultation with CMS and in accordance with the laws and regulations governing this program, the Contractor shall:

Task 3.1 Maintain, continuously improve, and revise as necessary and appropriate all aspects of the QECP Operations Manual which documents all QECP program operations, policy, and oversight.

Task 3.2 Maintain, continuously improve, and revise as necessary all other QECP policies

(e.g., Frequently Asked Questions, instructions, diagrams) outside of the QECP Operations Manual.

TASK 4: EVALUATION AND CERTIFICATION OF QUALIFIED ENTITIES

CMS is committed to ensuring the successful implementation of this program maximizing the efficient and effective use of data while minimizing the risk of disclosure of beneficiary information, as well as the appropriate use of rigorous measurement methodologies, and dissemination strategies and techniques. Accordingly the contractor will build on the approach for evaluation and certification currently employed in the Qualified Entity Certification Program (QECP). The contractor will continue to ensure that the approach is consistent with industry standards and shall continue to include but not be limited to the following areas:

1. Organizational Readiness and Commitment;

2. Data Security;

3. Data Integration and Measure Calculation; and,

4. Reporting

Task 4.1 Maintain, Continuously Improve, and Revise as Necessary and Appropriate

Policy on QE Evaluation

Task 4.2 Disseminate Policy on QE Evaluation

Task 4.3 Maintain, Continuously Improve, and Revise as Necessary and Appropriate all program Application materials

Task 4.4 Disseminate program Application materials

Task 4.5 Implement the Policy on QE Evaluation and Evaluate QEs on the program requirements

Task 4.6 Recommend to CMS the organizations which merit certification as Qualified

Entities.

TASK 5 MONITORING AND ONGOING PROGRAM ADMINISTRATION

Task 5.1 Maintain, Continuously Improve, and Revise as Necessary and Appropriate

Policy on QE Monitoring and Ongoing Program Administration

Task 5.2 Disseminate Policy on QE Monitoring and Ongoing Program Administration

Task 5.3 Implement Policy on QE Monitoring and Ongoing Program Administration

Task 5.4 Notify CMS of organizations undergoing QE Monitoring and Ongoing Program Administration and their results and recommendations

Task 5.5 Maintain list of QECP provider performance measures.

TASK 6 POLICY, EVALUATION, AND ONGOING PROGRAM

ADMINISTRATION OF QE CONSENSUS-BASED ENTITIES

42 CFR 401G §401.715(a)(1)(v) requires CMS to approve certain organizations as consensus-based entities for the purposes of allowing that organization’s endorsed performance measures to be used as Standard Measures as part of the Medicare Data Sharing Program.

Task 6.1 Maintain, Continuously Improve, and Revise as Necessary and

Appropriate Minimum Requirements for Certification as Consensus- Based Entity (CBE) under the Qualified Entity Program

Task 6.2 Disseminate Minimum Requirements for Certification as Consensus-

Based Entity (CBE) under the Qualified Entity Program

Task 6.3 Implement Minimum Requirements for Certification as Consensus-Based Entity (CBE) under the Qualified Entity Program

Task 6.4 Review applications from potential QE consensus-based entities.

Task 6.5 Recommend to CMS the organizations which merit approval as QE consensus-based entities.

Task 6.6 Monitor CBE performance and notify CMS with the results of ongoing program administration activities, including recommendations.

TASK 7: DEVELOP AND IMPLEMENT OUTREACH PROGRAM

The contractor shall:

Task 7.1 Develop a comprehensive work plan for conducting outreach/marketing/education/dissemination/information sharing of all aspects of the Medicare Data Sharing Program for Performance Measurement to all relevant stakeholders for the purpose of increasing awareness and visibility of the QE program.

Task 7.2 Submit the plan to CMS for approval.

Task 7.3 Implement the plan upon CMS approval.

Task 7.4 Work with CMS, its data user support contractor, or CMS designee, where necessary and appropriate, to train-the-trainer, support enhanced training opportunities, and other relevant outreach dissemination and support activity.

TASK 8 ASSIST CMS WITH PREPARATION OF PRA PACKAGE

Task 8.1 The Application and Re-application information gathered from organizations participating in the Medicare Data Sharing Program is considered a collection of information subject to the Paperwork Reduction Act. The collection of this information is approved by the Office of Management and Budget and assigned OMB CONTROL NUMBER: 0938-1144. OMB approval is valid for three year periods. This work may include, but not be limited to, preparing written documents to support the application, preparing respondent burden hour estimates, soliciting public input (as determined necessary by the COR), processing public comments, submitting a public comment summary, etc. The Contractor, in consultation with the COR, will also coordinate with other federal and federally-sponsored groups to obtain and summarize input, as necessary.

TASK 9 AD HOC CMS POLICY/PROGRAM ANALYSES

The results of the successful implementation of this program have implications for CMS, as well as inter-Departmental program policy, operations and research objectives. As such, limited analyses are requested on an ad hoc basis from various CMS components and Federal agencies within the Department of Health and Human Services (e.g., Office of the Secretary).

The Contractor shall:

Task 9.1 In consultation with CMS, conduct up to 8 studies that examine key aspects of the Medicare Data Sharing Program and support CMS and/or Departmental ad hoc policy/program requests. The final number of studies will be determined by CMS.

Direction on the number of topics and on content areas will come from the CMS

COR.

TASK 10 IMPLEMENTATION PROCESS EVALUATION/FINAL REPORT

Task 10.1 Produce an annual implementation process evaluation that provides lessons learned, feedback from the Qualified Entities, recommendations for improvement, and direction of future activities in accordance with Sections II.C, Report Requirements and III, Quality Assurance of this SOW. This document should objectively evaluate the implementation process by presenting a data driven report delineating which elements of the process were effective, which were ineffective, and recommendations for improvement.

C. Report Requirements

All reports shall be submitted in electronic version to the COR in Microsoft Word format. This requirement applies to all products of this contract, unless otherwise directed within the SOW or Schedule of Deliverables.

The Government will exercise its authority to approve all written materials produced under this contract. Unless otherwise directed, the Contractor shall submit both DRAFT and FINAL version of all materials required under this section of the SOW. Furthermore, the Contractor shall make changes to the DRAFT document as requested by the Government for the FINAL document. The FINAL document shall be due two (2) weeks after receipt of COR comments unless otherwise indicated.

1. Meeting/Teleconference Agendas:

The Contractor shall provide meeting and/or teleconference agendas and/or any appropriate materials to all meeting and teleconference attendees at least one day prior to the meetings or teleconferences. Although not all inclusive, the agenda(s) shall include, at a minimum, the topics to be discussed and any pertinent information or documents that each participant should have for each meeting/teleconference.

2. Meeting/Teleconference Minutes:

The Contractor shall provide meeting/teleconference minutes to the COR and all meeting/teleconference attendees within one week of meetings or teleconferences. The minutes shall include, at a minimum, a list of all attendees, a summary of the discussion, conclusions, decisions, and action items. The Contractor shall establish a mechanism to ensure that each participant has an opportunity to correct or comment on the minutes.

2. Project Plan:

The Contractor shall develop and maintain a project work plan that describes methods for quality control, plans for data confidentiality, operational details of implementing the contract, project timetables, and project evaluation, in accordance with Section II.B Task 1.1.

4. Monthly Progress Reports:

A detailed Monthly Progress Report (MPR) shall be submitted by the 5th business day of each month for the previous month’s effort, in accordance with Section II.B Task 1.2.

One (1) electronic version shall be submitted to the COR and one (1) electronic version to the Contract Specialist. Each report shall include, at a minimum, the following information organized by task:

• A summary of the current month’s project activities, plans for the subsequent month, information about problems with budget or schedule or Quality Assurance (QA);

• Status update on each requirement (Section II.B by Task), which specifically addresses substantive findings to date and the Contractor’s ongoing technical and operational oversight activities;

• Discussion of significant problems encountered or anticipated and their impact on project work plan, project schedule, and the Contractor’s (including Subcontractor’s) overall ability to accomplish the project goals;

• The Contractor’s plans to deal with any identified significant problem and, if appropriate, new delivery or completion dates shall be proposed and revised resource estimates included, in accordance with Section III, Quality Assurance (changes to the project work plan require CMS approval);

• Data on planned versus actual expenditures by major Task area (discrepancies greater than ten percent shall be noted).

5. Memoranda:

The Contractor shall produce memoranda as needed under the direction of the COR.

These memoranda shall succinctly report the information required. No hard copy memoranda are required.

6. Final Report/Implementation Process Evaluation (IPE) and Final Copies of

Deliverables:

Submit a CD of all Final copies of report deliverables to the Contract Specialist (exclude project work plan, monthly progress reports, and data deliverables). A copy of the cover letter shall be provided electronically to the COR.

The Contractor shall submit one (1) electronic version of a DRAFT Report/IPE in Microsoft Word to the COR, no later than 11 months after the start of the contract.

The Contractor shall submit one (1) electronic version of a FINAL Report/IPE in Microsoft Word to the COR, and a copy of the cover letter to the Contract Specialist, no later than four (4) weeks after receiving comments on the DRAFT document from CMS.

The Final Report, at a minimum, shall (by Section II.B Task):

• Display the Title, Deliverable Number and Date, Contractor’s Name and Address, CMS Contract Number, and Time Period, on the Report Cover;

• Provide an Executive Summary of the full report;

• Present a detailed narrative and evaluation of the accomplishments, challenges and lessons learned. Incorporate conclusions and recommendations of Expert Panels and/or Technical Consultants where applicable. Present negative, as well as positive findings. Include any charts, tables, or diagrams relevant to the subject matter;

• Present conclusions and recommendations drawn from the results, and identify any other innovations and general advances of special interest;

• Incorporate comments received by CMS.

7. Special Reports (Summary Reports, Technical Reports, Option Papers):

The Contractor shall submit one (1) electronic version of a DRAFT Report in Microsoft Word to the COR for each of the Special Reports.

The Contractor shall submit one (1) electronic version of a FINAL Report in Microsoft Word to the COR, and an electronic copy of the cover letter to the CO, no later than two weeks after receiving comments on the DRAFT document from CMS, unless otherwise indicated.

Additional formatting shall be mutually agreed upon between the COR and the Contractor.

III. QUALITY ASSURANCE (QA)

A. Quality Control Requirements

1. The Contractor shall participate in weekly conference calls with the CMS COR and other CMS staff as appropriate. These calls will be used to discuss and manage administrative and project issues.

2. The Contractor shall submit Monthly Progress Reports, Memoranda, Special

Reports, and Final Report in accordance with Section II.C, Report Requirements of this SOW.

3. The Contractor shall document all policies and procedures relevant to CMS that have received CMS approval, in accordance with Section II Requirements, of this

SOW.

4. If the Contractor obtains assistance from a Subcontractor(s), the Contractor shall assure that the subcontractor complies with all requirements, terms and conditions of this project.

5. Any applications developed or used in meeting the requirements of the Statement of

Work shall go through a rigorous set of system, unit and acceptance tests to assure data and system integrity. Each stage of testing shall be fully documented. For each application used or developed (i.e., data collection, data manipulation, data extraction, data transfer, data access), the Contractor shall provide CMS complete system documentation of the system design, test plans, test results, remedies, and will incorporate CMS proposed changes prior to proceeding.

6. The Contractor shall continuously monitor the quality of work products and deliverables for documentation of and adherence to established procedures.

B. Quality Assurance Requirements

1. The Contractor shall provide DRAFT documents to CMS for review in accordance with Section II.C, Report Requirements of this SOW. CMS shall review within 30 days and submit comments to the Contractor for inclusion in the FINAL document.

The Contractor shall incorporate all relevant CMS comments and instructions into FINAL documents generated under this contract. The COR, and other CMS staff, if appropriate, will review DRAFT documents described in this SOW and provide comment(s) to the Contractor within 30 days of receipt.

2. The Contractor shall document all CMS approved procedures, methodologies, and analyses associated with this contract. The Contractor shall develop a Quality Assurance (QA) plan to guide the process. This QA plan shall reflect the general and specific requirements found in Sections II.B, Tasks; II.C, Report Requirements; and, III, Quality Assurance of this SOW. This QA plan shall be included with the work plan found in Section II.B, Task 1.1.

3. The Contractor shall maintain data quality control procedures to ensure the security and integrity of any CMS data provided to the Contractor and stored on the Contractor’s system. The Contractor shall comply with all applicable Privacy and Freedom of Information legal requirements.

4. In addition to meeting and/or conference call summaries, “meeting support” includes the determination of items for discussion, provision of agendas and background materials, and documentation of key points and issues. CMS has the authority to approve all such materials prior to distribution.

4. CMS expects products to be well written and need minimal revisions. Failure to meet these expectations may result in the return of deliverables for further refinement.

IV. REFERENCES

• CMS Publication. 100-01: General Information, Eligibility, and Entitlement Manual.

Chapter 7 - Contract Administrative Requirements. Section 30 - Files Maintenance.

• HHS Section 508 Web site: http://508.hhs.gov/

• US General Services Administration (GSA) Section 508 Web site: http://www.section508.gov/index.cfm http://508.hhs.gov/ http://www.section508.gov/index.cfm

DELIVERABLE SCHEDULE

ACA SECTION 10332 –MEDICARE DATA SHARING PROGRAM FOR

PERFORMANCE MEASUREMENT – PROGRAM MANAGEMENT ACTIVITY

TASK DESCRIPTION QTY/RECIPIENT DUE DATE

BASE + OPTIONS 1-4

100 Project work plan and quality assurance plan Task 1.1

1 cc – COR 1 cc – CS

DRAFT – 4 weeks after effective date of award.

FINAL - 2 weeks after receiving CMS recommendations

101 Monthly progress reports Task 1.2

1 cc – COR 1 cc – CS

5th business day of each month

102 Respond to new inquiries Report in MPR 30 days from effective date of award

103 Work collaboratively with outgoing contract to ensure seamless transition of organizations currently in the Medicare Data Sharing Program

Report in MPR Ongoing after effective date of award.

104 Memo indicating that all organizations currently in all phases of the Medicare Data Sharing Program have been transitioned

1 cc – COR 1 cc – CS

September 1, 2018

200 Provide Operations Oversight and Technical Support Tasks 2.1 – 2.4

Report in MPR Ongoing after effective date of award.

300 Maintain, Continuously Improve, and Revise as Necessary and Appropriate QECP Operations Manual Task 3.1

Electronic version -

COR

Draft - January 15 of each Year FINAL – 2 weeks after receiving CMS

301 Maintain, Continuously Improve, and Revise as Necessary all other QECP Policies Task 3.2

Report in MPR Ongoing after effective date of award.

400 Maintain, Continuously Improve, and Revise as Necessary and Appropriate Policy on QE Evaluation Task 4.1

1 cc – COR Ongoing after effective date of award.

401 Disseminate Policy on QE Evaluation Task 4.2

Report in MPR Ongoing after effective data of award

402 Maintain, Continuously Improve, and Revise as Necessary and Appropriate all program Application materials

Task 4.3

1 cc – COR Ongoing after effective date of award

403 Disseminate all program Application materials for Medicare Data Task 4.4

Report in MPR Ongoing after effective date of award

404 Implement Policy on QE Evaluation and Evaluate QEs on the program requirements

Report in MPR Ongoing after award

405 Memo on organizations recommended for QE certification Task 4.6

1 cc – COR Ongoing after effective date of award

500 Maintain, Continuously Improve, and Revise as Necessary and Appropriate Policy on QE Monitoring and Ongoing Program Administration Task 5.1

1 cc – COR Ongoing after effective date of award

501 Develop and disseminate Policy on QE Monitoring and Ongoing Program Administration Task 5.2

Report in MPR Ongoing after effective date of award

502 Implement Policy on QE Monitoring and Ongoing Program Administration Task 5.3

Report in MPR Ongoing after effective date of award

503 Memo on organizations undergoing QE Monitoring and Ongoing Program Administration Task 5.4

1 cc - COR Ongoing after award

504 Maintain List of QECP Provider Performance Measures Task 5.5

Electronic version –

COR

Ongoing after effective date of award

600 Maintain, Continuously Improve, and Revise as Necessary and Appropriate Minimum Requirements for Certification as Consensus-Based Entity (CBE) under the Qualified Entity Program Task 6.1

1 cc – COR Ongoing after effective date of award

601 Develop and disseminate Minimum Requirements for Certification as Consensus- Based Entity (CBE) under the Qualified Entity Program Task 6.2

Report in MPR Ongoing after effective date of award

602 Implement Minimum Requirements for Certification as Consensus-Based Entity (CBE) under the Qualified Entity Program Task 6.3

Report in MPR Ongoing after effective date of award

603 Memo on organizations recommended as CBEs Task 6.5

1 cc – COR Ongoing after effective date of award

604 Memo on QE CBE Ongoing Program Administration activities Task 6.6

1 cc – COR Ongoing after effective date of award

700 QECP Outreach Plan Task 7.1

1 cc - COR DRAFT – April 1 of each year from receiving CMS recommendations

701 Implement approved QECP Outreach Plan Task 7.3

Report in MPR 7 DAYS from CMS approval of Task 700

800 Assist CMS with Preparation of PRA Package Task 10.1

1 cc – COR Ongoing after effective date of the award

900 Summary Reports documenting the results of the Policy or Program Analyses Task 11.1

1 cc – COR TBD between CMS and Contractor

1000 ANNUAL REPORT

/IMPLEMENTATION

PROCESS EVALUATION

Task 12.1

1 cc – COR 1 cc – CO

DRAFT – May 1 of each year from receiving CMS recommendations

The delivery schedule attempts to account for all potential delays that may occur over the course of this period of performance. In the event of unforeseen CMS administrative, legislative or programmatic issues that result in a significant change or delay to any part of this project, CMS will work closely with the contractor to make appropriate modifications to the deliverable schedule.

The contractor shall submit all required reports and deliverables in accordance with the following schedule, with the exception of deliverables that fall on, one business day before, or one business day after a scheduled Federal holiday. Task deliverables falling under these circumstances will be due two (2) business days after the scheduled Federal holiday. Reports and/or deliverables submitted under this option shall be in accordance with the Statement of Work.

Key to Abbreviations:

cc – Copy COR – Contracting Officer’s Representative CS – Contract Specialist CO – Contract Officer IAW – In Accordance With MPR – Monthly Progress Report NLT – No Later Than QTY – Quantity SOW – Statement of Work TBD – To Be Determined TL – Task Leader