AmendedRFPSectionsBthruE.doc

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TABLE OF CONTENTS

SECTION

TITLE

PAGE #

PART I

Section B – Supplies or Services and Prices/Costs

B.1

Description of Services

B.2

Type of Contract

B.3

Fees

B.4

Consideration and Payment

B.5

Special Projects

B.6

Ceilings

B.7

Transition Services

B.8

Incremental Funding

Section C – Scope of Work

C.1

Background and Overview

C.2

Contract Purpose

C.3

Technical Considerations

C.4

General Requirements

C.5

Overall Evaluation

C.6

Theme Requirements and Evaluation

C.7

Sub-National Requirements

C.8

Special Projects

C.9

Transition from Incumbent QIO to Successor QIO Section D – Packaging and Marking

D.1.

Marking

Section E – Inspection and Acceptance

E.1.

FAR 52.252-2 Clauses Incorporated by Reference

(FEB 1998)

E.2

Performance Improvement Plan

Section F – Schedule of Deliverables

F.1.

Period of Performance

F.2.

Items to be Furnished and Delivery Schedule

F.3.

FAR 52.252-2 Clauses Incorporated by Reference

(FEB 1998)

Section G – Contract Administration

G.1

Accounting and Appropriation Data

G.2

Invoicing and Payment Information

G.3

Indirect Costs

TABLE OF CONTENTS (Continued)

G.4

Other Provisions Applicable to Allowable Costs

G.5

A-133 Interim Audits (for non-profit QIOs only)

G.6

Closeout Audits For-Profit and Non-Profit

Organizations

G.7

Key Personnel

G.8

Project Officer

G.9

Government Theme Leader/Task Leader (GTL) G.10

Other Technical Personnel

G.11

Contracting Officer

G.12

Property Administrator

G.13

Representations and Certifications

G.14

Subcontracting Program for Small, Small

Disadvantaged and Women-Owned and

HubZones

G.15

Consent to Subcontract

G.16

Consultant Services Approval

G.17

Past Performance Database and Central Contractor

Registration

G.18

Data De-Identification Process

G.19

Engineering Review Board (ERB) Process for

Obtaining Additional Hardware/Software

G.20

Procedures for Section C.8 Special Projects (SP) G.21

On-Site Visits

G.22

Biennial Wage Determinations

G.23

Food Costs

G.24

Security Clause – Background Investigations for

Contractor Personnel

G.25

Contracting Officer’s Authorizations (COA)

Section H – Special Contract Requirements

H.1

Conditions for Performance

H.2

Evaluation Determination and Payment of

Award Fee

H.3

Performance Evaluation/Monitoring

H.4

Renewal of a QIO Contract

H.5

Non-Renewal of a QIO Contract

H.6

Performance Evaluation Criteria

H.7

Termination

H.8

Appropriate Use and Disclosure of Data

H.9

Governance Requirements

H.10

Diversity for QIOs

H.11

Conflict of Interest

TABLE OF CONTENTS (Continued)

H.12

CMS-Directed Subcontracts/Special Project

Lead QIOs

H.13

Severance Pay/Termination Costs

H.14

Changes in Clinical Science

H.15

QIO Manual Changes and SDPS User’s Guide

H.16

General Mailing Requirements

H.17

Definition of a QIO as a Large Business

H.18

HIPAA Business Associate Provision

H.19

Post Award Conference

H.20

Transition from Incumbent QIO to Successor QIO H.21

Section 508 Accessibility of Electronic and

Information Technology (EIT) to Federal Employees and the General Public with Disabilities

PART II

Section I – Contract Clauses

I.1

Contract Clauses

I.2

FAR 2.222-42 Statement of Equivalent Rates for

Federal Hires (FEB 1998)

PART III

Section J – List of Attachments

(**Page Numbers Not Provided for Attachments)

J-1

Glossary

J-2

Award Fee Plan

J-3

QIO Communication Handbook

J-4

Specific Manual Sections

J-5

Data Supplied by CMS

J-6

ERB User’s Guide

J-6a

Purchase Request User’s Guide

J-7

Budget Assumptions

J-8

9th SOW Business Proposal Format (Instructions)

J-8a

9th SOW Business Proposal Format Spreadsheet

9th SOW Disparities Business Proposal Spreadsheet

Format

9th SOW CKD Business Proposal Spreadsheet Format

J-8a

9th SOW Care Transitions Business Proposal Spreadsheet Format

J-9

Consent to Subcontract

J-10

Care Transitions Appendix A –Details on Measures

J-10a

Care Transitions Hardcopy Reference Materials

J-11

HHS Form 565

TABLE OF CONTENTS (Continued)

J-12

SDPS Site Plan and Inventory

J-13

Data Use Agreement

J-14

Department of Labor Wage Determination

J-15

Remedy’s HHS-22 – Items List Report

J-15a

Remedy’s HHS-22 – Items Summary Report

J-16

Question and Answer Template--RESERVED J-17

List of Facilities with Greatest Opportunity for

Improvement in Each Individual Measure

J-18

Sample Subcontracting Plan Format

J-19

Past Performance Questionnaire and Instructions

J-20

Case Review Volume Assumptions

J-21

Model CDAC Subcontract

PART IV

Section K – Representations, Certifications, and Other Statements of

Offerors or Quoters

K.1

CCR Registration

K.2

FAR 52.204-8 Annual Representations and

Certifications

K.3

Certification of Eligibility

K.4

Certification of QIO Performance

K.5

Certification of Proposal Preparation

K.6

Valid Offer

K.7

Representations and Instructions Financial

K.8

FAR 15.406-2 Certification of Current Cost or

Pricing Data

K.9.

HHSAR 352.204 Certification of Filing and Payment of Federal Taxes

Section L – Instructions, Conditions and Notices to Offerors

L.1

FAR 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)

L.2

FAR 52.215-1 Instructions to Offerors—Competitive

Acquisition (JAN 2004) Alternate (OCT 1997)

L.3

FAR 52.216-1 Type of Contract (APR 1984)

L.4

FAR 52.233-2 Service of Protest (SEP 2006)

L.5

Submission of Representations and Certifications L.6

National Association Industry Code Standards

(NAICS) Code and Small Business Standard L.7

Small Business Subcontracting Plan

L.8

Facsimile, Electronic, Written Proposals

L.9

Solicitation Questions--RESERVED

L.10

Eligibility Requirement for Proposal Submission TABLE OF CONTENTS (Continued)

L.11

General Information

L.12

Statement of Work Mandatory Requirements

L.13

Proposal Format

L.14

Technical Proposal Organization and Content

L.15

Business Proposal Instructions

L.16

Business Proposal Organization and Content

L.17

Proposal Delivery

Section M – Evaluation Factors for Award

M.1

General

M.2

Special Notice

M.3

Evaluation Factors for Award Mandatory Contract

Requirements

M.4

Sub-National Directed and Optional Requirements M.5

Evaluation Factors for Award by Contract by

Modification of Theme 7.1 Prevention-Disparities M.6

Evaluation Factors for Award by Contract

Modification of Theme 7.2 Care Transitions

M.7

Evaluation Factors for Award by Contract

Modification of Theme 7.3 Prevention-Chronic

Kidney Disease

M.8

Adjectival Evaluation Methodology

M.9

Business Proposal Evaluation

M.10

Selection Process for Mandatory Contract

Requirements

M.11

Award/Selection Process for Sub-National Directed

And Optional Theme Requirements

PART I

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1.

DESCRIPTION OF SERVICES

This is a contract with a Utilization and Quality Control Peer Review Organization (hereinafter referred to as a Quality Improvement Organization (QIO)) in accordance with Section 1154 of the Social Security Act. Performance of the requirements of Section C, Statement of Work (SOW) focuses on successful achievement of the following requirements for the QIO Program:

· Improve quality of care for beneficiaries;

· Protect the integrity of the Medicare Trust Fund by ensuring that Medicare pays only for services and goods that are reasonable and medically necessary and that are provided in the most appropriate setting; and

· Protect beneficiaries by expeditiously addressing individual complaints, notices and appeals, such as beneficiary complaints; provider-based appeals; Emergency Medical Treatment and Labor Act (EMTALA) violations; and other related statutory QIO responsibilities.

B.2.

TYPE OF CONTRACT

This contract contains cost-plus-award-fee (CPAF) and cost-plus-fixed-fee (CPFF) type requirements. All requirements contained in Section C SOW, with the exception of information systems and special projects, shall be performed on a CPAF basis. Section C.8. Special Projects (SP) and Information Systems (IS) shall be performed on a CPFF basis.

B.3.

FEES

A.

Core Contract Themes Payment of fee will be made based upon the requirements of Section B, Section C theme evaluation criteria and Section J, Attachment J-2 Award Fee Plan. The fees available under this contract are as follows:

Fixed Base Fee = $_______ (to be determined (TBD)) (excluding pass-thru and Section C.8. Special Project costs) associated with the three core Themes: Beneficiary Protection, Patient Safety, and Prevention. The fixed base fee will be reimbursed on a monthly basis.

Performance Award Fee = $_______ (TBD) (excluding pass-thru and Section C.8. Special Project costs) associated with the three core Themes: Beneficiary Protection, Patient Safety, and Prevention for which the QIO receives a rating of “pass” in accordance with the requirements specified in Section C.6. and elsewhere in the SOW.

Fixed Fee = $________ (TBD) for Information Systems (IS)

Section C.8. Special Project Fixed Fee will be negotiated on individual Special Projects at the time of issuance. The special project fixed fee will be reimbursed on a monthly basis.

B.

Directed Sub-National Requirement (Prevention Disparities)

Fixed Base Fee = $_______ (TBD) (excluding pass-thru) fixed base fee will be reimbursed on a monthly basis.

Performance Award Fee = $_______ (TBD) (excluding pass-thru) for which the QIO receives a rating of “pass” in accordance with the requirements specified in Section C.7. and elsewhere in the SOW.

C.

Optional Sub-National Requirement (Care Transitions)

Fixed Base Fee = $_______ (TBD) (excluding pass-thru) fixed base fee will be reimbursed on a monthly basis.

Performance Award Fee = $_______ (TBD) (excluding pass-thru) for which the QIO receives a rating of “pass” in accordance with the requirements specified in Section C.7. and elsewhere in the SOW.

D.

Optional Sub-National Requirement (Chronic Kidney Disease)

Fixed Base Fee = $_______ (TBD) (excluding pass-thru) fixed base fee will be reimbursed on a monthly basis.

Performance Award Fee = $_______ (TBD) (excluding pass-thru) for which the QIO receives a rating of “pass” in accordance with the requirements specified in Section C.7. and elsewhere in the SOW.

B.4.

CONSIDERATION AND PAYMENT

A.

Total Contract Amount

The total estimated cost-plus-fixed fees (TEC+Award, Base and Fixed Fee) is $_______________________

Note:

Special Projects (SP) will be incorporated into the contract by issuance and execution of a formal contract modification (see Section B.5.). Upon issuance of a SP contract modification, Section B.4.A., entitled, “Total Contract Amount” and Section B.4.B., entitled, “Table of Total Estimated Cost and Associated Fees,” will be modified accordingly.

B. Table of TEC and Associated Fees The QIO shall provide the necessary personnel, materials, services, facilities and supplies (except as may be otherwise specified in the contract) and otherwise do all things necessary for, or incident to, the performance of the work as set forth in Section C, SOW. In consideration of successful performance in accordance with the evaluation criteria set forth in Section C and Section J-2 Award Fee Plan, the QIO will be reimbursed as stated in the Table of TEC and Associated Fees on the following pages:

IS and SP

Theme 6.1

Beneficiary Protection

Theme 6.2

Patient Safety

(Total)

6.2.1

Pressure Ulcers

6.2.2 Physical Restraints

6.2.3 Surgical Care Improvement Project/Heart Failure

6.2.4

Methicillin-resistant Staphylococcus

Aureus (MRSA)

6.2.5 Drug Safety

6.2.6 Nursing Homes In Need

Theme 6.3 Core Prevention

Directed Sub-National

Theme 7.1 Prevention: Disparities

Optional Sub-National

Theme 7.2 Care Transitions

Optional Sub-National

Theme 7.3 Prevention: Chronic Kidney Disease

Section C.8 Special Projects

IS

Pass-Thru 6.1

Pass-Thru(6.2 & 6.3)

Pass-Thru

Directed

Sub-National Theme 7.1

Pass-Thru

Optional

Sub-National Theme 7.2

Pass-Thru

Optional

Sub-National Theme 7.3

TOTALS

C. Schedule for Payment of Base Fee and Fixed Fee

Payment of the fixed base fee and other fixed fees (IS and SP) will be made in accordance with the schedule provided below. As authorized under FAR 52.216-8, after payment of 85% of these fixed fees, CMS may elect to withhold 15% or $100,000 (whichever is less).

Month

Payment/Month

Total

1-35

Total

Note: Regardless of the period of performance of a SP, the associated fixed fee shall be allocated across the remaining months of the contract period (not period of performance for the SP). Therefore, as SPs are incorporated into the contract, the Section B.4.C. Schedule of Payment of Base Fee and Fixed Fee will be modified accordingly.

D.

Reallocation of Costs Costs provided in Table B.4.B are estimates only. During contract performance, the QIO may move funding at any time to ensure successful contract performance as follows:

1.

Theme 6.2 Patient Safety and 6.3 Core Prevention funds may be moved within and between Themes 6.2 and 6.3 components and associated pass-thru costs.

2.

Theme 6.1 Beneficiary Protection cannot be utilized for the performance of any other work.

3.

Directed Sub-National Theme 7.1 Prevention Disparities funding cannot be utilized for performance of any other work.

4.

Optional Sub-National Theme7.2 Care Transitions funding cannot be utilized for performance of any other work.

5.

Optional Sub-National Theme 7.3 Chronic Kidney Disease funding cannot be utilized for performance of any other work.

6.

IS funding cannot be utilized for performance of any other work.

B.5.

SPECIAL PROJECTS

A.

Special Projects As provided under Section C.8. and in accordance with the procedures contained in Section G.20, CMS reserves the right to direct the QIO to initiate a SP not currently defined under the SOW or to approve an application from a QIO to conduct a SP. SPs will be awarded on a CPFF basis. The table provided below will be completed (through execution of a formal contract modification) as SPs are incorporated into this contract.

B.

Reallocation of Funds for Special Projects Funds associated with Section C.8 SP cannot be redirected for performance of any other work. Additionally SP funding cannot be reallocated from one SP to another.

B.6.

CEILINGS

A.

General The cost limitations addressed in this Section apply to the total contract ceiling amount of the contract. The QIO is advised that all costs associated with this contract, either directly or indirectly, are subject to audit.

B.

Medical Records Photocopying/Pass-Thru Costs The QIO will be paid for a properly certified invoice/voucher for medical records photocopying costs at a rate of $.12 per page for reproduction of PPS provider records and $.15 per page for reproduction of non-PPS institutions and practitioner records, plus first class postage. Specifically, hospitals and other providers (such as critical access hospitals) under a Medicare cost reimbursement system, receive no photocopying reimbursement from the QIO. Capitation providers such as HMOs and dialysis facilities receive $.12 per page.

All other photocopying costs are to be directly charged to the theme to which they apply and shall be reimbursed on the basis of the costs that are allowable. In order for a cost to be determined allowable, the cost must be allocable and reasonable.

C.

Overnight Mail Contract deliverables shall not be submitted utilizing overnight mail. All other overnight mailings (e.g., provider-based discharge appeals, etc.) shall be at the discretion of the QIO and are subject to the Contracting Officer’s determination of reasonableness.

D.

Indirect Cost Rates The indirect cost rate ceiling(s) for this contract is/are:

Overhead:

______%TBD*

Fringe Benefits:

Other:

(*To Be Determined)

B.7.

TRANSITION SERVICES

In the event that CMS requires transition services from an incumbent QIO to a successor QIO, CMS will request a separate technical and business proposal for these services (see Section H.21.). These services will be incorporated into the contract if applicable.

B.8.

INCREMENTAL FUNDING

Due to funding limitations, CMS will partially fund the three-year contract award amount. CMS anticipates that the contract will be fully funded in Fiscal Year 2009 up to the three-year estimated cost plus-fixed fee ceiling amount. Accordingly, the following will apply:

(a) It is CMS’s intention to negotiate and award a contract using the incremental funding concepts described in the clause entitled Limitation of Funds, as specified in FAR 52.232-22. Under the clause, which will be included in the resultant contract, initial funds will be obligated under the contract to cover a portion of contract performance. CMS intends to allot additional funds up to and including the full estimated cost of the contract for the remaining years of performance by contract modification.

However, the Government is not obligated to reimburse the QIO for costs incurred in excess of the periodic allotments nor is the QIO obligated to perform in excess of the amount allotted.

(b) The Limitation of Funds clause to be included in the resultant contract, as specified in FAR 52.232-22, shall supersede the Limitation of Cost clause found in Section I, Contract Clauses.

SECTION C – SCOPE OF WORK

TABLE OF CONTENTS

Theme 6.1. Beneficiary Protection

Theme 6.2. Patient Safety

· Pressure Ulcers

· Physical Restraints

· Surgical Care Improvement Project

· Methicillin-resistant Staphylococcus aureus

· Drug Safety

· Nursing Homes In Need Theme 6.3. Prevention

Theme 7.1. Prevention: Disparities (Directed)

Theme 7.2. Care Transitions (Optional)

Theme 7.3. Prevention: Chronic Kidney Disease (Optional)

SECTION C. SCOPE OF WORK

C.1. BACKGROUND AND OVERVIEW

The statutory authority for this Scope of Work (SOW) is found in Part B of Title XI of the Social Security Act (hereinafter referred to as the Act), as amended by the Peer Review Improvement Act of 1982. The Act established the Utilization and Quality Control Peer Review Organization Program, now known as the Quality Improvement Organization (QIO) Program.

The statutory mission of the Program, as set forth in Section 1862(g) of the Act, is to improve the effectiveness, efficiency, economy, and quality of services delivered to Medicare beneficiaries.

Based on statutory language and the experience of the Centers for Medicare & Medicaid Services (CMS) in administering the Program, CMS has identified the following requirements for the QIO Program:

· Improve quality of care for beneficiaries;

· Protect the integrity of the Medicare Trust Fund by ensuring that Medicare pays only for services and goods that are reasonable and medically necessary and that are provided in the most appropriate setting;

· Protect beneficiaries by expeditiously addressing individual complaints, such as beneficiary complaints; provider-based notice appeals; Emergency Medical Treatment and Labor Act (EMTALA) violations; and other related statutory QIO responsibilities.

This SOW contains a number of quality improvement initiatives that are authorized by various provisions in the Act. The most relevant ones are described here. As a general matter, Section 1862(g) of the Act mandates that the Secretary enter into contracts with QIOs for the purpose of determining that Medicare services are reasonable and medically necessary, and for the purposes of promoting the effective, efficient, and economical delivery of health care services, and of promoting the quality of services of the type for which payment may be made under Medicare. CMS interprets the term “promoting the quality of services” to involve more than QIOs reviewing care on a case- by-case basis, but as covering a broad range of proactive initiatives that will promote higher quality. CMS has, for example, included in the SOW Tasks in which the QIO will provide technical assistance to Medicare-participating providers and practitioners in order to help them improve the quality of the care they furnish to Medicare beneficiaries. Additional authority for these activities appears in Section 1154(a)(8) of the Act, which requires that QIOs perform such duties and functions and assume such responsibilities and comply with such other requirements as may be required by the Medicare statute. CMS regards these activities as appropriate if they will directly benefit Medicare beneficiaries.

In addition, Section 1154(a)(10) of the Act specifically requires that the QIOs “coordinate activities, including information exchanges, which are consistent with economical and efficient operation of programs among appropriate public and private agencies or organizations, including other public or private review organizations as may be appropriate.” CMS regards this as specific authority for QIOs to coordinate and operate a broad range of collaboratives and community activities among private and public entities, as long as the predicted outcome will directly benefit the Medicare program. In addition, Section 1156(c) of the Act states that it is the duty of each QIO to use such authority or influence as it may possess as a professional organization, and to enlist the support of any other professional or governmental organization having influence or authority over healthcare practitioners or entities furnishing services in its area, in assuring that each practitioner or entity shall comply with all obligations imposed on them under Section 1156(a). Under these obligations, providers and practitioners must assure that they will provide services of a quality that meets professionally recognized standards of care.

C.2. CONTRACT PURPOSE

This SOW aims to improve the quality of care and protect Medicare beneficiaries through the following Themes and Sub-national Requirements:

· Beneficiary Protection

· Patient Safety

· Prevention

· Prevention: Disparities

· Care Transitions

· Prevention: Chronic Kidney Disease

C.3. TECHNICAL CONSIDERATIONS

The contractor (hereinafter referred to as “QIO”) undertaking this SOW shall comply with all technical requirements outlined in this contract.

C.4. GENERAL REQUIREMENTS

The QIO, acting independently and not as an agent of the federal government, shall furnish the necessary personnel, materials, services, facilities, and supplies (except as may be otherwise specified in the contract) and otherwise do all things necessary for, or incident to, the performance of the work as set forth in this SOW.

The QIO shall adhere to the following requirements as they apply to the specific Themes described in Section C.6.

1. Infrastructure Operations Support and Data Management:

Unless otherwise directed by CMS, the QIO shall adhere to the most current version of the policies and procedures outlined and posted on QIONET. These include the QIO Infrastructure Operations and Support Manual, the QIO Information Technology (IT) Administrator Manual, the SDPS Database Systems Administrator Guide, and the QualityNet System Security Policy, QualityNet Incident Response Procedures. Additional Policies and Procedures may be released requiring the QIO to comply.

The QIO shall maintain all necessary documentation that meets or exceeds the performance standards and deliverables specified in Chapter 8, Infrastructure Operations Support and Data Management, of the QIO Manual and Section F – QIO Schedule of Deliverables.

2. Hardware/Software:

CMS, either directly or through a CMS contractor, will provide each QIO with a file/print server and a workstation for each 0.5 or greater full-time equivalent (FTE) employee. The file/print server and each workstation will be equipped with a standard operating system and a software suite approved by CMS. If a QIO requires additional equipment and software, the QIO must receive approval from the Engineering Review Board (ERB) (see Section 2 of the QIO Infrastructure Operations and Support Manual; Attachment J-6 Engineering Review Board [ERB] User’s Guide; and G.17. Purchase Request Users Guide for Obtaining Additional Hardware/Software) and must pay for the additional equipment and software out of QIO contract funds.

3. Security

3.1 Certification by Information’s System Security Officer (ISSO) for Compliance with CMS Systems Security Requirements

The QIO designated ISSO equivalent, also referred to as the Security Point of Contact (SPOC) shall certify compliance with CMS’ Office of Clinical Standards and Quality’s Quality Improvement Program (QIP) systems security requirements.

3.2 Administer Security Program

· The QIO shall comply with all CMS security program requirements as specified within the Internet-Only Manual (IOM) Pub. 100-17 (Business Partner System Security Manual [BPSSM] – http://www.cms.hhs.gov/InformationSecurity/13_Policies.asp#TopOfPage), the CMS Information Security (IS) “Virtual Handbook”, which is the collection of all CMS policies, procedures, standards and guidelines which implement the CMS Information Security Program found at www.cms.hhs.gov/informationsecurity and the QualityNet Security Policy and Procedures found at http://www.cms.hhs.gov/manuals/downloads/qio110c08.pdf.

· The QIO shall adhere to all deadlines and formats outlined in official CMS communications (e.g., Joint Signature Memoranda or JSMs).

· The QIO shall comply with the CMS Policy for the Information Security Program (PISP) and all CMS methodologies, policies, standards, and procedures contained within the CMS PISP unless otherwise directed by CMS in writing.

· The QIO shall comply with the Federal Information Security Management Act of 2002 (FISMA) requirements set forth in the e-Government Act of 2002.

· The QIO shall fully cooperate with (including the timely installation of CMS test software on the QIO systems) CMS audits, reviews, evaluations, tests, and assessments of QIO systems, processes, and facilities.

· The QIO shall visit the CMS security website (www.cms.hhs.gov/informationsecurity) and the QualityNet security website (http://qionet.sdps.org/training_resources/qnet_security.shtml) at least monthly for updates. Refer to the CMS (IOM Pub. 100-17) (Business Partner System Security Manual [BPSSM] – http://www.cms.hhs.gov/InformationSecurity/13_Policies.asp#TopOfPage) and related QIO program materials (http://qionet.sdps.org) for updates. The QIO shall visit the QualityNet Conference website (http://www.qualitynetonline.com/) annually for QualityNet Program and Security briefings and training opportunities. The QIO shall participate in the CMS Security Best Practices conferences and audio conferences as directed by CMS.

· The QIO shall document its compliance with CMS security requirements and maintain such documentation in the Systems Security Profile as directed by CMS.

3.3 Correct Deficiencies

· The QIO shall correct any security deficiencies, conditions, weaknesses, findings, or gaps identified by all audits, reviews, evaluations, tests, and assessments, including but not limited to, Office of the Inspector General (OIG) audits, self-assessments, QIO management review, QIO security audits, and vulnerability assessments in a timely manner.

· The QIO shall develop, in conjunction with CMS, Corrective Action Plans (CAPS) for all identified weaknesses, findings, gaps, or other deficiencies in accordance with IOM Pub. 100-17 (BPSSM) or as otherwise directed by CMS.

· The QIO shall validate and document that corrective actions have been implemented and demonstrated to be effective.

· The QIO shall provide CAPs and quarterly progress reports to CMS as directed by CMS.

3.4 Corrective Action Attestation

The QIO shall provide attestation of corrective actions to CMS upon request.

3.5 Security Review and Verification

· The QIO shall comply with the CMS Certification and Accreditation (C&A) methodology, policies, standards, procedures, and guidelines for contractor facilities and systems (http://www.cms.hhs.gov/InformationSecurity/14_standards.asp#TopOfPage).

· The QIO shall conduct or undergo an independent evaluation and test of its systems security program in accordance with CMS Reporting Standard for Information Security (IS) Testing (http://www.cms.hhs.gov/InformationSecurity/14_Standards.asp#TopOfPage). The report should follow the template as prescribed in CMS Reporting Standard for Information Security (IS) Template (http://www.cms.hhs.gov/InformationSecurity/14_Standards.asp#TopOfPage).

· The QIO shall support CMS validation and accreditation of contractor systems and facilities in accordance with CMS’ C&A methodology.

· The QIO shall provide annual certification in accordance with C&A methodology that certifies it has examined the management, operational, and technical controls for its systems supporting the QIO contract function and considers these controls adequate to meet CMS’ security standards and requirements.

4. Reporting Requirements:

The QIO shall report to CMS as directed in Section F – QIO Schedule of Deliverables and the sections of the QIO Manual referenced in this SOW. The QIO shall use all components and adhere to all procedures of the Standard Data Processing System (SDPS) data collection and reporting systems (including those outlined in the SDPS User’s Guide and Section F – QIO Schedule of Deliverables) to manage and report work performed under this SOW.

5. Confidentiality:

The QIO shall adhere to the privacy, confidentiality and disclosure requirements set forth in Section 1160 of the Act, and in Section 42 of the Code of Federal Regulation (CFR) Part 480; Section H of this contract, which limits uses and disclosures when the QIO is acting as a business associate of CMS and contains the business associate agreement required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules; the QIO Manual; and other applicable federal laws, regulations and administrative directives.

The business associate agreement requirement applies if the QIO conducts any activities on behalf of CMS’ Medicare fee-for-service health plan function involving the use or disclosure of protected health information or electronic protected health information such as for payment or health care operations. The business associate agreement in Section H applies only where the QIO is serving as a HIPAA business associate of CMS’ Medicare FFS health plan function, which includes conducting payment or health care operations activities. The business associate agreement does not apply when the QIO is not serving as a HIPAA business associate of CMS’ Medicare FFS health plan function such as when the QIO is providing health oversight activities as defined by the Act, based on the grant of authority provided to it by CMS to conduct authorized health oversight activities.

6. Government Data:

A listing of data to be supplied by CMS and the schedule by which they will be provided appears in Section J, Attachment J-5 - Data Supplied by CMS. In general, Part A reported data will be available from the CMS Data Warehouse. CMS support contractors will create and deliver to CMS state/jurisdiction-level measurement and analytic datasets for distribution to the QIO. A QIO request for additional data or analytic datasets will be reviewed and approved by the Project Officer (PO).

7. Clinical Data Abstraction Center Subcontract:

The QIO shall sign a subcontract with the Clinical Data Abstraction Center (CDAC) and shall work directly with the CDAC on records management activities. The CDAC will (1) request medical records on behalf of the QIO; (2) work with the QIO to track which medical records have been received; and (3) track and report to the QIO on all photocopying and mailing costs incurred by providers or practitioners. The CDAC may pay the pass-through costs if the QIO chooses to include this as a provision of its subcontract with the CDAC.

The QIO may choose to subcontract additional functions to the CDAC, as it would to any other potential subcontractor. However, these subcontracting arrangements shall be handled separately from the data abstraction subcontract and shall be individually negotiated between the QIO and the CDAC and subject to approval by the Contracting Officer (CO).

8. Coordination with Stakeholders:

The QIO may coordinate certain of its activities with those of stakeholder organizations in its state/jurisdiction working on comparable improvement efforts or interested in teaming with the QIO. Stakeholders are organizations that have common goals with those of the QIO and may include fiscal intermediaries (FIs), Carriers, Medicare Administrative Contractors (MACs), Recovery Audit Contractors (RACs), Medicare provider membership associations; health care alliances; professional associations; clinical specialty organizations; state licensing, certification and survey agencies; state and local health departments; accreditation organizations; payers; beneficiary advocacy groups; Medicare suppliers; state Medicaid agencies; and End-Stage Renal Disease (ESRD) Networks. Coordination with stakeholders may involve creating, joining, and supporting partnerships with organizations with similar goals and objectives, or facilitating ongoing discussion among the various stakeholders. The nature of the activity to facilitate coordination must be consistent with the terms of the contract and may require advance approval from the CO.

9. Communications:

For communications activities, the QIO may use Attachment J-3 QIO Communications Handbook as a resource.

The QIO shall manage its resources as efficiently and effectively as possible. In this regard, CMS recognizes three major sources from which the QIO can obtain marketing materials and resources: (1) other CMS contractors, (2) the ESRD Networks, and (3) other external sources that provide non-copyrighted materials and resources. In addition, the QIO may develop its own materials.

The QIO shall make available to the general QIO community (1) any CMS-approved new materials developed by the QIO, and (2) any CMS-approved substantial adaptations by the QIO of CMS- or CMS contractor-developed materials. The QIO shall provide a copy of such materials in a file format specified by CMS to the PO.

The QIO shall adhere to review requirements with regard to media activities and/or materials supporting high-profile events and national initiatives. Once a submitted document has been approved and any required changes made, the QIO shall provide a copy of the final version to the PO.

The QIO shall adhere to the following requirements in conducting its communications activities:

a. Publications–Peer-Reviewed:

A QIO that seeks to publish reports on results of specific activities in technical or professional journals or to present such results at technical or professional meetings shall follow CMS-issued procedures.

b. Publications–Outreach Materials:

All QIO-printed outreach material shall conform to the Department of Health and Human Services (DHHS)/CMS standards issued through CMS.

c. Use of Web Technology:

The QIO may create or maintain a website(s) on which communications pursuant to the QIO's Medicare contract activities appear. The QIO shall adhere to the following in presenting its Medicare contract-related communications on that site(s):

i. Follow the CMS Contractor Website Guidelines as specified in www.cms.hhs.gov/AboutWebsite/13_contractorwebguidlines.asp. The QIO shall refer to this website regularly for the current standards and guidelines;

ii. Follow the Accessibility and Section 508 Amendment to the Rehabilitation Act of 1973 Requirements;

iii. Follow the Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons,” promulgated on June 12, 2002

iv. Follow the HHS guidance promulgated on August 4, 2003 “Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons”

v. Follow any other CMS directives.

vi. Only use the website for informational purposes, no application design usage unless approved by CMS as described in section C.4.15.

d. Emergency Preparedness

Medicare beneficiaries would likely be affected in the event of many kinds of emergency situations, such as a pandemic flu outbreak. When emergency situations occur, the QIO shall assist CMS’ public health efforts by disseminating information and messages as directed by CMS. CMS will utilize the QIO’s relationship with providers, including its partnerships and collaborations to serve as additional channels for communications. The QIO, in working with its state or jurisdiction’s health department, shall ensure that the QIO has established point(s) of contact with the Immunization Bureau or others at the health department to assure effective dissemination of DHHS and CMS information. The QIO may, as needed, work actively within its state/jurisdiction performing activities such as:

1. Assist the health department in provider education/information;

2. Participate in the state’s/jurisdiction’s disaster planning process (the QIO is encouraged to establish contacts and make sure information on existing contacts remains current to ensure coordination in advance of any disaster);

3. Participate in the state’s/jurisdiction’s Pandemic Readiness Committee(s) as necessary to help bridge communications and mobilize physician practices (PPs), hospitals, nursing homes, home health agencies and ESRD Networks;

4. Subscribe to established listservs for emergencies/disasters and pandemics, as appropriate, to ensure consistency with message and status for pandemic readiness.

10. Education, Information and Outreach:

In performing the work of the Themes (Beneficiary Protection, Care Transitions, Patient Safety and Prevention) the QIO shall incorporate various tactics in its effort to stimulate widespread positive changes in the attitudes and behavior of various target audiences such as providers and Medicare beneficiaries. To create broad impact and significant improvement in the Theme areas, a QIO is encouraged to engage in health promotion campaigns utilizing any of the tactical approaches below or its own creative strategies.

In conducting education, information and outreach, a QIO must make available to CMS a marketing (or communications) plan with specific strategies and other details for outlining the intended approach within each Theme in its contract. A QIO shall include recruitment efforts in its marketing/communications plan and is encouraged to utilize efficiencies in product development by maximizing the use of CMS-available materials.

In developing its own local products, a QIO must effectively manage adherence to CMS policy requirements and agency and Departmental directives. In addition, a QIO must utilize social marketing theories in its development of strategies and products to ensure that content, design, and dissemination appropriately conform to target audience(s).

QIO work in supporting the Themes may include but is not limited to the following:

· Promoting dialogue among providers around the discharge and receiving of patients;

· Assisting providers in meeting the communication needs of individuals who do not speak English as their primary language (i.e., are limited-English- proficient) or who are deaf or hard of hearing. Individuals are patients or potential patients (rather than hospital employees or others);

· Improving methods of communications with patients and families in various health care settings, such as the hospitals;

· Influencing community leadership to promote buy-in and community ownership in quality improvement efforts;

· Developing and supporting provider workgroups to focus more specifically on specific inter-provider transitions;

· Developing strategies and materials to improve networking with partners/stakeholders for leveraging awareness;

· Managing public recognition, including announcements of provider participation;

· Monitoring public inquiries and stimulating relations with media to help build awareness and value of the Program;

· Developing and utilizing multimedia campaigns to increase provider and/or beneficiary awareness of the Program and QIO services;

· Influencing providers and other audiences through promotion of QIO accomplishments;

· Providing tools and training to support provider changes in practice;

· Marketing and disseminating training programs that assist providers;

· Marketing materials to convey Theme messages in specific settings, such as in hospitals for use on the day of discharge;

· Identifying and developing tactical products, such as tip sheets and checklists to help empower beneficiaries;

· Assisting with targeting disadvantaged populations to ensure maximum utilization of QIO resources.

11. Internal Quality Control:

The objectives of the Internal Quality Control (IQC) program are to support and foster continuous quality improvement within the QIO in support of each of the Themes in Section C.6 and C.7.

The QIO shall implement an IQC program as described in Sections 13000–13030 of the QIO Manual. CMS encourages each QIO to collaborate with other QIOs in developing and implementing IQC programs. The QIO shall share lessons learned regarding these IQC activities with other QIOs using the available mechanisms, including QIO conferences, newsletters, and databases. The QIO shall submit its IQC plan in accordance with Section F – QIO Schedule of Deliverables.

12. Information Collection Activities

A QIO that seeks to conduct information collection activities, including surveys, as part of its work on the Themes in Section C.6 and Section C.7., shall do so in accordance with the Paperwork Reduction Act; Sections 12600–12670 of the QIO Manual; and other administrative directives.

13. Staffing

The QIO shall, to the extent necessary to carry out its contract activities, enter into arrangements with entities and individuals with expertise in the following areas:

a. Medicine, nursing, and related medical/clinical disciplines–including expertise in nursing home, home health, hospital and physician practice settings; managed care; pharmacy; and prescription drug plans;

b. Health education, health promotion, social marketing and formative research, public relations, market research, media, Web design, and related communications disciplines;

c. Diagnostic coding expertise;

d. Quality and safety of care and performance improvement;

e. Epidemiology, statistics, survey research, data analysis, information systems (implementing electronic health record systems), computer science, and related empirical and analytic disciplines;

f. Social and behavioral sciences including human factors disciplines;

g. Administrative and clinical aspects of case review, including case management and the use of mediation to resolve complaints;

h. IT networking, file server, and workstation support expertise in Microsoft and Novell Technologies, Microsoft Certified Systems Administrator (MCSA) preferred;

i. Database support and administration expertise in Oracle;

j. IT security and data management expertise with at least 3+ years IT security experience in the work of Section C.4.3.

14. Independent Evaluation

The QIO shall fully facilitate and provide requested data, subject to the QIO confidentiality provisions in section 1160 of the Act and 42 CFR Part 480, for any evaluation of the QIO Program that the Secretary, or CMS on behalf of the Secretary chooses to conduct using an external contractor.

15. Systems Development

The QIO shall develop software only with prior approval through their Project Officer from CMS and follow all current QualityNet Systems/Software Development Life Cycle (SDLC) procedures and rules.

16. Cross-cutting Themes

In addition to the four themes outlined in Sections C.6.1, C.6.2, C.6.3 and C.7.2.—Beneficiary Protection, Patient Safety, Prevention, and Care Transitions—there are 3 cross-cutting themes within the 9th SOW. They are

· Health Disparities

· Health Information Technology

· Value Driven Health Care Each of these relates to Agency, Department, and/or Presidential priorities and is important to provide care that is safe, effective, patient-centered, timely, efficient, and equitable.

QIOs, in carrying out the work specified in Sections C.6 and C.7, shall endeavor to incorporate each of the cross-cutting themes in their activities and should be able to demonstrate that to the Project Officer and or Government Task Leader upon request.

C.5. OVERALL CONTRACT EVALUATION

Under this SOW, the QIO’s performance in undertaking activities to carry out the requirements of each of the Themes (Beneficiary Protection, Care Transitions, Patient Safety and Prevention) and components within those Themes will be used to determine the QIO’s success or failure in meeting the overall evaluation criteria as specified below. The QIO shall be evaluated on the Themes and components under the Theme required under the contract. If a QIO is not tasked to work on a Theme or a specific component under the Theme, the QIO will not be evaluated under that particular Theme or component. Any Special Project (SP) that the QIO may carry out will be evaluated separately and will not be considered in the overall evaluation criteria.

There will be two periods of evaluation under this SOW. The first evaluation will focus on the QIO’s work in three Theme areas (Care Transitions, Patient Safety, and Prevention) and will occur at the end of 18 months using the most recent data available to CMS. The second evaluation will examine the QIO’s performance on Tasks within all Theme areas (Beneficiary Protection, Care Transitions, Patient Safety, and Prevention). The second evaluation will take place at the end of the 28th month of the contract term and will be based on the most recent data available to CMS. The performance results of the evaluation at both time periods (that is 18 months and 28 months) will be used to determine the performance on the overall contract.

The first contract evaluation will determine if the QIO has met the performance criteria in the Theme areas of Care Transitions, Patient Safety, and Prevention and in the components within a Theme. The Themes or components within the Theme as appropriate will be evaluated on an individual basis with the determination relative to only that area.

The second contract evaluation will determine if the QIO has met the performance criteria in all Theme areas of Beneficiary Protection, Care Transitions, Patient Safety and Prevention, and in the components within the Themes. The performance on the Beneficiary Protection Theme will cover the 28-month contract period.

The results of the first and second evaluations at the end of the 18- and 28-month periods will be used to determine how the contractor performed on the overall contract in total.

18-Month Evaluation Criteria (By Theme or component of the Theme excluding Beneficiary Protection)

· Pass = Criteria met and CMS may elect the option to continue the work (and funding) of the Theme or component of the Theme where appropriate.

· Fail = Criteria not met and CMS may, among other remedies, elect NOT to continue the work (or the funding) for the Theme or component of the Theme where appropriate for the contract duration.

28-Month Evaluation Criteria (By Theme or component of the Theme including Beneficiary Protection for the 28-month contract period)

· Pass = Criteria met for Theme or component of the Theme where appropriate.

· Fail = Criteria not met for Theme or component of the Theme where appropriate.

Overall Contract Performance

· Pass = Pass on all Themes and components within the Theme at both evaluation periods

· Fail = Fail any Theme or component within the Theme in either evaluation period

If CMS chooses, CMS may notify the QIO of the intention not to renew the QIO contract, and inform the QIO of the QIO’s rights under the then current statute.

The specific evaluation criteria are described below for each Theme or component within a Theme as appropriate. In general, for areas of work that have been performed under the 8th SOW or other recent QIO SOWs where historical data is available for analysis, the acceptable performance expectation is a specific target or tighter target range than for areas of work that have not been in previous SOWs and where the experience under a previous SOW demonstrated that there was a range for acceptable performance. For the purpose of determining scores for all Themes, components within a Theme, or measures within a Theme, all percentages will be rounded to two places (with the value at or above five in the thousands position [e.g., .005, .015, etc.] rounded up).

Beneficiary Protection:

· Pass = 90% of Target

· Fail = <90%

Patient Safety: Surgical Care Improvement Project/Heart Failure (SCIP/HF), Pressure Ulcers and Physical Restraints

· Pass = 70 – 100% of Target

· Fail = <70%

Patient Safety: Methicillin Resistant Staphylococcus Aureus (MRSA)

· Pass = 70 – 100% of Target

· Fail = <70%

Patient Safety: Drug Safety, Nursing Homes In Need (NHIN)

· Pass = 70 - 100% of Target

· Fail = <70%

Prevention: Cancer Screening, Mammograms, and Immunizations

· Pass = 100% of Target

· Fail = <100%

Prevention: Disparities

· Pass = 80% of Target

· Fail = <80%

Care Transitions

· Pass = 100%-80% of Target

· Fail = <80%

Prevention: Chronic Kidney Disease (CKD)

· Pass = 100%-80% of Target

· Fail = <80%

The list of measures and performance criteria for each QIO will be recorded on the CMS Dashboard, which will be available on QIOnet (http://qionet.sdps.org), the standard information system that supports the QIO Program. CMS will also post these measures on the publicly accessible CMS website (http://www.cms.gov).

CMS will monitor the QIO’s performance on Themes, components within the Theme and measures within Themes against established criteria on a quarterly basis, and may take appropriate contract action (e.g., providing warning for the need for adjustment, instituting a formal correction plan, terminating an activity, or recommending early termination of a contract because of failure to meet contract timelines as specified in Section C.6 and Section C.7.).

CMS reserves the right at any point prior to the notification of CMS’ intention not to continue the option for a Theme and/or to renew the contract to adjust the expected minimum thresholds for satisfactory performance or remove criteria from a Theme or Theme component evaluation protocol for any reason, including, but not limited to, data gathered based on experience…