Amendment 75FCMC23R0006-0002.pdf

(x)

75FCMC23R0006

x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

AGG/DS1

Baltimore MD 21244 Mailstop: B3-30-03 7500 Security Boulevard Domonique Sparks

ASG - DQC

BALTIMORE MD 21244-1850

7500 SECURITY BLVD., MS: B3-30-03

CMS,OAGM,ASG,DQC

02/13/20230002

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

01/12/2023

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Period of Performance: 05/01/2023 to 04/30/2028

The purpose of this Amendment is correct Appendix D. Cells H8 and H9 of the document have been changed from “No” to “Yes”.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

Jonathan Nolan

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

TABLE OF CONTENTS

SECTION B- SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 DESCRIPTION OF SERVICES

B.2 TYPE OF CONTRACT

B.3 SCHEDULE OF SERVICES

B.4 PAYMENT SCHEDULE

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF OBJECTIVES

C.1 STATEMENT OF WORK

SECTION D – PACKAGING AND MARKING

D.1 PACKAGING AND MARKING

SECTION E - INSPECTION AND ACCEPTANCE

E.1 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

E.2 INSPECTION AND ACCEPTANCE

SECTION F - DELIVERABLES OR PERFORMANCE

F.1 FAR 52.252-2 CONTRACT CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

F.2 PERIOD OF PERFORMANCE (JAN 2014)

F.3 ITEMS TO BE FURNISHED AND DELIVERY SCHEDULE

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 ACCOUNTING AND APPROPRIATION DATA

G.2 PAYMENTS – INVOICES – (August 2020)

G.3 GOVERNMENT REPRESENTATIVES AND RESPONSIBILITIES (SEPT 2021)

G.4 SERVICE OF CONSULTANTS/ SUBCONTRACTORS

G.5 CORRESPONDENCE PROCEDURES

G.6 CONTRACTOR PAST PERFORMANCE EVALUATION(S) (OCT 2014)

G.7 CONTRACT WORK PERFORMED OUTSIDE THE UNITED STATES (JAN 2021)

G.8 DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATIONS

(HHSAR) CLAUSES INCORPORATED BY REFERENCE (JUN 2015)

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 CONFLICT OF INTEREST (OCT 2020)

H.2 HIPAA BUSINESS ASSOCIATE CLAUSE (OCT 2014)

H.3 CMS INFORMATION SECURITY (OCT 2020)

H.4 CMS SECURITY CLAUSE (MAY 2018)

H.5 HHSAR 352.224-71 CONFIDENTIAL INFORMATION (DEC 2015)

H.6 HHSAR 352.237-75 KEY PERSONNEL (DEC 2015)

H.7 WAGE DETERMINATIONS

H.8 MANDATORY CONTRACTOR TRAINING (JAN 2021)

SECTION I – CONTRACT CLAUSES

I.1 FEDERAL ACQUISITION REGULATIONS (FAR) 52.252-2 CLAUSES INCORPORATED

BY REFERENCE (FEB 1998)

I.2 DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATIONS

(HHSAR) CLAUSES INCORPORATED BY REFERENCE (JUN 2015)

I.3 FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

I.4 FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

I.5 FAR 52.219-11 SPECIAL 8(a) CONTRACT CONDITIONS (JAN 2017)

I.6 FAR 52.219-12 – SPECIAL 8(a) SUBCONTRACT CONDITIONS (OCT 2019)

SECTION J – LIST OF APPENDICES AND ATTACHMENTS

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

OFFERORS OR RESPONDENTS

K.1 FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998) 40

K.2 FAR 52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (MAR 2020)

K.3 FAR 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018) .. 44

K.4 FAR 52.215-6 PLACE OF PERFORMANCE (OCT 1997)

K.5 FAR 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SREVICES OR EQUIPMENT (DEC 2019)

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS OR

RESPONDENTS

L.1 FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998) 47

L.2 DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATIONS

(HHSAR) PROVISIONS INCORPORATED BY REFERENCE (JAN 2016)

L.3 FAR 52.216-1 TYPE OF CONTRACT (APR 1984)

L.4 HHSAR 352.239-73 ELECTRONIC INFORMATION AND TECHNOLOGY

ACCESSIBILITY NOTICE

L.5 FAR 52.233-2 SERVICE OF PROTEST (SEP 2006)

L.6 GENERAL INSTRUCTIONS

L.7 SUBMISSION OF INTENT

L.8 SUBMISSION OF QUESTIONS

L.9 SUBMISSION OF PROPOSALS

L.10 PROPOSAL ORGANIZATION

L.11 TECHNICAL PROPOSAL INSTRUCTIONS (Volume I)

1: Accuracy/Validation and Clinical Evidence Literature Review Experience

2: Key Personnel/ Clinical Expertise Support:

3: Technical Understanding and approach:

4: Past Performance:

5: 508 Compliance:

L.12 BUSINESS PROPOSAL INSTRUCTIONS (Volume II)

L.13 CONFLICTS OF INTEREST PROPOSAL SUBMISSION INSTRUCTIONS VOLUME III-

Conflicts of Interest

SECTION M - EVALUATION FACTORS FOR AWARD

M.1 FAR 52.217-5 EVALUATION OF OPTIONS (JUL 1990)

M.2 GENERAL PROCEDURES FOR AWARD

M.3 EVALUATION FACTORS

Technical Proposal Evaluation

A. Technical Proposals Will Be Evaluated Based on The Following Factors:

Factor 1: Accuracy/Validation and Clinical Evidence Literature Review Experience

Factor 2: Key Personnel/ Clinical Expertise Support

Factor 3: Technical Understanding and Approach

Factor 4: Past Performance

Factor 5: 508 Compliance

B. Business Proposal Evaluation

C. Conflict of Interest Evaluation (OCT 2020)

M.4 EVALUATION METHODOLOGY

M.5 AWARD/SELECTION PROCESS

SECTION B- SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 DESCRIPTION OF SERVICES

The purpose of this contract is to complete needed Environmental Scans (ESs) efficiently and quickly in support of timely policymaking. CMS’s Coverage and Analysis Group (CAG) will identify up to 30 high-priority ESs to be completed by the contractor over the period of performance (POP) based on CMS priorities. You will find more information in the Statement of Work provided as Attachment J.1.

B.2 TYPE OF CONTRACT

The contract is a Firm Fixed Price (FFP) type. A contract line item number (CLIN) is established for the base period and each 1-year optional period. The total Firm Fixed Price amount for the amount for the base period is $TBD. The total potential amount of the contract (based period plus three optional periods) is $TBD.

B.3 SCHEDULE OF SERVICES

The total negotiated firm fixed price is as follows:

CLIN Description Firm Fixed Price Funded Period of Performance

0001 Base Period $TBD $TBD 05/01/2023 – 04/30/2024

0001AA Tasks 1-14 $TBD $TBD

0001AB

Optional Task

15 $TBD $TBD

0002 Option Period 1 $TBD $TBD 05/01/2024 – 04/30/2025

0002AA Tasks 1-14 $TBD $TBD

0002AB

Optional Task

15 $TBD $TBD

0003 Option Period 2 $TBD $TBD 05/01/2025 – 04/30/2026

0003AA Tasks 1-14 $TBD $TBD

0003AB

Optional Task

15 $TBD $TBD

0004 Option Period 3 $TBD $TBD 05/01/2026 – 04/30/2027

0004AA Tasks 1-14 $TBD $TBD

0004AB

Optional Task

15 $TBD $TBD

0005 Option Period 4 $TBD $TBD 05/01/2027 – 04/30/2028

0005AA Tasks 1-14 $TBD $TBD

0005AB

Optional Task

15 $TBD $TBD

Option to Extend 6 months $TBD $TBD 05/01/2028 – 11/30/2028

0006AA Tasks 1-14 $TBD $TBD

0006AB

Optional Task

15 $TBD $TBD

B.4 PAYMENT SCHEDULE

The Government shall pay the Contractor for performing this contract the fixed price specified in the schedule below. Payment of the fixed price will be made in accordance with the schedule provided below:

A. Base Period – May 1, 2023 – April 30, 2024

Month Payment Total

1-11 TBD

12 TBD

Total TBD

B. Option Period 1 – May 1, 2024 – April 30, 2025

13-23 TBD

24 TBD

C. Option Period 2 – May 1, 2025 – April 30, 2027

25-35 TBD

36 TBD

D. Option Period 3 – May 1, 2026 – April 30, 2027

37-47 TBD

48 TBD

E. Option Period 4 – May 1, 2026 – April 30, 2027

49-59 TBD

60 TBD

(End of Section B)

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF OBJECTIVES

C.1 STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, facilities, and supplies, not otherwise provided by the Government as needed to perform the requirements set forth in the Statement of Work, attachment J.1 entitled “CAG ES SOW.”

(End of Section C)

SECTION D – PACKAGING AND MARKING

D.1 PACKAGING AND MARKING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Attachment J.2 Schedule of Deliverables.

(End of Section D)

SECTION E - INSPECTION AND ACCEPTANCE

E.1 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

http://www.acquisition.gov/far/

Federal Acquisition Regulation (FAR) Clauses:

NUMBER TITLE DATE

52.246-4 INSPECTION OF SERVICES – FIXED PRICE– FIXED AUG 1996

E.2 INSPECTION AND ACCEPTANCE

a. All work under this contract is subject to inspection and final acceptance by the Contracting Officer or the duly authorized representative of the Government.

b. The Contracting Officer Representative or Alternate Contracting Officer Representative is a duly authorized representative of the Government and is responsible for inspection and acceptance of all items to be delivered under this contract.

c. Inspection and acceptance of the Contractor's performance shall be in accordance with the applicable FAR Clauses in Section E.1 above.

(End of Section E)

SECTION F - DELIVERABLES OR PERFORMANCE

F.1 FAR 52.252-2 CONTRACT CLAUSES INCORPORATED BY REFERENCE

(FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

52.242-15 STOP-WORK ORDER AUG 1989

52.242-17 GOVERNMENT DELAY OF WORK APR 1984

F.2 PERIOD OF PERFORMANCE (JAN 2014)

The period of performance is a base period of twelve (12) months from the date of award with four (4) – one (1) year option periods. The Contractor shall commence work immediately upon notice of award. The period of performance is as follows:

A. Base Period: May 1, 2023 – April 30, 2024 B. Option Period 1: May 1, 2024 – April 30, 2025 C. Option Period 2: May 1, 2025 – April 30, 2026 D. Option Period 3: May 1, 2026 – April 30, 2027 E. Option Period 4: May 1, 2027 – April 30, 2028

F.3 ITEMS TO BE FURNISHED AND DELIVERY SCHEDULE

The Schedule of Deliverables (SOD) is provided as Attachment J.2 and incorporated as part of this Contract.

Satisfactory performance under this task order shall be deemed to occur upon delivery and acceptance by the CO, or the duly authorized representative, in accordance with Attachment J.2, Schedule of Deliverables.

All required contract deliverables shall be reviewed by the Contracting Officer’s Representative (COR) to determine acceptance. The COR will respond, in writing, within 45 days of receipt of any contract deliverable indicating if final acceptance has been granted. If deficiencies in Contractor’s deliverable are identified, the COR shall provide feedback to the Contractor prior to the 45-day timeframe for final acceptance. If the Contractor does not receive a written indication from the COR within the 45 days, then the Contractor shall consider the deliverable to be accepted. The Contractor is responsible for ensuring the COR is in receipt of the deliverables. Receipt can be acknowledged in any form of writing (mail or electronic). The 45-day timeframe begins on receipt of deliverable, not acknowledgment of receipt.

(End of Section F)

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 ACCOUNTING AND APPROPRIATION DATA

CLIN Appropriation Object Class CAN Amount

0001 TBD TBD TBD TBD

G.2 PAYMENTS – INVOICES – (August 2020)

a. GENERAL: Effective August 31, 2020, the contractor/vendor shall create an invoice within the Invoice

Processing Platform (IPP), a secure Web-based service for federal agencies and their vendors to manage government invoicing from purchase order (PO) through payment notification. Note: All invoice terms and conditions are contract specific and may vary from contract to contract.

b. CONTENT OF INVOICE - FAR 32.905 Payment Documentation and Process, provides the required content for a proper invoice. In addition to the requirements of FAR 32.905, the following items shall also be included on the invoice to be considered proper:

• Line item number (i.e. CLIN/SLIN as applicable);

• Contractor’s DUNS Number;

• Period of performance or delivery date of goods or services provided;

• Attachments

c. INVOICE SUBMISSION: The contractor/vendor shall create an invoice from the Purchase Order

(PO)/Contract via the IPP website http://www.ipp.gov/. For questions, call IPP Customer Support at (866) 973-3131 or email the IPP Customer Support at IPPCustomerSupport@fiscal.treasury.gov.

d. PAYMENTS: The Government shall make payment of all proper invoices in accordance with the following clauses, as applicable and included in the respective PO/Contract:

• FAR 52.232-33 Payments by Electronic Funds Transfer – System for Award Management,

• FAR 52.232-1 Payments

• FAR 52.212-4 Contract Terms and Conditions – Commercial Items

• FAR 52.216-7 Allowable Cost and Payment

• FAR 52.232-7 Payments under Time-and-Materials and Labor-Hour Contract

Payment shall be made upon acceptance by the Contracting Officer’s Representative (COR)in accordance with the applicable FAR Inspection and Acceptance clause and the Contracting Officer’s approval, as appropriate.

Reimbursement for invoices submitted under this contract shall be made no later than 30 calendar days after receipt of a proper invoice from the Contractor requested at the paying office designated above. Contracts with a 15-day payment term are not subject to interest payments until after day 30.

e. INTEREST ON OVERDUE PAYMENT: The Prompt Payment Act, Public Law 97-177 (96 Stat.85.31 U.S.C. 1801) is applicable to payments under this contract and requires the payment of interest on payments made more than 30 calendar days after receipt of a proper invoice in IPP.

http://www.ipp.gov/

Determinations of interest due will be made in accordance with the provisions of the Prompt Payment Act and 5 CFR 1315.

G.3 GOVERNMENT REPRESENTATIVES AND RESPONSIBILITIES (SEPT 2021)

Following are the Government Representatives and their respective roles and responsibilities on this contract:

a. Contracting Officer

As defined in Federal Acquisition Regulation (FAR) 2.101, Definitions, and in accordance with FAR 1.602-1, Authority, “Contracting officers have authority to enter into, administer, and/or terminate contracts and make related determinations and findings.” There is no other authorized representative or any other Administrative Contracting Officer assigned to this contract to carry out a Contracting Officer’s duties, except for technical direction assigned to the Contracting Officer’s Representative, if applicable.

The Contracting Officer is:

Centers for Medicare & Medicaid Services Office of Acquisition & Grants Management Division of Quality Contracts ATTN: Jonathan Nolan 7500 Security Blvd.

Mail-stop: B3-30-03 Baltimore, MD 21244-1850 Phone: 410-786-7605 Email Address: Jonathan.Nolan1@cms.hhs.gov

b. Contract Specialist

Notwithstanding any of the other provisions of this Contract, the Contract Specialist will assist the Contracting Officer with his/her responsibilities as defined in the FAR.

The Contract Specialist is:

Centers for Medicare & Medicaid Services Office of Acquisition & Grants Management Division of Program Integrity & Financial Management Contracts ATTN: Domonique Sparks 7500 Security Blvd.

Mail-stop: B3-30-03 Baltimore, MD 21244-1850 Phone: 410-786-1896 Email Address: Domonique.Sparks@cms.hhs.gov

c. Contracting Officer’s Representative

The Contracting Officer’s Representative (COR), as defined in FAR 2.101, Definitions, is:

Centers for Medicare & Medicaid Services Coverage & Analysis Group (CAG)

ATTN: TBD

mailto:Jonathan.Nolan1@cms.hhs.gov mailto:Domonique.Sparks@cms.hhs.gov

7500 Security Blvd.

Baltimore, MD 21244-1850 Phone:

Email Address:

In accordance with FAR 1.602-2(d), Responsibilities, the COR’s delegated responsibilities are identified in the Contracting Officer’s appointment memorandum, a copy of which will be furnished to the contractor.

The COR will serve as the primary liaison between the Contractor and the Contracting Officer and perform duties within the limitations of the COR’s responsibilities in accordance with FAR 1.602-2(d).

Technical direction must be within the general scope of the work stated in the contract. The term "technical direction" is defined to include, without limitation, the following:

(1) Directions to the Contractor which direct the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual technical requirements as identified in the Statement of Work or Performance Work Statement; or

(2) Provision of information to the Contractor, which assists in the interpretation of drawings, specifications, or technical portions of the work description.

Technical direction within the scope of the contract, shall be “in writing” whenever possible and routed through the CO prior to release to the Contractor. If technical direction is verbally communicated, the COR must immediately confirm its direction in writing. Where doubt exists as to whether proposed technical direction is within or outside the scope of the contract, the CO shall be contacted.

If, in the opinion of the Contractor, any instruction or direction issued by a Government representative constitutes a change to the contract or constitutes a “Change Order” as defined in FAR 2.101, Definitions, the Contractor shall follow the instructions identified in FAR 52.243-7 Notification of Changes.

The COR “has no authority to make any commitments or changes that affect price, quality, quantity, delivery, or other terms and conditions of the contract nor in any way direct the contractor or its subcontractors to operate in conflict with the contract terms and conditions” See FAR 1.202-2(d)(5).

). The COR’s authority is not re-delegable and the COR may be personally liable for unauthorized acts in accordance with FAR 1.202-(d)(7)(iv) and (v). For example, the COR does not have the authority to:

1. Make changes to contract terms and conditions;

2. Direct the contractor to perform work or make deliveries not specifically required under the contract;

3. Waive or relax the Government’s rights with regard to the Contractor’s compliance with the specifications, price, delivery or any other terms or conditions of the contract;

4. Make any commitments or approve any actions that would create any financial obligation on the part of the Government; or

5. Issue direction that constitutes a “change” as defined in:

FAR 52.243-1, Changes – Fixed Price;

FAR 52.243-2, Changes – Cost Reimbursement;

FAR 52.243-3, Changes – Time and Material and Labor Hour;

FAR 52.243-4, Changes; or, FAR 52.243-5, Changes and Changed Conditions.

In addition to the above responsibilities, the COR and/or Contractor shall immediately notify the Contracting Officer of any contractual concerns related to the following:

1. Personal Services: FAR 37.104(a) provides that, “[a] personal services contract is characterized by the employer-employee relationship it creates between the Government and the contractor’s personnel. The Government is normally required to obtain its employees by direct hire under competitive appointment or other procedures required by the civil service laws. Obtaining personal services by contract, rather than by direct hire, circumvents those laws unless Congress has specifically authorized acquisition of the services by contract.”

Under this contract, the services to be performed do not require the Contractor or the Contractor’s personnel to exercise personal judgement and discretion on behalf of the Government. Rather, the Contractor’s personnel will act and exercise personal judgement and discretion on behalf of the Contractor. The services to be performed under this contract are not for personal services as defined by

FAR 37.104.

Both the Government and the Contractor have a responsibility to monitor contract activities. The CO must be notified immediately if at any time during contract performance the interaction between the Government representative and Contractor personnel constitutes or is perceived to constitute personal services. Both the Government and Contractor personnel must exercise caution to ensure that service contracts not personal in nature avoid even the appearance of a personal services contract.

2. Inherently Governmental Functions: The agency shall not use contractors for the performance of inherently governmental functions unless issued under statutory authority See FAR 7.5 Inherently Governmental Functions. As defined in FAR 2.101, “Inherently Governmental Function” means, as a matter of policy, a function that is so intimately related to the public interest as to mandate performance by Government employees. An inherently governmental function includes activities that require either the exercise of discretion in applying Government authority, or the making of value judgments in making decisions for the Government. Inherently governmental functions DO NOT normally include gathering information for or providing advice, opinions, recommendations, or ideas to Government officials.

FAR 7.503(c) provides a list of examples of functions considered to be inherently governmental functions or which shall be treated as such.

To this effect, during contract performance, care should be taken to ensure that any change or expansion in scope of the requirement does not include inherently governmental functions. Further, due to the nature of a given requirement, there is a potential for close working relationships to develop between Government and Contractor personnel; however, care should be taken to ensure that any familiarity established between the Government and Contractor personnel never promotes or fosters an environment that allows for the assignment of inherently governmental functions to contractor employee(s).

3. Unauthorized Commitments: In carrying out his/her duties, in accordance with FAR 1.602- 2(d)(5), the COR “[h[as no authority to make any commitments or changes that affect price, quality, quantity, delivery, or other terms and conditions of the contract, or in any way direct the Contractor, or its Subcontractors, to operate in conflict with the contract terms and conditions.” Doing so constitutes an https://www.acquisition.gov/content/part-1-federal-acquisition-regulations-system#i1126427 https://www.acquisition.gov/content/part-1-federal-acquisition-regulations-system#i1126427

“unauthorized commitment.” The Contracting Officer is the only individual with the authority to enter into an agreement on behalf of the Government. An unauthorized commitment is defined as “an agreement that is not binding solely because the Government representative who made it lacked the authority to enter into that agreement on behalf of the Government.” FAR 1-602-3(a). Examples of unauthorized commitments include, but are not limited to, the following:

• Orders placed with a Contractor without a valid contractual instrument in place.

• Directing any Contractor to do additional work, in excess of the contract value, or work beyond the Period of Performance.

• Authorize new work to a contract without notifying the Contracting Officer (CO) or Contract Specialist (CS) and having a modification in place for the new work.

• Directing the Contractor, in any way that could change the terms and conditions of the contractual instrument or be deemed outside the Scope of the contract.

Unauthorized commitments are a serious matter and may result in personal liability on the part of the employee who committed the unauthorized commitment. Ratification, is “the act of approving an unauthorized commitment by an official who has the authority to do so.” FAR 1.602-3(a).

G.4 SERVICE OF CONSULTANTS/ SUBCONTRACTORS

a. For the purposes of this contract, consultants are considered subcontractors.

b. The Contractor shall follow the procedures established in the following Federal Acquisition Regulation

(FAR) clauses when requesting Contracting Officer consent to subcontract for Consultants and/or other subcontracts:

52.244-2 SUBCONTRACTS JUN 2020

52.244-5 COMPETITION IN SUBCONTRACTING DEC 1996

52.244-6

SUBCONTRACTING FOR COMMERCIAL ITEMS JUN 2020

G.5 CORRESPONDENCE PROCEDURES

To promote timely and effective administration, correspondence (except for invoices) submitted under this contact shall be subject to the following procedures:

a. Technical Correspondence - Technical correspondence (as used herein, this term excludes technical correspondence which proposes or otherwise involves waivers, deviations or modifications to the requirements, terms or conditions of this contract) shall be addressed to the COR with an informational copy of the basic correspondence to the Contracting Officer.

b. Other Correspondence - All other correspondence shall be addressed to the Contracting Officer, in duplicate, with an informational copy of the basic correspondence to the COR.

c. Subject Lines - All correspondence shall contain a subject line, commencing with the contract number as illustrated below:

EXAMPLE: Contract No. 75FCMC20CXXXX

G.6 CONTRACTOR PAST PERFORMANCE EVALUATION(S) (OCT 2014)

a. General:

In accordance with Federal Acquisition Regulation (FAR) 42.15, Contractor Performance Information, past performance evaluations shall be prepared at least annually and at the time the work under a contract or order is completed. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary.

CMS will utilize the Contractor Performance Assessment Reporting System (CPARS), the Government-wide evaluation reporting tool for all past performance reports on contracts and orders, as appropriate. CPARS is a secure Internet website located at https://www.cpars.gov.

b. CPARS Process:

1. CPARS Training: Contractors may obtain CPARS training material and register for on-line training https://www.cpars.gov.

2. Post-Award Contract Registration: CMS is responsible for registering the contract in CPARS within 30 calendar days of contract award. The Contractor shall:

i. Designate at least one (1) point of contact that will be responsible for serving as the

Contractor’s Representative (CR). Additional CRs may also be identified; and,

ii. Provide the CMS Contract Specialist with the name(s) and email address(es) of the

CPARS point(s) of contact.

Once CMS registers the contract in CPARS, the CR(s) will receive an automated CPARS email message that contains User IDs and instructions for creating a password for future past performance evaluation processing.

3. Interim, Annual and Final Past Performance Evaluation Reports:

i. Issuing the Evaluation: Once the CMS Assessing Official (AO) issues an evaluation to the Contractor in CPARS, the CR(s) will receive an email instructing them to login to CPARS to review the evaluation.

ii. Contractor Comments: The CR has the option to provide comments on the evaluation, indicate if they concur or do not concur with the evaluation, sign, and then return the evaluation to the AO. The CR has a total of 60 days following the AO’s evaluation signature date to submit comments. If the CR submits comments within the first 14 days following the AO’s signature date and the AO closes the evaluation, the evaluation will become available in Past Performance Information Retrieval System - Report Card (PPIRS-RC) within 1 day.

On day 15 following the AO’s evaluation signature date, the evaluation will become available in PPIRS-RC with or without CR comments and whether or not it has been closed by the AO. If no CR comments have been sent and the evaluation has not been closed, it will be marked as “Pending” in PPIRS-RC.

If the CR sends comments at any time prior to 61 days following the AO’s evaluation https://www.cpars.gov/ https://www.cpars.gov/ signature date, those comments will be reflected in PPIRS-RC within 1 day. On day 61 following the AO’s evaluation signature date, the CR will be “locked out” of the evaluation and may no longer send comments.

G.7 CONTRACT WORK PERFORMED OUTSIDE THE UNITED STATES (JAN 2021)

To comply with requirements of Homeland Security Presidential Directive -12 (HSPD-12) and Personal Identity Verification (PIV) of Federal Employees and Contractors, CMS must achieve appropriate security assurance for multiple CMS information systems by efficiently verifying the claimed identity of individuals working on the contract. The Contractor and its subcontractor(s) shall not perform any activities under this contract, including the transmission of data or other information, outside of the United States (U.S.) and its Territories without the prior written approval of the Contracting Officer. If work must be performed outside the U.S., the Contractor shall submit a request to the Contracting Officer, in writing, at least 45 calendar days prior to the work beginning.

The Contracting Officer will consider the following factors in making a decision whether to authorize the performance of work outside the U.S. and its Territories:

1. The necessity of the work to be performed outside the United States and its territories;

2. The Statement of Work under contract that will be performed outside the U.S. and its

Territories;

3. Total projected dollar value of the work to be performed outside the U.S.;

4. Total projected number of labor hours and length of time to be performed for each individual employee working outside the U.S.;

5. The desired country/location where the work will be performed;

6. FAR Part 25, Foreign Acquisitions, and all other laws and regulations applicable to the performance of work outside the U.S.;

7. The contractor and/or its subcontractor(s) plans to adequately protect and secure CMS data, as well as abide by all applicable laws and regulations when work is performed outside of the U.S. and its Territories. Plans shall include -

a. Adequate contract terms regarding system security;

b. Adequate contract terms regarding the confidentiality and privacy requirements for information and data protection;

c. Adequate contract terms that are otherwise relevant, including the requirements of the

Statement of Work;

d. The Contractor’s corporate compliance plan and internal policies and procedures designed to prevent and detect violations of applicable law, regulations, rules and ethical standards by employees, agents and others; and,

8. The necessity of Government Furnished Equipment (GFE) or Contractor Owned/Contractor Operated (COCO) devices to be used outside the U.S. and verification of a secure VPN access.

9. Compliance with Executive Order 13940 Aligning Federal Contracting and Hiring Practices With the Interests of American Workers. Determine if approval will reduce opportunities for the United States contractor workers performing in the United States and if this would cause any potential effects to national security.

10. Conformance with Section 889 “Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment”, of Public Law 115-232.

11. Determination that approval is in best interest of the Government.

The Contractor’s request for authorization to perform work outside the U.S. shall include supplemental information to demonstrate that the performance of the work outside the U.S.

satisfies all of the above factors. Contracting Officer approval to perform work outside the U.S. may require additional Statement of Work requirements, additional contract terms and conditions and/or Federal Acquisition Regulation (FAR) clauses to be incorporated into the contract.

G.8 DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATIONS

(HHSAR) CLAUSES INCORPORATED BY REFERENCE (JUN 2015)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were provided in full text. Upon request, the Contracting Officer will provide the information in full text. The full text of a clause is also available electronically at http://www.hhs.gov/policies/hhsar/.

352.232-71 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS FEB 2022

(End of Section G) http://www.hhs.gov/policies/hhsar/

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 CONFLICT OF INTEREST (OCT 2020)

a. General: The contractor and the services provided under this contract shall be free, to the greatest extent possible, of all Organizational and Personal Conflicts of Interest. Consistent with these terms and conditions, all references to Organizational and/or Personal Conflicts of Interests will be referred to individually or collectively, as Conflicts of Interest (COI). Except as defined by these terms and conditions and in accordance with FAR 9.503, the Contracting Officer shall not maintain a contract with a contractor the Contracting Officer (CO) determines has, or has the potential for, an unresolved COI.

b. Definitions:

Actual COI– The COI is either currently in existence as determined by the contractor or CMS. This form of COI will require avoidance, neutralization or mitigation acceptable to CMS.

Affiliates –Associated business concerns or individual(s) if, directly or indirectly, either one controls or can control the other; or a third party controls or can control both.

Apparent (Perceived) COI – The COI on first observation appears to be an actual or potential COI, but may or may not be after analysis.

Avoidance – To prevent the occurrence of a COI through actions such as exclusion of sources or modification of requirements. Avoidance precludes the conflict.

Contractor – The term contractor is used synonymously with offeror.

Financial Relationships – A direct or indirect ownership or investment interest (including a stock option or non-vested interest) in any entity that exists through equity, debt, or other means and includes any indirect ownership or investment interest no matter how many levels removed from a direct interest.

Mitigation– To reduce the effects of a COI to an acceptable level of risk so that the Government’s interest with regard to fair competition and/or contract performance are not impaired. The conflict remains but action was taken that minimizes the impact of the conflict to an acceptable level of risk.

Mitigation Plan – The contractor’s written approach to mitigating a COI as documented in J.3 Section B.4.

Neutralization – To counteract, through a specific action, the effects of potential or actual COI.

The conflict remains, but the impact of the conflict has been negated.

Organizational Conflict of Interest – Occurs when other activities or relationships with other persons, a person is unable or potentially unable to render impartial assistance or advice to the Government, or the person’s objectivity in performing the contract work is or might be otherwise impaired, or a person has an unfair competitive advantage.

Personal Conflicts of Interest – A situation in which a person has a financial interest, personal activity, or relationship that could impair the person’s ability to act impartially and in the best interest of the Government when performing under this contract.

Potential COI – A future situation or circumstance that would create a conflict of interest.

Three (3) Types of COIs include:

Conflict Types Definitions

Biased Ground Rules

Consists of situations where a contractor and/or its affiliate(s), as part of its performance of a Government contract, has helped (or is in a position to help) set the ground rules for another Government contract by, for example, writing the statement of work or the specifications, or establishing source-selection criteria. In these “biased ground rules” cases, the primary concern is that the entity could skew the competition, whether intentionally or not, in favor of itself and/or its affiliates.

Impaired Objectivity

Consists of situations where a contractor and/or its affiliate(s) has an interest (typically financial) that may conflict with the interest of the Government to whom the contractor has a contractual obligation, and where the entity’s work under the Government contract could give the contractor the opportunity to benefit its other business interests. If the entity is providing recommendations, judgment or advice, and its other business interests could be affected by that recommendation, judgment or advice, it’s objectivity may be impaired. An example is where the entity was evaluating itself or evaluating an affiliate or a competitor, either through an assessment of performance under another contract or an evaluation of proposals.

Unequal Access to Information

“Unfair” access to non-public information – Consists of situations where a contractor and/or its affiliate(s) has access to nonpublic information (including proprietary information and non-public source-selection information) as part of its performance of a Government contract and that information may provide the entity with a competitive advantage in a later competition for a Government contract. In these “unequal access to information” cases, the concern is limited to the risk of the contractor and/or its affiliates gaining an unfair competitive advantage; there is no issue of bias. Note: Incumbency alone does not constitute “unequal access to information.”

c. Significant Potential Conflict of Interest:

1. Nature of Conflict: Although not all inclusive, the following are considered to be an actual, potential or apparent COI with the work to be performed under this contract. The contractor shall promptly notify the CO if it is an entity, or affiliated with an entity, where any of the following circumstances exist:

a) Biased Ground rules, impaired objectivity or unequal access to information as explained in the definitions above and/or;

b) Within the three types of conflicts of interest, the CO has identified the following specific circumstances of conflicts: N/A

2. Proposed Restraint on Future Contractor Activities: CMS is proposing to restrain future contractor activities as follows: N/A

d. Conflict of Interest Oversight and Mitigation Plan:

1. Conflict of Interest Oversight Program: The contractor shall maintain an effective COI Oversight Program throughout the performance of the contract which includes procedures to monitor and disclose all Organizational and Personal Conflicts of Interest. A COI oversight program should include the monitoring of personal conflicts of interest such as, but not limited to:

a) Managers or Key Personnel who would be, or are involved with, the performance of this contract;

b) Governing Body Members (e.g., Board of Directors; Trustees); and

c) Principals of the organization as defined by FAR 52.203-13, Contractor Code of Business

Ethics and Conduct.

2. Mitigation Plan: At any time during the performance of the contract if an actual, potential, or apparent COI is identified whether by the CO, the contractor or otherwise, the contractor shall submit a mitigation plan (J.3 Contractor/Offeror COI Submission Template) within 30 days unless otherwise specified by the CO. It is the contractor’s responsibility under the terms and conditions to provide timely notification to the CO those COIs that are self-identified. The CO will notify the contractor regarding the specifics for submission. The Government will review the submission at which time a determination will be made whether a COI has been satisfactorily mitigated or if further action is necessary and will notify the contractor accordingly. In cases where a COI cannot be, or has not been, mitigated to the Government’s satisfaction, the Government may take the following actions (this list is not all inclusive):

a) Request a waiver in accordance with FAR 9.503 Waiver, from the Head of the Contracting

Activity;

b) Make changes to the requirements of the contract;

c) Require a subcontractor change (if the conflict lies with the subcontractor); and/or

d) Terminate the contract in whole or in part.

e. Subcontractor Flow-Down Terms and Conditions: The prime contractor is responsible for avoiding, neutralizing and mitigating all actual, potential, or apparent COIs of its subcontractors, in accordance with these terms and conditions. Therefore, the prime contractor shall flow-down terms and conditions H.1 Conflict of Interest, of this contract in all subcontracts. For subcontractors, wherever the term “contractor” is used, insert “subcontractor.”

H.2 HIPAA BUSINESS ASSOCIATE CLAUSE (OCT 2014)

All Protected Health Information (PHI), as defined in 45 C.F.R. §160.103, that is relevant to this Contract, shall be administered in accordance with the Health Insurance Portability and Accountability Act of 1996 ("HIPAA," 42 U.S.C. § 1320d), as amended, as well as the corresponding implementing regulations and this HIPAA Business Associate Clause.

a. Definitions:

All terms used herein and not otherwise defined, shall have the same meaning as in HIPAA, as amended, and the corresponding implementing regulations. Non-HIPAA related provisions governing the Contractor's duties and obligations, such as those under the Privacy Act and any applicable data use agreements, are generally covered elsewhere in the Contract.

The following definitions apply to this Contract Clause:

"Business Associate'' shall mean the Contractor (and/or the Contractor’s subcontractors or agents) if/when it uses individually identifiable health information on behalf of CMS, i.e. PHI, to carry out CMS’ HIPAA-covered functions.

"Covered Entity" shall mean the portions of CMS that are subject to the HIPAA Privacy Rule.

"Secretary" shall mean the Secretary of the Department of Health & Human Services or the Secretary's designee.

b. Obligations and Activities of Business Associate:

Except as otherwise provided in this Contract, Business Associate, as defined above, shall only use or disclose PHI on behalf of, or to provide services to, Covered Entity in accordance with this Contract and the HIPAA Privacy and Security Rules.

Business Associate shall document in writing the policies and procedures that will be used to meet HIPAA requirements. The policies and procedures shall include the following, at a minimum:

1. Business Associate shall not:

a. Use or disclose PHI that is created, received, maintained or transmitted by Business Associate from, or on behalf of, Covered Entity other than as permitted or required by this Contract or as required by law;

b. Sell PHI; or,

c. Threaten, intimidate, coerce, harass, discriminate against, or take any other retaliatory action against any individual for:

i. Filing a complaint under 45 CFR § 160.306;

ii. Testifying, assisting or participating in an investigation, compliance review, proceeding or hearing under 45 CFR Part 160; or

iii. Opposing any act or practice that is unlawful under HIPAA, provided there is a good faith belief that the practice is unlawful, the manner of opposition is reasonable, and the opposition does not involve the disclosure of PHI in violation of subpart E of Part 164.

2. Business Associate shall:

a. Have a security official who will be responsible for development and implementation of its security policies and procedures, including workforce security measures, to ensure proper security awareness and training (including security incident response and reporting), and security incident procedures, in accordance with this Contract, including this HIPAA Business Associate Clause and the Contract’s clause entitled “CMS Information Security.”

b. Use administrative, physical and technical safeguards to prevent use or disclosure of PHI created, received, maintained or transmitted by Business Associate from, or on behalf of Covered Entity only as provided for by this Contract. In doing so, it shall implement policies and procedures to address the following and, where applicable, ensure that such policies and procedures are also in conformance with this Contract’s clause entitled “CMS Information Security:”

i. Prevent, detect, contain and correct security violations through the use of:

1. Risk analyses (including periodic technical and nontechnical evaluations);

2. Appropriate risk management strategies, including system activity review;

3. Information access procedures for approving individual’s access rights to PHI

(including the implementation of workforce security measures to ensure continued appropriate role-based access to PHI), and technical policies and procedures to ensure compliance with grants of access (including unique user identification and tracking of users) and;

4. The imposition of sanctions for violations.

ii. Limit physical access to its electronic information systems and the facility or facilities in which they are housed.

iii. Implement policies, procedures and physical security measures that will limit access to

PHI through workstations and other devices, including access through mobile devices.

iv. Implement media controls covering the movement of devices containing PHI within or outside of the Business Associate’s facility as well as the disposal and reuse of media containing PHI.

v. Implement appropriate administrative, physical and technical safeguards that reasonably and appropriately protect the confidentiality, integrity and availability (including the use of contingency plans) of any electronic protected health information ("EPHI") it creates, receives, maintains or transmits from, or on behalf of the Covered Entity to prevent impermissible use, disclosure, maintenance or transmission of such EPHI. In the establishment of such safeguards, Business Associate shall consider its size, complexity and capabilities, as well as its technical infrastructure, and its hardware and software security capabilities.

c. Assess, and implement, where appropriate, any addressable implementation specifications associated with applicable PHI security standards.

d. Mitigate, to the extent practicable, any harmful effect that is known to Business Associate of a use or disclosure of PHI by Business Associate in violation of the requirements of this Contract.

e. Comply with the following Incident Reporting:

(a) Report to Covered Entity any security incident/breach involving unsecured PHI, of which it becomes aware, including those of its agents and subcontractors. The Business Associate shall report any violation of the terms of this contract involving PHI and any security incidents/breaches involving unsecured PHI to CMS within one (1) hour of discovery in accordance with the CMS Risk Management Handbook (RMH), specifically “RMH Vol II Procedure 7-2 Incident Handling Procedure” and “RMH Vol III Standard 7-1 Incident Handling.” These procedures can be found at http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information- Technology/InformationSecurity/Information-Security-Library.html In addition, the Business Associate will also notify the CMS Contracting Officer and the Contracting Officer’s Representative (COR) by email within one (1) hour of identifying such violation or incident.

(b) Upon Covered Entity's knowledge of any material security incident/breach by Business

Associate, Covered Entity will provide an opportunity for Business Associate to cure the breach or end the violation consistent with the termination clause of this Contract. See also paragraph D. Term of Clause below.

f. Ensure that any agent or subcontractor agrees through a written contract, or other legally enforceable arrangement, to the same restrictions and conditions that apply through this HIPAA Contract Clause, when creating, receiving, maintaining or transmitting PHI from, or on behalf of, Covered Entity.

g. Upon Covered Entity’s request:

i. Provide the Covered Entity or its designee with access to the PHI created, received, maintained or transmitted by Business Associate from or on behalf of the Covered Entity in the…