Section H.pdf

SECTION H – SPECIAL CONTRACT REQUIREMENTS

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

This contract incorporates one or more clauses provisions 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.arnet.gov/far/

H.2 352.237-75 KEY PERSONNEL (DEC 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

Name Labor Category TBD Project Director

TBD TBD

H.3 CONFLICT OF INTEREST (AUG 2024)

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.

a. 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.6 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:

Not applicable at this time.

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

Not applicable at this time.

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) Key Personnel (as defined in HHSAR 352.237-75 Key Personnel) and managers 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.6 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 and Compliance, of this contract in all subcontracts. For subcontractors, wherever the term “contractor” is used, insert “subcontractor.”

H.4 CMS INFORMATION SECURITY (OCT 2020)

All CMS information shall be protected from unauthorized access, use, disclosure, duplication, modification, diversion, or destruction, whether accidental or intentional, in order to maintain the security, confidentiality, integrity, and availability of such information. Therefore, if this contract requires the contractor to provide services (both commercial and non-commercial) for Federal Information/Data, to include any of the following requirements:

Process any Information/Data; or Store any Information/Data (includes “Cloud” computing services); or Facilitate the transport of Information/Data; or Host/maintain Information/Data (including software and/or infrastructure developer/maintainers); or Have access to, or use of, Personally Identifiable Information (PII), including instances of remote access to, or physical removal of, such information beyond agency premises or control, The contractor shall become familiar and remain compliant with all aspects of the Statement of Work (SOW), Statement of Objectives (SOO), Performance Work Statement (PWS), which includes CMS Information Security requirements.

The contractor shall ensure that the following Federal information security standards are met for all of its CMS contracts:

Federal Information Security Management Act (FISMA) – FISMA information can be found at https://csrc.nist.gov/projects/risk-management. FISMA requires each Federal agency to develop, document, and implement an agency-wide program to provide information security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source; and, Federal Risk and Authorization Management Program (FedRAMP) – FedRAMP information can be found at https://www.gsa.gov/technology/government-it-initiatives/fedramp. The FedRAMP is a government-wide program that provides a standardized approach to security assessment, authorization, and continuous monitoring for cloud products and services.

The Contractor shall include in all awarded subcontracts the FISMA/FedRAMP compliance requirements set forth at the CMS Information Security website at https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information- Technology/InformationSecurity/Info-Security-Library-Items/CMS-Security-and-Privacy- Language-for-Procurements.

H.5 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:

i. 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;

ii. Sell PHI; or,

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

A. Filing a complaint under 45 CFR § 160.306;

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

i. 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.”

ii. 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:”

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

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

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

c. 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;

d.The imposition of sanctions for violations.

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

C. Implement policies, procedures and physical security measures that will limit access to PHI through workstations and other devices, including access through mobile devices.

D. 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.

E. 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.

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

iv. 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.

v. 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.

vi. 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.

vii. Upon Covered Entity’s request:

A. 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 course of contract performance in order to ensure Covered Entity’s ability to meet the requirements under 45 CFR § 164.524.

B. Amend PHI as Covered Entity directs or agrees to pursuant to 45

CFR § 164.526.

viii. Make its facilities and any books, records, accounts, and any sources of

PHI, including any policies and procedures, that are pertinent to ascertaining its own compliance with this contract or the Covered Entity’s compliance with the applicable HIPAA requirements, available to Covered Entity, or, in the context of an investigation or compliance review, to the Secretary for purposes of the Secretary determining Covered Entity's compliance with the various rules implementing the HIPAA.

ix. Document disclosures of PHI and information related to such disclosures as would be required for Covered Entity to respond to a request by an Individual for an accounting of disclosures of PHI in accordance with 45

CFR § 164.528.

x. Provide to Covered Entity, or an individual identified by the Covered Entity, information collected under this Contract, to permit Covered Entity to respond to a request by an Individual for an accounting of disclosures of PHI in accordance with 45 CFR § 164.528.

xi. Make reasonable efforts to limit the PHI it uses, discloses or requests to the minimum necessary to accomplish the intended purpose of the permitted use, disclosure or request.

c. Obligations of Covered Entity

Covered Entity shall notify Business Associate of any:

1. Limitation(s) in its Notice of Privacy Practices in accordance with 45 CFR § 164.520, to the extent that such limitation may affect Business Associate's use or disclosure of PHI;

2. Changes in, or revocation of, permission by an Individual to use or disclose their PHI, to the extent that such changes may affect Business Associate's use or disclosure of PHI; and,

3. Restriction to the use or disclosure of PHI that Covered Entity has agreed to in accordance with 45 CFR § 164.522, to the extent that such restriction may affect Business Associate's use or disclosure of PHI.

d. Term of Clause

1. The term of this Clause shall be effective as of date of Contract award, and shall terminate when all of the PHI provided to Business Associate by the Covered Entity or a Business Associate of the Covered Entity, or created or received by Business Associate on behalf of Covered Entity, is destroyed or returned to Covered Entity in accordance with “CMS Information Security” procedures. Business Associate shall not retain any PHI.

2. Security Incident/Breach:

Upon Covered Entity's knowledge of a material breach by Business Associate, Covered Entity shall take action consistent with the terms of this Contract, and, as appropriate, the following:

i. Federal Acquisition Regulation (FAR) Contracts – Covered Entity may:

A. Terminate this Contract in accordance with FAR Part 49, Termination of Contracts, if the Business Associate does not cure the security incident/breach within the time specified by Covered Entity and/or cure is not possible; or, B. If neither termination nor cure is feasible, Covered Entity shall report the violation to the Secretary.

ii. Other Agreements –Covered Entity shall either:

A. Provide an opportunity for Business Associate to cure the breach or end the violation consistent with the termination terms of this Contract. Covered Entity may terminate this Contract for default if the Business Associate does not cure the breach or end the violation within the time specified by Covered Entity; or, B. Consistent with the terms of this Contract, terminate this Contract for default if Business Associate has breached a material term of this Contract and cure is not possible; or, C. If neither termination nor cure is feasible, Covered Entity shall report the violation to the Secretary.

3. Returning or Destroying PHI:

Business Associate, as defined above, which includes subcontractors or agents of the Contractor, shall:

i. Upon expiration or termination of this Contract, for any reason, return or destroy all PHI received from Covered Entity or another Business Associate of the Covered Entity, as well as any PHI created, received, maintained or transmitted from or on behalf of Covered Entity, or another Business Associate of the Covered Entity, in accordance with this contract, including the “CMS Information Security” clause.

ii. In the event that Business Associate determines that returning or destroying the PHI is infeasible, provide to Covered Entity notification of the conditions that make return or destruction infeasible. Upon such notice that return or destruction of PHI is infeasible, Business Associate shall extend the protections of this Contract to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as Business Associate maintains such

PHI.

e. Miscellaneous

1. A reference in this Contract to a section in the Rules issued under HIPAA means the section as in effect or as amended.

2. The respective rights and obligations of Business Associate under paragraph

D.3.b of the section entitled "Term of Clause" shall survive the termination of this Contract.

Any ambiguity in this Contract clause shall be resolved to permit Covered Entity to comply with the Rules implemented under HIPAA.

H.6 OPEN GOVERNMENT PROACTIVE PREDISCLOSURE NOTIFICATION

(AUG 2023)

In order to reduce the administrative burden of responding to Freedom of Information Act (FOIA) requests for high visibility/high public interest contracts throughout contract administration, the Contractor shall submit its review of the awarded contract (and contract modifications, if requested) for FOIA disclosure exemptions within thirty (30) calendar days of contract award. The review will substantiate “…Trade secrets and commercial or financial information obtained from a person and privileged or confidential…” information, in accordance with 5 U.S.C. §552 FOIA, Exemption (b)(4), which could reasonably be expected to cause substantial competitive harm.

Submissions: The Contractor shall submit all 5 U.S.C. § 552 FOIA Exemption (b)(4), “Trade Secrets, Commercial or Financial Information that is Privileged or “Confidential” (Confidential Business Information or CBI) and information otherwise known as public release/non-Confidential Business Information (non-CBI), with the information identified as follows:

a. CBI Highlighted Copy of Contract: One copy of the contract with all CBI highlighted for CMS FOIA review.

b. Contractor Proposed Redacted Public Release Copy of Contract: An additional copy of the contract will be provided for public release with all the identified information redacted. Redactions shall be made using “black” boxes, which cannot be removed or uncovered by a reader.

c. Pre-Disclosure Concerns - Comments/Rationale for Non-Disclosure of Trade Secrets, Commercial or Financial Information Which is Privileged or Confidential: The

Contractor shall provide, in a separate document, rationale for why disclosure of “…Trade Secrets, Commercial or Financial Information Which is Privileged or Confidential…” would cause the Contractor organization substantial competitive harm if disclosed to other entities. Rationale shall be provided for each individual recommended redaction. Generalized conclusions of competitive harm are not a sufficient basis for the CMS FOIA office to invoke the exemption and thereby protect the Contractor’s interest.

Contractor submissions shall be sent via email to the CMS FOIA office at FOIA12600@cms.hhs.gov, with a copy to the Contracting Officer and Contracting Officer’s Representative (COR), within thirty (30) calendar days of contract award and within thirty (30) calendar days of a CMS request, i.e., for existing or modified contracts.

All files must be submitted in Portable Document Format (.pdf) format.

File Naming Conventions: The Contractor shall name the files with the Contract Number and utilize the following file naming conventions:

Contract Number – Highlighted

Contract Number – Redacted

Contract Number – Pre-Disclosure Concerns

The CMS FOIA Office makes the final determination as to what information is released to the public, after considering feedback from the Contracting Officer and/or the Contractor.

H.7 CMS SECURITY CLAUSE (MAY 2018)

a. Applicability In accordance with OMB Memorandum M-05-24, Implementation of Homeland Security Presidential Directive 12 (HSPD-12): Policy for a Common Identification Standard for Federal Employees and Contractors, dated August 27, 2004, and Federal Information Processing Standard (FIPS) PUB Number 201-2, Personal Identity Verification (PIV) of Federal Employees and Contractors, CMS must achieve appropriate security assurance for multiple applications by efficiently verifying the claimed identity of individuals seeking physical access to Federally controlled government facilities and/or logical access to federally controlled information systems.

Contractors that require routine physical access to a CMS facility and/or routine access to a CMS federally controlled information system will be required to obtain a CMS issued PIV, PIV-I or Locally Based Physical Access card. FIPS PUB 201-2 specifies the architecture and technical requirements for a common identification standard for Federal employees and Contractors.

When a PIV or PIV-I card is provided, it shall be used in conjunction with a compliant card reader and middleware for logical system access. The Contractor shall (1) Include FIPS 201-2 compliant, HSPD-12 card readers with the purchase of servers, desktops, and laptops; and (2) comply with FAR 52.204-9, Personal Identity Verification of

Contractor Personnel.

b. Definitions “Agency Access” means access to CMS facilities, sensitive information, information systems or other CMS resources.

“Applicant” is a Contractor employee for whom the Contractor submits an application for a CMS identification card.

“Contractor Employee” means prime Contractor and subcontractor employees who require agency access to perform work under a CMS contract.

“Official station”— As defined by Federal Travel Regulations, An area defined by the agency that includes the location where the employee regularly performs his or her duties or an invitational traveler’s home or regular place of business. The area may be a mileage radius around a particular point, a geographic boundary, or any other definite domain, provided no part of the area is more than 50 miles from where the employee regularly performs his or her duties or from an invitational traveler’s home or reg-ular place of business. If the employee’s work involves recur-ring travel or varies on a recurring basis, the location where the work activities of the employee’s position of record are based is considered the regular place of work.

“Federal Identification Card” (or “ID card”) means a federal government issued or accepted identification card such as a Personal Identity Verification (PIV) card, Personal Identity Verification-Interoperable (PIV-I) card, or a Local-Based Physical Access Card issued by CMS, or a Local-Based Physical Access Card issued by another Federal agency and approved by CMS. “Issuing Office” means the CMS entity that issues identification cards to Contractor employees.

“Locally Based Physical Access Card” means an access Card that is graphically personalized for visual identification, that does not contain an embedded computer chip, and is only used for physical access.

“Local Security Servicing Organization” means the CMS entity that provides security services to the CMS organization sponsoring the contract, Division of Physical Security and Strategic Information (DPSSI).

“Logical Access” means the ability for the Contractor to interact with CMS information systems, databases, digital infrastructure, or data via access control procedures such as identification, authentication, and authorization.

“Personal Identity Verification (PIV) card,” as defined in FIPS PUB 201-2, is a physical artifact (e.g., identity card, “smart” card) issued to an individual that contains a PIV Card Application which stores identity credentials (e.g., photograph, cryptographic keys, digitized fingerprint representation) so that the claimed identity of the cardholder can be verified against the stored credentials by another person (human readable and verifiable) or an automated process (computer readable and verifiable).

“Personal Identity Verification-Interoperable (PIV-I) card” similar to a PIV card, is a physical artifact (e.g., identity card, “smart” card) issued to an individual that contains a PIV Card Application which stores identity credentials (e.g., photograph, cryptographic keys, digitized fingerprint representation) so that the claimed identity of the cardholder can be verified against the stored credentials by another person (human readable and verifiable) or an automated process (computer readable and verifiable). PIV-I cards are issued by a non-federal government entity to non-federal government staff. PIV-I cards are issued in a manner that allows federal relying parties to trust the cards. The PIV-I cards uses the same standards of vetting and issuance developed by the U.S.

government for its employees

c. Screening of Contractor Employees

i. Contractor Screening of Applicants

1. Contractor Responsibility: The Contractor shall pre-screen individuals designated for employment under any CMS contract by verifying minimum suitability requirements to ensure that only qualified candidates are considered for contract employment. At the discretion of the government, the government reserves the right to request and/or review Contractor employee vetting processes. The federal minimum suitability requirements can be found below in section (c)(2)—Suitability Requirements, and are also contained in 5 CFR 731.202. The Contractor shall exercise due diligence in pre-screening all employees prior to submission to CMS for agency access.

2. Alien Status: The Contractor shall monitor an alien’s (foreign nationals) continued authorization for employment in the United States. If requested by the Agency, the Contractor shall provide documentation to the Contracting Officer (CO) or the Contracting Officer’s Representative (COR) that validates that the Employment Eligibility Verification (e- Verify) requirement has been met for each Contractor or sub-Contractor employee working on the contract in accordance with Federal Acquisition Regulation (FAR) 52.222-54 - Employment Eligibility Verification.

3. Residency Requirement: All CMS Contractor applicants shall have lived in the United States at least three (3) out of the last five (5) years prior to submitting an application for a Federal ID Card. CMS will process background investigations for foreign nationals in accordance with Office of Personnel Management (OPM) guidance. Contractor employees who worked for the U. S. Government as an employee overseas in a Federal or military capacity; and/or been a dependent of a U.S. Federal or military employee serving overseas, must be able to provide state-side reference coverage. State-side coverage information is required to make a suitability or security determination. Examples of state-side coverage information include: the state-side address of the company headquarters where the applicant’s personnel file is located, the state-side address of the Professor in charge of the applicant’s “Study Abroad” program, the religious organization, charity, educational, or other non-profit organization records for the applicant’s overseas missions, and/or the state-side addresses of anyone who worked or studied with the applicant while overseas.

4. Selective Service Registration: All males born after December 31, 1959, must meet the Federal Selective Service System requirements as established on www.sss.gov.

ii. Identification Card Application Process

ID Card Sponsor: The CMS Contracting Officer’s Representative (COR) will be the CMS ID card Sponsor and point of contact for the Contractor’s application for a CMS ID card. The COR will review and approve/deny the HHS ID Badge Request before the form is submitted to the CMS, Office of Support Services and Operations, (OSSO), Division of Personnel Security Services (DPS), for processing. If approved, an applicant may be issued either a Personal Identity Verification (PIV) or PIV- I card that meets the standards of HSPD-12 or a Local- Based Physical Access Card.

Contractor Application Required Submissions: All applicants shall submit an HHS ID Badge Request form for issuance of a Federal ID Card. Unless otherwise directed by the ID Card Sponsor or DPS, applicants are required to electronically submit the request form via CMS’ Enterprise User Administration (EUA) Electronic Front-end Interface (EFI) system, which is located at https://eua.cms.gov/efi. To assist users with the application process, a user’s guide is located at:https://www.cms.gov/About-CMS/Contracting-With- CMS/ContractingGeneralInformation/Contracting-Policy-and-Resources.html.

The EUA users guide link should be used to obtain the most current instructional guidance.

PIV Training: Contractors who need PIV or PIV-I card shall complete HHS PIV Applicant Training, which is found at https://www.cms.gov/About- CMS/Contracting-With-CMS/ContractingGeneralInformation/Contracting-Policy-and-Resources.html. A copy of the completion certificate shall be included with the EFI application.

CMS Applicant Evaluations: CMS will evaluate an applicant’s required access level. Once the review is complete and accepted for further processing, the applicant will be contacted by DPS to submit the below information, as applicable.

1. e-QIP: Contractor employees will be required to submit information into e-QIP, a web-based automated system that is designed to facilitate the processing of standard investigative forms used when conducting background investigations for Federal security, suitability, fitness and credentialing purposes.

2. Fingerprints: Instructions for obtaining fingerprints will be provided by

CMS, OSSO, DPS.

3. OF 306: Contractor employees may be required to complete the Optional Form (OF) 306, Declaration for Federal Employment which can be found at https://www.opm.gov/forms/pdf_fill/of0306.PDF.

4. Access to Restricted Area(s): The CMS COR will initiate all Federal ID card holders’ physical access requests via Physical Access Control System (PACS) Central at https://pam.cms.local.

Suitability Requirements: CMS may decline to grant agency access to a Contractor employee including, but not limited to, any of the criteria cited below:

1. Misconduct or negligence in employment;

2. Criminal or dishonest conduct;

3. Material, intentional false statement, or deception or fraud in examination or appointment;

4. Refusal to furnish testimony as required by § 5.4 of 5 CFR 731.202;

5. Alcohol abuse, without evidence of substantial rehabilitation, of a nature and duration that suggests that the applicant or appointee would be prevented from performing the duties of the position in question, or would constitute a direct threat to the property or safety of the applicant or appointee or others;

6. Illegal use of narcotics, drugs, or other controlled substances without evidence of substantial rehabilitation;

7. Knowing and willful engagement in acts or activities designed to overthrow the U.S. Government by force; and

8. Any statutory or regulatory bar which prevents the lawful employment of the person involved in the position in question.

Badge Issuance: Upon approval of the badging application process and prior to starting work on the contract, applicants whose official station is located within 50 miles from CMS’ central office or one of its regional offices will be contacted to appear in person, at least two times (estimated at one hour for each visit), and shall provide two (2) original forms of identity source documents in order to generate the badge/ID. The identity source documents shall come from the list of acceptable documents included in FIPS 201-2, located at http://nvlpubs.nist.gov/nistpubs/FIPS/NIST.FIPS.201-2.pdf. At least one (1) document shall be a valid State or Federal government-issued picture ID. PIV-I mobile enrollment stations will be made available for applicants that have an official station more than 50 miles from CMS or any of its regional offices, and the employee will not need to travel to a CMS Office. The Contractor will be contacted by CMS for further instructions on the badging process in this scenario.

d. CMS Position Designation Assessment

CMS will assign a risk and sensitivity level designation analysis to the overall contract and/or to Contractor employee positions by category, group or individual. The risk and sensitivity level designations will be the basis for determining the level and type of personnel security investigations required for Contractor employees. At a minimum, the FBI National Criminal History Check (fingerprint check) must be favorably adjudicated. Additionally, the OPM e-QIP and other required forms must be accepted by DPS before a CMS identification card will be issued.

e. Post Badging Training Requirements:

Contractor employees that receive an HHS ID Badge are expected to complete the following online trainings each year, according to the timeframes indicated below, and annually thereafter. The below list is not all inclusive and the COR may indicate training that must be taken in addition to the below:

i. Security and Insider Threat Awareness and Training (30 days after receiving badge): This course outlines the role of Contractors with regard to protecting information and ensuring the secure operation of CMS federally controlled information systems. Estimated time to complete is one hour.

ii. Computer Based Training (CBT) (within 3 days of approved EUA account):

This training offers several modules to familiarize contractor employees with features of CMS’ webinar service. Estimated time to complete is one hour.

f. Background Investigation and Adjudication

Upon contract award and receipt of an HHS ID Badge Request, CMS will initiate the Agency Access procedures, to include a background investigation.

CMS may accept favorable background investigation adjudications from other Federal agencies when there has been no break in service. A favorable adjudication does not preclude CMS from initiating a new investigation when deemed necessary. Each CMS sponsored Contractor shall use the OPM e-QIP system to complete any required investigative forms.

The Contractor remains fully responsible for ensuring contract performance pending completion of background investigations of Contractor personnel. Employees that do not require access to CMS federally controlled information systems, facilities, or sensitive information in order to perform their duties may begin work on a contract immediately and need not submit an HHS ID Badge Request

i. Failure to cooperate with OPM or Agency representatives during the background investigation process is considered grounds for removal from the contract.

ii. DPS may provide written notification to the Contractor employee, with a copy to the COR, of all suitability/non-suitability decisions. A CMS adjudicative decision (based on criminal history results or completed investigation results) is final, and is not subject to appeal.

iii. Contractor personnel for whom DPS determines to be ineligible for ID issuance will be required to cease working on the contract immediately.

iv. The Contractor shall immediately submit an adverse information report, in writing to the CO with a copy to the COR, of any adverse information regarding any of its employees that may impact their ability to perform under this contract. Reports should be based on reliable and substantiated information, not on rumor or innuendo. The report shall include, at a minimum, the Contractor employee's name and associated contract number along with the adverse information. The COR will forward the adverse information report to the DPS for review and/or action.

v. At the Agency’s discretion, Contractor personnel may be provided an opportunity to explain or refute unfavorable information before an adjudicative decision is rendered on whether or not to withdraw the Federal ID from the individual in question. Under the provision of the Privacy Act of 1974, Contractor personnel may request a copy of their own investigation by submitting a written request to the OPM Federal Investigative Services (FIS) Freedom of Information (FOI) office. The following OPM-FOI link is being provided to afford one the instructions for obtaining a copy of one’s file:

https://www.opm.gov/investigations/freedom-of-information-and-privacy-act-requests/.

g. Background Investigation Cost The government will bear the cost of background investigations that are performed at the direction of CMS’ personnel security representatives by the Federal government’s approved and designated background investigation service provider, the OPM.

At the Agency's discretion, if an investigated Contractor employee leaves the employment of the Contractor, or otherwise is no longer associated with the contract within one (1) year from the date the background investigation was completed, the Contractor may be required to reimburse CMS for the full cost of the investigation. Depending upon the type of background investigation conducted and the cost incurred by CMS, the Contractor cost will be determined based upon the current OPM fiscal year billing rates, which can be found at https://nbib.opm.gov/hr-security-personnel/investigations-billing-rates-resources/. The amount to be paid by the Contractor shall be due and payable when the CO submits a written letter notifying the Contractor as to the cost of the investigation. The Contractor shall pay the amount due within thirty (30) days of the date of the CO's letter by check, made payable to the "United States Treasury." The Contractor shall provide a copy of the CO's letter as an attachment to the check and submit both to the Office of Financial Management at the following address:

Centers for Medicare & Medicaid Services PO Box 7520 Baltimore, Maryland 21207

h. Identification Card Custody and Control

The Contractor is responsible for the custody and control of all forms of Federal identification issued by CMS to Contractor employees. The Contractor shall immediately notify the COR when a Contractor employee no longer requires agency access due to transfer, completion of a project, retirement, removal from work on the contract, or termination of employment. Return all CMS Federal ID cards to:

The Centers for Medicare and Medicaid Services Attn: DPS, Mailstop: SL-17-06 7500 Security Boulevard Baltimore, Maryland 21244

The Contractor shall also ensure that Contractor employees comply with CMS requirements concerning the renewal, loss, theft, or damage of an ID card.

Failure to comply with the requirements for custody and control of CMS issued ID cards may result in a delay in withholding final payment or contract termination, based on the potential for serious harm caused by inappropriate access to CMS facilities, sensitive information, information systems or other CMS resources.

i. Renewal: A Contractor employee’s CMS issued ID card is valid for a maximum of five (5) years and 9 months or until the contract expiration date (including option periods), whichever occurs first. The renewal process should begin six weeks before the ID card expiration date by contacting the COR. If an ID card is not renewed before it expires, the Contractor employee will be required to sign-in daily for facility access and may have limited access to information systems and other resources. Contractor ID card certificate(s) require yearly updates from the issuance date. The yearly updates should be coordinated between the contractor and the COR.

ii. Lost/Stolen: Immediately upon detection that an ID card is lost or stolen, the

Contractor or Contractor employee shall report a lost or stolen ID card to the COR and the local security servicing organization at SECURITY@cms.hhs.gov. The Contractor shall also submit an Incident Report within 48 hours, to the COR, DPS at Badging@cms.hhs.gov, and the local security servicing organization. The Incident Report shall describe the circumstances of the loss or theft. If the loss or theft is reported by the Contractor to the local police, a copy of the police report shall be provided to the COR. The Contractor employee shall sign in daily for facility access and may have limited access to information systems and other resources until the replacement card is issued.

iii. Replacement: An ID card will be replaced if it is damaged, contains incorrect data, or is lost or stolen for more than three (3) days, provided there is a continuing need for agency access to perform work under the contract.

In the event that the PIV card or certificate(s) are not renewed in a timely fashion, or the ID card requires replacement due to being lost, stolen, or damaged, the contractor employee will go through the “Badge Issuance” process again as described in above in section (c)(2). In any of these events, contact your COR to coordinate the appropriate next steps.

i. Surrender ID Cards/Access Cards, Government Equipment

CMS reserves the right to suspend or withdraw ID card access at any time for any reason. Access will be restored upon the resolution of the issue(s).

Upon notification that routine access to CMS facilities, sensitive information, federally controlled information systems or other CMS resources is no longer required, the Contractor shall surrender the CMS issued ID card, access card, keys, computer equipment, and other government property to the CMS COR or directly to CMS at the address referenced above in section (f). DPS Contractor personnel who do not return their government issued property within 48 hours of the last day of authorized access to CMS, may be permanently barred from CMS systems and facilities and may be subject to fines and penalties, as authorized by applicable Federal or State laws.

H.8 352.224-70 PRIVACY ACT (DEC 2015)

This contract requires the Contractor to perform one or more of the following:

(a) design; (b) develop; or (c) operate a federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) [5 U.S.C.

552a(m)(1)] and applicable agency…