Model Contract for SCT Services.docx

Contract Between The Executive Office of Health and Human Services And [Contractor Name] For COVID-19 Self-Collected Testing Services

This COVID-19 Self-Collected Testing Services Contract (the “Contract”) is by and between the Executive Office of Health and Human Services for the Commonwealth of Massachusetts (“EOHHS”) and [Contractor Name] (“Contractor”).

WHEREAS, EOHHS oversees 16 state agencies and is the single state agency responsible for the administration of the Medicaid program and the State Children’s Health Insurance Program within Massachusetts (collectively, MassHealth) and other health and human services programs designed to pay for medical services for eligible individuals pursuant to M.G.L. c. 118E, Title XIX of the Social Security Act (42 U.S.C. sec. 1396 et seq.), Title XXI of the Social Security Act (42 U.S.C. sec. 1397aa et seq.), and other applicable laws and waivers;

WHEREAS, in response to the COVID-19 emergency, EOHHS seeks to increase access to COVID-19 testing across Massachusetts;

WHEREAS, in accordance with EOHHS’ Due Diligence Posting of Notice of Intent, dated November 25, 2020, EOHHS seeks to enter into an emergency contract with the Contractor pursuant to 801 CMR 21.05(3) to purchase COVID-19 self-collected testing services from the Contractor;

WHEREAS, the Contractor has been deemed qualified and has agreed to provide such services in accordance with the following terms and conditions; and

WHEREAS, EOHHS and the Contractor agree to enter into the Contract effective upon execution;

NOW THEREFORE, in consideration of the mutual promises herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

SECTION I. DEFINITIONS

The following terms appearing capitalized throughout this Contract have the following meanings, unless the context clearly indicates otherwise.

Self-Collected COVID-19 Testing (SCT) Services: Testing services for COVID-19 performed for EOHHS in conformance with the provisions of the Contract, and as further set forth in Section II. Such services expressly exclude COVID-19 Laboratory Processing Services, which shall be performed by the Designated Laboratory pursuant to a separate contract between the Designated Lab and EOHHS.

COVID-19: A contagious, sometimes fatal, respiratory disease caused by a newly discovered coronavirus, SARS-CoV-2, that led to the declaration of a federal public health emergency and a state of emergency for the Commonwealth of Massachusetts.

COVID-19 Laboratory Processing Services: Processing of collected specimens in a CLIA-certified Designated Laboratory in order to determine the presence or absence of SARS-CoV-19, the virus which causes COVID-19.

Designated Laboratory or Designated Lab: A laboratory designated by EOHHS that is capable of performing COVID-19 Testing with the Test Kit provided by the Contractor. The Designated Laboratory shall initially be the Broad Institute of MIT and Harvard. EOHHS acknowledges and agrees that the Designated Lab is not a subcontractor of Contractor under this Contract.

Executive Office of Health and Human Services (EOHHS): A Massachusetts Secretariat that oversees 12 agencies, in addition to 2 soldiers’ homes and is responsible for the administration of the MassHealth program, pursuant to M.G.L. c. 118E and Title XIX and XXI of the Social Security Act and other applicable laws and waivers.

HIPAA: The Health Insurance Portability and Accountability Act Rules (inclusive of 45 CFR Parts 160, 162, and 164), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (the “HITECH Act”) and under the American Recovery and Reinvestment Act of 2009 (“ARRA”).

PII: Any “protected health information” as defined under HIPAA, any “personal data” as defined in M.G.L. c. 66A, and “personal information” as defined in M.GL. c. 93H, and any other individually identifiable information that is treated as private, security, or confidential under applicable law, agreement, pursuant to Section II.2.c, that the Contractor uses, maintains, discloses, receives, creates, transmits or otherwise obtains in connection with its performance of the SCT Services. Information, including aggregate information, is considered PII if it is not fully de-identified in accord with 45 CFR §§164.514(a)-(c).

Test Kit: All materials necessary for the self-administered collection of a specimen for the purposes of determining the presence or absence of SARS-CoV-2 viral material in said specimen.

SECTION II. CONTRACTOR RESPONSIBILITIES

The Contractor shall perform the following obligations:

A. SCT Services

1. Collect individual patient PII (including demographics) through an online, digital registration portal. Registration and intake information must be sufficient to meet reporting requirements established by the Massachusetts Department of Public Health and for the Designated Lab to process the completed Test Kits and provide results to the Contractor.

2. Establish an online, digital intake mechanism which can register sites or organizations, including but not limited to the site address and point of contact, and to which individual patients employed or operating at that site or organization can be linked for the purpose of delivering results.

3. Transmit sample requisitions and support digital accessioning for collected samples for the Designated Laboratory, by using commercially reasonable efforts to integrate the SCT Services with the laboratory information management system (“LIMS”) of the Designated Lab. Once integration is achieved, if the Designated Laboratory makes material modifications to its LIMS which require additional services from Contractor, such services shall be out of scope of this contract and the parties shall discuss in good faith an amendment hereto relating to reasonable changes in pricing and other terms, if any, to support the modified LIMS system.

4. Provide FDA issued Emergency Use Authorization (“EUA”) at-home or on-site COVID-19 testing Test Kits, individually or in bulk, which can be self-administered by non-clinical individuals (with or without supervision), which do not require clinical supervision. Contractor may modify its Test Kits pursuant to a new EUA, amendment to an existing EUA, or pursuant to FDA regulations and guidance regarding performance of lab-developed tests without an EUA. The parties acknowledge and agree that the Designated Laboratory shall only process tests using Test Kits that are subject to an EUA approving standalone, unmonitored test kits.

5. Provide shipping logistics and arrange for:

a. The delivery of all Test Kits purchased by EOHHS to the address(es) specified by EOHHS, either via courier service, shipping service, or dispensary pick-up and drop-off, as designated by EOHHS, and

b. The delivery of the collected specimens to the Designated Lab on the same day the specimens are collected.

6. Digitally report testing results directly to the patient and additional third parties (e.g., employers) when requested by EOHHS. The Contractor shall have an electronic process for receiving results from the Designated Lab and sharing those results with the patient, and additional third parties, if any, as specified by EOHHS. Both positive and negative results shall be communicated electronically.

a. In order to facilitate the reporting of test results to third parties, such as employers, the Contractor shall provide a HIPAA Authorization process, pursuant to the HIPAA Privacy and Security Rules at 45 CFR Parts 160 – 164, in which the patient authorizes the Contractor to share test results with applicable third parties (e.g., employers). This HIPAA Authorization process and the results reporting process shall be in full compliance with state and federal privacy laws and the provisions of this Contract.

b. Test results shall be delivered to the patient and additional third parties no more than 2 hours after the time the results have been transmitted by the Designated Lab to the Contractor.

7. Provide a method through which individuals may share their test results with a designated healthcare provider, if desired by that individual.

8. Deliver the results into the Massachusetts Virtual Epidemiologic Network (MAVEN).

9. For any patient that tests positive for COVID-19, immediately provide instructions (to be provided by EOHHS) for self-isolation to the patient, inform the patient that the patient may receive a call from a contact tracer, and encourage the patient to answer the call.

10. Provide a method through which patients can obtain information about the status of their test result and ask general questions, and a method through which sites designated to receive Test Kits may ask general questions. The Contractor shall make reasonable efforts to respond to such inquiries within 24 hours.

11. As requested by EOHHS and with reasonable notice, participate in meetings with EOHHS at which EOHHS and Contractor may discuss the services rendered under this Contract, Contractor’s performance of the terms of this Contract, or any other item related to the Contract.

12. Comply with all state and federal laws and regulations applicable to the privacy and security of personal and other confidential information related requirements, including a HIPAA-compliant electronic recordkeeping system.

13. Maintain all appropriate licenses or waivers as required to perform all required SCT-related medical services.

14. Reporting Requirements

a. For all Test Kits purchased by EOHHS, the Contractor shall provide one or more digital dashboards which contain, at a minimum, the following information for each site or organization for which Test Kits have been purchased:

1. The name and address of the site or organization

2. Total volume of Test Kits ordered

3. Of the volume of Test Kits ordered, the number which are:

i. Not yet delivered (i.e., processing, or in-transit)

ii. Delivered

iii. Returned to the laboratory

iv. Results delivered

b. The Contractor shall provide the following information at the request of EOHHS:

1. Average time between purchase of Test Kits by EOHHS and delivery of the Test Kits at the address(es) specified by EOHHS;

2. Average time between receipt of Test Kits at the processing laboratory, and the delivery of results to the patient; and

3. Number of individual tests for which the time between the receipt of the Test Kit at the processing laboratory and the delivery of the result took more than 72 hours

c. In addition to the aggregated data described above, the Contractor shall provide deidentified individual-level backup data for each of their bi-weekly reports, at the request of EOHHS.

d. The Contractor shall comply with any additional reasonable reporting requests made by EOHHS throughout the term of this Contract, including requests for ad hoc reports.

e. All reports required under this Section II.9 shall be sent via secure email to an individual designated by EOHHS or access can be provided to a secure database providing the information contained in the required reports.

B. Privacy and Security

1. By executing this Contract, and to memorialize compliance for permitted disclosures of Protected Health Information under HIPAA, including disclosures for Treatment, Payment, and Health Care Operations purposes, Contractor certifies that: (i) Contractor is a Covered Entity; or (ii) Contractor is a Business Associate of another Covered Entity relevant to this Contract, (iii) or otherwise complaint with HIPAA for such disclosures. If the Contractor cannot satisfy any of the aforementioned HIPAA certifications, the Contractor shall provide immediate notice to EOHHS prior to providing services under this Contract, and shall promptly execute and comply with any amendment to this Contract that EOHHS determines is necessary to ensure compliance with all applicable statutes, orders, and regulations promulgated by any federal, state, municipal, agreements, or other governmental authority pertaining to the privacy or security of personally identifiable information. For the avoidance of doubt, such amendments may require compliance with obligations in addition to those applicable to a Business Associate under HIPAA. Such capitalized terms, not defined in this Contract, shall be construed in a manner consistent with HIPAA Rules (inclusive of 45 CFR Parts 160, 162 and 164). The parties agree that Contractor may deidentify the data in accordance with 45 CFR 164.514 (a)-(c) and use it for any lawful purpose. The parties acknowledge and agree that disclosures to EOHHS of individual-level test results pursuant to Section II.15.c is permitted under applicable law, including, but not limited to, as a disclosure for the parties’ treatment, payment, and health care operations under 45 CFR 164.512(c).

2. The Contractor acknowledges that it will receive PII subject to certain privacy and security requirements, including, but not limited to M.G.L. c. 66A and HIPAA Rules. Such PII shall, at a minimum, be safeguarded by recognized industry standards for administrative, physical and technical security. The security of PII shall mean prevention of unauthorized access, dissemination, misuse, reproduction, removal or damage to data or materials used by or in the possession of the Contractor.

3. Any audit or inspection of records conducted under this Contract shall limit the disclosure of PHI to the “minimum necessary” for the audit or inspection, as contemplated under HIPAA, and such audit or inspection shall be conducted during normal business hours without unreasonable disruption to Contractor’s business operations.

SECTION III. EOHHS RESPONSIBILITIES

EOHHS shall:

1. Provide general contract management assistance to Contractor in working with the sites or organizations for which Test Kits have been purchased;

2. Use reasonable efforts to ensure the Designated Lab reasonably cooperates with the Contractor in performing COVID-19 Laboratory Processing Services, and in integrating the Designated Lab LIMS with the SCT Services provided hereunder;

a. EOHHS understands and agrees that a failure by the Designated Lab to reasonably cooperate with the Contractor may impede or prevent the Contractor from meeting the terms outlined in Section II. Lack of reasonable cooperation by the Designated Lab will be considered by EOHHS prior to action against the Contractor for noncompliance or breach of contract.

b. Contractor's noncompliance or failure to perform under this contract shall not be deemed a breach of contract if the Contractor's performance has been rendered impossible due to the conduct or actions of the Designated Laboratory, provided that the Contractor has provided EOHHS prompt notice of the Contractor's inability to perform due to such actions or conduct by the Designated Laboratory.

3. Meet with the Contractor to discuss the services rendered under this Contract, the Contractor’s performance of the terms of this Contract, or any other item related to the Contract, as determined necessary or advisable by EOHHS;

4. Pay the Contractor in accordance with Section IV for SCT Services performed; and

5. Provide physician orders for all tests purchased under the Contract, unless the provision of an order for COVID-19 Laboratory Processing Services becomes unnecessary in Massachusetts.

SECTION IV. PAYMENT

1. This Contract creates no guarantee that SCT Services will be purchased from the Contractor.

2. EOHHS shall pay the Contractor pursuant to the authority established in 101 CMR 446.00: COVID-19 Payment Rates for Certain Community Health Care Providers, which allows for individual consideration of the rates paid for “self-administered COVID-19 testing service completed by an eligible provider, including transport of testing materials, laboratory processing, ordering, resulting, and follow-up counseling services, per test.”

3. Subject to all terms and conditions of the Contract, the total amount paid for each test purchased by EOHHS will be the sum of the Per-Test Rate and the Shipping Costs, as described below:

$25 per Test Kit if calendar month Test Kit purchases are 25,001 or greater

4. If the Designated Laboratory makes any changes to its COVID-19 Laboratory Processing Services which require changes to the contents of the Test Kit (such as changing the type collection tube to be used), providing changed test kits is out of scope of this Contract and the parties shall discuss in good faith an amendment to this Contract to provide such changed test kits.

5. Restrictions on Payments

a. The Contractor shall not be eligible for payment under this Contract for any testing services provided pursuant to a separate COVID-19 testing contract with EOHHS.

b. The Contractor shall not bill EOHHS for testing services for which the Contractor bills any insurer or healthcare payor, including but not limited to Medicare, Medicaid, or commercial insurance.

6. Payments made by EOHHS on invoices that conform to the requirements of this Contract shall be considered payment in full for SCT Services.

7. Payment will be made in accordance with this Contract, including the Commonwealth’s Standard Contract Form and the Commonwealth Terms and Conditions, and other applicable Commonwealth payment terms such as the 45 day payment cycle through EFT, in accordance with the Commonwealth Bill Paying Policy. Payees may be entitled to accelerated payments if a prompt payment discount (PPD) is provided.

8. Payment is contingent on the Contractor’s compliance with all conditions and requirements of the Contract. In cases where EOHHS deems Contractor has not complied with all such conditions and requirements, EOHHS shall provide written notice of such noncompliance and may provide, at its sole discretion, an opportunity for the Contractor to cure or end such noncompliance.

9. The Contractor may suspend services if EOHHS has overdue and outstanding invoices, until such invoices are paid in full, provided however that the Contractor may not suspend services for any overdue or outstanding invoices if such invoices or payment terms do not comply with the requirements of this Contract. Prior to suspending services, the Contractor shall provide written notice to EOHHS no less than 30 days prior to suspending service.

SECTION V. OTHER CONTRACTUAL TERMS

1. This Contract shall expire December 31, 2021. At the option of EOHHS, the Contract may be extended for up to 12 additional months in any increment of time. The Contract may also be extended for any reasonable time period EOHHS determines necessary to complete a subsequent procurement.

2. This Contract, which includes and incorporates the Commonwealth’s Standard Contract Form and the Commonwealth Terms and Conditions, along with Contractor’s Due Diligence Posting Response, contain the entire Contract and understanding between EOHHS and Contractor. There are no additional promises or terms other than as contained in this Contract.

3. The parties agree to negotiate in good faith to cure any omissions, ambiguities, or manifest errors herein. By mutual Contract, or if such amendment is necessary to comply with applicable laws, the parties may amend this Contract where such amendment does not violate state or federal statutory, regulatory provisions, provided that such amendment is in writing, signed by both parties, and attached hereto.

4. Notices to the parties as to any matter hereunder will be sufficient if given in writing to the following addresses (or successors as designated by the parties):

To EOHHS:

Carson Yates, Strategy Manager, MassHealth Carson.Yates@mass.gov

With a copy to:

Office of the General Counsel Executive Office of Health and Human Services One Ashburton Place, 11th Floor Boston, MA 02108

EOHHS Contracts Unit 600 Washington Street, 7th Floor Boston, MA 02111

To the Contractor:

[Contractor address]

5. If any clause or provision of this Contract is in conflict with any state or federal law or regulation, that clause or provision shall be null and void and any such invalidity shall not affect the validity of the remainder of this Contract.

6. Contractor is fully responsible for the performance of its subcontractors. Subcontracts will not relieve or discharge Contractor from any duty, obligation, responsibility or liability arising under this Contract. All subcontracts and other agreements or arrangements for reimbursement will be in writing and will contain terms consistent with all terms and conditions of the Contract. The use of subcontractors shall not cause any additional administrative burden on EOHHS as a result of the use of multiple entities.

7. Notwithstanding the indemnification language in the Terms and Conditions, Contractor retains all defenses to indemnification and other claims available to it at law (e.g. comparative or contributory negligence defenses).

8. EOHHS shall have the option at its sole discretion to modify, increase, reduce or terminate any activity related to this Contract whenever, in the judgment of EOHHS, the goals of the project have been modified or altered in a way that necessitates such changes. In the event that the scope of work or portion thereof must be changed, EOHHS shall provide written notice of such action to the Contractor and the parties shall negotiate in good faith to implement any such changes proposed by EOHHS.

9. EOHHS additionally reserves the right, at its sole discretion, to amend the Contract to implement state or federal statutory or regulatory requirements, judicial orders, settlement agreements, or any state or federal initiatives or changes affecting EOHHS or the Contract. EOHHS shall provide written notice of such action to the Contractor and the parties shall negotiate in good faith to implement any such changes proposed by EOHHS.

10. EOHHS may terminate the Contract after written notice thereof to the Contractor upon any of the following events:

a. If EOHHS determines, in its sole discretion, that the Contractor has materially breached any of its obligations under this Contract or fails to complete obligations under this Contract to EOHHS’s satisfaction;

b. If EOHHS determines, in its sole discretion, that EOHHS underutilizes the Contractor’s services under the Contract; or

c. If EOHHS determines, in its sole discretion, that the Contractor has rejected purchase requests excessively or without reasonable cause.

Prior to terminating this Contract as permitted in Sections V.10.a. and c. above, EOHHS shall provide an opportunity for the Contractor to cure or end any breach. If such an opportunity is provided, but cure is not feasible, or the Contractor fails to cure the breach or end the violation within a time period set by EOHHS, EOHHS may terminate the Contract.

11. Either party may terminate this Contract without cause by giving written notice to the other party of its intent to do so at least sixty (60) days prior to the effective date of such termination. This sixty (60) day period shall not commence until the other party has received such notice. Such notice must be sent by certified mail or overnight courier service.

12. The Contractor shall obtain prior approval from EOHHS before the Contractor or any of its officers, agents, employees or subcontractors respond to any media inquiry, make any public comment or issue other public communication regarding any aspect of the Contract.

Further, the Contractor shall not (a) issue or authorize the issuance, display, distribution or publication of any news story, publicity release, interview, promotional or marketing material, public announcement, testimonial, advertising or other marketing materials or collateral (collectively, “Collateral”) relating to (i) this Contract or (ii) the services provided hereunder and/or (b) use the name or marks of, refer to, or identify the Commonwealth, EOHHS or any of its agencies in any Collateral without the prior written approval of EOHHS (which approval EOHHS may withhold in its sole discretion), except no such written approval is required to the extent any such disclosure is required by law. EOHHS may withdraw such consent at any time.

13. The Contractor is responsible for the professional quality, technical accuracy, and timely completion and delivery of all responsibilities performed by the Contractor under this Contract. The Contractor shall, without additional compensation, correct or revise any errors, omissions, or other deficiencies in its performance of its responsibilities.

14. Prohibited Activities and Conflict of Interest.

a. The Contractor certifies and agrees that neither it nor any of its owners, employees, affiliates, Subcontractors, consultants, and those who have a contract with the Contractor shall:

1. Have any interest that will conflict with the performance of services under this Contract or that may be otherwise anti-competitive, as determined by EOHHS, for the duration of the Contract; and

2. Have been excluded from participation in any program under Titles XVIII, XIX, or XXI of the Social Security Act or debarred by any federal agency, or subject to a civil money penalty under the Social Security Act.

15. Contractor shall disclose any financial, legal or ethical conflict of interest, whether potential or actual, to EOHHS prior to commencing the duties set forth herein, and where such conflicts are unforeseeable, it shall disclose immediately as any such conflict arises. A conflict shall include any relationship or action, past, present or future, that would lead a prudent person to make a disclosure under this paragraph. Contractor shall demonstrate to the satisfaction of EOHHS that Contractor’s compliance with this section of the Contract.

16. Representations and Warranties.

a. Mutual. Each party represents and warrants that: (i) it has full power to enter into this Contract and to grant to the other party the rights granted to such other party under this Contract, (ii) it has obtained all necessary approvals to enter into and execute the Contract, and (iii) this Contract is its legal, valid and binding obligation, enforceable against it in accordance with the terms and conditions hereof.

b. Test Kit Warranties. Contractor represents and warrants that all Test Kits supplied hereunder will be (i) manufactured in accordance with applicable law, (ii) free from material defects under normal use, and (iii) free and clear of any security interest, lien, or other encumbrance at the time title to such Test Kits passes to EOHHS as provided in this Contract.

c. By EOHHS. EOHHS acknowledges that each Test Kit requires registration with Contractor by the individual from which the sample is collected, in accordance with Contractor’s standard operating procedures.

d. Disclaimer. Except as provided in this contract, neither party makes any warranties (express, implied, statutory, or otherwise, including implied warranties of merchantability, fitness for a particular purpose or noninfringement of third party intellectual property rights) with respect to the subject matter hereof, and each party expressly disclaims such additional warranties. Neither party is making any warranty with respect to the performance of the Designated Lab responsibilities.

17. Feedback. During the course of this Contract, EOHHS agrees to use reasonable efforts to provide and Contractor may solicit EOHHS’s input regarding the Contractor’s software, services, business, or technology plans provided to EOHHS under this Contract, including, without limitation, comments or suggestions regarding the possible creation, modification, correction, improvement or enhancement of the Contractor’s software, products and/or services, or input in connection with the Contractor’s development direction of the same (such EOHHS input, excluding any EOHHS confidential information, EOHHS property or any data or other information provided to or received by Contractor from or on behalf of EOHHS in furtherance of the services provided under this Contract, the “Feedback”). EOHHS acknowledges and agrees that any Contactor information disclosed by Contractor during discussions related to Feedback shall be considered Contractor confidential information and shall be protected from disclosure in accordance with the terms of the Contract. Subject to the obligations set forth in this Contract, including, without limitation, Section V.12, Contractor may utilize the Feedback in any manner Contractor chooses and may display, perform, copy, make, have made, use, sell, and otherwise dispose of Contractor’s products or services embodying the Feedback in any manner without restriction or remuneration of any kind with respect to EOHHS and/or its representatives. EOHHS acknowledges that the information related to software or Contractor, products, services, business or technology plans, disclosed to it under this Contract in connection with this Section V.17, is only intended as possible strategies, developments, and functionalities of the Contractor products or services and is not intended to be binding upon Contractor to any particular course of business, product strategy, and/or development.

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