COVID19 Mobile Surveillance Testing Program RFR Attachment A Model Contract.docx

Attachment A: Model Contract

The COVID-19 Mobile Surveillance Testing Program (MSTP)

This Mobile Surveillance Testing Program 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”), and shall be effective [DATE].

WHEREAS, the purpose of MSTP is to increase access to COVID-19 testing across Massachusetts;

WHEREAS, the MSTP Services under this Contract include, but are not limited to, ordering provider, patient registration and intake, specimen collection, specimen transport, test result reporting, patient follow-up, and answering patient inquires made via telephone and email; and

WHEREAS, Contractor has been deemed appropriate and has agreed to provide such MSTP Services in accordance with the following terms and conditions:

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

SECTION 1: DEFINITIONS

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

Authorized Site: A site that EOHHS has directed Contractor to travel to or set up for purpose of providing MSTP Services or is within the category of mobile testing sites authorized by EOHHS within the Contractor’s assigned geography.

Broad Institute: Broad Institute of MIT and Harvard is a biomedical and genomic research center located in Cambridge, Massachusetts that has been contracted by the Commonwealth to provide COVID-19 lab processing services.

Calendar Year: The twelve-month period commencing January 1 and ending December 31.

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

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.

MassHealth: The medical assistance or benefit programs administered by EOHHS to provide and pay for medical services to eligible MassHealth members pursuant to Title XIX of the Social Security Act, Title XXI of the Social Security Act, M.G.L. c. 118E, and other applicable laws and waivers. MassHealth members receive services either through MassHealth fee-for-service or a MassHealth managed care plan.

Mobile Testing Unit: A maximum of three staff members at an Authorized Site who are providing MSTP services including on-site registration, test administration, and observation and specimen transport services.

Project: Work designed and implemented by the Contractor, the purpose of which is to achieve objectives and satisfy requirements described in this Contract.

Personal Protective Equipment (PPE): Specialized clothing or equipment worn by an employee for protection against infectious materials. In the case of COVID-19, PPE may include equipment such as protective face masks, face shields, disposable gowns, and nitrile gloves.

MSTP Services: Testing services for COVID-19 performed at Authorized Sites in conformance with this Contract, including all requirements set forth in Section III.

Surveillance Testing Payments: Payments made pursuant to this Attachment A for MSTP Services completed at Authorized Sites at the rates set forth in Section V.

SECTION II: MINIMUM REQUIREMENTS

Contractor certifies that it meets the following minimum requirements for entering into the Contract:

1. Contractor has the capacity to complete MSTP Services for at least 100 individuals per day cumulatively across all site locations, with the minimum capacity of MSTP Services per day per site to be specified by EOHHS in the form and manner specified in this Contract.

2. Contractor can source sufficient staff (including appropriate clinical staff), an ordering provider, PPE, testing supplies (excluding test kits which will be supplied by the Broad Institute or other laboratory identified by EOHHS), and equipment to complete MSTP Services for the duration of this Contract.

3. Contractor has the flexibility to move their testing site(s) to another priority location within Massachusetts given 48 hours’ notice from EOHHS;

4. Contractor commits it will not bill or charge patients’ insurance, other third-party payor, or the patients directly for any MSTP Services; EOHHS payment is payment in full for MSTP services;

5. Contractor can 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.

6. Contactor can secure all equipment necessary to establish mobile or site-specific testing locations and perform the services required under this Contract.

7. Contractor has all appropriate licenses or waivers in place to perform all required MSTP-related medical services.

8. Contractor will ensure that staff designated to implement aspects of the Project that involve direct patient contact are:

A. Knowledgeable of appropriate specimen collection techniques;

B. Trained in safe infection control protocols as established by the CDC, including proper PPE donning and doffing practices; and C. Able to provide linguistically competent care to patients as well as accessible care to patients who are deaf and hard of hearing, including through the use of translation services as necessary.

9. Contractor will send all specimens collected at an Authorized Site to the Broad Institute, or alternative laboratory identified by EOHHS, for processing. Contractor will properly collect and send specimens in the manner accepted by the laboratory identified by EOHHS as described in Section III.

SECTION III. SCOPE OF WORK

1. As set forth below, Contractor, at the direction of EOHHS, shall go to Authorized Sites, and perform the services listed below in this section. EOHHS does not guarantee that Contractor will be assigned to a particular Authorized Site or any Authorized Site at all. EOHHS shall provide direction to the Contractor regarding the Authorized Site, dates of testing, required capacity, and lab to deliver specimens to. EOHHS will provide direction regarding Authorized Sites via the form in Appendix 1, as such form may be amended from time to time. Contractor may reject the assignment of an Authorized Site, provided that in order to do so Contractor must notify EOHHS in writing within 24 hours of being assigned an Authorized Site that it rejects this assignment (unless EOHHS agrees to an extension).

2. Contractor must be able to provide an ordering provider to prepare clinician orders for testing, if necessary. In cases in which the patient does not have a test order from an existing provider, registration/intake information must be sufficient to meet reporting requirements established by the Massachusetts Department of Public Health (DPH) and for Contractor’s ordering provider to order a COVID-19 test and provide the results to the patient. In cases in which a patient’s primary care provider (PCP) or other appropriate clinician orders a COVID-19 test, Contractor must ensure that all registration/intake information is sufficient to utilize the order, and ensure that test results are provided to the PCP or ordering clinician.

3. Contractor must be able to coordinate with sites and schedule testing at least 24 hours in advance and provide a method for patients to register without pre-scheduled appointments. For individual patients’ registration, Contractor may collect information and schedule appointments in advance, preferably through an online platform; however, the Contractor must be able to accommodate patients who did not register in advance even when a scheduling system is used. If directed by EOHHS, Contractor must use a centralized online scheduling platform provided by EOHHS (as it becomes available). Patient data should be maintained in a HIPAA-compliant electronic recordkeeping system for purposes of privacy, security, and applicable covered transactions.

4. In addition to the requirements above, when conducting testing via mobile deployment to an Authorized Site, it must establish an intake mechanism which can accomplish the following:

A. Receive incoming requests for MSTP Services directly from sites seeking mobile deployment;

B. Determine if the incoming request for MSTP Services falls within the Contractor’s assigned geography and is an Authorized Site, as specified by EOHHS;

C. Determine if the incoming request for MSTP Services meets the guidelines for testing as defined by the DPH or otherwise specified by EOHHS; and D. Schedule a visit to the site with at least 24 hours advance notice to the site’s designated point of contact with the Contractor’s estimated time of arrival and estimated time on site.

5. Contractor must provide all staff, equipment, supplies, and logistical support to perform specimen collection. This will include sourcing PPE but does not include test kits which will be provided by the laboratory identified by EOHHS. As part of specimen collection, Contractor must be able to perform the following:

A. Evaluate an individual’s eligibility for surveillance testing, based on the direction of EOHHS;

B. Order a test through an appropriately licensed ordering provider;

C. Collect the specimen for testing, ensuring that the specimen collector is following all relevant infection control protocols (e.g., wearing appropriate PPE); and D. Maintain testing kit inventory and request additional supplies from the laboratory as necessary to meet volume demands.

6. Contractor must have their specimen collection protocols approved by EOHHS prior to Project launch. While anterior nasal swabbing is currently the preferred specimen collection method for COVID-19 testing, Contractor should be able to adapt their processes to accommodate other specimen collection types (e.g., nasopharyngeal, saliva, etc.) and approved testing methods as necessary.

7. Contractor must complete specimen collection for COVID-19 tests with anterior nasal swabs or another collection method specified by EOHHS by using test kits provided by the laboratory partner identified by EOHHS, in accordance with specimen collection protocols set forth by the laboratory partner, and transportation protocols for all specimens collected established by the laboratory partner. While the Broad Institute is currently the likely laboratory partner with which Contractors will work, Contractor must adapt their processes to accommodate other laboratory partners such as the State Public Health Lab or another lab identified by EOHHS. The specimen collection and transportation protocols at this time that must be followed include, but are not limited to, the following, except as directed by EOHHS:

A. Specimens should be collected by trained personnel in accordance with manufacturer guidelines and in accordance with FDA-approved collection devices.

B. Collection and transportation protocol for anterior nasal swabs[footnoteRef:2]: [2: https://covid-19-test-info.broadinstitute.org/safe-for-school/#sample-shipping-and-courier-logistics]

i. All data collected that is required for testing must be entered into the Broad portal (CareEvolve) and a barcode label printed from the portal must be affixed to the specimen tube.

ii. Specimen collections of anterior nasal swabs should be inserted into the tube and then placed into the provided secondary packaging, VWR CryoPro box.

iii. Consolidate sealed Cyroboxes into as few shipping kits as possible. Do not use wet ice for packaging

iv. Place printed manifest file (generated from the CareEvolve platform) into the box

v. Seal the box shut with tape and fill out to the Sender’s address label placing it on the shipping box.

vi. Affix a CRSP shipping label to shipping boxes

vii. If shipping with FedEx or UPS, follow shipping regulations for UN 3373 Biological Substance, Category B. Refer to Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID19)[footnoteRef:3]. [3: https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html]

viii. Dry specimens are stable long term at room temperature. All tests must arrive at the Broad within 12 hours after collection, they must be delivered to the following address:

CRSP Laboratory 320 Charles Street Cambridge, MA 02141 C. A paper manifest file is required in the box with all specimen collections. This paper manifest is generated automatically from all of the information that is entered into the Broad portal (CareEvolve) upon patient registration and intake. The manifest should be printed and included in each box with specimen collections.

D. If an alternative Massachusetts lab partner is selected, EOHHS will work with the Contractor to establish processes similar to those described in Section III.7.B.

8. Contractor must transport collected specimens to the Broad Institute processing lab, or other partner laboratory, within twelve hours of specimen collection. Contractor must track specimen collection times and delivery times to processing labs.

9. Contractor must report test results to patients within 12 hours of the receipt of results from the laboratory. Contractor must have an electronic process for receiving results from processing labs and sharing those results with the patient, and the patient’s PCP, if any, and any other medical provider designated by the patient at intake. If a patient has opted into electronic communication, both positive and negative results can be communicated electronically. However, Contractor must have qualified staff designated to immediately communicate test results back to patients and their care providers as appropriate when a patient has not opted into electronic communication. Contractor must track time from specimen collection to result reporting for all patients.

10. Contractor must ensure that follow-up counseling is provided to all COVID-19 positive patients, either directly or through coordination with the patient’s PCP, if any, and any other medical provider designated by the patient at intake. Additionally, Contractor must share the test result with its associated ordering provider in all cases, including when the ordering provider is not directly contracted by Contractor.

For any patient that tests positive for COVID-19, Contractor must immediately provide instructions for self-isolation to the patient and inform the patient that they will receive a call from a contact tracer and urge them to answer the call. The following information must be communicated to all positive cases:

· Contact tracing calls will appear with the area code 833 or 857 and will appear as “MA COVID Team” on caller ID. Calls are made daily from 8 a.m. to 8 p.m.

· The patient must self-isolate until they have been fever-free for at least 72 hours without the use of medication, any of their respiratory symptoms have improved, and at least 10 days have passed since their symptoms first appeared.

· If their symptoms become so severe that they are unable to take care of themself (i.e., unable to consume liquids and food, experiencing excessive light-headedness, etc.), they should immediately reach out to their healthcare provider, or for emergencies dial 911.

11. Contractor must provide a toll-free customer service telephone line and email address where patients can obtain information about the status of their test result and ask general questions. At minimum, the service line must be staffed during the hours the testing site is operating and have a voicemail system to record patient messages 24 hours a day, 7 days a week. Patients' phone and email inquiries should be resolved within 24 hours.

SECTION IV. REPORTING

1. Contractor must gather data to quantify the impact of the Project as a part of project implementation. Contractor will be required to submit a weekly report to EOHHS that contains the following metrics (measured daily), by Authorized Site, along with any additional metrics developed by EOHHS throughout the duration of MSTP, in a form and manner specified by EOHHS:

A. Number of patients tested at each site;

B. Number of patients who refused testing, if any;

C. Number of patients with a test ordered by their PCP or other existing health care provider;

D. Number of patients with a test ordered by Contractor’s associated ordering provider;

E. Number of patients with positive test results;

F. Number of patients with negative test results;

G. Number of patients who received a communication about their test result;

H. Race/ethnicity distribution across patients tested;

I. Average length of time between test collection and receipt of results from the laboratory; and J. Average length of time between test collection and result reported to the patient

2. Average length of time between test collection and result reported to patient; In addition to the aggregated data described above, Contractor must be able to provide deidentified individual-level backup data for each of their weekly reports at the request of EOHHS.

3. Contractor must comply with any additional reasonable reporting requests not listed above in Section IV.1 as defined by EOHHS throughout the term of this Contract, including requests for ad hoc reports.

4. As requested by EOHHS and with reasonable notice, Contractor shall 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.

5. All reports required under this Section IV shall be sent via secure email to [INSERT CONTACT], or access can be provided to a secure database providing the information contained in the required reports.

SECTION V. PAYMENT

1. EOHHS shall pay Contractor Surveillance Testing Payments based on the rates set by EOHHS in 101 CMR 446.00: COVID-19 Payment Rates for Certain Community Health Care Providers, $20.81 per test and $60 per hour per staff member of a Mobile Testing Unit at the Authorized Site, maximum of 3 staff per unit. Contractors will only be paid the rate for services provided at an Authorized site as specified by EOHHS

2. EOHHS shall pay Contractor the $60 per hour per staff member rate only for staff members included within a Mobile Testing Unit selected to provide services at an Authorized Site. For the purposes of calculating payment, a Mobile Testing Unit may not consist of more than three staff members whose roles include on-site patient registration, other on-site administrative services, test administration or observation or specimen transport services. Any additional staff members that a Contractor deems necessary is considered paid for by the per test rate of $20.81.

3. EOHHS may authorize Contractors to send more than one Mobile Testing Unit to a single Authorized Site if the expected volume demands it but EOHHS will only pay for Mobile Testing Units that were directed by EOHHS to provide MSTP Services at Authorized Sites. Hours eligible for the $60 per hour per staff member rate include the hours in which a Mobile Testing Unit is directly engaged in COVID-19 on-site patient registration and specimen collection, plus a maximum of (2) hours of transportation time. Transportation time may include time spent traveling to the Authorized Site, as well as time spent transporting completed specimens from the Authorized Site to the laboratory. Providers should record transportation time only for the staff members engaged in transportation. On an exception basis, a Contractor may bill more than 2 hours of transportation time if authorized to do so in writing by EOHHS and an exceptional amount of travel is required for a particular assignment. EOHHS shall not pay the $60 per hour rate for any services described in Sections III.3, 9, 10, and 11 above, which shall be covered by the $20.81 fee per test, nor will it pay the hourly rate for logistical support or services other than described in this Section V.3.

4. EOHHS shall pay Contractor $20.81 fee per test. This fee shall cover ordering, resulting, and follow-up counseling services described in Sections III.3, 9, 10, 11 above. This includes providing a clinician order for testing, if necessary, receiving results and reporting these results to all patients tested, as well as any designated central point of contact, where necessary and in compliance with privacy laws, operating a customer service line to receive questions about test results, and distributing materials and information, in accordance with EOHHS guidance and protocols, for all COVID-19 positive patients.

5. Before tests can be considered complete for purposes of this Section V, results must have been provided to the patient. Any MSTP Services where the testing result is provided more than 12 hours after the result is delivered to the Contractor by the laboratory may not be counted for purposes of calculating the Surveillance Testing Payment.

6. EOHHS shall pay Contractor only for MSTP Services at Authorized Sites. Any testing done at sites other than an Authorized Site as directed by EOHHS is not eligible for payment under this contract. EOHHS shall have no obligation to assign or authorize Contractor to provide MSTP Services at an Authorized Site, and there is no minimum payment under this Contract. EOHHS may elect to not direct Contractor to provide any MSTP Services at Authorized Sites, and in such case no payment would be owed to Contractor.

7. Payment will be in accordance with this Contract, including the State Standard Contract Form and the Commonwealth Terms and Conditions.

8. Contractor is not entitled to payment of the Surveillance Testing Payment if it fails to comply with all conditions of the Contract.

9. Payment pursuant to this Contract is separate and distinct from any payment arrangements developed between Contractor and employers or other third parties. EOHHS will not be liable for any payments for medical services, administrative, or overhead costs associated with such arrangements.

10. Contractor must accept as payment in full for all services provided under the MSTP the Surveillance Testing Payments by EOHHS described in this Section V.

11. Contractor is not be eligible to receive a Mobile Surveillance Testing Payment pursuant to this Contract relating to any testing services conducted pursuant to a separate COVID-19 testing contract with EOHHS or for testing services for which Contractor is eligible to bill MassHealth using code A0998 under the terms of a special conditions addendum to the Contractor’s MassHealth provider contract.

SECTION VI: OTHER CONTRACTUAL TERMS

1. This Contract, which includes and incorporates the State Standard Contract Form and the Commonwealth Terms and Conditions, along with the MSTP request for responses (MSTP RFR) and Contractor’s response to the MSTP RFR (in that order of precedence), contain the entire Contract and understanding between EOHHS and Contractor. There are no additional promises or terms other than as contained in this Contract.

2. 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.

3. 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:

Dayva Briand, Strategy Analyst, MassHealth Dayva.Briand@mass.gov

Tim Hoitink, Assistant General Counsel, EOHHS Timothy.S.Hoitink@mass.gov

EOHHS Contracts Unit 600 Washington Street, 7th Floor Boston, MA 02111 To the Contractor:

4. If any clause or provision of this Contract is in conflict with any state or federal law or regulation, as such laws and regulations apply and are in effect during the State of Emergency, that clause or provision shall be null and void and any such invalidity shall not affect the validity of the remainder of this Contract.

5. 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.

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. 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.

8. 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.

9. Contractor shall have Procedures to report to EOHHS any instance of suspected fraud or abuse.

10. Contractor shall notify EOHHS in writing within ten (10) calendar days if it or, where applicable, any of its subcontractors receive or identify any information that gives them reason to suspect that a patient or provider has engaged in fraud or abuse. In the event of suspected fraud or abuse, no further contact shall be initiated with the member or patient on that specific matter without EOHHS’ approval.

11. Contractor and, where applicable, its subcontractors shall cooperate fully with the investigations or audits by EOHHS, the Office of the Attorney General or other state or federal agencies that conduct investigations. Such cooperation shall include, but not be limited to, providing at no charge, prompt access and copies of any documents and other available information determined necessary by such agencies to carry out their official responsibilities, maintaining the confidentiality of any such investigations, and making knowledgeable staff available at no charge to support any investigation, court, or administrative proceeding.

12. 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 at 45 CFR Parts 160, 162 and 164.

APPENDIX 1

EOHHS Direction to Contractor Regarding Authorized Sites Pursuant to Section III.1 of this Contract, EOHHS is hereby directing Contractor to:

This/these site(s) is/are [an] Authorized Site(s) for these dates for purposes of this Contract.

Unless Contractor rejects this assignment in writing within 24 hours of receipt, Contractor must provide MSTP Services at this/these Authorized Site(s), including providing a minimum testing capacity of [] tests per day while at this/these Authorized Site(s), and meet all other requirements set forth in Contractor’s Executed MSTP Contract.

By: ________________________________

(Signature)

(Printed Name)

(Official Title)

(Date)

A1-1