04062020 J A ADD DMP CLIN to Contract FINAL SIGNED - Redacted FINAL.pdf

DEPARTMENT OF VETERANS AFFAIRS

NATIONAL ACQUISITION CENTER

COMMODITIES AND SERVICES ACQUISITION SERVICE

555 CORPORATE CIRCLE

GOLDEN, CO 80401

Justification & Approval for Other than Full & Open Competition Home Telehealth Contracts VA791-17-D-0001 & VA791-17-D-0004, HMS Technologies, Inc. & Medtronic Care Management Services, LLC April 6, 2020

1. Contracting Agency & Activity Department of Veterans Affairs, the Commodities & Services Acquisition Service (CSAS), 555 Corporate Circle, Golden, Colorado, 80401 submits a Justification and Approval for Other than Full and Open Competition to issue a modification to add a Disease Management Protocol (DMP) CLIN to Home Telehealth Contracts: VA791-17- D-0001, HMS Technologies, Inc. & VA791-17-D-0004, Medtronic Care Management Services, LLC.

2. Nature & Description of the Action Being Processed:

Request approval to issue a modification to Home Telehealth Contracts: VA791-17-D- 0001, HMS Technologies, Inc. & VA791-17-D-0004, Medtronic Care Management Services, LLC, to add a CLIN for “Development and Deployment of each new VHA Standardized Disease Management Protocol (DMP)”.

3. Description of Supplies/Services Required to Meet Agency Needs:

Background: The Department of Veterans Affairs (VA) supports the ongoing and emerging business needs of the Veterans Health Administration (VHA) national Home Telehealth Program (HT). VHA’s HT Program relies upon home telehealth platforms from commercial contractors that the VA classifies as Medical Device Data Systems (MDDS). These systems are purchased by VHA and used in the patient’s home to maintain their independent living capability, throughout the U.S. The HT program is considered a mission essential program within the VHA.

Veterans use the home technologies to upload vital signs, clinical question responses, and other measurements that can help them self-manage their condition and alert to the need for active care/case management, including referral for clinic and/or hospital care.

This data includes, but is not limited to, the following: blood glucose, blood pressure, pulse, temperature, weight, pain, and pulse oximetry. All these measurements are obtained from peripheral devices (except pain which is subjective and manually entered using a Likert Scale). Peripheral devices are provided with the HT platform and transmit the data by wired or wireless connection, or self-reported via manual entry. The data

Justification & Approval to Modify the Contract to Add a CLIN for Adding of a DMP to Contract that is collected on the HT platform is sent to a Clinician Web Viewer on the contractor website. The monitoring information is then available for the purposes of managing the health conditions of the Veterans.

Current: VA’s purpose in undertaking this modification to the contract is to add scope for the contractors to implement a newly developed VHA DMP CLIN for Infectious Disease.

This effort will directly and positively impact the Enterprise-wide Home Telehealth (HT) Program, as well as to meet the emerging needs related to the COVID-19 pandemic.

The United States is currently experiencing the Coronavirus Disease 2019 (COVID-19), which has been named a pandemic by the World Health Organization (WHO) on March 11, 2020. President Trump designated this pandemic as a National Emergency on March 13, 2020, thus paving the way for appropriate measures to be taken to mitigate exposure. The COVID-19 pandemic, and its resulting complications spreads by person-to-person contact and age is a contributing factor to being considered “high-risk”.

On the prior contract (VA797-P-0255), there was a CLIN (10.0) for this effort to “Development and Deployment of each new VHA Standardized Disease Management Protocol (DMP).” It appears that adding the same CLIN on this contract was overlooked.

Due to the COVID-19 pandemic, VHA quickly developed an infectious disease DMP that they wanted the contractors to implement, but there is not an established CLIN to support this scope.

The proposed contract modification necessitating this Justification and Approval is the need to incorporate a CLIN into both the Medtronic and HMS contracts that will support the scope of work and payment to incorporate the VHA developed Infectious Disease DMP. The estimated value for each contract action is approximately to implement the VHA Infectious Disease DMP.

According to the Center for Disease Control & Prevention, older Veterans and others with underlying conditions such as high blood pressure, heart disease, lung disease, and diabetes are considered High-Risk for catching this virus. As a good portion of our Veterans who are utilizing Home Telehealth meet these characteristics, it is imperative that the VA take prompt steps to not only prevent their exposure but make every effort to prevent the spread to our facilities for this and future infectious disease(s).

Therefore, the VA requires this new DMP be implemented by both vendors, which will provide essential information to the Veterans on their current symptoms and how to get medical help if required, but in a manner that will avoid potentially infecting or encountering others. The vendors are HMS Technologies, Inc. Contract VA791-17-D- 0001 and Medtronic Care Management Services (MCMS), LLC, contract VA791-17-D- 0004.

In each vendor’s contract, under Section B.5. “Statement of Work” 8.1 “Disease Management Protocols”, a detailed narrative is provided regarding the VA’s viewpoint of DMPs and how they will be utilized in the contract. The contract states, “All DMPs provided by the VA will take precedence over vendor DMPs.” The contract also states, “The VA will issue task orders as needed for the implementation of new DMPs.”

Given this information, the Contracting Officer asserts the VA Acquisition Team intended to allow for the addition of new VHA DMPs, but the specific CLIN was erroneously omitted from the final contract architecture. This Justification & Approval’s intent is to modify the contract to add the CLIN as the contract intended.

The contracting officer has requested each contractor provide a rough order of magnitude for both cost and schedule to implement the VHA DMP. HMS provided an estimate of and implementation time of . Medtronic provided an estimate of to implement and would take at least .

4. Statutory Authority Permitting Action:

The statutory authority that permits this action is 41 U.S.C. 3304 (a)(2) as implemented by FAR 6.302 Only one responsible source and no other supplies or services will satisfy agency requirements per FAR 6.302-1.

5. Demonstrate that the proposed contractor’s unique qualifications or the nature of the acquisition requires of the authority cited:

The Government would normally issue a Task Order against the contract to add the DMP, along with fair and reasonable pricing associated with it, but there is not an appropriate CLIN in the current infrastructure of either vendor’s contract to allow for the issuance of this Task Order.

In both contracts, under Section B.5. 8.1 “Disease Management Protocols”, a detailed narrative is provided regarding the VA’s viewpoint of DMPs and how they will be utilized in the contract. The VA uses standardized DMP’s, and they have been fully vetted by VA management. The VA’s DMP’s are preferred over those of the vendor, as noted by the sentence, “All DMPs provided by the VA will take precedence over vendor DMPs.”

The contract then states, “the contractor may use their own content or individual VA developed DMPs may be used to implement co-morbid DMPs. The VA will issue Task Orders as needed for the implementation of new DMPs.” Given this information, the Contracting Officer asserts the Acquisition Team’s original intent was to allow for the addition of new DMPs, but the specific CLIN was erroneously omitted from the final contract architecture. This Justification & Approval’s intent is to modify the contract to add the DMP CLIN as the original team intended.

The proposed contract modification necessitating this Justification & Approval is the need to add a CLIN to each vendor’s contract that will allow work and payment for the addition of an Infectious Disease DMP to each contract.

6. Description of Efforts Made to Ensure Offers are Solicited from as Many Potential Sources as practicable:

Due to the fact these vendors, MCMS and HMS Technologies are needed to implement the VHA DMP on their existing platforms and software, no additional sources were solicitied on this action.

7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable:

Adequate price competition was utilized for the original contract in accordance with 15.403-3(b), Adequate Price Competition. The current contract utilized full and open competition, and eighteen (18) proposals were received for consideration.

As the CLIN was not added prior to contract award, and this item has not been previously negotiated, the Contracting Officer will request proposals from each vendor upon approval of this Justification and Approval. The CO has also requested an IGCE from the Contracting Officer’s Representative (COR).

These documents will be analyzed, as well as taking into consideration the previously awarded VHA DMP prices, and all shall provide the basis to negotiate fair and reasonable pricing to support this action.

Certified cost or pricing data shall not be required, as this modification meets the exception noted in FAR Subpart 15.403-1(b)(3).

8. Description of the Market Research Conducted and the Results or a Statement of the Reasons Market Research was not Conducted:

Both vendors, MCMS and HMS Technologies, have developed and implemented their own DMPs for Infectious Disease, which is industry standard on these commercial contracts. Given the severity of the COVID-19 Worldwide pandemic, VHA also developed their own DMP for Infectious Disease and determined they wanted to give VA Care Coordinators the option to use either the vendor developed DMP or VHA developed DMP for Infectious Disease. Additionally, on the past contracts, Cardiocom (which was acquired by MCMS) was responsible to develop and implement the VHA DMPs, reflecting that they have performed the work in the past.

Due to the Urgent & Compelling nature of this modification with the enrollment of or more veterans per day utilizing the Infectious Disease DMPs that each vendor created, coupled with the fact no other sources would be able to implement the VHA developed DMP, market research has been limited to the information listed above.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Not applicable.

10. Listing of Sources that Expressed in Writing, an Interest in the Acquisition:

Not applicable to this action.

11. A Statement of the Action, if any, the Agency May Take to Remove or Overcome any Barriers to Competition Before Making Subsequent Acquisitions for the Supplies or Services Required:

The Acquisition Team is currently working on re-acquisition of the HT program requirement as the current contract expires on January 31, 2022. The Acquisition Team is also considering the addition of an optional DMP CLIN that will more easily allow the addition of a DMP if necessary on the follow-on procurement.

Requirements Certification:

I certify that the requirement outlined in this Justification & Approval is a Bona Fide need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Alyssa Urquhart Contracting Officer

4-6-2020