11-24-0005 CTS TeleMAT Services- Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

COMMUNITY TREATMENT SERVICES

Medication-Assisted Treatment (MAT) by Telehealth

(Herein called “TeleMAT”)

1. Agency:

The United States Department of Justice, Federal Bureau of

Prisons (Bureau), Administration Division, Acquisitions

Branch, Community Treatment Services Contracting Section.

2. Description of Action Being Approved:

Pursuant to the Federal Acquisition Regulation (FAR)

Part 6.302-2(b)(1) and (2), the Bureau determined the continued need for TeleMAT services for adults in custody

(AICs) of the Bureau while in community placement meets the criteria established for other than full and open competition.

This limitation of competition is justified in accordance with

FAR Subpart 6.303-2 Content.

The action to be approved is for a six-month contract to

Wellpath, LLC under unusual and compelling urgency, permitted under other than full and open competition procedures. The contract would provide TeleMAT services to AICs in Bureau custody who are residing in Residential Reentry Centers

(RRCs), on Home Confinement or Federal Location Monitoring, or reporting to a Day Reporting Center, at locations across the

United States.

3. Description of the Services Required to Meet the Agency Needs:

Over the past year, the Bureau has implemented a hub-and-spoke model to create MAT capacity at all of its facilities. In collaboration with the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration

(SAMHSA), the Bureau has rapidly developed this capacity and is currently working to increase it. The Bureau estimates as much as 10% of the current population may benefit from these services in the future.

As AICs transfer from Bureau facilities to RRCs or Home

Confinement, the Bureau must also ensure continuity of care for these individuals. MAT services initiated or identified as needed in its facilities must continue or can begin upon transfer to community placement. Additionally, individuals who did not start the MAT screening process while in Bureau custody may choose to be evaluated for MAT upon transfer to community placement.

The First Step Act requires the Bureau to “assess the availability of and the capacity to treat heroin and opioid abuse through evidence-based programs, including medication-assisted treatment.” To effectively meet the need to provide

MAT services for AICs while in community placement nationwide, the Bureau currently has a contract for medication-assisted treatment being delivered by telehealth (TeleMAT). This TeleMAT contract provides for the delivery of MAT services for AICs in community placement in need of such services in of the 50 states. However, this TeleMAT contract will end on December

31, 2023, leaving a gap in MAT services beginning January 1, 2024, unless a sole source contract is awarded to continue these services. Therefore, TeleMAT services are required to be provided on a nationwide scale from January 1, 2024 to June 30, 2024.

The estimated maximum quantities are based on units of

TeleMAT Buprenorphine Follow-Up & Report, units of TeleMAT

Naltrexone Follow-Up & Report, units of TeleMAT

Buprenorphine Psychiatric Evaluation & Report, and units of

TeleMAT Naltrexone Psychiatric Evaluation & Report. The estimated maximum quantities have been adjusted from the current contract for two services only, TeleMAT Buprenorphine

Follow-Up & Report and TeleMAT Buprenorphine Psychiatric

Evaluation & Report, due to a significant increase in need for this type of treatment. However, the estimated maximum quantities for TeleMAT Naltrexone Follow-Up & Report and

TeleMAT Naltrexone Psychiatric Evaluation & Report are remaining the same.

The estimated maximum amount of $3,478,380.00 is based on of TeleMAT Buprenorphine Follow-Up & Report, of TeleMAT Naltrexone Follow-Up & Report, of TeleMAT Buprenorphine Psychiatric Evaluation

& Report, and of TeleMAT Naltrexone Psychiatric

Evaluation & Report.

4. Statutory Authority Permitting Other than Full and Open

Competition:

Other than full and open competition is based on the authority of 41 U.S.C. 3304(a)(2) as implemented by FAR 6.302-2, Unusual and Compelling Urgency.

5. Determination that proposed Contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited:

The current contract, 15BCTS23D0000003, requires a maximum of units of TeleMAT Buprenorphine Follow-Up & Report, units of TeleMAT Naltrexone Follow-Up & Report, units of

TeleMAT Buprenorphine Psychiatric Evaluation & Report, and units of TeleMAT Naltrexone Psychiatric Evaluation & Report, which currently provide TeleMAT services to approximately 526

AICs who are in community placement. This contract will expire on December 31, 2023.

Acquisition planning for a new long-term contract has been ongoing throughout the year for several months involving market research, revising the current Statement of Work, and, of utmost importance, following the changing laws and regulations related to telehealth and prescribing of controlled substances. This planning has had to take into consideration federal laws and other policies which have significantly affected the ability of practitioners to prescribe and dispense, by telehealth, Schedule II and III controlled substances, which includes those used in MAT.

Consequently, the solicitation in development, when issued, will be for MAT services to be delivered on a nationwide scale to AICs predominantly by telehealth and by in-person services

(if required by regulations) due to recent and upcoming changes to telehealth flexibilities, as explained below.

On February 24, 2023, the DEA announced proposed rules for prescribing controlled substances via telehealth after the

COVID-19 Public Health Emergency (PHE) expired. At that time, the DEA proposed creating a new limited and more restrictive option for telehealth prescribing of controlled substances, especially for MAT medications, without a prior in-person exam than what had been allowed for the past three years under the

PHE waivers. The DEA’s rule would require these clients to have in-person exams and block them from fully virtual telehealth care. This included those individuals who were currently taking MAT medications and those who had not had a prior in-person exam.

Two days before the COVID-19 PHE was set to expire, on May 9, 2023, due to major backlash to its proposed rules released in

February, the DEA said it would extend telehealth flexibilities for another six months, which enabled practitioners to virtually prescribe controlled medications to their clients.

On May 10, 2023, the DEA and SAMHSA issued the First Temporary

Rule, which extended telehealth flexibilities adopted during the COVID-19 PHE. The temporary rule took effect on May 11, 2023, and extended the full set of telehealth flexibilities adopted during the COVID-19 PHE for six months – through

November 11, 2023. Additionally, only for any practitioner-patient telehealth relationships established up to November

11, 2023, the full set of telehealth flexibilities regarding prescription of controlled medications established during the

COVID-19 PHE would be extended for one year – through November

11, 2024.

After the First Temporary Rule was issued, the DEA hosted listening sessions to receive additional input concerning the practice of telehealth with regards to prescribing controlled medications. Consequently, in response to comments received regarding the First Temporary Rule and the listening sessions, on October 10, 2023, the DEA issued a Second Temporary Rule, extending the full set of telehealth flexibilities regarding prescription of controlled medications as were in place during the COVID–19 PHE, through December 31, 2024.1

As stated above, the First Temporary Rule specified certain circumstances under which practitioners would be able to prescribe controlled substances by telehealth, for a narrow period, to patients whom the practitioner had never evaluated in person. This extension, issued on October 10, 2023, now authorizes all DEA-registered practitioners to prescribe controlled medications via telehealth through December 31, 2024, whether or not the patient and practitioner established a telehealth relationship on or before November 11, 2023.

The purpose of this Second Temporary Rule, like the one before it, is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telehealth for controlled medication prescriptions, as well as allow adequate time for providers to come into compliance with any new standards or safeguards. DEA is working to promulgate new standards or safeguards by the fall of 2024.

Because the solicitation in development, and the resulting contract depend heavily on the requirement to deliver MAT by

1 https://www.federalregister.gov/documents/2023/10/10/2023-22406/second-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled telehealth, planning for an acquisition needed to address the capability of the market to continue to provide the services the Bureau required as well as the telehealth flexibilities afforded to practitioners under current regulations and after the flexibilities potentially expire. The Bureau could not reasonably anticipate when or what changes to regulations regarding telehealth flexibilities would occur. For example, the First Temporary Rule, expected to be supplemented by another rule prior to the expiration date of November 11, 2023, was issued on October 10, 2023. Ultimately, it is expected a final set of regulations regarding telehealth flexibilities will be implemented by fall of 2024.

Recognizing that fluctuations in laws for providing telehealth could materially affect the developing solicitation and perhaps even the six-month contract, the Bureau will take this time to assess and refine the requirements for providing MAT services, whether by telehealth or in-person, for AICs in community placement. Notwithstanding the final regulations on telehealth flexibilities from the DEA, the Bureau plans to move forward with the next acquisition to avoid any disruption or lapse in services while taking into consideration the current regulatory landscape and any potential changes to the provision of telehealth services.

To provide continuity of care and ensure telehealth services continue without interruption during this time, a six-month contract, beginning January 1, 2024, with the current vendor is needed. From a technical standpoint, Wellpath has the capability to meet the requirements for TeleMAT as it has the infrastructure and personnel with licensed practitioners, who can provide services in

, for the Bureau. Over 1,100 AICs have received services from Wellpath since the start of the contract on February 1, 2023. Although some CTS contractors can perform MAT services, not every location can do so. That is where Wellpath fills in the gap and does so in areas where a local CTS contractor is not able to provide MAT. Community

Treatment Services (CTS) and the CTS Contracting Section have determined that Wellpath can provide the required services at the required quantity by the performance start date of January

1, 2024. The Contracting Officer has reviewed all the documentation and agrees that Wellpath can continue providing services without risk to the community and the Bureau by

January 1, 2024.

Due to the Bureau’s essential need, the required services are of unusual and compelling urgency. Further, this proposed contract action is not due to lack of advanced planning by the agency, as demonstrated above. The ending of the PHE, in conjunction with a regulatory landscape that is currently in flux, has resulted in a situation where the Bureau is attempting to continue the provision of potentially life-saving MAT services, while also attempting to develop the next procurement with requirements that comport with any updated

DEA regulations and allows for the successful transition of

AICs receiving MAT services to the next contractor. The very nature of the services is such that continuation of MAT for those in maintenance treatment, i.e., individuals who initiated treatment while in a Bureau facility, is critical, in addition to evaluating those requesting MAT services upon entering the community. For those in maintenance treatment, the withdrawal of MAT medications, which could come from a lapse in treatment services, increases the risk for adverse consequences. Avoidable potential consequences include onset of withdrawal symptoms (requiring medical management and monitoring), increase in disciplinary problems, drop out from treatment, and dramatic increases in overdose-related deaths.

Some individuals who request MAT once in community placement may be in withdrawal symptoms and require immediate services.

This is relevant because individuals are at a significantly increased risk of an overdose death during the first 2 weeks post-release. However, use of MAT medications substantially reduces this risk.

If MAT services cannot continue with the current vendor, the

Bureau has two options: Transfer AICs to another RRC location where they can continue receiving services with a local CTS contractor who is providing MAT or return the AICs to a secure institution.

Relocating AICs to different RRCs or returning AICs to a secure institution for the period requested in this justification would negatively impact the Bureau’s mission and disrupt the AICs reentry programming. AICs are typically assigned to an RRC near where they will eventually be released. RRCs help AICs gradually rebuild ties to their community, reintegrate with their families, and provide a period of community readjustment, along with the necessary treatment for a successful release.

Therefore, both options are unfavorable and would substantially harm the Bureau in its efforts to support the overall mission of preparing individuals for successful reentry into our communities.

6. Efforts made to solicit from as many sources as practicable, including whether or not a notice was published in the

Government Point of Entry (GPE):

Based on the urgent requirements of these services, the exception at FAR 5.202(a)(2) applies; therefore, a notice was not published in the GPE. Although the Competition in

Contracting Act (CICA) requires that agencies solicit offers from as many potential sources as is practicable when using the unusual and compelling urgency exception to limit competition, 10 U.S.C. § 2304€, an agency nonetheless may limit a procurement to the only firm it reasonably believes can properly perform the work in the time available. McGregor

Mfg. Corp., B-285341, Aug. 18, 2000, 2000 CPD ¶ 151 at 6.

Maintaining continuity of MAT services is a critical and immediate need which, if interrupted or discontinued, could cause harm to AICs currently in or in need of treatment, affect their health and wellbeing, and prevent the Bureau from meetings its mission of preparing individuals for successful reentry into our communities. During this limited time, conducting competition for a new contract or even a sole source contract to another vendor could potentially lead to an interruption in services as there are few companies who can provide MAT services by telehealth on a nationwide scale, in as many states as the current vendor. Therefore, it is essential that, in the time available, a reasonable effort be made to continue services without interruption or delay.

It is anticipated a solicitation for a new contract, with a period of performance to begin on July 1, 2024, with a base year, and two option years, will be issued between November and December 2023. A firm-fixed-price, indefinite delivery/indefinite quantity (IDIQ) type contract is expected to be utilized.

7. Contracting Officer’s determination that cost to the

Government will be fair and reasonable:

The Contracting Officer has determined that the anticipated costs to the Government will be fair and reasonable based on comparing the estimated pricing provided by the incumbent for the six-month contract, their current Government contract prices for TeleMAT services, and the contract prices from the previous TeleMAT contractor.

requirements. Third, sources currently providing MAT services for CTS were contacted as well as sources who had expressed interest in the previous acquisition. Lastly, additional information, such as estimated pricing, was collected from any sources expressing interest in a future solicitation.

Currently, the incumbent is planning to continue to provide

MAT by telehealth with no lapse in services. At the same time, Wellpath is aware of federal rules and regulations regarding telehealth flexibilities and has personnel and other resources to satisfy both Bureau requirements, while meeting state and federal regulatory requirements.

9. Other facts supporting the use of other than full and open competition:

N/A

10. List of sources, expressing in writing, interest in the acquisition:

The sources expressing interest in the past, listed alphabetically, are:

11. Actions taken by the agency to remove or overcome barriers to competition:

It takes the Bureau approximately nine to eleven months to award a CTS contract when using the tradeoff process as the source selection approach; therefore, there is not enough time to solicit for these services, as discussed above. Sufficient planning has been ongoing in developing a solicitation in concert with changing regulations regarding telehealth flexibilities. The Bureau is currently preparing to solicit for and award a new competitive contract for TeleMAT services, to be delivered on a nationwide scale, to AICs in community placement.

12. Contracting Officer’s Certification:

I certify that the justification is accurate and complete to the best of the Contracting Officer’s knowledge and belief.