CTS Telemat Services Redacted JOFOC.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

COMMUNITY TREATMENT SERVICES (CTS)

Medication-Assisted Treatment (MAT) by Telehealth

(Herein called “TeleMAT”)

1. FAR 6.303-2(b)(1): Identification of the agency and the contracting activity, and specific identification of the document as a Justification for other than full and open competition:

Federal Bureau of Prisons

Community Treatment Services

Contracting Section

320 First Street N.W., Room 901-5

Washington, D.C. 20534

2. FAR 6.303-2(b)(2): Nature and/or description of the action being approved:

Pursuant to the Federal Acquisition Regulation (FAR)

Part 6.302-2(b)(1) and (2), the Federal Bureau of Prisons

(FBOP) determined the continued need for TeleMAT services for adults in custody (AICs)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.

The action to be approved is for a one-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 FBOP 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. FAR 6.303-2(b)(3): Description of the supplies or services required to meet the agency’s needs (including the estimated value):

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

(SAMHSA), the FBOP has rapidly developed this capacity and is currently working to increase it. The FBOP estimates as much as

10% of its current population may benefit from these services in the future.

As AICs transfer from FBOP facilities to RRCs or Home

Confinement, the FBOP 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 FBOP custody may choose to be evaluated for MAT upon transfer to community placement.

The First Step Act requires the FBOP to “assess the availability of and the capacity to treat heroin and opioid abuse through evidence-based programs, including medicationassisted treatment.” To effectively meet the need to provide MAT services for AICs while in community placement nationwide, the FBOP currently has a contract for medication-assisted treatment being delivered by telehealth (TeleMAT).

The TeleMAT contract provides for the delivery of MAT services for AICs in community placement in need of such services in of the 50 states. The current two-month TeleMAT contract will end on August 31, 2024, leaving a gap in MAT services beginning

September 1, 2024, until a contract is awarded to continue these services. Therefore, TeleMAT services are required to be provided on a nationwide scale, for an additional one month via a bridge contract, from September 1, 2024, to September 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 amount of 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. FAR 6.303-2(b)(4): An identification of the 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. FAR 6.303-2(b)(5): A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited:

The current contract, 15BCTS24D00000008, requires a maximum of

1800 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 provides TeleMAT services to approximately

AICs who are in community placement. This contract will expire on August 31, 2024.

Acquisition planning for the new long-term contract had been ongoing throughout the last 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 had to take into consideration federal laws and other policies which significantly affected the ability of practitioners to prescribe and dispense, by telehealth, Schedule II and III controlled substances, including those used in MAT.

Consequently, the solicitation called 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 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, was 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 currently working to promulgate new standards or safeguards by the fall of 2024.

1 https://www.federalregister.gov/documents/2023/10/10/2023-22406/second-temporary-extension-of-covid-

19telemedicine-flexibilities-for-prescription-of-controlled

Because the solicitation, and the resulting contract depended heavily on the requirement to deliver MAT by telehealth, planning for an acquisition needed to address the capability of the market to continue to provide the services the FBOP required as well as the telehealth flexibilities afforded to practitioners under current regulations and after the flexibilities potentially expire. The FBOP 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.

Notwithstanding the final regulations on telehealth flexibilities from the DEA, the FBOP moved forward with its 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 acquisition, a one-month contract, beginning September 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, . 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. 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

September 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 FBOP by September 1, 2024.

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, resulted in a situation where the

FBOP, while continuing the provision of potentially lifesaving

MAT services, and allowing for the successful transition of

AICs receiving MAT services to the next contractor, was also attempting to develop and acquire the next procurement with requirements that comport with any updated DEA regulations.

Due to the FBOP’s essential need, the required services are of unusual and compelling urgency. 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 FBOP 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 two weeks postrelease. However, use of MAT medications substantially reduces this risk.

If MAT services cannot continue with the current vendor, the

FBOP 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 FBOP’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 FBOP in its efforts to support the overall mission of preparing individuals for successful reentry into our communities.

6. FAR 6.303-2(b)(6): A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.:

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 FBOP 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

Concurrence: