Cancer Clinical Trials

Documentation Required to Submit Requests for Review

The following list covers all required information and documentation you must submit to TRICARE when submitting authorization requests for Phase I, Phase II, or Phase III clinical trials:

  • Protocol number, phase, and title listed on the title face sheet of the protocol
  • Protocol plan of treatment/schematic
  • Consent form
  • Calendar that includes follow-up after treatment is complete
  • Proof of National Cancer Institute (NCI) sponsorship in the form of designated NCI cancer treatment documentation, cooperative group agreement, or NCI grant
  • Institutional Review Board (IRB) approval letter specific to the requested trial, including date of approval stamp dated within the last year
  • Recent history and physical (H&P) or evaluation visit note
  • Patient demographics:
    • Mailing address
    • Home phone number
    • Policy information for other health insurance (OHI)
  • Facility mailing address and point of contact

Providers can submit request documentation via fax to 1-877-989-0025.

Once TRICARE receives all required information, the Cancer Clinical Trials team will review the request and follow up with either an approval or denial.

TRICARE Contact Information

PGBA, LLC
TRICARE T5 West Cancer Clinical Trials
P.O. Box 202166
Florence, SC 29502-2166

Fax: 1-877-989-0025
Toll Free: 1-855-722-5837

Virtual Health

Virtual Health Care Coverage

You must follow all virtual health regulatory, licensing, credentialing, privileging, and malpractice/insurance laws. You must also comply with the required regulatory and accrediting agencies. Visit the TRICARE Policy Manual, Chapter 7, Section 22.1 to learn more.

When practicing virtual health:

  • Follow Guidelines: Adhere to professional and national practice guidelines. Any changes must meet your field’s clinical requirements.
  • Emergency Plans: Plan for emergencies at the start of treatment. Plans should match local procedures. Include steps for hospitalization or civil commitment in the beneficiary’s area.
  • Verify Identities: Confirm the identities of both the provider and beneficiary for live virtual health
    • Identities can be verified at the facility if meeting at an authorized facility.
    • If meeting from a place without a health professional (like the beneficiary’s home), you must share your qualifications and licensure information. The beneficiary must use two-factor authentication.
  • Document Locations: Record the locations of yourself and the beneficiary in the medical record for proper payment. Include details like city, state, and ZIP code (or country for overseas services).
  • Secure Data: Ensure all data sent or stored during virtual health services is on a secure network and follows HIPAA rules. Have a backup plan for communication (like phone or video call) if technology fails.
    • You and the beneficiary should develop a backup plan at the start of treatment.
    • Virtual health can only resume once all technology requirements are back in place.
  • Follow HIPAA privacy and security requirements for all virtual health

Mental Health

Outpatient Mental Health Care Options

The TRICARE mental health care outpatient network includes:

  • Psychiatrists and other physicians
  • Clinical psychologists
  • Certified psychiatric nurse specialists (CPNS)
  • Certified clinical social workers
  • TRICARE-certified mental health counselors
  • Certified marriage and family therapists
  • Supervised licensed pastoral counselors
  • Supervised behavioral health counselors
  • Licensed psychological associates
  • Board Certified Behavior Analysts (BCBA)
  • Board Certified Behavior Analysts-Doctoral (BCBA-D)
  • ABA licensed/certified providers

To be a TRICARE-authorized provider, you must:

  • Have TRICARE certification
  • Have a license where you provide care (Title 32, Code of Federal Regulations, Part 199.6)

Intensive Outpatient Programs (IOP)

  • IOPs can be part of a TRICARE-authorized institution or a standalone program.
  • You must be accredited by one of the following to be TRICARE certified:
    • The Joint Commission (TJC)
    • Commission on Accreditation of Rehabilitation Facilities (CARF)
    • Council on Accreditation (CoA)
    • An accrediting organization approved by the DHA Director
  • If an acute care hospital is TRICARE-authorized, its IOP is also TRICARE-authorized.

To become a network provider, IOP facilities (excluding VA facilities) must:

  • Complete the TriWest contracting process
  • Sign an agreement to follow all TRICARE policies before servicing TRICARE beneficiaries

PTSD Awareness & Screening

You must keep clinical records as proof that the care you provided was medically or psychologically necessary.

You must keep records in accordance with TJC, CARF, CoA, or a DHA-approved accrediting organization.

Acceptable clinical documents include:

  • Psychiatric and psychological evaluations
  • Physician orders
  • Treatment plans
  • Physician and/or integrated progress notes
  • Discharge summaries.

For PTSD diagnosis, you must assess patients using the PTSD Checklist (PCL-5).

You must complete the following cultural training courses:

  • “Military Culture: Core Competencies for Healthcare Professionals” accessed through accessed through Availity.
  • The Center for Deployment Psychology (CDP) offers training to prepare providers for delivering care under TRICARE. Eligible providers must complete all listed modules to receive the TPRD.

Find links to training courses in Availity.

Substance Use Disorder/Addiction Therapy

TRICARE covers substance use disorder (SUD) treatments under the following conditions:

  • Acute Inpatient Care: Covers hospital treatment for alcohol or drug abuse complications. Preauthorization isn’t needed for emergency admissions, but you must notify TRICARE.
  • Rehabilitation: Requires preauthorization for inpatient care
  • Outpatient Services: Includes individual, group, and family therapy, as well as partial hospitalization and intensive outpatient programs

As stated in the Provider Handbook, you must notify the referring provider or MTF if a TRICARE beneficiary:

  • Is a potential harm to themself (serious risk of self-harm due to the condition or its treatment).
  • Is a potential harm to others (serious risk of harming others due to the condition or its treatment).
  • Is a potential harm to the mission (serious risk to a military mission, affecting impulsiveness, insight, reliability, or judgment).
  • Is admitted to or discharged from any inpatient mental health facility or Substance Use Disorder Rehabilitation Facility (SUDRF).
  • Has an acute medical condition or is receiving acute medical treatment that affects their ability to perform duties.
  • Has entered or is being discharged from a SUD program.

Quality & Reporting

Submit Potential Quality Issues (PQIs)

The Clinical Quality Management (CQM) department investigates Potential Quality Issues (PQI) and Patient Safety Issues (PSI) that are referred to TriWest. It also investigates beneficiary PQI and PSI and performs clinical quality review studies and quality improvement projects. Refer to the Provider Handbook for more information.

To submit PQI, download the PQI form available under the Customer Service section of the TRICARE West Region Provider Forms webpage.

Due to Federal and/or state privacy regulations, TriWest will not share the results of, or actions taken during or after, the quality issue investigation.

To submit non-clinical customer service concerns, download the TRICARE West Region Grievance form.

 

Patient Safety & Satisfaction

For more information on patient safety and satisfaction, refer to the following trainings: 

  • Building a Culture of Patient Safety 
  • Enhancing Patient Satisfaction: Strategies for Healthcare Providers

You can access these trainings by navigating to the TriWest Learning Center in the TRICARE West Payer Space in the provider portal.

Additionally, the Patient Safety website provides information on how beneficiaries contribute to patient safety.