ADM Regulatory Compliance & Standards 3 — Questions and Answers
Question 1: Under federal OTP regulations (42 CFR Part 8), which of the following is required for a patient to receive take-home methadone doses in the first 90 days of treatment?
- Patients may receive take-home doses if they have stable employment
- No take-home doses are permitted during the first 90 days unless an exception is granted (Correct answer)
- Patients may receive up to 3 take-home doses per week after 30 days
- Take-home doses require only prescriber discretion at any time
Correct answer: No take-home doses are permitted during the first 90 days unless an exception is granted
In the first 90 days of OTP treatment, federal regulations prohibit take-home methadone doses; patients must receive supervised administration at the clinic.
Question 2: Which DEA schedule classification applies to buprenorphine products approved for opioid use disorder treatment?
- Schedule II
- Schedule III (Correct answer)
- Schedule IV
- Schedule V
Correct answer: Schedule III
Buprenorphine is classified as a Schedule III controlled substance, which allows prescriptions to be called in and refilled, unlike Schedule II drugs.
Question 3: When must a prescriber file a DEA Form 106?
- When ordering controlled substances from a DEA-registered supplier
- When reporting theft or significant loss of controlled substances (Correct answer)
- When transferring controlled substance records between practice locations
- When prescribing Schedule II controlled substances to a hospice patient
Correct answer: When reporting theft or significant loss of controlled substances
DEA Form 106 must be filed to report theft or significant loss of controlled substances to both the DEA and local law enforcement.
Question 4: A physician working in an OTP discovers that counseling records are being shared with the patient's employer without consent. Which regulation is most directly violated?
- HIPAA Privacy Rule only
- 42 CFR Part 2 only
- Both HIPAA and 42 CFR Part 2 (Correct answer)
- The Americans with Disabilities Act (ADA)
Correct answer: Both HIPAA and 42 CFR Part 2
Both HIPAA and 42 CFR Part 2 are violated because employer disclosure without consent breaches general health privacy law and the stricter SUD-specific confidentiality regulation.
Question 5: The CSAT (Center for Substance Abuse Treatment) accreditation of OTPs is performed by which type of organization?
- The DEA directly
- SAMHSA-approved accreditation bodies such as CARF or The Joint Commission (Correct answer)
- State health departments exclusively
- The American Society of Addiction Medicine (ASAM)
Correct answer: SAMHSA-approved accreditation bodies such as CARF or The Joint Commission
SAMHSA certifies OTPs and requires them to be accredited by a SAMHSA-approved accreditation body such as CARF, The Joint Commission, or COLA.
Question 6: Which of the following is a mandatory reporting requirement that typically applies to addiction medicine practitioners under state law?
- Reporting all patients who test positive for illicit substances to law enforcement
- Reporting suspected child abuse or neglect to child protective services (Correct answer)
- Reporting all opioid prescriptions to the DEA within 24 hours
- Reporting patients who miss appointments to their insurance carriers
Correct answer: Reporting suspected child abuse or neglect to child protective services
Mandatory reporting of suspected child abuse or neglect to child protective services is a universal state law requirement for healthcare practitioners, including addiction medicine physicians.
Question 7: Which provision of the Americans with Disabilities Act (ADA) most directly protects individuals in recovery from opioid use disorder who are taking buprenorphine?
- Title I (Employment), which prohibits discrimination against qualified individuals with disabilities (Correct answer)
- Title II (Public Services), which mandates accessible government facilities
- Title III (Public Accommodations), which covers physical accessibility standards
- Title IV (Telecommunications), which ensures relay services for the deaf
Correct answer: Title I (Employment), which prohibits discrimination against qualified individuals with disabilities
Title I of the ADA prohibits employment discrimination based on disability, and courts have recognized OUD as a disability protected under this title, including for individuals in MAT.
ADM Regulatory Compliance & Standards 3
Under federal OTP regulations (42 CFR Part 8), which of the following is required for a patient to receive take-home methadone doses in the first 90 days of treatment?