ADM Regulatory Compliance & Standards 2 — Questions and Answers
Question 1: Under the Ryan Haight Online Pharmacy Consumer Protection Act, how many in-person medical evaluations must a prescriber conduct before prescribing controlled substances via telemedicine?
- None if the state permits telehealth prescribing
- At least one in-person evaluation (Correct answer)
- At least two in-person evaluations
- At least three in-person evaluations
Correct answer: At least one in-person evaluation
The Ryan Haight Act requires at least one in-person medical evaluation before a practitioner may prescribe controlled substances via the internet.
Question 2: Which federal agency oversees the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver program for office-based buprenorphine treatment?
- Drug Enforcement Administration (DEA)
- Centers for Medicare & Medicaid Services (CMS)
- Substance Abuse and Mental Health Services Administration (SAMHSA) (Correct answer)
- Food and Drug Administration (FDA)
Correct answer: Substance Abuse and Mental Health Services Administration (SAMHSA)
SAMHSA oversees the DATA 2000 waiver (now largely eliminated by the SUPPORT Act) that allowed qualifying practitioners to prescribe buprenorphine for OUD in office-based settings.
Question 3: The SUPPORT for Patients and Communities Act of 2018 made which major change to buprenorphine prescribing?
- Eliminated the X-waiver patient cap for all practitioners immediately
- Extended the X-waiver requirement to nurse practitioners
- Allowed nurse practitioners and physician assistants to prescribe buprenorphine for OUD (Correct answer)
- Required all buprenorphine prescribers to register with SAMHSA annually
Correct answer: Allowed nurse practitioners and physician assistants to prescribe buprenorphine for OUD
The SUPPORT Act permanently authorized nurse practitioners and physician assistants to obtain DATA waivers and prescribe buprenorphine for OUD treatment.
Question 4: A patient on methadone maintenance at an OTP misses three consecutive days of dosing. According to federal regulations, what must the OTP do before reinstating the patient?
- Automatically discharge the patient from the program
- Resume dosing at the full maintenance dose
- Reassess the patient clinically before restarting, potentially at a lower dose (Correct answer)
- Obtain DEA approval before resuming treatment
Correct answer: Reassess the patient clinically before restarting, potentially at a lower dose
Federal OTP regulations require clinical reassessment after significant medication gaps to determine a safe reinduction dose and minimize overdose risk.
Question 5: Under 42 CFR Part 2, which of the following is NOT a circumstance that permits disclosure of substance use disorder treatment records without patient consent?
- Medical emergencies threatening life
- Audit or evaluation activities by oversight entities
- A subpoena issued by the prosecutor in a criminal investigation (Correct answer)
- Research activities meeting specific regulatory criteria
Correct answer: A subpoena issued by the prosecutor in a criminal investigation
A standard prosecutor's subpoena alone does not authorize disclosure under 42 CFR Part 2; a court order meeting specific criteria is required for most non-emergency disclosures.
Question 6: Which of the following best describes the Consolidated Appropriations Act of 2023 changes to buprenorphine prescribing?
- Reinstated the X-waiver requirement with a 30-patient cap
- Eliminated the X-waiver requirement entirely, allowing any DEA-registered practitioner to prescribe buprenorphine for OUD (Correct answer)
- Limited buprenorphine prescribing to addiction medicine specialists only
- Required pharmacies to report buprenorphine dispensing to SAMHSA monthly
Correct answer: Eliminated the X-waiver requirement entirely, allowing any DEA-registered practitioner to prescribe buprenorphine for OUD
The Consolidated Appropriations Act of 2023 eliminated the X-waiver requirement, allowing any DEA-registered practitioner with Schedule III authority to prescribe buprenorphine for OUD.
Question 7: Which ASAM level of care corresponds to a medically managed intensive inpatient program (Level 4)?
- Outpatient services with monitoring visits every 2 weeks
- Residential services in a non-hospital setting with 24-hour support
- Medically monitored intensive inpatient treatment in a freestanding facility
- A hospital-based inpatient program with 24-hour physician management (Correct answer)
Correct answer: A hospital-based inpatient program with 24-hour physician management
ASAM Level 4 (Medically Managed Intensive Inpatient) requires 24-hour physician-managed care, typically provided in a hospital or hospital-equivalent setting.
ADM Regulatory Compliance & Standards 2
Under the Ryan Haight Online Pharmacy Consumer Protection Act, how many in-person medical evaluations must a prescriber conduct before prescribing controlled substances via telemedicine?