ASAM members who have a Drug Enforcement Administration (DEA) registration to prescribe buprenorphine/naloxone or buprenorphine setting may be inspected by the Drug Enforcement Agency (DEA). The DEA is authorized, per the Controlled Substances Act, to inspect any DATA-waivered physicians.
In order to better understand and facilitate the inspection process, ASAM has organized the following information. This inofrmation is not intended to replace or misrepresent any inofrmation provided by the DEA or in the regulaitons for DATA 2000 or the Controlled Substances Act.
HOW TO COMPLY WITH A DEA AUDIT/INSPECTION:
- Doctor has valid “X” waiver (current DEA registration) that denotes he/she is waivered to prescribe for 30 or 100 patients. You must be ASAM-, ABPN-, or AOAAM- certified or have taken an in-person or web-based course on prescribing buprenorphine to be waivered.
- Doctor adheres to patient prescribing limit, ie, if waivered for less than 1 year, may prescribe to 30 patients; if waivered for more than 1 year, may prescribe to 100 patients (if they have already notified CSAT of their intent to do so).
- Doctor maintains proper records of quantities prescribed and dispensed from office.
Dispensing is defined as: dispensing buprenorphine/naloxone and/or buprenorphine from a purchased stock bottle into a pill bottle that is properly labeled (DEA requires that label includes: date, patient name, name of medication, dose strength of medication, number of dispensed pills, refills, directions on how to take the medication, and expiration date of medication).
- Stock bottles of buprenorphine/naloxone 2mg and/or 8mg pills must be kept in a secure safe place, e.g, double locked medicine cabinet, safe or locker.
- Doctor maintains a chart (paper or electronic) on all patients receiving buprenorphine/naloxone and/or buprenorphine.
- Doctor has access to a network of behavioral health professionals.
- Doctor’s prescription pad has standard and “X” DEA registration number printed or written onto his/her prescription pad for each prescription of buprenorphine/naloxone and/or buprenorphine.
WHAT TO EXPECT WHEN THE DEA COMES TO YOUR OFFICE:
- 1 or more inspectors will identify themselves with a badge. DEA inspectors are required to present their badge to the physician.
- The inspector will ask the prescribing physician to sign a Notice of Inspection, before proceeding with the audit. The physician’s Statement of Rights is clearly printed on the Notice. Take the time to review your rights.
- The inspector may ask the physician to provide the following details:
- Current DEA registration denoting “X” waivered status
- Patient Prescription Log
- Patient Dispensing Log (if dispensing)
- Safe and secure area where buprenorphine/naloxone and/or buprenorphine stock bottle(s) are stored
- List of patients receiving buprenorphine/naloxone and/or buprenorphine (list may identify patients by codes or numbers so as to protect patient privacy, see sample chart at ASAM website)
- Physician’s access to behavioral health professionals.
HOW TO PREPARE FOR DEA AUDIT/INSPECTION
- Make sure you are in compliance with all of the above inspection elements and that all required documentation is readily accessible.
- Notify your staff that the DEA is authorized to audit all waivered physicians, including this office. All DEA inspectors are trained to conduct these particular audits. Physicians and their staff should expect the audit to be congenial and efficient.
- Staff is allowed to oversee the inspection. Identify and train one or two staff people on what to expect from the inspection and how to prepare for one.
- Allocate a space in your office where the inspector and you/staff may continue the audit in private.
- Be professional. Be cooperative. Know your rights.
Information on how to acquire a buprenorphine prescribing waiver, DEA Requirements for DATA-Waived Physicians, and what is covered in the Drug Addiction and Treatment Act of 2000 can also be found at:
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