Confidentiality And Privacy
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Confidentiality and Privacy
Prior to initiating office-based opioid addiction treatment, practice policies and procedures should be established that will guarantee the privacy and confidentiality of addiction treatment patients. Providers must comply with all applicable laws and regulations regarding the privacy and confidentiality of medical records in general, and of information pertaining to addiction treatment services in particular.
The privacy and confidentiality of individually identifiable information relating to patients receiving drug or alcohol treatment is protected by SAMHSA confidentiality regulation Title 42, Part 2 of the Code of Federal Regulations (42 C.F.R. Part 2). This regulation mandates that addiction treatment information in the possession of substance abuse treatment providers be handled with a greater degree of confidentiality than general medical information.
Occasionally, physicians will need to communicate with pharmacists and other healthcare providers about the addiction treatment of a particular patient (e.g., to verify a Suboxone® or Subutex® prescription). Regulation 42 C.F.R. Part 2 requires physicians providing opioid addiction treatment to obtain signed patient consent before disclosing individually identifiable addiction treatment information to any third party. It is recommended that physicians have each new buprenorphine patient sign a copy of this form to prevent confidentiality problems at pharmacies when patients present with buprenorphine prescriptions.
It is particularly important to obtain patient consent when telephoning or faxing prescriptions to pharmacies, as this information constitutes disclosure of the patient's addiction treatment. When physicians directly transmit prescriptions to pharmacies, further redisclosure of patient-identifying information by the pharmacy is prohibited, unless signed patient consent is obtained by the pharmacy. Regulation 42 C.F.R. Part 2 does not apply to pharmacies, however, when the patient delivers a buprenorphine prescription without telephone confirmation or other direct communication from a physician to the pharmacist.
The Health Insurance Portability and Accountability Act (HIPAA) of 1996, Public Law 104-191 (see http://www.hhs.gov/ocr/privacy/) which amends the Internal Revenue Service Code of 1986, mandates standardization of exchange formats for patient health, administrative, and financial data; requires development of unique identifiers for individuals, employers, health plans, and healthcare providers; and establishes security standards for protecting the confidentiality and integrity of individually identifiable health information.
SAMHSA has prepared a document titled Comparison Between the Confidentiality of Alcohol and Substance Abuse Patient Records (42 C.F.R. Part 2) and the Health Insurance Portability and Accountability Act 1996. This document and a number of other HIPAA technical assistance tools are available on the SAMHSA HIPAA Web pages at http://www.samhsa.gov/healthprivacy/
See also the SAMHSA Treatment Assistance Publication (TAP) 13 Confidentiality of Patient Records for Alcohol and Other Drug Treatment (Lopez 1994), available on the SAMHSA Treatment Improvement Exchange Web site at http://kap.samhsa.gov/products/manuals/taps/13.htm
Additionally, the Subutex® and Suboxone® package labels also contains information on Federal confidentiality rules and regulations. Physicians should also consult with their State medical authorities concerning privacy and confidentiality rules in their locales. Figure 6-2 lists some of the privacy and confidentiality issues that can arise in the course of addiction treatment.
Figure 6-2. Privacy and Confidentiality Issues in Addiction Treatment
* Information covered by the doctor/patient privilege
* Circumstances in which confidential information is protected
* Exceptions to State laws protecting medical information
* Duty to report
* Communications with third parties (e.g., families, employers,
allied health care providers, third party payers, law- enforce-
ment officers, responses to subpoenas)
Buprenorphine Use in Opiate Treatment Programs
On May 22, 2003, SAMHSA announced an interim final rule permitting OTPs serving individuals addicted to opioids to offer buprenorphine treatment along with methadone and levo-alpha-acetyl-methadol (LAAM). The rule enables OTPs that are certified by SAMHSA to provide Subutex® and Suboxone® for opioid maintenance or detoxification treatment.
The provision of opioid addiction treatment with Subutex® and Suboxone® in SAMHSA-certified OTPs does not require a DATA 2000 waiver. Additionally, such treatment is not subject to the 30-patient limit that applies to individual physicians and group practices providing opioid addiction treatment outside the OTP system under the authority of a DATA 2000 waiver. The provision of opioid addiction treatment with Subutex® or Suboxone® in treatment settings other than OTPs, even by physicians who are licensed to work in OTPs, does require a DATA 2000 waiver and is subject to the 100-patient limit for individual physicians and group practices.
OTPs providing Subutex® and Suboxone® for opioid maintenance or detoxification treatment must conform to the Federal opioid treatment standards set forth under 42 C.F.R. § 8.12. These regulations require that OTPs provide medical, counseling, drug abuse testing, and other services to patients admitted to treatment. To offer Subutex® and Suboxone®, OTPs need to modify their registration with the DEA to add Schedule III narcotics to their registration certificates. OTPs can initiate this streamlined process by fax or letter. The letter should include the OTP's DEA registration number and request that the registration be amended to list Schedule III narcotic drugs. The letter must be signed by the program sponsor (program director) or medical director.
Further information about this process can be found on the Drug Enforcement Agency Drug Registration Website at: www.deadiversion.usdoj.gov
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References: (1) Clinical Guidelines For The Use Of Buprenorphine In The Treatment of Opioid Addiction TIP 40 Chapter 6 pp.83-85
Compiled and Written: Deborah Shrira August 2007
Assistant Editor: Dee Black Updated: February 2012