Frequently Asked Questions About Buprenorphine Drug Addiction Act of 2000 (DATA 2000)
If you believe you can, you probably can.
If you believe you can't, you most assuredly won't.
Belief is the ignition that gets you off the launching pad.-Anonymous
1.How do I find a doctor who prescribes buprenorphine for the treatment of opioid addiction?
Doctors in each State who have waivers to prescribe buprenorphine for the treatment of opioid addiction are listed on the SAMHSA Buprenorphine Physician Locator Web site.
Announcing SAMHSA Buprenorphine Locator:
2. Can buprenorphine be used to treat addiction to prescription pain relievers, such as oxycodone or codeine?
Prescription pain relievers like oxycodone and codeine are opioids. Buprenorphine is used to treat addiction to opioids. Buprenorphine prevents withdrawal symptoms so that a person can stop taking the opioid drug to which he or she is addicted. A doctor who is qualified in the use of buprenorphine can determine if it is a good choice for a patient who is addicted to opioid pain relievers.
3. Can Buprenex®, or any other medications besides Subutex® and Suboxone®, be prescribed/dispensed for opioid addiction treatment in practice settings other than Opioid Treatment Programs (OTPs) (i.e., methadone clinics)?
No. At the present time Subutex® and Suboxone® are the only Schedule III, IV, or V substances to have received Food and Drug Administration approval for opioid addiction treatment. Thus, they are the only opioid medications that may be prescribed or dispensed for this indication outside the OTP setting. The approval of Subutex® and Suboxone® does not affect the status of any other medications. Buprenex® is not approved for treatment of opioid addiction. The status of methadone is also unchanged. Methadone, still can be only dispensed, not prescribed, for opioid addiction, and only at Federally regulated OTPs.
4. I submitted my waiver notification to SAMHSA a few weeks ago and received an acknowledgment letter, but I haven’t heard anything since. How can I check on the status of my waiver?
If you have submitted a notification and received an acknowledgment letter (or e-mail) from us, then your notification is under active review. It is SAMHSA’s intent to complete the review of notifications within 45 days of receipt. When processing of your notification is complete, we will mail you a letter confirming your waiver and containing your prescribing identification number. If you have submitted a notification and received an acknowledgment from us, and it has been more than 2 months since you submitted your notification, OR if you submitted a notification and you did not receive an acknowledgment from us that it had been received, please call 1-866-BUP-CSAT (1-866-287-2728) or e-mail firstname.lastname@example.org. Please be prepared to provide the date when you submitted your original notification and other identifying information.
5. I am a waived physician and would like to add, change, or remove my listing on the SAMHSA Buprenorphine Physician Locator Web site. How do I do this?
Waived physicians may call 1-866-BUP-CSAT (1-866-287-2728) or e-mail email@example.com with requests to change Locator listings.
6. I am a waived physician, and I've moved my practice location since receiving my waiver. Do I need to notify SAMHSA or DEA of my new practice address?
Waived physicians who change the primary practice address at which they intend to treat opioid addiction under the authority of their DATA 2000 waiver must notify SAMHSA by calling 1-866-BUP-CSAT (1-866-287-2728) or via e-mail at firstname.lastname@example.org. The Drug Enforcement Administration must also be notified. Call the DEA Office of Diversion Control at 1-800-882-9539. Phone numbers for local DEA offices can be found on the DEA Web site at http://www.dea.gov.
7. With a DATA 2000 waiver, can I prescribe Subutex® or Suboxone® for opioid addiction in more than one practice location? Can I dispense Subutex® or Suboxone® from more than one location?
Physicians with DATA 2000 waivers may prescribe Subutex® or Suboxone® for opioid addiction in any appropriate practice setting in which they are otherwise credentialed to practice (e.g., office, hospital). However, they may store and dispense Subutex® or Suboxone® (or any other controlled substances) only at the practice address(es) that they have registered with the DEA. Only one DATA-waiver unique identification number will be issued for each DATA-waived physician, no matter how many practice locations or DEA registrations a physician may have.
8. I've heard this new model for the treatment of opioid addiction referred to as "office-based opioid therapy." Does that mean that physicians with DATA 2000 waivers can use Subutex® and Suboxone® to treat opioid addiction only in the office-based setting?
No. Treatment of opioid addiction under the authority of a DATA 2000 waiver is not confined to the office-based setting. Physicians with DATA 2000 waivers may treat opioid addiction with Subutex® and Suboxone® in any practice settings in which they are otherwise credentialed to practice and in which such treatment would be medically appropriate (e.g., office, community hospital, health department).
9. Are there specific Federal record keeping requirements for office-based opioid therapy?
DEA record keeping requirements for office-based opioid therapy go beyond the Schedule III record keeping requirements. According to DEA:
Practitioners must keep records (including an inventory that accounts for amounts received and amounts dispensed) for all controlled substances dispensed, including Subutex and Suboxone (21 PART 1304.03[b]).In some cases, patients return to the prescribing physician with their filled Subutex or Suboxone prescriptions so that the practitioner can monitor the induction process. While it is acceptable for the patient to return to the practitioner with their filled prescription supplies, practitioners shall not store and dispense controlled substances that are the result of filled patient prescriptions.
Practitioners must keep records for controlled substances prescribed and dispensed to patients for maintenance or detoxification treatment (21 CFR Section 1304.03[c]). Many practitioners comply with this requirement by creating a log that identifies the patient (an ID number may be used instead of name), the name of the drug prescribed or dispensed, as well as the strength and quantity and date of issuance or dispensing. Some physicians comply with this requirement by keeping a copy of the prescription in the patient record.
Alternatively, DEA suggests that practitioners could keep separate records for controlled substances prescribed and dispensed for maintenance or detoxification treatment to facilitate the record reviews during physician inspections for DATA compliance. This way, DEA will only review those records related to controlled substances prescribed and dispensed for maintenance or detoxification treatment for physicians maintaining separate records.
10. Does DATA 2000 limit the number of patients who may be treated for opioid addiction at any one time by a physician group practice?
The physician group practice limit was eliminated by Public Law 109-56, which became effective August 2, 2005.
11. Is there a limit on the number of patients a practitioner may treat with buprenorphine at any one time?
Yes. DATA 2000, as amended in December 2006, specifies that an individual physician may have a maximum of 30 patients on opioid therapy at any one time for the first year.
One year after the date on which a physician submitted the initial notification, the physician may submit a second notification of the need and intent to treat up to 100 patients.
12. Can an Opioid Treatment Program (i.e., methadone clinic or OTP) dispense Subutex® and Suboxone® to patients admitted to the program? If so, is there a limit on the number of patients who can be treated with Subutex® and Suboxone® for opioid addiction treatment in an OTP? Is a DATA 2000 waiver required?
New SAMHSA regulations permit OTPs serving persons addicted to prescription opioids or heroin to offer buprenorphine treatment along with methadone. These regulations enable OTPs that are certified by SAMHSA to use Subutex® and Suboxone® for opioid maintenance or detoxification treatment. Follow this link to read the text of the Federal regulation (PDF, 43 kb). http://buprenorphine.samhsa.gov/InterimFinalRule-05-22-2003.pdf
The provision of opioid addiction treatment with Subutex® and Suboxone® in OTPs certified by SAMHSA/CSAT does not require a DATA 2000 waiver. Additionally, such treatment is not subject to the patient limits that apply to individual physicians 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 practice in OTPs, does require a DATA 2000 waiver and is subject to the patient limits for individual physicians.
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 will need to review their State licensing laws and regulations and to modify their registration with the DEA to add Schedule III narcotics to their registration certificates. Opioid treatment programs 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. The completed letter can be either faxed to Ms. Ghana Giles at 202-353-1125 or mailed to Ms. Giles at: DEA, Registration Unit - OPRR, Washington, DC, 20537. In addition, OTPs can access the DEA registration Web site for more information.
Once the registration has been modified, OTPs can order Subutex® and Suboxone® directly from Reckitt Benckiser, the product manufacturer, by calling 1-877-782-6966.
13. Can the medical personnel in correctional facilities dispense (or administer) buprenorphine to incarcerated individuals?
Qualified physicians who have obtained a DATA 2000 waiver can dispense or prescribe Subutex® or Suboxone® for addiction treatment in any practice setting, including in correctional facilities. Currently, State laws and policies vary considerably regarding opioid-assisted (methadone) treatment within correctional facilities. It is assumed that this same variation will occur with the use of buprenorphine in this setting. The patient limits per waived physician as stated in the DATA 2000 legislation also apply to the prescribing or dispensing of this treatment in correctional facilities.
14. Can physicians and other authorized hospital staff administer buprenorphine to a patient who is addicted to opioids but who is admitted to a hospital for a condition other than opioid addiction?
Neither the Controlled Substances Act (as amended by the Drug Addiction Treatment Act of 2000) nor DEA implementing regulations (21 CFR 1306.07(c)) impose any limitations on a physician or other authorized hospital staff to maintain or detoxify a person with an opioid treatment drug like buprenorphine as an incidental adjunct to medical or surgical conditions other than opioid addiction.
Thus, a patient with opioid addiction who is admitted to a hospital for a primary medical problem other than opioid addiction, e.g., myocardial infarction, may be administered opioid agonist medications (e.g., methadone, buprenorphine) to prevent opioid withdrawal that would complicate the primary medical problem. A DATA 2000 waiver is not required for practitioners in order to administer or dispense buprenorphine (or methadone) in this circumstance. It is good practice for the admitting physician to consult with the patient's addiction treatment provider, when possible, to obtain treatment history.
15. Can Physician Assistants or Nurse Practitioners prescribe buprenorphine for opioid addiction treatment in States that permit them to prescribe Schedule III, IV, or V medications?
No. Under DATA 2000, waivers to permit the prescription of Schedule III, IV, or V medications for opioid addiction treatment are available only to "qualifying physicians." The term "qualifying physician" is specifically defined in DATA 2000 as a “physician who is licensed under State law," has DEA registration to dispense controlled substances, has the capacity to refer patients for counseling and ancillary services, will treat no more than 30 such patients at any one time, and is qualified by certification, training, and/or experience to treat opioid addiction.
16. May physicians in residency training programs obtain DATA waivers?
The DATA legislation does not specify that a physician in a residency training program who otherwise meets the qualifications for a DATA waiver is ineligible to apply for and obtain a waiver. Therefore, SAMHSA has granted DATA waivers to physicians in residency training who have unrestricted licenses and the appropriate DEA registration. Individual States may have laws with more restrictive rules regarding who may prescribe or dispense Schedule III narcotic drugs for detoxification or maintenance treatment.
17. Where can I get a copy of the Buprenorphine Clinical Practice Guidelines?
Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, Treatment Improvement Protocol (TIP) 40, is available via SAMHSA's National Clearinghouse for Alcohol and Drug Information (NCADI), or by calling 1-800-729-6686. It will also be available in the near future from the National Library of Medicine (NLM), or by calling 1-888-346-3656.
18. Are Subutex® and Suboxone® available in pharmacies?
Subutex® and Suboxone® are available in pharmacies throughout the United States. Pharmacies and physicians can obtain the medications by contacting a pharmaceutical wholesaler directly, or by contacting the drug manufacturer, Reckitt Benckiser, at 1-877-782-6966. Consumers may also call the same toll-free number for additional information.
19. Do pharmacies need waivers to dispense buprenorphine?
No. Physicians are required to obtain DATA 2000 waivers to prescribe and dispense buprenorphine (Subutex® and Suboxone®) for opioid addiction, but pharmacists and pharmacies are not required to have any special credentials for dispensing these medications above and beyond those for other Schedule III medications. Certain Federal laws and regulations, however, do affect pharmacy practice with regard to opioid addiction treatment prescriptions.
20. How can a pharmacist verify if a physician has a waiver to prescribe buprenorphine (Subutex® or Suboxone®) for the treatment of opioid addiction?
Effective July 25, 2005, physicians must include their DATA 2000 waiver ID number on prescriptions for opioid addiction treatment medications. The practitioner's DEA registration number and the unique identification number (DATA 2000 waiver ID number or "X" number) must be on the prescription 21 CFR 1306.05(a). The identification number is not in lieu of the DEA registration number, it is an addition. If the prescription is telephoned to the pharmacy, the pharmacist must have both of these numbers on the prescription record so the physician can provide the numbers or the pharmacist may have them on file.
The SAMHSA Buprenorphine Physician Locator Web site lists the physicians in each State who have DATA 2000 waivers. A physician listed on the site can be considered to have a valid DATA 2000 waiver. Note, however, that the site does not list every physician with a valid waiver, only those who have agreed to be listed on the site. Physicians with valid waivers may choose not to be listed on the site.
A pharmacist desiring to verify that a physician who is not listed on the site has a valid DATA 2000 waiver can contact SAMHSA by phone at 240-276-2716 or by e-mail at Nicholas.Reuter@samhsa.hhs.gov.
Pharmacists should convey their DEA registration number with these requests.
21. Can Subutex® or Suboxone® be prescribed for conditions other than opioid addiction, e.g., pain control?
Subutex® and Suboxone® have received FDA approval only for the treatment of opioid addiction. However, once approved, a drug product may be prescribed by a licensed physician for any use that, based on the physician’s professional opinion, is deemed to be appropriate. Neither the FDA nor the Federal government regulates the practice of medicine. Any approved product may be used by a licensed practitioner for uses other than those stated in the product label. Off-label use is not illegal, but it means that the data to support that use has not been independently reviewed by the FDA. Information on FDA policy regarding off-label use of pharmaceuticals is available on the FDA Web site, http://www.fda.gov/cder/cancer/tour.htm or
Physicians and other practitioners who are authorized to prescribe Schedule III controlled narcotic medications under Federal and State laws are eligible and the unique identifier under the Drug Addiction Treatment Act is not required.
22. Can buprenorphine be used to treat cocaine addiction?
Cocaine is not an opioid drug. According to the approved product labeling, Suboxone® and Subutex® are indicated for the treatment of opioid addiction. In addition, under DATA 2000, codified at 21 U.S.C. 823(g), is limited to physicians who meet certain qualifying requirements, and have notified the Secretary of Health prescription use of Suboxone® and Subutex® in the treatment of opioid addiction and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid addiction.
The final cost to consumers of prescribed outpatient medication such as buprenorphine is determined by several parties: the pharmaceutical manufacturer, the insurer, the health plan (if any) or prescribing clinic, and finally, by the retail pharmacies that typically dispense the medication. It is important to note that the cost of buprenorphine itself is only one part of the cost of outpatient opioid treatment, which also includes the cost of each physician visit, any charges for laboratory analyses or emergency detoxification or stabilization, and any necessary ongoing service referrals and visits that are determined by the physician who prescribes the medication.
25. Will Medicare and Medicaid cover substance abuse treatment and buprenorphine?
Medicare – Substance abuse treatment may be covered under Medicare if it is determined to be medically necessary and it is provided in an inpatient or outpatient treatment center that is Medicare-certified according to the HHS. Medicare does not generally cover prescription drugs that are prescribed or dispensed to individuals on an outpatient basis. If buprenorphine is administered by a Medicare-certified facility as a component of inpatient or emergency treatment such as detoxification or early stage stabilization treatment, rather than being a separate outpatient prescription, the medication’s cost could be covered during that episode of care, just as the cost for any other medication used in the treatment process is covered when administered within a certified program/facility. However, this reimbursement would only occur if the Medicare-certified facility had buprenorphine on its list of eligible drugs and if the patient received the treatment at the facility.
There is currently no Medicare fee-for-service coverage for buprenorphine prescribed by a physician during an outpatient office visit, whether for outpatient detoxification, early stabilization, or maintenance. However, if a person is covered by a Medicare HMO that has a substance abuse and a pharmacy benefit, buprenorphine could be covered if it is on that particular plan’s formulary and is determined to be medically necessary under the plan’s coverage policies.
23. Can a person currently being treated with methadone switch to buprenorphine without suffering withdrawal symptoms?
Patients can switch from methadone to buprenorphine treatment, but because the two drugs are very different, patients are not always satisfied with the results. A number of factors affect whether buprenorphine is a good choice for someone who is currently receiving methadone. It is also possible for patients receiving buprenorphine to be switched to methadone. Patients interested in finding out more about the possibility of switching treatment should discuss this with the doctor who is prescribing their medication.
24. How much will a dose of buprenorphine cost a consumer?
Additionally, some Medicare beneficiaries have Medicare supplementary or Medi-gap insurance that covers some pharmaceutical benefits. Again, however, even under a supplementary plan, there may or may not be benefits for substance abuse treatment or for buprenorphine if it is not on the supplementary insurer’s formulary. Medicare HMO members should read their coverage bulletins or call their plans to determine whether they have coverage for buprenorphine and for substance abuse treatment. Many HMOs do not cover outpatient substance abuse treatment except on an emergency basis required by law.
Medicaid – Medicaid coverage of substance abuse treatment and medication such as buprenorphine varies considerably by State and by whether or not the State’s Medicaid plan is offered under managed care/HMO arrangements. Coverage of buprenorphine and/or substance abuse treatment connected with buprenorphine under Medicaid benefits will not only be a State-by-State decision, but will also be subject in most States to rules about prior authorization and medical necessity. In addition, in many States, Medicaid programs operate with a preferred drug list on which buprenorphine must be placed before it can be reimbursed. State Medicaid programs administered by HMOs may have an additional level of formulary and treatment authorization that affects whether or not buprenorphine, and treatment connected to it, is covered.
26. Will buprenorphine be available in treatment programs for indigent patients and patients who don't have Medicaid or Medicare?
Community health centers, clinics, and hospitals offering free care to indigent individuals may or may not make buprenorphine available. Availability will depend on whether or not that health center or hospital offers substance abuse treatment or emergency care of addictions and whether or not buprenorphine is available on its formulary, as well as whether there is a staff/attending physician associated with the hospital who is qualified to administer the drug and whether the medication is determined to be medically necessary.
Individuals not eligible for Medicaid or Medicare who are not indigent fall into two categories: those who have commercial insurance coverage and those who do not. If an individual has insurance coverage outside of Medicare and Medicaid, the individual’s insurance plan may or may not cover all or part of buprenorphine medication, depending on medical necessity, whether or not pharmaceuticals are covered, whether or not there is a required co-payment, and whether or not buprenorphine is on the plan’s approved drug list. Individuals who are not insured but who are neither indigent nor eligible for Medicaid or Medicare will have to pay themselves for buprenorphine and any treatment associated with it.
27. Where can I find out more information about buprenorphine treatment for opioid addiction?
In addition to this Web site, you can visit the FDA’s buprenorphine pages at http://www.fda.gov/cder/drug/infopage/subutex_suboxone/default.htm
and the manufacturer’s Web site at http://www.suboxone.com
Additionally, you can contact the SAMHSA Buprenorphine Information Center by telephone, toll-free at 1-866-BUP-CSAT (1-866-287-2728), or by e-mail at email@example.com.
28. As a physician employed by the Federal Government (Veterans Administration, Indian Health Service, Federal Department of Corrections, etc.) practicing in a Federal Government installation, am I eligible for a DATA 2000 waiver?
Yes. Physicians employed by an agency of the Federal Government are eligible for DATA 2000 waivers. In order to be eligible for a waiver under DATA 2000, a physician must have a valid, individually assigned DEA registration number (in addition to a license to practice medicine and the credentialing/training discussed elsewhere). A physician who is directly employed by the Federal Government may obtain a DEA number, free of charge, without being licensed in the state where the Federal facility is located (the physician must have a valid state license in one of the 50 states, the District of Columbia, Virgin Islands or Puerto Rico).
In order to receive a DEA number under this program, each physician must complete a DEA registration application that includes the physician's official business address and the name and phone number of the certifying official who can verify the physicians' eligibility for this program. This DEA registration number may only be used for practice within the Federal Government installation and may not be used for practice outside this setting.
29. Can physicians begin immediately treating patients if they have checked “Immediate” on the waiver notification form?
A place to check “Immediate” is included on the form to address a provision in the Drug Addiction Treatment Act to permit treatment while a notification is under review. Checking “Immediate” is only one of three requirements that a physician must meet in order to start a patient on treatment, and treatment is limited to ONE patient per form submitted. (Each form must have a different submission date.)The three requirements are that, first, the physician must “in good faith” meet the criteria for obtaining a waiver (i.e., valid medical license, valid DEA registration, credentialing, or 8 hours of qualifying training). Second, the physician must check “Immediate” on the waiver. Third, the physician must contact the Buprenorphine Information Center at 1-866-BUP-CSAT to verify that the notification form has been received and to notify CSAT of his/her intent to begin treating ONE patient.
Since the physician will not have the unique identifying number, pharmacists may question prescriptions received under this provision. Pharmacists may contact the Buprenorphine Information Center if additional information is needed.
30. Are there exceptions when Subutex and Suboxone may be administered by a practitioner without the DATA 2000 waiver?
Under the Narcotic Addiction Treatment Act of 1974, all practitioners who use narcotic drugs for treating opiate addiction must obtain a separate registration under 21 U.S.C. Section 823(g)(1) or a DATA 2000 Waiver under 21 U.S.C. Section 823(g)(2). However, according to the Drug Enforcement Administration (DEA), an exception to the registration requirement, known as the "three-day rule" (Title 21, Code of Federal Regulations, Part 1306.07(b)), allows a practitioner who is not separately registered as a narcotic treatment program or certified as a “waivered DATA 2000 physician,” to administer (but not prescribe) narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient’s referral fortreatment, under the following conditions: 1) not more than one day’s medication may be administered or given to a patient at one time; 2) this treatment may not be carried out for more than 72 hours; and 3) this 72-hour period cannot be renewed or extended.
The intent of 21 CFR 1306.07(b) is to provide practitioner flexibility in emergency situations where he or she may be confronted with a patient undergoing withdrawal. In such emergencies, it is impractical to require practitioners to obtain a separate registration. The 72-hour exception offers an opioid dependent individual relief from experiencing acute withdrawal symptoms, while the physician arranges placement in a maintenance/detoxification treatment program. This provision was established to augment, not to circumvent, the separate registration requirement. The three-day (72-hour) emergency exception cannot be renewed or extended. Because this is a Drug Enforcement Administration (DEA) rule, for further details consult DEA. This information may be found at http://www.deadiversion.usdoj.gov/drugreg/faq.htm
Written and Compiled: Deborah Shrira Dated: 17 October 2007