Licensed physicians who have had a waiver to treat 100 patients for at least 1 year can become eligible for the patient limit of 275 in one of two ways:
1) By holding additional credentialing (defined below)
2) By practicing in a qualified practice setting (defined below). Additionally, practitioners must not have had their Medicare enrollment and billing privileges revoked and must not have been found to be in violation of the Controlled Substances Act (CSA).
What additional credentialing is required for a practitioner using this pathway to become eligible for the patient limit increase?
Practitioners who are using the “additional credentialing” pathway must hold board certification in addiction medicine or addiction psychiatry by the American Board of Addiction Medicine or the American Board of Medical Specialties, or certification by the American Board of Addiction Medicine or the American Society of Addiction Medicine.*
What constitutes a qualified practice setting?
Practitioners who are using the “qualified practice setting” pathway must practice in a setting that does the following:
1) Provides professional coverage for patient medical emergencies during hours when the practice is closed.
2) Provides access to case management services for patients, including referral and follow-up services for programs that provide or financially support medical, behavioral, social, housing, employment, educational, or other related services.
3) Uses health information technology if it is already required in the practice setting.
4) Is registered for their state prescription drug monitoring program where operational and in accordance with federal and state law.
5) Accepts third-party payment for some services, though not necessarily for buprenorphine-related services and not necessarily all third-party payers.
What is the process to request a patient limit of 275?
Eligible practitioners who want to increase their patient limit to 275 must submit a completed Request for Patient Limit Increase form and a statement certifying that they do the following eight things:
1) Adhere to nationally recognized evidence-based guidelines for treating patients with opioid use disorder (defined below). * The language of the final rule also references “certification” by the “American Osteopathic Academy of Addiction Medicine” (often simply referred to as AOAAM) as part of the definition of “additional credentialing.” The department is currently taking steps to clarify this reference. 1
2) Provide patients with necessary behavioral health services (defined below) either directly or through a formal agreement with another entity.
3) Provide appropriate releases of information in accordance with federal and state laws and regulations to permit coordination of care with behavioral health, medical, and other practitioners.
4) Use patient data to inform improvement of outcomes.
5) Adhere to a diversion control plan to reduce the possibility of diversion of buprenorphine (described below).
6) Have considered how to ensure continuous access in the event of an emergency situation (defined below).
7) Notify all patients above the 100-patient limit that they will no longer be able to provide Medication-Assisted Treatment (MAT) services using buprenorphine in the event that their request for the higher patient limit is not renewed or the renewal request is denied, and will also make every effort to transfer patients to other treatment providers.
8) Practitioners must also provide any additional documentation to demonstrate compliance as requested by the Substance Abuse Mental Health Services Administration (SAMHSA).
What are nationally recognized evidence-based guidelines?
Nationally recognized evidence-based guidelines are documents produced by a national or international medical professional association, public health entity, or governmental body with the aim of ensuring the appropriate use of evidence to guide individual diagnostic and therapeutic clinical decisions. Some examples are the American Society of Addiction Medicine National Practice Guidelines for the Use of Medications in the Treatment of Addiction Involving Opioid Use; SAMHSA’s Treatment Improvement Protocol 40: Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction; the World Health Organization Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence; the Department of Veterans Affairs /Department of Defense/ Clinical Practice Guideline on Management of Substance Use Disorder; and the Federation of State Medical Boards’ Model Policy on the Drug Addiction Treatment Act of 2000 and Treatment of Opioid Addiction in the Medical Office.
What are behavioral health services?
Behavioral health services are any nonpharmacological interventions carried out in a therapeutic context at an individual, family, or group level. Interventions may include structured, professionally administered interventions (e.g., cognitive behavioral therapy or insight-oriented psychotherapy) delivered in person, interventions delivered remotely by telemedicine shown in clinical trials to facilitate MAT outcomes, or nonprofessional interventions such as 12-step meeting participation.
What is included in a diversion control plan?
A diversion control plan should contain specific measures to reduce the possibility of diversion of buprenorphine from legitimate treatment use and should assign specific responsibilities of the medical and administrative staff of the practice setting for carrying out these measures. The plan should address how the environment at the practice setting can prevent onsite diversion; how to 2 prevent diversion with regard to dosing and take-home medication; and how to prevent patients from receiving a prescription from more than one practitioner and later diverting some of the prescribed medication.
How is “emergency situation” defined?
An emergency situation is defined as any situation during which an existing substance use disorder system is overwhelmed or unable to meet the existing need for MAT as a direct consequence of a clear precipitating event. The precipitating event must have an abrupt onset, such as practitioner incapacity; a natural or human-caused disaster; or an outbreak associated with drug use. It must also result in significant death, injury, exposure to life-threatening circumstances, hardship, suffering, loss of property, or loss of community infrastructure.
How will a Request for Patient Limit Increase be processed?
Similar to the processing of waiver requests for other patient limits, within 45 days of receiving an initial or renewal Request for Patient Limit Increase, SAMHSA will approve or deny the request. If SAMHSA determines that the practitioner holds additional credentialing or practices in a qualified practice setting—and is able to meet the eight attestations described in “What is the process to request a patient limit of 275?”—the request will be approved. After it is approved, SAMHSA will notify the Drug Enforcement Administration of this approval. The request will be denied if the request is deficient in any respect or if the practitioner has knowingly submitted false statements or made misrepresentations of fact. If the request is denied, SAMHSA will notify the practitioner of the reason (or reasons) for denial. However, if the deficiencies are resolved in a manner and time approved by SAMHSA, the request will be approved.
How will a Request for Patient Limit Increase be processed?
Practitioners who are approved for the patient limit increase must maintain all eligibility requirements, including either holding additional credentialing or practicing in a qualified practice setting, and meeting the eight attestations described in “What is the process to request a patient limit of 275?” during the 3-year approval term. If practitioners fail to maintain these requirements, SAMHSA may revoke its approval.
What is the process for renewing a Request for Patient Limit Increase approval?
To renew the patient limit increase after the 3-year approval term, practitioners must submit a renewal request, which includes the same information that is required for an initial patient limit increase request. The renewal request must be submitted at least 90 days before the expiration of the previous approval term. If SAMHSA does not reach a final decision on the renewal request before the expiration of the previous approval term, the approval term will be extended until SAMHSA reaches a final decision.
What are the responsibilities of practitioners who do not submit a renewal Request for Patient Limit Increase, or whose renewal request is denied?
If practitioners do not submit a renewal request or if the renewal request is denied, they must notify all patients above the 100 limit that they will no longer be able to provide MAT services using buprenorphine. They must also make every effort to transfer patients to other MAT providers.
Can SAMHSA’s approval of a practitioner’s Request for Patient Limit Increase be suspended or revoked?
Yes. SAMHSA may suspend or revoke the approval of the patient limit increase if it is determined that any of the following events is in effect or has taken place:
1) Immediate action is necessary to protect public health or safety.
2) The practitioner made misrepresentations in his or her request for the patient limit increase.
3) The practitioner no longer satisfies the requirements of the patient limit increase.
4) The practitioner has been found to have violated the CSA.
Can a practitioner request to temporarily treat up to 275 patients in emergency situations?
Yes. Practitioners with a current waiver to prescribe up to 100 patients and who are not otherwise eligible to treat up to 275 patients under §8.610 may request a temporary increase for up to 6 months to address emergency situations, as defined in “How is ‘emergency situation’ defined?” To obtain the temporary increase, practitioners must provide documentation that
1) Describes the emergency situation in enough detail to allow a determination to be made.
2) Identifies a period, not longer than 6 months, in which the higher patient limit should apply, and provides a rationale for the time requested.
3) Describes a plan to meet public and individual health needs of patients once the temporary approval expires. To the extent possible, before approving the temporary request, SAMHSA will consult with appropriate governmental authorities to determine that the emergency situation justifies the immediate increase. If the temporary increase is approved, SAMHSA will notify the practitioner. If the practitioner wants to extend the temporary approval, he or she must submit a request at least 30 days before the expiration and certify that the emergency situation is still taking place. Again, to the extent possible, SAMHSA will consult with appropriate governmental authorities to determine that the emergency situation justifies continuation of the increase. Practitioners may be eligible for temporary patient limit increase in emergency situations even if they do not hold additional credentialing or practice in a qualified practice setting. They are also not required to meet the requirements outlined above for practitioners who request the patient limit increase in non-emergencies.
Do new formulations of buprenorphine count toward the 275-patient limit?
All patients receiving buprenorphine, including those receiving new formulations of the drug, will be counted toward the 275-patient limit.
Disclaimer:This Clinical Practice Guideline is intended for use only as a tool to assist a clinician/healthcare professional and should not be used to replace clinical judgment.
Sponsored by American Academy of Addiction Psychiatry
Adam Bisaga, M.D.
Professor of Psychiatry
Columbia University Medical Center, New York, NY
Video Description: This video briefly illustrates preparation and administration of the naltrexone injection. This video is designed to complement other educational materials available through the PCSS-MAT program and to be used in conjunction with the PCSS-MAT mentoring program. The video will help providers to gain familiarity with the medication administration procedure in order to minimize the incidence of failed procedures and the incidence of adverse injection site reactions.
This video is to be used only for illustrative purposes and not to be used as a replacement for the detailed instructions for the use of medication that is found in Vivitrol Prescribing Information. A more comprehensive video summarizing directions for use of Vivitrol can also be found on the manufacturer’s website.
We do not offer CME credit for this activity.
Additional Educational Activities:
Archived MAT CHAT: Q & A Discussion with Dr. Adam Bisaga (No CME)
Some questions discussed: How Does the Effectiveness of XR-naltrexone Compare to the Effectiveness of Other Treatments for opioid use disorder? Can Patients be Transitioned from Methadone Maintenance Onto Naltrexone?
ONDCP recently hosted a webinar on MAT and Primary Care Coordination. The webinar showcased two approaches to care in which Medication Assisted Treatment is provided and care for individuals with substance use disorders is integrated with regular medical care. Watch webinar.
There are two main ways of treating opioid addiction:
1) Detoxification followed by complete abstinence: After completing the detoxification and withdrawal process, a person may remain abstinent (going completely without) any kind of opioid drug. This treatment plan usually involves a long and difficult recovery process, with a high risk of relapse.
12-step groups such as Narcotics Anonymous (NA), which often encourage this abstinence-approach to recovery, can be helpful. This treatment plan does not involve the help of any type of opioid medication.
Medication-free recovery can be possible for a small number of stable patients with high motivation. The small number of patients who are able to recover without help from medication report relying on personal motivation, past treatment experiences, religion/spirituality, and support from family and close friends. 
However, as many as 90% of those detoxified from opioid use will relapse within first 1-2 months unless treated with medications.
2) Detoxification + Induction onto Agonist Maintenance: Medication Assisted Treatment (MAT)
MAT can help make opioid detoxification safer and more manageable. After detox, MAT involves continued treatment with one of three main types of medications: methadone, buprenorphine, or naloxone. MAT with these medications can help make the difficult process of recovery for opioid addiction less risky and more manageable. There is still a risk of relapse in this treatment plan, but it is less likely than among patients receiving no help from medication. When compared to recovery treatment without medication, MAT has been proven to:
- Increase treatment retention
- Reduce risk of relapse
- Improve social functioning
- Reduce the risks of infectious-disease transmission
- Reduce criminal activity
Any reduction in relapse risk can be life saving.
One of the most important benefits of MAT is that it can reduce the risk of relapse compared to abstinence without medication support. People dealing with physical dependence on opioids typically experience multiple relapses over the course of their treatment. During each period of abstinence, a person’s tolerance for opioids decreases. If a patient relapses after a period of time without the drug, and begins to take the same amount of drug that he or she used before detoxification, they are at a high risk of fatal overdose because the body is no longer used to such a large amount of opioids. By reducing a patient’s risk of relapse, MAT has been shown to reduce this risk of death from overdose during recovery.
|Summary of Medications for Opioid Addiction Treatment|
|Class||Full Agonist:Fully activates opioid receptors||Partial Agonist:Activates opioid receptors, but with a smaller effect||Antagonist:Blocks opioid receptors|
|Dosing||Taken once per day by mouth||Usually taken once per day, by mouth or under the tongue||Vivitrol is taken by injection about once per month; older formulations are taken orally once per|
|Effects||Reduces opioid cravings and withdrawal symptoms||Blocks the effects of opioids in the brain|
|High strength, very effective when taken by mouth.||More availability: Can be prescribed by certified physicians in a “regular” medical office- no need to visit special drug clinics.Suboxone has a smaller risk of abuse by including naloxone, which causes withdrawal if the drug is injected rather than taken by mouth as prescribed.||Not addictive or sedating. Does not result in physical dependence. Vivitrol can be taken once a month instead of daily.|
|Patients must visit special methadone clinics daily to receive doses.||Difficult to take daily medication- new form of Vivitrol, taken only once a month, addresses this issue. Beginning this drug is more difficult, and requires about 7 days of opioid abstinence before the first dose.|
|Adapted from “Characteristics of Medications for Opioid-Addiction Treatment” in Volkow, N. D., et al. (2014). “Medication-Assisted Therapies – Tackling the Opioid-Overdose Epidemic.” N Engl J Med.|
— Flynn, P. M., Joe, G. W., Broome, K. M., Simpson, D. D., & Brown, B. S. (2003). Recovery from opioid addiction in DATOS. J Subst Abuse Treat. Oct 25(3). 177-86. Weiss RD, Sharpe Potter JS, Fiellin DA, Byrne M, Connery HS, Dickinson W, et al. (2011.) Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid use disorder: A 2-phase randomized controlled trial. Archives of General Psychiatry 68(12), 1238-46. Volkow, N. D., et al. (2014). “Medication-Assisted Therapies – Tackling the Opioid-Overdose Epidemic.” N Engl J Med.
- Why a patient is seeking treatment
- What substance(s) a patient is using
- How often they use
- The good and bad effects of the substance in their life
- How their day-to-day life is affected by the substance
- If any other emotional symptoms are present (depression, anxiety, etc.)
- If there is a present crisis
- The patient’s past drug or alcohol use
- Any past treatments or periods of abstinence
- The patient’s past medical history, current medications, and family and social history
Labs such as urine toxicology may also be done to test for the presence of opioids in the patient’s body.
With these facts, a physician can help the patient to sort out the pros and cons of seeking treatment and stopping use of opioid drug(s). The patient and their doctor may then decide on a treatment that would work best for them, based on the patient’s needs, safety, and local resources. The patient’s finances, insurance, criminal justice status, past responses to treatments, and any co-occurring psychiatric disorders may also be considered.
Adolescents and Young Adults: CRAFFT Screening
When an adolescent or young adult visits his or her doctor, the CRAFFT questions can help evaluate the risk for substance abuse problems.These questions are used all over the world, and are very effective at evaluating a young person’s risk of problems with substance abuse.
The CRAFFT questions can also be used at home by a young person or the family to help evaluate risk or to decide if medical help is needed.
During the past year, did you:
- Drink any alcohol(more than a few sips)?
- Smoke any marijuana or hashish?
- Use anything elseto get high? (“Anything else” includes illegal drugs, over-the-counter or prescription medicines, or anything that you sniff or “huff.”)
If the answer is “yes” to any of the first 3 questions, the following questions are used:
(If the answer is “no” to all of the first 3 questions, only the first CAR question will apply.)
Yes/No C Have you ever ridden in a CAR driven by someone (including yourself) who was “high,” or had been using alcohol or other drugs?
Yes/No R Do you ever use alcohol or other drugs to RELAX, feel better about yourself, or fit in?
Yes/No A Do you ever use alcohol or other drugs while you are ALONE?
Yes/No F Do you ever FORGET things you did while using alcohol or drugs?
Yes/No F Do your FAMILY or FRIENDS ever tell you that you should cut down on drinking or drug use?
Yes/No T Have you ever gotten into TROUBLE while you were using alcohol or drugs?
What does my CRAFFT score mean?
2 or more “yes” answers to the CRAFFT questions suggest that a young person is at high risk for substance abuse problems and/ or dangerous behavior. A young person who can answer “yes” to 2 or more CRAFFT questions should seek medical help as soon as possible. If the young person is already at a doctor’s office, further questions should be asked to see if treatment is necessary. These questions cannot diagnose a substance abuse disorder, but can help patients and doctors decide if further steps should be taken.
Adults: CAGE Questions
The CAGE questions are often used to screen for alcohol abuse in adults. However, they can also help identify other substance abuse problems. These questions include:
C Have you ever felt you needed to CUT DOWN on substance use?
A Have people ANNOYED you by criticizing your substance use?
G Have you ever felt GUILTY about substance use?
E Have you ever felt that you needed a drug first thing in the morning (EYE-OPENER)?
Other “red flags” that primary care doctor look for to detect substance abuse problems in adults include:
- Frequent absences from school or work
- Frequent accidental injuries
- Sleep problems
- Sexual dysfunction
- Digestive problems, like stomach pain, diarrhea, constipation, or weight changes
Urine Drug Tests
There are many different ways to test for the presence of opioid drugs in the body. Urine, blood, hair, saliva, sweat, and nails (toenails and fingernails) can all be used in different types of laboratory drug testing. However, urine samples are used most often, because they are easier to obtain. Opioid drugs and their metabolites, or breakdown products, are often concentrated in the urine after making their way through the body.
A general “screening” test can test for the presence of opioid drugs or their metabolites (the substances into which some drugs are broken down in the body). More specific tests can also be done to test for the presence of specific drugs or to confirm the results of earlier tests.
What can doctors tell from a urine drug test?
A urine sample can be tested for the presence of many different substances in the body, from opioid drugs to marijuana, cocaine, PCP, amphetamines, and/or benzodiazepines. Drugs can usually be detected in a urine sample within 1-2 days of use. However, detection times vary widely among different substances. For example, evidence of heroin use can be found in the urine up to 48 hours after last use, and evidence of methadone can be found for 3 days. Long-term marijuana use can be detected for up to 30 days.
Urine drug tests can tell doctors that a person has used a substance within a certain time period.
Urine drug tests cannot tell doctors how much of a substance a person has used, or how they used it (inhaled, injected, or taken by mouth.)
False positive tests can occur. Since some opioids are either derived from or similar to naturally occurring substances in the opium poppy seed, eating poppy-seed cookies or bagels prior to testing has caused false-positive results only in very sensitive tests. The use of prescription opioid pain relievers or certain antibiotics like rifampin, rifampicin, or quinolones can also cause false-positive urine tests for opioids. These possibilities should be discussed with a physician prior to testing.
Benefits of Frequent Urine Drug Testing
During an initial assessment and periodically throughout treatment, patients may be asked to provide a urine sample in the clinic. Patients are always encouraged to truthfully relate any drug use or relapse to their doctors before this sample is tested.
Clinics require urine testing to provide accountability to patients. Frequent testing has been shown to improve a patient’s chances of sticking with treatment. Drug testing is also helpful to keep patients safe: some addiction treatments like methadone and buprenorphine can be very dangerous when taken along with other drugs. If patients have relapsed to additional illicit drug use while using MAT, physicians need to know
— Greenfield, S. F., & Hennessy, G. (2008). Assessment of the Patient. In M Galanter & H Kleber (Ed.), Textbook of Substance Abuse and Treatment (4th ed.) Arlington, VA: American Psychiatric Publishing. The CRAFFT Screening Tool. (2009). Retrieved July 8, 2014, from http://www.ceasar-boston.org/CRAFFT/index.php Pilowsky, D. J., & Wu, L. T. (2013). Screening instruments for substance use and brief interventions targeting adolescents in primary care: a literature review. Addict Behav. May 38(5), 2146-53.  Mersy, D. J. (2003). Recognition of Alcohol and Substance Abuse. Am Fam Physician. Apr 1;67(7), 1529-1532.  Mersy, 2003.  Moeller, K. E., Lee, K. C., & Kissack, J. C. (2008). Urine drug screening: practical guide for clinicians. Mayo Clin Proc., Jan 83(1), 66-76.  Yee, D. A., Hughes, M. M., Guo, A. Y., Barakat, N. H., Tse, S. A., Ma, J. D., Best, B. M., & Atavee, R. S. (2014). Observation of improved adherence with frequent urine drug testing in patients with pain. J. Opioid Manag. Jan;83(1), 66-76.