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A bill was introduced in the Senate on 4/6/2006, by Sen. Arlen Specter. If passed the bill will eliminate the 30 patient limit for physicians who have had their waiver for more than one year, providing they submit a notification to the HHS Secretary in writing. It is part of a larger bill to reauthorize funding for the Office of National Drug Control Policy (ONDCP). If passed, here’s how it will read when inserted into DATA-2000, the law that created the waiver system in the first place:

Section 303(g)(2)(B)(iii) “(iii) The total of such patients of the practitioner at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, except that the Secretary unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat more than such applicable number of patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The Secretary may by regulation change such total number.”

Everything you want to know about the 30-limit
and this new bill can be found at:

http://www.naabt.org/30_patient_limit.cfm

The American Society of Addiction Medicine – ASAM
held its 37th Annual Medical-Scientific Conference May 4-7.
The 30-patient restriction was one of the topics of discussion.

Dr. H. Westley Clark, Director of CSAT/SAMHSA stated he was “in favor of a balance”. It appeared that he was not for total abolishment of the limit, as were many of the other attendees. He cited the fear that opioid-naïve people could become dependent on diverted buprenorphine. Someone from the audience pointed out that due to the cost of buprenorphine, the limited agonist effect, and the availability of stronger opioids on the streets, Buprenorphine would rarely end up the “best choice” for anyone intent on misuse, and thus would unlikely become a significant problem.

Denise Curry from the DEA seemed to support this theory with, “We have not seen diversion of buprenorphine for the most part” and implied that the DEA was aware of the limited risk to public health posed by any possible buprenorphine diversion, in comparison to the more dangerous diverted opioids.

Dr. Clark also mentioned the reason for the limit in the first place which was in response to a “fear that doctor’s offices could become methadone-like clinics”, and as an attempt to limit diversion by limiting supply. Several physicians noted that an unintended consequence of the restriction is diversion. People in need cannot find a legal source and are getting what they can off the street, yet still using it as it was intended; to stop illicit drug use.

The vast majority of the people who spoke, favored removing the limit and urged their colleagues to write to Congress and urge their support of this new legislation to “end this nonsense” and leave medical decision-making to the doctors.

Dr. Mark Kraus from Connecticut delivered an especially passionate statement, which served as a consensus of the majority of experts he polled on the issue. Below is his statement in its entirety:

“The 30 rule provision of DATA-2000 is arbitrary and capricious for several reasons including the following:

  1. It is in contravention of the public policy inherent in DATA-2000 to provide new access for opiate dependent patients in office based settings;
  2. It undermines an effective delivery of medical care and treatment for those the statute is designed to benefit - the opiate dependent patient; and
  3. It arbitrarily carves out a group for treatment necessarily depriving others equally in need of treatment from obtaining treatment. This constitutes de facto rationing of care without any basis.

As an internist, I am not restricted by an arbitrary number on how many diabetic, cardiac, hypertensive, pulmonary, or GI patients I can treat.

As an addiction medicine specialist working as a methadone treatment provider, I am not limited to an arbitrary number of opiate dependent patients I can treat with methadone. Yet there is an arbitrary number of opiate dependent patients I can treat with Suboxone. This is totally irrational - makes no sense! Government’s foray into this area of medicine has created more problems, more issues. If Government’s major purpose was/is to prevent diversion, rationing of care is not reasonably related to hat goal.

Common sense dictates that trained addiction medicine specialists be permitted to treat opiate dependent patients with Suboxone without arbitrary restriction by numbers. No other FDA-approved medication has an arbitrary limit as to the number of patients a physician is allowed to treat. The 30-rule rationing of care/treatment ignores the evidence and hurts the patients it was designed to benefit.

The 30 rule cannot stand!“

Arlene Stanton, Ph.D. Task Order Officer, CSAT, provided a comprehensive presentation on the results of the Evaluation of the Buprenorphine Waiver program. Final Results of SAMHSA evaluation concluded, among other things; that the 30-patient limit may be decreasing potential access to treatment. Due to the 30-limit, managed care network managers have reported difficulty finding physicians with open treatment slots. They also reported encountering physicians’ preference for detox instead of maintenance, despite clear evidence longer treatments have higher success rates. Comments provided by respondents to the wavered physicians’ survey included the following:

  • “It is a crime and unethical to continue to deny access to so many patients. Can you in good conscience not open up access to this life-saving treatment to thousands?”
  • “I don’t know any surgeons who limit appendectomies.”
  • “I no longer can offer maintenance therapy thus I have high relapse rates. The government is committing malpractice with this limit.”
  • “Until buprenorphine is treated like any other prescription with no additional constraints placed on doctors, both doctors and patients will continue to stigmatize this area of medical care.”
  • “It is unconscionable to turn patients away because of some ureaucratic limits.”

DATA-2000 has a provision so that the Secretary of HHS, by regulatory change, can eliminate or change the limit independent of Congress. It’s hoped that the data in this final report will be the catalyst of such change. The need is clear.

what's new at naabt.org

The April NAABT Newsletter contained two bad links. We apologize for the inconvenience. Please note the corrections below:

CSAT Director Advises Physicians of Concerns Regarding Buprenorphine In the interest of patient safety and public health, Dr. Clark addresses concerns on Compounding and Selling
Buprenorphine
.


In the World Health Organization article: “...Based on this input and extensive similar opposition, on March 31, 2006...”

Corrections, if needed, will always be posted on the News section.

Sahmsa

Final results of the SAMHSA/CSAT Evaluation of the Buprenorphine Waiver Program:
http://buprenorphine.samhsa.gov/
ASAM_06_Final_Results.pdf


If you are a certified physician please be sure your information is correct on the locator. Please check for spelling and correct phone number. If you know of a colleague who is on the list but should not be due to no longer practicing, please advise.
1-866-287-2728
info@buprenorphine.samhsa.gov

AATOD National Conference

In addition to Connecticut, the Patient-
Physician Matching System is now available in Maryland, Washington DC, and the greater Atlanta and Pittsburgh areas.

Patients in these locations now have an additional way to connect with a certified physician. Click Patient/Doctor onnection at naabt.org

in the coming months
• Patient expectations
• More on the ASAM conference
• Damage due to stigma
• Counseling
naabt.org

The Physician Locator (Doctor/Patient button) sorts physicians by distance in geographic proximity, regardless of city, town, county, or state borders.

Click here to try it for yourself.

Current Newsletters are available at the naabt.org homepage. Past editions are available as PDF files on our Literature page, under Other Literature.

The National Alliance of Advocates for Buprenorphine Treatment is a non-profit organization formed to help people, in need of treatment, find treatment providers who are willing and able to treat opioid dependency in the privacy of a doctor’s office. Our website offers answers to frequently asked questions, a glossary, actual patient experiences, a discussion board, information on the history and treatments of opioid addiction, current news on the subject and more.

This newsletter is provided to keep you informed on matters relating to Buprenorphine Treatment. Please feel free to contact us at newsletter@naabt.org with feedback, suggestions, or perhaps you would like to contribute a story. Also feel free to photocopy or print as many as these newsletters as you wish for distribution.

To add yourself or someone you know to the mailing list, please either write us or email us at subscribe@naabt.org.

naabt
The National Alliance of Advocates for Buprenorphine Treatment NAABT, Inc. • P.O. Box 333 • Farmington, CT 06034 Tel: 860.269.4390 • Fax: 860.269.4391 • email: MakeContact@naabt.orgnaabt.org