Attachment-E-Comment

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225 Varick Street, ,lth Floor . New York, NY 100f4 . Phone: (2I2) 566-5555 . Fax: (212) 366-4647
E-mail: [email protected] I www.aatod.org

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June5. 2015
SummerKing
Reports ClearanceOfficer
SAMHSA
I Choke Cherry Road
Room 2 - 1057
Rockville,MD 20857

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Re: Federal Register Notice Vol.
80, No.65 Notification Form
(sMA - 167)

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Dear Ms. King,
I am writing in response to the Department's notification with SAMHSA
concemingdatacollectionactivitiesfor DATA 2000 reporting.I am specifically
referencingthe notification form (SMA-167) that SAMHSA useswith regardto
provider notification as part of the Drug Abuse Treatment Act of 2000 and its
subsequentamendments.
The Department's primary question is whether the proposed collection of
information, obtained through the above referenced notification form, is
necessaryfor the proper performanceand functions of the SubstanceAbuse and
Mental Health Services Administration. The obvious answer from our
Association's point of view is yes. Our Associationrepresentsapproximately
1,000 Opioid TreatmentPrograms(OTPs) throughout the U.S., which are all
certified through SAMHSA.
We think it is important when any DATA 2000 practitioner wishes to increase
the number of patients being treated as part of their practice from 30 to 100
patients to provide sufficient information to SAMHSA to guide SAMHSA's
decisionmaking.
We believe that it is fair to state that SAMHSA does not currently collect
adequate information about the care being provided within DATA 2000
practices. Illustratively, no one has any idea of how many patients are treated
through DATA 2000 practices at any given point in time. No one has any
centralized data on what kinds of services are offered to patients, including
counseling and other clinical support services, beyond the prescribing of
ScheduleIII opioids to treat opioid addiction.No one has any idea if DATA
2000 practicesare conductingtoxicology testing to guide therapeuticdecision
making. No one has any centralized data collection with regard to DATA 2000
practices checking PDMP databaseseither prior to admitting the patient and
throughout the patient's care.

Washington, D(liriatt (.rissttllttr
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R i t : h a r c lB i l a n g i . l l 5

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These are not academicquestions.Accuratelesponseswill provide SAMHSA
with an understanding if the existing DATA 2000 practices are following
SAMHSA's Best Practicesrecommendationsin treating opioid addiction (TIP
40), in addition to the recently releasedNational PracticeGuidelinesfrom the
American Societyof Addiction Medicine.
In our judgment, SAMHSA should collect such information on a routine basis
from DATA 2000 practices. This kind of information could easily be captured
as such practices are transitioning from a 30 patient capacity to a 100 patient
capacity.
In order to avoid significant burden to DATA 2000 practitioners who are filing
such forms, the form could simply add a few basic elements that answer the
following important patient care questions:

a
a

How many patients are currently in treatment and how many patients do
you intend to care for?
What kinds of clinical support servicesdo you provide to your patients
directly? Through casemanagementreferral?
Do you check PDMP databasesbefore the patient is treated and
throughout the patient's care?
On average,how long doesthe patient remain in continuous treatment in
your practice?
What is your patient drop out rate?
Do you conduct toxicology tests during the course of the patient's care?
If so, what is the frequencyof toxicology collection and what drugs are
being tested?
What percentageof patientshave discontinuedthe use of illicit drugs?

These are some basic questionsthat should be addedto the form, in addition to
the currently collected information including the state medical license number,
DEA registration number, addressof primary location, telephone,fax, and email
addresses,to gain an understandingof the type of care being provided in DATA
2000 practices.
From our Association's point of view, adding such elements to the form will
provide SAMHSA with someof the basic information that it should have as part
of its decision making to certiff such DATA 2000 practices and provide
increasedopportunities to treat patients in their practices. Further, it will allow
SAMHSA to understandwhether thesepracticesfollow best practice guidelines,
as containedin SAMHSA's Clinical Guidelinesfor the Use of Buprenorphinein
the Treatment of Opioid Addiction (TIP 40), as referencedabove, and the
recently releasedand comprehensiveNational Practice Guideline for the Use of

Medications in the Treatment of Addiction Involving Opioid Use (American
Societyof Addiction Medicine).
Thank you for taking thesecommentsinto account.

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Mark W. Parrino
President