AATOD Letter to Secretary Burwell

Please see letter below sent to the Honorable Sylvia Mathews Burwell, Secretary of the
U.S. Department of Health and Human Services from Mark  W. Parrino, AATOD President.

Burwell_Letter 8-13-14 | Alcoholism and Drug Abuse Weekly August 11 2014


Dear Secretary Burwell,

I am writing you pursuant to correspondence that you had received, dated June
26,2014 from five US Senators. They were discussing their concerns about
untreated opioid addiction in the United States, and indicated that the
Department might have the ability to raise the patient cap for DATA 2000
practices without Congressional authorization.

I understand that the Department will be considering a number of policymaking
initiatives in order to respond to the current public health crisis of untreated
opioid addiction in our country, including the use of buprenorphine products in
certified DATA 2000 practices and Opioid Treatment Programs (OTPs). At the
present time, we have conducted a survey among the nation’s State Opioid
Treatment Authorities and AATOD member programs, concluding that
buprenorphine is an underutilized medication in the OTPs based on the lack of
reimbursement through third party payers.

We recognize that addiction to prescription opioids and heroin has been steadily
increasing for a number of years. AATOD has been carefully tracking this
phenomenon since January of 2005 in managing one of the RADARSTM
Systems under the auspices of the Denver Health and Hospital Authority. More
than 72,000 newly admitted patients have completed survey instruments at time
of admission, with 45oA of this patient number, indicating addiction to
prescription opioids.

I am enclosing a policy paper, which our Association published on July 2,2014.
It discussesa number of important elementso f any effective opioid addiction
treatment strategy. In our judgment, the fact that we have such a complicated
national public health problem, which took many years to develop, requires a
combination of thoughtful solutions. It is inaccurate to think that this
complicated problem will be resolved by simply lifting the existing cap of the
number of patients that a SAMHSA approved, DATA 2000 practice can treat.
As indicated in the policy paper, more OTPs and DATA 2000 practices need to
open as a means of increasing access to care.

There should be consideration given to increasing the cap for DATA 2000
practices, when it has been clearly established that existing practices are at
capacity. We recommend against any across the board lifting of the cap until we
know how effective these practices have proven to be in reducing drug abuse
and treating related co-morbid conditions. Many DATA 2000 physicians prefer
not to treat a large number of patients at their practices for several reasons,
including anecdotal reports of feeling overwhelmed by treating patients with
significant co-morbid conditions while they are also treating other patients as
part of their general medical practice. We have also urged SAMHSA to conduct
a survey of the approximately 7,500 certified DATA 2000 practitioners to
determine how many medical practitioners have reached their 100 patient limit.

The enclosed paper also questions what we know about existing DATA 2000
practices and discusses some of the primary questions that should be asked and
answered before any significant shift is made in federal policy. In our judgment,
there is a reasonable question about how many opioid addicted patients can be
effectively treated by a medical practitioner in a DATA 2000 practice. Can such
a practitioner effectively treat between 250-500 patients, without proper clinical
and administrative support personnel or without the ability to case manage the
services that the patient should be receiving, based on all that we have learned in
treating chronic opioid addiction over the past 50 years? In this regard, it is
important to point out that SAMHSA is at the end stage of reviewing their draft
and updated Guidelines for the Acueditation of OTPs, which were initially
released on May 16,2013. The initial draft provides 69 pages of extremely
detailed administrative and clinical direction to the nation’s certified OTPs
concerning every conceivable aspect of treating chronic opioid addiction. These
guidelines include a section on Diversion Control Strategies. No such
counterpart applies to DATA 2000 practices, effectively creating a two-tiered
system of treating this illness.

There are also innovative models being utilized in the states about how we
maximize the use of existing treatment resources. The hub and spoke model in
Vermont provides a case in point as Opioid Treatment Programs are also being
opened as a means of providing increased access to care and creating referral
opportunities between OTPs and DATA 2000 practices. We certainly think that
the Department should consider a number of treatment initiatives, including
having the Veteran’s Administration have more medical practitioners’ DATA
2000 certified to treat patients in VA settings in addition to having physicians
certified in Federally Qualified Health Centers.

The enclosed paper has also recommended the consideration of adding midlevel
practitioners as a new group of approved health care providers under the aegis of
DATA 2000. Once again, if this were to happen, there would be a significant
increase in the number of patients being treated with buprenorphine through a
greater network of certified and trained practitioners. This would increase access
to care without compromising the integrity of treatment services provided to
each patient.

There has also been a public debate about what constitutes a therapeutic use of a
diverted medication. A number of individuals have indicated that the vast
majority of diverted buprenorphine is being used therapeutically by patients who
cannot get access to care. As the paper indicates, this is a complex question that
needs further exploration, prior to any significant shift in policy, as stated above,
which may inadvertently increase buprenorphine diversion to the black market
which will not be used therapeutically.

Naloxone overdose prevention kits are being increasingly distributed to first
responders in different cities and states in the country. The early results are
promising and this should be a part of any solution to the crisis of increasing
opioid addiction in this country. The enclosed policy paper also underscores the
need to connect saving patients through such interventions to ongoing treatment.
If this is not accomplished through coordinating service delivery systems, the
beneficial results will be limited.

Finally, a third federally approved medication (Naltrexone/Vivitrol) is an
underutilized medication. This medication can be used in general medical
practice settings through a monthly injection. AATOD has published clinical
guidelines to OTPs, encouraging the use of this medication as a relapse
prevention tool.

AATOD has been in existence since 1984 and represents 950 Opioid Treatment
Programs (OTPs) in the United States and Mexico. AATOD is also the
organizational co-founder with EUROPAD of the World Federation for the
Treatment of Opioid Dependence. This worldwide federation was founded in
2007 and has Special Consultative Status with the United Nations. This World
Federation provided guidance in the development of the World Health
Organization’s “Guidelines for the Psychosocially Assisted Pharmacological
Treatment of Opioid Dependence” (2009). It is useful to cite a reference from
this WHO report, which discussed the benefits of medication assisted treatment
for opioid addiction. “In the context of high quality, supervised, and well
organized treatrnent services, these medications interupt the cycle of
intoxication and withdrawal, greatly reducing heroin and other illicit opioid use,
crime, and the risk of death through overdose.”

We have also worked with all federal and state agencies in the United States
which have jurisdiction in this particular field. AATOD has continued to work
with SAMHSA’s leadership on a broad number of policymaking initiatives and
we are extremely grateful for their efforts during such challenging times.

In closing, we recognize that this will be an ongoing policy discussion and
urgent solutions are necessary. In our judgment, these solutions should be
comprehensive, thoughtful, and based on what we have learned over the course
of the past 50 years. We are urging the Department to work effectively with all
of the federal and state agencies and other knowledgeable parties, which have a
stake in this policy matter. Once again, the simple solution of lifting the existing
DATA 2000 cap without proper review of scope of services as indicated above,
is likely to create unintended and negative consequences. I look forward to
future collaboration and thank you for taking these perspectives into

Sincerely yours,

Mark W. Parrino, M.P.A.
American Association for the Treatment of Opioid Dependence (AATOD)

Alcoholism and Drug Abuse Weekly August 11 2014

Burwell_Letter 8-13-14

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