Special CME Issue - West Virginia State Medical Association

Legislative | NEWS
2012 Legislative Summary
Visit www.wvsma.com for a complete 2012 Legislative Summary
Controlled Substances Bill Biggest Healthcare Issue of Session
Governor Tomblin signed into
law SB 437 on March 29, 2012. This
was the biggest healthcare related
piece of legislation of the Session
and is the most comprehensive
approach taken in recent history
on addressing the epidemics of
prescription drug diversion and
substance abuse. The bill was
offered by the Governor following
regional meetings held around the
state which included stakeholders
from all sides of the issue. The bill
included many recommendations
issued last fall by the WVSMA
in our report “Physician
Leadership in Addressing
Prescription Drug Diversion”.
The bill contains five
main areas of focus:
• Implements additional
regulation of opioid treatment
centers (Methadone Clinics);
• Establishes licensing and
regulation of Chronic Pain Clinics;
• Establishes review capabilities
of the Controlled Substances
Database under the Board of
Pharmacy to flag abnormal
or unusual usage patterns
of controlled substances by
patients and unusual prescribing
or dispensing patterns by
licensed practitioners;
• Implements a requirement
for continued education
for physicians and other
prescribers, dispensers and
persons who administer
controlled substances; and,
• Regulates the sale of
pseudoephedrine.
The following is a brief synopsis
of the law. For a detailed synopsis
of this bill and the other healthcare
related legislation that passed or
failed please visit www.wvsma.com:
1. Methadone clinics are
subject to monitoring by the
DHHR; additional education and
safety training for employees is
established and the clinics must
follow national guidelines that
include a recovery model in
the individualized treatment of
care, among other regulations.
2. Requires licensure of “pain
management clinics” which are
defined as: All privately owned pain
management clinics: (1) Where in
any month more than fifty percent
of the patients of the prescribers
or dispensers are prescribed
or dispensed opioids or other
controlled substances specified in
rules for chronic pain resulting from
non-malignant conditions; (2) The
facility meets any other identifying
criteria established by DHHR rule.
Chronic pain is defined as:
“pain that has persisted after
reasonable medical efforts have
been made to relieve the pain
or cure its cause and that has
continued, either continuously or
episodically, for longer than three
continuous months. Chronic pain
does not include pain associated
with a terminal condition or with
a progressive disease that, in the
normal course of progression,
may reasonably be expected to
result in a terminal condition.”
There is a lengthy list of
exemptions from this regulation
including all practices associated
with medical schools and hospitals,
hospice, nursing homes and
ambulatory care facilities. There
are many specific operational
requirements set in law.
3. The 2 hours of CME in “end
of life care and pain management”
is removed from law. A new
biennial requirement is established
for “drug diversion training” and
“best practices for prescribing of
controlled substances training”
for prescribers, dispensers
and those who administer
controlled substances.
4. Prescribing a combination of
buprenorphine and naloxone to
treat opioid addiction is limited
to sublingual film unless the film
is clinically contraindicated.
5. An Advisory Board of
physicians and pharmacists is
established under the Board of
Pharmacy to review the controlled
substances database and “develop,
implement, and recommend
parameters to be used in identifying
abnormal or unusual usage
patterns of patients in the state…”
A Database Review Committee
of physicians, prosecutors and a
pharmacist is established to make
determinations on specific unusual
prescribing or dispensing patterns.
6. Prescribers and dispensers
are granted immunity for reporting
suspected doctor shoppers.
7. All prescribers and dispensers
are required to check the controlled
substances database upon
initially prescribing or dispensing
a pain relieving controlled
substance to a patient for chronic
nonmalignant, non-terminal
pain and annually thereafter.
8. It is now a felony for
unauthorized use or disclosure of
the controlled substances database
information and is punishable
by imprisonment for 1-5 years or
fined $3,000-$10,000, or both.
9. The sale of pseudoephedrine
products at retail pharmacies is
further regulated by requiring the
use of a Multi-State Real-Time
tracking system and limiting the sale
to individuals without prescription
to 3.6g per day, 7.2 grams monthly
and 48 grams annually.
102 West Virginia Medical Journal