Summary of 2013 Legislation of Interest to Pharmacists
This summary includes only those bills enacted by the Tennessee General Assembly in
2013 that are of interest to pharmacists. It does not discuss bills which were considered but not
passed by the General Assembly.
Affordable Care Act (Obamacare)
1. After much consideration, Governor Haslam decided not to expand Tennessee’s Medicaid
program (i.e., TennCare) at the present time. Although the Affordable Care Act required all
states to expand their Medicaid programs to cover persons who earn up to 138% of the poverty
level, the U. S. Supreme Court ruled last year that this is too coercive and that it should be an
option, not a requirement, for the states. The Governor also decided not to create a state-run
health care exchange, which means that the federal government will create such an exchange in
Tennessee. The purpose of the exchange is to provide a mechanism for individuals and small
businesses to purchase health care insurance.
2. Senate Bill 1145 (Green)
House Bill 881 (Pitts)
Chapter 377 of the Public Act of 2013
This bill sets up a scheme for the licensure and regulation of “navigators”, who will assist
consumers in securing health insurance through the federally run exchange that will be set up
pursuant to the Affordable Care Act.
Prescription Drug Abuse
I.
Senate Bill 676 (Yager)
House Bill 1264 (Dunn)
Chapter 430 of the Public Acts of 2013
As originally introduced at the request of law enforcement agencies, this bill was a
draconian multi-prong effort to address the issue of prescription drug abuse. As passed by the
General Assembly, the law becomes effective on October 1, 2013, and does the following things:
1. It requires the Tennessee Commissioner of Health to develop (by January 1, 2014) and
annually update treatment guidelines for the prescribing of opioids, benzodiazepines,
barbiturates, and carisoprodol, to be used by prescribers as a guide in caring for their
patients. All prescribers of controlled substances will be notified of these guidelines
through bulletins or newsletters issued by the Department of Health.
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2. Beginning July 1, 2014, all prescribers who hold a DEA license and prescribe controlled
substances must complete at least 2 hours of continuing education related to controlled
substance prescribing biennially. The education must focus on the Department’s
guidelines, addiction, risk management tools, and other topics approved by the licensing
board for each profession.
3. Prescription of opioids, benzodiazepines, barbiturates, and carisoprodol may not exceed a
quantity sufficient for 30 days. Prescribers who dispense these drugs must report the
transaction to the Controlled Substance Database. Prescribers of these drugs must
consider mandatory urine drug screening of patients with a chronic condition who are
receiving drug therapy for more than 90 days.
4. Wholesalers and manufacturers of controlled substances must report certain information
set forth in the new law to the Controlled Substance Database.
5. Each board which licenses providers who prescribe controlled substances must prepare
and submit to the General Assembly annually a comprehensive report on its actions
relative to prescription drug abuse and pain management clinics.
6. In 2011 the General Assembly passed a law (codified at T.C.A. §§63-1-301 et seq.)
which requires all pain management clinics to obtain a certificate from the Tennessee
Department of Health. Chapter 430 makes several changes in that law.
The current definition of a “pain management clinic” is:
“Pain management clinic” means a privately-owned facility
in which a majority of the facility’s patients, seen by any or all of
its medical doctors, osteopathic physicians, advanced practice
nurses with certificates of fitness to prescribe, or physician
assistants, are provided pain management services by being
prescribed or dispensed, opioids, benzodiazepines, barbiturates, or
carisoprodol, but not suboxone, for more than ninety (90) days in a
twelve (12) month period.
On October 1, 2013, the definition of a “pain management clinic” will change to the
following, which is a much broader definition that will require additional facilities to
register as a pain management clinic:
“Pain management clinic” means a privately-owned facility
in which a medical doctor, an osteopathic physician, an advanced
practice nurse, a physician assistant, or any other health care
provider licensed under title 63 provides pain management services
to patients, a majority of whom are issued a prescription for, or are
dispensed, opioids, benzodiazepines, barbiturates, or carisoprodol
and provides prescriptions for more than ninety (90) days in a
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twelve-month period. For purposes of determining if a clinic
should be registered under this part, patients of health care
providers who do not prescribe controlled substances shall be
excluded from the count. “Pain management clinic” shall also
mean any privately owned clinic, facility, or office which
advertises in any medium for any type pain management services
and in which one (1) or more employees or contractors prescribe
controlled substances;
Every pain management clinic must have a medical director, who must be on-site at
least 20% of the clinic’s weekly total number of operating hours. Beginning October 1,
2013, a medical director may serve as medical director for no more than four (4) pain
management clinics.
Pain management clinics may not accept cash payment for their services (except the
copay or deductible). Beginning October 1, 2013, a clinic may accept only a check or
credit card in payment for services provided at the clinic.
II.
Senate Bill 529 (McNally)
House Bill 49 (Shepard)
Chapter 396 of the Public Acts of 2013
This bill started as a caption bill. It was subsequently amended to accomplish several
things that the sponsors believe will address the prescription drug abuse problem:
1. A nurse practitioner or physician assistant can prescribe only those controlled substances
that are on his/her formulary, unless specific approval is given by the supervising
physician for a drug not on the formulary.
2. A nurse practitioner or physician assistant can issue a prescription for only a 30-day
supply of a Schedule II or III opioid, unless the supervising physician approves a
prescription for a longer period of time, such as 60 or 90 days.
3. The Department of Health is required to send a letter annually to the Top 50 Prescribers
of controlled substances in the past year (based on data in the Controlled Substance
Database) asking each prescriber to explain why they are prescribing so many controlled
substances. Each prescriber must respond to the letter within 15 days and explain why
he/she has prescribed so many controlled substances.
III.
Senate Bill 955 (McNally)
House Bill 541 (Shepard)
Chapter 232 of the Public Acts of 2013
This new law applies to all practitioners who can legally prescribe controlled substances.
If such a practitioner is indicted for an offense involving the sale or dispensing of
controlled substances under state or federal law, the practitioner must within seven (7) days
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report the indictment to his/her licensing board, which must within 15 days conduct an expedited
review of the practitioner’s conduct to determine whether the matter merits an expedited
investigation by the Department of Health.
The knowing failure of a practitioner to report the indictment to the licensing board is
unprofessional, dishonorable, or unethical conduct which may be grounds for disciplinary action
against the practitioner.
IV.
Senate Bill 1363 (Haile)
House Bill 1294 (Lamberth)
Chapter 151 of the Public Acts of 2013
This new law amends the Identity Theft Victims’ Rights Act by making it a criminal
offense to use a prescription for a controlled substance which is misrepresented as having been
issued by a licensed health care provider. The new law amends the definition of the term
“personal identifying information” to include the name, number, and other information used on a
prescribing pad or other form used by a health care provider to prescribe a controlled substance.
The new law calls this new crime prescription drug fraud.
Dispensing Drugs at Pain Management Clinics
Senate Bill 705 (McNally)
House Bill 868 (Sexton)
Chapter 336 of the Public Acts of 2013
This new law prohibits certain named health care professionals who work at pain
management clinics (MD, DO, APN, PA) from dispensing controlled substances at those clinics.
However, one of these professionals working at a pain management clinic may provide his/her
patients, without charge, a sample of a Schedule IV or V controlled substance in a quantity
limited to an amount that is adequate to treat the patient for a maximum of 72 hours.
Tamper-Resistant Prescriptions
Senate Bill 963 (McNally)
House Bill 319 (Shepard)
Chapter 74 of the Public Acts of 2013
This new law adds the words “or printed utilizing a technology that results in a tamperresistant prescription” to several sections of the Code as an alternative to the current requirement
that prescriptions be written on tamper-resistant prescription paper. Several years ago the
General Assembly passed legislation requiring that all prescriptions be written on tamperresistant prescription paper. This new law allows the use of a new technology approved by CMS
that generates a tamper-resistant prescription which is as effective as writing it on tamperresistant paper. The new technology is already being used in some hospitals.
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Assaults on Health Care Providers
Senate Bill 412 (Green)
House Bill 306 (Favors
Chapter 325 of the Public Acts of 2013
This bill amends the current criminal statutes on assaults to recognize as a criminal
offense an assault on a licensed health care provider acting in the discharge of the provider’s
duties.
Licensure and the Military
Senate Bill 493 (Green)
House Bill 422 (Pitts)
Chapter 122 of the Public Acts of 2013
In 2011 the General Assembly adopted a law (now codified as T.C.A. §68-1-101(b))
which requires each health-related board to establish a procedure to expedite the issuance of a
license to a person:
(A)
(B)
(C)
(D)
Who is certified or licensed in a state other than Tennessee to perform certain
professional services in that state;
Whose spouse is a member of the armed forces of the United States;
Whose spouse is the subject of a military transfer to this state; and
Who left employment to accompany the person’s spouse to this state.
The procedure established by the board must provide for the issuance of a Tennessee license if
“in the opinion of the board” the licensure requirements of the state where the person is licensed
are “substantially equivalent” to the licensure requirements of Tennessee. Alternatively, the
board must develop a method to authorize the person to perform professional services in
Tennessee by issuing a “temporary permit for a limited period of time.”
The above requirements, which apply solely to military spouses, are already a part of the
Tennessee Code.
The new law extends these provisions to two additional categories of persons:
1) a person who is a member of the armed forces and has a license to perform
“substantially similar professional services” in a state other than Tennessee; and
2) a person who applies for a license within 180 days of being discharged or retiring
from the armed forces or being released from active duty to the reserves.
The new law also requires each health-related board to “accept military education,
training or experience” towards meeting the requirements for licensure if the board determines
that such military education, training or experience is “substantially equivalent to the standards
of this state.”
The new law further provides that the health professional license of a member of the
national guard or reserves who is called to active duty shall remain active during the period of
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active duty and shall be temporarily renewed without payment of fees or obtaining continuing
education credits. The renewal of the license continues until six months after the person is
released from active duty.
Duties Imposed on Pharmacists
Senate Bill 962 (McNally)
House Bill 542 (Shepard)
Chapter 276 of the Public Acts of 2013
This new law adds the following items to the Pharmacists’ practice act:
1. The owner or manager of a pharmacy must respect the professional judgment of a
pharmacist in putting the health and safety of the patient above all else.
2. A pharmacist must make every effort to prevent abuse of the drugs that the
pharmacist dispenses.
3. A pharmacist may decline to dispense a legend drug to a patient if the pharmacist
believes the drug lacks a therapeutic value for that patient or is not for a legitimate
purpose.
4. A pharmacist is not subject to any penalty for declining to dispense a legend drug to a
patient through an exercise of the pharmacist’s professional judgment.
5. It is a Class A misdemeanor for the owner or manager of a pharmacy to restrict or
interfere with (or establish a protocol that restricts or interferes with) a pharmacist’s
duty to counsel with patients, to evaluate the patients’ pharmaceutical needs, and to
determine whether it is appropriate to dispense a legend drug to a patient.
Compounding
1. Senate Bill 582 (Haile)
House Bill 317 (Shepard)
Chapter 266 of the Public Acts of 2013
The current definition of “compounding” in the Pharmacy Practice Act, found at T.C.A.
§63-10-204(4), states:
(4) “Compounding” means the preparation,
packaging or labeling of a drug or device:
mixing,
assembling,
(A) As the result of a prescription order or initiative based on the
prescriber-patient-pharmacist relationship in the course of professional
practice;
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(B) In anticipation of prescription orders based on routine,
regularly observed prescribing patterns; or
(C) For the purpose of, or as an incident to, research, teaching or
chemical analysis and not for sale or dispensing;
This new law adds four subsections to that definition:
(D) For use in a licensed prescribing practitioner’s office for
administration to the prescribing practitioner’s patient or patients when
the product is not commercially available upon receipt of an order from
the prescriber;
(E) For use in a health care facility for administration to a patient
or patients receiving treatment or services provided by that facility when
the product is not commercially available upon receipt of an order from
an authorized licensed medical practitioner of the facility;
(F) For use by emergency medical services for administration to a
patient or patients receiving services from them under authorized medical
control when the product is not commercially available upon receipt of an
order from a licensed prescriber authorized to provide medical control; or
(G) For use by a licensed veterinarian for administration to their
nonhuman patient or patients or for dispensing to non-human patients in
the course of the practice of veterinary medicine upon receipt of an order
from a veterinarian when the product is not commercially available.
The new law also adds several words to the current definition of the term “dispense” in
the statute:
(12) “Dispense” means preparing, packaging, compounding or
labeling for delivery and actual delivery of a prescription drug,
nonprescription drug or device in the course of professional practice to a
patient or the patient’s agent by or pursuant to the lawful order of a
prescriber;
The new law also adds the following new section (§63-10-216) intended to ensure the
safety of compounded drugs:
63-10-216.
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(a) Prior to initial licensure in this state as a compounding pharmacy, a
pharmacy located outside of this state must have an inspection by the
regulatory or licensing agency of the state in which the pharmacy practice
site is physically located. Out-of-state pharmacy practice sites must
provide a copy of the most recent inspection by the regulatory or licensing
agency of the state in which the pharmacy practice site is physically
located, which must have been within the previous twelve (12) months.
Prior to renewal of its license in this state, an out-of- state pharmacy
practice site must provide the most recent inspection by the regulatory or
licensing agency of the state in which the pharmacy practice site is
physically located or equivalent regulatory entity, and which must have
been within the previous twelve (12) months. The board of pharmacy shall
have the right to require additional information before issuing or
renewing a pharmacy license to insure compliance with applicable laws of
this state and any rules, and policies of the board.
(b) Any compounding pharmacy having an active Tennessee license shall
notify the board within fourteen (14) business days of receipt of any order
or decision by a regulatory agency, other than the Tennessee board of
pharmacy, imposing any disciplinary action, including any warning, on
the pharmacy.
(c) Any pharmacies engaged in sterile compounding must comply with
relevant United States Pharmacopeia (USP) guidelines as adopted by the
board by rule or policy.
(d) Any pharmacies engaging in sterile compounding, except hospital
pharmacies compounding for inpatients of a hospital, shall report on a
quarterly basis to the Board the quantity of sterile compounded products
dispensed in a defined time period in accordance with policies adopted by
the board; provided, however, the executive director of the board may
request this information from a hospital pharmacy for cause and the
hospital pharmacy shall be required to respond in a timely manner as
defined by the executive director of the board.
Methamphetamine and Pseudoephedrine
Senate Bill 614 (Yager)
House Bill 1043 (Lundberg)
Chapter 433 of the Public Acts of 2013
This new law amends the definition of “imitation controlled substance” by replacing the
words “or substantially similar to” with the words “or analogue of”. The definition currently
reads:
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(d) For purposes of this section, “imitation controlled substance” means
a pill, capsule, tablet, or substance in any form whatsoever:
(1) Which is not a controlled substance enumerated in this part,
which is subject to abuse, and which by express or implied
representations, purports to act like a controlled substance as a stimulant
or depressant of the central nervous system and which is not commonly
used or recognized for use in that particular formulation for any purpose
other than for such stimulant or depressant effect, unless marketed,
promoted, or sold as permitted by the United States food and drug
administration; and
(2) The chemical structure of which is a derivative of, or
substantially similar to, the chemical structure of a controlled substance.
Pharmacy Benefit Contracts
1. Senate Bill 63 (Yager)
House Bill 228 (Sanderson)
Chapter 408 of the Public Acts of 2013
This new law requires the Department of Finance and Administration to monitor the
Pharmacy Benefit Manager’s compliance with the provisions of any state pharmacy benefit
contract and to have an audit of that contract performed by an independent auditor. The
Department must also perform annually a risk assessment to determine the areas of this contract
that pose the greatest risk of noncompliance, fraud, waste, or abuse.
The Department must prepare a monitoring and auditing plan that includes a review of:
(1)
Repricing of pharmacy claims at the drug level;
(2)
Validation of the national drug code (NDC) usage;
(3)
Appropriateness of the nationally recognized reference prices, or
average wholesale price (AWP), in accordance with § 56-7-3104;
(4)
Eligibility of beneficiaries for pharmacy claims paid;
(5)
Reconciliation of the pharmacy benefits manager’s payments to
pharmacies with the state’s reimbursement to the pharmacy benefit manager (for
pharmacy benefits contracts entered into on or after July 1, 2013);
(6)
Confirmation that the pharmacy benefits manager’s payments to
pharmacies do not reflect disparity among network pharmacies attributable to
preferential treatment of one or more pharmacies;
(7)
Recalculation of discount and dispensing fee guarantees;
(8)
Review of the state’s claim utilization to ensure that per claim
rebate guarantees were accurately calculated by the pharmacy benefit manager;
(9)
Review of rebate contracts between the pharmacy benefit manager
and five drug manufacturers, to be selected by the benefits administration division
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of the department, and the contracted auditor to ensure that eligible rebate
utilization was accurately invoiced on behalf of the state;
(10) Comparison of total rebates collected by the PBM (pass-through
rebates) to the minimum rebate guarantees (per claim rebates) to ensure that
annual reconciliation of rebate payments to the state represented the greater of
the two amounts;
(11) Monitor the activities of the pharmacy benefits manager to ensure
that the contractor is conducting audits and other reviews of pharmacies as
provided in the contractor’s scope of services; and
(12) Consideration of other industry related risks to reduce the risk of
financial losses due to fraud, waste, and abuse.
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