Enrolled Version - Final Version
House Bill 4084 History
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ENROLLED
H. B. 4084
(By Delegates Michael, Mezzatesta, Leach, Warner,
Foster, Varner and Stalnaker)
[Passed March 13, 2004; in effect from passage.]
AN ACT to amend the code of West Virginia, 1931, as amended, by
adding thereto a new article, designated §5A-3C-1, §5A-3C-2,
§5A-3C-3, §5A-3C-4, §5A-3C-5, §5A-3C-6, §5A-3C-7, §5A-3C-8,
§5A-3C-9, §5A-3C-10, §5A-3C-11, §5A-3C-12, §5A-3C-13, §5A-3C-
14, §5A-3C-15, §5A-3C-16 and §5A-3C-17, all relating generally
to the creation of a pharmaceutical program for the state;
legislative findings; definitions; creation of the
prescription drug assistance clearinghouse program; requiring
costs of program to be paid by drug manufacturers; transfer of
ownership of the program to the state; establishment of
pharmaceutical discount program; eligibility for participation
in the pharmaceutical discount program; discount pass through;
creation of a West Virginia pharmaceutical cost management
council; establishing membership; establishing powers and
responsibilities; reporting requirements; authority to
investigate the feasibility of purchasing Canadian drugs; authority to establish a pricing schedule to be implemented
upon concurrent resolution of the Legislature; authority to
explore numerous strategies, policies, and programs,
including, but not limited to, referenced prices for
prescription drug purchases and pricing in the state;
authority to implement certain designated programs; state
responsibilities; prohibiting restraint of trade; providing
civil and criminal penalties for restraint of trade;
advertising costs and reporting; rule-making authority; sunset
provisions; and identifying potential use of savings.
Be it enacted by the Legislature of West Virginia:
That the code of West Virginia, 1931, as amended, be amended
by adding thereto a new article, designated §5A-3C-1, §5A-3C-2,
§5A-3C-3, §5A-3C-4, §5A-3C-5, §5A-3C-6, §5A-3C-7, §5A-3C-8,
§5A-3C-9, §5A-3C-10, §5A-3C-11, §5A-3C-12, §5A-3C-13, §5A-3C-14,
§5A-3C-15, §5A-3C-16 and §5A-3C-17, all to read as follows:
ARTICLE 3C. PHARMACEUTICAL AVAILABILITY AND AFFORDABILITY ACT OF
2004.
§5A-3C-1. Title.
The provisions of this article shall be known as and referred
to as the "West Virginia Pharmaceutical Availability and
Affordability Act".
§5A-3C-2. Purpose.
(a) The Legislature finds:
(1) That the rising cost of prescription drugs has imposed a
significant hardship on individuals who have limited budgets, are
uninsured or who have prescription coverage that is unable to
control costs successfully due to cost shifting and disparate
pricing policies;
(2) That the average cost per prescription for seniors rose
significantly between one thousand nine hundred ninety-two and two
thousand, and is expected to continue increasing significantly
through two thousand ten;
(3) That there is an increasing need for citizens of West
Virginia to have affordable access to prescription drugs; and
(4) That the Legislature does not intend the imposition of the
programs under this article to penalize or otherwise jeopardize the
benefits of veterans and other recipients of federal supply
schedule drug prices.
(b) In an effort to promote healthy communities and to protect
the public health and welfare of West Virginia residents, the
Legislature finds that it is its responsibility to make every
effort to provide affordable prescription drugs for all residents
of West Virginia.
§5A-3C-3. Definitions.
In this article:
(1) "Advertising or marketing" means any manner of
communication of information, either directly or indirectly, that is paid for and usually persuasive in nature about products,
services or ideas related to pharmaceuticals by identified sponsors
through various media, persons or other forms as further defined by
legislative rule.
(2) "AWP" or "average wholesale price" means the amount
determined from the latest publication of the blue book, a
universally subscribed pharmacist reference guide annually
published by the Hearst corporation. "AWP" or "average wholesale
price" may also be derived electronically from the drug pricing
database synonymous with the latest publication of the blue book
and furnished in the national drug data file (NDDF) by first data
bank (FDB), a service of the Hearst corporation.
(3) "Dispensing fee" means the fee charged by a pharmacy to
dispense pharmaceuticals.
(4) "Drug manufacturer" or "pharmaceutical manufacturer" means
any entity which is engaged in: (A) The production, preparation,
propagation, compounding, conversion or processing of prescription
drug products, either directly or indirectly by extraction from
substances of natural origin, or independently by means of chemical
synthesis or by a combination of extraction and chemical synthesis;
or (B) in the packaging, repackaging, labeling, relabeling or
distribution of prescription drug products. "Drug manufacturer" or
"pharmaceutical manufacturer" does not include a wholesale
distributor of drugs or a retail pharmacy licensed under state law.
(5) "Federal supply schedule" or "FSS" means the price
available to all federal agencies for the purchase of
pharmaceuticals authorized in the Veterans Health Care Act of 1992,
PL 102-585. FSS prices are intended to equal or better the prices
manufacturers charge their "most-favored" non-federal customers
under comparable terms and conditions.
(6) "Multiple-source drug", "innovator drug" and "noninnovator
drug" mean the following:
(A) The term "multiple-source drug" means, for which there are
two or more drug products which are: Rated as therapeutically
equivalent (under the food and drug administration's most recent
publication of "Approved Drug Products with Therapeutic Equivalence
Evaluations"), except as provided in paragraph (B) of this
subdivision, are pharmaceutically equivalent and bioequivalent, as
determined by the food and drug administration, and the term
"innovator drug" shall hereinafter be referred to as "brand". The
term "innovator drug" means a drug which is produced or distributed
under an original new drug application approved by the food and
drug administration, including a drug product marketed by any
cross-licensed producers or distributors operating under the new
drug application and any multiple-source drug that was originally
marketed under an original new drug application approved by the
food and drug administration. The term "noninnovator drug" shall
hereinafter be referred to as "generic". The term "noninnovator drug" means a multiple-source drug that is not an "innovator drug".
(B) Paragraph (A) of this subdivision shall not apply if the
food and drug administration changes by regulation the requirement
that, for purposes of the publication described in paragraph (A) of
this subdivision, in order for drug products to be rated as
therapeutically equivalent, they must be pharmaceutically
equivalent and bioequivalent.
(7) "Labeler" means an entity or person that receives
prescription drugs from a manufacturer or wholesaler and repackages
those drugs for later retail sale and that has a labeler code from
the federal food and drug administration pursuant to 21 C. F. R.
§207.20 (1999).
(8) "Person" means any natural person or persons or any
corporation, partnership, company, trust or association of persons.
(9) "Pharmaceutical drug detailing" or "detailing" means the
function performed by a sales representative who is employed by a
pharmaceutical manufacturer for the purpose of: Promotion of
pharmaceutical drugs or related products; education about
pharmaceutical drugs or related products; or to provide samples of
pharmaceutical drugs, related products or related materials, gifts,
food or meals.
(10) "Savings" means the difference between the previous price
of a prescription drug including any discounts, rebates or price
containments and the current price after the effective date of this article for the public employees insurance agency, children's
health insurance program, medicaid and workers' compensation
programs or other programs which are payors for prescription drugs.
(11) "Sole source" means a pharmaceutical that provides a
unique and powerful advantage available in the market to a broad
group of patients established under federal law.
(12) "West Virginia Pharmaceutical Cost Management Council" or
"council" means the council created pursuant to section eight of
this article.
§5A-3C-4. Creation of clearinghouse program.
(a) There is hereby created the state prescription drug
assistance clearinghouse program. The brand pharmaceutical
manufacturers shall create and implement a program to assist state
residents who are low income or uninsured to gain access to
prescription medications through existing private and public sector
programs and prescription drug assistance programs offered by
manufacturers, including discount and coverage programs. The brand
pharmaceutical manufacturers shall use available computer software
programs that access an eligible individual with the appropriate
private or public programs relating to the individual's medically
necessary drugs. The brand pharmaceutical manufacturers shall
provide education to individuals and providers to promote the
program and to expand enrollment and access to necessary
medications for low-income or uninsured individuals qualifying for the programs. The participating brand pharmaceutical manufacturers
shall be responsible for the cost of the establishment of the
program, and be responsible for running the program, regardless of
the date of transfer of the program to the state, for the period of
time until a date no earlier than the thirtieth day of June, two
thousand five, and ownership of the technology, website and other
program features shall be transferred to the state on the same
date. The secretary of the department of health and human resources
and the director of the public employees insurance agency shall
provide joint oversight over the establishment and construction of
the program and program features for the period of time prior to
the transfer of ownership to the state. The pharmaceutical council
shall recommend the state agency to own, control and operate the
program, technology and program features, and shall include such
recommendation in its report on or before the first day of
September, two thousand four, to the joint committee on government
and finance, as provided for in section eight of this article. In
addition, the pharmaceutical manufacturers shall report to the
Joint Committee on Government and Finance on a monthly basis all
activities related to the implementation of this program including
the number of citizens serviced and the services provided.
(b) The participating brand pharmaceutical manufacturers shall
contribute the funding for the promotion of the public relations
program attendant to the establishment of the program. The participating brand pharmaceutical manufacturers shall be
responsible for the cost of the establishment of the program and
the cost of the ongoing program, regardless of the date of transfer
of ownership of the program to the state, for the period of time
until the thirty-first day of December, two thousand four.
§5A-3C-5. Pharmaceutical discount program; establishment; eligible
individuals; discount pass through; terms.
There is hereby established a discount drug program to provide
low-income, uninsured individuals with access to prescription drugs
from participating brand pharmaceutical companies and pharmacists
through either a state-sponsored discount card program or a program
that extends current brand pharmaceutical manufacturer prescription
drug assistance programs:
(a) The state hereby establishes a state-sponsored
prescription drug discount card program for certain eligible
residents of West Virginia:
(1) Eligible individuals include uninsured residents of West
Virginia up to two hundred per cent of the federal poverty
guideline who have not been covered by a prescription drug program,
whether public or private, at least six months prior to applying to
the discount card program;
(2) The state may negotiate voluntary discounts with brand
pharmaceutical manufacturers and pharmacists: Provided, That the
total discount received from the manufacturer shall pass through to the eligible resident;
(3) Failure of a brand pharmaceutical manufacturer to
participate in the voluntary discount card program will not result
in prior authorization on drugs in the medicaid program which would
not otherwise be subject to prior authorization but for the failure
of the manufacturer to participate in this program; and
(4) The state shall not establish a formulary or preferred
drug list as part of the discount card program.
(b) The brand pharmaceutical manufacturers may extend existing
prescription drug assistance programs to eligible residents of West
Virginia. Eligible individuals include uninsured residents of West
Virginia up to two hundred percent of the federal poverty level who
have not been covered by a prescription drug program, whether
public or private, at least six months prior to applying to the
program.
(c)
The program established under this section shall be
structured so that a member presenting a discount card at a
participating pharmacy will receive the full benefit of the
pharmacy discount, as well as the manufacturer's discount, at a
point of sale transaction. The program, or the pharmacy benefit
manager contracted by the program, shall coordinate the drug
discount information provided by participating pharmacies and
manufacturers so that the available drug discounts are provided to
the member at the point of sale.
(d) Manufacturers participating in the voluntary program
established under this section shall cooperate with the program, or
the pharmacy benefit manager contracted by the program, to provide
the current list of drugs and the percentage of discount from the
AWP for such drugs, or the rebates that the manufacturer will
provide under the program. It is the intent of this program that
adequate drug price and discount or rebate information be provided
by the manufacturer, such that the program and participating
pharmacies will have available such drug prices and discounts or
rebates at a point of sale pharmaceutical drug transaction. Retail
pharmacies will be responsible for no more than fifty percent of
the discount offered by the manufacturer to the participant.
(1) Pharmacies participating in the voluntary program(s)
established under this section will be responsible for no more than
fifty percent of the discount offered by the manufacturer to the
participant, and be paid a dispensing fee of no more than three
dollars and fifty cents per prescription with regard to
prescriptions filled under the program(s).
(2) Upon the presentation of a valid discount card, payment
for the prescription and otherwise meeting appropriate criteria to
have their prescription filled, the cardholder will have their
prescription filled by a participating pharmacy. To accomplish the
transaction, the participating pharmacy shall electronically
transmit the transaction to the program or pharmacy benefit manager contracted by the program for processing. The program, or the
program's pharmacy benefit manager, shall determine the discounted
cost of the drug, including the discount provided, the discount
provided by the pharmacy, the discount or rebate provided by the
manufacturer, the pharmacy dispensing fee, and any pharmacy benefit
manager transaction fee. The program, or the program's pharmacy
benefit manager, shall then transmit to the manufacturer an
electronic statement of the amount the manufacturer owes on the
transaction to cover the manufacturer's discount or rebate and the
program's or the pharmacy benefit manager's processing fee. The
manufacturer shall, in turn, at least every fourteen days, transmit
such monetary amounts for the transaction to the program, or the
program's pharmacy benefit manager, and the program, or the
program's pharmacy benefit manager, shall pass such discount or
rebate amounts back to the participating pharmacy which originated
the transaction immediately.
(e) The pharmaceutical manufacturers shall report to the Joint
Committee on Government and Finance on a monthly basis all
activities related to the implementation of this program including
the number of citizens serviced and the services provided, as well
as, the benefits, the costs and the discounts obtained.
§5A-3C-6. Creation of program; administrative support; medicaid
and chip program.
(a) There is hereby created in the state a program to obtain favorable pharmaceutical prices for state agencies and other
qualified entities pursuant to this article.
(b) The medicaid program and the West Virginia children's
health insurance program may be exempt from participation in this
program until approval by the center for medicare and medicaid
services has been granted if it is determined to be required by the
council.
(c) Administrative staff support for the council created by
this article shall be provided by the departments represented on
the council.
(d) The council shall establish a pricing schedule using or
referencing the FSS prices, or using or referencing to the price,
as adjusted for currency valuations, set by Canada patented
medicine prices review board (PMPRB) or any other appropriate
referenced price that will maximize savings to the broadest
percentage of the population of this state.
(e) By September fifteenth of two thousand four, the council
shall report back to the Legislature the pricing schedule developed
and a strategic plan for implementation. The council shall
implement the proposed pricing schedule and strategic plan upon
concurrent resolution of the Legislature. If, at the time of the
acceptance or rejection of the concurrent resolution to implement
the proposed pricing schedule and strategy, the concurrent
resolution is not passed due to the Legislature's lack of acceptance of the same, the Legislature shall accept or reject a
concurrent resolution to implement the pricing schedule and
strategy using or referencing the FSS: Provided, That acceptance or
rejection of the above referenced resolutions shall occur prior to
the end of the regular session of the Legislature in two thousand
five.
(f) If neither of the above referenced resolutions pass during
the regular session of the Legislature in two thousand five, the
Legislature may, at any time in the future, pass a concurrent
resolution to implement the above referenced pricing schedule and
strategy or any subsequent recommendation of the council to the
Legislature and the Legislature determines that the proposed
pricing schedule and strategy are the most effective method of
reducing pharmaceutical prices for the citizens of the state.
(g) Qualified entities including, but not limited to, licensed
private insurers, self insured employers, free clinics and other
entities who provide pharmaceuticals either directly or through
some form of coverage to the citizens of West Virginia shall have
an option to apply for participation in the program established by
this article in the form and manner established by the council.
The council, in its sole discretion, shall approve or deny
participation through review of documentation determined to be
necessary for full consideration and as established by rule. The
council shall consider, but not be limited to, the fiscal stability and the size of each applicant.
(h) Pharmaceutical manufacturers may request a waiver from
the pricing schedule to be granted by the council for a particular
drug in which the development, production, distribution costs,
other reasonable costs and reasonable profits, but exclusive of
all marketing and advertising costs as determined by the council,
is more than the pricing schedule rate of the pharmaceutical or in
those cases in which the pharmaceutical in question has a sole
source. The determination of reasonable costs and reasonable
profits may fluctuate between different pharmaceuticals under
consideration by the council. The council shall determine by
legislative rule fees to be paid by the applicant at the time a
waiver request is made and documentation required to be submitted
at the time of the waiver request.
5A-3C-7. Multistate discussion group.
For the purposes of reviewing or amending the program
establishing the process for making pharmaceuticals more available
and affordable to the citizens of West Virginia, the state may
continue to enter into multistate discussions and agreements. For
purposes of participating in these discussions, the state shall be
represented by members of the council created in section eight of
this article.
§5A-3C-8. West Virginia pharmaceutical cost management council.
(a) There is hereby created the West Virginia pharmaceutical cost management council which consists of the secretary of the
department of administration or his or her designee, the director
of the public employees insurance agency or his or her designee,
the commissioner of the bureau of medical services of the
department of health and human resources or his or her designee,
the secretary of the department of health and human resources or
his or her designee, the executive director of the workers'
compensation commission or his or her designee, bureau of senior
services or his or her designee and five members from the public
who shall be appointed by the governor with the advice and consent
of the Senate. One public member shall be a licensed pharmacist
employed by a community retail pharmacy, one public member shall be
a representative of a pharmaceutical manufacturer with substantial
operations located in the state of West Virginia that has at least
seven hundred fifty employees, one public member shall be a primary
care physician, one public member shall represent those who will
receive benefit from the establishment of this program and one
public member shall have experience in the financing, development
or management of a health insurance company which provides
pharmaceutical coverage. Each public member shall serve for a term
of four years. Of the public members of the council first
appointed, one shall be appointed for a term ending the thirtieth
day of June, two thousand six, and two each for terms of three and
four years. Each public member shall serve until his or her successor is appointed and has qualified. A member of the council
may be removed by the governor for cause.
(b) The secretary of the department of administration shall
serve as chairperson of the council, which shall meet at times and
places specified by the chairperson or upon the request of two
members of the council.
(c) Authority members shall not be compensated in their
capacity as members but shall be reimbursed for reasonable expenses
incurred in the performance of their duties.
(d) The council has the power and authority to:
(1) Contract for the purpose of implementing the cost
containment provisions of this article;
(2) File suit;
(3) Execute as permitted by applicable federal law,
prescription drug purchasing agreements with:
(A) All departments, agencies, authorities, institutions,
programs, any agencies or programs of the federal government,
quasi-public corporations and political subdivisions of this state,
including, but not limited to, the children's health insurance
program, the division of corrections, the division of juvenile
services, the regional jail and correctional facility authority,
the workers' compensation fund, state colleges and universities,
public hospitals, state or local institutions, such as nursing
homes, veterans' homes, the division of rehabilitation, public health departments, state programs, including, but not limited to,
programs established in sections four and five of this article, and
the bureau of medical services: Provided, That any contract or
agreement executed with or on behalf of the bureau of medical
services shall contain all necessary provisions to comply with the
provisions of Title XIX of the Social Security Act, 42 U. S. C.
§1396 et seq., dealing with pharmacy services offered to recipients
under the medical assistance plan of West Virginia;
(B) Governments of other states and jurisdictions and their
individual departments, agencies, authorities, institutions,
programs, quasi-public corporations and political subdivisions; and
(C) Regional or multi-state purchasing alliances or consortia,
formed for the purpose of pooling the combined purchasing power of
the individual members in order to increase bargaining power; and
(4) Consider strategies by which West Virginia may manage the
increasing costs of prescription drugs and increase access to
prescription drugs for all of the state's citizens, including the
authority to:
(A) Explore the enactment of fair prescription drug pricing
policies;
(B) Explore discount prices or rebate programs for seniors and
persons without prescription drug coverage;
(C) Explore programs offered by pharmaceutical manufacturers
that provide prescription drugs for free or at reduced prices;
(D) Explore requirements and criteria, including the level of
detail, for prescription drug manufacturers to disclose to the
council expenditures for advertising, marketing and promotion,
based on aggregate national data;
(E) Explore the establishment of counter-detailing programs
aimed at educating health care practitioners authorized to
prescribe prescription drugs about the relative costs and benefits
of various prescription drugs, with an emphasis on generic
substitution for brand name drugs when available and appropriate;
prescribing older, less costly drugs instead of newer, more
expensive drugs, when appropriate; and prescribing lower dosages of
prescription drugs, when available and appropriate;
(F) Explore disease state management programs aimed at
enhancing the effectiveness of treating certain diseases identified
as prevalent among this state's population with prescription drugs;
(G) Explore prescription drug purchasing agreements with
large private sector purchasers of prescription drugs and including
those private entities in pharmacy benefit management contracts:
Provided, That no private entity may be compelled to participate in
a purchasing agreement;
(H) Explore the feasibility of using or referencing, the
federal supply schedule or referencing to the price, as adjusted
for currency valuations, set by the Canada patented medicine prices
review board ("PMPRB"), or any other appropriate referenced price to establish prescription drug pricing for brand name drugs in the
state; and to review and determine the dispensing fees for
pharmacies in such as established in section six of this article;
(I) Explore , if possible, joint negotiations for drug
purchasing and a shared prescription drug pricing schedule and
shared preferred drug list for use by the public employees
insurance agency, the medicaid program, other state payors and
private insurers;
(J) Explore coordination between the medicaid program, the
public employees insurance agency and, to the extent possible, in-
state hospitals and private insurers toward the development of a
uniform preferred prescription drug list which is clinically
appropriate and which leverages retail prices;
(K) Explore policies which promote the use of generic drugs,
where appropriate;
(L) Explore a policy that precludes a drug manufacturer from
reducing the amounts of drug rebates or otherwise penalize an
insurer, health plan or other entity which pays for prescription
drugs based upon the fact that the entity uses step therapy or
other clinical programs before a drug is covered or otherwise
authorized for payment;
(M) Explore arrangements with entities in the private
sector, including self-funded benefit plans and nonprofit
corporations, toward combined purchasing of health care services, health care management services, pharmacy benefits management
services or pharmaceutical products on the condition that no
private entity be compelled to participate in the prescription drug
purchasing pool; and
(N) Explore other strategies, as permitted under state and
federal law, aimed at managing escalating prescription drug prices
and increasing affordable access to prescription drugs for all West
Virginia citizens;
(5) Contract with appropriate legal, actuarial and other
service providers required to accomplish any function within the
powers of the council;
(6) Develop other strategies, as permitted under state and
federal law, aimed at managing escalating prescription drug prices
and increasing affordable access to prescription drugs for all West
Virginia citizens;
(7) Explore the licensing and regulation of pharmaceutical
detailers, including the requirement of continuing professional
education, the imposition of fees for licensing and continuing
education, the establishment of a special revenue account for
deposit of the fees and the imposition of penalties for
noncompliance with licensing and continuing education requirements,
and rules to establish procedures to implement the provisions of
the subdivision;
(8) The council shall report to the Legislature's joint committee on government and finance on or before the first day of
September, two thousand four, and report on or before the thirty-
first day of December, two thousand four, and annually thereafter
to the Legislature, and provide recommendations to the Legislature
on needed legislative action and other functions established by the
article or requested by the joint committee on government and
finance of the Legislature; and
(9) The council shall, upon the passage of this article,
immediately commence to study the fiscal impact to this state of
the federal "Medicare Prescription Drug Improvement and
Modernization Act of 2003" and shall report to the Legislature's
joint committee on government and finance on or before the
fifteenth day of October, two thousand four, as to the findings of
the council.
(10) The council shall develop an evaluation methodology to
certify and audit savings in the discount savings program by
determining the impact on growth and profit of the pharmaceutical
manufacturers to ensure that prices have not been inflated to
offset the discount card value.
(11) The council shall evaluate the clearinghouse established
by this article and the discount card program established by this
article to report to the Joint Committee on Government and Finance,
and the Legislative Oversight Commission on Health and Human
Resources Accountability, their findings and recommendations for further action by the Legislature.
(12) The council shall further: (1) Review determine that the
implementation of the programs under this article will not
jeopardize, reduce or penalize the benefits of veterans or other
recipients of FSS drug prices, considering their respective co-pay
structures, and the pricing mechanisms of their respective
programs; (2) commence negotiations to obtain independent
agreements or multi-state agreements as many as ten states to use
or reference a pricing schedule as set forth in section six of this
article; (3) and determine the ability to establish a savings of
forty-two percent of the retail cost to be reported to the Joint
Committee on Government and Finance and the Legislative Oversight
Commission on Health and Human Resources Accountability, as
established in section eight of this article.
§5A-3C-9. Investigation of Canadian drugs; wholesaling; federal
waivers.
The council created in section eight of this article and the
director of the public employees insurance agency are authorized to
investigate the feasibility of purchasing prescription drugs from
sources in Canada, which may include the feasibility of the state
or an instrumentality thereof serving as a wholesale distributor of
prescription drugs in the state.
(a) Upon a determination by the council or the director of the
public employees insurance agency that the same is feasible and in the best interests of the citizens of the state, the council or the
director is authorized to pursue waivers from the federal
government, including, but not limited to, from the United States
food and drug administration, as necessary for the state to
accomplish prescription drug purchasing from sources in Canada
provided, however, if a waiver is not granted, the council is
authorized to take necessary legal action.
(b) Upon a favorable finding by the appropriate federal
agencies or courts, notwithstanding any provision of this code to
the contrary, the council or the director of the public employees
insurance agency may establish and implement a methodology to
provide wholesale drugs to licensed pharmacies located within West
Virginia, provided however, prior to the implementation, the
Legislature must adopt a concurrent resolution authorizing such
action.
§5A-3C-10. Director's powers; ability to enter drug purchasing
contracts.
Notwithstanding any provision of this code to the contrary,
nothing contained in this article shall be construed to limit the
powers and authority granted to the director of the public
employees insurance agency pursuant to article sixteen-c, chapter
five of this code. Notwithstanding any provision of this code to
the contrary and specifically subdivision four, subsection (a),
section four, article five-c, chapter five of this code, the director is authorized to execute prescription drug purchasing
agreements without further enactment of the Legislature.
§5A-3C-11. Agency's management ability continued.
Nothing contained in this article shall be construed to limit
the ability of the various state agencies to enter into contracts
or arrangements or to otherwise manage their pharmacy programs
until such time as the programs created or authorized pursuant to
this article are implemented.
§5A-3C-12. Restraint of trade; civil and criminal violations
defined.
(a) The following are considered to restrain trade or commerce
unreasonably and shall be unlawful:
(1) A contract, combination or conspiracy between two or more
persons:
(A) For the purpose or with the intent to fix, control or
maintain the market price, rate or fee of pharmaceuticals; or
(B) Allocate or divide customers or markets, functional or
geographic, for any pharmaceutical.
(2) The establishment, maintenance or use of a monopoly or an
attempt to establish a monopoly of trade or commerce, any part of
which is within this state, by any persons for the purpose of or
with the intent to exclude competition or control, fix or maintain
pharmaceutical prices.
(b) Any person violating the provisions of this section is guilty of a felony and, upon conviction thereof, shall be confined
in a state correctional facility for not less than one nor more
than ten years, or fined in an amount consistent with the Clayton
Act 15 U.S.C. §15 et seq., which may include treble damages, or
both fined and confined.
(c) Any person violating the provisions of this section is
liable for a civil penalty and fine in an amount consistent with
the Clayton Act 15 U.S.C. §15 et seq., which may include treble
damages, for each violation.
(d) The county prosecutor shall investigate suspected
violations of, and institute criminal proceedings pursuant to, the
provisions of this section.
(e) The attorney general or special counsel appointed by the
governor, in his or her discretion, shall represent the state in
all civil proceedings brought on behalf of the state to enforce the
provisions of this section. After payment of all attorney fees and
costs, no less than fifty percent of all judgments or settlements
shall be placed in the general revenue fund of the state.
§5A-3C-13. Advertising costs; reporting of same.
(a) Advertising costs for prescription drugs, based on
aggregate national data, must be reported to the state council by
all manufacturers and labelers of prescription drugs dispensed in
this state that employs, directs or utilizes marketing
representatives. The reporting shall assist this state in its role as a purchaser of prescription drugs and an administrator of
prescription drug programs, enabling this state to determine the
scope of prescription drug advertising costs and their effect on
the cost, utilization and delivery of health care services and
furthering the role of this state as guardian of the public
interest.
(b) The council shall establish, by legislative rule, the
reporting requirements of information by labelers and manufacturers
which shall include all national aggregate expenses associated with
advertising and direct promotion of prescription drugs through
radio, television, magazines, newspapers, direct mail and telephone
communications as they pertain to residents of this state.
(c) The following shall be exempt from disclosure
requirements:
(1) All free samples of prescription drugs intended to be
distributed to patients;
(2) All payments of reasonable compensation and reimbursement
of expenses in connection with a bona fide clinical trial. As used
in this subdivision, "clinical trial" means an approved clinical
trial conducted in connection with a research study designed to
answer specific questions about vaccines, new therapies or new ways
of using known treatments; or
(3) All scholarship or other support for medical students,
residents and fellows to attend significant educational, scientific or policy-making conference of national, regional or specialty
medical or other professional association if the recipient of the
scholarship or other support is selected by the association.
(d) The council is further authorized to establish time lines,
the documentation, form and manner of reporting required as the
council determines necessary to effectuate the purpose of this
article. The council shall report to the joint committee on
government and finance, in an aggregate form, the information
provided in the required reporting.
(e) Notwithstanding any provision of law to the contrary,
information submitted to the council pursuant to this section is
confidential and is not a public record and is not available for
release pursuant to the West Virginia freedom of information act.
Data compiled in aggregate form by the council for the purposes of
reporting required by this section is a public record as defined in
the West Virginia freedom of information act, as long as it does
not reveal trade information that is protected by state or federal
law.
§5A-3C-14. State role.
For purpose of implementing this article, the state
represented by the council shall have authority to negotiate
pharmaceutical prices to be paid by program participants. These
negotiated prices shall be available to all programs.
§5A-3C-15. Rulemaking.
The council may promulgate emergency rules pursuant to the
provisions of section fifteen, article three, chapter twenty-nine-a
of this code to implement any section of this article.
§5A-3C-16. Sunset provision.
The council shall continue to exist, pursuant to the
provisions of article ten, chapter four of this code, until the
first day of July, two thousand eight, unless sooner terminated,
continued or reestablished pursuant to the provisions of that
article.
§5A-3C-17. Potential use of savings.
Savings identified by all program participants shall be
quantified and certified to the council and included in the annual
report of the council to the Legislature provided for in section
eight of this article. Savings, or any part thereof, created by the
implementation of this program may, in the sole discretion of the
Legislature, be directed towards the maintenance of existing state
health programs and the expansion of insurance programs for the
uninsured and underinsured.