H. B. 3176
(By Delegates Stemple, Spencer, Long,
H. White and Ashley)
[Introduced February 21, 2003; referred to the
Committee on Health and Human Resources then Government
Organization.]
A BILL to amend and reenact section fifteen, article five, chapter
nine of the code of West Virginia, one thousand nine hundred
thirty-one, as amended; and to further amend said article by
adding thereto two new sections, designated sections fifteen-a
and fifteen-b, all relating to selection of prescription drugs
for inclusion on the medicaid preferred drug list based on
safety, effectiveness and clinical outcomes; prescription
drugs to be dispensed as written; new prescription drugs to be
added to medicaid preferred drug list when commercially
available for a period of at least six months; exemption of
certain prescription drugs used for treatment of mental
illness, HIV and AIDS, and exemption of certain medicaid
patients from prior authorization requirements incident to the
medicaid preferred drug list; and requiring pharmacists to
dispense prescription medications in accordance with
instructions from the prescriber.
Be it enacted by the Legislature of West Virginia:
That section fifteen, article five, chapter nine of the code
of West Virginia, one thousand nine hundred thirty-one, as amended,
be amended and reenacted; and that said article be further amended
by adding thereto two new sections, designated sections fifteen-a
and fifteen-b, all to read as follows:
ARTICLE 5. MISCELLANEOUS PROVISIONS.
§9-5-15. Medicaid program; preferred drug list and drug
utilization review.
The Legislature finds that it is a public necessity that trade
secrets, rebate amounts, percentage of rebate, manufacturer's
pricing and supplemental rebates that are contained in records, as
well as any meetings at which this information is negotiated or
discussed need confidentiality to insure the most significant
rebates available for the state. Information pertaining to similar
agreements with the federal government and negotiated by
pharmaceutical manufacturers is confidential pursuant to 42 U.S.C.
1396r-8. A rebate as a percentage of average manufacture price is
confidential under federal law and the federal rebate could be made
known if not protected by state law. Because of the protection
afforded by federal law, if this information is not protected by
state law, manufacturers will not be willing to offer a rebate in
West Virginia. Further, the Legislature finds that the number and
value of supplemental rebates obtained by the department will increase, to the benefit of Medicaid recipients, if information
related to the supplemental rebates is protected in the records of
the department and in meetings in which this information is
disclosed because manufacturers will be assured they will not to be
placed at a competitive disadvantage by exposure of this
information.
The secretary of the department of health and human resources
has the authority to develop a preferred drug list, in accordance
with federal law, which shall consist of federally approved drugs.
The department, through administration of the medicaid program, may
reimburse, where applicable and in accordance with federal law,
entities providing and dispensing prescription drugs from the
preferred drug list. Selection of a prescription drug for
inclusion on the preferred drug list shall be based first and
foremost upon clinical criteria. Decisions concerning clinical
effectiveness of prescription drugs are to be made by licensed
health practitioners, informed by the latest peer-reviewed
research. All interested parties shall have a meaningful
opportunity to present clinical data, and the secretary shall
proactively seek comments about proposed implementation or
modification of the preferred drug list from voluntary health
associations representing patients or specific disease areas. The
secretary shall consult with prescription drug manufacturers
regarding the establishment, implementation or modification of a preferred drug list. The secretary shall evaluate drugs and drug
classes for inclusion in the medicaid preferred drug list based on
safety, effectiveness and clinical outcomes of treatments. In
addition, the secretary shall evaluate drugs and drug classes to
determine whether the inclusion of such drugs or drug classes in a
starter dose program would be clinically efficacious and cost
effective. If the factors of safety, effectiveness and clinical
outcomes among drugs being considered in the same class indicate no
therapeutic advantage, then the secretary shall consider the cost
effectiveness and the net economic impact of the inclusion of such
drugs on the medicaid preferred drug list. Drugs which do not have
significant, clinically meaningful therapeutic advantage in terms
of safety, effectiveness or clinical outcomes over other drugs in
the same class which have been selected for the preferred drug list
may be excluded from the preferred drug list, and may be made
subject to prior authorization in accordance with state and federal
law, except where a prescriber has personally written "dispense as
written" or "DAW" or has signed the prescriber's name on the
"dispense as written" signature line.
Any prescription drug approved by the United States Food and
Drug Administration shall be added to the preferred drug list as
soon as it becomes commercially available. The secretary shall
conduct an evidence-based analysis of the drug to determine if the
drug shall be maintained on the preferred drug list. The analysis shall include, but not be limited to, the medical evidence of the
clinical effectiveness of the drug as well as evidence of the
cost-effectiveness of the drug in treating illness and disease. In
order to allow the development of meaningful data on the
utilization of a new product, the determination by the secretary on
any new drug approved by the United States Food and Drug
Administration shall be made no earlier than six months after the
drug becomes commercially available.
The secretary of the department is hereby authorized to
negotiate and enter into agreements with pharmaceutical
manufacturers for supplemental rebates for medicaid reimbursable
drugs.
The provisions of article three, chapter five-a of this code
shall not apply to any contract or contracts entered into under
this section.
Trade secrets, rebate amounts, percentage of rebate,
manufacturer's pricing and supplemental rebates which are contained
in the department's records and those of its agents with respect to
supplemental rebate negotiations and which are prepared pursuant to
a supplemental rebate agreement are confidential and exempt from
all of article one, chapter twenty-nine-b of this code.
Those portions of any meetings of the committee at which trade
secrets, rebate amounts, percentage of rebate, manufacturer's
pricing and supplemental rebates are disclosed for discussion or negotiation of a supplemental rebate agreement are exempt from all
of article nine-a, chapter six of this code.
The secretary of the department will monitor and evaluate the
effects of this provision on medicaid recipients, the medicaid
program, physicians and pharmacies.
The commissioner shall implement a drug utilization review
program to assure that prescribing and dispensing of drug products
result in the most rational cost-effective medication therapy for
medicaid patients.
Any moneys received in supplemental rebates will be deposited
in the medical services fund established in section two, article
four, chapter nine of this code.
§9-5-15a. Exemptions from medicaid preferred drug list; continuity
of care.
Drugs prescribed for medicaid patients who are residents of
nursing homes and other institutional residents, that are not
included on the medicaid preferred drug list, shall not be subject
to prior authorization and shall be available to such residents on
an unrestricted basis.
The following classes of prescription drugs shall be exempt
from the prior authorization requirements incident to the medicaid
preferred drug list, and shall be available to medicaid patients on
an unrestricted basis:
(a) Medications used to treat mental illnesses, behavior
disorders or disorders of the brain, such as schizophrenia, severe
depression or bipolar disorder, including all atypical
antipsychotic medications, conventional antipsychotic medications,
selective serotonin reuptake inhibitors, and other medications used
for the treatment of such illnesses;
(b) Medications approved by the United States Food and Drug
Administration when used for the treatment of HIV and AIDS,
including, without limitation, anti-retro viral prescription drug
medications;
Any medicaid patient who is stabilized on a prescription drug
medication prescribed by a health care provider prior to the
implementation of the medicaid preferred drug list as it relates to
the class of prescription drugs that includes the drug upon which
the patient is stabilized, is exempted from any prior authorization
requirements related to the medicaid preferred drug list
implemented by the secretary.
§9-5-15b. Pharmacist to dispense in accordance with instructions
from prescriber.
Except as provided in this section, it shall be unlawful for
any pharmacist, assistant pharmacist or pharmacist intern who
dispenses prescriptions, drugs and medicines to substitute an
article different from the one ordered, or deviate in any manner from the requirement of an order or prescription without the
approval of the prescriber.
(1) When a pharmacist receives a written prescription on which
the prescriber has personally written in handwriting "dispense as
written" or "DAW", or signed by the prescriber on the "dispense as
written" signature line, or an oral prescription in which the
prescriber has expressly indicated that the prescription is to be
dispensed as communicated, the pharmacist shall dispense the brand
name legend drug as prescribed.
(2) When a pharmacist receives a written prescription on which
the prescriber has not personally written in handwriting "dispense
as written" or "DAW", or has not signed on the "dispense as
written" signature line, or an oral prescription in which the
prescriber has not expressly indicated that the prescription is to
be dispensed as communicated, and there is available in the
pharmacist's stock a less expensive generically equivalent drug
that is rated equivalent by the United States Food and Drug
Administration and in the pharmacist's professional judgment, is
safely interchangeable with the prescribed drug, then the
pharmacist, after disclosing the substitution to the purchaser,
shall dispense the generic drug, unless the purchaser objects. A
pharmacist may also substitute pursuant to the oral instructions of
the prescriber. A pharmacist shall notify the purchaser if the pharmacist is dispensing a drug other than the brand name drug
prescribed.
NOTE: The purpose of this bill is to expand unrestricted
access to prescription drugs for medicaid patients by requiring
that prescription drugs be selected for inclusion on the medicaid
preferred drug list based first and foremost upon their therapeutic
effectiveness, safety and clinical outcomes; that newly approved
prescription drugs be automatically added to the medicaid preferred
drug list for at least six months; that prescription drugs be
dispensed by pharmacists in accordance with the instructions of the
prescriber; providing exemption from prior authorization for
prescription drugs used to treat HIV, AIDS and severe mental
illness, and for medicaid patients resident in nursing homes or
other institutionalized care facilities; and providing continuity
of care for stabilized medicaid patients.
Strike-throughs indicate language that would be stricken from
the present law, and underscoring indicates new language that would
be added.
§§9-5-15a and 15b are new, therefore, strike-throughs and
underscoring have been omitted.