05 LC 33
0578
Senate
Bill 85
By: Senators Tate of the 38th, Butler of the 55th, Seay of the 34th, Miles of the 43rd, Jones of the 10th and others
By: Senators Tate of the 38th, Butler of the 55th, Seay of the 34th, Miles of the 43rd, Jones of the 10th and others
A
BILL TO BE ENTITLED
AN ACT
AN ACT
To
amend Title 31 of the Official Code of Georgia Annotated, relating to health, so
as to establish the Georgia Rx Program to reduce prescription drug prices for
residents of this state; to provide a short title; to provide for legislative
intent; to provide definitions; to provide for operation of the program; to
establish the amount of rebates; to require disclosure of savings to program
enrollees; to require drug manufacturers who sell prescription drugs to the
state to enter into a rebate agreement; to provide for the commissioner of
community health to negotiate rebates with drug manufacturers; to require retail
pharmacies that participate in the program to discount the price of drugs
covered by a rebate agreement; to provide for participating pharmacies to submit
claims and receive reimbursement for discounted prices; to provide for the
collection of utilization data; to provide for the disclosure of the names of
manufacturers who do not enter into rebate agreements; to provide for resolution
of discrepancies in rebate amounts; to establish a dedicated fund for rebates;
to provide for reports; to provide for outreach efforts; to authorize the
adoption of rules and regulations; to repeal conflicting laws; and for other
purposes.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
SECTION
1.
Title
31 of the Official Code of Georgia Annotated, relating to health, is amended by
adding at the end a new chapter to read as follows:
"CHAPTER
46
31_46_1.
This
chapter shall be known and may be cited as the 'Georgia Rx Act.'
31_46_2.
The
General Assembly finds that affordability is critical in providing access to
prescription drugs for uninsured residents of this state. Since the state is
currently utilizing pharmacy benefit managers for a variety of programs, the
state may effectively and practically act as a market participant on behalf of
all uninsured residents. It is the intent of the General Assembly to create a
prescription drug program to enable the state to act as a pharmacy benefit
manager in order to make prescription drugs more affordable for qualified
residents of this state and to improve their overall health and quality of life
through negotiating voluntary rebates with prescription drug
companies.
31_46_3.
As
used in this chapter, the term:
(1)
'Average wholesale price' means the wholesale price charged on a specific
commodity that is assigned by the drug manufacturer and is listed in a
nationally recognized drug pricing file.
(2)
'Commissioner' means the commissioner of community health.
(3)
'Department' means the Department of Community Health.
(4)
'Discounted price' means a discounted price that is equal to the
manufacturer´s rebate obtained by the state less any administrative
fees.
(5)
'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 under 21
C.F.R. Section 207.20 (1999).
(6)
'Manufacturer' means a manufacturer of prescription drugs as defined in 42
U.S.C. Section 1396r-8(k)(5), including a subsidiary or affiliate of a
manufacturer.
(7)
'Participating retail pharmacy' or 'retail pharmacy' means a retail pharmacy
located in this state or another business licensed to dispense prescription
drugs in this state that participates in the state Medicaid program or
voluntarily agrees to participate in the program provided in this
chapter.
(8)
'Pharmacy benefit manager' means an entity that procures prescription drugs at a
negotiated rate under a contract.
(9)
'Program' means the Georgia Rx Program.
(10)
'Qualified resident' means a person who:
(A)
Either:
(i)
Is 55 years of age or older;
(ii)
Is eligible for assistance under the medicare program; or
(iii)
Has a net family income below 350 percent of the federal poverty level;
(B)
Has been a resident of this state for at least12 months;
(C)
Has no insurance coverage for prescription drugs;
(D)
Is not qualified for the state´s Medicaid program; and
(E)
Has obtained a program card from the department.
(11)
'Rebate' means the rebate supplied to the state by a drug manufacturer which
shall be sufficient to cover the administrative costs of the program to the
department as well as the discount provided to retail pharmacies.
31_46_4.
(a)
The Georgia Rx Program is established with the department to lower prescription
drug prices for qualified residents of this state through the negotiation of
discounts and rebates with drug manufacturers or labelers.
(b)
A drug manufacturer or labeler that sells prescription drugs in this state
through any publicly supported pharmaceutical assistance program shall enter
into a rebate agreement with the department for the program. The rebate
agreement shall require the manufacturer or labeler to make rebate payments to
the state each calendar quarter or according to a schedule established by the
department.
(c)
The commissioner shall negotiate the amount of the rebate required from a
manufacturer or labeler in accordance with this subsection:
(1)
The commissioner shall take into consideration the rebate calculated under the
Medicaid Drug Rebate Program pursuant to 42 U.S.C. Section 1396r-8, the price
provided to eligible entities under 42 U.S.C. Section 256b, the average
wholesale price of prescription drugs, and any other information on prescription
drug prices, discounts, and rebates; and
(2)
The commissioner shall use his or her best efforts to obtain an amount equal to
or greater than the amount of any discount, rebate, or price reduction for
prescription drugs provided to the federal government.
(d)
Retail pharmacies or other businesses licensed to dispense prescription drugs
located in this state that participate in the state Medicaid program shall
participate in this program.
(e)
No later than January 1, 2006, any participating retail pharmacy that sells
prescription drugs covered by a rebate agreement pursuant to this Code section
shall discount the retail price of those drugs sold to qualified residents as
follows:
(1)
The department shall establish discounted prices for drugs covered by a rebate
agreement and shall promote the use of efficacious and reduced-cost drugs,
taking into consideration reduced prices for state and federally capped drug
programs, differential dispensing fees, administrative overhead, and incentive
payments; and
(2)
In determining the amount of discounted prices, the department shall consider an
average of all rebates provided pursuant to this Code section, weighted by sales
of drugs subject to these rebates over the most recent 12 month period for which
the information is available.
31_46_5.
The
State Board of Pharmacy shall adopt rules and regulations pursuant to Chapter 13
of Title 50, the 'Georgia Administrative Procedure Act,' requiring disclosure by
participating retail pharmacies to qualified residents of the amount of savings
provided as a result of the Georgia Rx Program. The rules and regulations must
consider and protect information that is proprietary in nature.
31_46_6.
(a)
The department may not impose transaction charges under the program on retail
pharmacies that submit claims or receive payments under the
program.
(b)
A participating retail pharmacy shall submit claims to the department to verify
the amount charged to qualified residents.
(c)
On a biweekly basis, the department shall reimburse a participating retail
pharmacy for discounted prices provided to qualified residents and professional
fees. The professional fee shall be no less than $3.00 per
prescription.
(d)
The department shall collect utilization data from the participating retail
pharmacies submitting claims necessary to calculate the amount of the rebate
from the manufacturer or labeler. The department shall protect the
confidentiality of all information obtained under the program to the extent
provided by state or federal law, rule, or regulation.
31_46_7.
(a)
The names of manufacturers and labelers who do not enter into rebate agreements
pursuant to this chapter are public information and shall be released to health
care providers and the public.
(b)
The commissioner shall provide the General Assembly with an annual report of the
names of manufacturers and labelers who have entered into rebate agreements as
well as the names of manufacturers and labelers who have not entered into rebate
agreements pursuant to this chapter.
31-46-8.
(a)
The names of retail pharmacies and other businesses licensed to dispense
prescription drugs in this state who do not participate in the program under
this chapter are public information and shall be released to health care
providers and the public.
(b)
The commissioner shall provide the General Assembly with an annual report of the
names of retail pharmacies and other businesses licensed to dispense
prescription drugs in this state that do and that do not participate in the
program under this chapter.
31_46_9.
Discrepancies
in rebate amounts shall be resolved using the following process:
(1)
If there is a discrepancy in the manufacturer´s or labeler´s favor
between the amount claimed by a pharmacy and the amount rebated by the
manufacturer or labeler, the department, at the department´s expense, may
hire a mutually agreed upon independent auditor. If a discrepancy still exists
following the audit, the manufacturer or labeler shall justify the reason for
the discrepancy or make payment to the department for any additional amount
due;
(2)
If there is a discrepancy against the interest of the manufacturer or labeler in
the information provided by the department to the manufacturer or labeler
regarding the manufacturer´s or labeler´s rebate, the manufacturer or
labeler, at the manufacturer´s or labeler´s expense, may hire a
mutually agreed upon independent auditor to verify the accuracy of the data
supplied to the department. If a discrepancy still exists following the audit,
the department shall justify the reason for the discrepancy or refund to the
manufacturer or labeler any excess payment made by the manufacturer or labeler;
and
(3)
Following the procedures established in paragraphs (1) and (2) of this Code
section, either the department or the manufacturer or labeler may request a
hearing pursuant to the rules and regulations of the department and the Office
of State Administrative Hearings.
31_46_10.
The
Georgia Rx Dedicated Fund is established to receive revenue from manufacturers
and labelers who pay rebates as provided in this chapter. The purposes of the
fund are to reimburse retail pharmacies for discounted prices provided to
qualified residents pursuant to this chapter; to reimburse the department for
contracted services, administrative and associated computer costs, professional
fees paid to participating retail pharmacies, and other reasonable program
costs; and to benefit the program.
31_46_11.
The
department shall report the enrollment and financial status of the program to
the General Assembly by the second week of each regular legislative
session.
31_46_12.
(a)
The department shall establish simplified procedures for determining eligibility
and issuing program enrollment cards to qualified residents and shall undertake
outreach efforts to the extent funds are appropriated and made available to
build public awareness of the program and maximize enrollment of qualified
residents. The department shall be authorized to charge qualified residents an
annual enrollment fee not to exceed $15.00.
(b)
The department may adjust the requirements and terms of the program to
accommodate any new federally funded prescription drug program.
(c)
The department may enter into alliances and develop regional strategies with the
governments of other jurisdictions and with other public and private entities
for the purpose of reducing prescription drug prices under this
chapter.
31_46_13.
The
department may contract with a third party or third parties to administer any or
all components of the program, including, but not limited to, outreach,
eligibility, claims, administration, and rebate recovery and
distribution.
31_46_14.
The
department shall administer the program in a manner that is advantageous to the
program and the enrollees in the program. In implementing this chapter, the
department may coordinate with other programs and may take actions to enhance
efficiency, reduce the cost of prescription drugs, and maximize the benefits of
the program to enrollees.
31_46_15.
The
department may adopt rules and regulations pursuant to Chapter 13 of Title 50,
the 'Georgia Administrative Procedure Act,' to implement the provisions of this
chapter.
31_46_16.
The
department may seek any waivers of federal law, rule, or regulation necessary to
implement the provisions of this
chapter."
SECTION
2.
All
laws and parts of laws in conflict with this Act are repealed.