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78R1277 CLG-D
By: Delisi H.B. No. 1804
A BILL TO BE ENTITLED
AN ACT
relating to operation of the Medicaid vendor drug program,
including the adoption of a preferred drug list and the negotiation
of supplemental drug rebates.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subchapter B, Chapter 32, Human Resources Code,
is amended by adding Sections 32.0462-32.0467 to read as follows:
Sec. 32.0462. PHARMACY BENEFIT MANAGER FOR VENDOR DRUG
PROGRAM. (a) In this section, "pharmacy benefit manager" has the
meaning assigned by Section 1, Article 21.07-6, Insurance Code.
(b) The Health and Human Services Commission shall contract
with a pharmacy benefit manager or other entity that has experience
in the development of preferred drug lists or in negotiating
supplemental rebates with pharmaceutical manufacturers to
administer all or part of the vendor drug program.
Sec. 32.0463. SUPPLEMENTAL MEDICAL ASSISTANCE REBATES. (a)
In this section:
(1) "Labeler" means a person that:
(A) has a labeler code from the United States
Food and Drug Administration under 21 C.F.R. Section 207.20; and
(B) receives prescription drugs from a
manufacturer or wholesaler and repackages those drugs for later
retail sale.
(2) "Manufacturer" means a manufacturer of
prescription drugs as defined by 42 U.S.C. Section 1396r-8(k)(5),
as amended, including a subsidiary or affiliate of a manufacturer.
(3) "Wholesaler" means a person licensed under
Subchapter I, Chapter 431, Health and Safety Code.
(b) The Health and Human Services Commission shall
negotiate with manufacturers and labelers to obtain supplemental
medical assistance rebates for prescription drugs sold in this
state.
(c) A manufacturer or labeler that sells prescription drugs
in this state may voluntarily negotiate with the Health and Human
Services Commission and enter into an agreement to provide
supplemental medical assistance rebates for prescription drugs
provided under the vendor drug program in excess of the rebates
required by 42 U.S.C. Section 1396r-8, as amended.
(d) In negotiating terms for a supplemental medical
assistance rebate amount, the Health and Human Services Commission
shall consider:
(1) rebates calculated under the medical assistance
rebate program in accordance with 42 U.S.C. Section 1396r-8, as
amended; and
(2) any other available information on prescription
drug prices or rebates.
Sec. 32.0464. CONFIDENTIALITY OF REBATES, PRICING, AND
NEGOTIATIONS. Information obtained or maintained by the Health and
Human Services Commission regarding supplemental medical
assistance rebate negotiations or a supplemental medical
assistance rebate agreement, including trade secrets, rebate
amount, rebate percentage, and manufacturer or labeler pricing, is
confidential and not subject to disclosure under Chapter 552,
Government Code.
Sec. 32.0465. PREFERRED DRUG LIST FOR VENDOR DRUG PROGRAM.
(a) The Health and Human Services Commission shall adopt a
preferred drug list for the vendor drug program. In making a
decision regarding the placement of a drug on the preferred drug
list, the commission shall consider:
(1) the recommendations of the Medical Assistance
Pharmaceutical and Therapeutics Committee established under
Section 32.0467;
(2) the clinical efficacy of the drug; and
(3) the price of competing drugs after deducting any
federal and state rebate amounts.
(b) The commission shall provide for distribution of
current copies of the preferred drug list to all appropriate
providers of medical assistance in this state.
(c) In this subsection, "labeler" and "manufacturer" have
the meanings assigned by Section 32.0463. The commission shall
ensure that:
(1) a manufacturer or labeler that reaches an
agreement with the commission on supplemental medical assistance
rebates under Section 32.0463 has an opportunity to provide written
evidence supporting inclusion of a drug on the preferred drug list;
and
(2) any drug that has been approved or has had any of
its particular uses approved by the United States Food and Drug
Administration under a priority review classification will be
reviewed by the Medical Assistance Pharmaceutical and Therapeutics
Committee at the next regularly scheduled meeting of the committee.
On receiving notice from a manufacturer or labeler of the
availability of a new product, the commission, to the extent
possible, shall schedule a review for the product at the next
regularly scheduled meeting of the committee.
(d) A recipient of drug benefits under the vendor drug
program may use the Medicaid fair hearing process to appeal a
preferred drug list decision made by the commission.
Sec. 32.0466. PRIOR AUTHORIZATION UNDER THE VENDOR DRUG
PROGRAM. (a) The Health and Human Services Commission, in its
rules and standards governing the vendor drug program, shall
require prior authorization for the reimbursement of a drug that is
not included in the preferred drug list adopted under Section
32.0465, except for antiretroviral drugs and any drug exempted from
prior authorization requirements by federal law and except as
provided by Subdivision (4). The commission shall establish
procedures for the prior authorization requirement to ensure that:
(1) there will be a response to a request for prior
authorization by telephone or other telecommunications device
within 24 hours after receipt of a request for prior authorization
from the prescribing physician;
(2) a 72-hour supply of the drug prescribed will be
provided in an emergency or if the commission does not provide a
response within the time required by Subdivision (1);
(3) prior authorization is sought by the prescribing
physician and not by the pharmacy; and
(4) a recipient of medical assistance who is being
treated with a mental health-related drug at the time the
commission adopts a preferred drug list under Section 32.0465 that
does not include the drug continues to receive the medication after
the adoption of the list without obtaining prior authorization
under this section.
(b) The Medical Assistance Pharmaceutical and Therapeutics
Committee may make recommendations for the commission's
consideration regarding a prior authorization requirement for any
drug covered by the vendor drug program.
Sec. 32.0467. MEDICAL ASSISTANCE PHARMACEUTICAL AND
THERAPEUTICS COMMITTEE. (a) The Medical Assistance Pharmaceutical
and Therapeutics Committee is established for the purposes of
developing recommendations for a preferred drug list for the vendor
drug program.
(b) The committee consists of the following members
appointed by the governor:
(1) five physicians licensed under Subtitle B, Title
3, Occupations Code;
(2) five pharmacists licensed under Subtitle J, Title
3, Occupations Code; and
(3) one public member.
(c) In making appointments to the committee under
Subsection (b), the governor shall ensure that the committee
includes physicians or pharmacists participating in the medical
assistance program who:
(1) provide services to all segments of the program's
diverse population; and
(2) have experience in either developing or practicing
under a preferred drug list.
(d) A member of the committee is appointed for a two-year
term and may serve more than one term.
(e) The committee shall elect a presiding officer and an
assistant presiding officer from its membership, and each officer
shall serve a one-year term.
(f) The committee shall meet at least quarterly at the call
of the presiding officer.
(g) A member of the committee may not receive compensation
for serving on the committee but is entitled to reimbursement for
reasonable and necessary travel expenses incurred by the member
while conducting the business of the committee, as provided by the
General Appropriations Act.
(h) In developing its recommendations for the preferred
drug list, the committee shall consider the clinical efficacy,
safety, and cost-effectiveness of a product.
(i) The Health and Human Services Commission shall adopt
rules governing the operation of the committee, including rules
governing the procedures used by the committee for providing notice
of a meeting. The committee shall comply with the rules adopted
under this subsection.
(j) To the extent feasible, the committee shall review all
drug classes included in the preferred drug list adopted under
Section 32.0465 at least once every 12 months and may recommend
inclusions to and exclusions from the list to ensure that the list
provides for cost-effective medically appropriate drug therapies
for recipients of medical assistance.
(k) The committee shall conduct a closed meeting to consider
or discuss the negotiations of a supplemental medical assistance
rebate agreement under Section 32.0463 or any other information
relating to supplemental medical assistance rebates, including
trade secrets, rebate amount, rebate percentage, and manufacturer
or labeler pricing.
(l) The Health and Human Services Commission shall provide
administrative support and resources as necessary for the committee
to perform its duties under this section and Section 32.0466.
(m) Chapter 2110, Government Code, does not apply to the
committee.
SECTION 2. If before implementing any provision of this Act
a state agency determines that a waiver or other authorization from
a federal agency is necessary for implementation, the state agency
shall request the waiver or authorization and may delay
implementing that provision until the waiver or authorization is
granted.
SECTION 3. Not later than November 1, 2003, the governor
shall appoint members to the Medical Assistance Pharmaceutical and
Therapeutics Committee established under Section 32.0467, Human
Resources Code, as added by this Act.
SECTION 4. Not later than January 1, 2004, the Health and
Human Services Commission shall implement Section 32.0463, Human
Resources Code, as added by this Act.
SECTION 5. (a) Not later than January 1, 2004, the Medical
Assistance Pharmaceutical and Therapeutics Committee established
under Section 32.0467, Human Resources Code, as added by this Act,
shall submit recommendations for the preferred drug list the
committee is required to develop under that section to the Health
and Human Services Commission.
(b) Not later than March 1, 2004, the Health and Human
Services Commission shall adopt the preferred drug list as required
by Section 32.0465, Human Resources Code, as added by this Act.
SECTION 6. This Act takes effect September 1, 2003.