SENATE AMENDMENT
Bill No. CS for CS for SB 792
Amendment No. ___ Barcode 885628
CHAMBER ACTION
Senate House
.
.
1 .
.
2 .
.
3 .
.
4 ______________________________________________________________
5
6
7
8
9
10 ______________________________________________________________
11 Senator Silver moved the following amendment:
12
13 Senate Amendment (with title amendment)
14 On page 24, line 29, through page 30, line 26, delete
15 those lines
16
17 and insert:
18 Section 8. Section 409.91195, Florida Statutes, is
19 amended to read:
20 409.91195 Medicaid Pharmaceutical and Therapeutics
21 Committee.--There is created a Medicaid Pharmaceutical and
22 Therapeutics Committee within the Agency for Health Care
23 Administration for the purpose of developing a preferred drug
24 formulary pursuant to 42 U.S.C. s. 1396r-8. The committee
25 shall develop and implement a voluntary Medicaid preferred
26 prescribed drug designation program. The program shall provide
27 information to Medicaid providers on medically appropriate and
28 cost-efficient prescription drug therapies through the
29 development and publication of a voluntary Medicaid preferred
30 prescribed-drug list.
31 (1) The Medicaid Pharmaceutical and Therapeutics
1
8:28 PM 05/02/01 s0792c2c-38rjg
SENATE AMENDMENT
Bill No. CS for CS for SB 792
Amendment No. ___ Barcode 885628
1 Committee shall be comprised as specified in 42 U.S.C. s.
2 1396r-8 and consist of eleven members appointed by the
3 Governor. Four members shall be physicians, licensed under
4 chapter 458; one member licensed under chapter 459; five
5 members shall be pharmacists licensed under chapter 465; and
6 one member shall be a consumer representative. of nine members
7 appointed as follows: one practicing physician licensed under
8 chapter 458, appointed by the Speaker of the House of
9 Representatives from a list of recommendations from the
10 Florida Medical Association; one practicing physician licensed
11 under chapter 459, appointed by the Speaker of the House of
12 Representatives from a list of recommendations from the
13 Florida Osteopathic Medical Association; one practicing
14 physician licensed under chapter 458, appointed by the
15 President of the Senate from a list of recommendations from
16 the Florida Academy of Family Physicians; one practicing
17 podiatric physician licensed under chapter 461, appointed by
18 the President of the Senate from a list of recommendations
19 from the Florida Podiatric Medical Association; one trauma
20 surgeon licensed under chapter 458, appointed by the Speaker
21 of the House of Representatives from a list of recommendations
22 from the American College of Surgeons; one practicing dentist
23 licensed under chapter 466, appointed by the President of the
24 Senate from a list of recommendations from the Florida Dental
25 Association; one practicing pharmacist licensed under chapter
26 465, appointed by the Governor from a list of recommendations
27 from the Florida Pharmacy Association; one practicing
28 pharmacist licensed under chapter 465, appointed by the
29 Governor from a list of recommendations from the Florida
30 Society of Health System Pharmacists; and one health care
31 professional with expertise in clinical pharmacology appointed
2
8:28 PM 05/02/01 s0792c2c-38rjg
SENATE AMENDMENT
Bill No. CS for CS for SB 792
Amendment No. ___ Barcode 885628
1 by the Governor from a list of recommendations from the
2 Pharmaceutical Research and Manufacturers Association. The
3 members shall be appointed to serve for terms of 2 years from
4 the date of their appointment. Members may be appointed to
5 more than one term. The Agency for Health Care Administration
6 shall serve as staff for the committee and assist them with
7 all ministerial duties. The Governor shall ensure that at
8 least some of the members of the Medicaid Pharmaceutical and
9 Therapeutics Committee represent Medicaid participating
10 physicians and pharmacies serving all segments and diversity
11 of the Medicaid population, and have experience in either
12 developing or practicing under a preferred drug formulary. At
13 least one of the members shall represent the interests of
14 pharmaceutical manufacturers.
15 (2) Committee members shall select a chairperson and a
16 vice chairperson each year from the committee membership.
17 (3) The committee shall meet at least quarterly and
18 may meet at other times at the discretion of the chairperson
19 and members. The committee shall comply with rules adopted by
20 the agency, including notice of any meeting of the committee
21 pursuant to the requirements of the Administrative Procedure
22 Act.
23 (4) Upon recommendation of the Medicaid Pharmaceutical
24 and Therapeutics Committee the agency shall adopt a preferred
25 drug list. To the extent feasible, the committee shall review
26 all drug classes included in the formulary at least every 12
27 months, and may recommend additions to and deletions from the
28 formulary, such that the formulary provides
29 (2) Upon recommendation by the committee, the Agency
30 for Health Care Administration shall establish the voluntary
31 Medicaid preferred prescribed-drug list. Upon further
3
8:28 PM 05/02/01 s0792c2c-38rjg
SENATE AMENDMENT
Bill No. CS for CS for SB 792
Amendment No. ___ Barcode 885628
1 recommendation by the committee, the agency shall add to,
2 delete from, or modify the list. The committee shall also
3 review requests for additions to, deletions from, or
4 modifications of the list. The list shall be adopted by the
5 committee in consultation with medical specialists, when
6 appropriate, using the following criteria: use of the list
7 shall be voluntary by providers and the list must provide for
8 medically appropriate drug therapies for Medicaid patients
9 which achieve cost savings contained in the General
10 Appropriations Act.
11 (5) Except for mental health-related drugs,
12 anti-retroviral drugs, and drugs for nursing home residents
13 and other institutional residents, reimbursement of drugs not
14 included in the formulary is subject to prior authorization.
15 in the Medicaid program.
16 (6)(3) The Agency for Health Care Administration shall
17 publish and disseminate the preferred drug formulary voluntary
18 Medicaid preferred prescribed drug list to all Medicaid
19 providers in the state.
20 (7) The committee shall ensure that pharmaceutical
21 manufacturers agreeing to provide a supplemental rebate as
22 outlined in this chapter have an opportunity to present
23 evidence supporting inclusion of a product on the preferred
24 drug list. Upon timely notice, the agency shall ensure that
25 any drug that has been approved or had any of its particular
26 uses approved by the United States Food and Drug
27 Administration under a priority review classification will be
28 reviewed by the Medicaid Pharmaceutical and Therapeutics
29 Committee at the next regularly scheduled meeting. To the
30 extent possible, upon notice by a manufacturer the agency
31 shall also schedule a product review for any new product at
4
8:28 PM 05/02/01 s0792c2c-38rjg
SENATE AMENDMENT
Bill No. CS for CS for SB 792
Amendment No. ___ Barcode 885628
1 the next regularly scheduled Medicaid Pharmaceutical and
2 Therapeutics Committee.
3 (8) Until the Medicaid Pharmaceutical and Therapeutics
4 Committee is appointed and a preferred drug list adopted by
5 the agency, the agency shall use the existing voluntary
6 preferred drug list adopted pursuant to Chapter 2000-367,
7 Section 72, Laws of Florida. Drugs not listed on the voluntary
8 preferred drug list will require prior authorization by the
9 agency or its contractor.
10 (9) The Medicaid Pharmaceutical and Therapeutics
11 Committee shall develop its preferred drug list
12 recommendations by considering the clinical efficacy, safety,
13 and cost effectiveness of a product. When the preferred drug
14 formulary is adopted by the agency, if a product on the
15 formulary is one of the first four brand-name drugs used by a
16 recipient in a month the drug shall not require prior
17 authorization.
18 (10) The Medicaid Pharmaceutical and Therapeutics
19 Committee may also make recommendations to the agency
20 regarding the prior authorization of any prescribed drug
21 covered by Medicaid.
22 (11) Medicaid recipients may appeal agency preferred
23 drug formulary decisions using the Medicaid fair hearing
24 process administered by the Department of Children and Family
25 Services.
26
27
28 ================ T I T L E A M E N D M E N T ===============
29 And the title is amended as follows:
30 On page 2, lines 8-18, delete those lines
31
5
8:28 PM 05/02/01 s0792c2c-38rjg
SENATE AMENDMENT
Bill No. CS for CS for SB 792
Amendment No. ___ Barcode 885628
1 and insert:
2 and Therapeutics Committee; providing for
3 committee responsibilities; requiring the
4 agency to publish the preferred drug formulary;
5 providing for a hearing process;
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
6
8:28 PM 05/02/01 s0792c2c-38rjg