Florida Senate - 2005 SENATOR AMENDMENT
Bill No. CS for CS for SB 838
Barcode 181208
CHAMBER ACTION
Senate House
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05/03/2005 11:28 AM .
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11 Senator Peaden moved the following amendment:
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13 Senate Amendment (with title amendment)
14 On page 42, line 4, through
15 page 52, line 16, delete those lines
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17 and insert:
18 1. Medicaid prescribed-drug coverage for brand-name
19 drugs for adult Medicaid recipients is limited to the
20 dispensing of four brand-name drugs per month per recipient.
21 Children are exempt from this restriction. Antiretroviral
22 agents are excluded from this limitation. No requirements for
23 prior authorization or other restrictions on medications used
24 to treat mental illnesses such as schizophrenia, severe
25 depression, or bipolar disorder may be imposed on Medicaid
26 recipients. Medications that will be available without
27 restriction for persons with mental illnesses include atypical
28 antipsychotic medications, conventional antipsychotic
29 medications, selective serotonin reuptake inhibitors, and
30 other medications used for the treatment of serious mental
31 illnesses. The agency shall also limit the amount of a
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Florida Senate - 2005 SENATOR AMENDMENT
Bill No. CS for CS for SB 838
Barcode 181208
1 prescribed drug dispensed to no more than a 34-day supply. The
2 agency shall continue to provide unlimited generic drugs,
3 contraceptive drugs and items, and diabetic supplies. Although
4 a drug may be included on the preferred drug formulary, it
5 would not be exempt from the four-brand limit. The agency may
6 authorize exceptions to the brand-name-drug restriction based
7 upon the treatment needs of the patients, only when such
8 exceptions are based on prior consultation provided by the
9 agency or an agency contractor, but the agency must establish
10 procedures to ensure that:
11 a. There will be a response to a request for prior
12 consultation by telephone or other telecommunication device
13 within 24 hours after receipt of a request for prior
14 consultation;
15 b. A 72-hour supply of the drug prescribed will be
16 provided in an emergency or when the agency does not provide a
17 response within 24 hours as required by sub-subparagraph a.;
18 and
19 c. Except for the exception for nursing home residents
20 and other institutionalized adults and except for drugs on the
21 restricted formulary for which prior authorization may be
22 sought by an institutional or community pharmacy, prior
23 authorization for an exception to the brand-name-drug
24 restriction is sought by the prescriber and not by the
25 pharmacy. When prior authorization is granted for a patient in
26 an institutional setting beyond the brand-name-drug
27 restriction, such approval is authorized for 12 months and
28 monthly prior authorization is not required for that patient.
29 2. Reimbursement to pharmacies for Medicaid prescribed
30 drugs shall be set at the lesser of: the average wholesale
31 price (AWP) minus 15.4 percent, the wholesaler acquisition
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Florida Senate - 2005 SENATOR AMENDMENT
Bill No. CS for CS for SB 838
Barcode 181208
1 cost (WAC) plus 5.75 percent, the federal upper limit (FUL),
2 the state maximum allowable cost (SMAC), or the usual and
3 customary (UAC) charge billed by the provider.
4 3. The agency shall develop and implement a process
5 for managing the drug therapies of Medicaid recipients who are
6 using significant numbers of prescribed drugs each month. The
7 management process may include, but is not limited to,
8 comprehensive, physician-directed medical-record reviews,
9 claims analyses, and case evaluations to determine the medical
10 necessity and appropriateness of a patient's treatment plan
11 and drug therapies. The agency may contract with a private
12 organization to provide drug-program-management services. The
13 Medicaid drug benefit management program shall include
14 initiatives to manage drug therapies for HIV/AIDS patients,
15 patients using 20 or more unique prescriptions in a 180-day
16 period, and the top 1,000 patients in annual spending. The
17 agency shall enroll any Medicaid recipient in the drug benefit
18 management program if he or she meets the specifications of
19 this provision and is not enrolled in a Medicaid health
20 maintenance organization.
21 4. The agency may limit the size of its pharmacy
22 network based on need, competitive bidding, price
23 negotiations, credentialing, or similar criteria. The agency
24 shall give special consideration to rural areas in determining
25 the size and location of pharmacies included in the Medicaid
26 pharmacy network. A pharmacy credentialing process may include
27 criteria such as a pharmacy's full-service status, location,
28 size, patient educational programs, patient consultation,
29 disease-management services, and other characteristics. The
30 agency may impose a moratorium on Medicaid pharmacy enrollment
31 when it is determined that it has a sufficient number of
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Florida Senate - 2005 SENATOR AMENDMENT
Bill No. CS for CS for SB 838
Barcode 181208
1 Medicaid-participating providers. The agency must allow
2 dispensing practitioners to participate as a part of the
3 Medicaid pharmacy network regardless of the practitioner's
4 proximity to any other entity that is dispensing prescription
5 drugs under the Medicaid program. A dispensing practitioner
6 must meet all credentialing requirements applicable to his or
7 her practice, as determined by the agency.
8 5. The agency shall develop and implement a program
9 that requires Medicaid practitioners who prescribe drugs to
10 use a counterfeit-proof prescription pad for Medicaid
11 prescriptions. The agency shall require the use of
12 standardized counterfeit-proof prescription pads by
13 Medicaid-participating prescribers or prescribers who write
14 prescriptions for Medicaid recipients. The agency may
15 implement the program in targeted geographic areas or
16 statewide.
17 6. The agency may enter into arrangements that require
18 manufacturers of generic drugs prescribed to Medicaid
19 recipients to provide rebates of at least 15.1 percent of the
20 average manufacturer price for the manufacturer's generic
21 products. These arrangements shall require that if a
22 generic-drug manufacturer pays federal rebates for
23 Medicaid-reimbursed drugs at a level below 15.1 percent, the
24 manufacturer must provide a supplemental rebate to the state
25 in an amount necessary to achieve a 15.1-percent rebate level.
26 7. The agency may establish a preferred drug formulary
27 in accordance with 42 U.S.C. s. 1396r-8, and, pursuant to the
28 establishment of such formulary, it is authorized to negotiate
29 supplemental rebates from manufacturers that are in addition
30 to those required by Title XIX of the Social Security Act and
31 at no less than 14 percent of the average manufacturer price
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Florida Senate - 2005 SENATOR AMENDMENT
Bill No. CS for CS for SB 838
Barcode 181208
1 as defined in 42 U.S.C. s. 1936 on the last day of a quarter
2 unless the federal or supplemental rebate, or both, equals or
3 exceeds 29 percent. There is no upper limit on the
4 supplemental rebates the agency may negotiate. The agency may
5 determine that specific products, brand-name or generic, are
6 competitive at lower rebate percentages. Agreement to pay the
7 minimum supplemental rebate percentage will guarantee a
8 manufacturer that the Medicaid Pharmaceutical and Therapeutics
9 Committee will consider a product for inclusion on the
10 preferred drug formulary. However, a pharmaceutical
11 manufacturer is not guaranteed placement on the formulary by
12 simply paying the minimum supplemental rebate. Agency
13 decisions will be made on the clinical efficacy of a drug and
14 recommendations of the Medicaid Pharmaceutical and
15 Therapeutics Committee, as well as the price of competing
16 products minus federal and state rebates. The agency is
17 authorized to contract with an outside agency or contractor to
18 conduct negotiations for supplemental rebates. For the
19 purposes of this section, the term "supplemental rebates"
20 means cash rebates. Effective July 1, 2004, value-added
21 programs as a substitution for supplemental rebates are
22 prohibited. The agency is authorized to seek any federal
23 waivers to implement this initiative.
24 8. The agency shall establish an advisory committee
25 for the purposes of studying the feasibility of using a
26 restricted drug formulary for nursing home residents and other
27 institutionalized adults. The committee shall be comprised of
28 seven members appointed by the Secretary of Health Care
29 Administration. The committee members shall include two
30 physicians licensed under chapter 458 or chapter 459; three
31 pharmacists licensed under chapter 465 and appointed from a
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Florida Senate - 2005 SENATOR AMENDMENT
Bill No. CS for CS for SB 838
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1 list of recommendations provided by the Florida Long-Term Care
2 Pharmacy Alliance; and two pharmacists licensed under chapter
3 465.
4 9. The Agency for Health Care Administration shall
5 expand home delivery of pharmacy products. To assist Medicaid
6 patients in securing their prescriptions and reduce program
7 costs, the agency shall expand its current mail-order-pharmacy
8 diabetes-supply program to include all generic and brand-name
9 drugs used by Medicaid patients with diabetes. Medicaid
10 recipients in the current program may obtain nondiabetes drugs
11 on a voluntary basis. This initiative is limited to the
12 geographic area covered by the current contract. The agency
13 may seek and implement any federal waivers necessary to
14 implement this subparagraph.
15 10. The agency shall limit to one dose per month any
16 drug prescribed to treat erectile dysfunction.
17 11.a. The agency shall implement a Medicaid behavioral
18 drug management system. The agency may contract with a vendor
19 that has experience in operating behavioral drug management
20 systems to implement this program. The agency is authorized to
21 seek federal waivers to implement this program.
22 b. The agency, in conjunction with the Department of
23 Children and Family Services, may implement the Medicaid
24 behavioral drug management system that is designed to improve
25 the quality of care and behavioral health prescribing
26 practices based on best practice guidelines, improve patient
27 adherence to medication plans, reduce clinical risk, and lower
28 prescribed drug costs and the rate of inappropriate spending
29 on Medicaid behavioral drugs. The program shall include the
30 following elements:
31 (I) Provide for the development and adoption of best
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Florida Senate - 2005 SENATOR AMENDMENT
Bill No. CS for CS for SB 838
Barcode 181208
1 practice guidelines for behavioral health-related drugs such
2 as antipsychotics, antidepressants, and medications for
3 treating bipolar disorders and other behavioral conditions;
4 translate them into practice; review behavioral health
5 prescribers and compare their prescribing patterns to a number
6 of indicators that are based on national standards; and
7 determine deviations from best practice guidelines.
8 (II) Implement processes for providing feedback to and
9 educating prescribers using best practice educational
10 materials and peer-to-peer consultation.
11 (III) Assess Medicaid beneficiaries who are outliers
12 in their use of behavioral health drugs with regard to the
13 numbers and types of drugs taken, drug dosages, combination
14 drug therapies, and other indicators of improper use of
15 behavioral health drugs.
16 (IV) Alert prescribers to patients who fail to refill
17 prescriptions in a timely fashion, are prescribed multiple
18 same-class behavioral health drugs, and may have other
19 potential medication problems.
20 (V) Track spending trends for behavioral health drugs
21 and deviation from best practice guidelines.
22 (VI) Use educational and technological approaches to
23 promote best practices, educate consumers, and train
24 prescribers in the use of practice guidelines.
25 (VII) Disseminate electronic and published materials.
26 (VIII) Hold statewide and regional conferences.
27 (IX) Implement a disease management program with a
28 model quality-based medication component for severely mentally
29 ill individuals and emotionally disturbed children who are
30 high users of care.
31 c. If the agency is unable to negotiate a contract
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Florida Senate - 2005 SENATOR AMENDMENT
Bill No. CS for CS for SB 838
Barcode 181208
1 with one or more manufacturers to finance and guarantee
2 savings associated with a behavioral drug management program
3 by September 1, 2004, the four-brand drug limit and preferred
4 drug list prior-authorization requirements shall apply to
5 mental health-related drugs, notwithstanding any provision in
6 subparagraph 1. The agency is authorized to seek federal
7 waivers to implement this policy.
8 12.a. The agency shall implement a Medicaid
9 prescription-drug-management system. The agency may contract
10 with a vendor that has experience in operating
11 prescription-drug-management systems in order to implement
12 this system. Any management system that is implemented in
13 accordance with this subparagraph must rely on cooperation
14 between physicians and pharmacists to determine appropriate
15 practice patterns and clinical guidelines to improve the
16 prescribing, dispensing, and use of drugs in the Medicaid
17 program. The agency may seek federal waivers to implement this
18 program.
19 b. The drug-management system must be designed to
20 improve the quality of care and prescribing practices based on
21 best-practice guidelines, improve patient adherence to
22 medication plans, reduce clinical risk, and lower prescribed
23 drug costs and the rate of inappropriate spending on Medicaid
24 prescription drugs. The program must:
25 (I) Provide for the development and adoption of
26 best-practice guidelines for the prescribing and use of drugs
27 in the Medicaid program, including translating best-practice
28 guidelines into practice; reviewing prescriber patterns and
29 comparing them to indicators that are based on national
30 standards and practice patterns of clinical peers in their
31 community, statewide, and nationally; and determine deviations
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Florida Senate - 2005 SENATOR AMENDMENT
Bill No. CS for CS for SB 838
Barcode 181208
1 from best-practice guidelines.
2 (II) Implement processes for providing feedback to and
3 educating prescribers using best-practice educational
4 materials and peer-to-peer consultation.
5 (III) Assess Medicaid recipients who are outliers in
6 their use of a single or multiple prescription drugs with
7 regard to the numbers and types of drugs taken, drug dosages,
8 combination drug therapies, and other indicators of improper
9 use of prescription drugs.
10 (IV) Alert prescribers to patients who fail to refill
11 prescriptions in a timely fashion, are prescribed multiple
12 drugs that may be redundant or contraindicated, or may have
13 other potential medication problems.
14 (V) Track spending trends for prescription drugs and
15 deviation from best-practice guidelines.
16 (VI) Use educational and technological approaches to
17 promote best practices, educate consumers, and train
18 prescribers in the use of practice guidelines.
19 (VII) Disseminate electronic and published materials.
20 (VIII) Hold statewide and regional conferences.
21 (IX) Implement disease-management programs in
22 cooperation with physicians and pharmacists, along with a
23 model quality-based medication component for individuals
24 having chronic medical conditions.
25 13.12. The agency is authorized to contract for drug
26 rebate administration, including, but not limited to,
27 calculating rebate amounts, invoicing manufacturers,
28 negotiating disputes with manufacturers, and maintaining a
29 database of rebate collections.
30 14.13. The agency may specify the preferred daily
31 dosing form or strength for the purpose of promoting best
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Florida Senate - 2005 SENATOR AMENDMENT
Bill No. CS for CS for SB 838
Barcode 181208
1 practices with regard to the prescribing of certain drugs as
2 specified in the General Appropriations Act and ensuring
3 cost-effective prescribing practices.
4 15.14. The agency may require prior authorization for
5 the off-label use of Medicaid-covered prescribed drugs as
6 specified in the General Appropriations Act. The agency may,
7 but is not required to, preauthorize the use of a product for
8 an indication not in the approved labeling. Prior
9 authorization may require the prescribing professional to
10 provide information about the rationale and supporting medical
11 evidence for the off-label use of a drug.
12 16.15. The agency shall implement a return and reuse
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15 ================ T I T L E A M E N D M E N T ===============
16 And the title is amended as follows:
17 On page 2, lines 13-19, delete those lines
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19 and insert:
20 allowing dispensing practitioners to
21 participate in Medicaid; requiring that the
22 agency implement a Medicaid
23 prescription-drug-management system;
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