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Amendment CaShTmL-181208.HTM
    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:
12  
13         Senate Amendment (with title amendment) 
14         On page 42, line 4, through
15            page 52, line 16, delete those lines
16  
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
                                  1
    12:18 PM   05/02/05                            s0838c2c-02-j21

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 2 12:18 PM 05/02/05 s0838c2c-02-j21
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 3 12:18 PM 05/02/05 s0838c2c-02-j21
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 4 12:18 PM 05/02/05 s0838c2c-02-j21
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 5 12:18 PM 05/02/05 s0838c2c-02-j21
Florida Senate - 2005 SENATOR AMENDMENT Bill No. CS for CS for SB 838 Barcode 181208 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 6 12:18 PM 05/02/05 s0838c2c-02-j21
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 7 12:18 PM 05/02/05 s0838c2c-02-j21
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 8 12:18 PM 05/02/05 s0838c2c-02-j21
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 9 12:18 PM 05/02/05 s0838c2c-02-j21
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 13 14 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 18 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; 24 25 26 27 28 29 30 31 10 12:18 PM 05/02/05 s0838c2c-02-j21
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