Senate Bill sb1532
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Florida Senate - 2005 SB 1532
By Senator Wilson
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1 A bill to be entitled
2 An act relating to the Medicaid program;
3 amending s. 409.91195, F.S.; requiring that the
4 Medicaid Pharmaceutical and Therapeutics
5 Committee recommend medications used to relieve
6 the symptoms of the influenza virus to the
7 Agency for Health Care Administration;
8 providing that prior authorization for such
9 medications is not required during certain
10 months; amending s. 409.912, F.S.; authorizing
11 the agency to remove the prior-authorization
12 requirement for influenza drugs recommended by
13 the committee; requiring that the agency
14 reimburse a maximum supply of one medication
15 used to treat the influenza virus; providing an
16 effective date.
17
18 Be It Enacted by the Legislature of the State of Florida:
19
20 Section 1. Present subsection (11) of section
21 409.91195, Florida Statutes, is redesignated as subsection
22 (12), and a new subsection (11) is added to that section, to
23 read:
24 409.91195 Medicaid Pharmaceutical and Therapeutics
25 Committee.--There is created a Medicaid Pharmaceutical and
26 Therapeutics Committee within the Agency for Health Care
27 Administration for the purpose of developing a preferred drug
28 formulary pursuant to 42 U.S.C. s. 1396r-8.
29 (11) The Medicaid Pharmaceutical and Therapeutics
30 Committee shall recommend to the agency at least two
31 medications that diminish the effects of the influenza virus,
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1 and these medications will not require prior authorization
2 between the months of October and May of any year.
3 Section 2. Paragraph (a) of subsection (39) of section
4 409.912, Florida Statutes, is amended to read:
5 409.912 Cost-effective purchasing of health care.--The
6 agency shall purchase goods and services for Medicaid
7 recipients in the most cost-effective manner consistent with
8 the delivery of quality medical care. To ensure that medical
9 services are effectively utilized, the agency may, in any
10 case, require a confirmation or second physician's opinion of
11 the correct diagnosis for purposes of authorizing future
12 services under the Medicaid program. This section does not
13 restrict access to emergency services or poststabilization
14 care services as defined in 42 C.F.R. part 438.114. Such
15 confirmation or second opinion shall be rendered in a manner
16 approved by the agency. The agency shall maximize the use of
17 prepaid per capita and prepaid aggregate fixed-sum basis
18 services when appropriate and other alternative service
19 delivery and reimbursement methodologies, including
20 competitive bidding pursuant to s. 287.057, designed to
21 facilitate the cost-effective purchase of a case-managed
22 continuum of care. The agency shall also require providers to
23 minimize the exposure of recipients to the need for acute
24 inpatient, custodial, and other institutional care and the
25 inappropriate or unnecessary use of high-cost services. The
26 agency may mandate prior authorization, drug therapy
27 management, or disease management participation for certain
28 populations of Medicaid beneficiaries, certain drug classes,
29 or particular drugs to prevent fraud, abuse, overuse, and
30 possible dangerous drug interactions. The Pharmaceutical and
31 Therapeutics Committee shall make recommendations to the
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1 agency on drugs for which prior authorization is required. The
2 agency shall inform the Pharmaceutical and Therapeutics
3 Committee of its decisions regarding drugs subject to prior
4 authorization. The agency is authorized to limit the entities
5 it contracts with or enrolls as Medicaid providers by
6 developing a provider network through provider credentialing.
7 The agency may limit its network based on the assessment of
8 beneficiary access to care, provider availability, provider
9 quality standards, time and distance standards for access to
10 care, the cultural competence of the provider network,
11 demographic characteristics of Medicaid beneficiaries,
12 practice and provider-to-beneficiary standards, appointment
13 wait times, beneficiary use of services, provider turnover,
14 provider profiling, provider licensure history, previous
15 program integrity investigations and findings, peer review,
16 provider Medicaid policy and billing compliance records,
17 clinical and medical record audits, and other factors.
18 Providers shall not be entitled to enrollment in the Medicaid
19 provider network. The agency is authorized to seek federal
20 waivers necessary to implement this policy.
21 (39)(a) The agency shall implement a Medicaid
22 prescribed-drug spending-control program that includes the
23 following components:
24 1. Medicaid prescribed-drug coverage for brand-name
25 drugs for adult Medicaid recipients is limited to the
26 dispensing of four brand-name drugs per month per recipient.
27 Children are exempt from this restriction. Antiretroviral
28 agents are excluded from this limitation. No requirements for
29 prior authorization or other restrictions on medications used
30 to treat mental illnesses such as schizophrenia, severe
31 depression, or bipolar disorder may be imposed on Medicaid
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1 recipients. Medications that will be available without
2 restriction for persons with mental illnesses include atypical
3 antipsychotic medications, conventional antipsychotic
4 medications, selective serotonin reuptake inhibitors, and
5 other medications used for the treatment of serious mental
6 illnesses. The agency shall also limit the amount of a
7 prescribed drug dispensed to no more than a 34-day supply. The
8 agency shall continue to provide unlimited generic drugs,
9 contraceptive drugs and items, and diabetic supplies. Although
10 a drug may be included on the preferred drug formulary, it
11 would not be exempt from the four-brand limit. The agency may
12 authorize exceptions to the brand-name-drug restriction based
13 upon the treatment needs of the patients, only when such
14 exceptions are based on prior consultation provided by the
15 agency or an agency contractor, but the agency must establish
16 procedures to ensure that:
17 a. There will be a response to a request for prior
18 consultation by telephone or other telecommunication device
19 within 24 hours after receipt of a request for prior
20 consultation;
21 b. A 72-hour supply of the drug prescribed will be
22 provided in an emergency or when the agency does not provide a
23 response within 24 hours as required by sub-subparagraph a.;
24 and
25 c. Except for the exception for nursing home residents
26 and other institutionalized adults and except for drugs on the
27 restricted formulary for which prior authorization may be
28 sought by an institutional or community pharmacy, prior
29 authorization for an exception to the brand-name-drug
30 restriction is sought by the prescriber and not by the
31 pharmacy. When prior authorization is granted for a patient in
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1 an institutional setting beyond the brand-name-drug
2 restriction, such approval is authorized for 12 months and
3 monthly prior authorization is not required for that patient.
4 2. Reimbursement to pharmacies for Medicaid prescribed
5 drugs shall be set at the lesser of: the average wholesale
6 price (AWP) minus 15.4 percent, the wholesaler acquisition
7 cost (WAC) plus 5.75 percent, the federal upper limit (FUL),
8 the state maximum allowable cost (SMAC), or the usual and
9 customary (UAC) charge billed by the provider.
10 3. The agency shall develop and implement a process
11 for managing the drug therapies of Medicaid recipients who are
12 using significant numbers of prescribed drugs each month. The
13 management process may include, but is not limited to,
14 comprehensive, physician-directed medical-record reviews,
15 claims analyses, and case evaluations to determine the medical
16 necessity and appropriateness of a patient's treatment plan
17 and drug therapies. The agency may contract with a private
18 organization to provide drug-program-management services. The
19 Medicaid drug benefit management program shall include
20 initiatives to manage drug therapies for HIV/AIDS patients,
21 patients using 20 or more unique prescriptions in a 180-day
22 period, and the top 1,000 patients in annual spending. The
23 agency shall enroll any Medicaid recipient in the drug benefit
24 management program if he or she meets the specifications of
25 this provision and is not enrolled in a Medicaid health
26 maintenance organization.
27 4. The agency may limit the size of its pharmacy
28 network based on need, competitive bidding, price
29 negotiations, credentialing, or similar criteria. The agency
30 shall give special consideration to rural areas in determining
31 the size and location of pharmacies included in the Medicaid
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1 pharmacy network. A pharmacy credentialing process may include
2 criteria such as a pharmacy's full-service status, location,
3 size, patient educational programs, patient consultation,
4 disease-management services, and other characteristics. The
5 agency may impose a moratorium on Medicaid pharmacy enrollment
6 when it is determined that it has a sufficient number of
7 Medicaid-participating providers.
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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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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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:
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1 (I) Provide for the development and adoption of best
2 practice guidelines for behavioral health-related drugs such
3 as antipsychotics, antidepressants, and medications for
4 treating bipolar disorders and other behavioral conditions;
5 translate them into practice; review behavioral health
6 prescribers and compare their prescribing patterns to a number
7 of indicators that are based on national standards; and
8 determine deviations from best practice guidelines.
9 (II) Implement processes for providing feedback to and
10 educating prescribers using best practice educational
11 materials and peer-to-peer consultation.
12 (III) Assess Medicaid beneficiaries who are outliers
13 in their use of behavioral health drugs with regard to the
14 numbers and types of drugs taken, drug dosages, combination
15 drug therapies, and other indicators of improper use of
16 behavioral health drugs.
17 (IV) Alert prescribers to patients who fail to refill
18 prescriptions in a timely fashion, are prescribed multiple
19 same-class behavioral health drugs, and may have other
20 potential medication problems.
21 (V) Track spending trends for behavioral health drugs
22 and deviation from best practice guidelines.
23 (VI) Use educational and technological approaches to
24 promote best practices, educate consumers, and train
25 prescribers in the use of practice guidelines.
26 (VII) Disseminate electronic and published materials.
27 (VIII) Hold statewide and regional conferences.
28 (IX) Implement a disease management program with a
29 model quality-based medication component for severely mentally
30 ill individuals and emotionally disturbed children who are
31 high users of care.
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1 c. If the agency is unable to negotiate a contract
2 with one or more manufacturers to finance and guarantee
3 savings associated with a behavioral drug management program
4 by September 1, 2004, the four-brand drug limit and preferred
5 drug list prior-authorization requirements shall apply to
6 mental health-related drugs, notwithstanding any provision in
7 subparagraph 1. The agency is authorized to seek federal
8 waivers to implement this policy.
9 12. The agency is authorized to contract for drug
10 rebate administration, including, but not limited to,
11 calculating rebate amounts, invoicing manufacturers,
12 negotiating disputes with manufacturers, and maintaining a
13 database of rebate collections.
14 13. The agency may specify the preferred daily dosing
15 form or strength for the purpose of promoting best practices
16 with regard to the prescribing of certain drugs as specified
17 in the General Appropriations Act and ensuring cost-effective
18 prescribing practices.
19 14. The agency may require prior authorization for the
20 off-label use of Medicaid-covered prescribed drugs as
21 specified in the General Appropriations Act. The agency may,
22 but is not required to, preauthorize the use of a product for
23 an indication not in the approved labeling. Prior
24 authorization may require the prescribing professional to
25 provide information about the rationale and supporting medical
26 evidence for the off-label use of a drug.
27 15. The agency shall implement a return and reuse
28 program for drugs dispensed by pharmacies to institutional
29 recipients, which includes payment of a $5 restocking fee for
30 the implementation and operation of the program. The return
31 and reuse program shall be implemented electronically and in a
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1 manner that promotes efficiency. The program must permit a
2 pharmacy to exclude drugs from the program if it is not
3 practical or cost-effective for the drug to be included and
4 must provide for the return to inventory of drugs that cannot
5 be credited or returned in a cost-effective manner.
6 16. The agency may remove the requirement for prior
7 authorization for the drugs recommended by the Medicaid
8 Pharmaceutical and Therapeutics Committee, as prescribed by s.
9 409.91195(11), as treatment for the influenza virus. The
10 agency shall reimburse up to a 14-day supply of one of the
11 medications for any recipient having a prescription in order
12 to avoid hospitalizations and complications from the influenza
13 virus.
14 Section 3. This act shall take effect upon becoming a
15 law.
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17 *****************************************
18 SENATE SUMMARY
19 Requires the Medicaid Pharmaceutical and Therapeutics
Committee to make recommendations for medications used to
20 relieve the symptoms of the influenza virus to the Agency
for Health Care Administration. Provides that prior
21 authorization for such medications is not required during
certain months. Authorizes the agency to remove the
22 prior-authorization requirement for influenza drugs
recommended by the committee. Requires the agency to
23 reimburse a maximum supply of one medication used to
treat the influenza virus.
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