Bill Summary – FastDemocracy

       Florida Senate - 2024                                     SB 268
       
       
        
       By Senator Harrell
       
       
       
       
       
       31-00303-24                                            2024268__
                      A bill to be entitled                      
       An act relating to step-therapy protocols; amending s.
       409.901, F.S.; defining the term “serious mental
       illness”; amending s. 409.912, F.S.; requiring the
       Agency for Health Care Administration to approve drug
       products for Medicaid recipients for the treatment of
       serious mental illness without step-therapy prior
       authorization under certain circumstances; amending s.
       409.910, F.S.; conforming a cross-reference; directing
       the agency to include rate impacts resulting from the
       act in certain rates that become effective on a
       specified date; providing an effective date.
        
Be It Enacted by the Legislature of the State of Florida:

       Section 1. Present subsections (27) and (28) of section
409.901, Florida Statutes, are redesignated as subsections (28)
and (29), respectively, and a new subsection (27) is added to
that section, to read:
       409.901 Definitions; ss. 409.901-409.920.—As used in ss.
409.901-409.920, except as otherwise specifically provided, the
term:
       (27) “Serious mental illness” means any of the following
psychiatric disorders as defined by the American Psychiatric
Association in the Diagnostic and Statistical Manual of Mental
Disorders, Fifth Edition:
       (a) Bipolar disorders, including hypomanic, manic,
depressive, and mixed-feature episodes.
       (b) Depression in childhood or adolescence.
       (c) Major depressive disorders, including single and
recurrent depressive episodes.
       (d) Obsessive-compulsive disorders.
       (e) Paranoid personality disorder or other psychotic
disorders.
       (f) Schizoaffective disorders, including bipolar or
depressive symptoms.
       (g) Schizophrenia.
       Section 2. Paragraph (a) of subsection (5) of section
409.912, Florida Statutes, is amended to read:
       409.912 Cost-effective purchasing of health care.—The
agency shall purchase goods and services for Medicaid recipients
in the most cost-effective manner consistent with the delivery
of quality medical care. To ensure that medical services are
effectively utilized, the agency may, in any case, require a
confirmation or second physician’s opinion of the correct
diagnosis for purposes of authorizing future services under the
Medicaid program. This section does not restrict access to
emergency services or poststabilization care services as defined
in 42 C.F.R. s. 438.114. Such confirmation or second opinion
shall be rendered in a manner approved by the agency. The agency
shall maximize the use of prepaid per capita and prepaid
aggregate fixed-sum basis services when appropriate and other
alternative service delivery and reimbursement methodologies,
including competitive bidding pursuant to s. 287.057, designed
to facilitate the cost-effective purchase of a case-managed
continuum of care. The agency shall also require providers to
minimize the exposure of recipients to the need for acute
inpatient, custodial, and other institutional care and the
inappropriate or unnecessary use of high-cost services. The
agency shall contract with a vendor to monitor and evaluate the
clinical practice patterns of providers in order to identify
trends that are outside the normal practice patterns of a
provider’s professional peers or the national guidelines of a
provider’s professional association. The vendor must be able to
provide information and counseling to a provider whose practice
patterns are outside the norms, in consultation with the agency,
to improve patient care and reduce inappropriate utilization.
The agency may mandate prior authorization, drug therapy
management, or disease management participation for certain
populations of Medicaid beneficiaries, certain drug classes, or
particular drugs to prevent fraud, abuse, overuse, and possible
dangerous drug interactions. The Pharmaceutical and Therapeutics
Committee shall make recommendations to the agency on drugs for
which prior authorization is required. The agency shall inform
the Pharmaceutical and Therapeutics Committee of its decisions
regarding drugs subject to prior authorization. The agency is
authorized to limit the entities it contracts with or enrolls as
Medicaid providers by developing a provider network through
provider credentialing. The agency may competitively bid single
source-provider contracts if procurement of goods or services
results in demonstrated cost savings to the state without
limiting access to care. The agency may limit its network based
on the assessment of beneficiary access to care, provider
availability, provider quality standards, time and distance
standards for access to care, the cultural competence of the
provider network, demographic characteristics of Medicaid
beneficiaries, practice and provider-to-beneficiary standards,
appointment wait times, beneficiary use of services, provider
turnover, provider profiling, provider licensure history,
previous program integrity investigations and findings, peer
review, provider Medicaid policy and billing compliance records,
clinical and medical record audits, and other factors. Providers
are not entitled to enrollment in the Medicaid provider network.
The agency shall determine instances in which allowing Medicaid
beneficiaries to purchase durable medical equipment and other
goods is less expensive to the Medicaid program than long-term
rental of the equipment or goods. The agency may establish rules
to facilitate purchases in lieu of long-term rentals in order to
protect against fraud and abuse in the Medicaid program as
defined in s. 409.913. The agency may seek federal waivers
necessary to administer these policies.
       (5)(a) The agency shall implement a Medicaid prescribed
drug spending-control program that includes the following
components:
       1. A Medicaid preferred drug list, which shall be a listing
of cost-effective therapeutic options recommended by the
Medicaid Pharmacy and Therapeutics Committee established
pursuant to s. 409.91195 and adopted by the agency for each
therapeutic class on the preferred drug list. At the discretion
of the committee, and when feasible, the preferred drug list
should include at least two products in a therapeutic class. The
agency may post the preferred drug list and updates to the list
on an Internet website without following the rulemaking
procedures of chapter 120. Antiretroviral agents are excluded
from the preferred drug list. The agency shall also limit the
amount of a prescribed drug dispensed to no more than a 34-day
supply unless the drug products’ smallest marketed package is
greater than a 34-day supply, or the drug is determined by the
agency to be a maintenance drug in which case a 100-day maximum
supply may be authorized. The agency may seek any federal
waivers necessary to implement these cost-control programs and
to continue participation in the federal Medicaid rebate
program, or alternatively to negotiate state-only manufacturer
rebates. The agency may adopt rules to administer this
subparagraph. The agency shall continue to provide unlimited
contraceptive drugs and items. The agency must establish
procedures to ensure that:
       a. There is a response to a request for prior authorization
by telephone or other telecommunication device within 24 hours
after receipt of a request for prior authorization; and
       b. A 72-hour supply of the drug prescribed is provided in
an emergency or when the agency does not provide a response
within 24 hours as required by sub-subparagraph a.
       2. A provider of prescribed drugs is reimbursed in an
amount not to exceed the lesser of the actual acquisition cost
based on the Centers for Medicare and Medicaid Services National
Average Drug Acquisition Cost pricing files plus a professional
dispensing fee, the wholesale acquisition cost plus a
professional dispensing fee, the state maximum allowable cost
plus a professional dispensing fee, or the usual and customary
charge billed by the provider.
       3. The agency shall develop and implement a process for
managing the drug therapies of Medicaid recipients who are using
significant numbers of prescribed drugs each month. The
management process may include, but is not limited to,
comprehensive, physician-directed medical-record reviews, claims
analyses, and case evaluations to determine the medical
necessity and appropriateness of a patient’s treatment plan and
drug therapies. The agency may contract with a private
organization to provide drug-program-management services. The
Medicaid drug benefit management program shall include
initiatives to manage drug therapies for HIV/AIDS patients,
patients using 20 or more unique prescriptions in a 180-day
period, and the top 1,000 patients in annual spending. The
agency shall enroll any Medicaid recipient in the drug benefit
management program if he or she meets the specifications of this
provision and is not enrolled in a Medicaid health maintenance
organization.
       4. The agency may limit the size of its pharmacy network
based on need, competitive bidding, price negotiations,
credentialing, or similar criteria. The agency shall give
special consideration to rural areas in determining the size and
location of pharmacies included in the Medicaid pharmacy
network. A pharmacy credentialing process may include criteria
such as a pharmacy’s full-service status, location, size,
patient educational programs, patient consultation, disease
management services, and other characteristics. The agency may
impose a moratorium on Medicaid pharmacy enrollment if it is
determined that it has a sufficient number of Medicaid
participating providers. The agency must allow dispensing
practitioners to participate as a part of the Medicaid pharmacy
network regardless of the practitioner’s proximity to any other
entity that is dispensing prescription drugs under the Medicaid
program. A dispensing practitioner must meet all credentialing
requirements applicable to his or her practice, as determined by
the agency.
       5. The agency shall develop and implement a program that
requires Medicaid practitioners who issue written prescriptions
for medicinal drugs to use a counterfeit-proof prescription pad
for Medicaid prescriptions. The agency shall require the use of
standardized counterfeit-proof prescription pads by prescribers
who issue written prescriptions for Medicaid recipients. The
agency may implement the program in targeted geographic areas or
statewide.
       6. The agency may enter into arrangements that require
manufacturers of generic drugs prescribed to Medicaid recipients
to provide rebates of at least 15.1 percent of the average
manufacturer price for the manufacturer’s generic products.
These arrangements must shall require that if a generic-drug
manufacturer pays federal rebates for Medicaid-reimbursed drugs
at a level below 15.1 percent, the manufacturer must provide a
supplemental rebate to the state in an amount necessary to
achieve a 15.1-percent rebate level.
       7. The agency may establish a preferred drug list as
described in this subsection, and, pursuant to the establishment
of such preferred drug list, negotiate supplemental rebates from
manufacturers that are in addition to those required by Title
XIX of the Social Security Act and at no less than 14 percent of
the average manufacturer price as defined in 42 U.S.C. s. 1936
on the last day of a quarter unless the federal or supplemental
rebate, or both, equals or exceeds 29 percent. There is no upper
limit on the supplemental rebates the agency may negotiate. The
agency may determine that specific products, brand-name or
generic, are competitive at lower rebate percentages. Agreement
to pay the minimum supplemental rebate percentage guarantees a
manufacturer that the Medicaid Pharmaceutical and Therapeutics
Committee will consider a product for inclusion on the preferred
drug list. However, a pharmaceutical manufacturer is not
guaranteed placement on the preferred drug list by simply paying
the minimum supplemental rebate. Agency decisions will be made
on the clinical efficacy of a drug and recommendations of the
Medicaid Pharmaceutical and Therapeutics Committee, as well as
the price of competing products minus federal and state rebates.
The agency may contract with an outside agency or contractor to
conduct negotiations for supplemental rebates. For the purposes
of this section, the term “supplemental rebates” means cash
rebates. Value-added programs as a substitution for supplemental
rebates are prohibited. The agency may seek any federal waivers
to implement this initiative.
       8.a. The agency may implement a Medicaid behavioral drug
management system. The agency may contract with a vendor that
has experience in operating behavioral drug management systems
to implement this program. The agency may seek federal waivers
to implement this program.
       b. The agency, in conjunction with the Department of
Children and Families, may implement the Medicaid behavioral
drug management system that is designed to improve the quality
of care and behavioral health prescribing practices based on
best practice guidelines, improve patient adherence to
medication plans, reduce clinical risk, and lower prescribed
drug costs and the rate of inappropriate spending on Medicaid
behavioral drugs. The program may include the following
elements:
       (I) Provide for the development and adoption of best
practice guidelines for behavioral health-related drugs such as
antipsychotics, antidepressants, and medications for treating
bipolar disorders and other behavioral conditions; translate
them into practice; review behavioral health prescribers and
compare their prescribing patterns to a number of indicators
that are based on national standards; and determine deviations
from best practice guidelines.
       (II) Implement processes for providing feedback to and
educating prescribers using best practice educational materials
and peer-to-peer consultation.
       (III) Assess Medicaid beneficiaries who are outliers in
their use of behavioral health drugs with regard to the numbers
and types of drugs taken, drug dosages, combination drug
therapies, and other indicators of improper use of behavioral
health drugs.
       (IV) Alert prescribers to patients who fail to refill
prescriptions in a timely fashion, are prescribed multiple same
class behavioral health drugs, and may have other potential
medication problems.
       (V) Track spending trends for behavioral health drugs and
deviation from best practice guidelines.
       (VI) Use educational and technological approaches to
promote best practices, educate consumers, and train prescribers
in the use of practice guidelines.
       (VII) Disseminate electronic and published materials.
       (VIII) Hold statewide and regional conferences.
       (IX) Implement a disease management program with a model
quality-based medication component for severely mentally ill
individuals and emotionally disturbed children who are high
users of care.
       9. The agency shall implement a Medicaid prescription drug
management system.
       a. The agency may contract with a vendor that has
experience in operating prescription drug management systems in
order to implement this system. Any management system that is
implemented in accordance with this subparagraph must rely on
cooperation between physicians and pharmacists to determine
appropriate practice patterns and clinical guidelines to improve
the prescribing, dispensing, and use of drugs in the Medicaid
program. The agency may seek federal waivers to implement this
program.
       b. The drug management system must be designed to improve
the quality of care and prescribing practices based on best
practice guidelines, improve patient adherence to medication
plans, reduce clinical risk, and lower prescribed drug costs and
the rate of inappropriate spending on Medicaid prescription
drugs. The program must:
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