Florida Senate - 2024                                     SB 268
       
       
        
       By Senator Harrell
       
       
       
       
       
       31-00303-24                                            2024268__
    1                        A bill to be entitled                      
    2         An act relating to step-therapy protocols; amending s.
    3         409.901, F.S.; defining the term “serious mental
    4         illness”; amending s. 409.912, F.S.; requiring the
    5         Agency for Health Care Administration to approve drug
    6         products for Medicaid recipients for the treatment of
    7         serious mental illness without step-therapy prior
    8         authorization under certain circumstances; amending s.
    9         409.910, F.S.; conforming a cross-reference; directing
   10         the agency to include rate impacts resulting from the
   11         act in certain rates that become effective on a
   12         specified date; providing an effective date.
   13          
   14  Be It Enacted by the Legislature of the State of Florida:
   15  
   16         Section 1. Present subsections (27) and (28) of section
   17  409.901, Florida Statutes, are redesignated as subsections (28)
   18  and (29), respectively, and a new subsection (27) is added to
   19  that section, to read:
   20         409.901 Definitions; ss. 409.901-409.920.—As used in ss.
   21  409.901-409.920, except as otherwise specifically provided, the
   22  term:
   23         (27) “Serious mental illness” means any of the following
   24  psychiatric disorders as defined by the American Psychiatric
   25  Association in the Diagnostic and Statistical Manual of Mental
   26  Disorders, Fifth Edition:
   27         (a)Bipolar disorders, including hypomanic, manic,
   28  depressive, and mixed-feature episodes.
   29         (b)Depression in childhood or adolescence.
   30         (c)Major depressive disorders, including single and
   31  recurrent depressive episodes.
   32         (d)Obsessive-compulsive disorders.
   33         (e)Paranoid personality disorder or other psychotic
   34  disorders.
   35         (f)Schizoaffective disorders, including bipolar or
   36  depressive symptoms.
   37         (g)Schizophrenia.
   38         Section 2. Paragraph (a) of subsection (5) of section
   39  409.912, Florida Statutes, is amended to read:
   40         409.912 Cost-effective purchasing of health care.—The
   41  agency shall purchase goods and services for Medicaid recipients
   42  in the most cost-effective manner consistent with the delivery
   43  of quality medical care. To ensure that medical services are
   44  effectively utilized, the agency may, in any case, require a
   45  confirmation or second physician’s opinion of the correct
   46  diagnosis for purposes of authorizing future services under the
   47  Medicaid program. This section does not restrict access to
   48  emergency services or poststabilization care services as defined
   49  in 42 C.F.R. s. 438.114. Such confirmation or second opinion
   50  shall be rendered in a manner approved by the agency. The agency
   51  shall maximize the use of prepaid per capita and prepaid
   52  aggregate fixed-sum basis services when appropriate and other
   53  alternative service delivery and reimbursement methodologies,
   54  including competitive bidding pursuant to s. 287.057, designed
   55  to facilitate the cost-effective purchase of a case-managed
   56  continuum of care. The agency shall also require providers to
   57  minimize the exposure of recipients to the need for acute
   58  inpatient, custodial, and other institutional care and the
   59  inappropriate or unnecessary use of high-cost services. The
   60  agency shall contract with a vendor to monitor and evaluate the
   61  clinical practice patterns of providers in order to identify
   62  trends that are outside the normal practice patterns of a
   63  provider’s professional peers or the national guidelines of a
   64  provider’s professional association. The vendor must be able to
   65  provide information and counseling to a provider whose practice
   66  patterns are outside the norms, in consultation with the agency,
   67  to improve patient care and reduce inappropriate utilization.
   68  The agency may mandate prior authorization, drug therapy
   69  management, or disease management participation for certain
   70  populations of Medicaid beneficiaries, certain drug classes, or
   71  particular drugs to prevent fraud, abuse, overuse, and possible
   72  dangerous drug interactions. The Pharmaceutical and Therapeutics
   73  Committee shall make recommendations to the agency on drugs for
   74  which prior authorization is required. The agency shall inform
   75  the Pharmaceutical and Therapeutics Committee of its decisions
   76  regarding drugs subject to prior authorization. The agency is
   77  authorized to limit the entities it contracts with or enrolls as
   78  Medicaid providers by developing a provider network through
   79  provider credentialing. The agency may competitively bid single
   80  source-provider contracts if procurement of goods or services
   81  results in demonstrated cost savings to the state without
   82  limiting access to care. The agency may limit its network based
   83  on the assessment of beneficiary access to care, provider
   84  availability, provider quality standards, time and distance
   85  standards for access to care, the cultural competence of the
   86  provider network, demographic characteristics of Medicaid
   87  beneficiaries, practice and provider-to-beneficiary standards,
   88  appointment wait times, beneficiary use of services, provider
   89  turnover, provider profiling, provider licensure history,
   90  previous program integrity investigations and findings, peer
   91  review, provider Medicaid policy and billing compliance records,
   92  clinical and medical record audits, and other factors. Providers
   93  are not entitled to enrollment in the Medicaid provider network.
   94  The agency shall determine instances in which allowing Medicaid
   95  beneficiaries to purchase durable medical equipment and other
   96  goods is less expensive to the Medicaid program than long-term
   97  rental of the equipment or goods. The agency may establish rules
   98  to facilitate purchases in lieu of long-term rentals in order to
   99  protect against fraud and abuse in the Medicaid program as
  100  defined in s. 409.913. The agency may seek federal waivers
  101  necessary to administer these policies.
  102         (5)(a) The agency shall implement a Medicaid prescribed
  103  drug spending-control program that includes the following
  104  components:
  105         1. A Medicaid preferred drug list, which shall be a listing
  106  of cost-effective therapeutic options recommended by the
  107  Medicaid Pharmacy and Therapeutics Committee established
  108  pursuant to s. 409.91195 and adopted by the agency for each
  109  therapeutic class on the preferred drug list. At the discretion
  110  of the committee, and when feasible, the preferred drug list
  111  should include at least two products in a therapeutic class. The
  112  agency may post the preferred drug list and updates to the list
  113  on an Internet website without following the rulemaking
  114  procedures of chapter 120. Antiretroviral agents are excluded
  115  from the preferred drug list. The agency shall also limit the
  116  amount of a prescribed drug dispensed to no more than a 34-day
  117  supply unless the drug products’ smallest marketed package is
  118  greater than a 34-day supply, or the drug is determined by the
  119  agency to be a maintenance drug in which case a 100-day maximum
  120  supply may be authorized. The agency may seek any federal
  121  waivers necessary to implement these cost-control programs and
  122  to continue participation in the federal Medicaid rebate
  123  program, or alternatively to negotiate state-only manufacturer
  124  rebates. The agency may adopt rules to administer this
  125  subparagraph. The agency shall continue to provide unlimited
  126  contraceptive drugs and items. The agency must establish
  127  procedures to ensure that:
  128         a. There is a response to a request for prior authorization
  129  by telephone or other telecommunication device within 24 hours
  130  after receipt of a request for prior authorization; and
  131         b. A 72-hour supply of the drug prescribed is provided in
  132  an emergency or when the agency does not provide a response
  133  within 24 hours as required by sub-subparagraph a.
  134         2. A provider of prescribed drugs is reimbursed in an
  135  amount not to exceed the lesser of the actual acquisition cost
  136  based on the Centers for Medicare and Medicaid Services National
  137  Average Drug Acquisition Cost pricing files plus a professional
  138  dispensing fee, the wholesale acquisition cost plus a
  139  professional dispensing fee, the state maximum allowable cost
  140  plus a professional dispensing fee, or the usual and customary
  141  charge billed by the provider.
  142         3. The agency shall develop and implement a process for
  143  managing the drug therapies of Medicaid recipients who are using
  144  significant numbers of prescribed drugs each month. The
  145  management process may include, but is not limited to,
  146  comprehensive, physician-directed medical-record reviews, claims
  147  analyses, and case evaluations to determine the medical
  148  necessity and appropriateness of a patient’s treatment plan and
  149  drug therapies. The agency may contract with a private
  150  organization to provide drug-program-management services. The
  151  Medicaid drug benefit management program shall include
  152  initiatives to manage drug therapies for HIV/AIDS patients,
  153  patients using 20 or more unique prescriptions in a 180-day
  154  period, and the top 1,000 patients in annual spending. The
  155  agency shall enroll any Medicaid recipient in the drug benefit
  156  management program if he or she meets the specifications of this
  157  provision and is not enrolled in a Medicaid health maintenance
  158  organization.
  159         4. The agency may limit the size of its pharmacy network
  160  based on need, competitive bidding, price negotiations,
  161  credentialing, or similar criteria. The agency shall give
  162  special consideration to rural areas in determining the size and
  163  location of pharmacies included in the Medicaid pharmacy
  164  network. A pharmacy credentialing process may include criteria
  165  such as a pharmacy’s full-service status, location, size,
  166  patient educational programs, patient consultation, disease
  167  management services, and other characteristics. The agency may
  168  impose a moratorium on Medicaid pharmacy enrollment if it is
  169  determined that it has a sufficient number of Medicaid
  170  participating providers. The agency must allow dispensing
  171  practitioners to participate as a part of the Medicaid pharmacy
  172  network regardless of the practitioner’s proximity to any other
  173  entity that is dispensing prescription drugs under the Medicaid
  174  program. A dispensing practitioner must meet all credentialing
  175  requirements applicable to his or her practice, as determined by
  176  the agency.
  177         5. The agency shall develop and implement a program that
  178  requires Medicaid practitioners who issue written prescriptions
  179  for medicinal drugs to use a counterfeit-proof prescription pad
  180  for Medicaid prescriptions. The agency shall require the use of
  181  standardized counterfeit-proof prescription pads by prescribers
  182  who issue written prescriptions for Medicaid recipients. The
  183  agency may implement the program in targeted geographic areas or
  184  statewide.
  185         6. The agency may enter into arrangements that require
  186  manufacturers of generic drugs prescribed to Medicaid recipients
  187  to provide rebates of at least 15.1 percent of the average
  188  manufacturer price for the manufacturer’s generic products.
  189  These arrangements must shall require that if a generic-drug
  190  manufacturer pays federal rebates for Medicaid-reimbursed drugs
  191  at a level below 15.1 percent, the manufacturer must provide a
  192  supplemental rebate to the state in an amount necessary to
  193  achieve a 15.1-percent rebate level.
  194         7. The agency may establish a preferred drug list as
  195  described in this subsection, and, pursuant to the establishment
  196  of such preferred drug list, negotiate supplemental rebates from
  197  manufacturers that are in addition to those required by Title
  198  XIX of the Social Security Act and at no less than 14 percent of
  199  the average manufacturer price as defined in 42 U.S.C. s. 1936
  200  on the last day of a quarter unless the federal or supplemental
  201  rebate, or both, equals or exceeds 29 percent. There is no upper
  202  limit on the supplemental rebates the agency may negotiate. The
  203  agency may determine that specific products, brand-name or
  204  generic, are competitive at lower rebate percentages. Agreement
  205  to pay the minimum supplemental rebate percentage guarantees a
  206  manufacturer that the Medicaid Pharmaceutical and Therapeutics
  207  Committee will consider a product for inclusion on the preferred
  208  drug list. However, a pharmaceutical manufacturer is not
  209  guaranteed placement on the preferred drug list by simply paying
  210  the minimum supplemental rebate. Agency decisions will be made
  211  on the clinical efficacy of a drug and recommendations of the
  212  Medicaid Pharmaceutical and Therapeutics Committee, as well as
  213  the price of competing products minus federal and state rebates.
  214  The agency may contract with an outside agency or contractor to
  215  conduct negotiations for supplemental rebates. For the purposes
  216  of this section, the term “supplemental rebates” means cash
  217  rebates. Value-added programs as a substitution for supplemental
  218  rebates are prohibited. The agency may seek any federal waivers
  219  to implement this initiative.
  220         8.a. The agency may implement a Medicaid behavioral drug
  221  management system. The agency may contract with a vendor that
  222  has experience in operating behavioral drug management systems
  223  to implement this program. The agency may seek federal waivers
  224  to implement this program.
  225         b. The agency, in conjunction with the Department of
  226  Children and Families, may implement the Medicaid behavioral
  227  drug management system that is designed to improve the quality
  228  of care and behavioral health prescribing practices based on
  229  best practice guidelines, improve patient adherence to
  230  medication plans, reduce clinical risk, and lower prescribed
  231  drug costs and the rate of inappropriate spending on Medicaid
  232  behavioral drugs. The program may include the following
  233  elements:
  234         (I) Provide for the development and adoption of best
  235  practice guidelines for behavioral health-related drugs such as
  236  antipsychotics, antidepressants, and medications for treating
  237  bipolar disorders and other behavioral conditions; translate
  238  them into practice; review behavioral health prescribers and
  239  compare their prescribing patterns to a number of indicators
  240  that are based on national standards; and determine deviations
  241  from best practice guidelines.
  242         (II) Implement processes for providing feedback to and
  243  educating prescribers using best practice educational materials
  244  and peer-to-peer consultation.
  245         (III) Assess Medicaid beneficiaries who are outliers in
  246  their use of behavioral health drugs with regard to the numbers
  247  and types of drugs taken, drug dosages, combination drug
  248  therapies, and other indicators of improper use of behavioral
  249  health drugs.
  250         (IV) Alert prescribers to patients who fail to refill
  251  prescriptions in a timely fashion, are prescribed multiple same
  252  class behavioral health drugs, and may have other potential
  253  medication problems.
  254         (V) Track spending trends for behavioral health drugs and
  255  deviation from best practice guidelines.
  256         (VI) Use educational and technological approaches to
  257  promote best practices, educate consumers, and train prescribers
  258  in the use of practice guidelines.
  259         (VII) Disseminate electronic and published materials.
  260         (VIII) Hold statewide and regional conferences.
  261         (IX) Implement a disease management program with a model
  262  quality-based medication component for severely mentally ill
  263  individuals and emotionally disturbed children who are high
  264  users of care.
  265         9. The agency shall implement a Medicaid prescription drug
  266  management system.
  267         a. The agency may contract with a vendor that has
  268  experience in operating prescription drug management systems in
  269  order to implement this system. Any management system that is
  270  implemented in accordance with this subparagraph must rely on
  271  cooperation between physicians and pharmacists to determine
  272  appropriate practice patterns and clinical guidelines to improve
  273  the prescribing, dispensing, and use of drugs in the Medicaid
  274  program. The agency may seek federal waivers to implement this
  275  program.
  276         b. The drug management system must be designed to improve
  277  the quality of care and prescribing practices based on best
  278  practice guidelines, improve patient adherence to medication
  279  plans, reduce clinical risk, and lower prescribed drug costs and
  280  the rate of inappropriate spending on Medicaid prescription
  281  drugs. The program must:
  282         (I) Provide for the adoption of best practice guidelines
  283  for the prescribing and use of drugs in the Medicaid program,
  284  including translating best practice guidelines into practice;
  285  reviewing prescriber patterns and comparing them to indicators
  286  that are based on national standards and practice patterns of
  287  clinical peers in their community, statewide, and nationally;
  288  and determine deviations from best practice guidelines.
  289         (II) Implement processes for providing feedback to and
  290  educating prescribers using best practice educational materials
  291  and peer-to-peer consultation.
  292         (III) Assess Medicaid recipients who are outliers in their
  293  use of a single or multiple prescription drugs with regard to
  294  the numbers and types of drugs taken, drug dosages, combination
  295  drug therapies, and other indicators of improper use of
  296  prescription drugs.
  297         (IV) Alert prescribers to recipients who fail to refill
  298  prescriptions in a timely fashion, are prescribed multiple drugs
  299  that may be redundant or contraindicated, or may have other
  300  potential medication problems.
  301         10. The agency may contract for drug rebate administration,
  302  including, but not limited to, calculating rebate amounts,
  303  invoicing manufacturers, negotiating disputes with
  304  manufacturers, and maintaining a database of rebate collections.
  305         11. The agency may specify the preferred daily dosing form
  306  or strength for the purpose of promoting best practices with
  307  regard to the prescribing of certain drugs as specified in the
  308  General Appropriations Act and ensuring cost-effective
  309  prescribing practices.
  310         12. The agency may require prior authorization for
  311  Medicaid-covered prescribed drugs. The agency may prior
  312  authorize the use of a product:
  313         a. For an indication not approved in labeling;
  314         b. To comply with certain clinical guidelines; or
  315         c. If the product has the potential for overuse, misuse, or
  316  abuse.
  317  
  318  The agency may require the prescribing professional to provide
  319  information about the rationale and supporting medical evidence
  320  for the use of a drug. The agency shall post prior
  321  authorization, step-edit criteria and protocol, and updates to
  322  the list of drugs that are subject to prior authorization on the
  323  agency’s Internet website within 21 days after the prior
  324  authorization and step-edit criteria and protocol and updates
  325  are approved by the agency. For purposes of this subparagraph,
  326  the term “step-edit” means an automatic electronic review of
  327  certain medications subject to prior authorization.
  328         13. The agency, in conjunction with the Pharmaceutical and
  329  Therapeutics Committee, may require age-related prior
  330  authorizations for certain prescribed drugs. The agency may
  331  preauthorize the use of a drug for a recipient who may not meet
  332  the age requirement or may exceed the length of therapy for use
  333  of this product as recommended by the manufacturer and approved
  334  by the Food and Drug Administration. Prior authorization may
  335  require the prescribing professional to provide information
  336  about the rationale and supporting medical evidence for the use
  337  of a drug.
  338         14. The agency shall implement a step-therapy prior
  339  authorization approval process for medications excluded from the
  340  preferred drug list. Medications listed on the preferred drug
  341  list must be used within the previous 12 months before the
  342  alternative medications that are not listed. The step-therapy
  343  prior authorization may require the prescriber to use the
  344  medications of a similar drug class or for a similar medical
  345  indication unless contraindicated in the Food and Drug
  346  Administration labeling. The trial period between the specified
  347  steps may vary according to the medical indication. The step
  348  therapy approval process must shall be developed in accordance
  349  with the committee as stated in s. 409.91195(7) and (8). A drug
  350  product may be approved or, in the case of a drug product for
  351  the treatment of a serious mental illness, must be approved
  352  without meeting the step-therapy prior authorization criteria if
  353  the prescribing physician provides the agency with additional
  354  written medical or clinical documentation that the product is
  355  medically necessary because:
  356         a. There is not a drug on the preferred drug list to treat
  357  the disease or medical condition which is an acceptable clinical
  358  alternative;
  359         b. The alternatives have been ineffective in the treatment
  360  of the beneficiary’s disease;
  361         c. The drug product or medication of a similar drug class
  362  is prescribed for the treatment of a serious mental illness
  363  schizophrenia or schizotypal or delusional disorders; prior
  364  authorization has been granted previously for the prescribed
  365  drug; and the medication was dispensed to the patient during the
  366  previous 12 months; or
  367         d. Based on historical evidence and known characteristics
  368  of the patient and the drug, the drug is likely to be
  369  ineffective, or the number of doses have been ineffective.
  370  
  371  The agency shall work with the physician to determine the best
  372  alternative for the patient. The agency may adopt rules waiving
  373  the requirements for written clinical documentation for specific
  374  drugs in limited clinical situations.
  375         15. The agency shall implement a return and reuse program
  376  for drugs dispensed by pharmacies to institutional recipients,
  377  which includes payment of a $5 restocking fee for the
  378  implementation and operation of the program. The return and
  379  reuse program shall be implemented electronically and in a
  380  manner that promotes efficiency. The program must permit a
  381  pharmacy to exclude drugs from the program if it is not
  382  practical or cost-effective for the drug to be included and must
  383  provide for the return to inventory of drugs that cannot be
  384  credited or returned in a cost-effective manner. The agency
  385  shall determine if the program has reduced the amount of
  386  Medicaid prescription drugs which are destroyed on an annual
  387  basis and if there are additional ways to ensure more
  388  prescription drugs are not destroyed which could safely be
  389  reused.
  390         Section 3. Paragraph (a) of subsection (20) of section
  391  409.910, Florida Statutes, is amended to read:
  392         409.910 Responsibility for payments on behalf of Medicaid
  393  eligible persons when other parties are liable.—
  394         (20)(a) Entities providing health insurance as defined in
  395  s. 624.603, health maintenance organizations and prepaid health
  396  clinics as defined in chapter 641, and, on behalf of their
  397  clients, third-party administrators, pharmacy benefits managers,
  398  and any other third parties, as defined in s. 409.901(28) s.
  399  409.901(27), which are legally responsible for payment of a
  400  claim for a health care item or service as a condition of doing
  401  business in this the state or providing coverage to residents of
  402  this state, shall provide such records and information as are
  403  necessary to accomplish the purpose of this section, unless such
  404  requirement results in an unreasonable burden.
  405         Section 4. The Agency for Health Care Administration is
  406  directed to include the rate impact of this act in the Medicaid
  407  managed medical assistance program and long-term care managed
  408  care program rates that become effective on October 1, 2024.
  409         Section 5. This act shall take effect October 1, 2024.