Florida Senate - 2022                                     SB 534
       
       
        
       By Senator Harrell
       
       
       
       
       
       25-00651A-22                                           2022534__
    1                        A bill to be entitled                      
    2         An act relating to prescription drugs used in the
    3         treatment of schizophrenia for Medicaid recipients;
    4         amending s. 409.912, F.S.; authorizing the approval of
    5         drug products or certain medication prescribed for the
    6         treatment of schizophrenia or schizotypal or
    7         delusional disorders for Medicaid recipients who have
    8         not met the step-therapy prior authorization criteria,
    9         when the drug product or certain medication meets
   10         specified criteria; providing an effective date.
   11          
   12  Be It Enacted by the Legislature of the State of Florida:
   13  
   14         Section 1. Paragraph (a) of subsection (5) of section
   15  409.912, Florida Statutes, is amended to read:
   16         409.912 Cost-effective purchasing of health care.—The
   17  agency shall purchase goods and services for Medicaid recipients
   18  in the most cost-effective manner consistent with the delivery
   19  of quality medical care. To ensure that medical services are
   20  effectively utilized, the agency may, in any case, require a
   21  confirmation or second physician’s opinion of the correct
   22  diagnosis for purposes of authorizing future services under the
   23  Medicaid program. This section does not restrict access to
   24  emergency services or poststabilization care services as defined
   25  in 42 C.F.R. s. 438.114. Such confirmation or second opinion
   26  shall be rendered in a manner approved by the agency. The agency
   27  shall maximize the use of prepaid per capita and prepaid
   28  aggregate fixed-sum basis services when appropriate and other
   29  alternative service delivery and reimbursement methodologies,
   30  including competitive bidding pursuant to s. 287.057, designed
   31  to facilitate the cost-effective purchase of a case-managed
   32  continuum of care. The agency shall also require providers to
   33  minimize the exposure of recipients to the need for acute
   34  inpatient, custodial, and other institutional care and the
   35  inappropriate or unnecessary use of high-cost services. The
   36  agency shall contract with a vendor to monitor and evaluate the
   37  clinical practice patterns of providers in order to identify
   38  trends that are outside the normal practice patterns of a
   39  provider’s professional peers or the national guidelines of a
   40  provider’s professional association. The vendor must be able to
   41  provide information and counseling to a provider whose practice
   42  patterns are outside the norms, in consultation with the agency,
   43  to improve patient care and reduce inappropriate utilization.
   44  The agency may mandate prior authorization, drug therapy
   45  management, or disease management participation for certain
   46  populations of Medicaid beneficiaries, certain drug classes, or
   47  particular drugs to prevent fraud, abuse, overuse, and possible
   48  dangerous drug interactions. The Pharmaceutical and Therapeutics
   49  Committee shall make recommendations to the agency on drugs for
   50  which prior authorization is required. The agency shall inform
   51  the Pharmaceutical and Therapeutics Committee of its decisions
   52  regarding drugs subject to prior authorization. The agency is
   53  authorized to limit the entities it contracts with or enrolls as
   54  Medicaid providers by developing a provider network through
   55  provider credentialing. The agency may competitively bid single
   56  source-provider contracts if procurement of goods or services
   57  results in demonstrated cost savings to the state without
   58  limiting access to care. The agency may limit its network based
   59  on the assessment of beneficiary access to care, provider
   60  availability, provider quality standards, time and distance
   61  standards for access to care, the cultural competence of the
   62  provider network, demographic characteristics of Medicaid
   63  beneficiaries, practice and provider-to-beneficiary standards,
   64  appointment wait times, beneficiary use of services, provider
   65  turnover, provider profiling, provider licensure history,
   66  previous program integrity investigations and findings, peer
   67  review, provider Medicaid policy and billing compliance records,
   68  clinical and medical record audits, and other factors. Providers
   69  are not entitled to enrollment in the Medicaid provider network.
   70  The agency shall determine instances in which allowing Medicaid
   71  beneficiaries to purchase durable medical equipment and other
   72  goods is less expensive to the Medicaid program than long-term
   73  rental of the equipment or goods. The agency may establish rules
   74  to facilitate purchases in lieu of long-term rentals in order to
   75  protect against fraud and abuse in the Medicaid program as
   76  defined in s. 409.913. The agency may seek federal waivers
   77  necessary to administer these policies.
   78         (5)(a) The agency shall implement a Medicaid prescribed
   79  drug spending-control program that includes the following
   80  components:
   81         1. A Medicaid preferred drug list, which shall be a listing
   82  of cost-effective therapeutic options recommended by the
   83  Medicaid Pharmacy and Therapeutics Committee established
   84  pursuant to s. 409.91195 and adopted by the agency for each
   85  therapeutic class on the preferred drug list. At the discretion
   86  of the committee, and when feasible, the preferred drug list
   87  should include at least two products in a therapeutic class. The
   88  agency may post the preferred drug list and updates to the list
   89  on an Internet website without following the rulemaking
   90  procedures of chapter 120. Antiretroviral agents are excluded
   91  from the preferred drug list. The agency shall also limit the
   92  amount of a prescribed drug dispensed to no more than a 34-day
   93  supply unless the drug products’ smallest marketed package is
   94  greater than a 34-day supply, or the drug is determined by the
   95  agency to be a maintenance drug in which case a 100-day maximum
   96  supply may be authorized. The agency may seek any federal
   97  waivers necessary to implement these cost-control programs and
   98  to continue participation in the federal Medicaid rebate
   99  program, or alternatively to negotiate state-only manufacturer
  100  rebates. The agency may adopt rules to administer this
  101  subparagraph. The agency shall continue to provide unlimited
  102  contraceptive drugs and items. The agency must establish
  103  procedures to ensure that:
  104         a. There is a response to a request for prior authorization
  105  by telephone or other telecommunication device within 24 hours
  106  after receipt of a request for prior authorization; and
  107         b. A 72-hour supply of the drug prescribed is provided in
  108  an emergency or when the agency does not provide a response
  109  within 24 hours as required by sub-subparagraph a.
  110         2. A provider of prescribed drugs is reimbursed in an
  111  amount not to exceed the lesser of the actual acquisition cost
  112  based on the Centers for Medicare and Medicaid Services National
  113  Average Drug Acquisition Cost pricing files plus a professional
  114  dispensing fee, the wholesale acquisition cost plus a
  115  professional dispensing fee, the state maximum allowable cost
  116  plus a professional dispensing fee, or the usual and customary
  117  charge billed by the provider.
  118         3. The agency shall develop and implement a process for
  119  managing the drug therapies of Medicaid recipients who are using
  120  significant numbers of prescribed drugs each month. The
  121  management process may include, but is not limited to,
  122  comprehensive, physician-directed medical-record reviews, claims
  123  analyses, and case evaluations to determine the medical
  124  necessity and appropriateness of a patient’s treatment plan and
  125  drug therapies. The agency may contract with a private
  126  organization to provide drug-program-management services. The
  127  Medicaid drug benefit management program shall include
  128  initiatives to manage drug therapies for HIV/AIDS patients,
  129  patients using 20 or more unique prescriptions in a 180-day
  130  period, and the top 1,000 patients in annual spending. The
  131  agency shall enroll any Medicaid recipient in the drug benefit
  132  management program if he or she meets the specifications of this
  133  provision and is not enrolled in a Medicaid health maintenance
  134  organization.
  135         4. The agency may limit the size of its pharmacy network
  136  based on need, competitive bidding, price negotiations,
  137  credentialing, or similar criteria. The agency shall give
  138  special consideration to rural areas in determining the size and
  139  location of pharmacies included in the Medicaid pharmacy
  140  network. A pharmacy credentialing process may include criteria
  141  such as a pharmacy’s full-service status, location, size,
  142  patient educational programs, patient consultation, disease
  143  management services, and other characteristics. The agency may
  144  impose a moratorium on Medicaid pharmacy enrollment if it is
  145  determined that it has a sufficient number of Medicaid
  146  participating providers. The agency must allow dispensing
  147  practitioners to participate as a part of the Medicaid pharmacy
  148  network regardless of the practitioner’s proximity to any other
  149  entity that is dispensing prescription drugs under the Medicaid
  150  program. A dispensing practitioner must meet all credentialing
  151  requirements applicable to his or her practice, as determined by
  152  the agency.
  153         5. The agency shall develop and implement a program that
  154  requires Medicaid practitioners who issue written prescriptions
  155  for medicinal drugs to use a counterfeit-proof prescription pad
  156  for Medicaid prescriptions. The agency shall require the use of
  157  standardized counterfeit-proof prescription pads by prescribers
  158  who issue written prescriptions for Medicaid recipients. The
  159  agency may implement the program in targeted geographic areas or
  160  statewide.
  161         6. The agency may enter into arrangements that require
  162  manufacturers of generic drugs prescribed to Medicaid recipients
  163  to provide rebates of at least 15.1 percent of the average
  164  manufacturer price for the manufacturer’s generic products.
  165  These arrangements shall require that if a generic-drug
  166  manufacturer pays federal rebates for Medicaid-reimbursed drugs
  167  at a level below 15.1 percent, the manufacturer must provide a
  168  supplemental rebate to the state in an amount necessary to
  169  achieve a 15.1-percent rebate level.
  170         7. The agency may establish a preferred drug list as
  171  described in this subsection, and, pursuant to the establishment
  172  of such preferred drug list, negotiate supplemental rebates from
  173  manufacturers that are in addition to those required by Title
  174  XIX of the Social Security Act and at no less than 14 percent of
  175  the average manufacturer price as defined in 42 U.S.C. s. 1936
  176  on the last day of a quarter unless the federal or supplemental
  177  rebate, or both, equals or exceeds 29 percent. There is no upper
  178  limit on the supplemental rebates the agency may negotiate. The
  179  agency may determine that specific products, brand-name or
  180  generic, are competitive at lower rebate percentages. Agreement
  181  to pay the minimum supplemental rebate percentage guarantees a
  182  manufacturer that the Medicaid Pharmaceutical and Therapeutics
  183  Committee will consider a product for inclusion on the preferred
  184  drug list. However, a pharmaceutical manufacturer is not
  185  guaranteed placement on the preferred drug list by simply paying
  186  the minimum supplemental rebate. Agency decisions will be made
  187  on the clinical efficacy of a drug and recommendations of the
  188  Medicaid Pharmaceutical and Therapeutics Committee, as well as
  189  the price of competing products minus federal and state rebates.
  190  The agency may contract with an outside agency or contractor to
  191  conduct negotiations for supplemental rebates. For the purposes
  192  of this section, the term “supplemental rebates” means cash
  193  rebates. Value-added programs as a substitution for supplemental
  194  rebates are prohibited. The agency may seek any federal waivers
  195  to implement this initiative.
  196         8.a. The agency may implement a Medicaid behavioral drug
  197  management system. The agency may contract with a vendor that
  198  has experience in operating behavioral drug management systems
  199  to implement this program. The agency may seek federal waivers
  200  to implement this program.
  201         b. The agency, in conjunction with the Department of
  202  Children and Families, may implement the Medicaid behavioral
  203  drug management system that is designed to improve the quality
  204  of care and behavioral health prescribing practices based on
  205  best practice guidelines, improve patient adherence to
  206  medication plans, reduce clinical risk, and lower prescribed
  207  drug costs and the rate of inappropriate spending on Medicaid
  208  behavioral drugs. The program may include the following
  209  elements:
  210         (I) Provide for the development and adoption of best
  211  practice guidelines for behavioral health-related drugs such as
  212  antipsychotics, antidepressants, and medications for treating
  213  bipolar disorders and other behavioral conditions; translate
  214  them into practice; review behavioral health prescribers and
  215  compare their prescribing patterns to a number of indicators
  216  that are based on national standards; and determine deviations
  217  from best practice guidelines.
  218         (II) Implement processes for providing feedback to and
  219  educating prescribers using best practice educational materials
  220  and peer-to-peer consultation.
  221         (III) Assess Medicaid beneficiaries who are outliers in
  222  their use of behavioral health drugs with regard to the numbers
  223  and types of drugs taken, drug dosages, combination drug
  224  therapies, and other indicators of improper use of behavioral
  225  health drugs.
  226         (IV) Alert prescribers to patients who fail to refill
  227  prescriptions in a timely fashion, are prescribed multiple same
  228  class behavioral health drugs, and may have other potential
  229  medication problems.
  230         (V) Track spending trends for behavioral health drugs and
  231  deviation from best practice guidelines.
  232         (VI) Use educational and technological approaches to
  233  promote best practices, educate consumers, and train prescribers
  234  in the use of practice guidelines.
  235         (VII) Disseminate electronic and published materials.
  236         (VIII) Hold statewide and regional conferences.
  237         (IX) Implement a disease management program with a model
  238  quality-based medication component for severely mentally ill
  239  individuals and emotionally disturbed children who are high
  240  users of care.
  241         9. The agency shall implement a Medicaid prescription drug
  242  management system.
  243         a. The agency may contract with a vendor that has
  244  experience in operating prescription drug management systems in
  245  order to implement this system. Any management system that is
  246  implemented in accordance with this subparagraph must rely on
  247  cooperation between physicians and pharmacists to determine
  248  appropriate practice patterns and clinical guidelines to improve
  249  the prescribing, dispensing, and use of drugs in the Medicaid
  250  program. The agency may seek federal waivers to implement this
  251  program.
  252         b. The drug management system must be designed to improve
  253  the quality of care and prescribing practices based on best
  254  practice guidelines, improve patient adherence to medication
  255  plans, reduce clinical risk, and lower prescribed drug costs and
  256  the rate of inappropriate spending on Medicaid prescription
  257  drugs. The program must:
  258         (I) Provide for the adoption of best practice guidelines
  259  for the prescribing and use of drugs in the Medicaid program,
  260  including translating best practice guidelines into practice;
  261  reviewing prescriber patterns and comparing them to indicators
  262  that are based on national standards and practice patterns of
  263  clinical peers in their community, statewide, and nationally;
  264  and determine deviations from best practice guidelines.
  265         (II) Implement processes for providing feedback to and
  266  educating prescribers using best practice educational materials
  267  and peer-to-peer consultation.
  268         (III) Assess Medicaid recipients who are outliers in their
  269  use of a single or multiple prescription drugs with regard to
  270  the numbers and types of drugs taken, drug dosages, combination
  271  drug therapies, and other indicators of improper use of
  272  prescription drugs.
  273         (IV) Alert prescribers to recipients who fail to refill
  274  prescriptions in a timely fashion, are prescribed multiple drugs
  275  that may be redundant or contraindicated, or may have other
  276  potential medication problems.
  277         10. The agency may contract for drug rebate administration,
  278  including, but not limited to, calculating rebate amounts,
  279  invoicing manufacturers, negotiating disputes with
  280  manufacturers, and maintaining a database of rebate collections.
  281         11. The agency may specify the preferred daily dosing form
  282  or strength for the purpose of promoting best practices with
  283  regard to the prescribing of certain drugs as specified in the
  284  General Appropriations Act and ensuring cost-effective
  285  prescribing practices.
  286         12. The agency may require prior authorization for
  287  Medicaid-covered prescribed drugs. The agency may prior
  288  authorize the use of a product:
  289         a. For an indication not approved in labeling;
  290         b. To comply with certain clinical guidelines; or
  291         c. If the product has the potential for overuse, misuse, or
  292  abuse.
  293  
  294  The agency may require the prescribing professional to provide
  295  information about the rationale and supporting medical evidence
  296  for the use of a drug. The agency shall post prior
  297  authorization, step-edit criteria and protocol, and updates to
  298  the list of drugs that are subject to prior authorization on the
  299  agency’s Internet website within 21 days after the prior
  300  authorization and step-edit criteria and protocol and updates
  301  are approved by the agency. For purposes of this subparagraph,
  302  the term “step-edit” means an automatic electronic review of
  303  certain medications subject to prior authorization.
  304         13. The agency, in conjunction with the Pharmaceutical and
  305  Therapeutics Committee, may require age-related prior
  306  authorizations for certain prescribed drugs. The agency may
  307  preauthorize the use of a drug for a recipient who may not meet
  308  the age requirement or may exceed the length of therapy for use
  309  of this product as recommended by the manufacturer and approved
  310  by the Food and Drug Administration. Prior authorization may
  311  require the prescribing professional to provide information
  312  about the rationale and supporting medical evidence for the use
  313  of a drug.
  314         14. The agency shall implement a step-therapy prior
  315  authorization approval process for medications excluded from the
  316  preferred drug list. Medications listed on the preferred drug
  317  list must be used within the previous 12 months before the
  318  alternative medications that are not listed. The step-therapy
  319  prior authorization may require the prescriber to use the
  320  medications of a similar drug class or for a similar medical
  321  indication unless contraindicated in the Food and Drug
  322  Administration labeling. The trial period between the specified
  323  steps may vary according to the medical indication. The step
  324  therapy approval process shall be developed in accordance with
  325  the committee as stated in s. 409.91195(7) and (8). A drug
  326  product may be approved without meeting the step-therapy prior
  327  authorization criteria if the prescribing physician provides the
  328  agency with additional written medical or clinical documentation
  329  that the product is medically necessary because:
  330         a. There is not a drug on the preferred drug list to treat
  331  the disease or medical condition which is an acceptable clinical
  332  alternative;
  333         b. The alternatives have been ineffective in the treatment
  334  of the beneficiary’s disease; or
  335         c. The drug product or medication of a similar drug class
  336  is prescribed for the treatment of schizophrenia or schizotypal
  337  or delusional disorders; prior authorization has been granted
  338  previously for the prescribed drug; and the medication was
  339  dispensed to the patient during the previous 12 months; or
  340         d. Based on historic evidence and known characteristics of
  341  the patient and the drug, the drug is likely to be ineffective,
  342  or the number of doses have been ineffective.
  343  
  344  The agency shall work with the physician to determine the best
  345  alternative for the patient. The agency may adopt rules waiving
  346  the requirements for written clinical documentation for specific
  347  drugs in limited clinical situations.
  348         15. The agency shall implement a return and reuse program
  349  for drugs dispensed by pharmacies to institutional recipients,
  350  which includes payment of a $5 restocking fee for the
  351  implementation and operation of the program. The return and
  352  reuse program shall be implemented electronically and in a
  353  manner that promotes efficiency. The program must permit a
  354  pharmacy to exclude drugs from the program if it is not
  355  practical or cost-effective for the drug to be included and must
  356  provide for the return to inventory of drugs that cannot be
  357  credited or returned in a cost-effective manner. The agency
  358  shall determine if the program has reduced the amount of
  359  Medicaid prescription drugs which are destroyed on an annual
  360  basis and if there are additional ways to ensure more
  361  prescription drugs are not destroyed which could safely be
  362  reused.
  363         Section 2. This act shall take effect July 1, 2022.