Florida Senate - 2021                             CS for SB 1292
       By the Committee on Health Policy; and Senator Bean
       588-03321-21                                          20211292c1
    1                        A bill to be entitled                      
    2         An act relating to Medicaid; amending s. 402.81, F.S.;
    3         deleting a requirement for the Agency for Health Care
    4         Administration to submit an annual report to the
    5         Legislature on the operation of the pharmaceutical
    6         expense assistance program; amending s. 409.815, F.S.;
    7         conforming a provision to changes made by the act;
    8         amending s. 409.908, F.S.; revising the method for
    9         determining prescribed drug provider reimbursements;
   10         deleting a requirement for the agency to implement
   11         certain fees for prescribed medicines; deleting
   12         authorization for the agency to increase certain
   13         dispensing fees by certain amounts; reenacting and
   14         amending s. 409.91195, F.S., relating to the Medicaid
   15         Pharmaceutical and Therapeutics Committee; deleting a
   16         requirement for the agency to ensure that the
   17         committee reviews certain drugs under certain
   18         circumstances; designating the agency, rather than the
   19         Department of Children and Families, as the
   20         administrator for certain hearings; amending s.
   21         409.912, F.S.; requiring the agency to establish
   22         certain procedures related to prior authorization
   23         requests rather than prior consultation requests;
   24         revising the method for determining prescribed drug
   25         provider reimbursements; deleting a requirement for
   26         the agency to expand home delivery of pharmacy
   27         products; deleting a dosage limitation on certain
   28         drugs; deleting a requirement for the agency to submit
   29         certain quarterly reports to the Governor and the
   30         Legislature; repealing s. 409.91213, F.S., relating to
   31         quarterly progress reports and annual reports;
   32         amending s. 409.913, F.S.; revising the definitions of
   33         the terms “medical necessity” and “medically
   34         necessary” to provide an exception for behavior
   35         analysis services determinations; requiring that
   36         determinations be based on information available at
   37         the time goods or services are requested, rather than
   38         at the time such goods or services are provided;
   39         repealing s. 765.53, F.S., relating to the Organ
   40         Transplant Advisory Council; providing an effective
   41         date.
   43  Be It Enacted by the Legislature of the State of Florida:
   45         Section 1. Subsection (4) of section 402.81, Florida
   46  Statutes, is amended to read:
   47         402.81 Pharmaceutical expense assistance.—
   48         (4) ADMINISTRATION.—The agency shall administer the
   49  pharmaceutical expense assistance program shall be administered
   50  by the agency, in collaboration with the Department of Elderly
   51  Affairs and the Department of Children and Families. By January
   52  1 of each year, the agency shall report to the Legislature on
   53  the operation of the program. The report shall include
   54  information on the number of individuals served, use rates, and
   55  expenditures under the program.
   56         Section 2. Paragraph (e) of subsection (2) of section
   57  409.815, Florida Statutes, is amended to read:
   58         409.815 Health benefits coverage; limitations.—
   59         (2) BENCHMARK BENEFITS.—In order for health benefits
   60  coverage to qualify for premium assistance payments for an
   61  eligible child under ss. 409.810-409.821, the health benefits
   62  coverage, except for coverage under Medicaid and Medikids, must
   63  include the following minimum benefits, as medically necessary.
   64         (e) Organ transplantation services.—Covered services
   65  include pretransplant, transplant, and postdischarge services
   66  and treatment of complications after transplantation for
   67  transplants deemed necessary and appropriate within the
   68  guidelines set by the Organ Transplant Advisory Council under s.
   69  765.53 or the Bone Marrow Transplant Advisory Panel under s.
   70  627.4236.
   71         Section 3. Subsection (14) of section 409.908, Florida
   72  Statutes, is amended to read:
   73         409.908 Reimbursement of Medicaid providers.—Subject to
   74  specific appropriations, the agency shall reimburse Medicaid
   75  providers, in accordance with state and federal law, according
   76  to methodologies set forth in the rules of the agency and in
   77  policy manuals and handbooks incorporated by reference therein.
   78  These methodologies may include fee schedules, reimbursement
   79  methods based on cost reporting, negotiated fees, competitive
   80  bidding pursuant to s. 287.057, and other mechanisms the agency
   81  considers efficient and effective for purchasing services or
   82  goods on behalf of recipients. If a provider is reimbursed based
   83  on cost reporting and submits a cost report late and that cost
   84  report would have been used to set a lower reimbursement rate
   85  for a rate semester, then the provider’s rate for that semester
   86  shall be retroactively calculated using the new cost report, and
   87  full payment at the recalculated rate shall be effected
   88  retroactively. Medicare-granted extensions for filing cost
   89  reports, if applicable, shall also apply to Medicaid cost
   90  reports. Payment for Medicaid compensable services made on
   91  behalf of Medicaid eligible persons is subject to the
   92  availability of moneys and any limitations or directions
   93  provided for in the General Appropriations Act or chapter 216.
   94  Further, nothing in this section shall be construed to prevent
   95  or limit the agency from adjusting fees, reimbursement rates,
   96  lengths of stay, number of visits, or number of services, or
   97  making any other adjustments necessary to comply with the
   98  availability of moneys and any limitations or directions
   99  provided for in the General Appropriations Act, provided the
  100  adjustment is consistent with legislative intent.
  101         (14) A provider of prescribed drugs shall be reimbursed in
  102  an amount not to exceed the lesser of the actual acquisition
  103  cost based on the Centers for Medicare and Medicaid Services
  104  National Average Drug Acquisition Cost pricing files plus a
  105  professional dispensing fee, the wholesale acquisition cost plus
  106  a professional dispensing fee, the state maximum allowable cost
  107  plus a professional dispensing fee, or the usual and customary
  108  charge billed by the provider the least of the amount billed by
  109  the provider, the provider’s usual and customary charge, or the
  110  Medicaid maximum allowable fee established by the agency, plus a
  111  dispensing fee. The Medicaid maximum allowable fee for
  112  ingredient cost must be based on the lowest of: the average
  113  wholesale price (AWP) minus 16.4 percent, the wholesaler
  114  acquisition cost (WAC) plus 1.5 percent, the federal upper limit
  115  (FUL), the state maximum allowable cost (SMAC), or the usual and
  116  customary (UAC) charge billed by the provider.
  117         (a) Medicaid providers must dispense generic drugs if
  118  available at lower cost and the agency has not determined that
  119  the branded product is more cost-effective, unless the
  120  prescriber has requested and received approval to require the
  121  branded product.
  122         (b) The agency shall implement a variable dispensing fee
  123  for prescribed medicines while ensuring continued access for
  124  Medicaid recipients. The variable dispensing fee may be based
  125  upon, but not limited to, either or both the volume of
  126  prescriptions dispensed by a specific pharmacy provider, the
  127  volume of prescriptions dispensed to an individual recipient,
  128  and dispensing of preferred-drug-list products.
  129         (c) The agency may increase the pharmacy dispensing fee
  130  authorized by statute and in the General Appropriations Act by
  131  $0.50 for the dispensing of a Medicaid preferred-drug-list
  132  product and reduce the pharmacy dispensing fee by $0.50 for the
  133  dispensing of a Medicaid product that is not included on the
  134  preferred drug list.
  135         (d) The agency may establish a supplemental pharmaceutical
  136  dispensing fee to be paid to providers returning unused unit
  137  dose packaged medications to stock and crediting the Medicaid
  138  program for the ingredient cost of those medications if the
  139  ingredient costs to be credited exceed the value of the
  140  supplemental dispensing fee.
  141         (c)(e) The agency may limit reimbursement for prescribed
  142  medicine in order to comply with any limitations or directions
  143  provided in the General Appropriations Act, which may include
  144  implementing a prospective or concurrent utilization review
  145  program.
  146         Section 4. Subsections (9) and (11) of section 409.91195,
  147  Florida Statutes, are amended, and subsection (4) of that
  148  section is reenacted for the purpose of incorporating the
  149  amendment made by this act to section 409.912, Florida Statutes,
  150  in a reference thereto, to read:
  151         409.91195 Medicaid Pharmaceutical and Therapeutics
  152  Committee.—There is created a Medicaid Pharmaceutical and
  153  Therapeutics Committee within the agency for the purpose of
  154  developing a Medicaid preferred drug list.
  155         (4) Upon recommendation of the committee, the agency shall
  156  adopt a preferred drug list as described in s. 409.912(5). To
  157  the extent feasible, the committee shall review all drug classes
  158  included on the preferred drug list every 12 months, and may
  159  recommend additions to and deletions from the preferred drug
  160  list, such that the preferred drug list provides for medically
  161  appropriate drug therapies for Medicaid patients which achieve
  162  cost savings contained in the General Appropriations Act.
  163         (9) Upon timely notice, the agency shall ensure that any
  164  therapeutic class of drugs which includes a drug that has been
  165  removed from distribution to the public by its manufacturer or
  166  the United States Food and Drug Administration or has been
  167  required to carry a black box warning label by the United States
  168  Food and Drug Administration because of safety concerns is
  169  reviewed by the committee at the next regularly scheduled
  170  meeting. After such review, the committee must recommend whether
  171  to retain the therapeutic class of drugs or subcategories of
  172  drugs within a therapeutic class on the preferred drug list and
  173  whether to institute prior authorization requirements necessary
  174  to ensure patient safety.
  175         (10)(11) Medicaid recipients may appeal agency preferred
  176  drug formulary decisions using the Medicaid fair hearing process
  177  administered by the Agency for Health Care Administration
  178  Department of Children and Families.
  179         Section 5. Paragraphs (a) and (c) of subsection (5) of
  180  section 409.912, Florida Statutes, are amended to read:
  181         409.912 Cost-effective purchasing of health care.—The
  182  agency shall purchase goods and services for Medicaid recipients
  183  in the most cost-effective manner consistent with the delivery
  184  of quality medical care. To ensure that medical services are
  185  effectively utilized, the agency may, in any case, require a
  186  confirmation or second physician’s opinion of the correct
  187  diagnosis for purposes of authorizing future services under the
  188  Medicaid program. This section does not restrict access to
  189  emergency services or poststabilization care services as defined
  190  in 42 C.F.R. s. 438.114. Such confirmation or second opinion
  191  shall be rendered in a manner approved by the agency. The agency
  192  shall maximize the use of prepaid per capita and prepaid
  193  aggregate fixed-sum basis services when appropriate and other
  194  alternative service delivery and reimbursement methodologies,
  195  including competitive bidding pursuant to s. 287.057, designed
  196  to facilitate the cost-effective purchase of a case-managed
  197  continuum of care. The agency shall also require providers to
  198  minimize the exposure of recipients to the need for acute
  199  inpatient, custodial, and other institutional care and the
  200  inappropriate or unnecessary use of high-cost services. The
  201  agency shall contract with a vendor to monitor and evaluate the
  202  clinical practice patterns of providers in order to identify
  203  trends that are outside the normal practice patterns of a
  204  provider’s professional peers or the national guidelines of a
  205  provider’s professional association. The vendor must be able to
  206  provide information and counseling to a provider whose practice
  207  patterns are outside the norms, in consultation with the agency,
  208  to improve patient care and reduce inappropriate utilization.
  209  The agency may mandate prior authorization, drug therapy
  210  management, or disease management participation for certain
  211  populations of Medicaid beneficiaries, certain drug classes, or
  212  particular drugs to prevent fraud, abuse, overuse, and possible
  213  dangerous drug interactions. The Pharmaceutical and Therapeutics
  214  Committee shall make recommendations to the agency on drugs for
  215  which prior authorization is required. The agency shall inform
  216  the Pharmaceutical and Therapeutics Committee of its decisions
  217  regarding drugs subject to prior authorization. The agency is
  218  authorized to limit the entities it contracts with or enrolls as
  219  Medicaid providers by developing a provider network through
  220  provider credentialing. The agency may competitively bid single
  221  source-provider contracts if procurement of goods or services
  222  results in demonstrated cost savings to the state without
  223  limiting access to care. The agency may limit its network based
  224  on the assessment of beneficiary access to care, provider
  225  availability, provider quality standards, time and distance
  226  standards for access to care, the cultural competence of the
  227  provider network, demographic characteristics of Medicaid
  228  beneficiaries, practice and provider-to-beneficiary standards,
  229  appointment wait times, beneficiary use of services, provider
  230  turnover, provider profiling, provider licensure history,
  231  previous program integrity investigations and findings, peer
  232  review, provider Medicaid policy and billing compliance records,
  233  clinical and medical record audits, and other factors. Providers
  234  are not entitled to enrollment in the Medicaid provider network.
  235  The agency shall determine instances in which allowing Medicaid
  236  beneficiaries to purchase durable medical equipment and other
  237  goods is less expensive to the Medicaid program than long-term
  238  rental of the equipment or goods. The agency may establish rules
  239  to facilitate purchases in lieu of long-term rentals in order to
  240  protect against fraud and abuse in the Medicaid program as
  241  defined in s. 409.913. The agency may seek federal waivers
  242  necessary to administer these policies.
  243         (5)(a) The agency shall implement a Medicaid prescribed
  244  drug spending-control program that includes the following
  245  components:
  246         1. A Medicaid preferred drug list, which shall be a listing
  247  of cost-effective therapeutic options recommended by the
  248  Medicaid Pharmacy and Therapeutics Committee established
  249  pursuant to s. 409.91195 and adopted by the agency for each
  250  therapeutic class on the preferred drug list. At the discretion
  251  of the committee, and when feasible, the preferred drug list
  252  should include at least two products in a therapeutic class. The
  253  agency may post the preferred drug list and updates to the list
  254  on an Internet website without following the rulemaking
  255  procedures of chapter 120. Antiretroviral agents are excluded
  256  from the preferred drug list. The agency shall also limit the
  257  amount of a prescribed drug dispensed to no more than a 34-day
  258  supply unless the drug products’ smallest marketed package is
  259  greater than a 34-day supply, or the drug is determined by the
  260  agency to be a maintenance drug in which case a 100-day maximum
  261  supply may be authorized. The agency may seek any federal
  262  waivers necessary to implement these cost-control programs and
  263  to continue participation in the federal Medicaid rebate
  264  program, or alternatively to negotiate state-only manufacturer
  265  rebates. The agency may adopt rules to administer this
  266  subparagraph. The agency shall continue to provide unlimited
  267  contraceptive drugs and items. The agency must establish
  268  procedures to ensure that:
  269         a. There is a response to a request for prior authorization
  270  consultation by telephone or other telecommunication device
  271  within 24 hours after receipt of a request for prior
  272  authorization consultation; and
  273         b. A 72-hour supply of the drug prescribed is provided in
  274  an emergency or when the agency does not provide a response
  275  within 24 hours as required by sub-subparagraph a.
  276         2. A provider of prescribed drugs is reimbursed in an
  277  amount not to exceed the lesser of the actual acquisition cost
  278  based on the Centers for Medicare and Medicaid Services National
  279  Average Drug Acquisition Cost pricing files plus a professional
  280  dispensing fee, the wholesale acquisition cost plus a
  281  professional dispensing fee, the state maximum allowable cost
  282  plus a professional dispensing fee, or the usual and customary
  283  charge billed by the provider Reimbursement to pharmacies for
  284  Medicaid prescribed drugs shall be set at the lowest of: the
  285  average wholesale price (AWP) minus 16.4 percent, the wholesaler
  286  acquisition cost (WAC) plus 1.5 percent, the federal upper limit
  287  (FUL), the state maximum allowable cost (SMAC), or the usual and
  288  customary (UAC) charge billed by the provider.
  289         3. The agency shall develop and implement a process for
  290  managing the drug therapies of Medicaid recipients who are using
  291  significant numbers of prescribed drugs each month. The
  292  management process may include, but is not limited to,
  293  comprehensive, physician-directed medical-record reviews, claims
  294  analyses, and case evaluations to determine the medical
  295  necessity and appropriateness of a patient’s treatment plan and
  296  drug therapies. The agency may contract with a private
  297  organization to provide drug-program-management services. The
  298  Medicaid drug benefit management program shall include
  299  initiatives to manage drug therapies for HIV/AIDS patients,
  300  patients using 20 or more unique prescriptions in a 180-day
  301  period, and the top 1,000 patients in annual spending. The
  302  agency shall enroll any Medicaid recipient in the drug benefit
  303  management program if he or she meets the specifications of this
  304  provision and is not enrolled in a Medicaid health maintenance
  305  organization.
  306         4. The agency may limit the size of its pharmacy network
  307  based on need, competitive bidding, price negotiations,
  308  credentialing, or similar criteria. The agency shall give
  309  special consideration to rural areas in determining the size and
  310  location of pharmacies included in the Medicaid pharmacy
  311  network. A pharmacy credentialing process may include criteria
  312  such as a pharmacy’s full-service status, location, size,
  313  patient educational programs, patient consultation, disease
  314  management services, and other characteristics. The agency may
  315  impose a moratorium on Medicaid pharmacy enrollment if it is
  316  determined that it has a sufficient number of Medicaid
  317  participating providers. The agency must allow dispensing
  318  practitioners to participate as a part of the Medicaid pharmacy
  319  network regardless of the practitioner’s proximity to any other
  320  entity that is dispensing prescription drugs under the Medicaid
  321  program. A dispensing practitioner must meet all credentialing
  322  requirements applicable to his or her practice, as determined by
  323  the agency.
  324         5. The agency shall develop and implement a program that
  325  requires Medicaid practitioners who issue written prescriptions
  326  for medicinal drugs to use a counterfeit-proof prescription pad
  327  for Medicaid prescriptions. The agency shall require the use of
  328  standardized counterfeit-proof prescription pads by prescribers
  329  who issue written prescriptions for Medicaid recipients. The
  330  agency may implement the program in targeted geographic areas or
  331  statewide.
  332         6. The agency may enter into arrangements that require
  333  manufacturers of generic drugs prescribed to Medicaid recipients
  334  to provide rebates of at least 15.1 percent of the average
  335  manufacturer price for the manufacturer’s generic products.
  336  These arrangements shall require that if a generic-drug
  337  manufacturer pays federal rebates for Medicaid-reimbursed drugs
  338  at a level below 15.1 percent, the manufacturer must provide a
  339  supplemental rebate to the state in an amount necessary to
  340  achieve a 15.1-percent rebate level.
  341         7. The agency may establish a preferred drug list as
  342  described in this subsection, and, pursuant to the establishment
  343  of such preferred drug list, negotiate supplemental rebates from
  344  manufacturers that are in addition to those required by Title
  345  XIX of the Social Security Act and at no less than 14 percent of
  346  the average manufacturer price as defined in 42 U.S.C. s. 1936
  347  on the last day of a quarter unless the federal or supplemental
  348  rebate, or both, equals or exceeds 29 percent. There is no upper
  349  limit on the supplemental rebates the agency may negotiate. The
  350  agency may determine that specific products, brand-name or
  351  generic, are competitive at lower rebate percentages. Agreement
  352  to pay the minimum supplemental rebate percentage guarantees a
  353  manufacturer that the Medicaid Pharmaceutical and Therapeutics
  354  Committee will consider a product for inclusion on the preferred
  355  drug list. However, a pharmaceutical manufacturer is not
  356  guaranteed placement on the preferred drug list by simply paying
  357  the minimum supplemental rebate. Agency decisions will be made
  358  on the clinical efficacy of a drug and recommendations of the
  359  Medicaid Pharmaceutical and Therapeutics Committee, as well as
  360  the price of competing products minus federal and state rebates.
  361  The agency may contract with an outside agency or contractor to
  362  conduct negotiations for supplemental rebates. For the purposes
  363  of this section, the term “supplemental rebates” means cash
  364  rebates. Value-added programs as a substitution for supplemental
  365  rebates are prohibited. The agency may seek any federal waivers
  366  to implement this initiative.
  367         8.a.The agency shall expand home delivery of pharmacy
  368  products. The agency may amend the state plan and issue a
  369  procurement, as necessary, in order to implement this program.
  370  The procurements must include agreements with a pharmacy or
  371  pharmacies located in the state to provide mail order delivery
  372  services at no cost to the recipients who elect to receive home
  373  delivery of pharmacy products. The procurement must focus on
  374  serving recipients with chronic diseases for which pharmacy
  375  expenditures represent a significant portion of Medicaid
  376  pharmacy expenditures or which impact a significant portion of
  377  the Medicaid population. The agency may seek and implement any
  378  federal waivers necessary to implement this subparagraph.
  379         9. The agency shall limit to one dose per month any drug
  380  prescribed to treat erectile dysfunction.
  381         10.a. The agency may implement a Medicaid behavioral drug
  382  management system. The agency may contract with a vendor that
  383  has experience in operating behavioral drug management systems
  384  to implement this program. The agency may seek federal waivers
  385  to implement this program.
  386         b. The agency, in conjunction with the Department of
  387  Children and Families, may implement the Medicaid behavioral
  388  drug management system that is designed to improve the quality
  389  of care and behavioral health prescribing practices based on
  390  best practice guidelines, improve patient adherence to
  391  medication plans, reduce clinical risk, and lower prescribed
  392  drug costs and the rate of inappropriate spending on Medicaid
  393  behavioral drugs. The program may include the following
  394  elements:
  395         (I) Provide for the development and adoption of best
  396  practice guidelines for behavioral health-related drugs such as
  397  antipsychotics, antidepressants, and medications for treating
  398  bipolar disorders and other behavioral conditions; translate
  399  them into practice; review behavioral health prescribers and
  400  compare their prescribing patterns to a number of indicators
  401  that are based on national standards; and determine deviations
  402  from best practice guidelines.
  403         (II) Implement processes for providing feedback to and
  404  educating prescribers using best practice educational materials
  405  and peer-to-peer consultation.
  406         (III) Assess Medicaid beneficiaries who are outliers in
  407  their use of behavioral health drugs with regard to the numbers
  408  and types of drugs taken, drug dosages, combination drug
  409  therapies, and other indicators of improper use of behavioral
  410  health drugs.
  411         (IV) Alert prescribers to patients who fail to refill
  412  prescriptions in a timely fashion, are prescribed multiple same
  413  class behavioral health drugs, and may have other potential
  414  medication problems.
  415         (V) Track spending trends for behavioral health drugs and
  416  deviation from best practice guidelines.
  417         (VI) Use educational and technological approaches to
  418  promote best practices, educate consumers, and train prescribers
  419  in the use of practice guidelines.
  420         (VII) Disseminate electronic and published materials.
  421         (VIII) Hold statewide and regional conferences.
  422         (IX) Implement a disease management program with a model
  423  quality-based medication component for severely mentally ill
  424  individuals and emotionally disturbed children who are high
  425  users of care.
  426         9.11. The agency shall implement a Medicaid prescription
  427  drug management system.
  428         a. The agency may contract with a vendor that has
  429  experience in operating prescription drug management systems in
  430  order to implement this system. Any management system that is
  431  implemented in accordance with this subparagraph must rely on
  432  cooperation between physicians and pharmacists to determine
  433  appropriate practice patterns and clinical guidelines to improve
  434  the prescribing, dispensing, and use of drugs in the Medicaid
  435  program. The agency may seek federal waivers to implement this
  436  program.
  437         b. The drug management system must be designed to improve
  438  the quality of care and prescribing practices based on best
  439  practice guidelines, improve patient adherence to medication
  440  plans, reduce clinical risk, and lower prescribed drug costs and
  441  the rate of inappropriate spending on Medicaid prescription
  442  drugs. The program must:
  443         (I) Provide for the adoption of best practice guidelines
  444  for the prescribing and use of drugs in the Medicaid program,
  445  including translating best practice guidelines into practice;
  446  reviewing prescriber patterns and comparing them to indicators
  447  that are based on national standards and practice patterns of
  448  clinical peers in their community, statewide, and nationally;
  449  and determine deviations from best practice guidelines.
  450         (II) Implement processes for providing feedback to and
  451  educating prescribers using best practice educational materials
  452  and peer-to-peer consultation.
  453         (III) Assess Medicaid recipients who are outliers in their
  454  use of a single or multiple prescription drugs with regard to
  455  the numbers and types of drugs taken, drug dosages, combination
  456  drug therapies, and other indicators of improper use of
  457  prescription drugs.
  458         (IV) Alert prescribers to recipients who fail to refill
  459  prescriptions in a timely fashion, are prescribed multiple drugs
  460  that may be redundant or contraindicated, or may have other
  461  potential medication problems.
  462         10.12. The agency may contract for drug rebate
  463  administration, including, but not limited to, calculating
  464  rebate amounts, invoicing manufacturers, negotiating disputes
  465  with manufacturers, and maintaining a database of rebate
  466  collections.
  467         11.13. The agency may specify the preferred daily dosing
  468  form or strength for the purpose of promoting best practices
  469  with regard to the prescribing of certain drugs as specified in
  470  the General Appropriations Act and ensuring cost-effective
  471  prescribing practices.
  472         12.14. The agency may require prior authorization for
  473  Medicaid-covered prescribed drugs. The agency may prior
  474  authorize the use of a product:
  475         a. For an indication not approved in labeling;
  476         b. To comply with certain clinical guidelines; or
  477         c. If the product has the potential for overuse, misuse, or
  478  abuse.
  480  The agency may require the prescribing professional to provide
  481  information about the rationale and supporting medical evidence
  482  for the use of a drug. The agency shall post prior
  483  authorization, step-edit criteria and protocol, and updates to
  484  the list of drugs that are subject to prior authorization on the
  485  agency’s Internet website within 21 days after the prior
  486  authorization and step-edit criteria and protocol and updates
  487  are approved by the agency. For purposes of this subparagraph,
  488  the term “step-edit” means an automatic electronic review of
  489  certain medications subject to prior authorization.
  490         13.15. The agency, in conjunction with the Pharmaceutical
  491  and Therapeutics Committee, may require age-related prior
  492  authorizations for certain prescribed drugs. The agency may
  493  preauthorize the use of a drug for a recipient who may not meet
  494  the age requirement or may exceed the length of therapy for use
  495  of this product as recommended by the manufacturer and approved
  496  by the Food and Drug Administration. Prior authorization may
  497  require the prescribing professional to provide information
  498  about the rationale and supporting medical evidence for the use
  499  of a drug.
  500         14.16. The agency shall implement a step-therapy prior
  501  authorization approval process for medications excluded from the
  502  preferred drug list. Medications listed on the preferred drug
  503  list must be used within the previous 12 months before the
  504  alternative medications that are not listed. The step-therapy
  505  prior authorization may require the prescriber to use the
  506  medications of a similar drug class or for a similar medical
  507  indication unless contraindicated in the Food and Drug
  508  Administration labeling. The trial period between the specified
  509  steps may vary according to the medical indication. The step
  510  therapy approval process shall be developed in accordance with
  511  the committee as stated in s. 409.91195(7) and (8). A drug
  512  product may be approved without meeting the step-therapy prior
  513  authorization criteria if the prescribing physician provides the
  514  agency with additional written medical or clinical documentation
  515  that the product is medically necessary because:
  516         a. There is not a drug on the preferred drug list to treat
  517  the disease or medical condition which is an acceptable clinical
  518  alternative;
  519         b. The alternatives have been ineffective in the treatment
  520  of the beneficiary’s disease; or
  521         c. Based on historic evidence and known characteristics of
  522  the patient and the drug, the drug is likely to be ineffective,
  523  or the number of doses have been ineffective.
  525  The agency shall work with the physician to determine the best
  526  alternative for the patient. The agency may adopt rules waiving
  527  the requirements for written clinical documentation for specific
  528  drugs in limited clinical situations.
  529         15.17. The agency shall implement a return and reuse
  530  program for drugs dispensed by pharmacies to institutional
  531  recipients, which includes payment of a $5 restocking fee for
  532  the implementation and operation of the program. The return and
  533  reuse program shall be implemented electronically and in a
  534  manner that promotes efficiency. The program must permit a
  535  pharmacy to exclude drugs from the program if it is not
  536  practical or cost-effective for the drug to be included and must
  537  provide for the return to inventory of drugs that cannot be
  538  credited or returned in a cost-effective manner. The agency
  539  shall determine if the program has reduced the amount of
  540  Medicaid prescription drugs which are destroyed on an annual
  541  basis and if there are additional ways to ensure more
  542  prescription drugs are not destroyed which could safely be
  543  reused.
  544         (c) The agency shall submit quarterly reports to the
  545  Governor, the President of the Senate, and the Speaker of the
  546  House of Representatives which must include, but need not be
  547  limited to, the progress made in implementing this subsection
  548  and its effect on Medicaid prescribed-drug expenditures.
  549         Section 6. Section 409.91213, Florida Statutes, is
  550  repealed.
  551         Section 7. Paragraph (d) of subsection (1) of section
  552  409.913, Florida Statutes, is amended to read:
  553         409.913 Oversight of the integrity of the Medicaid
  554  program.—The agency shall operate a program to oversee the
  555  activities of Florida Medicaid recipients, and providers and
  556  their representatives, to ensure that fraudulent and abusive
  557  behavior and neglect of recipients occur to the minimum extent
  558  possible, and to recover overpayments and impose sanctions as
  559  appropriate. Each January 15, the agency and the Medicaid Fraud
  560  Control Unit of the Department of Legal Affairs shall submit a
  561  report to the Legislature documenting the effectiveness of the
  562  state’s efforts to control Medicaid fraud and abuse and to
  563  recover Medicaid overpayments during the previous fiscal year.
  564  The report must describe the number of cases opened and
  565  investigated each year; the sources of the cases opened; the
  566  disposition of the cases closed each year; the amount of
  567  overpayments alleged in preliminary and final audit letters; the
  568  number and amount of fines or penalties imposed; any reductions
  569  in overpayment amounts negotiated in settlement agreements or by
  570  other means; the amount of final agency determinations of
  571  overpayments; the amount deducted from federal claiming as a
  572  result of overpayments; the amount of overpayments recovered
  573  each year; the amount of cost of investigation recovered each
  574  year; the average length of time to collect from the time the
  575  case was opened until the overpayment is paid in full; the
  576  amount determined as uncollectible and the portion of the
  577  uncollectible amount subsequently reclaimed from the Federal
  578  Government; the number of providers, by type, that are
  579  terminated from participation in the Medicaid program as a
  580  result of fraud and abuse; and all costs associated with
  581  discovering and prosecuting cases of Medicaid overpayments and
  582  making recoveries in such cases. The report must also document
  583  actions taken to prevent overpayments and the number of
  584  providers prevented from enrolling in or reenrolling in the
  585  Medicaid program as a result of documented Medicaid fraud and
  586  abuse and must include policy recommendations necessary to
  587  prevent or recover overpayments and changes necessary to prevent
  588  and detect Medicaid fraud. All policy recommendations in the
  589  report must include a detailed fiscal analysis, including, but
  590  not limited to, implementation costs, estimated savings to the
  591  Medicaid program, and the return on investment. The agency must
  592  submit the policy recommendations and fiscal analyses in the
  593  report to the appropriate estimating conference, pursuant to s.
  594  216.137, by February 15 of each year. The agency and the
  595  Medicaid Fraud Control Unit of the Department of Legal Affairs
  596  each must include detailed unit-specific performance standards,
  597  benchmarks, and metrics in the report, including projected cost
  598  savings to the state Medicaid program during the following
  599  fiscal year.
  600         (1) For the purposes of this section, the term:
  601         (d) “Medical necessity” or “medically necessary” means any
  602  goods or services necessary to palliate the effects of a
  603  terminal condition, or to prevent, diagnose, correct, cure,
  604  alleviate, or preclude deterioration of a condition that
  605  threatens life, causes pain or suffering, or results in illness
  606  or infirmity, which goods or services are provided in accordance
  607  with generally accepted standards of medical practice. For
  608  purposes of determining Medicaid reimbursement, the agency is
  609  the final arbiter of medical necessity. Determinations of
  610  medical necessity must be made by a licensed physician employed
  611  by or under contract with the agency, except for behavior
  612  analysis services, which may be determined by a licensed
  613  physician or a doctoral-level board-certified behavior analyst.
  614  Determinations and must be based upon information available at
  615  the time the goods or services are requested provided.
  616         Section 8. Section 765.53, Florida Statutes, is repealed.
  617         Section 9. This act shall take effect July 1, 2021.