Florida Senate - 2021                                    SB 1292
       By Senator Bean
       4-01233A-21                                           20211292__
    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.; deleting a requirement for
    9         the agency to submit an annual report to the
   10         Legislature on certain direct and indirect care costs;
   11         revising the method for determining prescribed drug
   12         provider reimbursements; deleting a requirement for
   13         the agency to implement certain fees for prescribed
   14         medicines; deleting authorization for the agency to
   15         increase certain dispensing fees by certain amounts;
   16         reenacting and amending s. 409.91195, F.S., relating
   17         to the Medicaid Pharmaceutical and Therapeutics
   18         Committee; deleting a requirement for the agency to
   19         ensure that the committee reviews certain drugs under
   20         certain circumstances; designating the agency, rather
   21         than the Department of Children and Families, as the
   22         administrator for certain hearings; amending s.
   23         409.912, F.S.; requiring the agency to establish
   24         certain procedures related to prior authorization
   25         requests rather than prior consultation requests;
   26         revising the method for determining prescribed drug
   27         provider reimbursements; deleting a requirement for
   28         the agency to expand home delivery of pharmacy
   29         products; deleting a dosage limitation on certain
   30         drugs; deleting a requirement for the agency to submit
   31         certain quarterly reports to the Governor and the
   32         Legislature; repealing s. 409.91213, F.S., relating to
   33         quarterly progress reports and annual reports;
   34         amending s. 409.913, F.S.; revising the definitions of
   35         the terms “medical necessity” and “medically
   36         necessary” to delete a requirement that determinations
   37         of medical necessity be made by certain licensed
   38         physicians; repealing s. 765.53, F.S., relating to the
   39         Organ Transplant Advisory Council; providing an
   40         effective date.
   42  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. Paragraph (b) of subsection (2) and subsection
   72  (14) of section 409.908, Florida Statutes, are 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         (2)
  102         (b) Subject to any limitations or directions in the General
  103  Appropriations Act, the agency shall establish and implement a
  104  state Title XIX Long-Term Care Reimbursement Plan for nursing
  105  home care in order to provide care and services in conformance
  106  with the applicable state and federal laws, rules, regulations,
  107  and quality and safety standards and to ensure that individuals
  108  eligible for medical assistance have reasonable geographic
  109  access to such care.
  110         1. The agency shall amend the long-term care reimbursement
  111  plan and cost reporting system to create direct care and
  112  indirect care subcomponents of the patient care component of the
  113  per diem rate. These two subcomponents together shall equal the
  114  patient care component of the per diem rate. Separate prices
  115  shall be calculated for each patient care subcomponent,
  116  initially based on the September 2016 rate setting cost reports
  117  and subsequently based on the most recently audited cost report
  118  used during a rebasing year. The direct care subcomponent of the
  119  per diem rate for any providers still being reimbursed on a cost
  120  basis shall be limited by the cost-based class ceiling, and the
  121  indirect care subcomponent may be limited by the lower of the
  122  cost-based class ceiling, the target rate class ceiling, or the
  123  individual provider target. The ceilings and targets apply only
  124  to providers being reimbursed on a cost-based system. Effective
  125  October 1, 2018, a prospective payment methodology shall be
  126  implemented for rate setting purposes with the following
  127  parameters:
  128         a. Peer Groups, including:
  129         (I) North-SMMC Regions 1-9, less Palm Beach and Okeechobee
  130  Counties; and
  131         (II) South-SMMC Regions 10-11, plus Palm Beach and
  132  Okeechobee Counties.
  133         b. Percentage of Median Costs based on the cost reports
  134  used for September 2016 rate setting:
  135         (I) Direct Care Costs........................100 percent.
  136         (II) Indirect Care Costs......................92 percent.
  137         (III) Operating Costs.........................86 percent.
  138         c. Floors:
  139         (I) Direct Care Component.....................95 percent.
  140         (II) Indirect Care Component................92.5 percent.
  141         (III) Operating Component...........................None.
  142         d. Pass-through Payments..................Real Estate and
  143  ...............................................Personal Property
  144  ...................................Taxes and Property Insurance.
  145         e. Quality Incentive Program Payment Pool..6.5 percent of
  146  September
  147  .......................................2016 non-property related
  148  ................................payments of included facilities.
  149         f. Quality Score Threshold to Quality for Quality Incentive
  150  Payment..................20th percentile of included facilities.
  151         g. Fair Rental Value System Payment Parameters:
  152         (I) Building Value per Square Foot based on 2018 RS Means.
  153         (II) Land Valuation...10 percent of Gross Building value.
  154         (III) Facility Square Footage......Actual Square Footage.
  155         (IV) Moveable Equipment Allowance.........$8,000 per bed.
  156         (V) Obsolescence Factor......................1.5 percent.
  157         (VI) Fair Rental Rate of Return................8 percent.
  158         (VII) Minimum Occupancy.......................90 percent.
  159         (VIII) Maximum Facility Age.....................40 years.
  160         (IX) Minimum Square Footage per Bed..................350.
  161         (X) Maximum Square Footage for Bed...................500.
  162         (XI) Minimum Cost of a renovation/replacements$500 per bed.
  163         h. Ventilator Supplemental payment of $200 per Medicaid day
  164  of 40,000 ventilator Medicaid days per fiscal year.
  165         2. The direct care subcomponent shall include salaries and
  166  benefits of direct care staff providing nursing services
  167  including registered nurses, licensed practical nurses, and
  168  certified nursing assistants who deliver care directly to
  169  residents in the nursing home facility, allowable therapy costs,
  170  and dietary costs. This excludes nursing administration, staff
  171  development, the staffing coordinator, and the administrative
  172  portion of the minimum data set and care plan coordinators. The
  173  direct care subcomponent also includes medically necessary
  174  dental care, vision care, hearing care, and podiatric care.
  175         3. All other patient care costs shall be included in the
  176  indirect care cost subcomponent of the patient care per diem
  177  rate, including complex medical equipment, medical supplies, and
  178  other allowable ancillary costs. Costs may not be allocated
  179  directly or indirectly to the direct care subcomponent from a
  180  home office or management company.
  181         4. On July 1 of each year, the agency shall report to the
  182  Legislature direct and indirect care costs, including average
  183  direct and indirect care costs per resident per facility and
  184  direct care and indirect care salaries and benefits per category
  185  of staff member per facility.
  186         5. Every fourth year, the agency shall rebase nursing home
  187  prospective payment rates to reflect changes in cost based on
  188  the most recently audited cost report for each participating
  189  provider.
  190         5.6. A direct care supplemental payment may be made to
  191  providers whose direct care hours per patient day are above the
  192  80th percentile and who provide Medicaid services to a larger
  193  percentage of Medicaid patients than the state average.
  194         6.7. For the period beginning July 1, 2020, the agency
  195  shall establish a unit cost increase as an equal percentage for
  196  each nursing home.
  197         7.8. For the period beginning on October 1, 2018, and
  198  ending on September 30, 2021, the agency shall reimburse
  199  providers the greater of their September 2016 cost-based rate
  200  plus the July 1, 2020, unit cost increase or their prospective
  201  payment rate plus the July 1, 2020, unit cost increase.
  202  Effective October 1, 2021, the agency shall reimburse providers
  203  the greater of 95 percent of their cost-based rate plus the July
  204  1, 2020, unit cost increase or their rebased prospective payment
  205  rate plus the July 1, 2020, unit cost increase, using the most
  206  recently audited cost report for each facility. This
  207  subparagraph shall expire September 30, 2023.
  208         8.9. Pediatric, Florida Department of Veterans Affairs, and
  209  government-owned facilities are exempt from the pricing model
  210  established in this subsection and shall remain on a cost-based
  211  prospective payment system. Effective October 1, 2018, the
  212  agency shall set rates for all facilities remaining on a cost
  213  based prospective payment system using each facility’s most
  214  recently audited cost report, eliminating retroactive
  215  settlements.
  217  It is the intent of the Legislature that the reimbursement plan
  218  achieve the goal of providing access to health care for nursing
  219  home residents who require large amounts of care while
  220  encouraging diversion services as an alternative to nursing home
  221  care for residents who can be served within the community. The
  222  agency shall base the establishment of any maximum rate of
  223  payment, whether overall or component, on the available moneys
  224  as provided for in the General Appropriations Act. The agency
  225  may base the maximum rate of payment on the results of
  226  scientifically valid analysis and conclusions derived from
  227  objective statistical data pertinent to the particular maximum
  228  rate of payment.
  229         (14) A provider of prescribed drugs shall be reimbursed in
  230  an amount not to exceed the lesser of the actual acquisition
  231  cost based on the Centers for Medicare and Medicaid Services
  232  National Average Drug Acquisition Cost pricing files plus a
  233  professional dispensing fee, the wholesale acquisition cost plus
  234  a professional dispensing fee, the state maximum allowable cost
  235  plus a professional dispensing fee, or the usual and customary
  236  charge billed by the provider the least of the amount billed by
  237  the provider, the provider’s usual and customary charge, or the
  238  Medicaid maximum allowable fee established by the agency, plus a
  239  dispensing fee. The Medicaid maximum allowable fee for
  240  ingredient cost must be based on the lowest of: the average
  241  wholesale price (AWP) minus 16.4 percent, the wholesaler
  242  acquisition cost (WAC) plus 1.5 percent, the federal upper limit
  243  (FUL), the state maximum allowable cost (SMAC), or the usual and
  244  customary (UAC) charge billed by the provider.
  245         (a) Medicaid providers must dispense generic drugs if
  246  available at lower cost and the agency has not determined that
  247  the branded product is more cost-effective, unless the
  248  prescriber has requested and received approval to require the
  249  branded product.
  250         (b) The agency shall implement a variable dispensing fee
  251  for prescribed medicines while ensuring continued access for
  252  Medicaid recipients. The variable dispensing fee may be based
  253  upon, but not limited to, either or both the volume of
  254  prescriptions dispensed by a specific pharmacy provider, the
  255  volume of prescriptions dispensed to an individual recipient,
  256  and dispensing of preferred-drug-list products.
  257         (c) The agency may increase the pharmacy dispensing fee
  258  authorized by statute and in the General Appropriations Act by
  259  $0.50 for the dispensing of a Medicaid preferred-drug-list
  260  product and reduce the pharmacy dispensing fee by $0.50 for the
  261  dispensing of a Medicaid product that is not included on the
  262  preferred drug list.
  263         (d) The agency may establish a supplemental pharmaceutical
  264  dispensing fee to be paid to providers returning unused unit
  265  dose packaged medications to stock and crediting the Medicaid
  266  program for the ingredient cost of those medications if the
  267  ingredient costs to be credited exceed the value of the
  268  supplemental dispensing fee.
  269         (c)(e) The agency may limit reimbursement for prescribed
  270  medicine in order to comply with any limitations or directions
  271  provided in the General Appropriations Act, which may include
  272  implementing a prospective or concurrent utilization review
  273  program.
  274         Section 4. Subsections (9) and (11) of section 409.91195,
  275  Florida Statutes, are amended, and subsection (4) of that
  276  section is reenacted for the purpose of incorporating the
  277  amendment made by this act to section 409.912, Florida Statutes,
  278  in a reference thereto, to read:
  279         409.91195 Medicaid Pharmaceutical and Therapeutics
  280  Committee.—There is created a Medicaid Pharmaceutical and
  281  Therapeutics Committee within the agency for the purpose of
  282  developing a Medicaid preferred drug list.
  283         (4) Upon recommendation of the committee, the agency shall
  284  adopt a preferred drug list as described in s. 409.912(5). To
  285  the extent feasible, the committee shall review all drug classes
  286  included on the preferred drug list every 12 months, and may
  287  recommend additions to and deletions from the preferred drug
  288  list, such that the preferred drug list provides for medically
  289  appropriate drug therapies for Medicaid patients which achieve
  290  cost savings contained in the General Appropriations Act.
  291         (9) Upon timely notice, the agency shall ensure that any
  292  therapeutic class of drugs which includes a drug that has been
  293  removed from distribution to the public by its manufacturer or
  294  the United States Food and Drug Administration or has been
  295  required to carry a black box warning label by the United States
  296  Food and Drug Administration because of safety concerns is
  297  reviewed by the committee at the next regularly scheduled
  298  meeting. After such review, the committee must recommend whether
  299  to retain the therapeutic class of drugs or subcategories of
  300  drugs within a therapeutic class on the preferred drug list and
  301  whether to institute prior authorization requirements necessary
  302  to ensure patient safety.
  303         (10)(11) Medicaid recipients may appeal agency preferred
  304  drug formulary decisions using the Medicaid fair hearing process
  305  administered by the Agency for Health Care Administration
  306  Department of Children and Families.
  307         Section 5. Paragraphs (a) and (c) of subsection (5) of
  308  section 409.912, Florida Statutes, are amended to read:
  309         409.912 Cost-effective purchasing of health care.—The
  310  agency shall purchase goods and services for Medicaid recipients
  311  in the most cost-effective manner consistent with the delivery
  312  of quality medical care. To ensure that medical services are
  313  effectively utilized, the agency may, in any case, require a
  314  confirmation or second physician’s opinion of the correct
  315  diagnosis for purposes of authorizing future services under the
  316  Medicaid program. This section does not restrict access to
  317  emergency services or poststabilization care services as defined
  318  in 42 C.F.R. s. 438.114. Such confirmation or second opinion
  319  shall be rendered in a manner approved by the agency. The agency
  320  shall maximize the use of prepaid per capita and prepaid
  321  aggregate fixed-sum basis services when appropriate and other
  322  alternative service delivery and reimbursement methodologies,
  323  including competitive bidding pursuant to s. 287.057, designed
  324  to facilitate the cost-effective purchase of a case-managed
  325  continuum of care. The agency shall also require providers to
  326  minimize the exposure of recipients to the need for acute
  327  inpatient, custodial, and other institutional care and the
  328  inappropriate or unnecessary use of high-cost services. The
  329  agency shall contract with a vendor to monitor and evaluate the
  330  clinical practice patterns of providers in order to identify
  331  trends that are outside the normal practice patterns of a
  332  provider’s professional peers or the national guidelines of a
  333  provider’s professional association. The vendor must be able to
  334  provide information and counseling to a provider whose practice
  335  patterns are outside the norms, in consultation with the agency,
  336  to improve patient care and reduce inappropriate utilization.
  337  The agency may mandate prior authorization, drug therapy
  338  management, or disease management participation for certain
  339  populations of Medicaid beneficiaries, certain drug classes, or
  340  particular drugs to prevent fraud, abuse, overuse, and possible
  341  dangerous drug interactions. The Pharmaceutical and Therapeutics
  342  Committee shall make recommendations to the agency on drugs for
  343  which prior authorization is required. The agency shall inform
  344  the Pharmaceutical and Therapeutics Committee of its decisions
  345  regarding drugs subject to prior authorization. The agency is
  346  authorized to limit the entities it contracts with or enrolls as
  347  Medicaid providers by developing a provider network through
  348  provider credentialing. The agency may competitively bid single
  349  source-provider contracts if procurement of goods or services
  350  results in demonstrated cost savings to the state without
  351  limiting access to care. The agency may limit its network based
  352  on the assessment of beneficiary access to care, provider
  353  availability, provider quality standards, time and distance
  354  standards for access to care, the cultural competence of the
  355  provider network, demographic characteristics of Medicaid
  356  beneficiaries, practice and provider-to-beneficiary standards,
  357  appointment wait times, beneficiary use of services, provider
  358  turnover, provider profiling, provider licensure history,
  359  previous program integrity investigations and findings, peer
  360  review, provider Medicaid policy and billing compliance records,
  361  clinical and medical record audits, and other factors. Providers
  362  are not entitled to enrollment in the Medicaid provider network.
  363  The agency shall determine instances in which allowing Medicaid
  364  beneficiaries to purchase durable medical equipment and other
  365  goods is less expensive to the Medicaid program than long-term
  366  rental of the equipment or goods. The agency may establish rules
  367  to facilitate purchases in lieu of long-term rentals in order to
  368  protect against fraud and abuse in the Medicaid program as
  369  defined in s. 409.913. The agency may seek federal waivers
  370  necessary to administer these policies.
  371         (5)(a) The agency shall implement a Medicaid prescribed
  372  drug spending-control program that includes the following
  373  components:
  374         1. A Medicaid preferred drug list, which shall be a listing
  375  of cost-effective therapeutic options recommended by the
  376  Medicaid Pharmacy and Therapeutics Committee established
  377  pursuant to s. 409.91195 and adopted by the agency for each
  378  therapeutic class on the preferred drug list. At the discretion
  379  of the committee, and when feasible, the preferred drug list
  380  should include at least two products in a therapeutic class. The
  381  agency may post the preferred drug list and updates to the list
  382  on an Internet website without following the rulemaking
  383  procedures of chapter 120. Antiretroviral agents are excluded
  384  from the preferred drug list. The agency shall also limit the
  385  amount of a prescribed drug dispensed to no more than a 34-day
  386  supply unless the drug products’ smallest marketed package is
  387  greater than a 34-day supply, or the drug is determined by the
  388  agency to be a maintenance drug in which case a 100-day maximum
  389  supply may be authorized. The agency may seek any federal
  390  waivers necessary to implement these cost-control programs and
  391  to continue participation in the federal Medicaid rebate
  392  program, or alternatively to negotiate state-only manufacturer
  393  rebates. The agency may adopt rules to administer this
  394  subparagraph. The agency shall continue to provide unlimited
  395  contraceptive drugs and items. The agency must establish
  396  procedures to ensure that:
  397         a. There is a response to a request for prior authorization
  398  consultation by telephone or other telecommunication device
  399  within 24 hours after receipt of a request for prior
  400  authorization consultation; and
  401         b. A 72-hour supply of the drug prescribed is provided in
  402  an emergency or when the agency does not provide a response
  403  within 24 hours as required by sub-subparagraph a.
  404         2. A provider of prescribed drugs is reimbursed in an
  405  amount not to exceed the lesser of the actual acquisition cost
  406  based on the Centers for Medicare and Medicaid Services National
  407  Average Drug Acquisition Cost pricing files plus a professional
  408  dispensing fee, the wholesale acquisition cost plus a
  409  professional dispensing fee, the state maximum allowable cost
  410  plus a professional dispensing fee, or the usual and customary
  411  charge billed by the provider Reimbursement to pharmacies for
  412  Medicaid prescribed drugs shall be set at the lowest of: the
  413  average wholesale price (AWP) minus 16.4 percent, the wholesaler
  414  acquisition cost (WAC) plus 1.5 percent, the federal upper limit
  415  (FUL), the state maximum allowable cost (SMAC), or the usual and
  416  customary (UAC) charge billed by the provider.
  417         3. The agency shall develop and implement a process for
  418  managing the drug therapies of Medicaid recipients who are using
  419  significant numbers of prescribed drugs each month. The
  420  management process may include, but is not limited to,
  421  comprehensive, physician-directed medical-record reviews, claims
  422  analyses, and case evaluations to determine the medical
  423  necessity and appropriateness of a patient’s treatment plan and
  424  drug therapies. The agency may contract with a private
  425  organization to provide drug-program-management services. The
  426  Medicaid drug benefit management program shall include
  427  initiatives to manage drug therapies for HIV/AIDS patients,
  428  patients using 20 or more unique prescriptions in a 180-day
  429  period, and the top 1,000 patients in annual spending. The
  430  agency shall enroll any Medicaid recipient in the drug benefit
  431  management program if he or she meets the specifications of this
  432  provision and is not enrolled in a Medicaid health maintenance
  433  organization.
  434         4. The agency may limit the size of its pharmacy network
  435  based on need, competitive bidding, price negotiations,
  436  credentialing, or similar criteria. The agency shall give
  437  special consideration to rural areas in determining the size and
  438  location of pharmacies included in the Medicaid pharmacy
  439  network. A pharmacy credentialing process may include criteria
  440  such as a pharmacy’s full-service status, location, size,
  441  patient educational programs, patient consultation, disease
  442  management services, and other characteristics. The agency may
  443  impose a moratorium on Medicaid pharmacy enrollment if it is
  444  determined that it has a sufficient number of Medicaid
  445  participating providers. The agency must allow dispensing
  446  practitioners to participate as a part of the Medicaid pharmacy
  447  network regardless of the practitioner’s proximity to any other
  448  entity that is dispensing prescription drugs under the Medicaid
  449  program. A dispensing practitioner must meet all credentialing
  450  requirements applicable to his or her practice, as determined by
  451  the agency.
  452         5. The agency shall develop and implement a program that
  453  requires Medicaid practitioners who issue written prescriptions
  454  for medicinal drugs to use a counterfeit-proof prescription pad
  455  for Medicaid prescriptions. The agency shall require the use of
  456  standardized counterfeit-proof prescription pads by prescribers
  457  who issue written prescriptions for Medicaid recipients. The
  458  agency may implement the program in targeted geographic areas or
  459  statewide.
  460         6. The agency may enter into arrangements that require
  461  manufacturers of generic drugs prescribed to Medicaid recipients
  462  to provide rebates of at least 15.1 percent of the average
  463  manufacturer price for the manufacturer’s generic products.
  464  These arrangements shall require that if a generic-drug
  465  manufacturer pays federal rebates for Medicaid-reimbursed drugs
  466  at a level below 15.1 percent, the manufacturer must provide a
  467  supplemental rebate to the state in an amount necessary to
  468  achieve a 15.1-percent rebate level.
  469         7. The agency may establish a preferred drug list as
  470  described in this subsection, and, pursuant to the establishment
  471  of such preferred drug list, negotiate supplemental rebates from
  472  manufacturers that are in addition to those required by Title
  473  XIX of the Social Security Act and at no less than 14 percent of
  474  the average manufacturer price as defined in 42 U.S.C. s. 1936
  475  on the last day of a quarter unless the federal or supplemental
  476  rebate, or both, equals or exceeds 29 percent. There is no upper
  477  limit on the supplemental rebates the agency may negotiate. The
  478  agency may determine that specific products, brand-name or
  479  generic, are competitive at lower rebate percentages. Agreement
  480  to pay the minimum supplemental rebate percentage guarantees a
  481  manufacturer that the Medicaid Pharmaceutical and Therapeutics
  482  Committee will consider a product for inclusion on the preferred
  483  drug list. However, a pharmaceutical manufacturer is not
  484  guaranteed placement on the preferred drug list by simply paying
  485  the minimum supplemental rebate. Agency decisions will be made
  486  on the clinical efficacy of a drug and recommendations of the
  487  Medicaid Pharmaceutical and Therapeutics Committee, as well as
  488  the price of competing products minus federal and state rebates.
  489  The agency may contract with an outside agency or contractor to
  490  conduct negotiations for supplemental rebates. For the purposes
  491  of this section, the term “supplemental rebates” means cash
  492  rebates. Value-added programs as a substitution for supplemental
  493  rebates are prohibited. The agency may seek any federal waivers
  494  to implement this initiative.
  495         8.a.The agency shall expand home delivery of pharmacy
  496  products. The agency may amend the state plan and issue a
  497  procurement, as necessary, in order to implement this program.
  498  The procurements must include agreements with a pharmacy or
  499  pharmacies located in the state to provide mail order delivery
  500  services at no cost to the recipients who elect to receive home
  501  delivery of pharmacy products. The procurement must focus on
  502  serving recipients with chronic diseases for which pharmacy
  503  expenditures represent a significant portion of Medicaid
  504  pharmacy expenditures or which impact a significant portion of
  505  the Medicaid population. The agency may seek and implement any
  506  federal waivers necessary to implement this subparagraph.
  507         9. The agency shall limit to one dose per month any drug
  508  prescribed to treat erectile dysfunction.
  509         10.a. The agency may implement a Medicaid behavioral drug
  510  management system. The agency may contract with a vendor that
  511  has experience in operating behavioral drug management systems
  512  to implement this program. The agency may seek federal waivers
  513  to implement this program.
  514         b. The agency, in conjunction with the Department of
  515  Children and Families, may implement the Medicaid behavioral
  516  drug management system that is designed to improve the quality
  517  of care and behavioral health prescribing practices based on
  518  best practice guidelines, improve patient adherence to
  519  medication plans, reduce clinical risk, and lower prescribed
  520  drug costs and the rate of inappropriate spending on Medicaid
  521  behavioral drugs. The program may include the following
  522  elements:
  523         (I) Provide for the development and adoption of best
  524  practice guidelines for behavioral health-related drugs such as
  525  antipsychotics, antidepressants, and medications for treating
  526  bipolar disorders and other behavioral conditions; translate
  527  them into practice; review behavioral health prescribers and
  528  compare their prescribing patterns to a number of indicators
  529  that are based on national standards; and determine deviations
  530  from best practice guidelines.
  531         (II) Implement processes for providing feedback to and
  532  educating prescribers using best practice educational materials
  533  and peer-to-peer consultation.
  534         (III) Assess Medicaid beneficiaries who are outliers in
  535  their use of behavioral health drugs with regard to the numbers
  536  and types of drugs taken, drug dosages, combination drug
  537  therapies, and other indicators of improper use of behavioral
  538  health drugs.
  539         (IV) Alert prescribers to patients who fail to refill
  540  prescriptions in a timely fashion, are prescribed multiple same
  541  class behavioral health drugs, and may have other potential
  542  medication problems.
  543         (V) Track spending trends for behavioral health drugs and
  544  deviation from best practice guidelines.
  545         (VI) Use educational and technological approaches to
  546  promote best practices, educate consumers, and train prescribers
  547  in the use of practice guidelines.
  548         (VII) Disseminate electronic and published materials.
  549         (VIII) Hold statewide and regional conferences.
  550         (IX) Implement a disease management program with a model
  551  quality-based medication component for severely mentally ill
  552  individuals and emotionally disturbed children who are high
  553  users of care.
  554         9.11. The agency shall implement a Medicaid prescription
  555  drug management system.
  556         a. The agency may contract with a vendor that has
  557  experience in operating prescription drug management systems in
  558  order to implement this system. Any management system that is
  559  implemented in accordance with this subparagraph must rely on
  560  cooperation between physicians and pharmacists to determine
  561  appropriate practice patterns and clinical guidelines to improve
  562  the prescribing, dispensing, and use of drugs in the Medicaid
  563  program. The agency may seek federal waivers to implement this
  564  program.
  565         b. The drug management system must be designed to improve
  566  the quality of care and prescribing practices based on best
  567  practice guidelines, improve patient adherence to medication
  568  plans, reduce clinical risk, and lower prescribed drug costs and
  569  the rate of inappropriate spending on Medicaid prescription
  570  drugs. The program must:
  571         (I) Provide for the adoption of best practice guidelines
  572  for the prescribing and use of drugs in the Medicaid program,
  573  including translating best practice guidelines into practice;
  574  reviewing prescriber patterns and comparing them to indicators
  575  that are based on national standards and practice patterns of
  576  clinical peers in their community, statewide, and nationally;
  577  and determine deviations from best practice guidelines.
  578         (II) Implement processes for providing feedback to and
  579  educating prescribers using best practice educational materials
  580  and peer-to-peer consultation.
  581         (III) Assess Medicaid recipients who are outliers in their
  582  use of a single or multiple prescription drugs with regard to
  583  the numbers and types of drugs taken, drug dosages, combination
  584  drug therapies, and other indicators of improper use of
  585  prescription drugs.
  586         (IV) Alert prescribers to recipients who fail to refill
  587  prescriptions in a timely fashion, are prescribed multiple drugs
  588  that may be redundant or contraindicated, or may have other
  589  potential medication problems.
  590         10.12. The agency may contract for drug rebate
  591  administration, including, but not limited to, calculating
  592  rebate amounts, invoicing manufacturers, negotiating disputes
  593  with manufacturers, and maintaining a database of rebate
  594  collections.
  595         11.13. The agency may specify the preferred daily dosing
  596  form or strength for the purpose of promoting best practices
  597  with regard to the prescribing of certain drugs as specified in
  598  the General Appropriations Act and ensuring cost-effective
  599  prescribing practices.
  600         12.14. The agency may require prior authorization for
  601  Medicaid-covered prescribed drugs. The agency may prior
  602  authorize the use of a product:
  603         a. For an indication not approved in labeling;
  604         b. To comply with certain clinical guidelines; or
  605         c. If the product has the potential for overuse, misuse, or
  606  abuse.
  608  The agency may require the prescribing professional to provide
  609  information about the rationale and supporting medical evidence
  610  for the use of a drug. The agency shall post prior
  611  authorization, step-edit criteria and protocol, and updates to
  612  the list of drugs that are subject to prior authorization on the
  613  agency’s Internet website within 21 days after the prior
  614  authorization and step-edit criteria and protocol and updates
  615  are approved by the agency. For purposes of this subparagraph,
  616  the term “step-edit” means an automatic electronic review of
  617  certain medications subject to prior authorization.
  618         13.15. The agency, in conjunction with the Pharmaceutical
  619  and Therapeutics Committee, may require age-related prior
  620  authorizations for certain prescribed drugs. The agency may
  621  preauthorize the use of a drug for a recipient who may not meet
  622  the age requirement or may exceed the length of therapy for use
  623  of this product as recommended by the manufacturer and approved
  624  by the Food and Drug Administration. Prior authorization may
  625  require the prescribing professional to provide information
  626  about the rationale and supporting medical evidence for the use
  627  of a drug.
  628         14.16. The agency shall implement a step-therapy prior
  629  authorization approval process for medications excluded from the
  630  preferred drug list. Medications listed on the preferred drug
  631  list must be used within the previous 12 months before the
  632  alternative medications that are not listed. The step-therapy
  633  prior authorization may require the prescriber to use the
  634  medications of a similar drug class or for a similar medical
  635  indication unless contraindicated in the Food and Drug
  636  Administration labeling. The trial period between the specified
  637  steps may vary according to the medical indication. The step
  638  therapy approval process shall be developed in accordance with
  639  the committee as stated in s. 409.91195(7) and (8). A drug
  640  product may be approved without meeting the step-therapy prior
  641  authorization criteria if the prescribing physician provides the
  642  agency with additional written medical or clinical documentation
  643  that the product is medically necessary because:
  644         a. There is not a drug on the preferred drug list to treat
  645  the disease or medical condition which is an acceptable clinical
  646  alternative;
  647         b. The alternatives have been ineffective in the treatment
  648  of the beneficiary’s disease; or
  649         c. Based on historic evidence and known characteristics of
  650  the patient and the drug, the drug is likely to be ineffective,
  651  or the number of doses have been ineffective.
  653  The agency shall work with the physician to determine the best
  654  alternative for the patient. The agency may adopt rules waiving
  655  the requirements for written clinical documentation for specific
  656  drugs in limited clinical situations.
  657         15.17. The agency shall implement a return and reuse
  658  program for drugs dispensed by pharmacies to institutional
  659  recipients, which includes payment of a $5 restocking fee for
  660  the implementation and operation of the program. The return and
  661  reuse program shall be implemented electronically and in a
  662  manner that promotes efficiency. The program must permit a
  663  pharmacy to exclude drugs from the program if it is not
  664  practical or cost-effective for the drug to be included and must
  665  provide for the return to inventory of drugs that cannot be
  666  credited or returned in a cost-effective manner. The agency
  667  shall determine if the program has reduced the amount of
  668  Medicaid prescription drugs which are destroyed on an annual
  669  basis and if there are additional ways to ensure more
  670  prescription drugs are not destroyed which could safely be
  671  reused.
  672         (c) The agency shall submit quarterly reports to the
  673  Governor, the President of the Senate, and the Speaker of the
  674  House of Representatives which must include, but need not be
  675  limited to, the progress made in implementing this subsection
  676  and its effect on Medicaid prescribed-drug expenditures.
  677         Section 6. Section 409.91213, Florida Statutes, is
  678  repealed.
  679         Section 7. Paragraph (d) of subsection (1) of section
  680  409.913, Florida Statutes, is amended to read:
  681         409.913 Oversight of the integrity of the Medicaid
  682  program.—The agency shall operate a program to oversee the
  683  activities of Florida Medicaid recipients, and providers and
  684  their representatives, to ensure that fraudulent and abusive
  685  behavior and neglect of recipients occur to the minimum extent
  686  possible, and to recover overpayments and impose sanctions as
  687  appropriate. Each January 15, the agency and the Medicaid Fraud
  688  Control Unit of the Department of Legal Affairs shall submit a
  689  report to the Legislature documenting the effectiveness of the
  690  state’s efforts to control Medicaid fraud and abuse and to
  691  recover Medicaid overpayments during the previous fiscal year.
  692  The report must describe the number of cases opened and
  693  investigated each year; the sources of the cases opened; the
  694  disposition of the cases closed each year; the amount of
  695  overpayments alleged in preliminary and final audit letters; the
  696  number and amount of fines or penalties imposed; any reductions
  697  in overpayment amounts negotiated in settlement agreements or by
  698  other means; the amount of final agency determinations of
  699  overpayments; the amount deducted from federal claiming as a
  700  result of overpayments; the amount of overpayments recovered
  701  each year; the amount of cost of investigation recovered each
  702  year; the average length of time to collect from the time the
  703  case was opened until the overpayment is paid in full; the
  704  amount determined as uncollectible and the portion of the
  705  uncollectible amount subsequently reclaimed from the Federal
  706  Government; the number of providers, by type, that are
  707  terminated from participation in the Medicaid program as a
  708  result of fraud and abuse; and all costs associated with
  709  discovering and prosecuting cases of Medicaid overpayments and
  710  making recoveries in such cases. The report must also document
  711  actions taken to prevent overpayments and the number of
  712  providers prevented from enrolling in or reenrolling in the
  713  Medicaid program as a result of documented Medicaid fraud and
  714  abuse and must include policy recommendations necessary to
  715  prevent or recover overpayments and changes necessary to prevent
  716  and detect Medicaid fraud. All policy recommendations in the
  717  report must include a detailed fiscal analysis, including, but
  718  not limited to, implementation costs, estimated savings to the
  719  Medicaid program, and the return on investment. The agency must
  720  submit the policy recommendations and fiscal analyses in the
  721  report to the appropriate estimating conference, pursuant to s.
  722  216.137, by February 15 of each year. The agency and the
  723  Medicaid Fraud Control Unit of the Department of Legal Affairs
  724  each must include detailed unit-specific performance standards,
  725  benchmarks, and metrics in the report, including projected cost
  726  savings to the state Medicaid program during the following
  727  fiscal year.
  728         (1) For the purposes of this section, the term:
  729         (d) “Medical necessity” or “medically necessary” means any
  730  goods or services necessary to palliate the effects of a
  731  terminal condition, or to prevent, diagnose, correct, cure,
  732  alleviate, or preclude deterioration of a condition that
  733  threatens life, causes pain or suffering, or results in illness
  734  or infirmity, which goods or services are provided in accordance
  735  with generally accepted standards of medical practice. For
  736  purposes of determining Medicaid reimbursement, the agency is
  737  the final arbiter of medical necessity. Determinations of
  738  medical necessity must be made by a licensed physician employed
  739  by or under contract with the agency and must be based upon
  740  information available at the time the goods or services are
  741  provided.
  742         Section 8. Section 765.53, Florida Statutes, is repealed.
  743         Section 9. This act shall take effect July 1, 2021.