Florida Senate - 2022                                    SB 1652
       
       
        
       By Senator Gibson
       
       
       
       
       
       6-01205-22                                            20221652__
    1                        A bill to be entitled                      
    2         An act relating to sickle-cell disease; amending s.
    3         381.815, F.S.; defining terms; requiring the
    4         Department of Health to establish and maintain a
    5         sickle-cell registry for a specified purpose;
    6         requiring certain providers to report specified
    7         information to the registry; requiring the department
    8         to use the reported information for specified
    9         purposes; requiring the department to analyze the
   10         reported information and make certain determinations;
   11         requiring the department to publish quarterly reports;
   12         providing requirements for the reports; providing
   13         duties for the department to promote early detection
   14         and treatment of sickle-cell disease; requiring the
   15         department to make grants or enter into contracts with
   16         certain community-based organizations for the
   17         provision of specified services; authorizing the
   18         department to adopt rules; amending s. 381.981, F.S.;
   19         requiring the department to include sickle-cell
   20         disease in its monthly health awareness campaigns;
   21         amending s. 383.14, F.S.; requiring the department to
   22         adopt rules requiring screening of newborns for
   23         sickle-cell disease and sickle-cell trait; requiring
   24         any positive test results to be reported to the
   25         department’s sickle-cell registry; requiring parents
   26         of newborns who test positive to be provided with
   27         information on further testing and treatment, as
   28         applicable; creating s. 409.9129, F.S.; requiring the
   29         Agency for Health Care Administration to require
   30         managed care organizations to implement a certain
   31         quality strategy for a specified purpose; providing
   32         requirements for the strategy; requiring managed care
   33         organizations to provide certain quarterly reports to
   34         the agency; requiring the agency to coordinate with
   35         managed care organizations to identify, document, and
   36         share certain best practices and to develop a certain
   37         plan; requiring the agency to establish performance
   38         measures for managed care organizations; requiring the
   39         agency to partner with a publicly funded university to
   40         develop an assessment tool for screening enrollees
   41         with sickle-cell disease for factors relevant to their
   42         care; requiring the agency to incorporate certain
   43         standard in its contracts with managed care
   44         organizations; requiring the agency to conduct an
   45         annual review of the Medicaid program’s coverage of
   46         medications, treatments, and services related to
   47         sickle-cell disease; providing requirements for the
   48         review; requiring the agency to submit a report of its
   49         findings and recommendations to the Governor and the
   50         Legislature by a specified date and annually
   51         thereafter; requiring the agency to publish the report
   52         on its website; requiring the agency to conduct a
   53         study of innovative approaches for reimbursement for,
   54         coverage of, and access to sickle-cell disease
   55         therapies; providing requirements for the study;
   56         requiring the agency to hold public meetings with
   57         relevant stakeholders; requiring the agency to hold
   58         its first meeting by a specified date; requiring the
   59         agency to prepare a report of its recommendations by a
   60         specified date; requiring the agency to submit the
   61         report to the Governor and the Legislature and publish
   62         it on its website; providing for expiration; creating
   63         s. 456.0315, F.S.; requiring certain boards to require
   64         their licensees and certificateholders to complete a
   65         continuing education course on sickle-cell disease as
   66         part of every second biennial license or certification
   67         renewal; providing requirements for the course;
   68         providing for submission of proof of completion of
   69         such course; authorizing the boards to approve
   70         additional equivalent courses; authorizing the boards
   71         to include such course within already required
   72         continuing education hours under certain
   73         circumstances; providing an accommodation for
   74         individuals who are dually licensed with regard to
   75         such courses; providing for discipline; authorizing
   76         the boards to adopt rules; creating ss. 627.64055,
   77         627.65741, and 641.31078, F.S.; defining the terms
   78         “fertility preservation” and “iatrogenic fertility”;
   79         requiring certain individual and group health insurers
   80         and health maintenance organizations, respectively, to
   81         provide coverage for certain fertility preservation
   82         services in connection with medically necessary
   83         treatments for sickle-cell disease; prohibiting such
   84         insurers and organizations from discriminating in
   85         their coverage of such services on the basis of
   86         specified factors; providing an effective date.
   87          
   88  Be It Enacted by the Legislature of the State of Florida:
   89  
   90         Section 1. Section 381.815, Florida Statutes, is amended to
   91  read:
   92         381.815 Sickle-cell program.—
   93         (1)DEFINITIONS.—As used in this section, the term:
   94         (a)“Community-based organization” means an organization in
   95  which survivors of sickle-cell disease hold significant
   96  decisionmaking responsibilities and which offers evidence-based
   97  sickle-cell disease education and support services at no cost to
   98  the public.
   99         (b)“Department” means the Department of Health.
  100         (c)“Health care provider” means a health care practitioner
  101  as defined in s. 456.001 or a health care facility or other
  102  entity licensed or certified to provide health services in this
  103  state.
  104         (2)SICKLE-CELL REGISTRY.—The department shall establish
  105  and maintain a registry for reporting information on the
  106  incidence of sickle-cell disease and its variants in this state
  107  and other information for epidemiological surveys and
  108  evaluations of treatments.
  109         (a)Health care providers who diagnose or treat patients
  110  with sickle-cell disease shall report the following information
  111  for each such patient to the department for inclusion in the
  112  registry:
  113         1.The patient’s name, address, age, and ethnicity.
  114         2.The variant of sickle-cell disease affecting the
  115  patient.
  116         3.The method of treatment used by the provider.
  117         4.Any other diseases the patient may have.
  118         5.The extent to which the patient uses or has access to
  119  health care services, if known.
  120         6.If the patient dies, the patient’s age at the time of
  121  death.
  122         (b)1.Health care providers who conduct newborn screenings
  123  for sickle-cell disease and the sickle-cell trait shall report
  124  any positive test results to the department for inclusion in the
  125  registry in a form and manner prescribed by the department.
  126         2.The department shall develop a notification system that
  127  informs parents of newborns entered in the registry under
  128  subparagraph 1. of the importance of consulting a physician
  129  following a diagnosis of the sickle-cell trait or sickle-cell
  130  disease. The department must send such notification immediately
  131  following the newborn’s registration in the registry and at
  132  least once in early childhood and again in later adolescence.
  133         (c)When an individual registered in the registry reaches
  134  18 years of age, the department shall make reasonable efforts to
  135  notify the individual of his or her inclusion in the registry
  136  and of the availability of educational services, genetic
  137  counseling, and other benefits and resources.
  138         (d)The department shall use information reported to the
  139  registry to assess trends, advance research and education, and
  140  facilitate the improvement of sickle-cell disease treatment in
  141  this state. The department shall analyze the data for trends of
  142  low usage of or poor access to health care services in
  143  particular geographical areas or demographic groups and conduct
  144  further investigation to determine whether improvements can be
  145  made to facilitate greater access to sickle-cell disease
  146  treatment.
  147         (e)The department shall publish quarterly reports based on
  148  information collected in the registry. The reports must include
  149  all of the following information:
  150         1.Aggregate data for the general population and for
  151  individuals 60 years of age or older which shows the
  152  geographical areas, demographics, and health services
  153  utilization of individuals with sickle-cell disease or its
  154  variants.
  155         2.Data on the transition of adolescents with sickle-cell
  156  disease from pediatric care to adult care.
  157         (3)PUBLIC OUTREACH AND SERVICES.—To promote early
  158  detection and treatment of sickle-cell disease, the department
  159  of Health shall do all of the following, to the extent that
  160  resources are available:
  161         (a)(1) Provide statewide education and outreach to inform
  162  the public the citizens of Florida about sickle-cell disease,
  163  including, but not limited to, available evidence-based sickle
  164  cell screening, detection, and education services.
  165         (b)Develop or approve education and training on sickle
  166  cell disease for health care providers. Such education and
  167  training must include, at a minimum, coverage of all of the
  168  following:
  169         1.The importance of early detection of sickle-cell
  170  disease.
  171         2.Medically appropriate clinical examinations and
  172  screening procedures, including the frequency with which they
  173  should be provided.
  174         3.Best practices for the detection and treatment of
  175  sickle-cell disease and for emergency treatment and management
  176  of patients with sickle-cell disease who present with vaso
  177  occlusive crises.
  178         4.The sickle-cell registry and the reporting requirements
  179  established under this section.
  180         (c)(2) Work cooperatively with nonprofit organizations not
  181  for-profit centers to provide community-based education, patient
  182  teaching, and counseling and to encourage diagnostic screening.
  183         (d)(3) Make grants or enter into contracts with nonprofit
  184  community-based organizations for provision of the following:
  185         1.Clinical examinations and screenings for sickle-cell
  186  disease.
  187         2.Counseling, information on treatment options, and
  188  referrals for treatment and services to individuals diagnosed
  189  with sickle-cell disease, including information on available
  190  economic assistance for treatment.
  191         3.Dissemination of information on sickle-cell disease,
  192  early detection, and screening to unserved or underserved
  193  populations, the general public, and health care practitioners.
  194         4.Identification of local sickle-cell disease screening
  195  services within the organization’s region.
  196         5.Any other services that promote early detection and
  197  treatment of sickle-cell disease not-for-profit centers.
  198         (4)RULES.—The department may adopt rules to implement this
  199  section.
  200         Section 2. Paragraph (v) is added to subsection (2) of
  201  section 381.981, Florida Statutes, to read:
  202         381.981 Health awareness campaigns.—
  203         (2) The awareness campaigns shall include the provision of
  204  educational information about preventing, detecting, treating,
  205  and curing the following diseases or conditions. Additional
  206  diseases and conditions that impact the public health may be
  207  added by the board of directors of the Florida Public Health
  208  Institute, Inc.; however, each of the following diseases or
  209  conditions must be included in an awareness campaign during at
  210  least 1 month in any 24-month period:
  211         (v) Sickle-cell disease.
  212         Section 3. Paragraph (a) of subsection (2) of section
  213  383.14, Florida Statutes, is amended to read:
  214         383.14 Screening for metabolic disorders, other hereditary
  215  and congenital disorders, and environmental risk factors.—
  216         (2) RULES.—
  217         (a) After consultation with the Genetics and Newborn
  218  Screening Advisory Council, the department shall adopt and
  219  enforce rules requiring that every newborn in this state shall:
  220         1. Before becoming 1 week of age, be subjected to a test
  221  for phenylketonuria;
  222         2. Before becoming 1 week of age, be subjected to a test
  223  for sickle-cell disease and the sickle-cell trait. If a newborn
  224  tests positive for sickle-cell disease or the sickle-cell trait,
  225  the result must be reported to the sickle-cell registry in
  226  accordance with s. 381.815 and the parents of the newborn must
  227  be given information on further testing and treatment, as
  228  applicable;
  229         3. Be tested for any condition included on the federal
  230  Recommended Uniform Screening Panel which the council advises
  231  the department should be included under the state’s screening
  232  program. After the council recommends that a condition be
  233  included, the department shall submit a legislative budget
  234  request to seek an appropriation to add testing of the condition
  235  to the newborn screening program. The department shall expand
  236  statewide screening of newborns to include screening for such
  237  conditions within 18 months after the council renders such
  238  advice, if a test approved by the United States Food and Drug
  239  Administration or a test offered by an alternative vendor is
  240  available. If such a test is not available within 18 months
  241  after the council makes its recommendation, the department shall
  242  implement such screening as soon as a test offered by the United
  243  States Food and Drug Administration or by an alternative vendor
  244  is available; and
  245         4.3. At the appropriate age, be tested for such other
  246  metabolic diseases and hereditary or congenital disorders as the
  247  department may deem necessary from time to time.
  248         Section 4. Section 409.9129, Florida Statutes, is created
  249  to read:
  250         409.9129 Quality assurance in coverage for enrollees with
  251  sickle-cell disease.—
  252         (1)QUALITY STRATEGY.—To ensure the availability of
  253  accessible, quality health care for enrollees with sickle-cell
  254  disease, the agency must require managed care organizations to
  255  implement a quality strategy, which must provide for, at a
  256  minimum, all of the following:
  257         (a)Improvements in identifying individuals with sickle
  258  cell disease.
  259         (b)An adequate provider network capacity to ensure timely
  260  access to specialty providers for sickle-cell disease treatment.
  261         (c)Care coordination strategies to assist enrollees with
  262  sickle-cell disease in accessing specialists and other related
  263  care supports.
  264         (d)Delivery of evidence-based training on sickle-cell
  265  disease to primary care providers. Such training must include,
  266  at a minimum, instruction on warning signs for emergencies and
  267  complications, evidence-based practices and treatment
  268  guidelines, and appropriate referrals to specialty treatment
  269  providers.
  270         (2)QUARTERLY REPORTS; COORDINATION; PERFORMANCE MEASURES.—
  271         (a)Managed care organizations shall provide quarterly
  272  reports to the agency which include the number of children and
  273  adults with sickle-cell disease enrolled in each plan and any
  274  other information the agency deems necessary to achieve the
  275  purposes of this section.
  276         (b)The agency, in coordination with the managed care
  277  organizations, shall:
  278         1.Identify, document, and share best practices regarding
  279  sickle-cell disease care management and coordination with
  280  enrolled primary care providers and specialty providers.
  281         2.Develop a plan for transitioning adolescent enrollees
  282  with sickle-cell disease from pediatric care to adult care,
  283  including, but not limited to, assisting enrollees who may age
  284  out of the Medicaid program to maintain Medicaid coverage under
  285  another eligibility category, if qualified.
  286         (c)The agency shall establish performance measures for
  287  managed care organizations relating to access to care and
  288  available therapies for sickle-cell disease, engagement in
  289  treatment, and outcomes for enrollees with sickle-cell disease.
  290  The agency may use financial incentives to encourage compliance
  291  with the performance measures.
  292         (3)ASSESSMENT TOOL.—The agency shall partner with a
  293  publicly funded university to develop a comprehensive sickle
  294  cell disease assessment tool to screen enrollees with sickle
  295  cell disease for factors relevant to their care.
  296         (4)CONTRACTS.—The agency shall incorporate standards for
  297  coverage of sickle-cell disease treatment in its contracts with
  298  managed care organizations, including financial or
  299  administrative penalties for noncompliance and adjustments to
  300  contracted plan rates to reflect enhanced care.
  301         (5)ANNUAL REVIEW.—The agency shall conduct an annual
  302  review of the Medicaid program’s coverage of medications,
  303  treatments, and services for enrollees diagnosed with sickle
  304  cell disease.
  305         (a)In its review, the agency shall do all of the
  306  following:
  307         1.Review all covered medications, treatments, and services
  308  to determine whether such coverage is adequate for the effective
  309  treatment of individuals diagnosed with sickle-cell disease and
  310  whether the agency should seek Medicaid coverage for additional
  311  medications, treatments, or services.
  312         2.Review Medicaid coverage of out-of-state treatment of
  313  enrollees with sickle-cell disease, comparing it with coverage
  314  for similar in-state treatment, to determine whether the program
  315  ensures coverage for an equivalent standard of care for patients
  316  who are referred or transferred to an out-of-state provider for
  317  treatment.
  318         3.Determine the extent to which Medicaid reimburses
  319  sickle-cell patients for reasonable interstate travel costs
  320  associated with treatment for sickle-cell disease.
  321         4.Review Medicaid coverage of treatment for emerging
  322  adults with sickle-cell disease as they transition into the
  323  adult care setting.
  324         5.Determine the extent to which emergency room physicians
  325  are adequately trained and prepared to treat and manage patients
  326  with sickle-cell disease who present with vaso-occlusive crises.
  327         6.Solicit and consider input from the public, including
  328  individuals impacted by sickle-cell disease and individuals or
  329  groups with knowledge or experience in sickle-cell disease
  330  treatment.
  331         (b)By January 15, 2023, and by January 15 of each year
  332  thereafter, the agency shall submit a report of its findings and
  333  recommendations to the Governor, the President of the Senate,
  334  and the Speaker of the House of Representatives. The agency
  335  shall also publish the report on its website.
  336         (6)STUDY OF INNOVATIVE PAYMENT MODELS TO ENHANCE ACCESS TO
  337  SICKLE-CELL DISEASE THERAPIES.—
  338         (a)The agency shall conduct a study of innovative
  339  approaches to reimbursement for, coverage of, and access to
  340  sickle-cell disease therapies, including, but not limited to,
  341  separate payments from inpatient bundling, outcomes-based
  342  arrangements, carving out sickle-cell disease treatment costs
  343  from managed care, and risk-sharing or reinsurance pools. The
  344  study must, at a minimum, assess whether current reimbursement
  345  methodologies restrict access to potentially curative one-time
  346  sickle-cell disease therapies.
  347         (b)The agency shall hold at least two public meetings
  348  providing an opportunity for public comments and involving
  349  discussions between the agency; health care providers who screen
  350  for, diagnose, or treat sickle-cell disease; community-based
  351  organizations that serve individuals diagnosed with sickle-cell
  352  disease; survivors of sickle-cell disease; and other relevant
  353  stakeholders. The agency must hold its first meeting by
  354  September 1, 2022.
  355         (c)By November 1, 2023, the agency shall prepare a report
  356  of its final recommendations for policies to be implemented by
  357  the agency to support equitable and appropriate access to
  358  innovative sickle-cell disease therapies and recommendations for
  359  any legislation required to allow the agency to implement such
  360  policies. The agency shall submit its report to the Governor,
  361  the President of the Senate, and the Speaker of the House of
  362  Representatives and publish the report on its website.
  363         (d)This subsection expires on December 1, 2023.
  364         Section 5. Section 456.0315, Florida Statutes, is created
  365  to read:
  366         456.0315 Requirement for instruction on sickle-cell
  367  disease.—
  368         (1)(a)The appropriate board shall require each person
  369  licensed under chapter 458, chapter 459, part I of chapter 464,
  370  or chapter 467 to complete, as part of every second biennial
  371  license or certification renewal, a 1-hour continuing education
  372  course, approved by the board, on sickle-cell disease. The
  373  course must cover at least all of the following:
  374         1.The importance of early detection of sickle-cell
  375  disease.
  376         2.Medically appropriate clinical examinations and
  377  screening procedures, including the frequency with which they
  378  should be provided.
  379         3.Best practices for the detection and treatment of
  380  sickle-cell disease and for emergency treatment and management
  381  of patients with sickle-cell disease who present with vaso
  382  occlusive crises.
  383         4.The sickle-cell registry and related reporting
  384  requirements established under s. 381.815.
  385         (b) Each licensee or certificateholder must submit
  386  confirmation of having completed the course on a form provided
  387  by the board when submitting fees for every second biennial
  388  license or certification renewal.
  389         (c) The board may approve additional equivalent courses
  390  that may be used to satisfy the requirements of paragraph (a),
  391  including the education and training developed or approved by
  392  the department under s. 381.815(3)(b). Each licensing board that
  393  requires a licensee to complete an educational course pursuant
  394  to this subsection may include the hour required for completion
  395  of the course in the total hours of continuing education
  396  required by law for such profession unless the continuing
  397  education requirements for such profession consist of fewer than
  398  30 hours biennially.
  399         (2) Any person holding two or more licenses or
  400  certifications subject to this section may show proof of having
  401  taken one board-approved course on sickle-cell disease, for
  402  purposes of renewing such additional licenses or certifications.
  403         (3) Failure to comply with this section constitutes grounds
  404  for disciplinary action under the chapters specified in
  405  paragraph (1)(a) and s. 456.072(1)(k). In addition to any
  406  discipline imposed by the board, the licensee also must be
  407  required to complete the required course.
  408         (4)Each applicable board may adopt rules to implement this
  409  section.
  410         Section 6. Section 627.64055, Florida Statutes, is created
  411  to read:
  412         627.64055 Coverage for fertility preservation services.—
  413         (1)As used in this section, the term:
  414         (a)“Fertility preservation” means the process by which a
  415  person’s eggs, sperm, or reproductive tissue is saved or
  416  protected for future attempts at conception.
  417         (b)“Iatrogenic infertility” means an impairment of
  418  fertility which is caused by a medical treatment that affects
  419  reproductive organs or processes.
  420         (2)A health insurance policy issued, delivered, or renewed
  421  in this state on or after July 1, 2022, which provides coverage
  422  for medically necessary treatments for sickle-cell disease must
  423  also provide coverage for fertility preservation services,
  424  including storage costs, if a medically necessary treatment for
  425  sickle-cell disease may directly or indirectly cause iatrogenic
  426  infertility of the insured.
  427         (3)In its coverage of fertility preservation services
  428  under this section, an insurer may not discriminate on the basis
  429  of the insured’s life expectancy, disability, degree of medical
  430  dependency, quality of life, or other health conditions or
  431  personal characteristics.
  432         Section 7. Section 627.65741, Florida Statutes, is created
  433  to read:
  434         627.65741 Coverage for fertility preservation services.—
  435         (1)As used in this section, the term:
  436         (a)“Fertility preservation” means the process by which a
  437  person’s eggs, sperm, or reproductive tissue is saved or
  438  protected for future attempts at conception.
  439         (b)“Iatrogenic infertility” means an impairment of
  440  fertility which is caused by a medical treatment that affects
  441  reproductive organs or processes.
  442         (2)A group health insurance policy issued, delivered, or
  443  renewed in this state on or after July 1, 2022, which provides
  444  coverage for medically necessary treatments for sickle-cell
  445  disease must also provide coverage for fertility preservation
  446  services, including storage costs, if a medically necessary
  447  treatment for sickle-cell disease may directly or indirectly
  448  cause iatrogenic infertility of the insured.
  449         (3)In its coverage of fertility preservation services
  450  under this section, an insurer may not discriminate on the basis
  451  of the insured’s life expectancy, disability, degree of medical
  452  dependency, quality of life, or other health conditions or
  453  personal characteristics.
  454         Section 8. Section 641.31078, Florida Statutes, is created
  455  to read:
  456         641.31078 Coverage for fertility preservation services.—
  457         (1)As used in this section, the term:
  458         (a)“Fertility preservation” means the process by which a
  459  person’s eggs, sperm, or reproductive tissue is saved or
  460  protected for future attempts at conception.
  461         (b)“Iatrogenic infertility” means an impairment of
  462  fertility which is caused by a medical treatment that affects
  463  reproductive organs or processes.
  464         (2)A health maintenance contract issued or renewed in this
  465  state on or after July 1, 2022, which provides coverage for
  466  medically necessary treatments for sickle-cell disease must also
  467  provide coverage for fertility preservation services, including
  468  storage costs, if a medically necessary treatment for sickle
  469  cell disease may directly or indirectly cause iatrogenic
  470  infertility of the subscriber.
  471         (3)In its coverage of fertility preservation services
  472  under this section, a health maintenance organization may not
  473  discriminate on the basis of the subscriber’s life expectancy,
  474  disability, degree of medical dependency, quality of life, or
  475  other health conditions or personal characteristics.
  476         Section 9. This act shall take effect July 1, 2022.