Florida Senate - 2015                                     SB 784
       
       
        
       By Senator Gaetz
       
       
       
       
       
       1-00079B-15                                            2015784__
    1                        A bill to be entitled                      
    2         An act relating to health care; providing that this
    3         act shall be known as the “Right Medicine, Right Time
    4         Act”; creating s. 402.90, F.S.; creating the Clinical
    5         Practices Review Commission; housing the commission,
    6         for administrative purposes, within the Division of
    7         Medical Quality Assurance of the Department of Health;
    8         specifying the composition of, qualifications for
    9         appointment to, and standards imposed on commission
   10         members; designating the members as public officers;
   11         requiring the executive director to submit to the
   12         Commission on Ethics a list of certain people subject
   13         to public disclosure requirements; providing penalties
   14         for failure to comply with such standards; specifying
   15         the duties and responsibilities of the commission;
   16         amending s. 409.967, F.S.; requiring a managed care
   17         plan that establishes a prescribed drug formulary or
   18         preferred drug list to provide a broad range of
   19         therapeutic options to the patient; requiring a
   20         managed care plan to comply with specified procedures;
   21         creating s. 627.6051, F.S.; requiring sufficient
   22         clinical evidence to support a proposed coverage
   23         limitation at the point of service; defining the term
   24         “sufficient clinical evidence”; requiring the
   25         commission to determine whether sufficient clinical
   26         evidence exists and the Office of Insurance Regulation
   27         to approve coverage limitations if the commission
   28         determines that such evidence exists; providing for
   29         the liability of a health insurer and its chief
   30         medical officer for injuries and damages resulting
   31         from restricted access to services if the insurer has
   32         imposed coverage limitations without the approval of
   33         the office; requiring insurers to establish reserves
   34         to pay for such damages; amending ss. 627.642 and
   35         627.6699, F.S.; requiring an outline of coverage and
   36         certain plans offered by a small employer carrier to
   37         include summary statements identifying specific
   38         prescription drugs and procedures that are subject to
   39         specified restrictions and limitations; requiring
   40         insurers and small employer carriers to post the
   41         summaries on the Internet; amending s. 627.651, F.S.;
   42         conforming a cross-reference; amending s. 627.662,
   43         F.S.; specifying that specified provisions relating to
   44         coverage limitations on prescription drugs and
   45         diagnostic or therapeutic procedures apply to group
   46         health insurance, blanket health insurance, and
   47         franchise health insurance; amending s. 641.31, F.S.;
   48         requiring a health maintenance contract summary
   49         statement to include a statement of any limitations on
   50         benefits, the identification of specific prescription
   51         drugs, and certain procedures that are subject to
   52         specified restrictions and limitations; requiring a
   53         health maintenance organization to post the summaries
   54         on the Internet; prohibiting a health maintenance
   55         organization from establishing certain procedures and
   56         requirements that restrict access to covered services;
   57         exempting limitations that are supported by sufficient
   58         clinical evidence; requiring the commission to
   59         evaluate the sufficiency of the evidence and the
   60         Office of Insurance Regulation to approve coverage
   61         limitations on the basis of the commission’s
   62         evaluation; providing an effective date.
   63          
   64  Be It Enacted by the Legislature of the State of Florida:
   65  
   66         Section 1. This act shall be known as the “Right Medicine,
   67  Right Time Act.”
   68         Section 2. Section 402.90, Florida Statutes, is created to
   69  read:
   70         402.90 Clinical Practices Review Commission.—There is
   71  created the Clinical Practices Review Commission, which is a
   72  commission as defined in s. 20.03.
   73         (1) The commission shall be housed for administrative
   74  purposes in the Division of Medical Quality Assurance of the
   75  Department of Health.
   76         (2)The commission shall consist of seven members
   77  appointed, subject to confirmation by the Senate, as follows:
   78         (a) Five physicians, one appointed by the Governor, two
   79  appointed by the President of the Senate, and two appointed by
   80  the Speaker of the House of Representatives, who are currently
   81  practicing medicine in this state and have clinical expertise,
   82  as evidenced by the following:
   83         1. A doctoral degree in medicine or osteopathic medicine
   84  from an accredited school;
   85         2. An active and clear license issued by this state or
   86  another state;
   87         3. Board certification in one or more medical specialties;
   88  and
   89         4. At least 15 years of clinical experience.
   90         (b) One individual, appointed by the Governor, with a
   91  doctorate in either pharmacology or pharmacy and at least 10
   92  years of experience in research or clinical practice with
   93  applicable postlicensure credentials.
   94         (c) One member, appointed by the Governor, with expertise
   95  in the analysis of clinical research, evidenced by a doctoral
   96  degree in biostatistics or a related field and at least 10 years
   97  of experience in clinical research.
   98         (3) A commission member may not currently be an officer,
   99  director, owner, operator, employee, or consultant of any entity
  100  subject to regulation by the commission. The executive director,
  101  senior managers, and members of the commission are subject to
  102  part III of chapter 112, including, but not limited to, the Code
  103  of Ethics for Public Officers and Employees and the public
  104  disclosure and reporting of financial interests pursuant to s.
  105  112.3145. For purposes of applying part III of chapter 112 to
  106  the activities of the executive director, senior managers, and
  107  members of the commission, such persons shall be considered
  108  public officers or employees and the commission shall be
  109  considered their agency.
  110         (a) Notwithstanding s. 112.3143(2), a commission member may
  111  not vote on any measure that would inure to his or her special
  112  private gain or loss; that he or she knows would inure to the
  113  special private gain or loss of any principal by whom he or she
  114  is retained, or to the parent organization or subsidiary of a
  115  corporate principal by which he or she is retained, other than
  116  an agency as defined in s. 112.312; or that he or she knows
  117  would inure to the special private gain or loss of a relative or
  118  business associate of the public officer. A commission member
  119  who is prohibited from voting for such reasons shall publicly
  120  state to the assembly, before such a vote is taken, the nature
  121  of his or her interest in the matter from which he or she is
  122  abstaining from voting and, within 15 days after the vote,
  123  disclose the nature of his or her interest as a public record in
  124  a memorandum filed with the person responsible for recording the
  125  minutes of the meeting, who shall incorporate the memorandum in
  126  the minutes.
  127         (b) Senior managers and commission members shall also file
  128  the disclosures required under paragraph (a) with the Commission
  129  on Ethics. The executive director of the commission or his or
  130  her designee shall notify each standing and newly appointed
  131  commission member and senior manager of his or her duty to
  132  comply with the reporting requirements of part III of chapter
  133  112. At least quarterly, the executive director or his or her
  134  designee shall submit to the Commission on Ethics a list of
  135  names of the senior managers and members of the commission who
  136  are subject to the public disclosure requirements under s.
  137  112.3145.
  138         (c) Notwithstanding s. 112.3148, s. 112.3149, or any other
  139  law, an employee or member of the commission may not knowingly
  140  accept, directly or indirectly, any gift or expenditure from a
  141  person or entity, or an employee or representative of such
  142  person or entity, which has a contractual relationship with the
  143  commission or which is under consideration for a contract.
  144         (d) An employee or member of the commission who fails to
  145  comply with this subsection is subject to the penalties provided
  146  under ss. 112.317 and 112.3173.
  147         (4) The duties and responsibilities of the commission
  148  include:
  149         (a) Development and implementation of policies and
  150  procedures for the review of prior authorization, step therapy,
  151  or other protocols that limit, at the point of service, access
  152  to covered services, including diagnostic procedures,
  153  pharmaceutical services, and other therapeutic interventions.
  154         (b) Development of any operational policies and procedures
  155  that would facilitate the work of the commission, including the
  156  establishment of bylaws, the election of a chair, and other
  157  administrative procedures.
  158         (c) Determination as to the sufficiency of clinical
  159  evidence submitted in support of any proposed coverage
  160  limitation.
  161         (d) Preparation of reports and recommendations that
  162  document the proceedings of the commission and identify
  163  necessary resources or legislative action.
  164         (5) Subject to appropriations, a commission member may
  165  receive compensation and per diem and travel expenses as
  166  provided in s. 112.061.
  167         Section 3. Paragraph (c) of subsection (2) of section
  168  409.967, Florida Statutes, is amended to read:
  169         409.967 Managed care plan accountability.—
  170         (2) The agency shall establish such contract requirements
  171  as are necessary for the operation of the statewide managed care
  172  program. In addition to any other provisions the agency may deem
  173  necessary, the contract must require:
  174         (c) Access.—
  175         1. The agency shall establish specific standards for the
  176  number, type, and regional distribution of providers in managed
  177  care plan networks to ensure access to care for both adults and
  178  children. Each plan must maintain a regionwide network of
  179  providers in sufficient numbers to meet the access standards for
  180  specific medical services for all recipients enrolled in the
  181  plan. The exclusive use of mail-order pharmacies may not be
  182  sufficient to meet network access standards. Consistent with the
  183  standards established by the agency, provider networks may
  184  include providers located outside the region. A plan may
  185  contract with a new hospital facility before the date the
  186  hospital becomes operational if the hospital has commenced
  187  construction, will be licensed and operational by January 1,
  188  2013, and a final order has issued in any civil or
  189  administrative challenge. Each plan shall establish and maintain
  190  an accurate and complete electronic database of contracted
  191  providers, including information about licensure or
  192  registration, locations and hours of operation, specialty
  193  credentials and other certifications, specific performance
  194  indicators, and such other information as the agency deems
  195  necessary. The database must be available online to both the
  196  agency and the public and have the capability to compare the
  197  availability of providers to network adequacy standards and to
  198  accept and display feedback from each provider’s patients. Each
  199  plan shall submit quarterly reports to the agency identifying
  200  the number of enrollees assigned to each primary care provider.
  201         2. A managed care plan that establishes a prescribed drug
  202  formulary or preferred drug list shall:
  203         a.Provide a broad range of therapeutic options for the
  204  treatment of disease states which are consistent with the
  205  general needs of an outpatient population. If feasible, the
  206  formulary or preferred drug list must include at least two
  207  products in each therapeutic class.
  208         b.2.Each managed care plan must Publish the any prescribed
  209  drug formulary or preferred drug list on the plan’s website in a
  210  manner that is accessible to and searchable by enrollees and
  211  providers. The plan must update the list within 24 hours after
  212  making a change. Each plan must ensure that the prior
  213  authorization process for prescribed drugs is readily accessible
  214  to health care providers, including posting appropriate contact
  215  information on its website and providing timely responses to
  216  providers.
  217         3. For enrollees Medicaid recipients diagnosed with
  218  hemophilia who have been prescribed anti-hemophilic-factor
  219  replacement products, the agency shall provide for those
  220  products and hemophilia overlay services through the agency’s
  221  hemophilia disease management program.
  222         4.3. Managed care plans, and their fiscal agents or
  223  intermediaries, must accept prior authorization requests for any
  224  service electronically.
  225         5.4. Managed care plans serving children in the care and
  226  custody of the Department of Children and Families shall must
  227  maintain complete medical, dental, and behavioral health
  228  encounter information and participate in making such information
  229  available to the department or the applicable contracted
  230  community-based care lead agency for use in providing
  231  comprehensive and coordinated case management. The agency and
  232  the department shall establish an interagency agreement to
  233  provide guidance for the format, confidentiality, recipient,
  234  scope, and method of information to be made available and the
  235  deadlines for submission of the data. The scope of information
  236  available to the department is shall be the data that managed
  237  care plans are required to submit to the agency. The agency
  238  shall determine the plan’s compliance with standards for access
  239  to medical, dental, and behavioral health services; the use of
  240  medications; and followup on all medically necessary services
  241  recommended as a result of early and periodic screening,
  242  diagnosis, and treatment.
  243         6.Managed care plans shall comply with the procedures for
  244  approval of coverage limitations established pursuant to ss.
  245  627.6051 and 641.31(44).
  246         Section 4. Section 627.6051, Florida Statutes, is created
  247  to read:
  248         627.6051 Required approval for certain coverage
  249  limitations.—
  250         (1) A coverage limitation imposed by the insurer at the
  251  point of service must be supported by sufficient clinical
  252  evidence proving that the limitation does not inhibit timely
  253  diagnosis or effective treatment of the specific illness or
  254  condition for the covered patient. The term “sufficient clinical
  255  evidence” means:
  256         (a) A body of research consisting of well-controlled
  257  studies conducted by independent researchers and published in
  258  peer reviewed journals or comparable publications which
  259  consistently support the treatment protocol or other coverage
  260  limitation as a best practice for the specific diagnosis or
  261  combination of presenting complaints.
  262         (b) Results of a multivariate predictive model which
  263  indicate that the probability of achieving desired outcomes is
  264  not negatively altered or delayed by adherence to the proposed
  265  protocol.
  266         (2) The Clinical Practices Review Commission established
  267  under s. 402.90 shall determine whether sufficient clinical
  268  evidence exists for a proposed coverage limitation imposed by
  269  the insurer at the point of service. In each instance in which
  270  the commission finds that sufficient clinical evidence exists to
  271  support a coverage limitation, the office shall approve the
  272  coverage limitation.
  273         (3) If an insurer, without the approval of the office,
  274  imposes a coverage limitation at the point of service,
  275  including, but not limited to, a prior authorization procedure,
  276  step therapy requirement, treatment protocol, or other
  277  utilization management procedure that restricts access to
  278  covered services, the insurer and its chief medical officer
  279  shall be liable for any injuries or damages, as defined in s.
  280  766.202, and economic damages, as defined in s. 768.81(1)(b),
  281  that result from the restricted access to services determined
  282  medically necessary by the physician treating the patient. An
  283  insurer that imposes such a coverage limitation at the point of
  284  service shall establish reserves sufficient to pay for such
  285  damages.
  286         Section 5. Subsection (2) of section 627.642, Florida
  287  Statutes, is amended to read:
  288         627.642 Outline of coverage.—
  289         (2) The outline of coverage must shall contain:
  290         (a) A statement identifying the applicable category of
  291  coverage afforded by the policy, based on the minimum basic
  292  standards set forth in the rules issued to effect compliance
  293  with s. 627.643.
  294         (b) A brief description of the principal benefits and
  295  coverage provided in the policy.
  296         (c) A summary statement of the principal exclusions and
  297  limitations or reductions contained in the policy, including,
  298  but not limited to, preexisting conditions, probationary
  299  periods, elimination periods, deductibles, coinsurance, and any
  300  age limitations or reductions.
  301         (d)A summary statement identifying specific prescription
  302  drugs that are subject to prior authorization, step therapy, or
  303  any other coverage limitation and the applicable coverage
  304  limitation policy or protocol. The insurer shall post the
  305  summary statement at a prominent and readily accessible location
  306  on the Internet.
  307         (e)A summary statement identifying any specific diagnostic
  308  or therapeutic procedures that are subject to prior
  309  authorization or other coverage limitations and the applicable
  310  coverage limitation policy or protocol. The insurer shall post
  311  the summary statement at a prominent and readily accessible
  312  location on the Internet.
  313         (f)(d) A summary statement of the renewal and cancellation
  314  provisions, including any reservation of the insurer of a right
  315  to change premiums.
  316         (g)(e) A statement that the outline contains a summary only
  317  of the details of the policy as issued or of the policy as
  318  applied for and that the issued policy should be referred to for
  319  the actual contractual governing provisions.
  320         (h)(f) When home health care coverage is provided, a
  321  statement that such benefits are provided in the policy.
  322         Section 6. Subsection (4) of section 627.651, Florida
  323  Statutes, is amended to read:
  324         627.651 Group contracts and plans of self-insurance must
  325  meet group requirements.—
  326         (4) This section does not apply to any plan that which is
  327  established or maintained by an individual employer in
  328  accordance with the Employee Retirement Income Security Act of
  329  1974, Pub. L. No. 93-406, or to a multiple-employer welfare
  330  arrangement as defined in s. 624.437(1), except that a multiple
  331  employer welfare arrangement shall comply with ss. 627.419,
  332  627.657, 627.6575, 627.6578, 627.6579, 627.6612, 627.66121,
  333  627.66122, 627.6615, 627.6616, and 627.662(8) 627.662(7). This
  334  subsection does not allow an authorized insurer to issue a group
  335  health insurance policy or certificate which does not comply
  336  with this part.
  337         Section 7. Present subsections (7) through (14) of section
  338  627.662, Florida Statutes, are redesignated as subsections (8)
  339  through (15), respectively, and a new subsection (7) is added to
  340  that section, to read:
  341         627.662 Other provisions applicable.—The following
  342  provisions apply to group health insurance, blanket health
  343  insurance, and franchise health insurance:
  344         (7) Section 627.642(2)(d) and (e), relating to coverage
  345  limitations on prescription drugs and diagnostic or therapeutic
  346  procedures.
  347         Section 8. Paragraph (b) of subsection (12) of section
  348  627.6699, Florida Statutes, is amended to read:
  349         627.6699 Employee Health Care Access Act.—
  350         (12) STANDARD, BASIC, HIGH DEDUCTIBLE, AND LIMITED HEALTH
  351  BENEFIT PLANS.—
  352         (b)1. Each small employer carrier issuing new health
  353  benefit plans shall offer to any small employer, upon request, a
  354  standard health benefit plan, a basic health benefit plan, and a
  355  high deductible plan that meets the requirements of a health
  356  savings account plan as defined by federal law or a health
  357  reimbursement arrangement as authorized by the Internal Revenue
  358  Service, which that meet the criteria set forth in this section.
  359         2. For purposes of this subsection, the terms “standard
  360  health benefit plan,” “basic health benefit plan,” and “high
  361  deductible plan” mean policies or contracts that a small
  362  employer carrier offers to eligible small employers which that
  363  contain:
  364         a. An exclusion for services that are not medically
  365  necessary or that are not covered preventive health services;
  366  and
  367         b. A procedure for preauthorization or prior authorization
  368  by the small employer carrier, or its designees;
  369         c. A summary statement identifying specific prescription
  370  drugs that are subject to prior authorization, step therapy, or
  371  any other coverage limitation and the applicable coverage
  372  limitation policy or protocol. The carrier shall post the
  373  summary statement in a prominent and readily accessible location
  374  on the Internet; and
  375         d. A summary statement identifying any specific diagnostic
  376  or therapeutic procedures subject to prior authorization or
  377  other coverage limitations and the applicable coverage
  378  limitation policy or protocol. The carrier shall post the
  379  summary statement in a prominent and readily accessible location
  380  on the Internet.
  381         3. A small employer carrier may include the following
  382  managed care provisions in the policy or contract to control
  383  costs:
  384         a. A preferred provider arrangement or exclusive provider
  385  organization or any combination thereof, in which a small
  386  employer carrier enters into a written agreement with the
  387  provider to provide services at specified levels of
  388  reimbursement or to provide reimbursement to specified
  389  providers. Any such written agreement between a provider and a
  390  small employer carrier must contain a provision under which the
  391  parties agree that the insured individual or covered member has
  392  no obligation to make payment for any medical service rendered
  393  by the provider which is determined not to be medically
  394  necessary. A carrier may use preferred provider arrangements or
  395  exclusive provider arrangements to the same extent as allowed in
  396  group products that are not issued to small employers.
  397         b. A procedure for utilization review by the small employer
  398  carrier or its designees.
  399  
  400  This subparagraph does not prohibit a small employer carrier
  401  from including in its policy or contract additional managed care
  402  and cost containment provisions, subject to the approval of the
  403  office, which have potential for controlling costs in a manner
  404  that does not result in inequitable treatment of insureds or
  405  subscribers. The carrier may use such provisions to the same
  406  extent as authorized for group products that are not issued to
  407  small employers.
  408         4. The standard health benefit plan shall include:
  409         a. Coverage for inpatient hospitalization;
  410         b. Coverage for outpatient services;
  411         c. Coverage for newborn children pursuant to s. 627.6575;
  412         d. Coverage for child care supervision services pursuant to
  413  s. 627.6579;
  414         e. Coverage for adopted children upon placement in the
  415  residence pursuant to s. 627.6578;
  416         f. Coverage for mammograms pursuant to s. 627.6613;
  417         g. Coverage for children with disabilities handicapped
  418  children pursuant to s. 627.6615;
  419         h. Emergency or urgent care out of the geographic service
  420  area; and
  421         i. Coverage for services provided by a hospice licensed
  422  under s. 400.602 in cases where such coverage would be the most
  423  appropriate and the most cost-effective method for treating a
  424  covered illness.
  425         5. The standard health benefit plan and the basic health
  426  benefit plan may include a schedule of benefit limitations for
  427  specified services and procedures. If the committee develops
  428  such a schedule of benefits limitation for the standard health
  429  benefit plan or the basic health benefit plan, a small employer
  430  carrier offering the plan must offer the employer an option for
  431  increasing the benefit schedule amounts by 4 percent annually.
  432         6. The basic health benefit plan must shall include all of
  433  the benefits specified in subparagraph 4.; however, the basic
  434  health benefit plan must shall place additional restrictions on
  435  the benefits and utilization and may also impose additional cost
  436  containment measures.
  437         7. Sections 627.419(2), (3), and (4), 627.6574, 627.6612,
  438  627.66121, 627.66122, 627.6616, 627.6618, 627.668, and 627.66911
  439  apply to the standard health benefit plan and to the basic
  440  health benefit plan. However, notwithstanding such said
  441  provisions, the plans may specify limits on the number of
  442  authorized treatments, if such limits are reasonable and do not
  443  discriminate against any type of provider.
  444         8. The high-deductible high deductible plan associated with
  445  a health savings account or a health reimbursement arrangement
  446  must shall include all the benefits specified in subparagraph 4.
  447         9. Each small employer carrier that provides for inpatient
  448  and outpatient services by allopathic hospitals may provide as
  449  an option of the insured similar inpatient and outpatient
  450  services by hospitals accredited by the American Osteopathic
  451  Association if when such services are available and the
  452  osteopathic hospital agrees to provide the service.
  453         Section 9. Subsection (4) of section 641.31, Florida
  454  Statutes, is amended and subsection (44) is added to that
  455  section, to read:
  456         641.31 Health maintenance contracts.—
  457         (4) Each Every health maintenance contract, certificate, or
  458  member handbook must shall clearly state all of the services to
  459  which a subscriber is entitled under the contract and must
  460  include a clear and understandable statement of any limitations
  461  on the benefits, services, or kinds of services to be provided,
  462  including any copayment feature or schedule of benefits required
  463  by the contract or by any insurer or entity that which is
  464  underwriting any of the services offered by the health
  465  maintenance organization. The contract, certificate, or member
  466  handbook must shall also state where and in what manner the
  467  comprehensive health care services may be obtained. The health
  468  maintenance organization shall prominently post the statement
  469  regarding limitations on benefits, services, or kinds of
  470  services provided on its website in a readily accessible
  471  location on the Internet. The statement must include, but need
  472  not be limited to:
  473         (a)The identification of specific prescription drugs that
  474  are subject to prior authorization, step therapy, or any other
  475  coverage limitation and the applicable coverage limitation
  476  policy or protocol.
  477         (b)The identification of any specific diagnostic or
  478  therapeutic procedures that are subject to prior authorization
  479  or other coverage limitations and the applicable coverage
  480  limitation policy or protocol.
  481         (44) Health maintenance organizations and prepaid health
  482  plans are prohibited from establishing prior authorization
  483  procedures, step therapy requirements, treatment protocols, or
  484  other utilization management procedures that restrict access to
  485  covered services unless expressly authorized to do so under this
  486  subsection. A coverage limitation imposed by a health
  487  maintenance organization or prepaid health plan at the point of
  488  service must be supported by sufficient clinical evidence, as
  489  defined in s. 627.6051, which demonstrates that the limitation
  490  does not inhibit timely diagnosis or optimal treatment of the
  491  specific illness or condition for the covered patient.
  492         Section 10. This act shall take effect October 1, 2015.