Florida Senate - 2016                          SENATOR AMENDMENT
       Bill No. CS for CS for SB 212
       
       
       
       
       
       
                                Ì561928GÎ561928                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                 Floor: WD/2R          .                                
             03/08/2016 04:39 PM       .                                
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       Senator Hays moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete lines 544 - 571
    4  and insert:
    5         Section 8. Effective January 1, 2018, section 627.42393,
    6  Florida Statutes, is created to read:
    7         627.42393Continuity of care for medically stable
    8  patients.—
    9         (1) As used in this section, the term:
   10         (a) “Complex or chronic medical condition” means a
   11  physical, behavioral, or developmental condition that does not
   12  have a known cure or that can be severely debilitating or fatal
   13  if left untreated or undertreated.
   14         (b) “Rare diseasehas the same meaning as in 42 U.S.C. s.
   15  287a-1(c).
   16         (2) A pharmacy benefits manager or an individual or a group
   17  insurance policy that is delivered, issued for delivery,
   18  renewed, amended, or continued in this state and that provides
   19  medical, major medical, or similar comprehensive coverage must
   20  continue to cover a drug for an insured with a complex or
   21  chronic medical condition or a rare disease if:
   22         (a) The drug was previously covered by the insurer for a
   23  medical condition or disease of the insured; and
   24         (b) The prescribing provider continues to prescribe the
   25  drug for the medical condition or disease, the drug is
   26  appropriately prescribed, and neither of the following has
   27  occurred:
   28         1. The United States Food and Drug Administration has
   29  issued a notice, a guidance, a warning, an announcement, or any
   30  other statement about the drug which calls into question the
   31  clinical safety of the drug; or
   32         2. The manufacturer of the drug has notified the United
   33  States Food and Drug Administration of any manufacturing
   34  discontinuance or potential discontinuance as required by s.
   35  506C of the Federal Food Drug and Cosmetic Act, 21 U.S.C. s.
   36  356c.
   37         (3) With respect to a drug for an insured with a complex or
   38  chronic medical condition or a rare disease which meets the
   39  conditions of paragraphs (2)(a) and (b), except during open
   40  enrollment periods, a pharmacy benefits manager or an individual
   41  or a group insurance policy may not:
   42         (a) Set forth, by contract, limitations on maximum coverage
   43  of prescription drug benefits;
   44         (b) Subject the insured to increased out-of-pocket costs;
   45  or
   46         (c) Move a drug for an insured to a more restrictive tier,
   47  if an individual or a group insurance policy or a pharmacy
   48  benefits manager uses a formulary with tiers.
   49         (4) This section does not apply to a grandfathered health
   50  plan as defined in s. 627.402, or to benefits set forth in s.
   51  627.6561(5)(b)-(e).
   52         Section 9. Effective January 1, 2018, paragraph (e) of
   53  subsection (5) of section 627.6699, Florida Statutes, is amended
   54  to read:
   55         627.6699 Employee Health Care Access Act.—
   56         (5) AVAILABILITY OF COVERAGE.—
   57         (e) All health benefit plans issued under this section must
   58  comply with the following conditions:
   59         1. For employers who have fewer than two employees, a late
   60  enrollee may be excluded from coverage for no longer than 24
   61  months if he or she was not covered by creditable coverage
   62  continually to a date not more than 63 days before the effective
   63  date of his or her new coverage.
   64         2. Any requirement used by a small employer carrier in
   65  determining whether to provide coverage to a small employer
   66  group, including requirements for minimum participation of
   67  eligible employees and minimum employer contributions, must be
   68  applied uniformly among all small employer groups having the
   69  same number of eligible employees applying for coverage or
   70  receiving coverage from the small employer carrier, except that
   71  a small employer carrier that participates in, administers, or
   72  issues health benefits pursuant to s. 381.0406 which do not
   73  include a preexisting condition exclusion may require as a
   74  condition of offering such benefits that the employer has had no
   75  health insurance coverage for its employees for a period of at
   76  least 6 months. A small employer carrier may vary application of
   77  minimum participation requirements and minimum employer
   78  contribution requirements only by the size of the small employer
   79  group.
   80         3. In applying minimum participation requirements with
   81  respect to a small employer, a small employer carrier shall not
   82  consider as an eligible employee employees or dependents who
   83  have qualifying existing coverage in an employer-based group
   84  insurance plan or an ERISA qualified self-insurance plan in
   85  determining whether the applicable percentage of participation
   86  is met. However, a small employer carrier may count eligible
   87  employees and dependents who have coverage under another health
   88  plan that is sponsored by that employer.
   89         4. A small employer carrier shall not increase any
   90  requirement for minimum employee participation or any
   91  requirement for minimum employer contribution applicable to a
   92  small employer at any time after the small employer has been
   93  accepted for coverage, unless the employer size has changed, in
   94  which case the small employer carrier may apply the requirements
   95  that are applicable to the new group size.
   96         5. If a small employer carrier offers coverage to a small
   97  employer, it must offer coverage to all the small employer’s
   98  eligible employees and their dependents. A small employer
   99  carrier may not offer coverage limited to certain persons in a
  100  group or to part of a group, except with respect to late
  101  enrollees.
  102         6. A small employer carrier may not modify any health
  103  benefit plan issued to a small employer with respect to a small
  104  employer or any eligible employee or dependent through riders,
  105  endorsements, or otherwise to restrict or exclude coverage for
  106  certain diseases or medical conditions otherwise covered by the
  107  health benefit plan.
  108         7. An initial enrollment period of at least 30 days must be
  109  provided. An annual 30-day open enrollment period must be
  110  offered to each small employer’s eligible employees and their
  111  dependents. A small employer carrier must provide special
  112  enrollment periods as required by s. 627.65615.
  113         8. A small employer carrier must provide continuity of care
  114  for medically stable patients as required by s. 627.42393.
  115         Section 10. Effective January 1, 2018, subsections (44) and
  116  (45) are added to section 641.31, Florida Statutes, to read:
  117         641.31 Health maintenance contracts.—
  118         (44) A health maintenance organization may not require a
  119  health care provider, by contract with another health care
  120  provider, a patient, or another individual or entity, to use a
  121  clinical decision support system or a laboratory benefits
  122  management program before the provider may order clinical
  123  laboratory services or in an attempt to direct or limit the
  124  provider’s medical decisionmaking relating to the use of such
  125  services. This subsection may not be construed to prohibit any
  126  prior authorization requirements that the health maintenance
  127  organization may have regarding the provision of clinical
  128  laboratory services. As used in this subsection, the term:
  129         (a) “Clinical decision support system” means software
  130  designed to direct or assist clinical decisionmaking by matching
  131  the characteristics of an individual patient to a computerized
  132  clinical knowledge base and providing patient-specific
  133  assessments or recommendations based on the match.
  134         (b) “Clinical laboratory services” means the examination of
  135  fluids or other materials taken from the human body, which
  136  examination is ordered by a health care provider for use in the
  137  diagnosis, prevention, or treatment of a disease or in the
  138  identification or assessment of a medical or physical condition.
  139         (c) “Laboratory benefits management program” means a health
  140  maintenance organization protocol that dictates or limits health
  141  care provider decisionmaking relating to the use of clinical
  142  laboratory services.
  143         (45)(a) A pharmacy benefits manager or a health maintenance
  144  contract that is delivered, issued for delivery, renewed,
  145  amended, or continued in this state and that provides medical,
  146  major medical, or similar comprehensive coverage must continue
  147  to cover a drug for a subscriber with a complex or chronic
  148  medical condition or a rare disease if:
  149         1. The drug was previously covered by the health
  150  maintenance organization for a medical condition or disease of
  151  the subscriber; and
  152         2. The prescribing provider continues to prescribe the drug
  153  for the medical condition or disease, the drug is appropriately
  154  prescribed, and neither of the following has occurred:
  155         a. The United States Food and Drug Administration has
  156  issued a notice, a guidance, a warning, an announcement, or any
  157  other statement about the drug which calls into question the
  158  clinical safety of the drug; or
  159         b. The manufacturer of the drug has notified the United
  160  States Food and Drug Administration of any manufacturing
  161  discontinuance or potential discontinuance as required by s.
  162  506C of the Federal Food Drug and Cosmetic Act, 21 U.S.C. s.
  163  356c.
  164         (b) With respect to a drug for a subscriber with a complex
  165  or chronic medical condition or a rare disease which meets the
  166  conditions of subparagraphs (c)1. and (c)2., except during open
  167  enrollment periods, a pharmacy benefits manager or a health
  168  maintenance contract may not:
  169         1.Set forth, by contract, limitations on maximum coverage
  170  of prescription drug benefits;
  171         2. Subject the subscriber to increased out-of-pocket costs;
  172  or
  173         3. Move a drug for a subscriber to a more restrictive tier,
  174  if a health maintenance contract or a pharmacy benefits manager
  175  uses a formulary with tiers.
  176         (c) As used in this subsection, the term:
  177         1.“Complex or chronic medical condition” means a physical,
  178  behavioral, or developmental condition that does not have a
  179  known cure or that can be severely debilitating or fatal if left
  180  untreated or undertreated.
  181         2.“Rare disease” has the same meaning as 42 U.S.C. s.
  182  287a-1(c).
  183         (d) This section does not apply to a grandfathered health
  184  plan as defined in s. 627.402.
  185  
  186  ================= T I T L E  A M E N D M E N T ================
  187  And the title is amended as follows:
  188         Delete lines 76 - 82
  189  and insert:
  190         defining the term “fail-first protocol”; creating s.
  191         627.42393, F.S.; defining terms; requiring a pharmacy
  192         benefits manager or a specified individual or group
  193         insurance policy to continue to cover a drug for
  194         specified insureds under certain circumstances;
  195         prohibiting certain actions by a pharmacy benefits
  196         manager or an individual or a group policy with
  197         respect to a drug for a certain insured except under
  198         certain circumstances; providing applicability;
  199         amending s. 627.6699, F.S.; expanding a list of
  200         conditions that certain health benefit plans must
  201         comply with; amending s. 641.31, F.S.; prohibiting a
  202         health maintenance organization from requiring that a
  203         health care provider use a clinical decision support
  204         system or a laboratory benefits management program in
  205         certain circumstances; defining terms; providing for
  206         construction; requiring a pharmacy benefits manager or
  207         a specified health maintenance contract to continue to
  208         cover a drug for specified subscribers under certain
  209         circumstances; prohibiting certain actions by a
  210         pharmacy benefits manager or a health maintenance
  211         contract with respect to a drug for a certain
  212         subscriber except under certain circumstances;
  213         defining terms; providing applicability; creating s.
  214         641.394, F.S.; requiring a