Florida Senate - 2019               CS for CS for CS for SB 1180
       
       
        
       By the Committees on Rules; Health Policy; and Banking and
       Insurance; and Senators Mayfield and Harrell
       
       
       
       
       595-04820-19                                          20191180c3
    1                        A bill to be entitled                      
    2         An act relating to prescription drug formulary
    3         consumer protection; creating s. 627.42393, F.S.;
    4         requiring insurers issuing individual or group health
    5         insurance policies to provide certain notices to
    6         current and prospective insureds within a certain
    7         timeframe before the effective date of any change to a
    8         prescription drug formulary during a policy year;
    9         specifying requirements for a notice of medical
   10         necessity that an insured’s treating physician may
   11         submit to the insurer within a certain timeframe;
   12         specifying means by which the notice is to be
   13         submitted; requiring the Financial Services Commission
   14         to adopt a certain rule; specifying a requirement and
   15         prohibited acts relating to certain coverage changes
   16         by an insurer if the treating physician provides
   17         certain certification; providing construction and
   18         applicability; providing an exception for certain
   19         increases in prescription drug prices by the drug
   20         manufacturer; specifying notification requirements for
   21         insurers under such circumstances; requiring insurers
   22         to maintain a record of formulary changes and submit
   23         an annual report to the Office of Insurance Regulation
   24         delineating such changes within a certain timeframe;
   25         requiring the commission to adopt a certain form by
   26         rule; amending s. 627.6699, F.S.; requiring small
   27         employer carriers to comply with certain requirements
   28         for any change to a prescription drug formulary under
   29         the health benefit plan; amending s. 641.31, F.S.;
   30         requiring health maintenance organizations to provide
   31         certain notices to current and prospective subscribers
   32         within a certain timeframe before the effective date
   33         of any change to a prescription drug formulary during
   34         a contract year; specifying requirements for a notice
   35         of medical necessity that a subscriber’s treating
   36         physician may submit to the health maintenance
   37         organization within a certain timeframe; specifying
   38         means by which the notice is to be submitted;
   39         requiring the commission to adopt a certain rule;
   40         specifying a requirement and prohibited acts relating
   41         to certain coverage changes by a health maintenance
   42         organization if the treating physician provides
   43         certain certification; providing construction and
   44         applicability; providing an exception for certain
   45         increases in prescription drug prices by the drug
   46         manufacturer; specifying notification requirements for
   47         health maintenance organizations under such
   48         circumstances; requiring health maintenance
   49         organizations to maintain a record of formulary
   50         changes and submit an annual report to the office
   51         delineating such changes within a certain timeframe;
   52         requiring the commission to adopt a certain form by
   53         rule; providing a declaration of important state
   54         interest; providing an effective date.
   55          
   56  Be It Enacted by the Legislature of the State of Florida:
   57  
   58         Section 1. Section 627.42393, Florida Statutes, is created
   59  to read:
   60         627.42393Health insurance policies; changes to
   61  prescription drug formularies; requirements.—
   62         (1)At least 60 days before the effective date of any
   63  change to a prescription drug formulary during a policy year, an
   64  insurer issuing individual or group health insurance policies in
   65  this state shall:
   66         (a)Provide general notification of the change in the
   67  formulary to current and prospective insureds in a readily
   68  accessible format on the insurer’s website; and
   69         (b)Notify, electronically or by first-class mail, any
   70  insured currently receiving coverage for a prescription drug for
   71  which the formulary change modifies coverage and the insured’s
   72  treating physician, including information on the specific drugs
   73  involved and a statement that the submission of a notice of
   74  medical necessity by the insured’s treating physician to the
   75  insurer at least 30 days before the effective date of the
   76  formulary change will result in continuation of coverage at the
   77  existing level.
   78         (2)The notice provided by the treating physician to the
   79  insurer must include a completed one-page form in which the
   80  treating physician certifies to the insurer that coverage of the
   81  prescription drug for the insured is medically necessary. The
   82  treating physician shall submit the notice electronically or by
   83  first-class mail. The insurer may provide the treating physician
   84  with access to an electronic portal through which the treating
   85  physician may electronically file the notice. The commission
   86  shall prescribe a form by rule for the notice.
   87         (3)If the treating physician certifies to the insurer, in
   88  accordance with subsection (2), that the prescription drug is
   89  medically necessary for the insured, the insurer:
   90         (a)Must authorize coverage for the prescribed drug based
   91  solely on the treating physician’s certification that coverage
   92  is medically necessary; and
   93         (b)May not modify the coverage related to the covered drug
   94  by:
   95         1.Increasing the out-of-pocket costs for the covered drug;
   96         2.Moving the covered drug to a more restrictive tier; or
   97         3.Denying an insured coverage of the drug for which the
   98  insured has been previously approved for coverage by the
   99  insurer.
  100         (4)This section does not:
  101         (a) Prohibit the addition of prescription drugs to the list
  102  of drugs covered under the policy during the policy year.
  103         (b)Apply to a grandfathered health plan as defined in s.
  104  627.402, to benefits specified in s. 627.6513(1)-(14), or to any
  105  policy issued or delivered between March 23, 2010, and December
  106  31, 2013, inclusive.
  107         (c)Alter or amend s. 465.025, which provides conditions
  108  under which a pharmacist may substitute a generically equivalent
  109  drug product for a brand name drug product.
  110         (d)Alter or amend s. 465.0252, which provides conditions
  111  under which a pharmacist may dispense a substitute biological
  112  product for the prescribed biological product.
  113         (e) Apply to a Medicaid managed care plan under part IV of
  114  chapter 409.
  115         (5)(a)This section does not apply if a drug manufacturer
  116  increases the list price of a prescription drug on the health
  117  insurer’s formulary to the health insurer or the pharmacy
  118  benefit manager after November 1 of the year before the health
  119  insurer’s earliest required rate submission date to applicable
  120  state and federal rate review authorities for the succeeding
  121  calendar or policy year.
  122         (b)However, at least 60 days before the effective date of
  123  a formulary change as a result of circumstances described in
  124  paragraph (a), the health insurer shall provide general
  125  notification of the formulary change to current and prospective
  126  insureds in a readily accessible format on the insurer’s
  127  website; and notify, electronically or by first-class mail, any
  128  insured currently receiving coverage for a prescription drug for
  129  which the formulary change modifies coverage and the insured’s
  130  treating physician, including information on the specific drugs
  131  involved.
  132         (6)A health insurer shall maintain a record of any change
  133  in its formulary during the calendar or plan year and, within 45
  134  days after the end of the plan year, submit an annual report to
  135  the office delineating such changes. The commission shall
  136  prescribe a form by rule for such reports.
  137         Section 2. Paragraph (e) of subsection (5) of section
  138  627.6699, Florida Statutes, is amended to read:
  139         627.6699 Employee Health Care Access Act.—
  140         (5) AVAILABILITY OF COVERAGE.—
  141         (e) All health benefit plans issued under this section must
  142  comply with the following conditions:
  143         1. For employers who have fewer than two employees, a late
  144  enrollee may be excluded from coverage for no longer than 24
  145  months if he or she was not covered by creditable coverage
  146  continually to a date not more than 63 days before the effective
  147  date of his or her new coverage.
  148         2. Any requirement used by a small employer carrier in
  149  determining whether to provide coverage to a small employer
  150  group, including requirements for minimum participation of
  151  eligible employees and minimum employer contributions, must be
  152  applied uniformly among all small employer groups having the
  153  same number of eligible employees applying for coverage or
  154  receiving coverage from the small employer carrier, except that
  155  a small employer carrier that participates in, administers, or
  156  issues health benefits pursuant to s. 381.0406 which do not
  157  include a preexisting condition exclusion may require as a
  158  condition of offering such benefits that the employer has had no
  159  health insurance coverage for its employees for a period of at
  160  least 6 months. A small employer carrier may vary application of
  161  minimum participation requirements and minimum employer
  162  contribution requirements only by the size of the small employer
  163  group.
  164         3. In applying minimum participation requirements with
  165  respect to a small employer, a small employer carrier shall not
  166  consider as an eligible employee employees or dependents who
  167  have qualifying existing coverage in an employer-based group
  168  insurance plan or an ERISA qualified self-insurance plan in
  169  determining whether the applicable percentage of participation
  170  is met. However, a small employer carrier may count eligible
  171  employees and dependents who have coverage under another health
  172  plan that is sponsored by that employer.
  173         4. A small employer carrier shall not increase any
  174  requirement for minimum employee participation or any
  175  requirement for minimum employer contribution applicable to a
  176  small employer at any time after the small employer has been
  177  accepted for coverage, unless the employer size has changed, in
  178  which case the small employer carrier may apply the requirements
  179  that are applicable to the new group size.
  180         5. If a small employer carrier offers coverage to a small
  181  employer, it must offer coverage to all the small employer’s
  182  eligible employees and their dependents. A small employer
  183  carrier may not offer coverage limited to certain persons in a
  184  group or to part of a group, except with respect to late
  185  enrollees.
  186         6. A small employer carrier may not modify any health
  187  benefit plan issued to a small employer with respect to a small
  188  employer or any eligible employee or dependent through riders,
  189  endorsements, or otherwise to restrict or exclude coverage for
  190  certain diseases or medical conditions otherwise covered by the
  191  health benefit plan.
  192         7. An initial enrollment period of at least 30 days must be
  193  provided. An annual 30-day open enrollment period must be
  194  offered to each small employer’s eligible employees and their
  195  dependents. A small employer carrier must provide special
  196  enrollment periods as required by s. 627.65615.
  197         8. A small employer carrier shall comply with s. 627.42393
  198  for any change to a prescription drug formulary.
  199         Section 3. Subsection (36) of section 641.31, Florida
  200  Statutes, is amended to read:
  201         641.31 Health maintenance contracts.—
  202         (36) Except as provided in paragraphs (a), (b), and (c), a
  203  health maintenance organization may increase the copayment for
  204  any benefit, or delete, amend, or limit any of the benefits to
  205  which a subscriber is entitled under the group contract only,
  206  upon written notice to the contract holder at least 45 days in
  207  advance of the time of coverage renewal. The health maintenance
  208  organization may amend the contract with the contract holder,
  209  with such amendment to be effective immediately at the time of
  210  coverage renewal. The written notice to the contract holder must
  211  shall specifically identify any deletions, amendments, or
  212  limitations to any of the benefits provided in the group
  213  contract during the current contract period which will be
  214  included in the group contract upon renewal. This subsection
  215  does not apply to any increases in benefits. The 45-day notice
  216  requirement does shall not apply if benefits are amended,
  217  deleted, or limited at the request of the contract holder.
  218         (a) At least 60 days before the effective date of any
  219  change to a prescription drug formulary during a contract year,
  220  the health maintenance organization shall:
  221         1.Provide general notification of the change in the
  222  formulary to current and prospective subscribers in a readily
  223  accessible format on the health maintenance organization’s
  224  website; and
  225         2.Notify, electronically or by first-class mail, any
  226  subscriber currently receiving coverage for a prescription drug
  227  for which the formulary change modifies coverage and the
  228  subscriber’s treating physician, including information on the
  229  specific drugs involved and a statement that the submission of a
  230  notice of medical necessity by the subscriber’s treating
  231  physician to the health maintenance organization at least 30
  232  days before the effective date of the formulary change will
  233  result in continuation of coverage at the existing level.
  234         (b)The notice provided by the treating physician to the
  235  insurer must include a completed one-page form in which the
  236  treating physician certifies to the health maintenance
  237  organization that coverage of the prescription drug for the
  238  subscriber is medically necessary. The treating physician shall
  239  submit the notice electronically or by first-class mail. The
  240  health maintenance organization may provide the treating
  241  physician with access to an electronic portal through which the
  242  treating physician may electronically file the notice. The
  243  commission shall prescribe a form by rule for the notice.
  244         (c)If the treating physician certifies to the health
  245  maintenance organization, in accordance with paragraph (b), that
  246  the prescription drug is medically necessary for the subscriber,
  247  the health maintenance organization:
  248         1.Must authorize coverage for the prescribed drug based
  249  solely on the treating physician’s certification that coverage
  250  is medically necessary; and
  251         2.May not modify the coverage related to the covered drug
  252  by:
  253         a.Increasing the out-of-pocket costs for the covered drug;
  254         b.Moving the covered drug to a more restrictive tier; or
  255         c.Denying a subscriber coverage of the drug for which the
  256  subscriber has been previously approved for coverage by the
  257  health maintenance organization.
  258         (d) Paragraphs (a), (b), and (c) do not:
  259         1. Prohibit the addition of prescription drugs to the list
  260  of drugs covered under the contract during the contract year.
  261         2. Apply to a grandfathered health plan as defined in s.
  262  627.402 or to benefits specified in s. 627.6513(1)-(14).
  263         3. Alter or amend s. 465.025, which provides conditions
  264  under which a pharmacist may substitute a generically equivalent
  265  drug product for a brand name drug product.
  266         4. Alter or amend s. 465.0252, which provides conditions
  267  under which a pharmacist may dispense a substitute biological
  268  product for the prescribed biological product.
  269         5. Apply to a Medicaid managed care plan under part IV of
  270  chapter 409.
  271         (e)1.Paragraphs (a), (b), and (c) do not apply if a drug
  272  manufacturer increases the list price of a prescription drug on
  273  the health maintenance organization’s formulary to the health
  274  maintenance organization or the pharmacy benefit manager after
  275  November 1 of the year before the health maintenance
  276  organization’s earliest required rate submission date to
  277  applicable state and federal rate review authorities for the
  278  succeeding calendar or policy year.
  279         2. However, at least 60 days before the effective date of a
  280  formulary change as a result of circumstances described in
  281  subparagraph 1., the health maintenance organization shall
  282  provide general notification of the formulary change to current
  283  and prospective subscribers in a readily accessible format on
  284  the health maintenance organization’s website; and notify,
  285  electronically or by first-class mail, any subscriber currently
  286  receiving coverage for a prescription drug for which the
  287  formulary change modifies coverage and the subscriber’s treating
  288  physician, including information on the specific drugs involved.
  289         (f) A health maintenance organization shall maintain a
  290  record of any change in its formulary during the calendar or
  291  plan year and, within 45 days after the end of the plan year,
  292  submit an annual report to the office delineating such changes.
  293  The commission shall prescribe a form by rule for such reports.
  294         Section 4. The Legislature finds that this act fulfills an
  295  important state interest.
  296         Section 5. This act shall take effect January 1, 2020.