Florida Senate - 2021                                     SB 390
       
       
        
       By Senator Wright
       
       
       
       
       
       14-00250A-21                                           2021390__
    1                        A bill to be entitled                      
    2         An act relating to prescription drug coverage;
    3         amending s. 624.3161, F.S.; authorizing the Office of
    4         Insurance Regulation to examine pharmacy benefit
    5         managers; specifying that certain examination costs
    6         are payable by persons examined; transferring,
    7         renumbering, and amending s. 465.1885, F.S.; revising
    8         the entities conducting pharmacy audits to which
    9         certain requirements and restrictions apply;
   10         authorizing audited pharmacies to appeal certain
   11         findings; providing that health insurers and health
   12         maintenance organizations that transfer a certain
   13         payment obligation to pharmacy benefit managers remain
   14         responsible for certain violations; amending ss.
   15         627.64741 and 627.6572, F.S.; revising the definition
   16         of the term “maximum allowable cost”; authorizing the
   17         office to require health insurers to submit to the
   18         office certain contracts or contract amendments
   19         entered into with pharmacy benefit managers;
   20         authorizing the office to order health insurers to
   21         cancel such contracts under certain circumstances;
   22         authorizing the commission to adopt rules; revising
   23         applicability; amending s. 627.6699, F.S.; requiring
   24         certain health benefit plans covering small employers
   25         to comply with certain provisions; amending s.
   26         641.314, F.S.; revising the definition of the term
   27         “maximum allowable cost”; authorizing the office to
   28         require health maintenance organizations to submit to
   29         the office certain contracts or contract amendments
   30         entered into with pharmacy benefit managers;
   31         authorizing the office to order health maintenance
   32         organizations to cancel such contracts under certain
   33         circumstances; authorizing the commission to adopt
   34         rules; revising applicability; providing an effective
   35         date.
   36          
   37  Be It Enacted by the Legislature of the State of Florida:
   38  
   39         Section 1. Subsections (1) and (3) of section 624.3161,
   40  Florida Statutes, are amended to read:
   41         624.3161 Market conduct examinations.—
   42         (1) As often as it deems necessary, the office shall
   43  examine each pharmacy benefit manager as defined in s. 624.490;
   44  each licensed rating organization;, each advisory organization;,
   45  each group, association, carrier, as defined in s. 440.02, or
   46  other organization of insurers which engages in joint
   47  underwriting or joint reinsurance;, and each authorized insurer
   48  transacting in this state any class of insurance to which the
   49  provisions of chapter 627 are applicable. The examination shall
   50  be for the purpose of ascertaining compliance by the person
   51  examined with the applicable provisions of chapters 440, 624,
   52  626, 627, and 635.
   53         (3) The examination may be conducted by an independent
   54  professional examiner under contract to the office, in which
   55  case payment shall be made directly to the contracted examiner
   56  by the insurer or person examined in accordance with the rates
   57  and terms agreed to by the office and the examiner.
   58         Section 2. Section 465.1885, Florida Statutes, is
   59  transferred, renumbered as section 624.491, Florida Statutes,
   60  and amended to read:
   61         624.491 465.1885 Pharmacy audits; rights.—
   62         (1) A health insurer or health maintenance organization
   63  providing pharmacy benefits through a major medical individual
   64  or group health insurance policy or a health maintenance
   65  organization contract, respectively, shall comply with the
   66  requirements of this section when the insurer or health
   67  maintenance organization or any person or entity acting on
   68  behalf of the insurer or health maintenance organization,
   69  including, but not limited to, a pharmacy benefit manager as
   70  defined in s. 624.490, audits the records of a pharmacy licensed
   71  under chapter 465. The person or entity conducting such audit
   72  must If an audit of the records of a pharmacy licensed under
   73  this chapter is conducted directly or indirectly by a managed
   74  care company, an insurance company, a third-party payor, a
   75  pharmacy benefit manager, or an entity that represents
   76  responsible parties such as companies or groups, referred to as
   77  an “entity” in this section, the pharmacy has the following
   78  rights:
   79         (a) Except as provided in subsection (3), notify the
   80  pharmacy To be notified at least 7 calendar days before the
   81  initial onsite audit for each audit cycle.
   82         (b) Not schedule an To have the onsite audit during
   83  scheduled after the first 3 calendar days of a month unless the
   84  pharmacist consents otherwise.
   85         (c) Limit the duration of To have the audit period limited
   86  to 24 months after the date a claim is submitted to or
   87  adjudicated by the entity.
   88         (d) In the case of To have an audit that requires clinical
   89  or professional judgment, conduct the audit in consultation
   90  with, or allow the audit to be conducted by, or in consultation
   91  with a pharmacist.
   92         (e) Allow the pharmacy to use the written and verifiable
   93  records of a hospital, physician, or other authorized
   94  practitioner, which are transmitted by any means of
   95  communication, to validate the pharmacy records in accordance
   96  with state and federal law.
   97         (f) Reimburse the pharmacy To be reimbursed for a claim
   98  that was retroactively denied for a clerical error,
   99  typographical error, scrivener’s error, or computer error if the
  100  prescription was properly and correctly dispensed, unless a
  101  pattern of such errors exists, fraudulent billing is alleged, or
  102  the error results in actual financial loss to the entity.
  103         (g) Provide the pharmacy with a copy of To receive the
  104  preliminary audit report within 120 days after the conclusion of
  105  the audit.
  106         (h) Allow the pharmacy to produce documentation to address
  107  a discrepancy or audit finding within 10 business days after the
  108  preliminary audit report is delivered to the pharmacy.
  109         (i) Provide the pharmacy with a copy of To receive the
  110  final audit report within 6 months after receipt of receiving
  111  the preliminary audit report.
  112         (j) Calculate any To have recoupment or penalties based on
  113  actual overpayments and not according to the accounting practice
  114  of extrapolation.
  115         (2) The rights contained in This section does do not apply
  116  to:
  117         (a) Audits in which suspected fraudulent activity or other
  118  intentional or willful misrepresentation is evidenced by a
  119  physical review, review of claims data or statements, or other
  120  investigative methods;
  121         (b) Audits of claims paid for by federally funded programs;
  122  or
  123         (c) Concurrent reviews or desk audits that occur within 3
  124  business days after of transmission of a claim and where no
  125  chargeback or recoupment is demanded.
  126         (3) An entity that audits a pharmacy located within a
  127  Health Care Fraud Prevention and Enforcement Action Team (HEAT)
  128  Task Force area designated by the United States Department of
  129  Health and Human Services and the United States Department of
  130  Justice may dispense with the notice requirements of paragraph
  131  (1)(a) if such pharmacy has been a member of a credentialed
  132  provider network for less than 12 months.
  133         (4)Pursuant to s. 408.7057, and after receipt of the final
  134  audit report issued by the health insurer or health maintenance
  135  organization, a pharmacy may appeal the findings of the final
  136  audit as to whether a claim payment is due and as to the amount
  137  of a claim payment.
  138         (5)A health insurer or health maintenance organization
  139  that, under terms of a contract, transfers to a pharmacy benefit
  140  manager the obligation to pay any pharmacy licensed under
  141  chapter 465 for any pharmacy benefit claims arising from
  142  services provided to or for the benefit of any insured or
  143  subscriber remains responsible for any violations of this
  144  section, s. 627.6131, or s. 641.3155, as applicable.
  145         Section 3. Section 627.64741, Florida Statutes, is amended
  146  to read:
  147         627.64741 Pharmacy benefit manager contracts.—
  148         (1) As used in this section, the term:
  149         (a) “Maximum allowable cost” means the per-unit amount that
  150  a pharmacy benefit manager reimburses a pharmacist for a
  151  prescription drug:
  152         1.As specified at the time of claim processing and
  153  directly or indirectly reported on the initial remittance advice
  154  of an adjudicated claim for a generic drug, brand name drug,
  155  biological product, or specialty drug;
  156         2.Which amount must be based on pricing published in the
  157  Medi-Span Master Drug Database or, if the pharmacy benefit
  158  manager uses only FDB MedKnowledge, on pricing published in FDB
  159  MedKnowledge; and
  160         3.,Excluding dispensing fees, prior to the application of
  161  copayments, coinsurance, and other cost-sharing charges, if any.
  162         (b) “Pharmacy benefit manager” means a person or entity
  163  doing business in this state which contracts to administer or
  164  manage prescription drug benefits on behalf of a health insurer
  165  to residents of this state.
  166         (2) A health insurer may contract only with a pharmacy
  167  benefit manager that satisfies all of the following conditions A
  168  contract between a health insurer and a pharmacy benefit manager
  169  must require that the pharmacy benefit manager:
  170         (a) Updates Update maximum allowable cost pricing
  171  information at least every 7 calendar days.
  172         (b) Maintains Maintain a process that will, in a timely
  173  manner, will eliminate drugs from maximum allowable cost lists
  174  or modify drug prices to remain consistent with changes in
  175  pricing data used in formulating maximum allowable cost prices
  176  and product availability.
  177         (c)(3)Does not limit A contract between a health insurer
  178  and a pharmacy benefit manager must prohibit the pharmacy
  179  benefit manager from limiting a pharmacist’s ability to disclose
  180  whether the cost-sharing obligation exceeds the retail price for
  181  a covered prescription drug, and the availability of a more
  182  affordable alternative drug, pursuant to s. 465.0244.
  183         (d)(4)Does not require A contract between a health insurer
  184  and a pharmacy benefit manager must prohibit the pharmacy
  185  benefit manager from requiring an insured to make a payment for
  186  a prescription drug at the point of sale in an amount that
  187  exceeds the lesser of:
  188         1.(a) The applicable cost-sharing amount; or
  189         2.(b) The retail price of the drug in the absence of
  190  prescription drug coverage.
  191         (3)The office may require a health insurer to submit to
  192  the office any contract or amendments to a contract for the
  193  administration or management of prescription drug benefits by a
  194  pharmacy benefit manager on behalf of the insurer.
  195         (4)After review of a contract submitted under subsection
  196  (3), the office may order the insurer to cancel the contract in
  197  accordance with the terms of the contract and applicable law if
  198  the office determines that any of the following conditions
  199  exists:
  200         (a)The fees to be paid by the insurer are so unreasonably
  201  high as compared with similar contracts entered into by
  202  insurers, or as compared with similar contracts entered into by
  203  other insurers in similar circumstances, that the contract is
  204  detrimental to the policyholders of the insurer.
  205         (b)The contract does not comply with this section or any
  206  other provision of the Florida Insurance Code.
  207         (c)The pharmacy benefit manager is not registered with the
  208  office as required under s. 624.490.
  209         (5)The commission may adopt rules to administer this
  210  section.
  211         (6)(5) This section applies to contracts entered into,
  212  amended, or renewed on or after July 1, 2021 2018. All contracts
  213  entered into or renewed between July 1, 2018, and June 30, 2021,
  214  are governed by the law in effect at the time the contract was
  215  entered into or renewed.
  216         Section 4. Section 627.6572, Florida Statutes, is amended
  217  to read:
  218         627.6572 Pharmacy benefit manager contracts.—
  219         (1) As used in this section, the term:
  220         (a) “Maximum allowable cost” means the per-unit amount that
  221  a pharmacy benefit manager reimburses a pharmacist for a
  222  prescription drug:
  223         1.As specified at the time of claim processing and
  224  directly or indirectly reported on the initial remittance advice
  225  of an adjudicated claim for a generic drug, brand name drug,
  226  biological product, or specialty drug;
  227         2.Which amount must be based on pricing published in the
  228  Medi-Span Master Drug Database or, if the pharmacy benefit
  229  manager uses only FDB MedKnowledge, on pricing published in FDB
  230  MedKnowledge; and
  231         3.,Excluding dispensing fees, prior to the application of
  232  copayments, coinsurance, and other cost-sharing charges, if any.
  233         (b) “Pharmacy benefit manager” means a person or entity
  234  doing business in this state which contracts to administer or
  235  manage prescription drug benefits on behalf of a health insurer
  236  to residents of this state.
  237         (2) A health insurer may contract only with a pharmacy
  238  benefit manager that satisfies all of the following conditions A
  239  contract between a health insurer and a pharmacy benefit manager
  240  must require that the pharmacy benefit manager:
  241         (a) Updates Update maximum allowable cost pricing
  242  information at least every 7 calendar days.
  243         (b) Maintains Maintain a process that will, in a timely
  244  manner, will eliminate drugs from maximum allowable cost lists
  245  or modify drug prices to remain consistent with changes in
  246  pricing data used in formulating maximum allowable cost prices
  247  and product availability.
  248         (c)(3)Does not limit A contract between a health insurer
  249  and a pharmacy benefit manager must prohibit the pharmacy
  250  benefit manager from limiting a pharmacist’s ability to disclose
  251  whether the cost-sharing obligation exceeds the retail price for
  252  a covered prescription drug, and the availability of a more
  253  affordable alternative drug, pursuant to s. 465.0244.
  254         (d)(4)Does not require A contract between a health insurer
  255  and a pharmacy benefit manager must prohibit the pharmacy
  256  benefit manager from requiring an insured to make a payment for
  257  a prescription drug at the point of sale in an amount that
  258  exceeds the lesser of:
  259         1.(a) The applicable cost-sharing amount; or
  260         2.(b) The retail price of the drug in the absence of
  261  prescription drug coverage.
  262         (3)The office may require a health insurer to submit to
  263  the office any contract or amendments to a contract for the
  264  administration or management of prescription drug benefits by a
  265  pharmacy benefit manager on behalf of the insurer.
  266         (4)After review of a contract submitted under subsection
  267  (3), the office may order the insurer to cancel the contract in
  268  accordance with the terms of the contract and applicable law if
  269  the office determines that any of the following conditions
  270  exists:
  271         (a)The fees to be paid by the insurer are so unreasonably
  272  high as compared with similar contracts entered into by
  273  insurers, or as compared with similar contracts entered into by
  274  other insurers in similar circumstances, that the contract is
  275  detrimental to the policyholders of the insurer.
  276         (b)The contract does not comply with this section or any
  277  other provision of the Florida Insurance Code.
  278         (c)The pharmacy benefit manager is not registered with the
  279  office as required under s. 624.490.
  280         (5)The commission may adopt rules to administer this
  281  section.
  282         (6)(5) This section applies to contracts entered into,
  283  amended, or renewed on or after July 1, 2021 2018. All contracts
  284  entered into or renewed between July 1, 2018, and June 30, 2021,
  285  are governed by the law in effect at the time the contract was
  286  entered into or renewed.
  287         Section 5. Paragraph (h) is added to subsection (5) of
  288  section 627.6699, Florida Statutes, to read:
  289         627.6699 Employee Health Care Access Act.—
  290         (5) AVAILABILITY OF COVERAGE.—
  291         (h) A health benefit plan covering small employers which is
  292  issued or renewed in this state on or after July 1, 2021, must
  293  comply with s. 627.6572.
  294         Section 6. Section 641.314, Florida Statutes, is amended to
  295  read:
  296         641.314 Pharmacy benefit manager contracts.—
  297         (1) As used in this section, the term:
  298         (a) “Maximum allowable cost” means the per-unit amount that
  299  a pharmacy benefit manager reimburses a pharmacist for a
  300  prescription drug:
  301         1.As specified at the time of claim processing and
  302  directly or indirectly reported on the initial remittance advice
  303  of an adjudicated claim for a generic drug, brand name drug,
  304  biological product, or specialty drug;
  305         2.Which amount must be based on pricing published in the
  306  Medi-Span Master Drug Database or, if the pharmacy benefit
  307  manager uses only FDB MedKnowledge, on pricing published in FDB
  308  MedKnowledge; and
  309         3.,Excluding dispensing fees, prior to the application of
  310  copayments, coinsurance, and other cost-sharing charges, if any.
  311         (b) “Pharmacy benefit manager” means a person or entity
  312  doing business in this state which contracts to administer or
  313  manage prescription drug benefits on behalf of a health
  314  maintenance organization to residents of this state.
  315         (2) A health maintenance organization may contract only
  316  with a pharmacy benefit manager that satisfies all of the
  317  following conditions A contract between a health maintenance
  318  organization and a pharmacy benefit manager must require that
  319  the pharmacy benefit manager:
  320         (a) Updates Update maximum allowable cost pricing
  321  information at least every 7 calendar days.
  322         (b) Maintains Maintain a process that will, in a timely
  323  manner, will eliminate drugs from maximum allowable cost lists
  324  or modify drug prices to remain consistent with changes in
  325  pricing data used in formulating maximum allowable cost prices
  326  and product availability.
  327         (c)(3)Does not limit A contract between a health
  328  maintenance organization and a pharmacy benefit manager must
  329  prohibit the pharmacy benefit manager from limiting a
  330  pharmacist’s ability to disclose whether the cost-sharing
  331  obligation exceeds the retail price for a covered prescription
  332  drug, and the availability of a more affordable alternative
  333  drug, pursuant to s. 465.0244.
  334         (d)(4)Does not require A contract between a health
  335  maintenance organization and a pharmacy benefit manager must
  336  prohibit the pharmacy benefit manager from requiring a
  337  subscriber to make a payment for a prescription drug at the
  338  point of sale in an amount that exceeds the lesser of:
  339         1.(a) The applicable cost-sharing amount; or
  340         2.(b) The retail price of the drug in the absence of
  341  prescription drug coverage.
  342         (3)The office may require a health maintenance
  343  organization to submit to the office any contract or amendments
  344  to a contract for the administration or management of
  345  prescription drug benefits by a pharmacy benefit manager on
  346  behalf of the health maintenance organization.
  347         (4)After review of a contract submitted under subsection
  348  (3), the office may order the health maintenance organization to
  349  cancel the contract in accordance with the terms of the contract
  350  and applicable law if the office determines that any of the
  351  following conditions exists:
  352         (a)The fees to be paid by the health maintenance
  353  organization are so unreasonably high as compared with similar
  354  contracts entered into by health maintenance organizations, or
  355  as compared with similar contracts entered into by other health
  356  maintenance organizations in similar circumstances, that the
  357  contract is detrimental to the subscribers of the health
  358  maintenance organization.
  359         (b)The contract does not comply with this section or any
  360  other provision of the Florida Insurance Code.
  361         (c)The pharmacy benefit manager is not registered with the
  362  office as required under s. 624.490.
  363         (5)The commission may adopt rules to administer this
  364  section.
  365         (6)(5) This section applies to pharmacy benefit manager
  366  contracts entered into, amended, or renewed on or after July 1,
  367  2021 2018. All contracts entered into or renewed between July 1,
  368  2018, and June 30, 2021, are governed by the law in effect at
  369  the time the contract was entered into or renewed.
  370         Section 7. This act shall take effect July 1, 2021.