Florida Senate - 2012                          SENATOR AMENDMENT
       Bill No. CS for CS for HB 787
       
       
       
       
       
       
                                Barcode 482012                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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               Floor: 1c/AD/2R         .            Floor: C            
             03/09/2012 10:51 PM       .      03/10/2012 12:03 AM       
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       Senator Hays moved the following:
       
    1         Senate Amendment to Amendment (109490) (with title
    2  amendment)
    3  
    4         Between lines 1141 and 1142
    5  insert:
    6         Section 34. Subsection (37) of section 409.912, Florida
    7  Statutes, is amended to read:
    8         409.912 Cost-effective purchasing of health care.—The
    9  agency shall purchase goods and services for Medicaid recipients
   10  in the most cost-effective manner consistent with the delivery
   11  of quality medical care. To ensure that medical services are
   12  effectively utilized, the agency may, in any case, require a
   13  confirmation or second physician’s opinion of the correct
   14  diagnosis for purposes of authorizing future services under the
   15  Medicaid program. This section does not restrict access to
   16  emergency services or poststabilization care services as defined
   17  in 42 C.F.R. part 438.114. Such confirmation or second opinion
   18  shall be rendered in a manner approved by the agency. The agency
   19  shall maximize the use of prepaid per capita and prepaid
   20  aggregate fixed-sum basis services when appropriate and other
   21  alternative service delivery and reimbursement methodologies,
   22  including competitive bidding pursuant to s. 287.057, designed
   23  to facilitate the cost-effective purchase of a case-managed
   24  continuum of care. The agency shall also require providers to
   25  minimize the exposure of recipients to the need for acute
   26  inpatient, custodial, and other institutional care and the
   27  inappropriate or unnecessary use of high-cost services. The
   28  agency shall contract with a vendor to monitor and evaluate the
   29  clinical practice patterns of providers in order to identify
   30  trends that are outside the normal practice patterns of a
   31  provider’s professional peers or the national guidelines of a
   32  provider’s professional association. The vendor must be able to
   33  provide information and counseling to a provider whose practice
   34  patterns are outside the norms, in consultation with the agency,
   35  to improve patient care and reduce inappropriate utilization.
   36  The agency may mandate prior authorization, drug therapy
   37  management, or disease management participation for certain
   38  populations of Medicaid beneficiaries, certain drug classes, or
   39  particular drugs to prevent fraud, abuse, overuse, and possible
   40  dangerous drug interactions. The Pharmaceutical and Therapeutics
   41  Committee shall make recommendations to the agency on drugs for
   42  which prior authorization is required. The agency shall inform
   43  the Pharmaceutical and Therapeutics Committee of its decisions
   44  regarding drugs subject to prior authorization. The agency is
   45  authorized to limit the entities it contracts with or enrolls as
   46  Medicaid providers by developing a provider network through
   47  provider credentialing. The agency may competitively bid single
   48  source-provider contracts if procurement of goods or services
   49  results in demonstrated cost savings to the state without
   50  limiting access to care. The agency may limit its network based
   51  on the assessment of beneficiary access to care, provider
   52  availability, provider quality standards, time and distance
   53  standards for access to care, the cultural competence of the
   54  provider network, demographic characteristics of Medicaid
   55  beneficiaries, practice and provider-to-beneficiary standards,
   56  appointment wait times, beneficiary use of services, provider
   57  turnover, provider profiling, provider licensure history,
   58  previous program integrity investigations and findings, peer
   59  review, provider Medicaid policy and billing compliance records,
   60  clinical and medical record audits, and other factors. Providers
   61  are not entitled to enrollment in the Medicaid provider network.
   62  The agency shall determine instances in which allowing Medicaid
   63  beneficiaries to purchase durable medical equipment and other
   64  goods is less expensive to the Medicaid program than long-term
   65  rental of the equipment or goods. The agency may establish rules
   66  to facilitate purchases in lieu of long-term rentals in order to
   67  protect against fraud and abuse in the Medicaid program as
   68  defined in s. 409.913. The agency may seek federal waivers
   69  necessary to administer these policies.
   70         (37)(a) The agency shall implement a Medicaid prescribed
   71  drug spending-control program that includes the following
   72  components:
   73         1. A Medicaid preferred drug list, which shall be a listing
   74  of cost-effective therapeutic options recommended by the
   75  Medicaid Pharmacy and Therapeutics Committee established
   76  pursuant to s. 409.91195 and adopted by the agency for each
   77  therapeutic class on the preferred drug list. At the discretion
   78  of the committee, and when feasible, the preferred drug list
   79  should include at least two products in a therapeutic class. The
   80  agency may post the preferred drug list and updates to the list
   81  on an Internet website without following the rulemaking
   82  procedures of chapter 120. Antiretroviral agents are excluded
   83  from the preferred drug list. The agency shall also limit the
   84  amount of a prescribed drug dispensed to no more than a 34-day
   85  supply unless the drug products’ smallest marketed package is
   86  greater than a 34-day supply, or the drug is determined by the
   87  agency to be a maintenance drug in which case a 100-day maximum
   88  supply may be authorized. The agency may seek any federal
   89  waivers necessary to implement these cost-control programs and
   90  to continue participation in the federal Medicaid rebate
   91  program, or alternatively to negotiate state-only manufacturer
   92  rebates. The agency may adopt rules to administer this
   93  subparagraph. The agency shall continue to provide unlimited
   94  contraceptive drugs and items. The agency must establish
   95  procedures to ensure that:
   96         a. There is a response to a request for prior consultation
   97  by telephone or other telecommunication device within 24 hours
   98  after receipt of a request for prior consultation; and
   99         b. A 72-hour supply of the drug prescribed is provided in
  100  an emergency or when the agency does not provide a response
  101  within 24 hours as required by sub-subparagraph a.
  102         2. Reimbursement to pharmacies for Medicaid prescribed
  103  drugs shall be set at the lowest of: the average wholesale price
  104  (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
  105  plus 1.5 percent, the federal upper limit (FUL), the state
  106  maximum allowable cost (SMAC), or the usual and customary (UAC)
  107  charge billed by the provider.
  108         3. The agency shall develop and implement a process for
  109  managing the drug therapies of Medicaid recipients who are using
  110  significant numbers of prescribed drugs each month. The
  111  management process may include, but is not limited to,
  112  comprehensive, physician-directed medical-record reviews, claims
  113  analyses, and case evaluations to determine the medical
  114  necessity and appropriateness of a patient’s treatment plan and
  115  drug therapies. The agency may contract with a private
  116  organization to provide drug-program-management services. The
  117  Medicaid drug benefit management program shall include
  118  initiatives to manage drug therapies for HIV/AIDS patients,
  119  patients using 20 or more unique prescriptions in a 180-day
  120  period, and the top 1,000 patients in annual spending. The
  121  agency shall enroll any Medicaid recipient in the drug benefit
  122  management program if he or she meets the specifications of this
  123  provision and is not enrolled in a Medicaid health maintenance
  124  organization.
  125         4. The agency may limit the size of its pharmacy network
  126  based on need, competitive bidding, price negotiations,
  127  credentialing, or similar criteria. The agency shall give
  128  special consideration to rural areas in determining the size and
  129  location of pharmacies included in the Medicaid pharmacy
  130  network. A pharmacy credentialing process may include criteria
  131  such as a pharmacy’s full-service status, location, size,
  132  patient educational programs, patient consultation, disease
  133  management services, and other characteristics. The agency may
  134  impose a moratorium on Medicaid pharmacy enrollment if it is
  135  determined that it has a sufficient number of Medicaid
  136  participating providers. The agency must allow dispensing
  137  practitioners to participate as a part of the Medicaid pharmacy
  138  network regardless of the practitioner’s proximity to any other
  139  entity that is dispensing prescription drugs under the Medicaid
  140  program. A dispensing practitioner must meet all credentialing
  141  requirements applicable to his or her practice, as determined by
  142  the agency.
  143         5. The agency shall develop and implement a program that
  144  requires Medicaid practitioners who prescribe drugs to use a
  145  counterfeit-proof prescription pad for Medicaid prescriptions.
  146  The agency shall require the use of standardized counterfeit
  147  proof prescription pads by Medicaid-participating prescribers or
  148  prescribers who write prescriptions for Medicaid recipients. The
  149  agency may implement the program in targeted geographic areas or
  150  statewide.
  151         6. The agency may enter into arrangements that require
  152  manufacturers of generic drugs prescribed to Medicaid recipients
  153  to provide rebates of at least 15.1 percent of the average
  154  manufacturer price for the manufacturer’s generic products.
  155  These arrangements shall require that if a generic-drug
  156  manufacturer pays federal rebates for Medicaid-reimbursed drugs
  157  at a level below 15.1 percent, the manufacturer must provide a
  158  supplemental rebate to the state in an amount necessary to
  159  achieve a 15.1-percent rebate level.
  160         7. The agency may establish a preferred drug list as
  161  described in this subsection, and, pursuant to the establishment
  162  of such preferred drug list, negotiate supplemental rebates from
  163  manufacturers that are in addition to those required by Title
  164  XIX of the Social Security Act and at no less than 14 percent of
  165  the average manufacturer price as defined in 42 U.S.C. s. 1936
  166  on the last day of a quarter unless the federal or supplemental
  167  rebate, or both, equals or exceeds 29 percent. There is no upper
  168  limit on the supplemental rebates the agency may negotiate. The
  169  agency may determine that specific products, brand-name or
  170  generic, are competitive at lower rebate percentages. Agreement
  171  to pay the minimum supplemental rebate percentage guarantees a
  172  manufacturer that the Medicaid Pharmaceutical and Therapeutics
  173  Committee will consider a product for inclusion on the preferred
  174  drug list. However, a pharmaceutical manufacturer is not
  175  guaranteed placement on the preferred drug list by simply paying
  176  the minimum supplemental rebate. Agency decisions will be made
  177  on the clinical efficacy of a drug and recommendations of the
  178  Medicaid Pharmaceutical and Therapeutics Committee, as well as
  179  the price of competing products minus federal and state rebates.
  180  The agency may contract with an outside agency or contractor to
  181  conduct negotiations for supplemental rebates. For the purposes
  182  of this section, the term “supplemental rebates” means cash
  183  rebates. Value-added programs as a substitution for supplemental
  184  rebates are prohibited. The agency may seek any federal waivers
  185  to implement this initiative.
  186         8. The agency shall expand home delivery of pharmacy
  187  products. The agency may amend the state plan and issue a
  188  procurement, as necessary, in order to implement this program.
  189  The procurements must include agreements with a pharmacy or
  190  pharmacies located in the state to provide mail order delivery
  191  services at no cost to the recipients who elect to receive home
  192  delivery of pharmacy products. The procurement must focus on
  193  serving recipients with chronic diseases for which pharmacy
  194  expenditures represent a significant portion of Medicaid
  195  pharmacy expenditures or which impact a significant portion of
  196  the Medicaid population. The agency may seek and implement any
  197  federal waivers necessary to implement this subparagraph.
  198         9. The agency shall limit to one dose per month any drug
  199  prescribed to treat erectile dysfunction.
  200         10.a. The agency may implement a Medicaid behavioral drug
  201  management system. The agency may contract with a vendor that
  202  has experience in operating behavioral drug management systems
  203  to implement this program. The agency may seek federal waivers
  204  to implement this program.
  205         b. The agency, in conjunction with the Department of
  206  Children and Family Services, may implement the Medicaid
  207  behavioral drug management system that is designed to improve
  208  the quality of care and behavioral health prescribing practices
  209  based on best practice guidelines, improve patient adherence to
  210  medication plans, reduce clinical risk, and lower prescribed
  211  drug costs and the rate of inappropriate spending on Medicaid
  212  behavioral drugs. The program may include the following
  213  elements:
  214         (I) Provide for the development and adoption of best
  215  practice guidelines for behavioral health-related drugs such as
  216  antipsychotics, antidepressants, and medications for treating
  217  bipolar disorders and other behavioral conditions; translate
  218  them into practice; review behavioral health prescribers and
  219  compare their prescribing patterns to a number of indicators
  220  that are based on national standards; and determine deviations
  221  from best practice guidelines.
  222         (II) Implement processes for providing feedback to and
  223  educating prescribers using best practice educational materials
  224  and peer-to-peer consultation.
  225         (III) Assess Medicaid beneficiaries who are outliers in
  226  their use of behavioral health drugs with regard to the numbers
  227  and types of drugs taken, drug dosages, combination drug
  228  therapies, and other indicators of improper use of behavioral
  229  health drugs.
  230         (IV) Alert prescribers to patients who fail to refill
  231  prescriptions in a timely fashion, are prescribed multiple same
  232  class behavioral health drugs, and may have other potential
  233  medication problems.
  234         (V) Track spending trends for behavioral health drugs and
  235  deviation from best practice guidelines.
  236         (VI) Use educational and technological approaches to
  237  promote best practices, educate consumers, and train prescribers
  238  in the use of practice guidelines.
  239         (VII) Disseminate electronic and published materials.
  240         (VIII) Hold statewide and regional conferences.
  241         (IX) Implement a disease management program with a model
  242  quality-based medication component for severely mentally ill
  243  individuals and emotionally disturbed children who are high
  244  users of care.
  245         11. The agency shall implement a Medicaid prescription drug
  246  management system.
  247         a. The agency may contract with a vendor that has
  248  experience in operating prescription drug management systems in
  249  order to implement this system. Any management system that is
  250  implemented in accordance with this subparagraph must rely on
  251  cooperation between physicians and pharmacists to determine
  252  appropriate practice patterns and clinical guidelines to improve
  253  the prescribing, dispensing, and use of drugs in the Medicaid
  254  program. The agency may seek federal waivers to implement this
  255  program.
  256         b. The drug management system must be designed to improve
  257  the quality of care and prescribing practices based on best
  258  practice guidelines, improve patient adherence to medication
  259  plans, reduce clinical risk, and lower prescribed drug costs and
  260  the rate of inappropriate spending on Medicaid prescription
  261  drugs. The program must:
  262         (I) Provide for the adoption of best practice guidelines
  263  for the prescribing and use of drugs in the Medicaid program,
  264  including translating best practice guidelines into practice;
  265  reviewing prescriber patterns and comparing them to indicators
  266  that are based on national standards and practice patterns of
  267  clinical peers in their community, statewide, and nationally;
  268  and determine deviations from best practice guidelines.
  269         (II) Implement processes for providing feedback to and
  270  educating prescribers using best practice educational materials
  271  and peer-to-peer consultation.
  272         (III) Assess Medicaid recipients who are outliers in their
  273  use of a single or multiple prescription drugs with regard to
  274  the numbers and types of drugs taken, drug dosages, combination
  275  drug therapies, and other indicators of improper use of
  276  prescription drugs.
  277         (IV) Alert prescribers to recipients who fail to refill
  278  prescriptions in a timely fashion, are prescribed multiple drugs
  279  that may be redundant or contraindicated, or may have other
  280  potential medication problems.
  281         12. The agency may contract for drug rebate administration,
  282  including, but not limited to, calculating rebate amounts,
  283  invoicing manufacturers, negotiating disputes with
  284  manufacturers, and maintaining a database of rebate collections.
  285         13. The agency may specify the preferred daily dosing form
  286  or strength for the purpose of promoting best practices with
  287  regard to the prescribing of certain drugs as specified in the
  288  General Appropriations Act and ensuring cost-effective
  289  prescribing practices.
  290         14. The agency may require prior authorization for
  291  Medicaid-covered prescribed drugs. The agency may prior
  292  authorize the use of a product:
  293         a. For an indication not approved in labeling;
  294         b. To comply with certain clinical guidelines; or
  295         c. If the product has the potential for overuse, misuse, or
  296  abuse.
  297  
  298  The agency may require the prescribing professional to provide
  299  information about the rationale and supporting medical evidence
  300  for the use of a drug. The agency shall may post prior
  301  authorization, step-edit criteria and protocol, and updates to
  302  the list of drugs that are subject to prior authorization on the
  303  agency’s an Internet website within 21 days after the prior
  304  authorization and step-edit criteria and protocol and updates
  305  are approved by the agency. For purposes of this subparagraph,
  306  the term “step-edit” means an automatic electronic review of
  307  certain medications subject to prior authorization without
  308  amending its rule or engaging in additional rulemaking.
  309         15. The agency, in conjunction with the Pharmaceutical and
  310  Therapeutics Committee, may require age-related prior
  311  authorizations for certain prescribed drugs. The agency may
  312  preauthorize the use of a drug for a recipient who may not meet
  313  the age requirement or may exceed the length of therapy for use
  314  of this product as recommended by the manufacturer and approved
  315  by the Food and Drug Administration. Prior authorization may
  316  require the prescribing professional to provide information
  317  about the rationale and supporting medical evidence for the use
  318  of a drug.
  319         16. The agency shall implement a step-therapy prior
  320  authorization approval process for medications excluded from the
  321  preferred drug list. Medications listed on the preferred drug
  322  list must be used within the previous 12 months before the
  323  alternative medications that are not listed. The step-therapy
  324  prior authorization may require the prescriber to use the
  325  medications of a similar drug class or for a similar medical
  326  indication unless contraindicated in the Food and Drug
  327  Administration labeling. The trial period between the specified
  328  steps may vary according to the medical indication. The step
  329  therapy approval process shall be developed in accordance with
  330  the committee as stated in s. 409.91195(7) and (8). A drug
  331  product may be approved without meeting the step-therapy prior
  332  authorization criteria if the prescribing physician provides the
  333  agency with additional written medical or clinical documentation
  334  that the product is medically necessary because:
  335         a. There is not a drug on the preferred drug list to treat
  336  the disease or medical condition which is an acceptable clinical
  337  alternative;
  338         b. The alternatives have been ineffective in the treatment
  339  of the beneficiary’s disease; or
  340         c. Based on historic evidence and known characteristics of
  341  the patient and the drug, the drug is likely to be ineffective,
  342  or the number of doses have been ineffective.
  343  
  344  The agency shall work with the physician to determine the best
  345  alternative for the patient. The agency may adopt rules waiving
  346  the requirements for written clinical documentation for specific
  347  drugs in limited clinical situations.
  348         17. The agency shall implement a return and reuse program
  349  for drugs dispensed by pharmacies to institutional recipients,
  350  which includes payment of a $5 restocking fee for the
  351  implementation and operation of the program. The return and
  352  reuse program shall be implemented electronically and in a
  353  manner that promotes efficiency. The program must permit a
  354  pharmacy to exclude drugs from the program if it is not
  355  practical or cost-effective for the drug to be included and must
  356  provide for the return to inventory of drugs that cannot be
  357  credited or returned in a cost-effective manner. The agency
  358  shall determine if the program has reduced the amount of
  359  Medicaid prescription drugs which are destroyed on an annual
  360  basis and if there are additional ways to ensure more
  361  prescription drugs are not destroyed which could safely be
  362  reused.
  363         (b) The agency shall implement this subsection to the
  364  extent that funds are appropriated to administer the Medicaid
  365  prescribed-drug spending-control program. The agency may
  366  contract all or any part of this program to private
  367  organizations.
  368         (c) The agency shall submit quarterly reports to the
  369  Governor, the President of the Senate, and the Speaker of the
  370  House of Representatives which must include, but need not be
  371  limited to, the progress made in implementing this subsection
  372  and its effect on Medicaid prescribed-drug expenditures.
  373  
  374  ================= T I T L E  A M E N D M E N T ================
  375         And the title is amended as follows:
  376         Delete line 1323
  377  and insert:
  378         provisions to changes made by the act; amending s.
  379         409.912, F.S.; revising provisions requiring the
  380         agency to post certain information relating to drugs
  381         subject to prior authorization on its Internet
  382         website; providing a definition of the term “step
  383         edit”; providing an