House Bill hb0743

    Florida House of Representatives - 2001                 HB 743

        By Representative Kosmas






  1                      A bill to be entitled

  2         An act relating to Medicaid prescription drugs;

  3         amending s. 409.91195, F.S.; providing for the

  4         development of a restricted drug formulary by

  5         the Medicaid Pharmaceutical and Therapeutics

  6         Committee; revising membership of the

  7         committee; requiring the Agency for Health Care

  8         Administration to establish a restricted drug

  9         formulary upon recommendation by the committee;

10         providing for revisions to the formulary by the

11         committee and the agency; requiring the agency

12         to publish and disseminate the formulary to all

13         Medicaid providers in the state; amending s.

14         409.912, F.S.; revising the method of

15         determining reimbursement to pharmacies for

16         Medicaid-prescribed drugs under the

17         Medicaid-prescribed drug spending-control

18         program implemented by the agency; authorizing

19         the agency to establish a restricted formulary

20         and to negotiate supplemental rebates from

21         manufacturers; providing an effective date.

22

23  Be It Enacted by the Legislature of the State of Florida:

24

25         Section 1.  Section 409.91195, Florida Statutes, is

26  amended to read:

27         409.91195  Medicaid Pharmaceutical and Therapeutics

28  Committee.--There is created a Medicaid Pharmaceutical and

29  Therapeutics Committee for the purpose of developing a

30  restricted drug formulary. The committee shall develop and

31  implement a voluntary Medicaid preferred prescribed drug

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  1  designation program. The program shall provide information to

  2  Medicaid providers on medically appropriate and cost-efficient

  3  prescription drug therapies through the development and

  4  publication of a restricted drug formulary voluntary Medicaid

  5  preferred prescribed-drug list.

  6         (1)  The Medicaid Pharmaceutical and Therapeutics

  7  Committee shall be comprised of nine members as specified in

  8  42 U.S.C. s. 1396. appointed as follows:  one practicing

  9  physician licensed under chapter 458, appointed by the Speaker

10  of the House of Representatives from a list of recommendations

11  from the Florida Medical Association; one practicing physician

12  licensed under chapter 459, appointed by the Speaker of the

13  House of Representatives from a list of recommendations from

14  the Florida Osteopathic Medical Association; one practicing

15  physician licensed under chapter 458, appointed by the

16  President of the Senate from a list of recommendations from

17  the Florida Academy of Family Physicians; one practicing

18  podiatric physician licensed under chapter 461, appointed by

19  the President of the Senate from a list of recommendations

20  from the Florida Podiatric Medical Association; one trauma

21  surgeon licensed under chapter 458, appointed by the Speaker

22  of the House of Representatives from a list of recommendations

23  from the American College of Surgeons; one practicing dentist

24  licensed under chapter 466, appointed by the President of the

25  Senate from a list of recommendations from the Florida Dental

26  Association; one practicing pharmacist licensed under chapter

27  465, appointed by the Governor from a list of recommendations

28  from the Florida Pharmacy Association; one practicing

29  pharmacist licensed under chapter 465, appointed by the

30  Governor from a list of recommendations from the Florida

31  Society of Health System Pharmacists; and one health care

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  1  professional with expertise in clinical pharmacology appointed

  2  by the Governor from a list of recommendations from the

  3  Pharmaceutical Research and Manufacturers Association. The

  4  members shall be appointed to serve for terms of 2 years from

  5  the date of their appointment. Members may be appointed to

  6  more than one term. The Agency for Health Care Administration

  7  shall serve as staff for the committee and assist them with

  8  all ministerial duties.

  9         (2)  Upon recommendation by the committee, the Agency

10  for Health Care Administration shall establish a restricted

11  drug formulary the voluntary Medicaid preferred

12  prescribed-drug list. Upon further recommendation by the

13  committee, the agency shall add to, delete from, or modify the

14  list. The committee shall also review requests for additions

15  to, deletions from, or modifications of the formulary as

16  presented to it by the agency, and upon further recommendation

17  by the committee, the agency shall add to, delete from, or

18  modify the list as appropriate list. The list shall be adopted

19  by the committee in consultation with medical specialists,

20  when appropriate, using the following criteria:  use of the

21  list shall be voluntary by providers and the list must provide

22  for medically appropriate drug therapies for Medicaid patients

23  which achieve cost savings in the Medicaid program.

24         (3)  The Agency for Health Care Administration shall

25  publish and disseminate the Medicaid restricted drug formulary

26  voluntary Medicaid preferred prescribed drug list to all

27  Medicaid providers in the state.

28         Section 2.  Paragraph (a) of subsection (37) of section

29  409.912, Florida Statutes, is amended to read:

30         409.912  Cost-effective purchasing of health care.--The

31  agency shall purchase goods and services for Medicaid

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  1  recipients in the most cost-effective manner consistent with

  2  the delivery of quality medical care.  The agency shall

  3  maximize the use of prepaid per capita and prepaid aggregate

  4  fixed-sum basis services when appropriate and other

  5  alternative service delivery and reimbursement methodologies,

  6  including competitive bidding pursuant to s. 287.057, designed

  7  to facilitate the cost-effective purchase of a case-managed

  8  continuum of care. The agency shall also require providers to

  9  minimize the exposure of recipients to the need for acute

10  inpatient, custodial, and other institutional care and the

11  inappropriate or unnecessary use of high-cost services.

12         (37)(a)  The agency shall implement a Medicaid

13  prescribed-drug spending-control program that includes the

14  following components:

15         1.  Medicaid prescribed-drug coverage for brand-name

16  drugs for adult Medicaid recipients not residing in nursing

17  homes or other institutions is limited to the dispensing of

18  four brand-name drugs per month per recipient. Children and

19  institutionalized adults are exempt from this restriction.

20  Antiretroviral agents are excluded from this limitation. No

21  requirements for prior authorization or other restrictions on

22  medications used to treat mental illnesses such as

23  schizophrenia, severe depression, or bipolar disorder may be

24  imposed on Medicaid recipients. Medications that will be

25  available without restriction for persons with mental

26  illnesses include atypical antipsychotic medications,

27  conventional antipsychotic medications, selective serotonin

28  reuptake inhibitors, and other medications used for the

29  treatment of serious mental illnesses. The agency shall also

30  limit the amount of a prescribed drug dispensed to no more

31  than a 34-day supply. The agency shall continue to provide

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  1  unlimited generic drugs, contraceptive drugs and items, and

  2  diabetic supplies. The agency may authorize exceptions to the

  3  brand-name-drug restriction, based upon the treatment needs of

  4  the patients, only when such exceptions are based on prior

  5  consultation provided by the agency or an agency contractor,

  6  but the agency must establish procedures to ensure that:

  7         a.  There will be a response to a request for prior

  8  consultation by telephone or other telecommunication device

  9  within 24 hours after receipt of a request for prior

10  consultation; and

11         b.  A 72-hour supply of the drug prescribed will be

12  provided in an emergency or when the agency does not provide a

13  response within 24 hours as required by sub-subparagraph a.

14         2.  Reimbursement to pharmacies for Medicaid prescribed

15  drugs shall be set at the lower of the average wholesale price

16  less 13.25 percent, wholesaler acquisition costs plus 7

17  percent, federal or state pricing limits, or the provider's

18  usual and customary charge.

19         3.  The agency shall develop and implement a process

20  for managing the drug therapies of Medicaid recipients who are

21  using significant numbers of prescribed drugs each month. The

22  management process may include, but is not limited to,

23  comprehensive, physician-directed medical-record reviews,

24  claims analyses, and case evaluations to determine the medical

25  necessity and appropriateness of a patient's treatment plan

26  and drug therapies. The agency may contract with a private

27  organization to provide drug-program-management services.

28         4.  The agency may limit the size of its pharmacy

29  network based on need, competitive bidding, price

30  negotiations, credentialing, or similar criteria. The agency

31  shall give special consideration to rural areas in determining

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  1  the size and location of pharmacies included in the Medicaid

  2  pharmacy network. A pharmacy credentialing process may include

  3  criteria such as a pharmacy's full-service status, location,

  4  size, patient educational programs, patient consultation,

  5  disease-management services, and other characteristics. The

  6  agency may impose a moratorium on Medicaid pharmacy enrollment

  7  when it is determined that it has a sufficient number of

  8  Medicaid-participating providers.

  9         5.  The agency shall develop and implement a program

10  that requires Medicaid practitioners who prescribe drugs to

11  use a counterfeit-proof prescription pad for Medicaid

12  prescriptions. The agency shall require the use of

13  standardized counterfeit-proof prescription pads by

14  Medicaid-participating prescribers. The agency may implement

15  the program in targeted geographic areas or statewide.

16         6.  The agency may enter into arrangements that require

17  manufacturers of generic drugs prescribed to Medicaid

18  recipients to provide rebates of at least 15.1 percent of the

19  average manufacturer price for the manufacturer's generic

20  products. These arrangements shall require that if a

21  generic-drug manufacturer pays federal rebates for

22  Medicaid-reimbursed drugs at a level below 15.1 percent, the

23  manufacturer must provide a supplemental rebate to the state

24  in an amount necessary to achieve a 15.1-percent rebate level.

25  If a generic-drug manufacturer raises its price in excess of

26  the Consumer Price Index (Urban), the excess amount shall be

27  included in the supplemental rebate to the state.

28         7.  The agency may establish a restricted formulary in

29  accordance with 42 U.S.C. s. 1396r, and pursuant to the

30  establishment of such formulary, is authorized to negotiate

31  supplemental rebates from manufacturers at no less than 10

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  1  percent of the average wholesale price on the last day of each

  2  quarter. State supplemental manufacturer rebates will be

  3  invoiced concurrently with federal rebates.

  4         Section 3.  This act shall take effect July 1, 2001.

  5

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  7                          HOUSE SUMMARY

  8
      With respect to the regulation of prescription drugs
  9    under the Medicaid program, provides for the development
      of a restricted drug formulary by the Medicaid
10    Pharmaceutical and Therapeutics Committee. Replaces the
      voluntary Medicaid preferred prescribed drug designation
11    program with the restricted drug formulary. Revises
      membership of the committee. Requires the Agency for
12    Health Care Administration to establish a restricted drug
      formulary upon recommendation by the committee. Provides
13    for revisions to the formulary by the committee and the
      agency. Requires the agency to publish and disseminate
14    the formulary to all Medicaid providers in the state.

15
      Revises the method of determining reimbursement to
16    pharmacies for Medicaid-prescribed drugs under the
      Medicaid-prescribed drug spending-control program
17    implemented by the agency. Authorizes the agency to
      establish a restricted formulary and to negotiate
18    supplemental rebates from manufacturers.

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