CODING: Words stricken are deletions; words underlined are additions.



                                                   HOUSE AMENDMENT

                                                   Bill No. HB 413

    Amendment No. ___ (for drafter's use only)

                            CHAMBER ACTION
              Senate                               House
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  4  ______________________________________________________________

  5                                           ORIGINAL STAMP BELOW

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10  ______________________________________________________________

11  Representative(s) Gelber offered the following:

12

13         Amendment (with title amendment) 

14         On page 3, lines 6 through 7,

15

16  insert:

17         Section 3.  Section 409.960, Florida Statutes, is

18  created to read:

19         409.960  Short title.--Sections 409.960-409.984 may be

20  cited as the "Florida Prescription Drug Fair Pricing Act."

21         Section 4.  Section 409.962, Florida Statutes, is

22  created to read:

23         409.962  Florida Prescription Drug Fair Pricing Program

24  established; findings; purpose.--

25         (1)  It is the finding of the Legislature that

26  approximately one in four residents of Florida have no

27  prescription drug insurance coverage or wholly inadequate

28  prescription drug insurance coverage. These uninsured

29  residents pay excessive prices for prescription drugs, far

30  higher prices than are paid by managed care organizations,

31  insurance companies, and the Federal Government for the same

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                                                   HOUSE AMENDMENT

                                                   Bill No. HB 413

    Amendment No. ___ (for drafter's use only)





  1  medicines and dosages. In many cases, these excessive drug

  2  prices have the effect of denying residents access to

  3  medically necessary care, thereby threatening their health and

  4  safety. Many Florida residents require repeated doctor or

  5  medical clinic appointments, having become sicker because they

  6  could not afford to purchase the prescription drugs prescribed

  7  for them. Many residents are admitted to or treated at

  8  hospitals each year because they cannot afford the

  9  prescription drugs that could have prevented the need for

10  hospitalization. Many others enter expensive institutional

11  care settings because they cannot afford the necessary

12  prescription drugs that could have supported them outside of

13  an institution. In each of these circumstances, state medical

14  assistance programs, including the Medicaid program, literally

15  pay the price. One major reason uninsured residents pay such

16  high prices for prescription drugs is that, unlike insured

17  residents, they have no prescription benefits manager

18  negotiating a fair price with drug companies on their behalf.

19  State government currently provides prescription drugs and

20  acts as a prescription benefit manager through a variety of

21  health plans and assistance programs and, in 2001, the

22  Legislature expanded the state's role in negotiating better

23  prescription drug prices for Medicaid. State government is the

24  only agent that, as a practical matter, can play an effective

25  role as a market participant on behalf of all residents who

26  are uninsured or underinsured. The state can and should act as

27  a prescription benefit manager, negotiating drug rebates and

28  using these funds to reimburse retail pharmacies for offering

29  lower drug prices.

30         (2)  Recognizing that the state already acts as a

31  prescription benefit manager for a variety of health plans and

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                                                   HOUSE AMENDMENT

                                                   Bill No. HB 413

    Amendment No. ___ (for drafter's use only)





  1  assistance programs, including the Medicaid program, the

  2  Florida Prescription Drug Fair Pricing Program is established

  3  within the Agency for Health Care Administration. The purpose

  4  of the program is to expand Medicaid eligibility for

  5  prescription drug benefits only, at a level that does not

  6  exceed available funding, thereby providing prescription drug

  7  coverage to new populations by expanding the state's role as a

  8  participant in the prescription drug marketplace, negotiating

  9  rebates from drug companies, and using the funds from such

10  rebates to make prescription drugs more affordable to Florida

11  residents. Each program participant shall receive a discount

12  toward the purchase of any prescription drug included on the

13  state Medicaid preferred drug formulary established pursuant

14  to s. 409.912. No discount shall be applied toward the

15  purchase of any prescription drug that is not included on such

16  formulary. The Legislature finds that such a program will

17  improve public health and welfare, promote the economic

18  strength of our society, and substantially benefit state

19  health assistance programs, including the Medicaid program.

20         Section 5.  Section 409.964, Florida Statutes, is

21  created to read:

22         409.964  Definitions.--As used in this act, unless the

23  context otherwise indicates, the following terms have the

24  following meanings:

25         (1)  "Agency" means the Agency for Health Care

26  Administration.

27         (2)  "Labeler" means an entity or person that receives

28  prescription drugs from a manufacturer or wholesaler and

29  repackages those drugs for later retail sale and that has a

30  labeler code from the federal Food and Drug Administration

31  under 21 C.F.R. s. 207.20 (1999).

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                                                   HOUSE AMENDMENT

                                                   Bill No. HB 413

    Amendment No. ___ (for drafter's use only)





  1         (3)  "Manufacturer" means a manufacturer of

  2  prescription drugs and includes a subsidiary or affiliate of a

  3  manufacturer.

  4         (4)  "Participating retail pharmacy" means a retail

  5  pharmacy or other business licensed to dispense prescription

  6  drugs in this state that:

  7         (a)  Participates in the state Medicaid program; or

  8         (b)  Agrees to participate in the Florida Prescription

  9  Drug Fair Pricing Program.

10         (5)  "Program" means the Florida Prescription Drug Fair

11  Pricing Program.

12         (6)  "Secretary" means the Secretary of Health Care

13  Administration, or the secretary's designee.

14         (7)  "Qualified resident" means an uninsured resident

15  of the state who has obtained from the agency a Florida

16  Prescription Drug Fair Pricing Program enrollment card.

17         Section 6.  Section 409.966, Florida Statutes, is

18  created to read:

19         409.966  Prescription drug discounts; negotiation of

20  discounts or rebates; calculation of discounts.--The Secretary

21  of Health Care Administration shall operate the Florida

22  Prescription Drug Fair Pricing Program as a state

23  pharmaceutical assistance program under 42 U.S.C. s.

24  1396r-8(c)(1)(C)(i)(III) to provide discounts to participants

25  for prescription drugs covered by a rebate agreement.

26         (1)  The secretary shall negotiate discount prices or

27  rebates for prescription drugs from drug manufacturers and

28  labelers for the program. Using sums from negotiated rebates,

29  the agency shall contract with participating retail pharmacies

30  to deliver discounted prices to program participants.

31         (2)  In negotiating discount or rebate terms, the

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                                                   HOUSE AMENDMENT

                                                   Bill No. HB 413

    Amendment No. ___ (for drafter's use only)





  1  secretary shall take into consideration:

  2         (a)  The rebate calculated under the Medicaid rebate

  3  program pursuant to 42 U.S.C. s. 1396r-8;

  4         (b)  The price provided to eligible entities under 42

  5  U.S.C. s. 256b; and

  6         (c)  Any other available information on prescription

  7  drug prices, discounts, and rebates.

  8         (3)  The secretary may consider any supplemental rebate

  9  negotiated pursuant to s. 409.912(37)(a)7.

10         (4)  The drug discounts received by program

11  participants shall be calculated by the secretary on a

12  quarterly basis.

13         Section 7.  Section 409.968, Florida Statutes, is

14  created to read:

15         409.968  Discounted prices for program participants.--

16         (1)  Each participant enrolled in the Florida

17  Prescription Drug Fair Pricing Program shall pay a coinsurance

18  amount equal to the Medicaid allowable charge minus the amount

19  paid by the agency.

20         (2)  A participating retail pharmacy shall charge the

21  Medicaid allowable rate for prescription drugs sold to

22  participants in the Florida Prescription Drug Fair Pricing

23  Program.

24         (3)  The participating retail pharmacy shall be

25  reimbursed by the agency at the agency's manufacturer

26  estimated rebate amount.

27         (4)  The Florida Prescription Drug Fair Pricing Program

28  as established in s. 409.962 is not an entitlement.  However,

29  the agency shall provide a subsidy in the amount of $1 toward

30  the purchase of prescription drugs under this program.

31         Section 8.  Section 409.970, Florida Statutes, is

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                                                   HOUSE AMENDMENT

                                                   Bill No. HB 413

    Amendment No. ___ (for drafter's use only)





  1  created to read:

  2         409.970  Program eligibility.--

  3         (1)  An individual is eligible to participate in the

  4  Florida Prescription Drug Fair Pricing Program if he or she:

  5         (a)  Is a resident of the state;

  6         (b)  Has no health insurance coverage, or has health

  7  insurance coverage, including Medicare, that does not include

  8  coverage for prescription drugs;

  9         (c)  Has a net family income at or below 200 percent of

10  the federal poverty level; and

11         (d)  Requests to be enrolled in the program.

12         (2)  An individual is ineligible to participate in the

13  Florida Prescription Drug Fair Pricing Program if he or she is

14  eligible for assistance under the state's Medicaid program or

15  is covered by an insurance policy that provides benefits for

16  prescription drugs equal to or greater than the benefits

17  provided under the Florida Prescription Drug Fair Pricing

18  Program, as delineated by rules promulgated by the secretary.

19         (3)  The agency shall establish simple procedures for

20  enrolling program participants. Such procedures shall include

21  the assessment of an annual enrollment fee of up to $25 per

22  enrollee. The agency shall undertake outreach efforts to build

23  public awareness of the program and maximize enrollment by

24  eligible residents. Revenues generated from program enrollment

25  fees and rebates from drug manufacturers shall be used for,

26  but not be limited to, offsetting state costs to administer

27  the program, the purchase of prescription drugs, and any

28  public awareness campaigns.

29         Section 9.  Section 409.972, Florida Statutes, is

30  created to read:

31         409.972  Program operation.--

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                                                   HOUSE AMENDMENT

                                                   Bill No. HB 413

    Amendment No. ___ (for drafter's use only)





  1         (1)  The Board of Pharmacy, as created by s. 465.004,

  2  in consultation with the Agency for Health Care

  3  Administration, is authorized to adopt rules pursuant to ss.

  4  120.536(1) and 120.54 requiring disclosure by participating

  5  retail pharmacies to program participants of the amount of

  6  savings provided as a result of the Florida Prescription Drug

  7  Fair Pricing Program. Such rules must protect information that

  8  is proprietary in nature.

  9         (2)  Participating retail pharmacies shall be paid in

10  advance for program discounts or shall be reimbursed by the

11  agency on a weekly or biweekly basis, in accordance with

12  contracts between the agency and such businesses.

13         (3)  The agency shall collect from the participating

14  retail pharmacies utilization data necessary to calculate the

15  amount of the rebate from the manufacturer or labeler. The

16  agency shall protect the confidentiality of all information

17  subject to confidentiality protection under the laws of this

18  state or federal laws, rules, or regulations.

19         Section 10.  Section 409.974, Florida Statutes, is

20  created to read:

21         409.974  Discrepancies in rebate

22  amounts.--Discrepancies in rebate amounts must be resolved

23  using the process established in this section.

24         (1)  If there is a discrepancy in the manufacturer's or

25  labeler's favor between the amount claimed by a participating

26  retail pharmacy and the amount rebated by the manufacturer or

27  labeler, the agency, at the agency's expense, may hire a

28  mutually agreed-upon independent auditor. If a discrepancy

29  still exists following the audit, the manufacturer or labeler

30  shall justify the reason for the discrepancy or make payment

31  to the agency for any additional amount due.

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                                                   HOUSE AMENDMENT

                                                   Bill No. HB 413

    Amendment No. ___ (for drafter's use only)





  1         (2)  If there is a discrepancy against the interest of

  2  the manufacturer or labeler in the information provided by the

  3  agency to the manufacturer or labeler regarding the

  4  manufacturer's or labeler's rebate, the manufacturer or

  5  labeler, at the manufacturer's or labeler's expense, may hire

  6  a mutually agreed-upon independent auditor to verify the

  7  accuracy of the data supplied to the agency. If a discrepancy

  8  still exists following the audit, the agency shall justify the

  9  reason for the discrepancy or refund the manufacturer or

10  labeler.

11         (3)  Following the completion of procedures established

12  in subsection (1) or subsection (2), the agency, the

13  manufacturer, or the labeler may request a hearing. Hearings

14  shall be conducted pursuant to ss. 120.569 and 120.57.

15  Supporting documentation must accompany the request for a

16  hearing.

17         Section 11.  Section 409.976, Florida Statutes, is

18  created to read:

19         409.976  Report.--The agency shall provide a report on

20  the enrollment and financial status of the Florida

21  Prescription Drug Fair Pricing Program to the Governor, the

22  President of the Senate, and the Speaker of the House of

23  Representatives by the second week in January each year.

24         Section 12.  Section 409.978, Florida Statutes, is

25  created to read:

26         409.978  Coordination with other programs.--The

27  secretary shall combine drug pricing negotiations to maximize

28  drug rebates where the secretary determines that the

29  combination of such negotiations is beneficial to both the

30  Florida Prescription Drug Fair Pricing Program and another

31  state program, including the state Medicaid program.

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                                                   HOUSE AMENDMENT

                                                   Bill No. HB 413

    Amendment No. ___ (for drafter's use only)





  1         Section 13.  Section 409.980, Florida Statutes, is

  2  created to read:

  3         409.980  Rulemaking.--The agency is authorized to adopt

  4  rules pursuant to ss. 120.536(1) and 120.54 to implement the

  5  provisions of this act. Such rules shall include eligibility

  6  requirements, limits on participation, benefit limitations, a

  7  requirement for generic drug substitution, and other program

  8  parameters comparable to those of the Medicaid program.

  9         Section 14.  Section 409.982, Florida Statutes, is

10  created to read:

11         409.982  Waivers.--The agency may seek any waivers of

12  federal law, rule, or regulation necessary to implement the

13  provisions of this act.

14         Section 15.  If any provision of this act or the

15  application thereof to any person or circumstance is held

16  invalid, the invalidity shall not affect other provisions or

17  applications of the act which can be given effect without the

18  invalid provision or application, and to this end the

19  provisions of this act are declared severable.

20         Section 16.  This act shall take effect July 1, 2002

21

22

23  ================ T I T L E   A M E N D M E N T ===============

24  And the title is amended as follows:

25         On page 1, line 12 after the semicolon,

26  remove:

27

28  and insert:

29         creating s. 409.960, F.S.; providing a short

30         title; creating s. 409.962, F.S.; creating the

31         "Florida Prescription Drug Fair Pricing

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                                                   HOUSE AMENDMENT

                                                   Bill No. HB 413

    Amendment No. ___ (for drafter's use only)





  1         Program"; providing purpose of the program;

  2         creating s. 409.964, F.S.; providing

  3         definitions; creating s. 409.966, F.S.;

  4         providing that the Secretary of Health Care

  5         Administration shall operate the Florida

  6         Prescription Drug Fair Pricing Program as a

  7         state pharmaceutical assistance program to

  8         provide discounts to participants for

  9         prescription drugs covered by a rebate

10         agreement; providing that the secretary shall

11         negotiate discount prices or rebates for

12         prescription drugs from manufacturers or

13         labelers; providing that the Agency for Health

14         Care Administration shall contract with

15         participating retail pharmacies to deliver

16         discounted prices to program participants;

17         providing factors to be considered in

18         negotiating discounts or rebates; providing for

19         quarterly calculation of discounts; creating s.

20         409.968, F.S.; requiring program participants

21         to pay a specified coinsurance amount;

22         requiring participating retail pharmacies in

23         the state to charge the rate allowable under

24         the Medicaid program for prescription drugs

25         sold to program participants; providing for

26         rate of reimbursement of participating retail

27         pharmacies; creating s. 409.970, F.S.;

28         providing for program eligibility; requiring

29         the Agency for Health Care Administration to

30         establish enrollment procedures; providing for

31         an annual enrollment fee; providing for use of

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                                                   HOUSE AMENDMENT

                                                   Bill No. HB 413

    Amendment No. ___ (for drafter's use only)





  1         enrollment fees and rebates from drug

  2         manufacturers; creating s. 409.972, F.S.;

  3         providing for operation of the program;

  4         authorizing the Board of Pharmacy to adopt

  5         certain rules; creating s. 409.974, F.S.;

  6         providing procedure for resolution of

  7         discrepancies in rebate amounts; creating s.

  8         409.976, F.S.; requiring an annual report;

  9         creating s. 409.978, F.S.; authorizing

10         coordination with other programs; creating s.

11         409.980, F.S.; authorizing the agency to adopt

12         rules; creating s. 409.982, F.S.; authorizing

13         the agency to seek certain waivers; providing

14         severability;

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