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                                                       PRINTER'S NO. 806

THE GENERAL ASSEMBLY OF PENNSYLVANIA


SENATE BILL

No. 7 Session of 2003


        INTRODUCED BY ORIE, MOWERY, HELFRICK, LEMMOND, GREENLEAF,
           O'PAKE, TARTAGLIONE, MUSTO, WOZNIAK, BOSCOLA, RAFFERTY AND
           TOMLINSON, MAY 5, 2003

        REFERRED TO AGING AND YOUTH, MAY 5, 2003

                                     AN ACT

     1  Amending the act of August 26, 1971 (P.L.351, No.91), entitled
     2     "An act providing for a State Lottery and administration
     3     thereof; authorizing the creation of a State Lottery
     4     Commission; prescribing its powers and duties; disposition of
     5     funds; violations and penalties therefor; exemption of prizes
     6     from State and local taxation and making an appropriation,"
     7     defining "best price"; and further providing for prescription
     8     drug programs generally, for reimbursement, for the
     9     Pharmaceutical Assistance Contract Needs Enhancement Tier,
    10     for amount of rebate and for excessive pharmaceutical price
    11     inflation discount.

    12     The General Assembly of the Commonwealth of Pennsylvania
    13  hereby enacts as follows:
    14     Section 1.  Section 502 of the act of August 26, 1971
    15  (P.L.351, No.91), known as the State Lottery Law, is amended by
    16  adding a definition to read:
    17  Section 502.  Definitions.
    18     The following words and phrases when used in this chapter
    19  shall have the meanings given to them in this section unless the
    20  context clearly indicates otherwise:
    21     * * *
    22     "Best price."  As defined in section 1927(c)(1)(C) of the

     1  Social Security Act (49 Stat. 620, 42 U.S.C. § 1396r-
     2  8(c)(1)(C)).
     3     * * *
     4     Section 2.  Sections 509, 515, 519, 705 and 706 of the act,
     5  added November 21, 1996 (P.L.741, No.134), are amended to read:
     6  Section 509.  Program generally.
     7     The program shall include the following:
     8         (1)  Participating pharmacies shall be paid within 21
     9     days of the contracting firm receiving the appropriate
    10     substantiation of the transaction. Pharmacies shall be
    11     entitled to interest for payment not made within the 21-day
    12     period at a rate approved by the board.
    13         (2)  Collection of the copayment by pharmacies shall be
    14     mandatory.
    15         (3)  Senior citizens participating in the program are not
    16     required to maintain records of each transaction.
    17         (4)  A system of rebates or reimbursements to eligible
    18     claimants for pharmaceutical expenses shall be prohibited.
    19         (5)  PACE shall include a participant copayment schedule
    20     for each prescription. The copayment may increase or decrease
    21     on an annual basis by the average percent change of
    22     ingredient costs for all prescription drugs, plus a
    23     differential to raise the copayment to the next highest 25¢
    24     increment. In addition, the department may approve a request
    25     for increase or decrease in the level of copayment based upon
    26     the financial experience and projections of PACE and after
    27     consultation with the board. The department is prohibited
    28     from approving adjustments to the copayment on more than an
    29     annual basis.
    30         (6)  The program shall consist of payments to pharmacies
    20030S0007B0806                  - 2 -     

     1     on behalf of eligible claimants [for]:
     2             (i)  For single-source drugs, 90% of the average
     3         wholesale costs of prescription drugs which exceed the
     4         copayment, plus a dispensing fee of at least $3.50 or the
     5         dispensing fee established by the department by
     6         regulation, whichever is greater.
     7             (ii)  For multiple-source drugs, the department shall
     8         adopt the Federal upper reimbursement limit for each
     9         multiple-source drug for which the FDA has rated three or
    10         more products therapeutically and pharmaceutically
    11         equivalent, regardless of whether all such additional
    12         formulations are rated as such and shall use only such
    13         formulations when determining any such upper limit.
    14         (7)  In no case shall the Commonwealth or any person
    15     enrolled in the program be charged more than the price of the
    16     drug at the particular pharmacy on the date of the sale.
    17  Section 515.  Reimbursement.
    18     For-profit third-party insurers, health maintenance
    19  organizations and not-for-profit prescription plans shall be
    20  responsible for any payments made to a providing pharmacy on
    21  behalf of a claimant covered by such a third party.
    22  Section 519.  The Pharmaceutical Assistance Contract for the
    23                 Elderly Needs Enhancement Tier.
    24     (a)  Establishment.--There is hereby established within the
    25  department a program to be known as the Pharmaceutical
    26  Assistance Contract for the Elderly Needs Enhancement Tier
    27  (PACENET).
    28     (b)  PACENET eligibility.--A claimant with an annual income
    29  of not less than $14,000 and not more than [$16,000] $17,000 in
    30  the case of a single person and of not less than $17,200 and not
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     1  more than [$19,200] $23,200 in the case of the combined income
     2  of persons married to each other shall be eligible for enhanced
     3  pharmaceutical assistance under this section. A person may, in
     4  reporting income to the department, round the amount of each
     5  source of income and the income total to the nearest whole
     6  dollar, whereby any amount which is less than 50¢ is eliminated.
     7     (c)  Deductible.--Upon enrollment in PACENET, eligible
     8  claimants in the income ranges set forth in subsection (b) shall
     9  be required to meet an annual deductible in unreimbursed
    10  prescription drug expenses of [$500] $480 per person. To qualify
    11  for the deductible set forth in this subsection the prescription
    12  drug must be purchased for the use of the eligible claimant from
    13  a provider as defined in this chapter. The department, after
    14  consultation with the board, may approve an adjustment in the
    15  deductible on an annual basis. The annual deductible may be met
    16  through unreimbursed drug expenses of $40 per person per
    17  calendar month.
    18     (d)  Copayment.--For eligible claimants under this section,
    19  the copayment schedule, which may be adjusted by the department
    20  on an annual basis after consultation with the board, shall be:
    21             (i)  eight dollars for noninnovator multiple source
    22         drugs as defined in section 702; or
    23             (ii)  fifteen dollars for single-source drugs and
    24         innovator multiple-source drugs as defined in section
    25         702.
    26  Section 705.  Amount of rebate.
    27     (a)  Single-source drugs and innovator multiple-source
    28  drugs.--With respect to single-source drugs and innovator
    29  multiple-source drugs, each manufacturer shall remit a rebate to
    30  the Commonwealth. Except as otherwise provided in this section,
    20030S0007B0806                  - 4 -     

     1  the amount of the rebate to the Commonwealth per calendar
     2  quarter with respect to each dosage form and strength of single-
     3  source drugs and innovator multiple-source drugs shall be as
     4  follows:
     5         (1)  For quarters beginning after September 30, 1992, and
     6     ending before January 1, 1997, the product of the total
     7     number of units of each dosage form and strength reimbursed
     8     by PACE and General Assistance in the quarter and the
     9     difference between the average manufacturer price and 85% of
    10     that price, after deducting customary prompt payment
    11     discounts, for the quarter.
    12         (2)  For quarters beginning after December 31, 1996, the
    13     product of the total number of units of each dosage form and
    14     strength reimbursed by [PACE, PACENET and] designated
    15     pharmaceutical programs other than PACE and PACENET in the
    16     quarter and the difference between the average manufacturer
    17     price and 83% of that price, after deducting customary prompt
    18     payment discounts.
    19         (3)  For quarters beginning after December 31, 2003, the
    20     product of the total number of units of each dosage form and
    21     strength reimbursed by PACE and PACENET in the quarter and
    22     the difference between the average manufacturer price and the
    23     best price, after deducting customary prompt payment
    24     discounts.
    25     (b)  Rebate for other drugs.--
    26         (1)  The amount of the rebate to the Commonwealth for a
    27     calendar quarter with respect to covered prescription drugs
    28     which are noninnovator multiple-source drugs shall be equal
    29     to the product of:
    30             (i)  the applicable percentage of the average
    20030S0007B0806                  - 5 -     

     1         manufacturer price, after deducting customary prompt
     2         payment discounts, for each dosage form and strength of
     3         such drugs for the quarter; and
     4             (ii)  the number of units of such form and dosage
     5         reimbursed by PACE and General Assistance in the quarter.
     6         (2)  For the purposes of paragraph (1), the applicable
     7     percentage for calendar quarters beginning after September
     8     30, 1992, and ending before January 1, 1997, is 11%.
     9     (c)  Revised rebate for other drugs.--Beginning after
    10  December 31, 1996:
    11         (1)  The amount of the rebate to the Commonwealth for a
    12     calendar quarter with respect to covered prescription drugs
    13     which are noninnovator multiple-source drugs shall be the
    14     greater of the product of:
    15             (i)  the applicable percentage of the average
    16         manufacturer price, after deducting customary prompt
    17         payment discounts, for each dosage form and strength of
    18         such drugs for the quarter; and
    19             (ii)  the number of units of such form and dosage
    20         reimbursed by PACE, PACENET and designated pharmaceutical
    21         programs in the quarter.
    22         (2)  For purposes of paragraph (1), the applicable
    23     percentage is 17%.
    24     (d)  Drugs approved after act takes effect.--In the case of a
    25  covered outpatient drug approved for marketing after the
    26  effective date of the act of August 14, 1991 (P.L.342, No.36),
    27  known as the Lottery Fund Preservation Act, any reference to
    28  January 1, 1991, shall be a reference to the first day of the
    29  first month during which the drug was marketed.
    30  Section 706.  Excessive pharmaceutical price inflation discount.
    20030S0007B0806                  - 6 -     

     1     (a)  General rule.--A discount shall be provided to the
     2  department for all covered prescription drugs. The discount
     3  shall be calculated as follows:
     4         (1)  For each quarter for which a rebate under section
     5     705(a) and (b) is to be paid after December 31, 1991, and
     6     before January 1, 1997, the average manufacturer price for
     7     each dosage form and strength of a covered prescription drug
     8     shall be compared to the average manufacturer price for the
     9     same form and strength in the previous calendar year, and a
    10     percentage increase shall be calculated.
    11         (2)  For each quarter under paragraph (1), the average
    12     percentage increase in the Producer Price Index for
    13     Pharmaceuticals over the same quarter in the previous
    14     calendar year shall be calculated.
    15         (3)  If the calculation under paragraph (1) is greater
    16     than the calculation under paragraph (2), the discount amount
    17     for each quarter shall be equal to the product of:
    18             (i)  the difference between the calculations under
    19         paragraphs (1) and (2); and
    20             (ii)  the total number of units of each dosage form
    21         and strength reimbursed by PACE and General Assistance
    22         and the average manufacturer price reported by the
    23         manufacturer under section 704(c)(1).
    24     (b)  Revised general rule.--A discount shall be provided to
    25  the department for all covered prescription drugs. The discount
    26  shall be calculated as follows:
    27         (1)  [For] Except as provided in subsection (b.1), for
    28     each quarter for which a rebate under section 705(a) and (c)
    29     is to be paid after December 31, 1996, the average
    30     manufacturer price for each dosage form and strength of a
    20030S0007B0806                  - 7 -     

     1     covered prescription drug shall be compared to the average
     2     manufacturer price for the same form and strength in the
     3     previous calendar year and a percentage increase shall be
     4     calculated.
     5         (2)  For each quarter under paragraph (1), the average
     6     percentage increase in the Consumer Price Index-Urban over
     7     the same quarter in the previous calendar year shall be
     8     calculated.
     9         (3)  If the calculation under paragraph (1) is greater
    10     than the calculation under paragraph (2), the discount amount
    11     for each quarter shall be equal to the product of:
    12             (i)  the difference between the calculations under
    13         paragraphs (1) and (2); and
    14             (ii)  the total number of units of each dosage form
    15         and strength reimbursed by PACE, PACENET and designated
    16         pharmaceutical programs and the average manufacturer
    17         price reported by the manufacturer under section
    18         704(c)(1).
    19     (b.1)  Discount after December 31, 2003, for PACE and
    20  PACENET.--A discount in lieu of the discount provided under
    21  subsection (b) shall be provided to the department for all the
    22  covered prescription drugs under this subsection. The discount
    23  shall be calculated as provided under this subsection. For each
    24  quarter for which a discount specified in this subsection for a
    25  rebate under section 705(a) and (c) is paid after December 31,
    26  2003, with respect to each dosage form and strength reimbursed
    27  by PACE and PACENET:
    28         (1)  the amount shall be increased by an amount equal to
    29     the product of:
    30             (i)  the total number of units of each dosage form
    20030S0007B0806                  - 8 -     

     1         and strength reimbursed by PACE and PACENET, for which
     2         payment was made under section 705(a) and (c) for the
     3         rebate period; and
     4             (ii)  the amount, if any, by which the average
     5         manufacturer price for the dosage form and strength of
     6         the drug for the period, exceeds the average manufacturer
     7         price for such dosage form and strength for the calendar
     8         quarter beginning July 1, 2003, without regard to whether
     9         or not the drug has been sold or transferred to an
    10         entity, including a division or subsidiary of the
    11         manufacturer, after the first day of such quarter,
    12         increased by the percentage by which the Consumer Price
    13         Index-Urban for the quarter before the quarter in which
    14         the rebate period begins exceeds such index for September
    15         2003; or
    16         (2)  in the case of covered prescription drugs that have
    17     not been marketed before October 1, 2003, the amount shall be
    18     increased by an amount equal to the product of:
    19             (i)  the total number of units of each dosage form
    20         and strength reimbursed by PACE and PACENET, for which
    21         payment was made under section 705(a) and (c) for the
    22         rebate period; and
    23             (ii)  the amount, if any, by which the average
    24         manufacturer price for the dosage form and strength of
    25         the drug for the period, exceeds the average manufacturer
    26         price for such dosage form and strength for the first
    27         full calendar quarter after the day on which the drug was
    28         first marketed, without regard to whether or not the drug
    29         has been sold or transferred to an entity, including a
    30         division or subsidiary of the manufacturer, after the
    20030S0007B0806                  - 9 -     

     1         first day of such quarter, increased by the percentage by
     2         which the Consumer Price Index-Urban for the quarter
     3         before the quarter in which the rebate period begins
     4         exceeds such index for the month prior to the first month
     5         of the first full calendar quarter after the day on which
     6         the drug was first marketed.
     7     (c)  New bimarketed drugs.--For covered prescription drugs
     8  that have not been marketed for a full calendar year, subsection
     9  (a) shall apply after the covered prescription drug has been on
    10  the market for four consecutive quarters. The drug's initial
    11  average manufacturer price shall be based on the first day of
    12  the first quarter that the drug was marketed.
    13     Section 3.  This act shall take effect in 60 days.












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