PRIOR PRINTER'S NOS. 1044, 1816, 1836, PRINTER'S NO. 2919
1889, 2098, 2117, 2794, 2871
No. 888 Session of 2003
INTRODUCED BY VANCE, EACHUS, KENNEY, WALKO, E. Z. TAYLOR,
GRUCELA, ADOLPH, BARD, BALDWIN, BARRAR, BASTIAN, BROWNE,
BUTKOVITZ, BUXTON, CAPPELLI, CASORIO, CORNELL, CORRIGAN,
COSTA, DAILEY, DALLY, J. EVANS, FEESE, FLICK, FREEMAN, GABIG,
GERGELY, GILLESPIE, GINGRICH, HARHAI, HARPER, HASAY,
HENNESSEY, HERMAN, HERSHEY, HORSEY, JAMES, KELLER, KIRKLAND,
LAUGHLIN, LEH, LEWIS, MACKERETH, MAHER, MARSICO, McCALL,
McGILL, McNAUGHTON, MELIO, MICOZZIE, R. MILLER, S. MILLER,
MUNDY, NAILOR, NICKOL, O'NEILL, PALLONE, PETRARCA, PETRI,
PICKETT, PISTELLA, RAYMOND, READSHAW, ROSS, RUBLEY, SAINATO,
SAYLOR, SCAVELLO, SCHRODER, SEMMEL, SHANER, SOLOBAY, STEIL,
R. STEVENSON, T. STEVENSON, J. TAYLOR, THOMAS, TIGUE,
TRAVAGLIO, TURZAI, WANSACZ, WATSON, WEBER, WILT, WRIGHT,
YOUNGBLOOD, YUDICHAK, ZUG, FABRIZIO, REED, SAMUELSON, OLIVER,
COY, TANGRETTI, HABAY, GEORGE, GORDNER AND DALEY,
MARCH 13, 2003
AMENDMENTS TO SENATE AMENDMENTS, HOUSE OF REPRESENTATIVES,
NOVEMBER 18, 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 further providing for definitions, for program generally, for
8 generic drugs, for restricted formulary, for reimbursement,
9 for nonliability, for the Pharmaceutical Assistance Contract
10 for the Elderly Needs Enhancement Tier, for the
11 Pharmaceutical Assistance Review Board; providing for
12 pharmacy best practices and cost controls; further providing
13 for penalties, for the Prescription Drug Education Program,
14 for rebate agreement, for terms of rebate agreement and for <--
15 amount of rebate; providing for a Pharmaceutical Assistance
16 Clearinghouse; further providing for annual report to General
17 Assembly; and providing for construction with Federal
18 programs and for continued use of Tobacco Settlement Fund.
1 The General Assembly of the Commonwealth of Pennsylvania
2 hereby enacts as follows:
3 Section 1. The definitions of "HCFA," "income," "maximum
4 annual income" and "provider" in section 502 of the act of
5 August 26, 1971 (P.L.351, No.91), known as the State Lottery
6 Law, added November 21, 1996 (P.L.741, No.134), are amended and
7 the section is amended by adding definitions to read:
8 Section 502. Definitions.
9 The following words and phrases when used in this chapter
10 shall have the meanings given to them in this section unless the
11 context clearly indicates otherwise:
12 * * *
13 "CMS." The Centers for Medicare and Medicaid Services of the
14 United States.
15 * * * <--
16 "DESI." The Drug Efficacy Study Implementation List.
17 * * *
18 ["HCFA." The Health Care Financing Administration of the
19 United States.]
20 "Health Maintenance Organization." An organized system which
21 combines the delivery and financing of health care and which
22 provides basic health services to voluntarily enrolled
23 subscribers for a fixed prepaid fee.
24 "Income." All income from whatever source derived,
25 including, but not limited to, salaries, wages, bonuses,
26 commissions, income from self-employment, alimony, support
27 money, cash public assistance and relief, the gross amount of
28 any pensions or annuities, including railroad retirement
29 benefits, all benefits received under the Social Security Act
30 (49 Stat. 620, 42 U.S.C. § 301 et. seq.) (except Medicare
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1 benefits), all benefits received under State unemployment
2 insurance laws and veterans' disability payments, all interest
3 received from the Federal Government or any state government or
4 any instrumentality or political subdivision thereof, realized
5 capital gains, rentals, workmen's compensation and the gross
6 amount of loss of time insurance benefits, life insurance
7 benefits and proceeds, except the first [$5,000] $10,000 of the
8 total of death benefits payments, and gifts of cash or property,
9 other than transfers by gift between members of a household, in
10 excess of a total value of $300, but shall not include surplus
11 food or other relief in kind supplied by a government agency or
12 property tax rebate.
13 "Maximum annual income." For PACE eligibility, the term
14 shall mean annual income which shall not exceed [$14,000]
15 $14,500 in the case of single persons nor [$17,200] $17,700 in
16 the case of the combined annual income of persons married to
17 each other. Persons may, in reporting income to the Department
18 of Aging, round the amount of each source of income and the
19 income total to the nearest whole dollar, whereby any amount
20 which is less than 50¢ is eliminated.
21 * * *
22 "Preferred Provider Organization." An entity organized and
23 operating under 40 Pa.C.S. Ch. 63 (relating to professional
24 health services plan corporations).
25 * * *
26 "Provider." A pharmacy [or], dispensing physician or
27 certified registered nurse practitioner enrolled as a provider
28 in the program.
29 Section 2. Sections 503, 504 and 509 of the act, added
30 November 21, 1996 (P.L.741, No.134), are amended to read:
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1 Section 503. Determination of eligibility.
2 The department shall adopt regulations relating to the
3 determination of eligibility of prospective claimants and
4 providers, including dispensing physicians and certified
5 registered nurse practitioners when acting in accordance with
6 rules and regulations promulgated by the State Board of Nursing
7 as required by the act of May 22, 1951 (P.L.317, No.69), known
8 as The Professional Nursing Law, and the State Board of Pharmacy
9 minimum standards of practice, and the determination and
10 elimination of program abuse. To this end, the department shall
11 establish a compliance unit staffed sufficiently to fulfill this
12 responsibility. The department shall have the power to declare
13 ineligible any claimant or provider who abuses or misuses the
14 established prescription plan. The department shall have the
15 power to investigate cases of suspected provider or recipient
16 fraud.
17 Section 504. Physician, certified registered nurse practitioner
18 and pharmacy participation.
19 Any physician, certified registered nurse practitioner,
20 pharmacist, pharmacy or corporation owned in whole or in part by
21 a physician, certified registered nurse practitioner or
22 pharmacist enrolled as a provider in the program or who has
23 prescribed medication for a claimant in the program who is
24 precluded or excluded for cause from the Department of Public
25 Welfare's Medical Assistance Program shall be precluded or
26 excluded from participation in the program. No physician or
27 certified registered nurse practitioner precluded or excluded
28 from the Department of Public Welfare's Medical Assistance
29 Program shall have claims resulting from prescriptions paid for
30 by the program.
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1 Section 509. Program generally.
2 The program shall include the following:
3 (1) Participating pharmacies shall be paid within 21
4 days of the contracting firm receiving the appropriate
5 substantiation of the transaction. Pharmacies shall be
6 entitled to interest for payment not made within the 21-day
7 period at a rate approved by the board.
8 (2) Collection of the copayment by pharmacies shall be
9 mandatory.
10 (3) Senior citizens participating in the program are not
11 required to maintain records of each transaction.
12 (4) A system of rebates or reimbursements to eligible
13 claimants for pharmaceutical expenses shall be prohibited.
14 (5) PACE shall include [a] participant copayment
15 [schedule] schedules for each prescription, including a
16 copayment for generic or multiple-source drugs that is less
17 than the copayment for single-source drugs. [The copayment
18 may increase or decrease on an annual basis by the average
19 percent change of ingredient costs for all prescription
20 drugs, plus a differential to raise the copayment to the next
21 highest 25¢ increment. In addition, the department may
22 approve a request for increase or decrease in the level of
23 copayment based upon the financial experience and projections
24 of PACE and after consultation with the board. The department
25 is prohibited from approving adjustments to the copayment on
26 more than an annual basis.] The department shall annually
27 calculate the copayment schedules based on the Prescription
28 Drugs and Medical Supplies Consumer Price Index. When the
29 aggregate impact of the Prescription Drugs and Medical
30 Supplies Consumer Price Index equals or exceeds $1, the
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1 department shall adjust the copayment schedules. Each
2 copayment schedule shall not be increased by more than $1 in
3 a calendar year.
4 (6) [The program shall consist of payments to pharmacies
5 on behalf of eligible claimants for 90% of the average
6 wholesale costs of prescription drugs which exceed the
7 copayment, plus a dispensing fee of at least $3.50 or the
8 dispensing fee established by the department by regulation,
9 whichever is greater.] The program payment shall be the lower
10 of the following amounts determined as follows:
11 (i) 90% of the average wholesale cost of the
12 prescription drug dispensed:
13 (A) with the addition of a dispensing fee of the
14 greater of:
15 (I) $4; or
16 (II) the amount set by the department by
17 regulation;
18 (B) the subtraction of the copayment; and
19 (C) if required the subtraction of the generic
20 differential; or
21 (ii) the pharmacy's usual charge for the drug
22 dispensed with the subtraction of the copayment and if
23 required the subtraction of the generic differential; or
24 (iii) if a generic drug, the most current Federal
25 upper payments limits established in the Medicaid Program
26 under 42 CFR § 447.332 (relating to upper limits for
27 multiple source drugs), plus a dispensing fee of $4 or
28 the amount set by the department by regulation, whichever
29 is greater minus the copayment. The department shall
30 update the average wholesale costs and the Federal upper
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1 payment limits at least every 30 days.
2 (7) In no case shall the Commonwealth or any person
3 enrolled in the program be charged more than the price of the
4 drug at the particular pharmacy on the date of the sale.
5 (8) The Governor may, based upon certified State Lottery
6 Fund revenue that is provided to both the chairman and
7 minority chairman of the Appropriations Committee of the
8 Senate and the chairman and minority chairman of the
9 Appropriations Committee of the House of Representatives, and
10 after consultation with the board, decrease the eligibility
11 limits established in this chapter.
12 Section 3. Section 510(a) of the act, added November 21,
13 1996 (P.L.741, No.134), is amended to read:
14 Section 510. Generic drugs.
15 (a) In general.--Notwithstanding any other statute or
16 regulation, if an A-rated generic therapeutically equivalent
17 drug is available for dispensing to a claimant, the provider
18 shall dispense the A-rated generic therapeutically equivalent
19 drug to the claimant. The department shall reimburse providers
20 based upon the most current listing of Federal upper payments
21 limits established in the Medicaid Program under 42 CFR §
22 447.332 (relating to upper limits for multiple source drugs),
23 plus a dispensing fee as set forth in section 509(6). The
24 department shall update the average wholesale costs and the
25 Federal upper payments limits on a regular basis, at least every
26 30 days. The department shall not reimburse providers for brand
27 name products except in the following circumstances:
28 (1) There is no A-rated generic therapeutically
29 equivalent drug available on the market. This paragraph does
30 not apply to the lack of availability of an A-rated generic
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1 therapeutically equivalent drug in the providing pharmacy
2 unless it can be shown to the department that the provider
3 made reasonable attempts to obtain the A-rated generic
4 therapeutically equivalent drug or that there was an
5 unforeseeable demand and depletion of the supply of the A-
6 rated generic therapeutically equivalent drug. In either
7 case, the department shall reimburse the provider for 90% of
8 the average wholesale cost plus a dispensing fee based on the
9 least expensive A-rated generic therapeutically equivalent
10 drug for the brand drug dispensed.
11 (2) An A-rated generic therapeutically equivalent drug
12 is deemed by the department, in consultation with a
13 utilization review committee, to have too narrow a
14 therapeutic index for safe and effective dispensing in the
15 community setting. The department shall notify providing
16 pharmacies of A-rated generic therapeutically equivalent
17 drugs that are identified pursuant to this paragraph on a
18 regular basis.
19 (3) The Department of Health has determined that a drug
20 shall not be recognized as an A-rated generic therapeutically
21 equivalent drug for purpose of substitution under section
22 5(b) of the act of November 24, 1976 (P.L.1163, No.259),
23 referred to as the Generic Equivalent Drug Law.
24 (4) At the time of dispensing, the provider has a
25 prescription on which the brand name drug dispensed is billed
26 to the program by the provider at a usual and customary
27 charge which is equal to or less than the least expensive
28 usual and customary charge of any A-rated generic
29 therapeutically equivalent drug reasonably available on the
30 market to the provider.
20030H0888B2919 - 8 -
1 * * *
2 Section 4. Sections 512, 515, 516, 519 and 520(b) of the
3 act, added November 21, 1996 (P.L.741, No.134), are amended to
4 read:
5 Section 512. Restricted formulary.
6 The department may establish a restricted formulary of the
7 drugs which will not be reimbursed by the program. This
8 formulary shall include only experimental drugs and drugs on the
9 Drug Efficacy Study Implementation List prepared by [the Health
10 Care Finance Administration] CMS. A medical exception may be
11 permitted by the department for reimbursement of a drug on the
12 Drug Efficacy Study Implementation List upon declaration of its
13 necessity on the prescription by the treating physician or
14 certified registered nurse practitioner, except that, for DESI
15 drugs for which the FDA has issued a Notice for Opportunity
16 Hearing (NOOH) for the purpose of withdrawing the New Drug
17 Application approved for that drug, reimbursement coverage shall
18 be discontinued under the provisions of this chapter.
19 Section 515. Reimbursement.
20 For-profit third-party insurers, health maintenance
21 organizations, preferred provider organizations and not-for-
22 profit prescription plans shall be responsible for any payments
23 made to a providing pharmacy on behalf of a claimant covered by
24 such a third party. Final determination as to the existence of
25 third-party coverage shall be the responsibility of the
26 department.
27 Section 516. Nonliability.
28 (a) [Persons rendering service] General rule.--Any person
29 rendering service as a member of a utilization review committee
30 for this program shall not be liable for any civil damages as a
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1 result of any acts or omissions in rendering the service as a
2 member of any such committee except any acts or omissions
3 intentionally designed to harm or any grossly negligent acts or
4 omissions which result in harm to the person receiving such
5 service.
6 (b) [Officer and employees of department] Department
7 personnel.--Any officer or employee of the department rendering
8 service as a member of a utilization review committee for this
9 program shall not be liable for any civil damages as a result of
10 any acts or omissions in rendering the service as a member of
11 any such committee or as a result of any decision or action in
12 connection with the program except any acts or omissions
13 intentionally designed to harm or any grossly negligent acts or
14 omissions which result in harm to the person receiving such
15 service.
16 Section 519. The Pharmaceutical Assistance Contract for the
17 Elderly Needs Enhancement Tier.
18 (a) Establishment.--There is hereby established within the
19 department a program to be known as the Pharmaceutical
20 Assistance Contract for the Elderly Needs Enhancement Tier
21 (PACENET).
22 (b) PACENET eligibility.--A claimant with an annual income
23 of not less than [$14,000] $14,500 and not more than [$16,000]
24 $23,500 in the case of a single person and of not less than
25 [$17,200] $17,700 and not more than [$19,200] $31,500 in the
26 case of the combined income of persons married to each other
27 shall be eligible for enhanced pharmaceutical assistance under
28 this section. A person may, in reporting income to the
29 department, round the amount of each source of income and the
30 income total to the nearest whole dollar, whereby any amount
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1 which is less than 50¢ is eliminated.
2 (c) Deductible.--Upon enrollment in PACENET, eligible
3 claimants in the income ranges set forth in subsection (b) shall
4 be required to meet [an annual] a deductible in unreimbursed
5 prescription drug expenses of [$500] $40 per person[.] per
6 month. The $40 monthly deductible shall be cumulative and shall
7 be applied to subsequent months to determine eligibility. The
8 cumulative deductible shall be determined on an enrollment year
9 basis for an annual total deductible not to exceed $480 in a
10 year. To qualify for the deductible set forth in this subsection
11 the prescription drug must be purchased for the use of the
12 eligible claimant from a provider as defined in this chapter.
13 The department, after consultation with the board, may approve
14 an adjustment in the deductible on an annual basis.
15 (d) Copayment.--
16 (1) For eligible claimants under this section, the
17 copayment schedule[, which may be adjusted by the department
18 on an annual basis after consultation with the board,] shall
19 be:
20 (i) eight dollars for noninnovator multiple source
21 drugs as defined in section 702; or
22 (ii) fifteen dollars for single-source drugs and
23 innovator multiple-source drugs as defined in section
24 702.
25 (2) The department shall annually calculate the
26 copayment schedules based on the Prescription Drugs and
27 Medical Supplies Consumer Price Index. When the aggregate
28 impact of the Prescription Drugs and Medical Supplies
29 Consumer Price Index equals or exceeds $1, the department
30 shall adjust the copayment schedules. Each copayment schedule
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1 shall not be increased by more than $1 in a calendar year.
2 Section 520. Board.
3 * * *
4 (b) Composition.--The board shall be comprised of the
5 following eight persons:
6 (1) The Secretary of Aging, who shall serve as its
7 chairman.
8 (2) The Secretary of Revenue.
9 (3) The Secretary of Health.
10 (4) Five public members, one appointed by the President
11 pro tempore of the Senate, one appointed by the Minority
12 Leader of the Senate, one appointed by the Speaker of the
13 House of Representatives, one appointed by the Minority
14 Leader of the House of Representatives and one appointed by
15 the Governor. Those appointed by the legislative officers
16 shall include two senior citizens who have not been a part of
17 the pharmaceutical industry to serve as consumer advocates
18 [and two representatives], one representative of the
19 pharmaceutical industry[, at least one of whom is a] and one
20 practicing Pennsylvania pharmacist. The individual appointed
21 by the Governor must be a physician. A public member who
22 misses two consecutive meetings without good cause acceptable
23 to the chairman shall be replaced by the appointing
24 authority.
25 * * *
26 Section 5. The act is amended by adding a section to read:
27 Section 520.1. Pharmacy best practices and cost controls
28 review.
29 (a) Review process.--The secretary shall review and
30 recommend pharmacy best practices and cost control mechanisms
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1 that maintain high quality in prescription drug therapies but
2 are designed to reduce the cost of providing prescription drugs
3 for PACE and PACENET enrollees including:
4 (1) A list of covered prescription drugs with
5 recommended copayment schedules. In developing the schedules,
6 the department shall take into account the standards
7 published in the United States Pharmacopeia-Drug Information.
8 (2) A drug utilization review procedure, incorporating a
9 prescription review process for copayment schedules.
10 (3) A step therapy program that safely and effectively
11 utilizes in a sequential manner the least costly
12 pharmacological therapy to treat the symptoms of or effect a
13 cure for the medical condition or illness for which the
14 therapy is prescribed.
15 (4) Education programs designed to provide information
16 and education on the therapeutic and cost-effective
17 utilization of prescription drugs to physicians, pharmacists,
18 certified registered nurse practitioners and other health
19 care professionals authorized to prescribe and dispense
20 prescription drugs.
21 (b) Report and recommendations.--No later than two years
22 from the effective date of this section, the department shall
23 submit a report with recommendations to the Aging and Youth
24 Committee, the Appropriations Committee and the Public Health
25 and Welfare Committee of the Senate and the Aging and Older
26 Adult Services Committee, the Appropriations Committee and the
27 Health and Human Services Committee of the House of
28 Representatives. The report shall include information regarding
29 the efficacy of the pharmacy best practices and control
30 mechanisms set forth in subsection (a) including recommended
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1 copayment schedules with impacted classes of drugs, exceptions,
2 cost effectiveness, improved drug utilization and therapies,
3 movement of market share and increased utilization of generic
4 drugs.
5 Section 6. Sections 521(d) and 522 of the act, added
6 November 21, 1996 (P.L.741, No.134), are amended to read:
7 Section 521. Penalties.
8 * * *
9 (d) [Repayment of gain] Reparation.--Any provider, recipient
10 or other person who is found guilty of a crime for violating
11 this chapter shall repay three times the value of the material
12 gain received. In addition to the civil penalty authorized
13 pursuant to subsection (b), the department may require the
14 provider, recipient or other person to repay up to three times
15 the value of any material gain to PACE or PACENET.
16 Section 522. Prescription drug education program.
17 The department, in cooperation with the Department of Health,
18 shall develop and implement a Statewide prescription drug
19 education program designed to inform older adults of the dangers
20 of prescription drug abuse and misuse. The prescription drug
21 education program shall include, but not be limited to,
22 information concerning the following:
23 (1) The hazards of prescription drug overdose.
24 (2) The potential dangers of mixing prescription drugs.
25 (3) The danger of retaining unused prescription drugs
26 after the need to take them no longer exists.
27 (4) The necessity to carefully question physicians,
28 certified registered nurse practitioners and pharmacists
29 concerning the effects of taking prescription drugs,
30 including the differences between brand-name drugs and
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1 generically equivalent drugs.
2 (5) The advisability of maintaining a prescription drug
3 profile or other record of prescription drug dosage and
4 frequency of dosage.
5 (6) The desirability of advising family members of the
6 types and proper dosage of prescription drugs which are being
7 taken.
8 (7) The dangers of taking prescription drugs in excess
9 of prescribed dosages.
10 (8) The need to obtain complete, detailed directions
11 from the physician, certified registered nurse practitioner
12 or pharmacist concerning the time period a prescription drug
13 should be taken.
14 Section 7. The definition of "provider" in section 702 of
15 the act, added November 21, 1996 (P.L.741, No.134), is amended
16 and the section is amended by adding a definition to read:
17 Section 702. 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." The lowest price available from the
23 manufacturer during the rebate period to any wholesaler,
24 retailer, provider, health maintenance organization, nonprofit
25 entity or any governmental entity subject to the exclusions and
26 special rules set forth in sections 1902 and 1927(c)(1)(C) of
27 the Social Security Act (49 Stat. 620, 42 U.S.C. §§1396c, 1396r-
28 8(c)(1)(C)).
29 * * *
30 "Provider." A licensed pharmacy [or], dispensing physician
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1 or certified registered nurse practitioner enrolled as a
2 provider in PACE, PACENET or designated pharmaceutical programs.
3 * * *
4 Section 8. Sections 703(e) and 704(c)(1) of the act, added <--
5 November 21, 1996 (P.L.741, No.134), are amended to read:
6 Section 703. Rebate agreement.
7 * * *
8 (e) Drug formulary.--Except as provided in section 512,
9 there shall be no drug formulary[, prior or retroactive approval
10 system or any similar restriction] imposed on the coverage of
11 outpatient drugs made by manufacturers who have agreements in
12 effect with the Commonwealth to pay rebates for drugs utilized
13 in PACE and PACENET, provided that such outpatient drugs were
14 approved for marketing by the Food and Drug Administration. This
15 subsection shall not apply to any act taken by the department
16 pursuant to its therapeutic drug utilization review program
17 under section 505.
18 SECTION 8. SECTION 704(C)(1) OF THE ACT, ADDED NOVEMBER 21, <--
19 1996 (P.L.741, NO.134), IS AMENDED TO READ:
20 Section 704. Terms of rebate agreement.
21 * * *
22 (c) Manufacturer provision of price information.--
23 (1) Each manufacturer with an agreement in effect under
24 this chapter shall report the average manufacturer price and
25 the best price for all covered prescription drugs produced by
26 that manufacturer to the department not later than 30 days
27 after the last day of each quarter.
28 * * *
29 Section 9. Section 705(a) and (c) of the act, added November
30 21, 1996, (P.L.741, No.134), are amended and the section is
20030H0888B2919 - 16 -
1 amended by adding a subsection to read:
2 Section 705. Amount of rebate.
3 (a) Single-source drugs and innovator multiple-source
4 drugs.--With respect to single-source drugs and innovator
5 multiple-source drugs, each manufacturer shall remit a rebate to
6 the Commonwealth. Except as otherwise provided in this section,
7 the amount of the rebate to the Commonwealth per calendar
8 quarter with respect to each dosage form and strength of single-
9 source drugs and innovator multiple-source drugs shall be as
10 follows:
11 (1) For quarters beginning after September 30, 1992, and
12 ending before January 1, 1997, the product of the total
13 number of units of each dosage form and strength reimbursed
14 by PACE and General Assistance in the quarter and the
15 difference between the average manufacturer price and 85% of
16 that price, after deducting customary prompt payment
17 discounts, for the quarter.
18 (2) For quarters beginning after December 31, 1996, and
19 ending before January 1, 2003, the product of the total
20 number of units of each dosage form and strength reimbursed
21 by PACE, PACENET and designated pharmaceutical programs in
22 the quarter and the difference between the average
23 manufacturer price and 83% of that price, after deducting
24 customary prompt payment discounts.
25 (3) For quarters beginning after December 31, 2002, each
26 manufacturer shall remit a rebate to the Commonwealth for the
27 total number of units of each dosage form and strength
28 reimbursed by PACE, PACENET and designated pharmaceutical
29 programs in the quarter pursuant to the determination
30 established by section 1927(c)(1) of the Social Security Act
20030H0888B2919 - 17 -
1 (49 Stat. 620, 42 U.S.C. § 1396r-8(c)(1)).
2 * * *
3 (c) Revised rebate for other drugs.--Beginning after
4 December 31, 1996, and ending before January 1, 2004, all of the
5 following shall apply:
6 (1) The amount of the rebate to the Commonwealth for a
7 calendar quarter with respect to covered prescription drugs
8 which are noninnovator multiple-source drugs shall be the
9 greater of the product of:
10 (i) The applicable percentage of the average
11 manufacturer price, after deducting customary prompt
12 payment discounts, for each dosage form and strength of
13 such drugs for the quarter; and
14 (ii) the number of units of such form and dosage
15 reimbursed by PACE, PACENET and designated pharmaceutical
16 programs in the quarter.
17 (2) For purposes of paragraph (1), the applicable
18 percentage is 17%.
19 (c.1) Rebates for other drugs for quarters beginning after
20 December 31, 2003.--For quarters beginning after December 31,
21 2003, all of the following shall apply:
22 (1) the amount of the rebate to the Commonwealth for a
23 calendar quarter with respect to covered prescription drugs
24 which are noninnovator multiple-source drugs shall be equal
25 to the product of:
26 (i) the applicable percentage of the average
27 manufacturer price, after deducting customary prompt
28 payment discounts, for each dosage form and strength of
29 such drugs for the quarter; and
30 (ii) the number of units of such form and dosage
20030H0888B2919 - 18 -
1 reimbursed by PACE, PACENET and designated pharmaceutical
2 programs in the quarter.
3 (2) For purposes of paragraph (1), the applicable
4 percentage is 14%.
5 * * * <--
6 Section 10. The act is amended by adding a chapter to read:
7 CHAPTER 8
8 PHARMACEUTICAL ASSISTANCE CLEARINGHOUSE
9 Section 801. Definitions.
10 The following words and phrases when used in this chapter
11 shall have the meanings given to them in this section unless the
12 context clearly indicates otherwise:
13 "Clearinghouse." The Pharmaceutical Assistance Clearinghouse
14 established in section 802.
15 "Department." The Department of Aging of the Commonwealth.
16 "Patient assistance program." A program offered by a
17 pharmaceutical manufacturer under which the manufacturer
18 provides prescription medications at no charge or at a
19 substantially reduced cost. The term does not include the
20 provision of a drug as part of a clinical trial.
21 "Voluntary health organization." An organization whose main
22 purpose is to educate the public on the symptoms, treatments and
23 research of a disease and that may provide support for persons
24 who have the disease.
25 Section 802. Pharmaceutical Assistance Clearinghouse.
26 (a) Establishment.--Within 120 days of the effective date of
27 this chapter, the department shall establish the Pharmaceutical
28 Assistance Clearinghouse. Each pharmaceutical manufacturer that
29 does business in this Commonwealth and offers a patient
30 assistance program shall inform the department of all of the
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1 following:
2 (1) The existence of the patient assistance program.
3 (2) The eligibility requirements for the patient
4 assistance program.
5 (3) The drugs covered by the patient assistance program.
6 (4) Information, such as a telephone number, which may
7 be used to apply for a patient assistance program.
8 (b) Information.--The clearinghouse shall maintain the
9 information submitted by pharmaceutical manufacturers and any
10 appropriate voluntary health organization that would like to
11 participate and make it available to the public.
12 (c) Staff.--The department shall ensure that the
13 clearinghouse is staffed at least during normal business hours.
14 Section 803. Toll-free telephone number.
15 The department shall establish a toll-free telephone number
16 through which members of the public may obtain information from
17 the clearinghouse about available patient assistance programs.
18 Section 804. Assistance available.
19 (a) Direct.--
20 (1) The clearinghouse shall assist without charge an
21 individual in determining whether a patient assistance
22 program is offered for a particular drug and whether the
23 individual may be eligible to obtain the drug through a
24 patient assistance program.
25 (2) The clearinghouse may assist without charge an
26 individual who wishes to apply for a patient assistance
27 program by assisting with the preparation of an application
28 and coordinating communications between the individual's
29 physician or certified registered nurse practitioner and a
30 pharmaceutical manufacturer on behalf of the individual for
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1 the purpose of obtaining approval to participate in the
2 patient assistance program.
3 (b) Referrals.--The clearinghouse shall make referrals to an
4 appropriate voluntary health organization or any publicly funded
5 program for which it deems a patient eligible.
6 Section 805. Reporting.
7 The department shall report annually to the Governor and the
8 General Assembly on the activities of the clearinghouse. The
9 report shall include:
10 (1) The number of individuals who have been assisted by
11 the clearinghouse under section 804(a)(1) and the number of
12 such individuals under section 804(a)(2).
13 (2) The number and benefits of patient assistance
14 programs listed with the clearinghouse.
15 (3) The number of patients referred to publicly funded
16 programs under section 804(b). Programs under this paragraph
17 include, but are not limited to, the Pharmaceutical
18 Assistance Contract for the Elderly Program, medical
19 assistance and programs of the Department of Veterans
20 Affairs.
21 (4) Other information deemed relevant by the department.
22 Section 806. Internet availability of information.
23 The department shall maintain and provide to the public the
24 information under this chapter on its World Wide Web site. The
25 department shall also provide to appropriate organizations the
26 information necessary for the organizations to establish a link
27 to the location of clearinghouse information on the department's
28 World Wide Web site.
29 Section 11. Section 2102(a) of the act, added November 21,
30 1996 (P.L.741, No.134), is amended to read:
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1 Section 2102. Annual report to General Assembly.
2 (a) Submission of report.--The department shall submit a
3 report no later than April 1 of each year to the chairman and
4 minority chairman of the Aging and Youth Committee of the
5 Senate, the chairman and minority chairman of the Aging and
6 [Youth] Older Adult Services Committee of the House of
7 Representatives and the Pharmaceutical Assistance Review Board.
8 * * *
9 Section 12. The act is amended by adding a section to read:
10 Section 2103. Federal programs.
11 If the Federal Government enacts programs similar to PACE or
12 PACENET, the State programs shall be construed to only
13 supplement the Federal programs and all persons qualified for
14 coverage under the Federal program shall utilize that Federal
15 program before utilizing any State program.
16 Section 13. Funding, to the extent authorized by section
17 306(b)(vii) of the act of June 26, 2001 (P.L.755, No.77), known
18 as the Tobacco Settlement Act, shall continue to be appropriated
19 from the Tobacco Settlement Fund to the Pharmaceutical
20 Assistance Contract for the Elderly Fund to support the program
21 expansions contained in this act.
22 Section 14. The Department of Aging may use a PACE or
23 PACENET program applicant's most recent annual income
24 information to determine program eligibility until April 1,
25 2004.
26 Section 15. The amendment of section 704(c)(1) of the act
27 shall apply retroactively to January 1, 2003.
28 Section 16. This act shall take effect as follows:
29 (1) The following provisions shall take effect January
30 1, 2004:
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1 (i) The amendment or addition of the definitions of
2 "CMS," "HFCA" and "maximum annual income" in section 502
3 of the act.
4 (ii) The amendment of section 519 of the act.
5 (2) The addition of section 509(8) of the act shall take
6 effect January 1, 2005.
7 (3) The remainder of this act shall take effect
8 immediately.
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